chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Eye movement disorder, Eyelid function disorder
Clinical narrative: nerve related/made it hard for her to shut one of her eye; had a reaction; This case was reported by a other health professional via call center representative and described the occurrence of eye movement disorder in a 52-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, unknown after receiving Shingrix, the patient experienced eye movement disorder and adverse event. On an unknown date, the outcome of the eye movement disorder and adverse event were unknown.   It was unknown if the reporter considered the eye movement disorder and adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a reaction and nerve related made it hard for her to shut one of her eyes. The patient said its time for the second vaccine and at the time of reporting was wondering how effective it was if she did not get the second vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Flank pain, Vaccine positive rechallenge
Clinical narrative: Pain in hips; pain in kidney area; Pain in hips; pain in upper kidney area; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (on and off since the age of 18 years).   In November 2018, the patient received the 1st dose of Shingrix. In February 2019, the patient received the 2nd dose of Shingrix. In September 2019, not applicable after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced pain in hip and flank pain. On an unknown date, the patient experienced pain in hip and flank pain. The patient was treated with gabapentin (Neurontin (Gabapentin)) and pregabalin (Lyrica). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in hip and flank pain were recovered/resolved and the outcome of the pain in hip and flank pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in hip and flank pain to be related to Shingrix. It was unknown if the reporter considered the pain in hip and flank pain to be related to Shingrix.  Additional details were provided as follows: The patient had shingles on and off since the age of 18 and had been on pain medications in the past such as Neurontin and Lyrica.  She states that the Neurontin did not help her and the Lyrica helped her but put her in a deep sleep. The patient states that she went to her pharmacy to asked about having another booster and she was told to call and that she could not get another dose. She states that she had terrible pain previously that went away when she had the 1st dose of Shingrix. Two and half months before the date of reporting, pain returned. She states that the pain was in her hips and upper kidney area. The patient asked if had any information regarding Marijuana for pain.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Vaccine Administered at Inappropriate Site; Swelling; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose, refer case US2019AMR235181).   On 18th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced swelling arm and pain. On 18th December 2019, the patient experienced vaccine administered at inappropriate site. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm, pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the swelling arm and pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and the vaccine was administered at a site not the deltoid, which led to vaccine administered at inappropriate site. She believes it was somewhere between the recommended site and the bicep.  Swelling developed in the arm and she believed that the vaccine leaked into the soft tissue.  The reporter consented to follow up. No additional data given.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site swelling, Night sweats, Pain
Clinical narrative: redness; pain; headache; fever; night sweats; swellling; This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unspecified day and had no side effects after that).   On 20th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced fever, night sweat and injection site swelling. On 20th December 2019, the patient experienced headache. On an unknown date, the patient experienced erythema and pain. On an unknown date, the outcome of the headache, fever and night sweat were resolved with sequelae and the outcome of the injection site swelling, erythema and pain were recovering/resolving.   It was unknown if the reporter considered the headache, fever, night sweat, injection site swelling, erythema and pain to be related to Shingrix.  Additional details were provided as follows:  On 20th December 2019, less than a day after receiving Shingrix the patient experienced headache. The patient had swelling at injection site of about 4 inches in diameter. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: redness; pain; headache; fever; night sweats; swellling; This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unspecified day and had no side effects after that).   On 20th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced fever, night sweat and injection site swelling. On 20th December 2019, the patient experienced headache. On an unknown date, the patient experienced erythema and pain. On an unknown date, the outcome of the headache, fever and night sweat were resolved with sequelae and the outcome of the injection site swelling, erythema and pain were recovering/resolving.   It was unknown if the reporter considered the headache, fever, night sweat, injection site swelling, erythema and pain to be related to Shingrix.  Additional details were provided as follows:  On 20th December 2019, less than a day after receiving Shingrix the patient experienced headache. The patient had swelling at injection site of about 4 inches in diameter. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Rash macular
