chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Loss of consciousness, Syncope, Tremor
Clinical narrative: Patient fainted, hit head upon falling to ground, regained consciousness within seconds. Elevated feet, blood pressure 112/62, HR 47, applied ice pack to head injury. Patient had history of fainting 3 times prior, never with vaccination. Recommended treatment to assess possible concussion, though wound looked superficial and did not bleed. Patient rested on floor for 5-10 minutes then sat up and drank water for 10 minutes. Patient stated he felt better, just shaky. We assisted him to standing and they exited the store. At 4:30pm Mom called pharmacy to report that she followed up w pediatrician who said to watch patient and keep icing head injury.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621931, expiration date: 26-JAN-2022 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Skin warm, Swelling
Clinical narrative: Area is really red; Area is swollen; Hot to touch; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced erythema, swelling and feeling hot. On an unknown date, the outcome of the erythema, swelling and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the erythema, swelling and feeling hot to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had received Shingrix shot two days before the reporting date, and the area was really red and swollen and hot to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rash.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: side effect; chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis.   On 14th October 2020, the patient received the 1st dose of SHINGRIX . In October 2020, less than a week after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced adverse event. On an unknown date, the outcome of the chills and adverse event were recovered/resolved.   It was unknown if the reporter considered the chills and adverse event to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received SHINGRIX and had Chills. The reporter asked how long did the side effects last.
Age: 0.42
Sex: F
Vaccine: RV1
Symptoms: Oral administration complication, Vomiting
Clinical narrative: 6 month old baby girl vomited; Possible underdose; This case was reported by a physician via call center representative and described the occurrence of vomiting in a 5-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3N4R7, expiry date 1st May 2022) for prophylaxis.   On 9th October 2020, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 9th October 2020, 1 hr after receiving Rotarix lyophilized formulation, the patient experienced vomiting. On an unknown date, the patient experienced underdose. On an unknown date, the outcome of the vomiting and underdose were unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation.  Additional details were reported as follows: The patient vomited, 1 hour after receiving 2nd dose of Rotarix.  The reporter asked did the dose needs to be repeated which led to possible underdose. The reporter consented to follow up. This case was considered as medication error with harm.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: group of kids" were administered the adult dose of Havrix; group of kids" were administered the adult dose of Havrix; This case was reported by a physician via call center representative and described the occurrence of overdose in a patient who received HAV (Havrix adult) (batch number S002507 ?, expiry date unknown), (batch number 94J24, expiry date unknown), (batch number G99R4, expiry date unknown) and (batch number J95H7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The physician reported that a group of kids were administered the adult dose of Havrix starting about a month ago to date, which led to overdose and inappropriate age at vaccine administration. There was no reports of symptomatic adverse event at the time of reporting. The reporter consented to follow up. The reporter provided Lot numbers but did not have expiration dates to provide for vaccines. The batch number of Havrix vaccine was reported as S002507. As per sales data, this number did not match with any Gsk lot. The batch number of Havrix vaccine was reported as 944J24, which was not available in sales datasheet, hence updated to 94J24.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Oral herpes, Pain in extremity
Clinical narrative: painful on her arm; painful / back and shoulders; painful / shoulders; cold sore; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, back pain, shoulder pain and cold sores. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the back pain, shoulder pain and cold sores were unknown.   It was unknown if the reporter considered the pain in arm, back pain, shoulder pain and cold sores to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced painful on her arm, back and shoulders and cold sore.  The reporter was in a hurry and did not provide much details. The reporter did not consent to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: itching on wrist; rash behind his left wrist; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2020, 2 days after receiving Shingrix, the patient experienced pruritus and rash. On an unknown date, the outcome of the pruritus and rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a rash behind his left wrist with itching which has not resolved. