chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & devel fussiness & irritability;pt recovered w/in 7 days;
Realized that the patient was given the second H1N1 vaccine only 17 days after the first instead of the recomended 28.
Dizziness, NauseaVomiting, Tachycardia, Lightheadedness, shakiness Narrative:
persistent and severe sore throat; dry mouth; Other Vaccine on Same date product: Flucelvax Quadravalent; Other Vaccine on Same date product: Flucelvax Quadravalent; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 23Sep2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose 3 (booster): unknown manufacture , Route of Administration: Intramuscular), administration date: Oct2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose 1; unknown manufacture), for COVID-19 Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Sep2022, outcome "unknown" and all described as "Other Vaccine on Same date product: Flucelvax Quadravalent"; DRY MOUTH (non-serious) with onset 24Sep2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 24Sep2022, outcome "not recovered", described as "persistent and severe sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, dry mouth.  Additional information: Patient administered Flucelvax Quadravalent in deltoid. Patient allergies, medical history was unknown and unknown if patient received any other medications in two weeks, and no other vaccine used in four weeks but used Flucelvax Quadravalent on same day on which covid vaccine was administered. Physician/patient reports persistent and severe sore throat following receipt of COVID19 bivalent booster and QIV flu vaccines associated with dry mouth. No fever or exudates. COVID19 antigen test negative x2. For oropharyngeal pain and dry mouth Taking ibuprofen with minimal relief. Not experienced COVID prior vaccination. Post vaccination nasal swab test result was negative.   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.
The mother described the pt having thrombocytopenia purpura following vaccination. He had a 2x2 inch purple bruise on the back of his right arm. The parents discussed this and decided a blood vessel must have been hit when the vaccine was given. After school started they began noticing more bruises. For awhile they attributed it to being a 4 year old and new playground equipment rough housing. The he started to get bruises in odd places like the stomach, face, and upper legs. We discussed this with preschool and daycare. After 2 months we decided to have a blood test done at our family doctor. The results were platelets 7,000. They were sent to another facility and once they were there the lab results were platelets - 2,000. We then had Win Rho administered. Since then we have had 9 more blood tests with up and down results. Per annual follow up last platelet was 22,000 in march 2002. Patient still bruises easily + cannot participate in the usually. activities(sports); telephone interview with mother.  Annual follow up 10/29/2003: "Vaccine recipient did not recover from the adverse events. 07/09/2003: Platelet count 76,000; normal value 150-400,000."
Left arm started to feel hot in the middle of the night on January 30 (8 days after vaccination).  Also, felt a few bumps and slightly itchy. On Sunday, January 31st, thighs and arms have raised hives on them in patches...more in upper thighs and backs of arms.
Uncontrolled shivering and fever.  Followed on 11/1/2016 by leg aches, severe head and neck ache, welt and bruise on arm.  General flu-like symptoms lasting 24 hours.
cold; pain the feet; problems with the stomach after eating; diarrhea; stomachache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain the feet), ABDOMINAL DISCOMFORT (problems with the stomach after eating), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomachache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain the feet), ABDOMINAL DISCOMFORT (problems with the stomach after eating), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomachache). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain the feet), ABDOMINAL DISCOMFORT (problems with the stomach after eating), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomachache) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1) N/A 2) 2nd does administered around 11:15 A.M 4/23. Onset of chills at 10:00 P.M. that day. Woke up at 7 A.M with no symptoms on 4/24. Around 10 A.M. on 4/24, chills began to set in, followed by fatigue, and a minor cough. I started to develop a fever around 1 P.M., at 99.0, then to 99.9 by 1:30, 100 by 1:45. I  reached 100.4 by 2 PM. After taking Ibuprofen and Tylenol, the fever and exhaustion began to fade. I took a 40 minute nap around 4 P.M. and was fever free afterwards. I woke at 7 A.M on 4/25 and felt great. Went through my daily activities, and by 4 P.M. that afternoon, I began to feel very warm and exhausted. I also developed a cough that was more forceful than the previous day. I never had a fever. I began to feel better after taking DayQuil around 6 P.M. On 4/26 I felt like I was experiencing a typical case of hives, my face felt itchy as well as my arms and legs.
This spontaneous report as received from a health care professional refers to a 30 year old male patient. No medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with GARDASIL (GARDASIL quadrivalent of GARDASIL 9 could not be ruled out so event is being reported as GARDASIL quadrivalent) (dose, lot#, route, frequency not reported). No concomitant medications reported. On an unknown date the patient experienced human papilloma viral (HPV) infection in the throat after unspecified time after receiving GARDASIL. The outcome of human papilloma viral (HPV) infection in the throat was unknown. Additional information is not expected, since health care worker declined to provide any information as the information that was provided is all that is known.