Clinical narrative: Red Blotch; Arm Pain/ on the outer arm above the elbow crease; Decreased Mobility of Arm; This case was reported by a consumer via call center representative and described the occurrence of red blotches in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, 1 day after receiving Shingrix, the patient experienced red blotches, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the red blotches was recovered/resolved and the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the red blotches, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient had no previous history with trouble in left arm. The patient received Shingrix dose in left arm sometime in August 2019. The next day, she developed a big red blotch approximately 3 inches below shoulder that was approximately 3 inches wide and 4 inches long. The patient was unsure when red blotch resolved but sated, it took a while for it to go away. She also reported, pain and decreased mobility in her left arm since receiving Shingrix even after icing. She described arm pain as it was on the outer arm above elbow crease and when in bed, she was not able to turn on arm because of pain when placing arm under pillow and had difficulty raising arm above head due to this. The patient consented to follow up ad provided her physician's address.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Dizziness, Feeding disorder, Nausea
Clinical narrative: Could not eat; NAUSEA; DIZZINESS; CHILLS/ shaking; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix. On 13th September 2019, less than a day after receiving Shingrix, the patient experienced nausea, dizziness, chills and unable to eat. On an unknown date, the outcome of the nausea, dizziness and chills were resolved with sequelae and the outcome of the unable to eat was unknown.   It was unknown if the reporter considered the nausea, dizziness, chills and unable to eat to be related to Shingrix.  Additional details were provided as follows: The patient's husband reported the case. The patient received Shingrix in her left arm. In the same afternoon, the patient presented several adverse reactions like nausea, dizziness and shaking. The patient could not eat due to the nausea. The patient was bed ridden with the symptoms for 2 days and events were lasted for 2 to 3 days. The reporter consented to follow up. This case was found to be duplicate of US2020000432. The case US2020000432 will be voided and all the future correspondence will be added in the present case which stands as a case of record for this patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Could not eat; NAUSEA; DIZZINESS; CHILLS/ shaking; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix. On 13th September 2019, less than a day after receiving Shingrix, the patient experienced nausea, dizziness, chills and unable to eat. On an unknown date, the outcome of the nausea, dizziness and chills were resolved with sequelae and the outcome of the unable to eat was unknown.   It was unknown if the reporter considered the nausea, dizziness, chills and unable to eat to be related to Shingrix.  Additional details were provided as follows: The patient's husband reported the case. The patient received Shingrix in her left arm. In the same afternoon, the patient presented several adverse reactions like nausea, dizziness and shaking. The patient could not eat due to the nausea. The patient was bed ridden with the symptoms for 2 days and events were lasted for 2 to 3 days. The reporter consented to follow up. This case was found to be duplicate of US2020000432. The case US2020000432 will be voided and all the future correspondence will be added in the present case which stands as a case of record for this patient.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood creatine phosphokinase increased, Gait inability, Laboratory test, Renal function test
Clinical narrative: PER ED Provider notes: Patient is an 85-year old male who presents to the emergency department. States that he has had increased weakness throughout the week. He lowered himself to the ground today and has been crawling around his apartment on his hands and knees. He states that he got the 2 shot series it sounds like on Thursday. He got the 2nd part of the shingrix vaccine for shingles. He said after that he felt great. He went to the gym and did a vigorous workout. He denies any chest pain. No shortness of breath. No syncope. No presyncopal symptoms. Has had no recent fevers , chills. No nausea, vomiting, or diarrhea. Denies any coughs or colds. He has tried nothing for this prior to arrival to the emergency room and denies any other concerns or complaints today.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Canalith repositioning procedure, Computerised tomogram, Deafness unilateral, Electroencephalogram
Clinical narrative: Woke up with L ear completely deaf
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging
Clinical narrative: Woke up with L ear completely deaf
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Blood test, Borrelia test, Computerised tomogram, Deafness unilateral
Clinical narrative: Woke up with L ear completely deaf
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysstasia, Electroencephalogram, Gait inability, Impaired driving ability
Clinical narrative: Woke up with L ear completely deaf
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Legionella test, Loss of personal independence in daily activities, Magnetic resonance imaging, Vertigo
Clinical narrative: Woke up with L ear completely deaf
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Screaming
Clinical narrative: Pt mom came in stated after her previous pediatricians office had administered his 2 month immunizations, patient was screaming, crying inconsolable for 3 hours straight. (Information in regards to the immz, taken from the state immunization website.)
