chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site rash, Injection site swelling, Peripheral swelling, Rash
Clinical narrative: pt reports having a rash and swelling in her left arm below the injection sites starting one day after immunizations. Rash and swelling extended from just below injection sites in left deltoid around her upper arm and down past her elbow. pt reported that she was seen in the local ER where the provider instructed her to take Benadryl and ibuprofen. no further treatment was needed. no lasting side effects were reported. patient called this health department on 10/29/2019 to report adverse event.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Patient reported about 8 to 10 days after receiving the shingrix vaccination that she started to develop a really itchy rash on her back and that she and her husband both felt it looked like shingles.  Patient ended up going to the local Clinic and the provider there did diagnose the rash as Shingles.  Patient received a short course of antiviral drug valacyclovir.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: body aches, ha, fever, injection site very hot, swollen, painful, could not even get out of bed x 3 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: body aches, ha, fever, injection site very hot, swollen, painful, could not even get out of bed x 3 days.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Patient describes symptoms of chills, sweats, fever and body aches for 36 hours following  the vaccination. Pt took Advil OTC which alleviated symptoms. Pt is doing fine now.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reaction occurred. Patient received a pediatric dose instead of adult dose.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash papular, Urticaria
Clinical narrative: my chest broke out in hives that are big and small raise bumps that are itchy.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Malaise, Rash, Rash vesicular, Varicella
Clinical narrative: Patient reports "not feeling well" on 10/23/19; went to his PCP and was given Amoxicillin.  The next day 10/24/19 he reports the development of a rash.  Describes as bumps; was seen by the nurse at his job on 10/24/19 and was informed that it looked like "he was having a reaction to the Chickenpox vaccine".  On 10/25/19 the patient reports that the "bumps" are all over his body, including his trunk and scalp; they are blister like bumps. Pt. presented to an urgent care facility on 10/25/19 at 3:55 pm with Diagnosis of Varicella without complications and Cellulitis Right Lower Leg.
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: whithin 2 hours of vaccine administration, the patient experienced a seizure; This spontaneous report was received from an office manager and refers to a currently 16-year old male patient. No information regarding his pertinent medical history was provided. He had no concomitant medications and drug reactions or allergies. On an unknown date, when the patient was a child, he was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, within two hours of the administration, the patient experienced seizure and was taken to an unspecified hospital for evaluation. It was unknown if the patient was admitted or discharged same day. No lab diagnostics were performed. The outcome of the event was reported as resolved on an unknown date. The causality assessment was not provided.  Upon internal review, the event of seizure was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction, Influenza like illness, Injection site pain
Clinical narrative: Shot has painful (not the prick) but the process of the medicine being injected; Flu like symptoms; Felt very poorly; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, flu like symptoms and feels poorly. On an unknown date, the outcome of the injection site pain and flu like symptoms were unknown and the outcome of the feels poorly was recovered/resolved.   It was unknown if the reporter considered the injection site pain, flu like symptoms and feels poorly to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter described the actual shot had painful (not the prick) but the process of the medicine being injected. The patient felt very poorly for about 24 hours afterward. This case has been linked with US2019AMR190698, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction, Influenza like illness, Injection site pain
Clinical narrative: Shot has painful (not the prick) but the process of the medicine being injected; Flu like symptoms; Felt very poorly; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms and feels poorly. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were unknown and the outcome of the feels poorly was recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and feels poorly to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter described the actual shot had painful (not the prick) but the process of the medicine being injected. The patient felt very poorly for about 24 hours afterward. This case has been linked with US2019AMR190692, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash, Rash erythematous, Vaccine positive rechallenge
