chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer Sponsored Program. An unspecified aged male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 20Feb2021 as a single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced COVID-19 positive (diagnosed on 25Jan2021)/received his dose last on 20Feb2021 and after a week on 27Feb2021 he experienced the feeling of tiredness. His second dose was supposed to be on 13Mar2021. The patient underwent lab tests and procedures which included COVID-19: Positive on 25Jan2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
developed generalized urticaria (no anaphylaxis) 18 hours after influenza vaccine. Treated with epinephrine, >50% improvement within 30 minutes, treated with diphenhydramine and famotidine
Healthy 25yo M with no personal or family hx CAD.   2 days after 2nd dose of vaccine had temp 38C and pleuritic chest pain. 3 days after vaccine woke with substernal chest pain, left arm numbness. EKG suggests pericarditis, markedly elevated troponin, possible myocarditis diagnosis (still pending).
7OCT97 approx between 6 & 8PM, flushed face, sore lt arm, uncomfortable sleeping on it per pt statement;8OCT97 h/a, fever, redness & swelling of entire back of lt arm;9OCT swelling extending to approx 4" below elbow;redness of all edematous
prettybad high fever; chills; really not well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3), for Covid-19 immunization, reaction(s): "really not well", "pretty bad high fever"; Bnt162b2 (Dose: 3), for COVID-19 Immunization, reaction(s): "Chills"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "pretty bad high fever"; Bnt162b2 (Dose: 2), for COVID-19 Immunization, reaction(s): "Chills", "really not well"; Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "was semi-okay".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "prettybad high fever"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "really not well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information :Reporter stated that it was not for him, it's concerning about his girlfriend. Yesterday, both of them got the Omicron, shot, at around 9am. She woke up having serious reactions right now. Right now her fever only about 100 but she was shivering and freezing and it has been since last few hours and vomiting too.When paraphrased the concern reporter stated, "Okay, she has had 4 of your shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well.When probed to clarify the concern with Pfizer COVID-19 Vaccine, reporter stated, "This was her 5th shot, with Pfizer, it's Pfizer, it was the Pfizer, yes with the Omicron variant (Hence, suspect product name captured as COVID-19 Vaccine).When probed to clarify the concern, reporter stated, "No, but he want to know what the best thing for him to do but he can't get anything for her.When informed to contact nearest emergency room or health care provider in case of emergency, reporter stated, she was vomitting and he would call later.  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-202201252978 same product, patient, different AEs, different dose;
Headache, Myalgia, NauseaVomiting, chills, malaise Narrative:
Itching on trunk, back, and groin, starting about 5 days after administration of vaccine.  No significant rash.
patient received MMR on 12/18/2018 instead of MMR-V as ordered. Patient not immunized with Varicella on this date. Varicella was given on 6/28/2019 as a catch up dose once error was discovered. No Varicella outbreak during lack of coverage.
Bi-lateral Pulmonary Embolism-14 days after vaccination. Aortic Aneurysm. Acute DVT. Kidney Failure. Leukocytosis Hyperfibrinogenemia Partially collapsed lungs. Ground glass opacities in upper lobes of both lungs. Hemoptysis Hematemesis Pleurisy Esophageal Bleeding/Lesion. Has developed  into GERD over past year despite protonix. Heart Arrythmia. Pericarditis. Vertigo. Tachycardia/hypotension. Possible Myocarditis. Blood coagulation disorder-Abnormal APTT, INR, Elevated D-Dimer 1+ year after vaccination. All is consistent with findings  and timeline of VITT, " Vaccine Induced immune Thrombotic Thrombocytopenia"
Hives on body, beginning 4 days after vaccine was given. Hives would appear and disappear over body (i.e. would occur on back and then one hour later, would not be on his back but would be on his arms/shoulders). Child reported it was itchy, was given allergy medicine for itch. No other symptoms.
Toothache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Toothache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (Toothache). At the time of the report, TOOTHACHE (Toothache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
2-19-2021 Received 1st Covid Injection 2-20-2021 Gasping for Air , LBP, EKG, transported via ambulance 2-21-2021 Admitted to Hospital LBP, EKG 2-22-2021 Surgery in which a pacemaker was installed
Patient had immediate swelling at injection site and bruising but reaction stayed localized. Patient was given (2) 25mg capsules of diphenhydramine and blood pressure was checked every 5min for 15min. No further symptoms developed and swelling decreased almost back to normal.
