chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes Zoster Ophthalmicus (HZO); onset of symptoms 05/02/2021, including painful rash, blisters, fatigue, headache, shooting and buring pain, swollen rash along forehead and over left eye.
Swelling and pain begin the first night. By the next morning I was in extreme pain putting on my shirt and coat.  Arm was swollen and painful to the touch.  Took ibuprofen for the next several days.  By 11-26-21 the swelling and pain was subsiding.  On 11-29-21 my right ring finger started turning purplish and continued for 36 hours after and then disappeared.  11-30-21 the arm started to swell up again with extreme pain, a knot could be seen in the mirror-noticeably different than the left arm.  12-1-21 Small red dot, then 2 then a couple small red hives started to appear- very itchy.  By the morning 12-2-21 Hives enveloped my upper right arm.  Itchy and getting worse I sought treatment at a doctors office where I saw a NP and she prescribed topical steroid and Benadryl/antihistamines for a few days.  Hives and arm swelling and pain improved over a few days and by 12-6 they were gone and pain was subsided.  No issues since.
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 28-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001:
pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax w/lot#4978296;
On 03/17/2002 the pt developed blisters, scab, redness which was increasing. Evaluated on 03/18/2002, necrosis, erythema, edema, warmth. Prescribed Prednisone orally
About a month after i received my shot I had a headache and nausea, stomach ache, headache would not subside. Contacted at the Clinic.
DTaP and Polio vaccine. Head-to-toe rash within 12-24 hours lasting 48-72 hours. MD informed X 2.
accidentally received three doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (accidentally received three doses of the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (accidentally received three doses of the Moderna COVID-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (accidentally received three doses of the Moderna COVID-19 vaccine) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received MENVEO (batch number M15144, expiry date 31st July 2017). On 5th August 2016, the patient received MENVEO (intramuscular) .5 ml. On 5th August 2016, an unknown time after receiving MENVEO, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional details were provided as follows: The reporter stated that, the patient only received the MenCYW-135 liquid conjugate vaccine component in left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide any further details at the time of reporting. The patient's physician was not notified at this time. Follow up information was received from pharmacist on 4th October 2016: The patient's weight and height was unknown. The reporter's contact details were updated. The patient received 1st dose of MENVEO. The patient experienced severe low blood pressure, dizziness and light headedness within minutes after vaccination with MENVEO. The VAERS details were updated.
This spontaneous report as received from a Licensed Practical Nurse refers to a 15 years old patient who on 17-MAY-2013 received a dose of PROQUAD (dose, route and lot number were not reported) due to a human error. Concomitant medications were not reported. No adverse effect reported. The outcome of patient was not reported. Additional information has been requested.
I looked at our Pfizer inventory today to check for possible incorrect expiration dates (because of the 10 week fridge time after receiving shipment). I found two incorrect expiration dates. I ran a "dosage report" in Immunization Information System to see if any patients were vaccinated with these two expired vaccines, there are two patients.  COVID PFR BIV 5y-11y GK1657 - expired 12/27/2022 (report ran from 12/29/2022 - 03/02/2022 given the two additional days per Pfizer, see attached)
Patient had nausea and vomiting on Friday and throughout the weekend and had no appetite on Monday. The patient's doctor was informed of the reaction on Monday morning.
On 2/25/2014, 4/21/2014 with series 1 and 2, seizure like activity; after MMR on 10/21/2014 and sometime after she began to have developmental delays and was later at the age of three diagnosed with mild to profound sensorineural hearing loss. She was too young to have the cognitive ability to tell me she was going deaf.
I am biting tongue. Eye coordination, blurry, foggy feeling. Tunnel vision . Always in a fog. Balance issues/Coordination issues when walking, Slurred Speech. complete sex drive disfunction. Dizzy spells. Enlarged Prostate. Lose train of thoughts more often. Insomnia, having difficulty sleeping. Unexplained Pressure in the head/brain.