Clinical narrative: Rash; Rash; Flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On 19th October 2019, less than a year after receiving Shingrix, the patient experienced red rash and rash. On an unknown date, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the red rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, red rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had flu like for 3 days. 2 days ago from the date of reporting, the patient had rash with large red circle on arms back and chest. This case was 1 of 2 linked cases.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, over a year ago, the patient reported that, experienced arm soreness after shingrix vaccination. No additional information available. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: all over body hives
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Bursitis on injection arm
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Flushing, Tremor
Clinical narrative: Onset of "shakiness" and facial flushing, generalized "hot" feeling which persisted all day. Went to sleep @ 5 pm day of vaccination, slept all night, then woke with symptoms resolved @ 8:48 am next morning. VS at clinic when reported symptoms at 2:55 pm on day of vaccination were: T (O) 97.9, BP 147/86, P 70. No other c/o, no s/sx anaphylaxis.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was given Menveo vaccine instead of Meningococcal B vaccine. Patient has no signs or symptoms.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Fever ranging from 102-104. Lasted 2-3 days.  visibly swollen glands in neck and groin. Still visable one week later (9/4/19). Rash appeared a day or two after fever resolved.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Throat tightness, Wheezing
Clinical narrative: Patient left the office without any symptoms.  Half hour later Mom called to say daughter was wheezing and claims it felt like something was stuck in her throat.  Doctor advised patient to return to our office.  Upon arrival, patient was wheezing and had a diffuse rash from her neck down to her chest. No swelling of lips or tongue.  10mL of Benadryl was administered in the office and we called EMS to transport to the ER. O2 sats were 97% without O2.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Severe headache, nausea, chills, body ache for 6 days and still continuing; Tylenol was not effective. Had to take ibuprofen (400 mg) three times a day.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenopia, Facial paralysis, Hypoaesthesia, Lacrimation increased, Peripheral coldness
Clinical narrative: Received flu shot received on 29 October at 0700.  Symptoms/Adverse Effects started on 29 October  at 1830 with left side facial numbness and  left eye heaviness feeling and left eye watering.  On 30 October at 0500 left side of body felt cool and right side of body felt warm.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Patient had cellulitis like reaction after receiving these vaccinations.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Paraesthesia, Pruritus
Clinical narrative: Tingling, itching , red, and burning sensation in both hands
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Dizziness, Electrocardiogram normal, Heart rate increased, Hypoaesthesia oral
Clinical narrative: Received email from client who received flu shot at school clinic. Later in the am she developed an "incredibly" fast heart rate, felt shaky and dizzy and said her lips turned numb. She left work and went home but eventually went to the ER and spent the night there. The doctor ran an EKG and did some blood work to confirm it wasn't something major. In the end he stated to her that "she was one of the unfortunate ones who got the reaction."  In addition he stated that her shot was done very high and might have hit a nerve or bone which also could have started the reaction.  I reviewed with the administering nurse her technique and she uses the same 3 finger, C technique on all clients.  This nurse has been excellent and has been observed twice by supervisory staff for technique and has never had any issues.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Nervousness, Product administered at inappropriate site
Clinical narrative: Received email from client who received flu shot at school clinic. Later in the am she developed an "incredibly" fast heart rate, felt shaky and dizzy and said her lips turned numb. She left work and went home but eventually went to the ER and spent the night there. The doctor ran an EKG and did some blood work to confirm it wasn't something major. In the end he stated to her that "she was one of the unfortunate ones who got the reaction."  In addition he stated that her shot was done very high and might have hit a nerve or bone which also could have started the reaction.  I reviewed with the administering nurse her technique and she uses the same 3 finger, C technique on all clients.  This nurse has been excellent and has been observed twice by supervisory staff for technique and has never had any issues.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Headache, nausea, extreme chills
Age: 47.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Vaccination error
Clinical narrative: Patient has not yet reported any adverse event. Error was realized after administration and patient has already left the facility. No treatment administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Overnight chills, fever (100.6) headache and dizziness.  Headache mildly persists, fever is going down.  Re Item 20, I am getting better.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pustular
Clinical narrative: No redness but severe, pustule like rashy bumps on both upper arms lasting approximately 4 days
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Palpitations
