chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EW0151), in right arm and on 28Apr2021 as dose 2, single (Lot number: ER8736) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Health business professional calling to report AE for improperly stored vaccines.; No additional AE information; This spontaneous report was received from a health business professional and referred to a patient of unknown gender, currently was 5-year-old.  The patient's concomitant therapies, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA))(PROQUAD) subcutaneous injection (lot #U022727, expiration date: 16-JAN-2023), administered for prophylaxis (strength, dose, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 6 Fahrenheit (F) up to 14 F (minus 14 degree Celsius up to minus 10 degree Celsius) minus 11.6 for a time frame for 30 minutes. There were no previous temperature excursions.   No additional adverse event (AE) information was provided.; Sender's Comments:  US-009507513-2206USA004540:
Arm was so sore could not use for about 10 days. Improving but 3 weeks later my bicep is still very sore
Pt. was given a Flu Shot by  RN on 9-25-18 during the Flu Clinic. Pt. called on  9-26-18 complaining about her arm hurting and being painful swollen and warm to touch and also not being able to raise her arm. Pt. instructed to come in and see the provider. Pt. came in to see the provider that morning. Provider saw pt. and wrote in plan reassurance pt. regarding common local side effects from IM injections along with life threating s/s of concern. Provider also wrote that the pt. may continue to get the Flu vaccine. Prescribed Motrin or Tylenol or Benadryl as needed.
Pt vax w/ Recombivax HB reported that a pt rec'd 4th dose was dx a week later w/ diabetes mellitus.  It was felt that DM is not related to hep vax. Pt was hosp for DM.
Received flu vaccine IM left deltoid at 1130; at 1140 reported that her throat felt swollen and she was light headed.  Her B/P was 90/60.  Epinephrine 1:1000 1mg/1ml 0.5cc given SQ in right arm at 1146.  Benadryl 50mg given IM right deltoid at 1152.  At 1153 B/P was 110/56, pulse 88, lungs clear.  At 1156 lungs clear, B/P 112/68, pulse 80.  Client was transported per private car to ER.
Red area with bumps showed up by my left eye, underneath on outside of left eyelid; Cold sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On 22-MAR-2023, the patient received the 1st dose of Shingles vaccine. In APR-2023, 1 month after receiving Shingles vaccine, the patient experienced red rash (Verbatim: Red area with bumps showed up by my left eye, underneath on outside of left eyelid) and cold sores (Verbatim: Cold sore). The patient was treated with hydrocortisone and docosanol. The outcome of the red rash and cold sores were resolving.   It was unknown if the reporter considered the red rash and cold sores to be related to Shingles vaccine.     It was unknown if the company considered the red rash and cold sores to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2023 and 14-JUN-2023 The patient received 1st dose of Shingles vaccine. Patient reported one month after receiving the vaccine had a red area with bumps showed up by left eye, underneath on outside of left eyelid.  Patient never had anything like this. Patient tried hydrocortisone cream 1% on it and it looked like it was going away, however it never did. Patient had PCP take a look and she recommended seeing a dermatologist.  Reporter had trouble getting in at dermatologist and appointment is scheduled on June 29th.  Patient just purchased some generic docosanol cream 10% to try on it.  It put it on very carefully with a Q-Tip and it appeared to be finally helping.  Patient had chicken pox as a child, but have never had a cold sore.  Patient read that the virus was related which prompted me to try Docosanol.
My sons broken out with an awful rash from head to toe. Looks like chicken pox. His doctor said it was caused by the chicken pox shot he recieved exactly a week before.
