chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bad, bitter taste in mouth. Diarrhea.) and DIARRHOEA (Bad, bitter taste in mouth. Diarrhea.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21A, 024C21A and 024C21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Drug allergy (None that  patient aware of). Concomitant products included VENLAFAXINE HCL from 22-Jan-2022 to an unknown date for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022, the patient experienced DYSGEUSIA (Bad, bitter taste in mouth. Diarrhea.). On 21-May-2022, the patient experienced DIARRHOEA (Bad, bitter taste in mouth. Diarrhea.). At the time of the report, DYSGEUSIA (Bad, bitter taste in mouth. Diarrhea.) and DIARRHOEA (Bad, bitter taste in mouth. Diarrhea.) outcome was unknown.            Pfizer has permission to contact patient about this report Pfizer also has permission to contact patient's healthcare provider about this report Patient post COVID vaccination medication was not tracked. the patient previously received a COVID-19 Vaccine Bad, bitter taste in mouth. Diarrhea. Device Date : 22May2022 . The treatment history was not provided.
got my second dose too early; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second dose too early) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second dose too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second dose too early) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided by the reporter.
Patient stated itching, had redness at site of injection, light headedness, tongue, cheek and lip swelling.
1st dose, very sore arm.  2nd dose, very sore arm, lump at injection site, pain radiating down to hand, headache, body aches, nausea
This spontaneous report as received from a nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On 23-SEP-2013, the unspecified number of unspecified patients may have been administered doses of MMR II after it was stored improperly. Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
arm where got shot feels like it will explode; fever, chills & sweating; rt sided feels numb all the way down; shoulder swollen & hard; 7APR pt took PCN tablets had-was told to go to the MD; pt had localized rxn given med; allerg react
Red macular patch rash right below injection site, denied pain, pruritus, fever, chills. Did not try any treatments prior to seeing me.
pt had severe rash all over body and slight shortness of breath 2 hours after taking vaccine. pt took benadryl. symptoms have not gotten worse. called pharmacy to update the next day.  pt has not been seen by provider.
Inflamed site, itchiness, swollen vaccine site, hives, pain on site as well as in the underarm, hard and warm to the touch on the vaccine site.
19:00 on 11/13/09, (1) day after administration of vaccine, papule formed. Papule burst and cause localized pain. Injection site papule.
6/5/08 Fussy, T max 100.5. 6/6 Fussy. 6/7 1600 tired that day then mom holding. Child stared, small pupils, limp, pallor 1-2 hr duration, also hoarse.    6/13/08 Reviewed hospital medical records of 6/7-6/8/2008. FINAL DX: none provided, do d/c summary available.  Neuro consult states possible febrile seizure. Records reveal patient experienced irritability & low grade fever s/p vaccinations then became hoarse, congested, sleepy then suddenly became pale, limp, pupils pinpoint & staring.  Neuro consult done.
Started having chills, body aches, headache, and stomachache. Started at 11pm day of shot. Last the whole next day til around 8 pm.
Severe headache and muscle aches and chills.  Had symptoms for 16 hours.
Metallic type taste and smell occurred within 5 minutes of the shot.  Slight swelling of the tongue and throat.  Caused the need to repeatedly clear my throat and some coughing.  Reported to staff who pulled me aside to keep me there longer.  After an hour of being there, they felt I was ok to leave and recommended I take an antihistamine when I get home, which I did.  The also advised to report adverse reactions stating I had a mile allergic reaction to the shot.  I also noticed the roof of my mouth was very swollen within two hours of the shot too.  The ridges on the roof of the mouth were very pronounced and painful.  Strong metallic taste with it.   Went to bed because I was so tired.  Woke up to my arm being extremely sore and the area of the shot was raised, warm and painful to the touch.  Felt very achy, headache, and exhausted the next day like I had the flu for about 24-36 hours.  Slept the majority of the next day.  Smell and taste resolved within a few hours but the roof of the mouth took 3 days before resolving.  Took advil and Zyrtec (Antihistamine) as recommended by the staff.
