chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose Number: 4: Pfizer / BioNTech; Dose Number: 3: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "hypercoagulable" (unspecified if ongoing), notes: hypercoagulable; "Known allergies Pcn" (unspecified if ongoing), notes: Known allergies Pcn. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 4: Pfizer / BioNTech; Dose Number: 3: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details, Product: COVID 19 Treatment, brand: Pfizer, Treatment start date: 28Dec2022, Treatment stop date: 01Jan2023, Lot number: Unknown, Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Drug ineffective and Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
no adverse effects reported; one-year old patient was administered PROQUAD instead of VARIVAX; This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not provided.  Concomitant therapies included sterile diluent.   On 01-JUL-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002496 and expiration date 23-JUL-2020, for prophylaxis (dosage schedule, route, anatomical location were not reported) instead of varicella virus vaccine live (Oka/Merck) (VARIVAX)(wrong product administered). No adverse effects reported.     The outcome of wrong product administered and no adverse event was unknown.
Severe constant headache causing lots of pressure. Chills low grade fever body aches fatigue joint pain difficulty breathing at night when sleeping. Difficultly being able to sleep or fall asleep due to excruciating headache and pressure and neck pain
I passed out and suffered a concussion. My wife found me on the floor when she heard me hit the ground. I was taken to the hospital and stayed for two nights while given numerous scans and tests. No indication of stroke or poor heart condition revealed by any of the tests. No other symptoms other than soreness (which could have been attributed to the fall).
Evening of shot, arm sore, slight nausea and headache. Woke up next morning arm hurt so bad could not lift above head, slight nausea, fatigue, headache and joint pain, slight fever. Multiple doses of alternating Tylenol and Motrin needed to combat. Also previous tinnitus heightened  after booster shot. Woke up second day with sore/swollen lymph nodes left armpit. Fatigue/headache/joint pain subsided day three. Day four arm pain pretty much gone, still sore to touch at injection site. Day seven lymph nodes almost back to normal.  Initial Covid doses were Pfizer administered on 3/26/21 and 4/23/21 by Hospital. No adverse reactions whatsoever to those, arm barely sore at injection site. After this Moderna booster, it is the worst I?ve felt in two years since I think I had Covid in March 2020 (limited testing then).
Patient had vaccine at approximately 1:00pm and at 6:00pm began having top lip swelling and sore throat.  Not witnessed.  Patient had eaten lean Quisine for lunch around noon.
Pimples all over his chest and back.  Similar to the effect of Egg ingestion.
Information has been received from a consumer concerning her daughter a 14 year old female with migraine who on 07-SEP-2007, 14-NOV-2008 and 19-MAR-2008 was administered her first, second and third doses with GARDASIL. Concomitant therapy included propranolol HCL. On 19-MAY-2008 the patient experienced seizure. On 20-MAY 2008 the patient "had another seizure in her sleep. Her eyes rolled back into her head", subsequently she was hospitalized for 5 days. On 23-AUG-2008 the patient came into the house "disoriented" after falling outside. Her mother suspected she had a seizure. The hospital did an X-ray which came out fine. Patient's right arm could not move, she did not remember the falling incident, and she was not herself at all. One of her eyes would go off to the side and her other eye to the other side, her mouth was twisted, her right side paralyzed, and she could not walk or talk or feel her right side. Even though her vision was checked and was 20/20, the patient's eyes still "kind of go off to the side when being talked to." Lab diagnostics studies performed included: MRI, MRA, EKG, EEG, X-ray, tests for drugs, heart problems diabetes, STD's, and pregnancy (results not reported). The patient will see a neurologist 09-OCT-2008. The patient present status was unknown. No more information reported. Upon internal review, right side paralysis was considered to be an other important event. Additional information has been requested.  12/2/08 Reviewed hospital medical records of 5/20-5/24/2008. FINAL DX: right-sided weakness; possible seizures Records reveal patient experienced episodes of weakness & unresponsiveness. Had been picked up from school w/migraine HA.  Had posturing movements, was unresponsive, & collapsed in restaurant.  Taken to ER & released.  Next AM had recurrent symptoms.  Taken to peds clinic & admitted.   Neuro consult done.  11/18/08 Reviewed neuro medical records of 06/12/2008. FINAL DX: Spell, seizure vs complex migraines vs non-epileptic/functional; HA migraines vs stress vs functional; Chiari brain malformation; abnormal EEG. Record reveals patient experienced migraine HA then began posturing, gaze palsy, drooling, unable to talk lasting approx 3 min.  Seen & released from ER w/EKG & tox screen neg.  Difficulty awakening next AM & then had another episode similar to initial episode.  Unable to use right arm for approx 1 hour.  No memory of either event.  Meds prescribed & referred for MRI of c-spine to rule out syrinx.