I developed a large rash around the injection site.  It itches slightly and it is very warm to the touch, almost hot.  No pain
no additional AE; administered PROQUAD and did not realize the expiration was dated for December 1, 2020; This spontaneous report was received from a reporter of unknown role and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  09-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # S017255, expiration date 01-DEC-2020, dose of 0.5 milliliter (formulation and route of administration were not reported) for prophylaxis (expired product administered). There was no other adverse event reported. The outcome of the event was unknown. It was unknown whether the patient received treatment or had any lab diagnostics/studies performed.
flu symptoms; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via social media.  This case involves a patient (age and gender unspecified) who had flu symptoms (Influenza), when he/she received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu symptoms(Influenza), 2 days following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Minimum recommended age for Covid-19 Janssen is 18 17years 7months when vaccinated
sore and swollen arm, headache, nausea, and vomited 4 times
SORE SHOULDER; SORE ARM OF INJECTION SITE; TIRED AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced sore shoulder. On 09-MAR-2021, the subject experienced sore arm of injection site. On 09-MAR-2021, the subject experienced tired after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore shoulder, sore arm of injection site, and tired after receiving vaccine. This report was non-serious.
Transverse myelltis at about the T4 level characterized by sensory and motor disturbance and palpable tenderness at about the T4 spine in the midline. Clinically she was otherwise healthy, although obese and has had a gastric sleeve procedure in the recent past. She is continent of bowel and bladder, but since 1 sep 2021 she has had progressive motor weakness which makes it difficult walking up stairs and she sometime stumbles.
Patient was given Pfizer 12+ and she is only 8 years old.  No side effects or adverse reactions noted.
Fatigue, insomnia, decreased concentration, brain fog - still ongoing on day 11 after vaccine.
pt recv vax 4DEC97 & reported lump @ site of inj approx 2 inches by 2 inches;site was red, warm & sensitive to touch;pt has been taking advil;pt was instructed to apply ice packs to site;
24 hrs. after injection developed left arm pain with radiation to elbow. Difficulty lifting arm with pain. No swelling redness or signs of infection. Seen in clinic on 10/31/2018 with persistent symptoms.
BASICALLY, THIS REPORT I'M WRITTING IS NOT AN ADVERSE EFFECT REPORT, IT IS MORE INFORMATIONAL OF A PREVIOUS MISUNDERSTANDING ABOUT VACCINE TWINRIX AND INDIVIDUAL HEP A & B COMBINED IN ONE SYRINGE AND GIVEN AS A  SINGLE SHOT. I NOW LEARNED THIS SHOULD NEVER BE DONE. NO REACTION REPORTED ON THE DAY OR AFTER THE DAY OF VACCINATION; EVEN TILL TODAY NO REACTION REPORTED TO THE CLINIC. I AM SUBMITTING THIS VAERS FORM MAINLY FOR INFORMATIONAL PURPOSE. I HAD A MISUNDERSTANDING ABOUT TWINRIX(HEP A& B) AND INDIVIDUAL HEP A & B VACCINES WHICH I GAVE TO THE PT AS A SINGLE SHOT. THIS IS THE ONLY ONE TIME THIS MIXED UP HAPPEN AND ONLY WITH THIS PT; AND I  HAVE LEARNED THAT THIS SHOULD NEVER BE DONE, THEREFORE I PROMISE THIS WILL NEVER REPEAT. PT'S MOM WAS INFORMED OF BOTH VACCINE COMBINATION BEFORE THE SHOT WAS GIVEN TO PT AND SHE SEEMED APPRECIATIVE AND SAID IT WILL DEFINETLY CAUSE LESS PAIN TO PT . I FULLY UNDERSTAND AS OF NOW THAT THE TWINRIX IS A DIFFERENT VACCINE AND THE INDIVIDUAL HEP A & HEP B VACCINE SHOULD NEVER EVER BE CONBINED AS A SINGLE SHOT. AGAIN, NO REACTION OR COMPLAINT REPORTED ABOUT THIS EVENT. THANKS
Initial unsolicited report received from other company via physician on 21 April 2016. Manufacturer report number:2016220600. This case involves a 65-year-old female patient who was vaccinated with a dose FLU VACCINE (batch number, expiry date, route and site of administration not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient developed allergy to flu vaccine. The patient's lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Significant tinnitus in right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Significant tinnitus in right ear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TINNITUS (Significant tinnitus in right ear). At the time of the report, TINNITUS (Significant tinnitus in right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
- 11/20/09: patient received Tdap vaccine, then presents with left arm redness and swelling. Left arm was red and warm for 4" x 2.5" patch below site of vaccination puncture site.  Patient diagnosed with cellulitis.
