chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US02020238 is an initial spontaneous report received from a health care professional (also patient) on 01 Oct 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. Her vaccination history included administration of other vaccines such as tetanus booster (unknown manufacturer, batch number: not reported) on unknown date and was well tolerated. She also received FLUVIRIN (batch number: not reported) intramuscularly in the past (unknown number of doses) and experienced events (see related case numbers: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237). She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on unspecified date. It was reported that on an unknown date after vaccination, her arm was swollen, red and hot. The outcome, seriousness and causality of the event were not reported. She was also vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in next 2 years and experienced similar events (see related case number: PHEH2014US020239, PHEH2014US020240).
Approximately 40mm in diameter hard tissue, redness, swelling and warmth to touch, non-painful per 4 year old child to left deltoid area, developing approximately 24 hours after immunization administered. Recommended apply cold compress, monitor temperature, assess for signs and symptoms of infection/abcess and administer tylenol for pain if needed. Currently no fever. If fever or other signs and symptoms of infection develop encouraged parent to see MD or take child to urgent care if after hours. Mom verbalizes understanding and repeats at least 3 signs and symptoms of infection.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (gender/age unknown). The patients' concurrent/historical conditions or concomitant therapies were not reported. On an unspecified date, since 20-APR-2015 the patients were vaccinated with PNEUMOVAX 23 (lot # K008410, exp. date 26-FEB-2016) (dose and route were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was inadvertently given Adult dose of Pfizer Comirnaty Vaccine.  Did not realize error until next working day.  Mother was called and she stated child had sore arm, no other issue at that time.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Additional Details: pt has redness and slight swelling by right eye.  2 front teeth chipped.  monitored for 30 minutes.  denies headache (states it feels like normal).  eyes reactive to light, no dilation of pupils.
rash all over her body; swelling; itchiness; shortness of breath; diarrhoea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash all over her body"; SWELLING (non-serious), outcome "unknown", described as "swelling"; PRURITUS (non-serious), outcome "unknown", described as "itchiness"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhoea".  Additional information: Reporter stated that she had her first dose for the Pfizer Covid-19 vaccine on 15Feb2022, and caller mentioned that she is experiencing severe allergic reaction now, she has a rash all over her body, swelling, itchiness and shortness of breath. She's afraid of taking the 2nd dose, but she said that she already has an appointment with the doctor. The doctor recommended she take a test, and once the result is out she can have the Johnson and Johnson vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, route and site reported) Lot # L020157 with expiration date on 12-MAR-2018, Lot # K010216 with expiration date on 17-SEP-2016, that on an unspecified date were improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patient sought medical attention. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
dizzied; get really sick/felt really sick/ felt really sick; little shaken; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness (dizzied), illness (get really sick, felt really sick) and tremor (little shaken).  The patient's medical history was not provided. Concomitant medications reported were Synthroid for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient stated she was feeling really sick, was dizzied and little shaken  after receiving the shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was reported to be unknown.
leukemia; Had fever in Dec and in Feb started fever; hand pain in right arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 9-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2, single (Lot number: FK5127) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Juvenile arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Vaccination history included: BNT162b2 (Dose 1 single, lot number: FK5127, vaccine location: Left arm), administration date: 12Nov2021, when the patient was 9-year-old, for Covid-19 immunization. The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. No known allergies.  The following information was reported: PYREXIA (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Had fever in Dec and in Feb started fever"; PAIN IN EXTREMITY (non-serious) with onset 24Dec2021, outcome "not recovered", described as "hand pain in right arm"; LEUKAEMIA (medically significant) with onset 24Dec2021, outcome "not recovered", described as "leukemia". The events "leukemia", "had fever in dec and in feb started fever" and "hand pain in right arm" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (24Dec2021) Unknown results, notes: Had fever in Dec and in Feb started fever and hand pain in right arm which was finally diagnosed as a pre be All leukemia. Therapeutic measures (included Chemotherapy) were taken as a result of leukaemia, pyrexia, pain in extremity. Adverse event resulted in: Emergency room/department or urgent care.
Fever ranging from 99.0- 102.0, then a rash all over his face, neck and torso
Head ache, high temperature, sore down side of injection and pains and tightening of chest .
