chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had an episode of dizziness, right hand numbness, and right hand temporary paralysis. The numbness and paralysis lasted only about 30 seconds. The patient also reports persisting decreased grip strength bilaterally. In the ER she had a negative CXR, CBC and monospot. In our office the day of the vaccine she had a negative rapid strep screen with a negative follow up strep PCR. She did have a significant orthostatic change in HR when orthostatic BP and HR were checked in office the day following the event. Due to persisting grip strength concerns I have referred her to a neurologist.
arm soreness 2nd shot; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9243), via an unspecified route of administration on 02Feb2021 at the age of 84-year-old in Left Arm at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 84 years old on 12Jan2021 for Covid-19 immunization and the following morning on 13Jan2021, he experienced headache and loose stools/ had really loose stool and was squirting liquid/diarrhea. The patient experienced arm soreness on an unspecified date which the patient was admitted to hospital.  The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021050412 Same patient/drug, different dose
This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner reported that on an unknown date, patients were inadvertently administered RECOMBIVAX HB that had been improperly stored. No adverse effects reported.  This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not give the consent to contact her.
First dose of Havrix on july 5th, 2019 but didn't receive the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old patient who received HAV (Havrix 1440) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 (received Havrix 1440 on 5th July 2019, batch number N39BM, expiry date 31st January 2022).   On an unknown date, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of Havrix till the time of reporting, which lead to incomplete course of vaccination. The reporter did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097940:Same reporter.
Pt received H1N1 vaccination.  Next day awoke with red, itchy rash to diffuse body.  Never before.  No uri.  No sob/cp/abd pain.  No n/v/d.  No ha/dizzy. No blisters/pus. No new meds.  No new foods.
Infant was receiving his 3rd injection (PCV) in LAT when he started to cry. Infant was crying so, hard he lost his breath. His face  and lips were turning blue. Mother very upset, she began yelling while strking him on back and buttocks she was holding infant in the air shaking him. Infant caught his breatha fter about 1 min of
36 YO MO F 60D POST-VAX PERSISTENT SCAB AT SITE WITH POISON OAK/IVY; CONSULT QUESTION TO CDC CLINICAL TEAM FROM PMD RE PULSE DOSE TEROID TX AND TAPER; ANSWER IS TO GIVE CAUTIOUSLY
Temperature of 103 for 24 hours. Managed with Tylenol every 6 hours. Temp of 101 with medication management. Extreme chills lasting roughly 6 hours. Body ache and fatigue lasting slightly over 24 hours.
Given right thigh Prevnar #4 and Hep A #1 on 6/18/2007. Prescribed cool compress Right thigh and Benadryl every 6 hours, seen 0n 6/20/2007.
I got the flu vax on Monday. Tuesday I got a shingles vax on Tuesday. Today Wednesday night my double stuck arm is on fire. The temperature is drastically different. I'm wondering if there is a potential interaction between the two.
Patient reported having little red, itchy bumps all over his body lasting nearly one month. Treated with topical OTC steroid creams and anti itch creams.
p/vax pt reporting abd & leg cramping, nausea, perspiration, felt faint sx 24 or 32hr p/vax;
This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Immunization reaction of 2cm sized firm mass under skin with induration on skin. Non-tender. Seems mild. Treated with Tylenol and observe.
Flu shot ordered by doctor. Medical Assistant pulled vaccine from refrigerator, gave vaccines to patient per nostril. MA documenting vaccines discovered expiration date passed. MA reported to RN supervisor. RN discovered age inappropriate for mist & protocol not followed. No treatment necessary.
heart attack; stage 3 kidney failure; diabetes; hypertension; This is a spontaneous report received from a contactable reporter (consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; RENAL FAILURE (medically significant), outcome "unknown", described as "stage 3 kidney failure"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; HYPERTENSION (non-serious), outcome "unknown". Clinical course: The patient called in seeking assistance with the medication Prevnar 20. During the call caller stated. "I'm a recent a heart attack patient, and I'm stage 3 kidney failure, diabetes, hypertension."  The information on the batch/lot number for Prevnar 20 has been requested and will be submitted if and when received.  Follow-up (15Sep2022): Follow-up attempts completed. No further information expected.