Information has been received from a physician concerning a 36 year old female who on07/13/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 07/13/01, in the evening, the patient experienced body aches, fatigue and a fever of 103.5. Unspecified medical attention was sought. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was feeling dizzy and put the pt on the floor she was breathing and concious called 911 and the felt better and put her on a sitting position to rest. Her husband said she has dizzinees and fainting problem. we get help they came and assessed her and pt was ok and walked to her car accompanied by her husband. Called her around 5:40p to make sure she is doing ok but no answer
Case number PHEH2014US025336, is an initial spontaneous report received from a medical assistant on 16 DEC 2014. This report refers to a 32 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 29 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on 10Nov2015, as single dose immunization. Medical history and concomitant medications were not reported. Approximately 6:00 PM on 13Nov2015, patient contacted her primary care. She reported the following events (onset in Nov2015): she experienced/was still experiencing side effects from a recent vaccination with PREVNAR on 10Nov2015. Symptoms included: extreme pain in the arm that received the injections/ significant pain in the arm and significant headache on 10Nov2015 and flesh in her arm which she received the injection became very hard to the touch (which has since subsided), rash, itching, chills and night sweats in Nov2015; had difficulty with her range of motion after the injection on an unspecified date. There was no hospitalization for the events. The patient took TYLENOL as needed for pain, no treatments were received for the other events. The outcome of the events were reported as fine now as of reporting on 02Feb2016. Follow-up (02Feb2016): New information reported from a contactable consumer includes: detailed event description, seriousness (no hospitalizations for events), treatment received (acetaminophen as needed) and outcome (fine now).
Severe chills for 24 hours Dry heaves Skin irritation around injections site down to elbow
Terrible diarrhea started the next day. Lasted about 24 hours. Upset stomach continues although diarrhea has stopped.
Minimal sore on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minimal sore on the arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 PAIN IN EXTREMITY (Minimal sore on the arm). At the time of the report, PAIN IN EXTREMITY (Minimal sore on the arm) outcome was unknown.            Concomitant medication was not provided by the reporter.  Treatment medication was not provided by the reporter.
Right sided ear pain and hearing loss, and ptosis of right eye that started 1 day after vaccine administered. Hearing loss has improved after 3 days, yet still diminished.
p/vax pt devel cellulitis characterized by redness, swelling & skin lesions; pt was treated w/an ATB;
chills; warm; headache; nausea; sweat last night; fever; This is a spontaneous report from a contactable Nurse reporting on herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number:unknown) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. the patient experienced chills, warm, headache, nausea, started to sweat last night, may have fever on an unspecified date. The patient wanted to know about taking second dose. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Vertigo/dizziness (Day 1?lasted 2 or so days) Insomnia (Night 1) Pain at injection site (Day 1-2) Headache turning into Migraine (Day 2 - 5)?saw doctor for migraine Rx (Fiorcet)
Case number PHEH2014US024974, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 67 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 24 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
BP: 120/70  - Lightheadedness, syncope.  Outcome: rested, stabilized.
allergic reaction; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; her face broke out and eye swoll up, mainly one eye, but eyes were puffy; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 19Apr2021 at14:30 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. She did not receive any vaccination prior. On unspecified date, the patient experienced allergic reaction (hypersensitivity) after the first dose she experienced puffy, swollen, and breaking out of the face. caller states she also felt like her throat was swelling (pharyngeal swelling) (skin swelling) (rash) (eye swelling). The patient underwent lab tests and procedures which included blood pressure measurement as 143/111 on unknown date. The outcome of the events Hypersensitivity was recovered, and rest of the events were unknown.  Follow up needed; Information on the lot/batch number has been requested.