9 days after 1st vaccination had slight redness and mild pain/itching on left arm where shot was given
12/5/18 6 PM-felt cold/feverish and nausea. 12/6/18 Flu-like symptoms all day; felt better later in day. 12/7/18 Red, bumpy rash to entire torso to mid neck, sides of neck to ears, pt questions if it was also present on head; itchy back, ears, neck and upper chest; harder than usual to swallow. Had similar symptoms after 1st SHINGRIX-rash, but no flu-like symptoms. Stated that some areas were hot and itchy prior to eruption of rash. Pt took 25 mg BENADRYL QD. Rash went away on 12/9/18. Continued BENADRYL until 12/12. Pt contacted on 12/12/18- Still has rash to back of torso, but not visible on anterior torso. Torso remains a little itchy, but pt states that she is feeling better.
He got COVID after getting the booster; He got COVID after getting the booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He got COVID after getting the booster". Clinical course: During a call, the patient mentioned that he got COVID after getting the booster, but he did not mention if the booster was from Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient received a diluted dose of the Pfizer/BioNTech COVID-19 vaccine as the vial used for administration (did not require reconstitution), but the pharmacy staff reconstituted the vial with 1.8mL of normal saline. This resulted in the dose of the vaccine being 15mcg, rather than 30mcg. Attempted to contact the patient and inform of event. Provider notified and recommended against redosing.
knee swelling; reddish; his both hands, fingers and entire thing and the feet, on bare feet right on bottom of the feet it is swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 18 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (First Shot: , Date of shot: 24Mar2021(Not clarified appropriately. Hence not captured in tab), LOT: ED6955), administration date: 24Mar2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (Second Shot: , Date of shot: 14Apr2021 , LOT: EW0151), administration date: 14Apr2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (Third Shot: , Date of shot: 25Dec2021 , LOT: Reporter stated, 33025EB, I don't know it little, 33025EB or 1B.), administration date: 25Dec2021, when the patient was 17-year-old, for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 17Dec2022, outcome "unknown", described as "his both hands, fingers and entire thing and the feet, on bare feet right on bottom of the feet it is swelling"; JOINT SWELLING (non-serious) with onset 17Dec2022, outcome "unknown", described as "knee swelling"; ERYTHEMA (non-serious) with onset 17Dec2022, outcome "unknown", described as "reddish". Therapeutic measures were taken as a result of joint swelling, erythema, peripheral swelling.  Additional information: It was reported that actually, day before yesterday, in evening, reporter son took a Pfizer vaccine, the booster, after it was a 4th and 5th combined right. So today, yesterday evening but today his both hands, fingers and entire thing and the feet, on bare feet right on bottom of the feet it is swelling. And the knees was also swelling. It was reddish and the swelling. Already he took 3 last year but this was the booster what was currently going on, he took it (Covid Vaccine Bivalent Booster). Patient did not have any prior vaccinations and did not have any medical conditions. Patient was taking regular medications such as Vitamins. Patient took treatment as Benadryl, allergic medicine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
devel redness, pain & swelling @ inj site 2 days p/vax;
sore arm; not feeling good; cold; lips and face twiching; Diarrhea; dizzy; fever; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching) and DIARRHOEA (Diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching), DIARRHOEA (Diarrhea), DIZZINESS (dizzy), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching), DIARRHOEA (Diarrhea), DIZZINESS (dizzy), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Took 3 doses on schedule and then travelled, missing the 4th dose; A spontaneous report was received from a nurse on 18AUG2022. It described a patient of unknown gender and age who "took 3 doses on schedule and then travelled, missed the fourth dose" (PT: Incomplete course of vaccination). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported a patient took 3 doses of Vivotif on schedule and then travelled and missed the fourth dose. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took 3 doses of Vivotif on schedule and then travelled, missed the fourth dose (incomplete course of vaccination). Further information is limited. The causality of incomplete course of vaccination is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took 3 doses of Vivotif on schedule and then travelled, missed the fourth dose (incomplete course of vaccination). Further information is limited. The causality of incomplete course of vaccination is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
After I got home, the redness and swelling started.  Grew to about 8 inches long and 6 inches wide.  A very hard localized spot also appeared.  Went to the pharmacist and they said everything normal.  Huge blisters then appeared.  Went back to the pharmacist and she said I had zoster blisters.  I had to stay in bed for 3 days.