05/27/21 - Fever/chills, tiredness, headache and diarrhea 05/28/21 - Minor muscle aches, minor joint pain and diarrhea
I WOKE UP AND HAD EXTREME PAIN IN MY SPINE AND IT LASTED FOR 4 DAYS I COULD BARELY MOVE THE PAIN WAS SO BAD THE PAIN SLOWLY WENT AWAY
From initial information received on 06/25/03 from a health care professional regarding an adverse event, occurring in the USA, it was reported that a 37 year old female pt received her first dose of JE-VAX Lot # ENJ210B, and first dose of Imovax Rabies, Lot # U0584, both administered in the right arm on 05/30/03.  The pt has no immediate reaction or side effects. During the day on 06/08/3 the pt noted mild intermitted malaise and occasional minimal tingling type paresthesia in the toes of both feet. These came in waves and lasted only short periods of time. During the night on 06/09/03 pt noted she felt a little lightheaded upon awakening.  When she laid back down, she had an episode of marked dizziness, which was non-spinning in type, more of a lightheaded sensation. She had alternate feelings that she was flushed or warm with being cold. She had no fever nor true shivers or rigorous chills. Pt developed bilateral tingling paresthesias in her hands and forearms symmetrically and a mild occipital throbbing headache, different in character than previous migraines. She did admit that she became somewhat anxious and may have hyperventilated. Pt went to ER for evaluation, her physical examination, sedimentation rate, CBC and other blood studies were unremarkable. She had no urticaria, rash, lip or tongue swelling, wheezing, nor shortness of breath, no myalgias, arthralgias, fever, speech or visual or other special sensory deficits, nor any motor weakness. Her symptoms abated in less than one hour of total duration. Pt had only mild lethargy the following day and then returned completely normal.  The pt had also received concurrent immunization with Td vaccine, Havrix and Engerix B on 05/29/03.
high pitched cry lasting 4-5 hrs; emesis x 1; slept few hrs then awakened crying shrilly again; cried for 2-3 days; lower extremities red & blotchy; felt warm to touch; t103 R;
no problems p/1st series; following 2nd series devel a temp of 104 ax 7 hrs p/shots; p/12 hrs pt cried for 2 hrs w/o stopping; mom had given APAP, cold packs to the site & tepid sponge bath; temp remained elevated 7 hrs; pt not taken to MD
sore throat; Maybe I have covid; cough; diarrhea; chills; aching here and there; shortness of breath; felt off; stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt off), ABDOMINAL PAIN UPPER (stomach cramps), DYSPNOEA (shortness of breath), CHILLS (chills) and OROPHARYNGEAL PAIN (sore throat) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7006320003 and 7006320006) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced MALAISE (felt off) and ABDOMINAL PAIN UPPER (stomach cramps). On 21-Jul-2021, the patient experienced DYSPNOEA (shortness of breath). On 22-Jul-2021, the patient experienced CHILLS (chills), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (Maybe I have covid), COUGH (cough), DIARRHOEA (diarrhea) and MYALGIA (aching here and there). At the time of the report, MALAISE (felt off), ABDOMINAL PAIN UPPER (stomach cramps), DYSPNOEA (shortness of breath), CHILLS (chills), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (Maybe I have covid), COUGH (cough), DIARRHOEA (diarrhea) and MYALGIA (aching here and there) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent. A 11-year-old male patient received bnt162b2, administered in arm right, administration date 09Nov2021 15:30 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 09Nov2021 15:45 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 09Nov2021 15:30, outcome "unknown", described as "Caller states she has 2 kids that got their Pfizer Covid shots and flu shots (11 Years old)"; CHEST PAIN (non-serious) with onset 09Nov2021 21:00, outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious) with onset 09Nov2021 21:00, outcome "unknown", described as "he said he has to stop doing something to catch his breath". Patient had not received any vaccine within 4 weeks prior to vaccinations. There was no relevant test. There were no adverse event following prior vaccinations. Reporter seriousness for both events were unspecified. Follow-up attempts are completed. No further information is expected.
Within 2-3 minutes experienced tingling in back of tongue and throat. Progressed at 20 minutes to inside of full mouth. Tingling not severe. Able to breath and swallow. Continued on to tightness in chest at approximately 45 minutes after vaccination. Still able to breathe without difficulty. Tingling/itching in face at approximately the same time. Currently at 2.5-3 hours after injection, chest discomfort resolved. Tingling in mouth almost gone, slight tingling in back of tongue continues. Face and eyes continue to be main issue with tingling and itching.
Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient developed swollen lymph node on the side of her neck after vaccination. It was reported that the patient was not administered vaccine in their office. A product quality complaint is not involved. No further information is available.
Same as the first two shots, pain in chest. Feels exactly like the precordial catch syndrome I used to have as a kid. The booster only lasted a few days, whereas the second shot lasted a few months.
pt to ED with increasing SOB, cough, congestion over past week; diagnosed with COVID; O2 sats at 80% on RA; came from SNF with hx of immobility and dementia; EKG revealed ST elevation; chose medical management over cardiac catherization; poor prognosis; pt's condition worsened; placed on comfort care and pt died in the hospital
This case was reported by a consumer via call center representative and described the occurrence of fever in a 81-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 4th June 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced incomplete course of vaccination. On 6th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left arm and experienced fever. The patient reported that she missed her 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The patient planned to continue follow-up with her pharmacy.