Pulsating rib and chest pains, began at 10:00pm (16/11), ceased at 1:00am (17/11). Slight shortness of breath/wheezing, began at 10:00pm (16/11), ceased upon waking the next morning (17/11). Tightness in the auxillary region on L side (injection side), began at 10:00pm (16/11), ceased at 9:00pm (17/11). Lightheadedness and moderate tension headache, exacerbated by bending over, began at 9:00pm (16/11), dissipated 36 hours later (morning of 18/11) Postural hypotension, began at 9:00pm (16/11), dissipated 36 hours later (morning of 18/11) Moderate to severe fatigue began at 9:00pm (16/11), dissipated 36 hours later (morning of 18/11) Worsening of sore throat, has not resolved yet. Moderate to severe joint pain and whole body achiness began at 9:00pm (16/11), has not resolved yet.   Most adverse events self-resolved. No medication was taken. Lengthy naps of 2-5 hours were taken throughout the first two days (16/11, 17/11) which I suspect made a tremendous impact on the recovery of adverse events.
Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), intramuscular in the left arm, on 26Jan2021 14:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included migraine and diabetes mellitus (diabetic). The patient has no allergies to medications, food or other products. Concomitant medication included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-10 post vaccination. The patient experienced migraine headaches, chills, body aches and sore arm on 26Jan2021 at 14:00. No treatment was given for the events. The outcome of the events was unknown. The events were assessed as non-serious.
Fever within hours of of DTaP/Hib #4, HBV #3, PCB #3. Very irritable with continuous crying, fell over x 3 with glazed look, eye rolling and ? fainted at 7:45 om 9/12/02 limp. ? sz. vs. hyporesponsive episode.
Kinrix given to a 4-month-old; Kinrix given instead of Pentacel; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 29-MAR-2023, the patient received Kinrix. On 29-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 4-month-old) and wrong vaccine administered (Verbatim: Kinrix given instead of Pentacel). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 29-MAR-2023 MD stated Kinrix was administered to a 4 month old.  The patient was supposed to get Pentacel. The vaccine administration facility was the same as primary reporter. The HCP did not had the lot number and expiration readily available.  The reporter consented to follow up via postal.  The patient received Kinrix instead of Pentacel, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Smallpox vaccine given 12/05/2001. Checked in office day 7. Adverse reaction on days 8-9, increased swelling, increase erthema approx. 2-5 inches in diameter. Fever 102 , no lymph, no streaking. treated with Levaquin 500 mg 1 po qd #5
This spontaneous report was received from a Registered Nurse refers to a 69 year old female patient. No medical history or drug reactions were reported. On 28-OCT-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J006082, 12-APR-2014) 0.5 ml, intramuscular. Concomitant therapies included aspirin, anastrozole, CLARITIN, gabapentin, hydrochlorothiazide, lovastatin, metoprolol, venlafaxine hydrochloride and verapamil. On 29-OCT-2013, the patient developed a large red area at the injection site and the deltoid of the right arm, which was painful to the touch. Patient sought medical attention. The nurse stated the red area was "10 by 13 centimeters". The patient was seen in the office on 29-OCT-2013, and an unspecified physician instructed her to use a cold compress on the area. No laboratory tests were performed. The outcome of the deltoid of the right arm, which is painful to the touch and large red area at the injection site was reported as not recovered. Additional information has been requested.
Patient complained of chest pain radiating to her L shoulder starting at 1620.  Patient moved to dental chair, Dr called and vitals taken at 16:30 was  O2 92%, BP 142/91. 16:38 pt complains of slightly improved CP and but tingling in  both arms and hands, O2 remains 92-98%. EMS called at 16:40. Aspirin 325mg chewed  given 16:50. Pt declined ambulance ride to ER but agrees to go to ER with  daughter immediately for further assessment.
10 days after MMRV vaccine administered -  fever, rash on trunk and febrile seizure.  EMS took child to hospital - labwork and overnight stay for observation.  02/26/2007 MR received for ER visit for 1 episode of tonic clonic jerking lasting 2-3 minutes 10 days after vax. on 01/17/2007. HPI:  Minor fever noted the night before.  After nap, child woke with a fever of 101.5'F rectally.  Shortly after temp. child fell back with arms and legs flexed and back arched, began jerking movements.  Cyanosis noted around the lips.  15-20 minute post-ictal period. PE shows mild papular rash on right chest. Otherwise WNL. Impression/Differential DX.  Seizure activity, likely febrile seizure.