This spontaneous report was received from a consumer who was patient's mother regarding her daughter a 2 year old female patient. There was no information about concurrent condition and historical medication. On an unknown date in July 2014, the patient was vaccinated with PEDVAXHIB dose 1 in the unspecified leg. The second dose was administered in September 2015 when she was 4 months old. A third dose was administered to the patient when she was 8 months old. The patient was behind on her booster and for an unspecified reason. No concomitant medication was reported. On an unknown date in July 2014 the patient experienced prolonged crying which lasted for 3 hours after receiving the first dose of PEDVAXHIB. On unknown date after the booster dose the patient experienced some swelling around injection site. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. Patient spoke to unspecified nurse to seek medical attention. No PQC (product quality complaint) was involved. Action taken with PEDVAXHIB was reported as dose not changed. The outcome of prolonged crying was reported as resolved. The outcome of swelling around injection site and second dose administered in September of 2015 when she was 4 months old, third dose when she was 8 months old and behind on her booster was unknown. Additional information is not expected as physician does not wants to get contacted.
Pfizer Dose 1 3/4/21 (EL9266) Pfizer Dose 2 4/1/21 (EN6205) Pfizer Dose 3 11/5/21 (FG3527) COVID Positive 2/8/22  2/8/22: This is a 71-year-old female with history of obesity, hypertension, hyperlipidemia, tobacco use, Sjogren syndrome, obstructive sleep apnea, recently diagnosed infiltrating ductal carcinoma of the left breast status post chemotherapy, chronic obstructive pulmonary disease and vertigo who presented to the emergency department with difficulty swallowing and a painful abdominal rash. Patient states that she finished a 5 day course of treatment for shingles. Her rash is present in the left upper quadrant of the abdomen and goes to the back. She describes her pain as burning, moderate in intensity, constant, worse with touch and without noticeable relieving factors.  She also has difficulty swallowing mostly with solids. She states that she slightly tolerates her liquids. She recently had an esophageal thrush for she which she was taking nystatin.  2/18/22: 71-year-old female with history of obesity, hypertension, hyperlipidemia, tobacco use, Sjogren syndrome, obstructive sleep apnea, recently diagnosed infiltrating ductal carcinoma of the left breast status post chemotherapy, chronic obstructive pulmonary disease and vertigo who presented to the emergency department with difficulty swallowing and a painful abdominal rash.  Status post upper GI endoscopy on 02/10/2022, preliminary report shows esophageal strictures needing dilation.  Patient had esophageal dilatation on 2/15/22.  Patient has been tolerating oral intake.  Patient was noted to have refeeding syndrome and after that has been replaced.  Patient will be discharged on p.o. potassium and magnesium oxide.  Patient to have a BMP repeated in 1 week.  During hospitalization patient was diagnosed with COVID-19.  Patient had mild symptoms. Patient did not require supplemental oxygen on discharge.   Patient also presented with herpes zoster infection. Acyclovir was.  Patient has completed treatment.  Patient continues to have neuropathic pain, continue gabapentin.   Precautions return to the ED extensively reviewed, patient has verbalized understand
The primary reporter is a forensic psychologist, patient, who declined to provide her contact information. She reports that "over 20 years ago", when she received the first of a series of 3 doses of Hepatitis B vaccine, she "developed shingles". She is certain that this occurrence was reported as an AE, since she received it at a state hospital. She states that the hospital called the manufacturer of the vaccine and was told by the manufacturer that it is possible for a person to develop shingles after receiving a Hepatitis B vaccine. She did not receive the additional two doses of the series. NO additional information available. Additional information is not expected.
Patient reported to clinic 2 days after receiving vaccine to report redness and firmness the size of a hand located at the site of injection. Area was warm to the touch. Patient was seen by experienced AI technician and was told to come back if symptoms worsen, because the reaction was unfortunate but common and WNL.
No additional AEs; improperly stored administered GARDASIL 9; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 29-APR-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1691180, expiration date 15-NOV-2022, 0.5 milliliter) for prophylaxis (product storage error).  Temperature excursion was 28.8 Fahrenheit degree for 2 hours and 35 minutes and 31.4 Fahrenheit degree for 0 hours and 15 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse event was reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004138: US-009507513-2106USA003990  :
EMPLOYEE RECEIVED HEPATITIS IMMUNIZATION AND ARM FELT NUMB. EMPLOYEE VOMITED IN THE MORNING ON 5/19/22. EMPLOYEE WENT OUTSIDE FOR FRESH AIR AND VOMITED AGAIN AND FELT FINE.
positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny nose; little diarrhea; tiny bit of shortness of breath; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable physician (patient himself). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), via intramuscular route on 17Dec2020 at single dose (dose 1, left deltoid) for COVID-19 immunization. The patient medical history included non-smoker. Concomitant medications were reported as none. The patient was scheduled to take the second dose on 05Jan2021, also reported as 08Jan2021. The patient experienced sore arm for 24 hours afterwards on Dec2020. Patient experienced mild COVID symptoms such as fever, chills, sore throat, cough, nasal congestion, runny nose, little diarrhea, and tiny bit of shortness of breath on 24Dec2020, but stated he was better now. The patient was positive in the COVID test on 28Dec2020. He wanted to know if it was normal to get COVID after getting the vaccine and if he should get the booster shot if he gets better.  He commented that testing positive for COVID was medically concerning. The patient did not require supplemental oxygen (including high flow ECMO) or receive a mechanical ventilation. Treatment included over the counter medication. No additional testing was done. The patient was not hospitalized. Outcome of the event sore arm was unknown; cough was not recovered; fever, chills, sore throat, nasal congestion, runny nose, little diarrhea, tiny bit of shortness of breath was recovering.  No follow-up attempts are needed. Information about lot/batch number was already obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
heart was pounding; skin became blotchy all over; tongue was tingling; blood pressure it was 186/123; excessive thirst; light-headedness; metal/chemical taste; extremely jittery; on edge feeling; loss of apatite; chills; fever; breathing was labored; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER 8732), via an unspecified route of administration in left arm on 26Mar2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included loratadine (CLARITIN) for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was allergic to penicillin. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021, within five minutes of vaccination, the patient experienced heart pounding, skin became blotchy all over, tingling tongue, and when the technician had a check her blood pressure was found to be186/123 (her blood pressure was usually 117/over 70). The patient went to an urgent care and the doctor told, it appeared to be an allergic reaction (though not anaphylactic shock) to the vaccine and advised not to receive the second dose. The other symptoms included were excessive thirst, light-headedness, metal/ chemical taste in her mouth, extremely jittery and on edge feeling, loss of appetite, chills and fever. The following day the patient experienced laboured breathing from lightly walking around (not usual for the patient). The patient did not receive any treatment for adverse events. The clinical outcome of the events heart pounding, blotchy skin all over, tingling tongue, hypertension, excessive thirst, light headedness, taste metallic, jitteriness, depressed mood, loss of appetite, chills and fever was resolved with sequelae on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
pt recv vax & devel swollen tongue; In f/u the pharmacist reported that pt was lost to f/u;
chills; headache; nausea; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as a DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unknown date as a DOSE 1, SINGLE for covid-19 immunization. It was reported that, the patient was calling about her husband but stated she received the second dose of her Pfizer vaccine on 10Jan2021 (may have meant 10Feb2021, noticed after call was complete) and on an unspecified date in 2021, the patient experienced chills, headache and nausea. The clinical outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
CHILLS; FEVER; POST COVID HIVES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, fever, and post covid hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from post covid hives, and the outcome of fever and chills was not reported. This report was non-serious. The suspected Product Quality Complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210804950.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
pt recv vax 11FEB98 & 14FEB98 pt c/o inc redness, swelling & hot to touch @ site of inj towards elbow;
The patient lives in a Nursing Home and was given 3 doses of the vaccination. They received the vaccinations on 12/29/2020, 01/19/2020 and on 02/09/2021.
Patient fainted in the observation area after receiving vaccine. Patient was assessed by RN and refused EMS. Patient appeared flushed and diaphoretic. Patient was unaccompanied but waited for her mother to pick her up. Patient left in stable condition.
Pt received vaccines on the morning of 2/6/2020. Mom notified the office on 2/7/2020 at approx. 1300 stating that patient had developed a generalized rash. She has a reddened raised area to the right thigh (site of Hep A injection) approx. 2 inches in diameter on assessment. Mom stated she also had reddened raised patches on her abdomen, torso, and around her mouth / face. She had given Benadryl and noted this improved.
redness on (L) leg where vaccine  given, 1.5 cm x 2 cm
BLOOD CLOT IN LEG; SWEATING; This spontaneous report received from a consumer concerned a 70 year old male of unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced sweating which lasted about one day. It was stated that patient received vaccine around 18-APR-2021. It was also reported that actual date of vaccination may have been prior to 18-APR-2021 but definitely in April. On 17-MAY-2021, patient visited hospital and got diagnosed with blood clot in leg. The patient was on unspecified medications to dissolve clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 2021, and had not recovered from blood clot in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210534558-Covid 19 Vaccine- This case concerns a 70 yr old male. Blood clot in leg, Sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).