improperly stored temperature excursion; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 06-AUG-2020, the patient was vaccinated an improperly store dose of  with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # S020160, expiration date 30-JUN-2021, frequency reported as "1" (dose, route and vaccination site were not reported) for prophylaxis.       Temperature- 50F Time frame - 6°F to 14°F for 1 hour and 15 minutes; 15°F to 46°F (44.SF) for 1 hour and 30 minutes; 47°F to 77°F for 2 hours and 30 minutes Previous temperature excursion? N Was call because ofa "data logger"? Y
(L) deltoid red w/ increasing pain from time of injection causing erythema, soreness (14cm x 11cm).
Fever with body rash - maculopapular type on abdomen and legs - questionable Kawasaki disease and/or Hand foot and mouth - recently being worked up for juvenile arthritis - swollen hands and feet cont. with fever - rash and fever would come and go.
Redness, swelling and hot to touch at injection site.  10/14/2005 weight 185 1/2 lbs, pulse 69, temperature 98, blood pressure 128/73.
A 88 year old female with no significant PMH who was brought to the HCF by her family from her apartment due to fall, poor oral intake and confusion. Patient was diagnosed with COVID 19 infection.  Not hypoxic and therefore no treatment for COVID indicated.  Mentation waxes and wanes with underlying dementia.  Evaluated by PT/OT with recommendation for SNF placement.   COVID-19 infection without Pneumonia Generalized weakness/fatigue Metabolic encephalopathy (resolved)  Patient's generalized weakness, fatigue and some confusion is probably due to Covid-19 Virus Infection on background dementia  Date of onset of symptoms: 12/20 Symptoms present on admission: fatigue, generalized weakness, confusion Date of covid positive test: 12/21 Vaccination status: not known Imaging: CXR. Does not show pneumonia Oxygen requirements on admission: none. Sats are 95% on RA Current oxygen requirements: None RA with sats 95-96% Medical therapy: not indicated Consultants following: none Anticipated special isolation end date: 12/31 Mentation tends to wax and wane  Plan to discharge to SNF   Hypoxia (resolved) Intermittently requiring oxygen Has not required most recently Saturation 95-98 on room air   Thrombocytopenia Likely due to viral illness Stable No bleeding noted   Fall -Secondary to generalized weakness. - CT brain and CT cervical spine did not show any fracture or intracranial bleed. PT/OT evaluated: Plan for SNF at discharge
Vaccine was found to be expired as of 8-31-21. Contacted MD. They then followed up with Moderna. Received confirmation from Moderna that vaccine given was still considered viable. No adverse outcomes noted.
Complaint of left sided deficit( numbness and tingling on cheek, forearm and leg, left side feels heavier than right side.
Within a few minutes of receiving her vaccine, the patient reported feeling warm and light headed. Her blood pressure was 67/48 initially. We gave her a cold pack to place on her neck/face and continued to monitor her bp every 5 minutes. Each bp reading was higher than the last (98/62, 126/77, 116/83). After the fourth bp reading, the patient reported that she felt well enough to go home and she left.
Patient was given expired Afluria Quadrivalent vaccine.  Vaccine expired on 30 Jun 2020.  Patient denied any adverse reactions at this time.
