chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report as received from a medical assistant referring to a male patient of unknown age. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 24-SEP-2019, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin (rHA)) (M-M-R II) lot # N034411, expiration date 04-DEC-2019 (vaccine dosage detail and route of administration were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 9 Celsius degrees for 15 minutes. There was no previous temperature excursion  reported. No adverse effects reported. No product quality complaint (PQC) was involved in this case. Digitial data logger was involved.; Sender's Comments:  US-009507513-1911USA003982:Original Case : 1911USA003982 US-009507513-2005USA003625: US-009507513-2005USA003625:
On Tuesday I woke up (the day after first shot) with pains on my right side of my back, I would move a certain way and the pain would burn, Wednesday I woke up at the pain moved slight closer to my arm pit but is still the same. Today, Thursday, I woke up and now the inside of my right HURTS and it's on my breast as well, if i sit up, I am in pain, it's a burning pain. My Breast is also numb
Upper respiratory symptoms and ear infections.  For weeks.  Had just finished a zpac and gotten over a URI so went and had my vaccine.  The next morning it was back with a vengeance.  It hung in for weeks in spite of going to the dr and getting antibiotic / steroid ear drops.  And I still have the tail end of it.
NAUSEA; TINNITUS; FEELING UNWELL; SEVERE ARM PAIN; SEVERE RIGORS; HEADACHE; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced tinnitus. On MAY-2021, the patient experienced feeling unwell. On MAY-2021, the patient experienced severe arm pain. On MAY-2021, the patient experienced severe rigors. On MAY-2021, the patient experienced headache. On 07-MAY-2021, the patient experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe arm pain, severe rigors, and headache on MAY-2021, had not recovered from tinnitus, and the outcome of feeling unwell and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817407 and 20210817554.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: PATIENT RECEIVED BOTH FLUZONE & PFIZER VACCINATIONS. SHE THEN BECAME LIGHT-HEADED/ DISORIENTED. WE FOUND HER SITTING ON THE FLOOR. WE GAVE HER A CHAIR TO SIT COMFORTABLY, THEN SHE WAS NAUSEOUS AND VOMITED ON THE FLOOR. SHE REMAINED SITTING THERE FOR 30 MINUTES WHILE WE MONITORED HER BEFORE SHE LEFT.
Flu shot at 2:30 PM 11/7/11. At 5:30 PM felt her throat closing up. Took an antihistamine at 9 PM and relief 1 hr. later.
Pt came to ER stated he had all the covid symptoms including diarrhea.  Stated he recieved his 1st moderna dose on 8/13/21.
1-10-08 Varivax given.  1-22-08 office visit.  On approximately 1-20-08 scattered rash started (sm bumps, slight erythematous, no vesicles) - fever on 1-21-08.  Several on back and extremities.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medication was not reported. On 17-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (route, dose, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
15-year-old received Moderna booster (0.25mL), administered in error. Patient's father notified of error on March 3, 2022. No reported adverse side effects. Family offered call from medical director. Advised to notify child's pediatrician.
This spontaneous report was received from a nurse practitioner, via a company representative, referring to a 14 years old female patient. The patient's medical history and concurrent conditions were not reported. In August 2016, the patient was vaccinated with her first dose of GARDASIL 9, 0.5 ml, intramuscularly, (strength, anatomical location of administration, lot # and expiration date were unknown). Concomitant therapies were not reported. On an unspecified date in 2016, the patient developed eczema at the injection site. No product quality complaint was involved. At the time of reporting, the outcome of the injection site eczema was unknown. The causality assessment between the injection site eczema and GARDASIL 9 was not provided. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medication, drug reactions or allergies provided. From 20-SEP-2015 to 30-SEP-215, the patients were vaccinate with improperly stored doses of ROTATEQ (lot # J015689, expiration date 11-NOV-2015, dose was not reported; orally). No adverse events were reported. Additional information has been requested.