This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of GARDASIL 9 lot number L036301, expiration date 20-DEC-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a "data logger". No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested. Sender's Comments: US-009507513-1705USA015783: US-009507513-1706USA004336: US-009507513-1706USA004338: US-009507513-1706USA004335.
pt recv vax 4SEP98 & returned to ER on 6SEP98 w/an inj site rxn;ER MD dx cellulitis;pt was treated in ER w/Ancef  & sent home w/a prescription for an oral ATB;
BNT162b2 mRNA vaccine related pulmonary eosinophilia; This is a literature report.  A 73-year-old male patient received BNT162b2 (BNT162B2), 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: "Non-smoker" (unspecified if ongoing); "nonproductive cough" (unspecified if ongoing); "wheezing" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY EOSINOPHILIA (hospitalization, medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "BNT162b2 mRNA vaccine related pulmonary eosinophilia". The patient underwent the following laboratory tests and procedures: Antibody test: weakly positive, notes: (1:4 titer); Antineutrophil cytoplasmic antibody: Normal; Antinuclear antibody: Normal; Aspergillus test: Negative; Biopsy: revealed organizing pneumonia with mixed, notes: mixed inflammatory infiltrate; Blood creatinine: elevated; Blood immunoglobulin E: normal; Bronchoalveolar lavage: 432, notes: Unit: cells/L revealed elevated WBC with neutrophilic predominance (85%); Computerised tomogram thorax: unremarkable; revealed a 2 cm rounded ground-glass opacity in, notes: the right upper lobe; Eosinophil count: 580, notes: Unit: cells/L eosinophilia at 5%; 6814, notes: marked eosinophilia at 29.5; FEV1/FVC ratio: 76 %; Fibrin D dimer: negative; Forced expiratory volume: 2.80 L, notes: (88% predicted); Forced vital capacity: 3.67 L, notes: 90% PREDICTED; anti-CCP: normal; negative; normal; RES-afebrile and audibly wheezing with a, notes: RES-afebrile and audibly wheezing  prolonged expiratory phase; normal; negative; Oxygen saturation: Unknown resul; 93 %, notes: tachypneic on 4LPM supplemental oxygen; Procalcitonin: negative; negative; Pulmonary function test: normal; Red blood cell sedimentation rate: negative; Respiratory viral panel: negative; White blood cell count: 85 %, notes: revealed elevated WBC with neutrophilic; White blood cell count: 13,200, notes: units as ml leukocytosis; 23100, notes: leukocytosis Unit: /mL. Therapeutic measures were taken as a result of pulmonary eosinophilia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Pulmonary eosinophilia" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202201210157 Same article/patient/drug and different event;
Fever; Chills; Body aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN, CLONAZEPAM and ESTRADIOL for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown and CHILLS (Chills) and MYALGIA (Body aches) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-053194 (Patient Link).
Edema, induration to 10cm, erythema and warmth started within hours, improving but not resolved by exam 3 days later. Claritin PO.
Local site reaction with swelling, throbbing pain, sore arm, rash, low-grade fever, broke a sweat, lethargy, and dizziness same evening day of vaccinations. Continued for 2 days with 2nd day symptoms of fever, dizziness subsiding. Rash, sore arm, and swelling (hard to the touch) persisted but diminished compared to previous day. On third and 4th days symptoms significantly diminished more but still having redness and sore arm.
area began to itch; pooled under my skin just below the injection site; area is red, raised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (area began to itch), VACCINATION SITE SWELLING (pooled under my skin just below the injection site) and VACCINATION SITE ERYTHEMA (area is red, raised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) 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 VACCINATION SITE PRURITUS (area began to itch), VACCINATION SITE SWELLING (pooled under my skin just below the injection site) and VACCINATION SITE ERYTHEMA (area is red, raised). At the time of the report, VACCINATION SITE PRURITUS (area began to itch), VACCINATION SITE SWELLING (pooled under my skin just below the injection site) and VACCINATION SITE ERYTHEMA (area is red, raised) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant F/U
When mixing the vaccine with the Diluent, I withdrew 0.8 ml of the diluent instead of 1.8 ml. Thus the vial was reconstituted with only 0.8 ml of 0.9% sodium chloride. The vial was gently inverted 10 times and 0.3 ml withdrawn for the first dose. This Pfizer vaccine 0.3 dose was injected into L deltoid of the patient. Patient was watched for 15 minutes and had no reaction. This was her second Pfizer vaccine. When the mistake was realized, I tried to call the patient three times; she did not answer the phone. I left a message to call me with any problems and advised her that the more concentrated dose may cause increased arm soreness and to take ibuprofen at bedtime. The next morning I was able to speak with the patient's husband who reported that she was doing well except for sore arm, body aches. She took Ibuprofen and went to work. On 8-4-2021 I again spoke with the patient who reported that arm hurt after the shot; the next day she had some nausea, diarrhea, sore throat lasting 5 days. This was similar to the reaction of her first pfizer vaccine shot 3 weeks earlier, but NOT worse than the real Covid infection which she had had 2 months prior to the first vaccine. I tried to call the Department of Health Pharmacy Services; there was no answer at 6:45 pm. I also looked for and received information from the CDC and Pfizer websites regarding incorrect dilution and administration of the vaccine.
Low grade fevers, hyperglycemia and ketonuria, headaches, L arm paresthesias and pain, and subsequent extremity weakness of arms and legs
Vertigo, severe dizziness, headaches, balance issues ongoing since 03/03/22. Has not yet been resolved
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
2-3 inch circle of redness around injection site on right arm. Went to little clinic on 4/23/15 and was treated with Bactrim ds for cellulitis.