FLOORED; FELT ILL; SEVERE FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of FALL (FLOORED), IMMUNISATION REACTION (FELT ILL) and FATIGUE (SEVERE FATIGUE) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for an unknown indication.    Patient had no known allergies.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. and IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. On an unknown date, the patient experienced FALL (FLOORED), IMMUNISATION REACTION (FELT ILL) and FATIGUE (SEVERE FATIGUE). At the time of the report, FALL (FLOORED), IMMUNISATION REACTION (FELT ILL) and FATIGUE (SEVERE FATIGUE) was resolving.            No concomitant drug taken by patient.  On an unknown date, the patient experienced severe fatigue, felt ill and floored after dose of Moderna booster. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Loss of range of motion due to pain in upper arm and right arm because I was injected in both my left and right shoulder area. It was the Pfizer vac. My second injection was 3/23/2021. I?ve been doing physical therapy for months   With no significant results. I had 2 cortisone injections in each arm but pain persists. I?ve had mri ?s done where the right arm shows a partial tear but the left arm which is just as painful as the right shows no tear.
Patient rpts that upper left arm was "almost immediately very painful" from shoulder to elbow.  A rash developed around site in injection, about 10mm in diameter on 2nd day. By day 9, when I saw patient, rash was flat and erythematous, 35mm in diameter.  Pt describes it as painful; pain can be controlled with Tylenol.
Information has been received from a physician concerning two female patients (age not reported) who on approximately 01-JUN-2007 were vaccinated with a first dose of Gardasil (lot number unknown). The females may have been siblings. The one patient may have fainted after watching her sister receive Gardasil. It is unspecified whether patient two received the dose. No additional information was provided. Follow-up information was received via telephone. The clinical manager stated that when the first girl received her shot the sister fainted. Both patient were fine. Additional information has been requested.
pt recv vax 17MAY96 12noon & 2PM pt awoke from nap w/inconsolable cry which lasted 5hrs;pt lt ant thigh was bright red in color & doubled in size;t101.2;bruise 3" in diameter which changed to pocky marks which lasted 1mo in duration;
Narrative: No documentation of ADR. Documentation of vaccine administration found, however no supporting evidence between date of administration to date of documentation of allergy. Patient also diagnosed with COVID at the time of allergy logged, which could present with similar symptoms.
Patient felt dizzy, light-headed after receiving 1st dose of Pfizer vaccine. She attributed to early hour, her blood pressure and cold temperature. No chest pain, shortness of breath. Initial VS - BP: 168/110, p74, r22, O2 97%. Patient observed 30 min and dc VS - BP: 148/84, p76, r18, O2 97% with symptoms resolved.
Moderna COVID-19 VACCINE EUA Patient stated "I went to bed around midnight and woke up at 2:30 with severe back pain. It went down into my legs and I couldn't move. I wasn't able to get out of bed until 7:30 am. "  States he did not go to hospital or call his doctor. States "I know it had to be because of the Moderna shot I got". Patient informed that he called Moderna because "I want them to know this was severe and I want to know who else this has happened to". States he was unable to understand the person he spoke with at Moderna and wants someone to tell him how often this side effect happens. Patient also states "I want to know if I should get future boosters". Patient states "I want someone to call me and talk to me about this."
very sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "very sore arm".  Additional information: Event took place after use of the product.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
unconsolable crying 1 1/2 hrs p/inject & lasting 5-6 hrs;
No reaction to vaccine- she was given a PENTACEL vaccine and a HIB vaccine in error- no reaction.