Patient was given Pfizer monovalent booster instead of Pfizer bivalent booster.  Patient was contacted and informed and was ok with receiving their bivalent booster in 2 months.
pt recvd vax approx 12n @ approx 1215 raised whelp noted above eye; w/in 1 5mins, hives noted on face & legs per mom; mom gave DPH-rash faded; hives reappeared next AM in approx same placed-face, ankles, calves;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-NOV-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-JUN-2016, the patient was treated at a medical center for a blistering outbreak that was diagnosed as severe herpes zoster or shingles. He was prescribed valacyclovir for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
localize swelling, redness, swelling in solid mass like an abscess. Pt had gotten Hep A and Hep B Separately prior to this w/o reaction.
pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.
confused, 102.7 fever, headache, chills, Charlie horses in both upper legs and couldn't walk, injection site very painful
No additional AE reported; improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a registered nurse and refers to patients of unknown age and gender. The patients' medical history, concurrent conditions abd concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error).  This is a non-valid case due to no exact patient number and no patients' identifiers.  Follow-up information has been received from a registered Nurse on 30-MAR-2023.  Report refers to a 13 month 21 days old female patient. Patient demographics updated. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), pneumococcal vaccine conj 13v (PREVENAR 13) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS).   On 20-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was administered via subcutaneous on right thigh and on 21-MAR-2023 it was found on the look back data logger monitoring that the defrost on the freezer (the temperature was getting too warm) out of range of manufacturer storage recommendations. No complications, no reactions, no complaints.   The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA011232: US-009507513-2303USA011231: US-009507513-2303USA011230: US-009507513-2303USA011233:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0164), in right arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030), in right arm and on 07Jun2022 as dose 4 (booster), single (Lot number: FP4559) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Severe Sleep Apnea" (unspecified if ongoing), notes: Other medical history: Severe Sleep Apnea, SVT; "SVT" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: TRINTELLIX (Brand: Takeda), start date: 01Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient experienced shortness of breath and fever which were part of symptoms and was deciding factor to confer MD who prescribed Paxlovid.  No follow-up attempts are possible. No further information is expected.
Patient stated that on the day after the second dose, she experienced pain on the right upper side of her chest aroud her lung. She coughed up what she described as a blood clot about the size of a half dollar. As of Friday,  November 5th, se was still experiencing pain/tightness in the upper right chest area.
It started as chills and body aches at 2 AM then progressed to a fever, borderline migraine, and nausea. I am unsure about whether or not I should take medicine for it so I have remained unmedicated thus far.
Fainting after vaccination with Pfizer vaccine . Patient was conscious and responded when asked "are you o.k". He laid flat on the floor . Pharmacy called 911 and EMT came .
Dizziness, chills, T 100.5, headache, sore throat, cough. Seen in urgent care clinic, given after breathing treatment and antibiotics. Coughing still after 3 weeks.
Boostrix instead of Dtap; Boostrix was administered to a 5-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On 20-AUG-2023, the patient received Boostrix. On 20-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Dtap) and inappropriate age at vaccine administration (Verbatim: Boostrix was administered to a 5-year-old patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: Receipt Date: 21-AUG-2023 Nurse called to report Boostrix was administered to a 5-year-old patient that was intended to receive Dtap, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow up.
Dizziness from 12/29/20 . Ongoing but has been decreasing as of 1/6/21
Large red rash 4.25 inches diameter at sight of injection with swelling 45 hours after injection.
pt passed out immed p/being vaxed w/MMR; No further details were provided;
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
HYPOTENSION 2/24/2023  &  2/28/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
little fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to the company on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little fever) 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (little fever). At the time of the report, PYREXIA (little fever) outcome was unknown.
Developed hives approx. 4 hrs after received flu vaccine. Took BENADRYL and resolved.