Hives and intense itching all over body staring a week after booster shot. All three have my my throat feel tight and hard to breathe. First two gage me horrible flu symptoms for 2 days which I expected. I did not expect the hives and I've never had them in my life and have no allergies. Been to allergist, emergency rooms, doctors and no one can figure out why I have them and the only thing that is different is the COVID shot.
Pre - Kclampsia, Anorectal Hemorrhage - Information has been received from a physician concerning a 27 year old female who on 18 Jan 2000 was vaccinated with one dose of varicella virus vaccine live ( site unknown) .   Subsequently, the patient learned that she was pregnant. LMP 20 Dec 1999.  This report is part of the pregnancy registry.  Follow up revealed that the patient developed mild pre-eclampsia during labor but on 16 Sep 2000 a normal healthy baby girl was delivered vaginally.  The baby has been seen since birth for rectal bleeding believed to be bacterial in origin and has since resolved.  No other information is available.
Severe Covid arm. Swelling, pain, redness, welt 6 inches in diameter, body aches, chills, headache, tiredness
06/03/2012 mild other. On the evening of 6/3/2012, client had nausea and a headache. On 6/4 the headache continued and he had a low grade fever of 99, sore throat, & complained that it hurt to swallow. Saw doctor on 6/5 for strep throat test that was (-) initially, but got official lab results on 6/6/12.
10/31/14 came back into office c/o redness and pain at site on (R) arm. 11 x 6 cm erythematous patch. No bleeding or oozing. Skin warm and tenderness at palpation. Cellulitis vs reaction to vaccine advised to take BENADRYL for itching and Ibuprofen for pain. Started clindamycin HCl 300mg.
Donor stated she began to feel dizzy approximately 10 minutes after she received vaccine. She then threw up and has a headache. Donor states she still feels nauseous. No treatment was initiated at this time. Employee was sent out to an emergency clinic for medical care by RN.
Extream muscle tightness, soreness, tenderness in lower back, shoulders, neck.
SHINGRIX was administered on 3/13/18. On 3/14/18, she ran fever of 102.5 degrees F, pulse 140, Respiratory rate of 30 with other vital sigs within normal limits. She also had a non-productive cough.  There was a "bulls-eye" type red, inflamed area on her upper left arm where the vaccine was administered. She is non-verbal and unable to give a report of pain. Acetaminophen was given for the fever and possible pain. It was effective and the fever subsided within 24 hours with no further intervention.
I have had friends and family that had " nasty" side effects from the second shot .; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have had friends and family that had " nasty" side effects from the second shot .) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I have had friends and family that had " nasty" side effects from the second shot .). At the time of the report, VACCINATION COMPLICATION (I have had friends and family that had " nasty" side effects from the second shot .) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment product information was not provided.  Concomitant product use was not provided.
No adverse event; before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.).    A patient has received 3 doses of the Moderna COVID-19 vaccines by intramuscular injection. First dose on 26-JUL-2022 (lot number 051B22A, expiration date unknown), second dose on 23-AUG-2022 (lot number 044C22A, expiration date unknown) and the final dose was bivalent vaccine which given less than 2 months after the completion of the primary series.  No concomitant medications was reported. No symptoms have been reported. No additional doses, medications, or treatments have been administered.
Severe Anaphylaxis onset at 3:00am. Epinephrine administered at home.  Transported to ER. BP 80/40 at admission. 2nd Epinephrine administered at ER. IV fluids. BP recovered and discharged at 7:30am. Prescribed Prednisone 20mg, Famotidine 20mg, and Cetirizine 10mg.
