chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother reported that child "fell flat on her back" after receiving kindergarten shots. Mother did not take child to physician or emergency room. Child was crying after fall, did not have LOC and participated in all usual activities after the event. Mother states did give TYLENOL after immunization visit but child never ran fever.
Menstrual cycle immediately following both 1st and 2nd vaccine. 3rd period starting October 5th. I have not had periods in 12 years due to Moderna birth control.
LOCALIZED REACTION WITHIN ONE HOUR, SECONDARY CELLULITIS BY THE FOLLOWING MORNING DESPITE ICE AND BENADRYL
next day injection site became reddened, warm to touch, and swollen. mother put ice to area and gave her Tylenol which helped
I started having a runny nose, dry cough, a lot of fatigue. I had been to a meeting where we had not been wearing masks. One of the individuals at the meeting tested positive. Once I started to feel unwell, I decided to go get tested at a pharmacy, I never got back to bed and sleep after sleeping all night so I knew I must have gotten COVID-19. Once I tested positive, I received a prescription for PAXLOVID and started taking it immediately. I did start feeling better in the five days, may have gotten rebound COVID-19 but I am not sure as I did not test for it.
Patient became very flushed and ee stated she was not feeling well. BP: 156/96-176-96 HR: 80-98. Patient states this was not normal bp. continued to monitor pt and noted to have reddened rash on face. Patient to ED for further evaluation.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter No treatment information provided Date of refrigeration: 07-May-2021   This case was linked to MOD-2021-365150 (Patient Link).
FELT LIKE CHEEKS WERE THROBBING; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, weight were not reported, and patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced flu-like symptoms. On 06-MAR-2021, the patient experienced felt like cheeks were throbbing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and felt like cheeks were throbbing. This report was non-serious.  Additional information was received from patient on 06-Mar-2021 following information was updated and incorporated into case narrative: Batch number added, Outcome changed from recovering/resolving to not recovered/not resolved for the event flu-like symptoms, for event FELT LIKE CHEEKS WERE THROBBING onset date updated from 05 March to 06 March.
The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their studies they provided, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
BlurredVision Fatigue Narrative: Advise patient to seek Medical attention if blurry vision con't for 48 hours or worsens. Keep patient advised of any change or updates of condition
My symptoms started on December 22, 2022. The roof of my mouth was itchy. I was running a slight fever. I had no energy. I noticed shortness of breath when I went to get the paper downstairs. I took a COVID-19 test. The result was negative. I took TYLENOL, drank hot tea with honey, and took a hot shower. I was very tired, so I went to bed. I didn't feel any better the next day. I kept taking TYLENOL and added MUCINEX. I used a NETTIE POT, but it didn't really help. I took another COVID-19 test on December 24, 2022. The result was positive. I called my doctor. They sent me a list of things to do to take care of myself. I self-isolated for six days.
RASH ON BOTH LEGS AND ARMS; This spontaneous case report (PVX2019-1835) was received from a pharmacist on 16-Jul-2019. It describes a female consumer who developed rash on both legs and arms (PT: Rash generalized), after the administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif on 11-Jul-2019, 13-Jul-2019, and 15-Jul-2019, respectively. On 13-Jul-2019, after taking the second dose she developed rash. The rash was on both legs and both arms. She took antihistamine as treatment and the rash went away. Again on 15-Jul-2019, after taking the third dose she developed rash and took an antihistamine dose again. She had no atypical exposure to any food, chemicals, and medications prior to the rash.  The reporter was not certain about the rash history of the consumer, but the consumer completed the course of Vivotif in 2005 and 2010 and there were no adverse reactions experienced from Vivotif both the time.  The consumer's had environmental allergies, for which she was takes Flonase (fluticasone).  Action taken with Vivotif was vaccine discontinued.  The consumer had recovered from the event on 15-Jul-2019.  Company's Comment: In this case, it was reported that the consumer had rash on both legs and arms after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had rash on both legs and arms after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Left arm pain and rash. Mom reports that patient received PEDIARIX 6/29/15 and the following day significant arm pain armpit to fingers develop a 2 in x 1 in itchy rash and firm lump 2".
Acute Myocarditis, evident on CT chest, EKG changes, Elevated Troponin
p/vax walked out of room & over to payment table & fell against table  & onto the floor-mom picked pt up eyes rolled back, ridged, foaming @ mouth, unconscious;laid on floor for approx 5min then picked up & put on cough;disoriented;
A LITTLE SORENESS IN THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced a little soreness in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little soreness in the injection site was not reported. This report was non-serious.