Clinical narrative: Client received flu vaccination without incident.  About 10-15 minutes later client returned with her child who said she was feeling light headed. School nurse was requested for interpretation and she asked client to sit down. Pulse 102 BP 118/78.  Briefly complained of heart palpitations . Client stated her symptoms were not severe but because she was driving with children in car she wanted to make sure she was okay to drive. Client refused to lay down but sat and said she had not eaten for  few hours.  Also stated she has had a similar reaction to vaccines in the past.  After about 10 minutes client felt better and good enough to drive and left with instructions to follow up with medical care if symptoms returned.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Approximately 24 hours after receiving the flu shot, the child developed hives in a dispersed pattern all over his body.  Within 5-6 hours, the hives became more prevalent and pronounced, covered more surface area - particularly the face, arms, legs, and trunk, became extremely itchy and uncomfortable.  At that time I, his mother, gave him Children's Benedryl 7.5ml orally.  After the medication took effect, the hives slowly diminished, the itching ceased and he felt better. There were no signs of respiratory distress or indications of life-threatening signs/symptoms, no rapid heartbeat, dizziness, weakness, or generalized swelling of the face / throat. The pediatrician has been notified via the patient portal system.  The pharmacy where the vaccine was given has also been informed via phone call.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Hypoaesthesia, Peripheral swelling
Clinical narrative: Patient reported on 10/29/19 late morning that he experienced afterwards numbness and swelling of his legs, that he didn't have before.  He still currently has some discomfort with it.  Patient has already seen a medical doctor, who didn't think it was from the shot as well, but advise patient to contact manufacturer.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fall, Limb discomfort, Magnetic resonance imaging normal, Muscular weakness, Pain in extremity
Clinical narrative: Patient reported on 10/29/19 late morning that he experienced afterwards numbness and swelling of his legs, that he didn't have before.  He still currently has some discomfort with it.  Patient has already seen a medical doctor, who didn't think it was from the shot as well, but advise patient to contact manufacturer.
Age: 76.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Fall, Fatigue, Muscular weakness, Pain, Pain in extremity
Clinical narrative: PT was administered High Dose Fluad and Pneumovax 23 vaccine at his annual visit appointment on 10/21/2019. The next day, he stated that his legs gave out on him as he was trying to get into his vehicle. He also states that his legs are sore and feels fatigued. He fell a second time, this time he fell out of his bed. He does not recall how he fell but only remembers waking up on the floor out of his bed. He had to call the EMT to help get him up of the floor.   I called the patient to check in on him, he says he is feeling well. He also says that he is a little sore but he thinks this may be related to him falling. I spoke with his PCP regarding these issues and he finds it best that the patient come back into the office to be evaluated.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Grimacing, Head titubation, Neurological examination normal, Tic
Clinical narrative: Tics started the next morning with head shake and eyebrow lifting Over the next 7 months he began having facial grimacing as well now as vocal tics.  Continued eyebrow lifts although head shake is a bit better
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: 4.5 INCH X 3 INCH area of erythema, warmth, and induration on left deltoid, pain with range of motion.  Diagnosis: cellulitis of upper arm. Prescribed Keflex suspension, 760mg daily by mouth for 7 days
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presents to office with redness and swelling to right upper arm at injection site
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Pt came in today stating she developed pain radiating from injection site down to thumb 3 days after vaccine. Still experiencing numbness in arm. States she has Dr appointment on 11/12/19 and will bring it up to physician.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: 4 hours after the shot the patient developed an injection site reaction in the deltoid that hurt all the way down to the elbow for 4 days
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: pt has been having right arm soreness from the shoulder down to elbow since his vaccination
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Nausea, Pharyngeal swelling, Pruritus, Tension