Patient is experiencing extreme pain in right arm. Patient can move arm, but experiences pain when doing so. Patient complains that they can not get comfortable and have not been able to sleep.
positive COVID-19 test with symptoms; itchy; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6O04, expiry date: 30Mar, as reported), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation, at a hospital. The patient's medical history and concomitant medications were not reported. The reporter and her husband received the vaccine on 09Mar2021 and then 5 days after (14Mar2021) they feel itchy, feel high fever, too much fever, it was going in and out; and the report is positive. They went to the hospital and had a COVID-19 test and the reports were positive, her husband and herself was positive. The hospital gave services in hotel for 9 days after that, the 10 day is in the house, so the second vaccine is schedule in March but they did not go to there because they are under the isolation. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Had a COVID-19 test and the reports were positive) on 14Mar2021. The outcome of the events was unknown  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440584 same reporter, drug, event; different patient
830AM 4/10/99 erythema, edema, pruritus & warm to touch from right shoulder to elbow treated w/DPH elixir x 2 days;also topical hydrocortisone cream to rt upper arm TID;
Information has been received from a physician concerning an "around" 60 year old female patient who on 15-MAR-2011 was vaccinated SC with a 0.65ml dose of ZOSTAVAX (Merck). On 15-MAR-2011 shortly after administration, the patient experienced redness and swelling of the body that lasted a week and a hot feeling around injection site for a few days. On approximately 03-APR-2011 ("this week"), the patient recovered. It was reported that the adverse events improved while on therapy (it was also reported that no treatment was given for the adverse events). The patient did not seek medical attention. No further information is available.
5 hrs of high pitched inconsolable crying & screaming; pt has been lt w/an uncontrolled sz disorder & severe development delay;
12/26/21 to 12/27/21 - Nausea, headache, fatigue, chills, and arm hurt. Two weeks later, side effects re-occurred for 24 hours. Three weeks later, arm still hurts (never stopped) and fatigue has been back since week 2.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-FEB-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 152 hours with the lowest recorded temperature of 0 Fahrenheit degree. The total cumulative excursion time of the second time was 776 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds). At the time of the report, PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter said it feels it was more that a gentle swirl.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-396573 (Patient Link).
Started to get a rash on her both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 03May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (First booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 09May2022, outcome "unknown", described as "Started to get a rash on her both legs".  Additional information: The reporter was reported raised. The patient was subtype reporter. The report his wife received the 2nd booster shot of the Pfizer-BioNTech COVID 19 Vaccine last Tuesday and 7 days later. She started to get a rash on her both legs. The reporter wants to know if this a common side effect due to the vaccine. The other products not provided. The regards to the COVID vaccine. His wife had the vaccine last week on Tuesday, 03May2022. It was the second booster shot. On Monday. 09May2022, seven days later, a rash appeared on both of her legs.   Follow-up (11May2022): This is a follow-up spontaneous report received from a same contactable consumer. This consumer (Patient's Spouse) reported for a female patient that: Updated Information: Reporter's address updated, Event onset date updated. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11/11/13 Patient started feeling flush immediately after inj. 11/12/13 Next day high fever T 102, rigors, general malaise exquisitely tender with axillary pain. DURICEF 500mg 2 PO now then one twice daily. 11/13/13 Swollen, more painful, fever down sent for MRI to R/O subcutaneous abscess. She was admitted 11/13/13 in the evening.
terrible migraine; fever 102 farenheit; muscle pain; chills; red eyes; not able to sleep the rest of the night; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00 (at the age of 24-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 20Jan2021 12:00 PM (at the age of 24-year-old) for COVID-19 immunization and experienced muscle pain in my arm. The patient did not receive any other vaccines in 4 weeks prior to the COVID vaccine. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 15Feb2021 18:00, patient experienced fever 102 farenheit, muscle pain, chills, red eyes, not able to sleep the rest of the night, terrible migraine on 16Feb2021 (the next day). Patient reported that initially got the shot, I noticed my muscle pain in my arm was not as bad as the 1st one. Later that day, I got chills which led to a fever 102 farenheit, red eyes, and I was not able to sleep the rest of the night. The next day, I had a terrible migraine. There was no treatment for the events. The events were assessed as non-serious. The patient underwent lab tests and procedures which included fever: 102 fahrenheit on 15Feb2021. The clinical outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.