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac pacemaker insertion, Injection site pain, Pain, Pyrexia, Soft tissue infection
Clinical narrative: I had a lot of pain initially at the site, which subsided after a few days. A week later, the pain returned-- much worse than at first. I started running a fever, and I pain shooting up and down my arm. The doctor diagnosed me with a soft tissue infection and gave me an antibiotic.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: Parents noticed rash at 5:00pm when they undressed her.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Injection site nodule
Clinical narrative: Evening of vaccine = mild headache like a sinus headache. Took no action. From hour of sleep to next morning, approximately 8 hours, experienced continuous shaking like the chills with muscle aches, like the flu. The shaking was the most concerning event. Got up several times during the night. Became so weak that by morning could not trust myself to safely stand and walk. Took 2 ibuprofen, rested, and eventually was able to get up. Continued to recover although felt weak all day on 1/4/2020. On 1/5/2020 noticed a red streak on my arm running from approximate location of injection site around lateral aspect of arm into axilla. This band is tender to touch and slightly itchy if touched. It appears to be resolving. It's about 2 cm wide. There is what feels like a small knot on the band as it nears the axilla. Standing in the anatomical position this band runs along the poster aspect of my upper arm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site streaking, Myalgia, Sinus headache
Clinical narrative: Evening of vaccine = mild headache like a sinus headache. Took no action. From hour of sleep to next morning, approximately 8 hours, experienced continuous shaking like the chills with muscle aches, like the flu. The shaking was the most concerning event. Got up several times during the night. Became so weak that by morning could not trust myself to safely stand and walk. Took 2 ibuprofen, rested, and eventually was able to get up. Continued to recover although felt weak all day on 1/4/2020. On 1/5/2020 noticed a red streak on my arm running from approximate location of injection site around lateral aspect of arm into axilla. This band is tender to touch and slightly itchy if touched. It appears to be resolving. It's about 2 cm wide. There is what feels like a small knot on the band as it nears the axilla. Standing in the anatomical position this band runs along the poster aspect of my upper arm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Evening of vaccine = mild headache like a sinus headache. Took no action. From hour of sleep to next morning, approximately 8 hours, experienced continuous shaking like the chills with muscle aches, like the flu. The shaking was the most concerning event. Got up several times during the night. Became so weak that by morning could not trust myself to safely stand and walk. Took 2 ibuprofen, rested, and eventually was able to get up. Continued to recover although felt weak all day on 1/4/2020. On 1/5/2020 noticed a red streak on my arm running from approximate location of injection site around lateral aspect of arm into axilla. This band is tender to touch and slightly itchy if touched. It appears to be resolving. It's about 2 cm wide. There is what feels like a small knot on the band as it nears the axilla. Standing in the anatomical position this band runs along the poster aspect of my upper arm
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Ongoing arm pain after injection. Pain shooting up into neck area and down arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Pain, Pyrexia
Clinical narrative: Fever (to 100.6 degrees, treated with naproxen sodium, 1 dose 200 mg 4 a.m.; to 100 degrees 16 hours later, again treated with 1 dose 200 mg naproxen sodium); aches, weakness and fatigue; splotchy redness and heat near vaccination site persisting past 48 hours; ~40 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Skin warm
Clinical narrative: Fever (to 100.6 degrees, treated with naproxen sodium, 1 dose 200 mg 4 a.m.; to 100 degrees 16 hours later, again treated with 1 dose 200 mg naproxen sodium); aches, weakness and fatigue; splotchy redness and heat near vaccination site persisting past 48 hours; ~40 hours.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphonia, Headache
Clinical narrative: In the middle of the night 12/19/19 approx 1:00am  (approx 16hrs after the flu shot, I moved from the couch - 18inches high - to bed  -29inches high, after walking room to room for a minute eg using the bathroom, turning off lights; After getting up on the bed, I leaned on my left hip to lie down and as I went to put my head on the pillow it felt like the bed and room were moving.  I had a sensation of falling.  This passed once I settled in bed.      The same thing happened going to bed that night Thurs 12/19/19.   12/20/19 I had the sensation while turning over.  For one week from Weds 12/18/19 I had a vague sensation it was starting a few times so I moved slowly when transitioning/turning over.   I had no trouble walking, driving, shopping,  shovelling snow.   I did not faint.  I also woke up with a headache -  I believe it was Sat 12/21/19  This is not uncommon but also not a regular thing.  I took 1000mg Tylenol and it resolved in a few hours.  My throat/voice were raspy as if I were coming down with a cold for a day and this passed.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse symptoms were reported.; a dose of GARDASIL 9 was administered to a 2-month-old patient; This spontaneous report was received from a medical assistant and refers to a 10-week-old (reported as 2-month-old) patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-DEC-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose and route of administration were not reported) (lot# reported as BR1621929, confirmed to be not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiry date reported as 06-DEC-2021) for prophylaxis. No additional adverse symptoms were reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse symptoms were reported; a patient received a dose of properly stored PROQUAD after its labeled expiration date; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, concomitant medication, drug allergy/reaction was not reported.  