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rashes in passing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rashes. The reporter consented to follow up. The HCP did not had any additional information for these rashes and they might had been reported to GSK.  For tolerances of 2nd dose, refer case US2020AMR206766, reported by same reporter for same patient. This case linked with US2020205662, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020205662:same reporter US-GLAXOSMITHKLINE-US2020AMR206766:same patient (2nd dose)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: received dose 1 on an uspecified date and exerpienced body aches; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 69-year-old female patient who received Herpes zoster SHINGRIX for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced body aches.   For tolerances of 2nd dose, refer case US2020AMR206781, reporter by same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206781:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Nasal discomfort, Nasal oedema
Clinical narrative: nose swelling; nose/ tender to touch on both sided; This case was reported by a pharmacist via call center representative and described the occurrence of nasal edema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced nasal edema and nasal soreness. On an unknown date, the outcome of the nasal edema and nasal soreness were recovered/resolved.   It was unknown if the reporter considered the nasal edema and nasal soreness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced nose swelling and tender to touch on both sided.  The event already recovered and the adverse events lasted 3 weeks. The reporter consented to follow up. The reporter did not had patient or vaccine's details and mentioned that she did not had that information but agreed to follow up. No further information was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Nausea
Clinical narrative: Muscle Pain; Joint Pain; Malaise; Nausea; 10 days of weakness  after first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 1st dose of Shingrix. On 26th July 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, joint pain, malaise, nausea and chills. On an unknown date, the outcome of the muscle pain, joint pain, malaise, nausea and chills were recovered/resolved.   It was unknown if the reporter considered the muscle pain, joint pain, malaise, nausea and chills to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose in right arm. She described her side effects as muscle pain, joint pain, malaise, and nausea.  She had recovered but wanted to know if she should get the second injection and how long would the efficacy of the vaccine last.  The reporter wanted to know how long would the efficacy of the vaccine last. The reporter did not consent to follow up.
Sex: F
Vaccine: RAB
Symptoms: Discomfort, Pain, Pyrexia
Clinical narrative: Fever; Body ache; Heaviness; This case was reported by a physician via call center representative and described the occurrence of fever in a 26-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA181A, expiry date 30th September 2022) for prophylaxis.   On 1st October 2020, the patient received the 2nd dose of RabAvert. In October 2020, less than 3 weeks after receiving RabAvert, the patient experienced fever, general body pain and sensation of heaviness. On an unknown date, the outcome of the fever, general body pain and sensation of heaviness were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and sensation of heaviness to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 25 or 26 year. The reporter stated that the patient presented with fever, body ache and heaviness after administration of Rabavert. The reported batch number ARDA1818 was not available in sales datasheet, hence updated as ARBA181A. The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Body temperature increased, Condition aggravated, Influenza, Pain of skin
Clinical narrative: I had a violent reaction to my high-dose flu shot last thurs 3pm. By around 9pm, uncontrollable shaking, skin hurt, wherever I have arthritis became enflamed.  I started taking Advil but even with that I had temp of 101 but became normal the next day. The worst was that it triggered my pericarditis very badly - the worst in many, many years. So painful I had to sleep sitting up.  I have been treating with Advil and much, much better. Flu symptoms now gone.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Pericarditis, Tremor
Clinical narrative: I had a violent reaction to my high-dose flu shot last thurs 3pm. By around 9pm, uncontrollable shaking, skin hurt, wherever I have arthritis became enflamed.  I started taking Advil but even with that I had temp of 101 but became normal the next day. The worst was that it triggered my pericarditis very badly - the worst in many, many years. So painful I had to sleep sitting up.  I have been treating with Advil and much, much better. Flu symptoms now gone.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Dehydration, Impaired work ability, Injection site pain