Clinical narrative: Received flu shot ~ 230pm 10/24/19, first flu shot in lifetime. Was fine until ~ 840pm - felt tense/anxious, took 1/2 Xanax went to sleep. Awoke 1am nauseous, itching, w/hives, then felt throat swelling. Took own epi pen & called 911. Was seen in ER, given IV Benadryl & steroids. Sent home on oral steroidsx5 days. No further issues. Had scheduled w/allergist.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Received flu shot ~ 230pm 10/24/19, first flu shot in lifetime. Was fine until ~ 840pm - felt tense/anxious, took 1/2 Xanax went to sleep. Awoke 1am nauseous, itching, w/hives, then felt throat swelling. Took own epi pen & called 911. Was seen in ER, given IV Benadryl & steroids. Sent home on oral steroidsx5 days. No further issues. Had scheduled w/allergist.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: the patient developed redness, swelling and tenderness at the site of VARIVAX injection; the patient developed redness, swelling and tenderness at the site of VARIVAX injection; the patient developed redness, swelling and tenderness at the site of VARIVAX injection; a patient received a dose of VARIVAX via the intramuscular route; This spontaneous report was received from a registered nurse, concerning a none pregnant 23 -years-old female patient. The patient had none medical history, concurrent conditions, drug allergies or reactions. Her concomitant therapies included vitamins (unspecified) and hormonal contraceptives (unspecified).  On 25-OCT-2019, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, intramuscularly (incorrect route of product administration), to prevent chickenpox (lot number S007076 with expiration date on 10-MAR-2021).  On 26-OCT-2019, the patient developed redness (injection site erythema), swelling (injection site swelling) and tenderness (injection site pain) at the site varicella virus vaccine live (Oka/Merck) (VARIVAX) injection. The patient sought medical attention (reported as patient called the physician). However, no laboratory diagnostics or studies were performed, and no treatment was given for the adverse events.  On 28-OCT-2019, the patient recovered from the events redness, swelling and tenderness at the injection site.  The causal relationship between the aforementioned events and therapy with varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: Herpes; Rash; This case was reported by a other health professional via sales rep and described the occurrence of herpes virus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced herpes virus infection and rash. On an unknown date, the outcome of the herpes virus infection and rash were unknown.   It was unknown if the reporter considered the herpes virus infection and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by physician assistant (PA) to the field representative. The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced a rash or herpes after receiving Shingrix.  No additional details were provided. The reporter consented to follow up. This case is 1 of the 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain from the injection; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, over a year ago, the patient reported that, experienced arm soreness after shingrix vaccination. No additional information available. The reporter did not consent to follow up.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: tenderness; redness; warmth; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a 34-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 54T44, expiry date 30th June 2020) for prophylaxis.   On 14th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 14th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site tenderness, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema and injection site warmth to be related to FluLaval Tetra 2019-2020 season.  Save and rerun narrative; Add sentence for discrepancy related to outcome of event (not updated by me)  Additional details were provided as follows: The patient received FluLaval Tetra 2019-2020 season in the left deltoid and within 12 hours experienced tenderness, redness and warmth at the injection site. The adverse events resolved within 24 hours. This case has been linked to US2019191760, reported by same reporter. There was a discrepancy in the reported outcomes in XML and the ones autoloaded in the database, however, outcome captured as per database.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Joint range of motion decreased
Clinical narrative: limited shoulder mobility; This case was reported by a pharmacist via call center representative and described the occurrence of joint range of motion decreased in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number FK77A, expiry date unknown) for prophylaxis.   On 10th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 10th September 2019, immediately after receiving Shingrix, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was unknown.   It was unknown if the reporter considered the joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. On the same day, right after vaccination, the patient experienced limited shoulder mobility. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Breast cancer female, Breast cancer stage I, Chemotherapy, Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; Stage 1 Breast Cancer; This case was reported by a consumer via call center representative and described the occurrence of breast cancer stage i in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2018, between 2 and 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced breast cancer stage i (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the breast cancer stage i and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the breast cancer stage i to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not provided. The patient diagnosed with Stage 1 breast cancer when she went for her routine mammogram. She went through chemotherapy. Now, the patient's blood test and all the results were normal. The patient was late for her 2nd dose and till the time of reporting she did not receive it, which led to incomplete course of vaccination. No further details were provided.      Lab Comments: On an unknown date, blood test was performed