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse via an other health care professional. This case involves 6 patients (gender unknown) who received vaccines ACT-HIB lot UI901AAA, expiry date: 17-Sep-2019 via intramuscular route in the right thigh and DAPTACEL lot C5101AA, expiry date: 26-Nov-2018 via intramuscular route in the right thigh. The patient's does have any past medical history, medical treatment(s), vaccination(s) and family history. On 03-Oct-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI901AAA, expiry date: 17-Sep-2019 via intramuscular route in the right thigh. On 03-Oct-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5101AA, expiry date: 26-Nov-2018 via intramuscular route in the right thigh. Concomitant medications included was 0.5ml PREVNAR 13 lot number: T36366, expiry date: 28-Feb-2020 via intramuscular route in left thigh on 03-Oct-2018 and TRUMENBA. It was an actual medication error due to product storage error. It was reported that 6 patients received ACT-HIB, DAPTACEL, PREVNAR 13 and TRUMENBA vaccines after the temperature excursion which was at -1.32 degrees Celsius for 20 minutes.  It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a physician concerning a female registered nurse with no known drug allergies and no past medical history who on 24APR2003 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the day following the vaccination, the patient developed a "fine maculopapular rash" on her "trunk and extremities" and fever of 101 deg F. The patient was reported as "recovering with sequalea". Unspecified medical attention was sought. Follow up information indicated that the patient developed a maculopapular rash on 28APR2003. No pustules were noted. The rash was described as a fine, itchy, maculopapular rash over her chest, trunk, abdomen, and upper extremities. The rash improved with diphenhydramine hydrochloride (BENADRYL) after two days. The outcome was reported as recovered. No further information is expected.
At midnight (Sun into Mon.), patient said she had vomiting and diarrhea. She then started having nerve pain from her butt down her legs, starting on her left side then down both sides of her body. Severe left arm pain at site of injection and left bicep. Very warm to the touch. At 6 a.m. she was brought to the ER, given morphine and TORADOL and discharged 3 hours later. She had chills throughout Mon. after and is still tired and has (L) arm pain.
Discomfort in right arm after vaccination turned to muscle soreness and weakness. Neck muscles were stiff and sore as well. The arm weakness continues. He is unable to put weight on arm. States range of motion was limited as well, that has return to some extent but not fully. He has not seen a doctor. Plans to give it a little more time before doing so. Recommended he see a doctor.
Information has been received from a licensed practical nurse concerning a 79 year old female, with allergic reaction to antibiotics and codeine, who on 3/13/06 was vaccinated IM in the left arm with a second dose of 0.5ml of Pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). Concomitant therapy included estradiol (Climara), patch. On 3/13/06 the pts left arm became swollen, red, warm to touch. She also developed flu like symptoms and felt nauseous. The pts present status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus infection. I became shaky and tingly. My arm was sore and felt heavy. My face became dark red and was hot to the touch. All symptoms still continue now (27 hours later) however my face is not as dark red, just pink.  About 10 hours after the vaccine my muscles in my neck and shoulders began to ache. I was very fatigued. My entire body felt week and movement become a chore.  Worst symptoms: Through the night I began to experience acid reflux. I have only experienced this a couple of times in my life and very mild. This was severe to the point that I couldn't sleep, my throat burned from the acid. Even drinking water was very painful and it would come back up. I  located some Tums and ate 4. This was also a challenge as I couldn't hardly swallow due to the pain. After about 35 min. I began burping which help a little with the ability to keep some water down. Today I feel exhausted, my eyes still hurt, still have the headache and sinus pressure,  and continue to have the acid reflux but not as severe as the night and early morning. I haven't tried to eat yet today.
Patient received the first of 2 Shingrix vaccine shots to protect her from developing Shingles on Wednesday, August 5, 2020.  On Monday, August 17, 2020, patient's spouse, broke out with Shingles.  Spouse saw MD on Friday August 21, 2020 when he realized that the painful rash on the front and back of his chest was Shingles.  It just seems like too much of a coincidence that patient's spouse, would develop Shingles less than 2 weeks after patient was vaccinated.
pt recvd vax; hives began 8 hr post inject; Mond recvd shot of pcn & broke out very red w/ hives; given IV meds;
patient started expiring "imbalance issues", especially when she was running or playing sports; the patient was experiencing fatigue and tiredness; has headaches; troat pain; Dizziness; neurological imbalance; This spontaneous report was received from a consumer and refers to her 12-year-old daughter. The patient's medical history was not reported. She was perfectly healthy.  On 02-SEP-2021, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1687293, expiration date: 30-APR-2023, administered for prophylaxis (strength, and route of administration were not provided). Concomitant medications included tozinameran (PFIZER BIONTECH COVID-19 VACCINE).  On an unknown date in November 2021, the patient experienced imbalance issues, especially when she was running or playing sports. It was also reported that the patient was experiencing fatigue and tiredness. Among other things, like headache, throat pain and dizziness, it was reported that all of these mentioned symptoms became "worse" during the month of December 2021. Since then, the symptoms were on and off every 3-4 weeks and they only really occurred when the patient was playing sports. The patient had such an imbalance that she could not run. The doctor thought that she had a neurological imbalance going on. It was also reported that the patient would not receive the second dose of the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine.  Causality assessment was not provided. The outcome of events was reported as not recovered.