Clinical narrative: The evening I received the seasonal Flu vaccine, I experienced the usual muscle aches and soreness at the injection site. Then around 10pm I started experiencing nausea which went from unpleasant to severe in minutes. Around 12am the nausea became so bad I vomited several times. This continued all night with me getting up every 45mins to an hour to vomit. As a result of not being able to keep fluids down, I became dehydrated and experienced chills and shaking. The nausea finally subsided around 10am but I still had to stay in bed all day because I was so weak and had to miss a day of work.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Nausea, Tremor, Vomiting
Clinical narrative: The evening I received the seasonal Flu vaccine, I experienced the usual muscle aches and soreness at the injection site. Then around 10pm I started experiencing nausea which went from unpleasant to severe in minutes. Around 12am the nausea became so bad I vomited several times. This continued all night with me getting up every 45mins to an hour to vomit. As a result of not being able to keep fluids down, I became dehydrated and experienced chills and shaking. The nausea finally subsided around 10am but I still had to stay in bed all day because I was so weak and had to miss a day of work.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Influenza like illness, Lymphadenopathy, Pain
Clinical narrative: Achy, flu-like symptoms, swollen lymph nodes, chills.  Spoke to physician on telephone.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: redness, swollen , and pain
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Scab, Skin wound
Clinical narrative: 24 hours after being vaccinated patient experienced intense itching all over scalp.  48 hours after vaccination she developed a small sore at the base of her hairline which scabbed over the following day.   She treated herself with diphenhydramine for 2 days until the itching resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: chills, headache, extreme tiredness, low grade fever - I felt like I had the flu
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site discolouration, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: I received my flu shot on 10/15/2020.  Afterwards the area became red, swollen and hot to the touch.   The next day, 10/16/2020, the redness and swelling had spread, it had also hardened into a knot and it was still hot to the touch.  By the evening of 10/16/2020 the area was continuing to grow in size.  I marked the outside edges with a sharpie marker to be able to determine how much it was increasing in size and also took some pictures.   The next morning, 10/17/2020, the area had only increased slightly in size and the redness had drastically decreased but was still hard and hot to the touch.   On 10/18/2020 the area wasn?t red but had more of a purple hue deep under the skin.  It was less swollen but still hard and it wasn?t as hot as it had been.  A few times throughout the day on 10/18/2020 I reached behind me for something or reached over my head into a cabinet.  Each time I would get what felt like a sharp muscle cramp that started at the injection site and shoot down the back and front side of my upper arm. On 10/19/2020 the area is still hard but less swollen, only slightly warm to the touch and is not discolored but it has a constant aching pain at the injection site.  When I dropped my daughter off at school I tried to reach behind me to pick up her lunch box from the back seat (something I can normally do with no issues) and had severe pain, starting at the injection site and going down the front and back of my upper arm.  I also had no strength and couldn?t pick up the lunchbox.  The remainder of the day movement in any direction caused increased pain starting from the injection site and going down the front and back of my upper arm.  I took ibuprofen, 600 mg, three times throughout the day on 10/18/2020.  Each time it helped for a few hours but then the pain would come back.    On 10/20/2020 there is a discolored area that is a faint brown color at the injection site.  There is still a constant aching pain at the injection site.  When I move my arm, I get a shooting pain down the front of my arm to the bend at the elbow and up the arm to my shoulder.  There is no longer any pain down the back of my arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Muscle spasms
Clinical narrative: I received my flu shot on 10/15/2020.  Afterwards the area became red, swollen and hot to the touch.   The next day, 10/16/2020, the redness and swelling had spread, it had also hardened into a knot and it was still hot to the touch.  By the evening of 10/16/2020 the area was continuing to grow in size.  I marked the outside edges with a sharpie marker to be able to determine how much it was increasing in size and also took some pictures.   The next morning, 10/17/2020, the area had only increased slightly in size and the redness had drastically decreased but was still hard and hot to the touch.   On 10/18/2020 the area wasn?t red but had more of a purple hue deep under the skin.  It was less swollen but still hard and it wasn?t as hot as it had been.  A few times throughout the day on 10/18/2020 I reached behind me for something or reached over my head into a cabinet.  Each time I would get what felt like a sharp muscle cramp that started at the injection site and shoot down the back and front side of my upper arm. On 10/19/2020 the area is still hard but less swollen, only slightly warm to the touch and is not discolored but it has a constant aching pain at the injection site.  