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mammogram abnormal
Clinical narrative: Inappropriate schedule of vaccine; Stage 1 Breast Cancer; This case was reported by a consumer via call center representative and described the occurrence of breast cancer stage i in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2018, between 2 and 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced breast cancer stage i (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the breast cancer stage i and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the breast cancer stage i to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not provided. The patient diagnosed with Stage 1 breast cancer when she went for her routine mammogram. She went through chemotherapy. Now, the patient's blood test and all the results were normal. The patient was late for her 2nd dose and till the time of reporting she did not receive it, which led to incomplete course of vaccination. No further details were provided.      Lab Comments: On an unknown date, blood test was performed
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Incorrect dose administered, Pain in extremity, Product preparation error
Clinical narrative: Diarrhea; Administered only the liquid portion of the vaccine / Vaccine was not mixed with the powder prior to administration; Inappropriate dose of vaccine administered; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. In October 2019, unknown after receiving Shingrix, the patient experienced pain in arm. On 22nd October 2019, the patient experienced diarrhea, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the diarrhea, pain in arm, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the diarrhea and pain in arm to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the patient's husband. The patient was administered only the liquid portion of the vaccine, which led to drug reconstitution and inappropriate dose of vaccine administered. The patient experienced diarrhea later that evening. The patient also experienced a sore arm. The reporter consented to follow up. This case has been linked with case US2019193748, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: A patient had a reaction to Prevnar 13/Allergic Reaction; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (25Oct2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable Pharmacist.   A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot number: AN85S1 Expiry Date: Nov2021, NDC number: 0005197101) at 0.5mL single dose via intramuscular route on 25Oct2019. The patient had not medical history. The concomitant medications were unknown. On the same date the patient experienced an allergic reaction to the vaccine. The patient got a shot of Benadryl, and she is feeling better. She has multiple comorbidities that warrant her getting the vaccine.  The  event was assessed as serious.
Sex: F
Vaccine: PNC13
Symptoms: Acute motor-sensory axonal neuropathy
Clinical narrative: had a variant of Guillan-Barre called Amsan; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, unknown lot number and expiration date) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her mom, the patient, had a variant of "Gulliame Barre" called AMSAN following the vaccine. Outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, the event variant of "Gulliame Barre" called AMSAN more likely represents an intercurrent medical condition associated with the patient's underlying contributory factors unlikely related to vaccination with PREVNAR 13.  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.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Vaccination site inflammation
Clinical narrative: swelling and rash from her elbow-up in the arm of the injection site; swelling; rash from her elbow-up in the arm of the injection site; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who experienced swelling and rash from her elbow-up in the arm of the injection site (vaccination site inflammation), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 10-Nov-2018, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ052AA and expiry date: 09-Jun-2019 via unknown route in left arm.  On 18-Oct-2019, 11 months 8 days after the vaccination the patient experienced swelling and rash from her elbow-up in the arm of the injection site (vaccination site inflammation) with symptoms swelling (vaccination site swelling) and rash from her elbow-up in the arm of the injection site (vaccination site rash).  (Other relevant tests included no lab data.)  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as recovered on an unknown date.; Sender's Comments: .   Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who experienced swelling and rash, while she using with the use of medical device FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started using FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE dosage unknown (lot - #UJ052AA, 09-Jun-2019) for Immunisation.  The patient developed an event of a non-serious swelling (extensive swelling of vaccinated limb) Unknown latency after starting use of FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE. The patient developed an event of a non-serious rash Unknown latency after starting use of FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE.   Final diagnosis was rash and swelling.    An unknown corrective treatment was received.  The patient outcome is reported as Recovered / Resolved on an unknown date for swelling and as Recovered / Resolved on an unknown date for rash.