S: 26 y/o M referred to clinic for evaluation of SPV site by MD. Patient presents to clinic at 10:09 on 17DEC12. Received primary SPV (LUE), AVA #1 & typhoid (RUE) on Thursday 06DEC12 at clinic, in preparation for work in FEB 2013. No other vaccines received in past month. Patient endorses URI sx - ST, congestion, cough, sneezing, HA as of 28NOV12. States cold will not go away. Has been self-medicating with DAYQUIL and NYQUIL, according to recommended dosing instructions on the box and prn ADVIL. Reports ALLERGY TO PCN- rash/hives since 2 yrs old. Denies difficulty wheezing, swelling face, lips or eyes or difficulty swallowing in first three hours s/p receipt of SPV, AVA #2 and typhoid on 06DEC12. Fine till SAT 15DEC12 (day #7 s/p SPV), when he noticed local redness and swelling at SPV site about the size of a 1/2 dollar. Redness increased over next 24 hours and yesterday evening (16DEC12), he began to experience chills, body ache, HA and noticed a red streak going from his SPV site on his LUE toward his left axilla. He denied any chest pain, pressure in the center of his chest or pleuritic SOB. This morning he saw his surgeon, who called the clinic and asked if we could see the patient. O: Local erythema and swelling 160 mm x 75 mm. + axillary lymphangitis. No palpable tender left axillary LAD. Jennerian Pustule is c/w 11-day evolution. A/P Last Updated by reporter at 19 Dec 2012 1936 1. Arm swelling left: 26 y/o M with Robust Take and left axillary lymphangitis on day # 11 s/p receipt of primary SPV (LUE), AVA#1 & typhoid (RUE) placed on 06DEC12 at clinic. 1. Robust take (LUE) at SPV site. Normal Variant. 2. Left axillary Lymphangitis w/o palpable left axillary LAD or tenderness. Normal Variant. 3. This is NOT cellulitis! No antibiotics necessary. This is a hyperimmune response to vaccine secondary to peak cytokine activity of SPV, which occurs between days 6-12 s/p immunization. Treatment is simply with anti-inflammatories. 4. Ibuprofen 800 mg po tid with meals x 5-7 days. Denies h/o gastritis  or ulcers. 5. Reviewed site care with patient. 6. To ED if any new onset CP, pleuritic SOB, or deep pressure in center of chest. 7. Establish relationship with PCM for primary care. 8. If Dx of Psoriasis is confirmed by provider when patient has another flare, NO MORE SPV IMMUNIZATIONS IN A PRE-EVENT SETTING. 9. Patient verbalizes understanding and compliance.
Dizzy for about 15 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy for about 15 seconds) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizzy for about 15 seconds). On 12-Feb-2021, DIZZINESS (Dizzy for about 15 seconds) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided. .   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23-jul-2021 and contains non-significant information
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 29-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Diagnosed with esophageal cancer after the first dose; soreness on the arm; soreness of the right arm after the first dose.; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-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 OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose) (seriousness criterion medically significant), PAIN IN EXTREMITY (soreness on the arm) and MYALGIA (soreness of the right arm after the first dose.). At the time of the report, OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose), PAIN IN EXTREMITY (soreness on the arm) and MYALGIA (soreness of the right arm after the first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose) to be not related. No further causality assessments were provided for PAIN IN EXTREMITY (soreness on the arm) and MYALGIA (soreness of the right arm after the first dose.).    No concomitant medications were reported.   Based on reporter's causality (the reported said that OESOPHAGEAL CARCINOMA is not related with the vaccine) this event is assessed as unlikely related to mRNA-1273.Otherwise, based on the current available information and temporal association between the use of the product and the start date of the event "pain in arm", a causal relationship cannot be excluded.; Sender's Comments: Based on reporter's causality (the reported said that OESOPHAGEAL CARCINOMA is not related with the vaccine) this event is assessed as unlikely related to mRNA-1273.Otherwise, based on the current available information and temporal association between the use of the product and the start date of the event "pain in arm", a causal relationship cannot be excluded.
This vaccine got my grandfather sick and now he s no more; This is a spontaneous report from a Pfizer sponsored program based on information received from a Consumer about the grandfather.  A male patient of an unspecified age received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history  and concomitant medications were not reported.  The patient  became  sick  and died  on an unspecified date.   It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sickness
Severe headache for 9 days and head cold symptoms, runny nose, congestion, feeling run down.