Scratchy voice, dyspnea and heaviness in throat within first 10 minutes of injection. Benadryl oral and Epi injection given
She is really achy; She has got a 101.3 fever; Nausea; Headache; This is a spontaneous report received from a contactable consumer or other non-healthcare professional. A 43-years-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 22May2021 (age at vaccination 43-years-old) as dose 2, single for COVID-19 immunisation. Medical history included was not included. Concomitant medications included Methadone for an unspecified indication. Patient previously took novocain and experienced drug hypersensitivity and lidocaine and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Reporter stated, Me and my wife both got the Pfizer Covid 19 second the second shot on yesterday and I am not experiencing any side effects but she is really achy, she has got a 101.3 fever, nausea, headache and its been going on over 24 hours on 22May2021. No treatment was received for the events. The patient underwent lab tests and medical procedures which included body Temperature: 101.3 on 22May2021 and body Temperature: 101.3 on 23May2021. The outcome of the events was reported as not recovered.  Information on lot/ batch number has been requested.  Follow-up (29Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a patient's mother concerning her 18 week old female child with no pertinent medical history and no known drug allergies/drug reactions who on 16-JUN-2009 was vaccinated with the first 2 mL dose of ROTATEQ by oral route. On 10-AUG-2009, the patient received the second 2 mL dose of ROTATEQ (Lot # 663399/0308Y) by oral route. Concomitant vaccines included PEDIARIX, ACTHIB and PREVNAR. It was reported that mom called the doctor office on 14-AUG-2009 stating child had diarrhea and diaper rash. It was reported that the child was seen at the office on 18-AUG-2009; still had diarrhea and diaper rash. There were no laboratory diagnostic tests performed. It was reported that NYSTATIN was treatment for the diaper rash. It was reported that child still had watery stools and had not recovered at the time of the report. Follow up information was received from a physician concerning a 4 months old female patient who on 10-AUG-2009, in the morning, was vaccinated with the second dose of ROTATEQ (Lot # 663399/0308Y) by oral route. Concomitant vaccines given intramuscularly into her thigh on the same day included the second dose of PEDIARIX (Lot # AC21B187AA), ACTHIB (Lot # UF604AB) and PREVNAR (Lot # D75884). There were no illnesses at time of vaccination. It was reported that the infant had persistent loose stools from the day following her vaccine on, and it was reported that it lasted 2 weeks more. On 25-AUG-2009, the patient recovered. No further information is available.
Shoulder pain; Fever; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Shoulder pain) and PYREXIA (Fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (Shoulder pain) and PYREXIA (Fever). At the time of the report, ARTHRALGIA (Shoulder pain) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SLIGHT SWELLING ON FIRST DAY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight swelling on first day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight swelling on first day was not reported. This report was non-serious.
Gave PCV13 to 53 yr old diabetic - should have been PPSV23 only for his age. Was reading the recommended adult IZ schedule for 2015, but was considering him immunocompromised and should have read further where it specifically addressed diabetic - upon talking with pt today 10/26/15, pt.  has had some  on and off tingling ring finger, middle finger and under arm L. No other symptoms will check out with provider if continues.
The patient received her flu vaccination. Upon walking away, the patient fell down to the floor. She was conscious but stated that she was dizzy and then blanked out. I called an ambulance for her. Upon their arrival she sat up. A while later she began to feel nauseous. Patient left with mom and ambulance.
Vx administered after inappropriate storage; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Boostrix, Infanrix, Menveo and Havrix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Infanrix, Menveo and Havrix, the patient experienced incorrect storage of drug (Verbatim: Vx administered after inappropriate storage). The outcome of the incorrect storage of drug 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: 05-MAY-2023 The nurse called to report, had a fridge that stores Bexsero, Boostrix, Infanrix, Menveo, Havrix that had a temperature excursion of minus 4 degree Celsius and some vaccines might had been administered, which led to incorrect storage of drug. The reporter did not know which vaccine, lot number or patients it could had been administered. The reporter did not consent to follow-up.
Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she received.  Pt states she was Covid positive on 12/8/21 and received the Covid vaccine on 1/20/21.  Later that day she reported feeling "woozy" and started to feel like she was "drunk" (pt states she has not had a drink since 2005).  On 1/21/21 she felt "sick as a dog" and started "violently vomiting".  She had a compazine suppository at home that she used which stopped the vomiting.  She reports she remained extremely nauseated and fatigued for the next 24 hours.  The nausea was only relieved when she would sleep or lie down flat.  Pt states she slept the rest of the day on 1/21/21 to "about noon" on 1/22/21 and started to feel better during the late afternoon.  She was able to eat dinner 1/22/21.  Pt reports she still feels tired but that she is better on 1/23/21.   Notified pt's PCP of events who followed up with pt with no further orders.  Last note from PCP on 1/27/21.   Spoke with pt 1/28/21 and pt states she remains without any further symptoms.