Patient's guardian/grandmother made appointment for a 2nd Pfizer vaccine. The electronic chart for the patient showed the 1st Pfizer vaccine was given 7/14/2021. The grandmother completed the 'patient checklist' and said she forgot the patient's COVID-19 vaccine card in the car. The nurse took the patient to an exam room and gave the vaccine. The grandmother completed 'patient checklists' on 5 other grandchildren then got the patient's COVID-19 card from the vehicle. The nurse started to chart on the card and noticed the patient had a 2nd Pfizer on 8/06/2021 at another location in town. No adverse reaction noted in 15-minute observation time.
suspected vaccination failure; had shingles shot then after my 2 / developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient reported that preventing was a lie. The patient had shingles shot then after 2 COVID shots, the patient developed the shingles which the patient thought that the patient was having a heart attack. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. It was unknown if the reporter considered the shingles to be related to Covid vaccine.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium
1/1/21- Severe right side eye pain  1/3/21 - Appearance of vesicular rash with sever pain above right eyelid 1/3/21 - Diagnosed with Zoster Ophthalmicus of Right Eye at urgent care and initiated on Valacyclovir 1000 mg PO TID x 10 days  1/4/21 - Ganciclovir eye drops added to treatment course  1/10/21- Rash crusted and resolved but with severe neuropathic pain and itch 1/12/21 - Second dose of COVID vaccine received
This case was reported by a physician and described the occurrence of seizure in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). Within a few weeks of vaccination with ENGERIX B, the subject experienced seizures. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 18 January 2012 from the physician. Concurrent medical condition included seizure disorder. On unspecified dates, the subject received 1st, 2nd and 3rd doses of ENGERIX B (details unknown). On an unspecified date after being vaccinated with ENGERIX B, the subject had a "negative titre" [not responding to therapy]. On an unspecified date, the subject received a 4th dose of ENGERIX B (details unknown). On an unspecified date after the 4th dose of ENGERIX B, the subject had a seizure. The event was considered resolved. On an unspecified date, one month after 4th dose of ENGERIX B, the subject received a 5th dose of ENGERIX B (details unknown) and "had no problems". The physician reported that he could not "correlated the two".
Patient has no known adverse events at this time. Patient requested bivalent vaccine and received monovalent pfizer vaccine.
Pt had reported on 12/1/2015 that her arm had gotten red from shoulder down her arm. Reported she had 2-3 days of it being warm to touch. No induration or shortness of breath, no signs of distress.
This spontaneous report as received from a Healthcare Worker (also was an Office Manager) refers to an unknown number of patients of unknown age who  may have received doses of GARDASIL (start date, dose, route and lot # not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same source. It was linked to MARRS#1308USA007998. Additional information has been requested.
PATIENT CLAIMED HE WAS ITCHY, HAD METALLIC TASTE, SKIN CRAWLING, NAUSEA AND SWEATING INSTANTLY AFTER RECEIVING VACCINE. AMBULANCE WAS CALLED BUT HE REFUSED TO BE TREATED AND LEFT UNDER HIS OWN POWER.
SOB, Bronchospasms, Respiratory distress, Hives, Seen at Emergency care ctr given: Vaponepaline 0.5cc, Prednisone 50mg PO, Caperidioxe x 5 days.
Per review of patient's chart: Patient reported adverse events to PCP two days after vaccine was given. Refused to go to emergency room until 1/8/14 after symptoms worsened. Diphenhydramine 50 MG QID.
With the first shat, a week after my arm started to swell and looked like I was hit in the arm by a baseball. School nurse told me to take benadryl to finally get the swelling down 3 days later, but the red mark stayed there tell shot #2.  Shot 2 my arm swelled the same day of the shot, and 1030 pm my joints all started to hurt severely and I ran a fever. I finally went to the dr on Monday and reported it to him. Motrin and benadryl did not take the swelling down. Still have random swelling in my hands.  And last Friday my arm hurt in the injection area for 2 hours, then went away.  No reason for it to hurt this far after the shot.
she doesn't want to since she got very ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13May2021 as single dose for COVID-19 immunization. Medical history included COVID from Feb2021 to an unknown date. The patient's concomitant medications were not reported. Patient stated she received the first dose of a Covid 19 vaccine on 13May2021, she was scheduled to get the second dose on 03Jun2021. She stated she heard she needs to quarantine for 14 days after receiving the second dose, but she needs to travel out of town on the 07Jun2021; and she was told that if she misses her appointment she should restart the series, which she doesn't want to since she got very ill on an unspecified date in 2021 and she also had Covid and was hospitalized for 10 days on February. She wanted to know if this information was true. Patient confirmed yesterday that she actually got the Pfizer vaccine. Before the vaccine, she had COVID and almost died. The outcome of event was unknown.  Information related to batch/Lot no. was requested.
she was very sick; This is a spontaneous report from a contactable consumer. A 47-years-old female patient (reporter's sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was very sick for the first shot. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
17DEC92 had swollen lt leg primarily @ site of inject red; fever started 19DEC92 8PM & leg was very sore; some tenderness w/sl lump;
severe red raised circular rash that was hot and painful around the circumference of my bicep and  deltoid  . This swelling lasted 6 days and was quite painful.