Age: 6.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever - 102 Pt given Tylenol by mom
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity
Clinical narrative: pt had alfuria 10-26-19. she came into pharmacy on wednesday 10-30-19 with complaints of arm pain. she said had trouble lifting/moving arm. she had no visible reaction (couldn't even see where vaccine was injected). The pain she stated was internal and not relieved by otc ibuprofen. She stated she is seeing her doctor this afternoon (10-30-19) to address the pain and she just wanted us to know. I appologized many times and asked her to please call me after her md appointment to let me know how it went.We discussed possible reasons for pain (injection to high in arm, body "rejecting" a "processed" flu shot. She stated that she "eats/lives clean" trying to avoid all "processed" food/products and she had a severe reaction in the past after changing to her clean lifestyle to anti-perspirant. she stated it was painful and "felt like shingles." I appologized repeatedly. She also asked if she could alternate tylenol with ibuprofen to which i told her yes. But there was no visible sign of any reaction on her left arm. Only pain reported by patient.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Middle ear effusion, Vision blurred
Clinical narrative: 4 hours after the shot, the patient developed blurry vision and could not read anything, her ears filled up with fluid, and she stayed like that till this morning (Tuesday).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Employee phoned on10/28/2019 stating that area was swollen at injection site. the size of a fist. itchy reddned
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Alopecia
Clinical narrative: She was administered the vaccine on 10/16 approximately at 3:30 in the afternoon.  One Thursday, October 24th, I notice a large quantity of hair in her hoodie.  On Monday, October 28,   I helped her by brushing her hair in the morning and noticed large spots of hair missing on the top and sides of her head.   I brought her to the Doctor on October 29th to have it looked at.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Blood test, Computerised tomogram, Eye swelling, Facial paralysis, Magnetic resonance imaging
Clinical narrative: Client Received on 10/11/2019 FLu and Zoster vaccine and PPD skin test Client reports the day after( 10/12/2019) having vaccines she had all over aches and took Ibuprofen. Reports her Left eye was read and swollen. On Sunday(10/13/2019) she noticed a sharp pain to her jaw and reports she has partial dentures that were not fitting into her mouth as normal. Reports she took Ibuprofen again for the pain.Went into work on Monday( 10/14/19) with eye swelling and redness and co-worker noticed a droop to clients mouth ( drooping to the right). Client contacted employee health who directed client to an Urgent Care Center. Was informed they would not be able to help and was sent to Hospital for follow up.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Ocular hyperaemia, Pain, Pain in jaw
Clinical narrative: Client Received on 10/11/2019 FLu and Zoster vaccine and PPD skin test Client reports the day after( 10/12/2019) having vaccines she had all over aches and took Ibuprofen. Reports her Left eye was read and swollen. On Sunday(10/13/2019) she noticed a sharp pain to her jaw and reports she has partial dentures that were not fitting into her mouth as normal. Reports she took Ibuprofen again for the pain.Went into work on Monday( 10/14/19) with eye swelling and redness and co-worker noticed a droop to clients mouth ( drooping to the right). Client contacted employee health who directed client to an Urgent Care Center. Was informed they would not be able to help and was sent to Hospital for follow up.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Magnetic resonance imaging brain normal, Malaise, Metabolic function test normal, Vertigo
Clinical narrative: Vaccine was administered at pharmacy on so I don't have any lot info.  Patient developed a headache, malaise, and vertigo
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: My arm felt sore after shot and hurt to move, but that often normal and I had a sweater on all day.  Evening I removed sweater and my upper arm was warm, very swollen and hard.  It was painful on movement. I have never had a reaction like that to any vaccine.  I took ibuprofen and applied an ice pack to the arm.  The next day, that part of my upper arm was still swollen, but less, still sore but less.  Swelling still there a little on Saturday as well, not completely gone until Sunday 10/27.  Called pharmacy to report on Friday, he said would report, but took no information.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Chest discomfort, Dizziness, Dyspnoea, Headache