Period cycle became extremely heavy after receiving vaccination. Ever since the vaccine I have been having my cycle for 2 full weeks at a time. There is about a week break of no bleeding and then another 2 week cycle.
3 hours of within injection, child developed swollen eyes, lips and red blotches to entire torso. Mom gave child Benadryl, times 3 doses, mom didn't call until 09/21/2001, she called to schedule FLU appt, it was then that she told of reactions.
This is a spontaneous report from a non-contactable consumer. A 29-year-old non-pregnant female patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on an unknown date in Apr2021 (Batch/Lot number was not reported, age at vaccination: 28-year-old) as dose 2, single and dose 1 via an unspecified route of administration, administered in Arm Left on an unknown date in Mar2021 (Batch/Lot number was not reported, age at vaccination: 28-year-old) as dose 1, single for covid-19 immunisation administered in clinic. The patient was not pregnant at the time of vaccination. No medical history was reported. The patient had no known allergies. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has been tested for covid-19 since the vaccination. On 16Jul2021, the patient contracted covid-19 and tested positive for at least 10 days. No treatment was received for the event. The patient underwent lab tests and procedures which included nasal swab test on 15Jul2021 and result was positive, on 19Jul2021 and result was positive, on 23Jul2021 and result was negative. The outcome of event contracted covid-19 and tested positive for at least 10 days (covid-19) was recovered on an unknown date in Jul2021. No follow up attempts are possible. No further information is expected.
The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 02-Mar-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 02-Mar-2022) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 030L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
Headache, Tachycardia, Fatigue, dizziness Narrative:
Patient received expired dose of Moderna COVID vaccine. Dose had beyond use date of 9/27 @  0027, but dose given to patient on 9/27 @ 1355. Patient currently in a prolonged admission at hospital and received both doses during stay. Patient remains admitted for non-vaccine-related reasons.
12-24 hours after vaccination, pt was sent to Extended care for pain, swelling in armpit and arm down to elbow, light headedness and a sore somewhat hoarse throat. TX Depo Medrol 80mg IM, Benadryl 50mg PO, Tylenol 1000mg PO Triamcinolone 0.1% cream topically.
Hives from Head to toes.  Swollen ears, slight lip swollen, fever 101
Patient was to receive second dose of Moderna vaccine and was mistakenly given the Pfizer vaccine.
Fever, body aches, headache, fatigue, and difficulty breathing that last 3 days after symptoms arose.
Tingling on face-bilateral sides, down his neck and arms to his elbows.  Patient states he "feels odd".
Pfizer Bivalent booster was administered instead of second dose of Pfizer monovalent.
Pt recvd vax 8JUL92 & the next day seen in clinic w/fever, enlarged cervical lymphnode, malaise, weakness & h/a; then seen in local ER w/fever of 103 & was told may be reaction to vax;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 18-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX 0.65 ml (route of administration and frequency were unspecified) (lot # K010969, expiration date: 10-NOV-2015). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information is not expected since the reporter wished not to be contacted.
PATIENT EXPERIENCED VOMITING & DIARRHEA STARTING ON 7/22/17 LASTING 3 DAYS AFTER IMMUNIZATIONS & THEN HAD A FIRST TIME SEIZURE LASTING 3-4MINUTES ON 7/24/17.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex of unspecified race and ethnicity. 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, expiry: unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had stroke. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of  stroke was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220414885- Covid-19 vaccine ad26.cov2.s- stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Severe vertigo,I have not personally been this ill in 12 years, as my understanding is this is not listed as a possible side effect and therefore should be reportedand well as a heber of 100.5 for 3 days.
outer edges become redder; itchiness at the injection site; hump near injection site; stinging at injection site; Large 3 inch rash around injection site, hot to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (outer edges become redder), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hump near injection site), VACCINATION SITE PAIN (stinging at injection site) and VACCINATION SITE RASH (Large 3 inch rash around injection site, hot to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hump near injection site), VACCINATION SITE PAIN (stinging at injection site) and VACCINATION SITE RASH (Large 3 inch rash around injection site, hot to touch). On 27-Jan-2021, the patient experienced ERYTHEMA (outer edges become redder). The patient was treated with HYDROCORTISONE (topical) for Antiinflammatory therapy, at a dose of UNK UNK, bid. At the time of the report, ERYTHEMA (outer edges become redder), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hump near injection site), VACCINATION SITE PAIN (stinging at injection site) and VACCINATION SITE RASH (Large 3 inch rash around injection site, hot to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Hydrocortisone cream twice daily for about a week. Follow up appointment with HCP on 27Jan2021.