Spoke to mother, by phone on 01/21/2022.  She reported that patient had been ill for 2 days following her vaccine.  She experienced body aches, shortness of breath and a fine rash on her chest the evening following her vaccine.  At the time that mother reported this, her symptoms had all resolved. It was recommended that she get written approval from a medical provider prior to her receiving her second dose. Spoke to mother by phone on 01/25/22 and she reported that their pediatrician was fine with her getting the second dose however upon further questioning, she had spoke with the nurse on the Nurse Advice Line and not the medical provider. When patient presented for second vaccine, she reported that she also had chills.  Vaccine was not given at this appointment.
Administered pediatric Pfizer concentration diluted with 1.8mL normal saline instead of adult dose.  Patient notified and asked to return for dose of adult Pfizer as recommended. Patient's mother called, concerned because patient is pregnant. I advised patient to contact obstetrician for further advice. Patient to see doctor Wednesday, January 12, 2022.
Pt was in for second series of pfizer and was given the booster pfizer bivalent.  Patient was asked to stay with this writer for 20 minutes and had no adverse affect.
This spontaneous report was received via social media from an association representative, referring to a female patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unspecified date, the patient was vaccinated with GARDASIL (dose, lot number, expiration date were not reported), or GARDASIL 9 (dose, lot number and expiration date were not reported). On an unspecified date, the patient experienced seizure, convulsions, epilepsy, hand tremors, excessive sweating, memory loss, lack of motivation and concentration, anxiety, joint pain, hospitalization (adverse event), food allergies, depression, aches/pains, sore, muscle pain, headache, sore throat and nausea. Upon internal review, the events of seizure, convulsions and epilepsy were considered to be medically significant. The causality assessment between the patient's events and therapy with GARDASIL, or GARDASIL 9, was not provided.
Pt received MMR at 7:45 AM. By 8:20 when pt presented to the ER, she complained of severe itching and hoarseness.
could not walk; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "could not walk"; PAIN (non-serious), outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was calm, sitting up on patient bed when I left the room following the visit. Nursing reportedly entered room and administered flu shot, left room. Brother says that patient was sitting up after flu shot, stood up to get ready to leave, and then fell forward onto the patient bed. When I entered the room, nursing was present and Dr was examining patient. On my arrival, patient was slumped forward over the patient bed drooling onto bed paper. Responsive to voice, able to gesture towards his chest indicating right chest pain. Able to lay supine onto bed, responsive to commands, difficulty talking. Coughing with intermittent gagging, continued to gesture towards right chest pain, denied throat tightening. No stridor. Started on albuterol nebulizer treatment when EMS arrived. Patient was taken to ED for further management.
Information has been received from a physician concerning an adult male with a history of chickenpox as a child who subsequently developed a rash over his anterior and posterior trunk and acute shortness of breath after daily exposure to patients who received a dose of varicella virus vaccine live. No treatment was given for the rash. EMS was called due to the patient's acute shortness of breath, for which he was treated with diphenhydramine HC1 (Benadryl) and oxygen. The patient was not hospitalized and was noted to be recovering. It was also noted the patient was not a recipient of the vaccine and did not directly administer the vaccine. The reporting physician considered the rash over anterior and posteriori trunk and acute shortness of breath to be immediately life-threatening. Additional information has been requested.
Extremely red blood shot eyes--slight discomfort.  Numbness in soft palate. 9:00 PM Extreme Chill.  Dry mouth, unquenchable thirst.
Patient stated that he was lightheaded. He was given water and remained seated for 10 minutes.  Felt better and had to use the bathroom. Walking there he fainted but his wife caught him protecting his head. His pulse and breathing were checked and the on-duty pharmacist stayed with him until the EMS arrived. By that time he was able to sit up and drink more water. He was not taken away by ambulance but was evaluated and walked out on his own.