On 03-JAN-2020, the patient was vaccinated with a properly stored, expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status:recombinant Human albumin (rHA), lot # R015746, expiration date:02-DEC-2019 (strength, dose number, route, anatomical location was not reported) for prophylaxis (expired product administered). Other suspect therapies included sterile diluent (strength, dose, dose number, route, anatomical location, lot/batch #, expiration date was not reported). No additional adverse events were reported. No product quality complaint was involved.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Muscular weakness, Neuropathy peripheral, Paraesthesia
Clinical narrative: The patient had leg weakness and tingling/Neuropathy in the legs; This is a spontaneous case, initially received from physician via Med Communications (reference number: SEQ19-07658) on 31-Dec-2019, concerning a 70-year-old male patient.   The patient's medical history included hypertension, pre-diabetes, hyperlipidaemia and upper respiratory infection.   The patient's past vaccine included two Shingrix vaccines (recombinant varicella zoster virus) received on 16-May-2019 and 18-Jul-2019. The patient's concomitant medication included Aspirin (acetylsalicylic acid), losartan, Lipitor (atorvastatin calcium), vitamin D and prednisolone for an unknown indication and Bactrim (sulfamethoxazole, trimethoprim) for upper respiratory infection.   On 21-Oct-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number and expiration date: not reported] for prevention of seasonal influenza.  On an unspecified date in 2019, seven to ten days after vaccination, the patient had leg weakness and tingling. The patient visited neurologist and medical doctor (MD) reported that the patient developed neuropathy in the legs. It was reported that the patient had not been hospitalized.   At the time of this report, the outcome of the event neuropathy in the legs was not reported.  The case was assessed as serious due to the criterion of medical significance.  The reported did not provide causality assessment.  Company comment: The patient experienced neuropathy peripheral associated with Fluad (TIV). Chronology needs more clarification. The patient's medical history included hypertension, pre-diabetes, hyperlipidaemia and upper respiratory infection. Also, advanced age of the patient might have contributed in developing reported event along with reported concomitant drugs. Causality is assessed as unlikely related.; Sender's Comments: The patient experienced neuropathy peripheral associated with Fluad (TIV). Chronology needs more clarification. The patient's medical history included hypertension, pre-diabetes, hyperlipidaemia and upper respiratory infection. Also, advanced age of the patient might have contributed in developing reported event along with reported concomitant drugs. Causality is assessed as unlikely related.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Biopsy artery, Fatigue, Headache, Influenza like illness
Clinical narrative: Approximately one month after receiving injection, started feeling fatigue.  At approximately two months after, had flu like symptoms which led to severe headaches and pain in neck, temple and jaw and vision problems.  My jaw then became too painful to open and close.    Was subsequently diagnosed with Giant Cell Arteritis for which I am currently and continually receiving treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Magnetic resonance imaging, Pain in jaw, Temporal arteritis, Visual impairment
Clinical narrative: Approximately one month after receiving injection, started feeling fatigue.  At approximately two months after, had flu like symptoms which led to severe headaches and pain in neck, temple and jaw and vision problems.  My jaw then became too painful to open and close.    Was subsequently diagnosed with Giant Cell Arteritis for which I am currently and continually receiving treatment.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests normal, Blood test, Dizziness, Influenza like illness, Lymphadenopathy
Clinical narrative: Strong flu-like symptoms for 48 hours after vaccination.  Neck discomfort began perhaps 1 month after vaccination .. eventually realizing there were one or more swollen lymph nodes.  This was accompanying by varying degrees of vertigo.    This has come and gone since the vaccination.  I have sought medical assistance though I have not been diagnosed with anything more than "swollen lymph node".   My medical "treatment" has included blood work in october and december, ultrasund of neck soft tissue and carotid arteries.  Xray of cervical spine.    These test as referred by my primary care physicial.   I have also seen an ENT specialist who believes the lymph node is resolving, but wishes to do additonal balance testing  in regards to the vertigo/dizziness I have experienced.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal discomfort, Spinal X-ray, Ultrasound Doppler, Ultrasound scan, Vertigo
Clinical narrative: Strong flu-like symptoms for 48 hours after vaccination.  Neck discomfort began perhaps 1 month after vaccination .. eventually realizing there were one or more swollen lymph nodes.  This was accompanying by varying degrees of vertigo.    This has come and gone since the vaccination.  I have sought medical assistance though I have not been diagnosed with anything more than "swollen lymph node".   My medical "treatment" has included blood work in october and december, ultrasund of neck soft tissue and carotid arteries.  Xray of cervical spine.    These test as referred by my primary care physicial.   I have also seen an ENT specialist who believes the lymph node is resolving, but wishes to do additonal balance testing  in regards to the vertigo/dizziness I have experienced.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Feeling hot, Nausea, Vomiting