Initial case was received from a healthcare professional on 04 November 2013. A 73 years old female had received a dose of FLUZONE HD vaccine, batch number UH787BA in the left deltoid on 29 October 2013 (dose number was not reported). Patient had no illness at the time of vaccination and had no known allergies. On 30 October 2013, the patient developed bruising on arm at the site of vaccination. Corrective treatments and laboratory investigations were not reported. As off this report, the outcome of the event was unknown. List of documents held by the sender none. Follow-up information received from healthcare professional on 14 January 2014. As of 14 January 2014, the outcome was recovered.
Patient described a very bad headache followed by vomiting. They have experienced these side effects from vaccines before and suffer from migraines that also cause this, but they wanted to report the reaction due to the vaccine being new.
After client was vaccinated, she reported weakness, dizziness, SOB and nausea.   ALS crew onsite took vitals - patient was initially tachycardic, hypoxic to 75% O2 sats with SOB, and hypertensive.  Medics placed client on 10L of O2 via nonrebreather. 10:45 VS 161/117 100% 102 HR, 10:54 VS 157/88 96% on O2, 70 HR,  11:00 VS 145/72, 96% on RA, 63 HR. Patient refused for ALS crew to take her to the ER. Pt was alert and oriented x 3.  Husband and sister at patient's side.  Pt left with sister and refused afain to go with the crew.
developed large red, raised, hot, and firm area about the size of a softball almost 24 hours after injection. Pain with movement of the arm and ache. Went down to our Employee Health Services the following morning to be seen.
Client passed out on the clinic bed for aproximately 15-30 seconds. She became rigid however but did not experience any jerking movements. She was placed in modified Trendelenburg position and recovered spontaneously. Client was hydrated, monitored, and slowly advanced to sitting and eventual up right position. Note, client was extremely anxious about receiving vaccine. Client had recently passed out after having her ears pierced. Cleint ambulated out of clinic on her own aproximately 30 minutes after the incident with her mother and sister at her side.
58 year old male who had already received two doses of shingrix (on 7/14/21 and 9/14/21) received 3rd dose of Shingrix today in error.  Immunization program was notified and consulted. Per Immunization program, there is no research supporting danger of getting an extra dose of shingrix. However, patient's immune response may be more robust and he may experience stronger side effects.  Patient was informed that shingrix dose he received today was in error and that he may experience increased side effects, but that it should not cause him any long-term harm.
70 yo female with 1-2 weeks ongoing URI symptoms including cough, SOB, fevers, nausea, sore throat, headache. Denies chronic lung issues. States she had her Pfizer vaccinations in march 2021. He presented to the ED on 7/19/21 and was found to be COVID positive.  CXR with patchy infiltrates. She also developed acute hypoxic respiratory failure and was started on heated high flow nasal canula. She is receiving remdesivir, decadron, and tocilizumab.
w/in hrs p/vax pt's cheeks/ears & upper body became scarlet, lower extremities devel roseola like rash; t99.1; c/o feeling tired;
I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle pain, also pain at the injection site. i felt very tired. The next day I had severe headaches, muscle pain and fatigue and took Ibuprofen as pain medication. My headache went from a severe to moderate. All the rest of days continued with headaches.
Patient called 4/25/2019 saying that the night before she noticed her back turning red from her neck all the way down to her lower back. She said she was not in pain but it felt warm and she was sweating. Since it was such a large area I recommended she have a doctor look at it. Later that day she was seen and given Prednisone.
No effect after three months after the vaccine, but on Jan 1st did not feel well, I tested Positive with a COVID-19 home Test. I called my doctor and he prescribed Paxlovid and took it for 5 days. On Jan 9th I did a consultation I still tested Positive and in January 14th I tested Negative.