When I dropped my daughter off at school I tried to reach behind me to pick up her lunch box from the back seat (something I can normally do with no issues) and had severe pain, starting at the injection site and going down the front and back of my upper arm.  I also had no strength and couldn?t pick up the lunchbox.  The remainder of the day movement in any direction caused increased pain starting from the injection site and going down the front and back of my upper arm.  I took ibuprofen, 600 mg, three times throughout the day on 10/18/2020.  Each time it helped for a few hours but then the pain would come back.    On 10/20/2020 there is a discolored area that is a faint brown color at the injection site.  There is still a constant aching pain at the injection site.  When I move my arm, I get a shooting pain down the front of my arm to the bend at the elbow and up the arm to my shoulder.  There is no longer any pain down the back of my arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: I received my flu shot on 10/15/2020.  Afterwards the area became red, swollen and hot to the touch.   The next day, 10/16/2020, the redness and swelling had spread, it had also hardened into a knot and it was still hot to the touch.  By the evening of 10/16/2020 the area was continuing to grow in size.  I marked the outside edges with a sharpie marker to be able to determine how much it was increasing in size and also took some pictures.   The next morning, 10/17/2020, the area had only increased slightly in size and the redness had drastically decreased but was still hard and hot to the touch.   On 10/18/2020 the area wasn?t red but had more of a purple hue deep under the skin.  It was less swollen but still hard and it wasn?t as hot as it had been.  A few times throughout the day on 10/18/2020 I reached behind me for something or reached over my head into a cabinet.  Each time I would get what felt like a sharp muscle cramp that started at the injection site and shoot down the back and front side of my upper arm. On 10/19/2020 the area is still hard but less swollen, only slightly warm to the touch and is not discolored but it has a constant aching pain at the injection site.  When I dropped my daughter off at school I tried to reach behind me to pick up her lunch box from the back seat (something I can normally do with no issues) and had severe pain, starting at the injection site and going down the front and back of my upper arm.  I also had no strength and couldn?t pick up the lunchbox.  The remainder of the day movement in any direction caused increased pain starting from the injection site and going down the front and back of my upper arm.  I took ibuprofen, 600 mg, three times throughout the day on 10/18/2020.  Each time it helped for a few hours but then the pain would come back.    On 10/20/2020 there is a discolored area that is a faint brown color at the injection site.  There is still a constant aching pain at the injection site.  When I move my arm, I get a shooting pain down the front of my arm to the bend at the elbow and up the arm to my shoulder.  There is no longer any pain down the back of my arm.
Age: 0.08
Sex: M
Vaccine: HEP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HIB, Prevnar 13 and RotaTeq given too early.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Erupted with multiple wheels/hives to deltoid region of Left arm.  Only placed DTaP/IPV on the arm. Redness & mild itching noted along with hives - 5 min after administration.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, diarrhea, body aches, fever as high as 102...used a digital ear thermometer and fever was only in left ear, same side of body where I had the shot.  Feeling better today, controlling symptoms with Tylenol.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Heart rate increased, Muscular weakness
Clinical narrative: Body Shakes like shivering, muscle weakness, rapid heartbeat
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Within 5 minutes after receiving the vaccine, patient fainted while shopping in the store. Patient gained consciousness immediately. He did mentioned that this is his first flu shot. Patient isn't diabetic.
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: patient reports arm pain and cannot raise arm above shoulder-height without pain
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Periarthritis
Clinical narrative: Patient experienced extreme pain at the injection site and has since been seen in urgent care where she was diagnosed with adhesive capsulitis of the left shoulder.  Patient is receiving physical therapy once a month to treat frozen shoulder.
Age: 84.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Pruritus, Swelling
Clinical narrative: redness swelling itching and cellulitis
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Aldolase, Antinuclear antibody, Blood creatine phosphokinase, C-reactive protein, Electromyogram
Clinical narrative: Guillain Barre Syndrome.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Guillain-Barre syndrome, Magnetic resonance imaging spinal, Metabolic function test, Nerve conduction studies
Clinical narrative: Guillain Barre Syndrome.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: Guillain Barre Syndrome.