Clinical narrative: Employee stated after 20 minutes when she received 3rd HEP - b shot, she felt nauseous and hot. Later she stated that she vomited twice. Clinic was contacted condition of employee was related to person on line. That person talked with employee, asked questions  employee stated that now she was having chest discomfort. Clinic advised that 911 should be called or someone transport her to the ER. 911 was called, Fire Department responded and employee to the ER. Unknown of the treatment employee received.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Joint effusion, Musculoskeletal discomfort, Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: Patient states that the vaccination was giving into the shoulder joint. It was causing him excessive pain and discomfort so he went to his physician. He was diagnosed with fluid in the shoulder joint. The physician recommended physical therapy which he is currently going through to treat the bursitis.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Chills, Diarrhoea, Fatigue
Clinical narrative: consistent fatigue, abdominal pain, diarrhea, muscle aches, chills, gas/bloating.  Currently on Day 3 of reactions and seems to be subsiding.  Took over the counter anti-gas, anti diarrhea and stomach remedies.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Flatulence, Myalgia
Clinical narrative: consistent fatigue, abdominal pain, diarrhea, muscle aches, chills, gas/bloating.  Currently on Day 3 of reactions and seems to be subsiding.  Took over the counter anti-gas, anti diarrhea and stomach remedies.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Computerised tomogram abdomen normal, Fatigue, Full blood count normal
Clinical narrative: Flu-like symptoms day after first injection (12/8/19)---extreme muscle ache, fatigue, headache. On 6th day post-injection (12/13/19), upper right quadrant abdominal pain continuing thru 8th day (12/15/19) when I went to Hospital emergency room. I had abdominal pain and increasing, spreading right-sided only numbness in entire body from right ankle all the way upward to right ear. Abdominal pain had lasted for 3 days to that point and the numbness began mid-morning on the 8th day and became worse & more widespread by late afternoon.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Hypoaesthesia, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms day after first injection (12/8/19)---extreme muscle ache, fatigue, headache. On 6th day post-injection (12/13/19), upper right quadrant abdominal pain continuing thru 8th day (12/15/19) when I went to Hospital emergency room. I had abdominal pain and increasing, spreading right-sided only numbness in entire body from right ankle all the way upward to right ear. Abdominal pain had lasted for 3 days to that point and the numbness began mid-morning on the 8th day and became worse & more widespread by late afternoon.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound abdomen normal
Clinical narrative: Flu-like symptoms day after first injection (12/8/19)---extreme muscle ache, fatigue, headache. On 6th day post-injection (12/13/19), upper right quadrant abdominal pain continuing thru 8th day (12/15/19) when I went to Hospital emergency room. I had abdominal pain and increasing, spreading right-sided only numbness in entire body from right ankle all the way upward to right ear. Abdominal pain had lasted for 3 days to that point and the numbness began mid-morning on the 8th day and became worse & more widespread by late afternoon.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: pain in arm persiting
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Patient states that she has ringing in the ears that started about a day after receiving her first dose of Shingrix.  She stated that she never experienced any episode of tinnitus before.  She denies being sick or receiving any other vaccinations at the same time.  She did not experience any issues prior to leaving the pharmacy.  She saw her primary doctor, who advised her to still receive the second dose of the vaccine and advised seeing an ENT.  She said she saw an ENT but could not recall his name.  She received the second dose of Shingrix on 09/29/2019.  She noted that on the VIS under section it notes that ringing in the ears is possible.  I explained it was in relation to signs and symptoms of fainting as a result of vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Pain in extremity, Rash, Rash erythematous, Rash papular
Clinical narrative: Right arm started hurting after injection 1/2/20 and developed red raised rash on the same arm immediately. similar rash appeared left side of face 2 days later.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Blood pressure increased, Dyspnoea, Feeling cold, Injection site pain, Laboratory test normal
Clinical narrative: Approximately 2 hours after receiving vaccine client reported extreme pain at injection site, extreme thirst, shaking, freezing, slight breathing difficulty (no oxygen was needed in ER), Heart Rate over 140 at increased blood pressure.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Thirst, Tremor
Clinical narrative: Approximately 2 hours after receiving vaccine client reported extreme pain at injection site, extreme thirst, shaking, freezing, slight breathing difficulty (no oxygen was needed in ER), Heart Rate over 140 at increased blood pressure.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Shot administered upper Left arm. Soreness in bicep area started with reddening of skin. I worried I was getting a Cellulitis. Treated topically with Neosporin until I got MD appt. By Wednesday morning area subsided. Area was as big as my Right hand covering my arm to inner aspect about 4 inches from injection site.