Clinical narrative: Client presented to flu clinic for vaccination. Client stated she had never received a flu vaccination.  She stated she had never reacted to any former vaccines.  Denied any allergies to medications. Within 1-2 minutes of administering the vaccination, client felt dizzy, light-headed, short of breath, faint and her chest felt tight. PB 106/84; HR 78 R 22. "I feel like I will be having an asthma attack." She proceeded to use her inhaler. She is also insulin dependent diabetic. Glucose level was checked and was 200. She also stated she thought a headache was started. Rechecked her vitals again: BP 106/82; Resp 24, HR 80. It was recommended to client to let nurse call EMS but she refused. Reviewed paper document showing the difference between psychological fright and anaphylaxis in Policy Manual and she agreed that it was more than likely the psychological fright as the symptoms were slowly improving. Client chose to leave the clinic area but nurse recommended that she have co-worker take her to ER if her symptoms worsened and did not continue to improve. Nurse also recommended she have her flu shot next year at a physician's office.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Mental disorder, Syncope
Clinical narrative: Client presented to flu clinic for vaccination. Client stated she had never received a flu vaccination.  She stated she had never reacted to any former vaccines.  Denied any allergies to medications. Within 1-2 minutes of administering the vaccination, client felt dizzy, light-headed, short of breath, faint and her chest felt tight. PB 106/84; HR 78 R 22. "I feel like I will be having an asthma attack." She proceeded to use her inhaler. She is also insulin dependent diabetic. Glucose level was checked and was 200. She also stated she thought a headache was started. Rechecked her vitals again: BP 106/82; Resp 24, HR 80. It was recommended to client to let nurse call EMS but she refused. Reviewed paper document showing the difference between psychological fright and anaphylaxis in Policy Manual and she agreed that it was more than likely the psychological fright as the symptoms were slowly improving. Client chose to leave the clinic area but nurse recommended that she have co-worker take her to ER if her symptoms worsened and did not continue to improve. Nurse also recommended she have her flu shot next year at a physician's office.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: pt felt dizzy shortly after vaccination. Pt was diaphoretic, skin clammy.  VSS. BP 132/78, P 106, R 16, SPO2 99% Pt rested and was observed for 30 mins and symptoms cleared up.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache
Clinical narrative: Within 2 hours of vaccine bad frontal headache and dizziness.  Symptoms have persisted until today- 2 days later
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The patient received an improperly stored dose of PROQUAD.; No adverse effects reported.; This spontaneous report was received from the Vaccine Coordinator referring to a patient of unknownn age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 15-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  recombinant Human albumin ( rHA) (PROQUAD) with lot # S008578 and expiration date on 16-SEP-2020 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis.   The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 2 hours and 35 minutes and 15°F to 46°F (16.3°F) for 44 minutes. There was a digital data logger involved, but there was no previous temperature excursion.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Pain post injection upper arm soreness; Pain post injection upper arm soreness; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. A patient of unknown age and gender received on an unknown date a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in the arm for immunization. Medical history and concomitant medications were not reported. The patient had pain post injection, upper arm soreness. Outcome was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: FLUR4
Symptoms: Bedridden, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: swelling of left arm and then swelling in left leg; painful; unable to bend; bedridden for 4 days; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who experienced swelling of left arm and then swelling in left leg (swelling), painful (pain),unable to bend (mobility decreased) and bedridden for 4 days (bedridden), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1938 (Expiry date 30-Jun-2020) via intramuscular route in unknown administration site.  On an unknown date, the patient developed a non-serious swelling of left arm and then swelling in left leg (swelling), painful (pain),unable to bend (mobility decreased) and bedridden for 4 days (bedridden) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   (Other relevant tests included no lab data.) Final diagnosis was bedridden for 4 days, unable to bend, painful and swelling of left arm and then swelling in left leg.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for all the events.