Age: 36.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Throbbing headache followed by nausea and vomiting, started approximately 24 hours administration, symptoms experienced following day 2 of administration, headaches continue on day 3 thus far
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Head titubation, Headache
Clinical narrative: PATIENT'S HUSBAND CALLED AT 5:35 PM REPORTING THAT Patient HAD SEVERE CHILLS AND SHIVERING WITH HEAD BOBBING. I CALLED Patient AT 6:30PM TO SEE HOW SHE WAS FEELING. THE SHAKING HAD CEASED AT 6:15PM. SHE SAID SHE HAD A HEADACHE AND VERY FATIGUED. ADVISED PATIENT TO CALL 911 IF SYMPTOMS BECAME SEVERE. SHE WAS ABLE TO TALK LUCENTLY AND ARTICULATE HOW SHE FELT. ADVISED HER TO CALL US IF SHE HAD ANY OTHER FURTHER QUESTIONS OR CONCERNS. Another co-worker FOLLOWED UP WITH A CALL TO SEE HOW SHE WAS FEELING ON SATURDAY
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Headache, Pyrexia
Clinical narrative: Headache, chills, slight fever, short of breath (but that might be because I have moderate sleep apnea--not sure).
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth, Rash macular
Clinical narrative: patient stated she is still experiencing pain around the injection site....she showed me the area and it is very red and spotchy with bruising in multiple spots around the injection sight.  She also stated the area is warm to the touch
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: received vaccine and site tender and at 3pm worsened and radiated to leg in the evening. remained sore and became difficult to walk the next day in the afternoon and continues.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Conjunctivitis, Lymphadenopathy, Swelling face
Clinical narrative: Flu shot (unknown brand, standard dose) given at workplace clinic.  Next day developed lymphadenopathy, facial swelling, conjunctivitis
Age: 92.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient experienced extreme pain and weakness in lower extremities resulting in hospitalization. Issues were resolved following 3 days in hospital. No treatment was given per son during stay.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored MMRII was administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided. On 05-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, injection (lot # S022753, expiry date: 22-JUL-2021; dose, dose number, route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (dose, lot number, expiry date and route of administration were not provided). Administered dose of vaccine experienced the temperature excursion of 50.5 degrees Fahrenheit for 168 hours. There were no previous excursions related. Data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621931, expiration date: 26-JAN-2022 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: was administered his third dose of GARDASIL9 (unknown lot/expiration), which was 2 weeks after his second dose of GARDASIL 9; No additional adverse effects reported; This spontaneous report as received from a nurse and refers to a 21-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-MAR-2016, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The dose was administered 2 weeks after his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), therefore the patient experienced inappropriate schedule of product administration. No additional adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: rashes in passing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash (1st dose received on an unknown date, refer link case US2020205664).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient experienced rash in passing after receiving dose of Shingrix. Health care professional did not have any additional information about rash. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020205662:same reporter US-GLAXOSMITHKLINE-US2020205664:same patient (1st dose)
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: got really bad chills last night; couldn't stop shaking; This case was reported by a consumer and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2020, the patient received Shingrix. On 14th October 2020, less than a day after receiving Shingrix, the patient experienced chills and tremor. On an unknown date, the outcome of the chills and tremor were recovered/resolved.   It was unknown if the reporter considered the chills and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The patient received one dose of Shingrix and experienced really bad chills last night and shaking. The reporter stated that the patient couldn't stop shaking until I got in bed with a hot pad. The information regarding consent to follow up was not reported. No further information was reported.