Age: 42.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site pain, Musculoskeletal pain, Nausea, Neck pain, Pruritus
Clinical narrative: Reaction from TDaP - Friday received shot and then Sunday noted rash and hives on neck, and then spread to arms and chest, itching and area of TDaP is burning and sore and per Pt had shoulder and neck pain, and nauseated yesterday. -Took BENADRYL last night and ZYRTEC, and not helping much. No SOB or oral lip or tongue swelling no trouble swallowing
Age: 42.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Reaction from TDaP - Friday received shot and then Sunday noted rash and hives on neck, and then spread to arms and chest, itching and area of TDaP is burning and sore and per Pt had shoulder and neck pain, and nauseated yesterday. -Took BENADRYL last night and ZYRTEC, and not helping much. No SOB or oral lip or tongue swelling no trouble swallowing
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Groin pain, Insomnia, Limb discomfort, Muscle spasms, Muscular weakness
Clinical narrative: The morning after shot I awoke to excruciating cramps in both calves (never experienced before) both calves very sore to touch after cramps closed, muscle pain proceeded up my legs to thighs (front and back) much like pain from excessive exercise, then to my buttocks. I now have extreme pain in my right leg with some pain in my left. I'm very active (or was) and am now having pain to use a cane due to muscle weakness, particularly in my right leg. My cardiologist retired the end of Nov. My P.C.P is not of the country. I'm in the midst of arranging for new doctors. I've been keeping pain at bay (through trial and error) with prednisone, hydrocodone, gabapentin and naproxen sodium. None of which can be good for my long range health care. Sleeping is difficult due to pain and there is a feelin of heaviness in my legs. I fear (my greatest fear) is that this condition is here to stay. I would much rather have the flu (which can be diagnosed) than go through these last few weeks. I failed to mention that the pain is exreme in my right groin area and if I do walk or try to do chores the pain is unmanageable even with the above mentioned meds. P.S. couldn't the gov. afford little more legible form?
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Myalgia, Pain, Pain in extremity, Walking aid user
Clinical narrative: The morning after shot I awoke to excruciating cramps in both calves (never experienced before) both calves very sore to touch after cramps closed, muscle pain proceeded up my legs to thighs (front and back) much like pain from excessive exercise, then to my buttocks. I now have extreme pain in my right leg with some pain in my left. I'm very active (or was) and am now having pain to use a cane due to muscle weakness, particularly in my right leg. My cardiologist retired the end of Nov. My P.C.P is not of the country. I'm in the midst of arranging for new doctors. I've been keeping pain at bay (through trial and error) with prednisone, hydrocodone, gabapentin and naproxen sodium. None of which can be good for my long range health care. Sleeping is difficult due to pain and there is a feelin of heaviness in my legs. I fear (my greatest fear) is that this condition is here to stay. I would much rather have the flu (which can be diagnosed) than go through these last few weeks. I failed to mention that the pain is exreme in my right groin area and if I do walk or try to do chores the pain is unmanageable even with the above mentioned meds. P.S. couldn't the gov. afford little more legible form?