On 01/05/2023 it started out as a headache. I put it off as stress and not eating correctly by the end of the day I thought I had the flu. We did have other workers who had COVID-19, I told the supervisor I would test at home and I did, It immediately popped positive. I had symptoms of being achy and sore and isolated for five days no respiratory problems only achy and headache and my sinuses were really bothering me. I went back to work on 01/16/2023.
shock/collapse type sx-6hr p/vax;pt woke from a nap, had an unusual cry/scream then began turning blue w/diff breathing, cold sweat;stopped breathing & went limp; 911 called w/in 5min pt struggling to breath again;
This spontaneous report was received from a registered nurse refers to a 4 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAR-2018, the patient was vaccinated with improperly stored dose of ROTATEQ vial (strength, dose and route of administration were not reported) (lot # N012762, expiry date: 04-FEB-2019) for prophylaxis. The vaccine experienced a temperature excursion of 0 degrees Celsius (C) to 1 C for 2 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information were provided. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA003508.
This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history was not reported. The reporter is not related to a study or program. Concomitant medications included unspecified medication (She does take other medications but does not know the significance). On 30Mar2021, the physician stated that, the patient developed immediate right-side neck pressure, skin and jaw tingling, and swollen lymph nodes. She did not have any trouble breathing and did not have any hives. These events were considered as medically significant. The pharmacist gave her 2 Benadryl and she stayed there for an hour. She said she does not think the Benadryl did anything for her. The physician stated that the patient went home and slept off the immediate reaction she experienced and had fatigue for 3 days. The patient had fatigue for 3 days and no other problems. The physician inquired on advisable information for the second dose. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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.
Received DTAP on 04/30/2003.  Brought child in the next day and had warm, red area approx. 3 1/2 by 4 1/2 inches at injection site.  She had given for Tylenol.  No fever.  No difficult walking-suggested Ibuprofen instead of Tylenol.  Called on 05/02 and states it was hurting more this afternoon and yesterday, so she took child to Dr. and Prednesone was prescribed x7 days.  It much improved today.  Also had fever of 101 degrees yesterday afternoon, a febrite today.
Arm was swollen so big and was in so much pain; Arm was swollen so big and was in so much pain; can't use the injection arm, can barely use it; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809) dose 1, via an unspecified route of administration, administered in Arm on 10Feb2021 as dose 1 single (at the age of 70 years) for covid-19 immunisation. Patient received the vaccine to avoid getting the virus.The patient medical history and concomitant medications were not reported. The patient experienced arm was swollen so big and was in so much pain, can't use the injection arm, can barely use it all on 12Feb2021. Patient screamed with the pain, called the doctor shoulder specialist, stated Vaccine was given too high on the shoulder. COVID-19 Vaccine should not have been administered that high. She has been seeing this shoulder specialist for problems with her other shoulder. Therapeutic measures were taken as a result of event. Rubbed her arm with alcohol. Put ice and heat on it. The swelling has gone down, arm just hurts now. Went to physical therapy on Friday and will be going back sometime. Doctor put patient in physical therapy to treat for it, patient has problems with her other arm and is supposed to have surgery scheduled for it. She was supposed to take second dose on 03Mar2021. She Wants to take second COVID-19 Vaccine, but doctor  recommends reporter receives it in her hip. Asked what kinds of plans she can make for this. The outcome of the event Arm was swollen so big was recovering while the other events were not recovered.   Follow-up attempts are completed. No further information is expected.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958348, 20210958321, 20210958423, 20210958993 and 20210958806.
This case was initially reported by a consumer, who is also the patient, on 15 December 2010. A 79-year-old female patient received an INFLUENZA VACCINE (manufacturer reported as "possibly Sanofi Pasteur", lot not reported) in the left arm on 22 November 2010. The patient had a history of increased blood pressure and temporal arteritis (for past 3 years); she had previously experienced swelling and a hard knot at the site of a pneumococcal vaccine, and had received numerous influenza vaccines in the past. Concomitant medications included prednisone, a blood pressure pill, and Vitamin B12 1000mg. According to the patient, approximately 6 hours post-vaccination she began experiencing fever, nausea, vomiting, and difficulty in moving. Approximately 12 hours post-vaccination, she had a fever of 103 degrees and was unable to get out of bed. She was seen by a physician the day after vaccination, at which time she complained of difficulty walking and "brain function problem", described as fuzziness, slow thinking process, and balance problems when walking. The patient noted that she had been seen by a "brain doctor". Outcome was not reported.