Sex: F
Vaccine: FLUX
Symptoms: Death, Vaccination complication
Clinical narrative: death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 25-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient died due to a domino effect started by taking the flu shot. It was unknown if the reporter consented to follow up.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Scratch, Swelling
Clinical narrative: Swelling, difficulty to breath, scratchy. Immediately patientwas taken to emergency room, epinephrine shot.; Difficulty to breath; Scratchy; This case was reported by a physician via call center representative and described the occurrence of swelling in a 29-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2SM24, expiry date unknown) for prophylaxis.   Previously administered products included Fluarix (Last year,2019, this patient received Fluarix with any problem), Fluarix (received in November 2018) and Fluarix (received in December 2018).   On 10th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 10th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced swelling (serious criteria clinically significant/intervention required), difficulty breathing (serious criteria clinically significant/intervention required) and scratch (serious criteria clinically significant/intervention required). The patient was treated with epinephrine. On an unknown date, the outcome of the swelling, difficulty breathing and scratch were unknown.   It was unknown if the reporter considered the swelling, difficulty breathing and scratch to be related to FluLaval Tetra 2020-2021 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient avoid egg. The patient experienced swelling, difficulty to breath, scratchy. The patient immediately taken to emergency room, and epinephrine was given. This case has been link with US2020202326, US2020204781 and US2020AMR206612 reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202326:same reporter US-GLAXOSMITHKLINE-US2020204781:same reporter US-GLAXOSMITHKLINE-US2020AMR206612:same reporter, several patient case
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: was feeling tired; Body ache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a month after receiving Shingrix, the patient experienced tiredness and general body pain. On an unknown date, the outcome of the tiredness and general body pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received the 1st dose of Shingrix experienced tiredness and body ache which was recovered till the time of reporting. The reporter stated this reaction last for 2 days after the vaccination date. The batch number and expiration date were unknown. The reporter did not consented to follow up. This case was linked with case US2020206848 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206848:same reporter
Sex: M
Vaccine: MENB
Symptoms: Uveitis
Clinical narrative: the patient was diagnosed with uveitis; This is a spontaneous report from a non-contactable physician via Pfizer Sales Representative. A 16-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. Medical history none (a very healthy teenager). Concomitant medication included influenza vaccine on an unspecified date for immunisation. On an unspecified date, the patient was diagnosed with uveitis 29 days after the first dose of TRUMENBA with outcome of unknown. The influenza vaccine was given prior to uveitis diagnosis but he has never experienced an adverse event from the influenza vaccine in past years.  No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported event of uveitis due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including eye examination at baseline and during subject drug therapy and Head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: low fever; stabbing pain in joints; chills; aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 15Oct2020 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that later in the day 15Oct2020, the patient experienced low fever, stabbing pain in joints, chills, and aches. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained .
Sex: U
Vaccine: UNK
Symptoms: Malaise, Type 1 diabetes mellitus
Clinical narrative: Symptoms of type 1 diabetes; Sickest ever been; This spontaneous case was received on 12-Oct-2020 from other non-health professional via Novartis (reference number: NUS2019US228530) and concerned patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unknown date, ten days after receiving influenza virus vaccine polyvalent, the patient was sickest than ever been.  On an unknown date, another ten days after receiving influenza virus vaccine polyvalent symptoms of type 1 diabetes showed up immediately.  The outcome of the events was not reported.   The reporter did not provide a causality assessment.  The event of 'Type 1 diabetes mellitus' was considered to be medically significant by a Physician within Risk Management Department.  Company comment: A patient of an unknown age and gender was administered influenza virus vaccine polyvalent. The patient developed malaise, ten days after receiving vaccine. Another ten days after receiving influenza virus vaccine polyvalent symptoms of type 1 diabetes. The patient's medical history and concomitant medications were not reported. Causal role of suspect vaccine is assessed as not related for type 1 diabetes, due to biological implausibility. For the event malaise, causality is assessed as not related due to implausible chronology.; Sender's Comments: A patient of an unknown age and gender was administered influenza virus vaccine polyvalent. The patient developed malaise, ten days after receiving vaccine. Another ten days after receiving influenza virus vaccine polyvalent symptoms of type 1 diabetes. The patient's medical history and concomitant medications were not reported. Causal role of suspect vaccine is assessed as not related for type 1 diabetes, due to biological implausibility. For the event malaise, causality is assessed as not related due to implausible chronology.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: Pain in right arm
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Cough, Diarrhoea, Headache
Clinical narrative: Fever, headache, diarrhea, body aches, chills, confusion, cough
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever, headache, diarrhea, body aches, chills, confusion, cough
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: Patient received these vaccines in error. Nurse mixed up patients and gave wrong injection to patient. No adverse reaction.