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: SEVERE MUSCLE ACHES - LEGS, ALL OVER. SEVERE CHILLS HEADACHE FATIGUE ... FOR 2 FULL DAYS FOLLOWING SHOT
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Vomiting
Clinical narrative: Vomiting before & after Immunizations.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No additional AE information; improperly stored VARIVAX was administrated to a patient; This spontaneous report has been received from a medical assistant referring to a 12 months old male patient. Information about the patient's past drug and medical history, as well as concurrent conditions and allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneously, lot number S024366, expiration date on 06-AUG-2021 (concentration, dose number, and anatomical location were not reported), for prophylaxis, that had been improperly stored in a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (14.1 Fahrenheit degrees) for 30 minutes, and 15 Fahrenheit degrees to 46 Fahrenheit degrees (26.6 Fahrenheit degrees) for 4 hours and 18 minutes; varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with sterile diluent (lot number and expiration date were not reported). No symptoms and no additional adverse events were reported. There was not previous temperature excursion and the temperature was recorded by a data logger.  The outcome of the event was unknown.
Sex: M
Vaccine: MMR
Symptoms: Cough, Respiratory tract infection
Clinical narrative: after getting the "first round of M-M-R II vaccine required by his school," she noticed post vaccination that her son developed a "respiratory tract infection"; The patient developed "persistent cough."; This spontaneous report has been received from a consumer, who was the patient's mother, referring to a male patient of unknown age. Information about the patient's pertinent medical history included a pre-existing condition such as sleep apnea. His concomitant medication and previous drug reactions or allergies were not provided by the reporter.  On an unspecified date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) required by his school for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided by the reporter).  Subsequently, the reporter noticed that the patient developed a respiratory tract infection and a persistent cough.  It was unknown if any treatment was given for the events, if any laboratory diagnostics/studies were performed or if the patient sought medical attention.  At the time of reporting, the outcome of the aforementioned events was not provided.  The causality assessment between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the reported events was not provided.  Upon internal review, respiratory tract infection was determined to be a medically significant event.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA000655:
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Specialist consultation, Thermal burn
Clinical narrative: Burn 2 inch diameter. went to wound specialist. going back and forth to rexamine and treat
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Diabetic ketoacidosis, Food intolerance, Irritability, Near death experience, Speech disorder developmental
Clinical narrative: Following vaccines on 6/16/2017 patient began throwing up his milk and wouldn't tolerate any solid foods. He began showing signs of speech delay, heavily wetting his diapers, irritabiltity and was misdiagnosed with GERD.   He began showing s/s of type 1 diabetes right after his vaccinations and was misdiagnosed until 9/10/2017 while in DKA.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Type 1 diabetes mellitus, Urine output increased, Vomiting
Clinical narrative: Following vaccines on 6/16/2017 patient began throwing up his milk and wouldn't tolerate any solid foods. He began showing signs of speech delay, heavily wetting his diapers, irritabiltity and was misdiagnosed with GERD.   He began showing s/s of type 1 diabetes right after his vaccinations and was misdiagnosed until 9/10/2017 while in DKA.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated her arm was very sore and she had difficulty moving it.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: I recieved the shot and it did not hurt but within 5 minutes I had itching and burning at the injection site. Later that evening I had the normal fever, swelling at the injection site that lasted 2 days. Now even months later I can still feel a knot/bump and i get shooting pains in my arm at the site.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: I recieved the shot and it did not hurt but within 5 minutes I had itching and burning at the injection site. Later that evening I had the normal fever, swelling at the injection site that lasted 2 days. Now even months later I can still feel a knot/bump and i get shooting pains in my arm at the site.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: No symptoms present, no treatment needed at time of report.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: When injecting needle, vaccine spilled out of syringe so patient did not receive dose.  I injected another full dose in the other arm.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Debridement, Escharotomy, Injection site bruising, Injection site cyst, Injection site erythema