Following vaccination patient reported "shakiness all over" and general weakness. VS 122/88, 75, 94% saturation. After 15 minutes symptoms resolved
felt sick, nostalgic, and she can barely take her home; felt sick, nostalgic, and she can barely take her home; This is a spontaneous report received from a contactable consumer from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID 19 vaccine (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "felt sick, nostalgic, and she can barely take her home".  Additional information: Patient's age was reported to be between 50s-70s.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
able to see the spot after the night in the next morning; itchy thumb area on right hand; slight rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (able to see the spot after the night in the next morning), PRURITUS (itchy thumb area on right hand) and RASH (slight rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-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 RASH MACULAR (able to see the spot after the night in the next morning), PRURITUS (itchy thumb area on right hand) and RASH (slight rash). At the time of the report, RASH MACULAR (able to see the spot after the night in the next morning), PRURITUS (itchy thumb area on right hand) and RASH (slight rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
neck pain, no fever.  Pain lessened with relation ans shoulder/neck massage.  still aches
Pt says he received the shingrix shot on 2/20/2023. On 3/3/2023 he reported that he was still experiencing a minor rash. He says there were no lifestyle changes or any new meds taken since the shot. He tried Benadryl once and it seemed to get better, said he would try another dose to see if it would help. Advised pt to contact MD to see if they recommend him getting the second dose of shingrix.
Headache at time of 2nd dose. Large painful swelling under right arm pit 2 days after injection.
Pediarix was given instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date 21st October 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via mail. Additional supportive information: The patient received a dose of Pediarix instead of Infanrix, which led to wrong vaccine administered.
Confirmed case of Multisystem Inflammatory Syndrome , onset 10/11/2021.
Patient noted that after 20-30 minutes after getting vaccine her face was flushed, and had chest itchiness. She felt lightheaded, nausea, and heart palpitations and dry mouth. Sent to ER and given 50 MD of Benadryl and symptoms slowly subsided.
Swollen left arm twice the size, red, itching, rash, pain, loss of arm mobility.
working in backyard when exp sudden onset of low back pain, to ER walking w/o problems but devel lower extremity paralysis acutely; Annual follow-up received on 12/13/2000 provided no additional data.
Breasts starting feeling swollen over several weeks.  Then I noticed some pain in both breasts.  I had a mammogram on 05/11/2021 and it came back with some areas that required further testing.  I am due for a diagnostic test on 05/24/2021.
broken blood vessel in left eye/It might have happened after the 1st dose too; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a broken blood vessel in left eye and stated that it was not going away. The outcome of event was not resolved.  Information about batch/lot number has been requested. Further information was expected.
Pt developed diffuse rash and itching X 4 days. Treated with Benadryl and Atarax. A follow up report received 10/19/2001 adds: Physician states family reported "AE" but not able to recall what type distress pt had; Nurse Practitioner went ahead with immunization. Symptoms did subside with 4 days of treatment with Benadryl and Atarax. He's otherwise doing well and his mind is clear.
On 12/24/2020 around 7PM, I started my menstrual period. My menstrual period should not have started until 1/2/2021 and I am usually very regular with my menstrual periods. This menstrual bleeding lasted through 12/26/2020 and stopped on 12/27/2020 AM. I did not experience any abdominal cramping. The blood flow was normal for what I would consider my 'normal period.'
Nausea; Headache; I have been in there ever since with severe pain; I am moving but with a lot of pain.; I already have some illnesses; I can barely get out of bed and barely walk.; the booster has had me in bed since the day I took it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "I have been in there ever since with severe pain; I am moving but with a lot of pain."; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I already have some illnesses; I can barely get out of bed and barely walk."; BEDRIDDEN (non-serious), outcome "unknown", described as "the booster has had me in bed since the day I took it.".  Additional information: It was reported that, patient was reporter. Patient had been in there ever since with severe pain; patient was moving but with a lot of pain. For next three- or four-months patient was feeling weak and tired all the time. What patient want to ask was, by on the 10Mar2022, patient took the Pfizer booster (later clarified as COVID-19 Vaccine) and patient had been in there ever since with severe pain and nausea and headache and patient wondering if this going to go away or was this react with something 'that patient already had' because patient already have some illnesses (Further not clarified). but patient was able to function now. Patient could barely get out of bed and barely walk and that was from Mar. Consumer was informed about Pfizer Medical information department. Patient was informed about the role of Pfizer Drug Safety. Patient stated, well, I want, I have a doctor 'appointment' but I did want to call you out and see this, If Is this, Am I only one whose having these symptoms or did he have been advised to 'bear' this symptom. Patient took the booster; patient took the two shots they didn't do me too bad, but the booster has had patient in bed since the day patient took it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200481511 Same patient, product, different dose and event