Clinical narrative: Pneumonia shot given in the R upper arm 11/11 Slight swelling, severe pain, and fever 11/12 Bruise and cystitis  start 11/13 Cystitis becomes larger and blister forms  at site of bruise. Given Doxycyclene by  Dr. 11/14 Visit to ER, seen by Dr., given Keflex 11/15 Blister breaks, eschar becomes visible surrounded by red, infected tissue. Given  AMOXICILLIN-CLAV by Dr. 11/22 Seen by Doctor at Wound Care.  Examination confirms eschar diagnosis. No action taken. 11/25 Seen by Doctor at Wound Care.  Examination of eschar. No action taken. 12/02 Seen by Doctor at Wound Care.  Surgical removal of eschar and debridement of wound. 12/09 Seen by Doctor at Wound Care.  Debridement of wound. 12/16 Seen by Doctor at Wound Care.  Debridement of wound. 12/26 Seen by Doctor at Wound Care.  Debridement of wound. 12/31 Will continue to see Doctor at Wound Care until wound heals.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site infection, Injection site vesicles, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pneumonia shot given in the R upper arm 11/11 Slight swelling, severe pain, and fever 11/12 Bruise and cystitis  start 11/13 Cystitis becomes larger and blister forms  at site of bruise. Given Doxycyclene by  Dr. 11/14 Visit to ER, seen by Dr., given Keflex 11/15 Blister breaks, eschar becomes visible surrounded by red, infected tissue. Given  AMOXICILLIN-CLAV by Dr. 11/22 Seen by Doctor at Wound Care.  Examination confirms eschar diagnosis. No action taken. 11/25 Seen by Doctor at Wound Care.  Examination of eschar. No action taken. 12/02 Seen by Doctor at Wound Care.  Surgical removal of eschar and debridement of wound. 12/09 Seen by Doctor at Wound Care.  Debridement of wound. 12/16 Seen by Doctor at Wound Care.  Debridement of wound. 12/26 Seen by Doctor at Wound Care.  Debridement of wound. 12/31 Will continue to see Doctor at Wound Care until wound heals.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination site eschar
Clinical narrative: Pneumonia shot given in the R upper arm 11/11 Slight swelling, severe pain, and fever 11/12 Bruise and cystitis  start 11/13 Cystitis becomes larger and blister forms  at site of bruise. Given Doxycyclene by  Dr. 11/14 Visit to ER, seen by Dr., given Keflex 11/15 Blister breaks, eschar becomes visible surrounded by red, infected tissue. Given  AMOXICILLIN-CLAV by Dr. 11/22 Seen by Doctor at Wound Care.  Examination confirms eschar diagnosis. No action taken. 11/25 Seen by Doctor at Wound Care.  Examination of eschar. No action taken. 12/02 Seen by Doctor at Wound Care.  Surgical removal of eschar and debridement of wound. 12/09 Seen by Doctor at Wound Care.  Debridement of wound. 12/16 Seen by Doctor at Wound Care.  Debridement of wound. 12/26 Seen by Doctor at Wound Care.  Debridement of wound. 12/31 Will continue to see Doctor at Wound Care until wound heals.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Nasopharyngitis, Rash, Rash morbilliform
Clinical narrative: Eleven days after administration of vaccination, patient presented with measles-like rash all over body and cold symptoms
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Cardiac monitoring normal, Endocrine test normal, Full blood count normal, Headache
Clinical narrative: Shortly after receiving the flu vaccine on 12/30/19 she experienced seeing white spots and then feeling like she was going to pass out.  She experienced a frontal headache after.  Later on in the evening she verbalized passing out at the dinner table.  She developed an urticarial rash on her upper back on 12/31/19.  She had several episodes of syncope on 12/31, each lasting a few minutes 9am, 1:30pm and 3:30pm.  After those episodes she sought medical evaluation.  Unsure if these events were caused by influenza vaccination or was triggered by influenza vaccination but felt the need to report.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Loss of consciousness, Rash, Syncope, Thyroid function test normal
Clinical narrative: Shortly after receiving the flu vaccine on 12/30/19 she experienced seeing white spots and then feeling like she was going to pass out.  She experienced a frontal headache after.  Later on in the evening she verbalized passing out at the dinner table.  She developed an urticarial rash on her upper back on 12/31/19.  She had several episodes of syncope on 12/31, each lasting a few minutes 9am, 1:30pm and 3:30pm.  After those episodes she sought medical evaluation.  Unsure if these events were caused by influenza vaccination or was triggered by influenza vaccination but felt the need to report.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria, Visual impairment
Clinical narrative: Shortly after receiving the flu vaccine on 12/30/19 she experienced seeing white spots and then feeling like she was going to pass out.  She experienced a frontal headache after.  Later on in the evening she verbalized passing out at the dinner table.  She developed an urticarial rash on her upper back on 12/31/19.  She had several episodes of syncope on 12/31, each lasting a few minutes 9am, 1:30pm and 3:30pm.  After those episodes she sought medical evaluation.  Unsure if these events were caused by influenza vaccination or was triggered by influenza vaccination but felt the need to report.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Lip and cheek swelling