chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 17-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified dates, the vaccine had a temperature excursion for 24 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Low-grade fever, joint pain, extreme fatigue, headache, body aches, nausea lasted for one day after vaccine. When I woke up the next day (22nd), I was fine.
During vaccination, patient moved and half of the fluid came out of the needle, no AE; Initial information was received on 21-Jul-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a 4 year old male patient who moved during vaccination with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and half of the fluid came out of the needle (Underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) for prophylactic vaccination.  On an unknown date (yesterday), the patient received a fifth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5523AA, Expiry date 20-Sep-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose.  A nurse reported that they were giving an injection to a 4 year old yesterday and he moved and half of the fluid came out of the needle.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
TOTAL BODY ITCHING AND FLUSHED SKIN. NO SHORTNESS OF AIR EMPLOYEE TOOK BENADRYL x 3
Breakthrough Covid infection.  No adverse event related to vaccine itself.  Tested positive (home test) 5/6/22, Called Dr. office and started Paxlovid 5/6/22 evening. Completed 5 day dosing as prescribed. Retested 5/11 (home test) positive. 5/13/22 (home test) negative.   Symptoms: low grade fever for 2-3 days, cough, congestion (relatively mild).  Mild residual cough through present date.  Self isolation for 6 days and then masking until tested negative.
Returned from a trip on 11/2 and expect that is where I came into contact with COVID-19. On 11/5 I started have sore throat and began to cough. Around 7PM I took a rapid test and it was negative. Went to bed that night and sore throat and cough got worse. Woke up the next morning much worse and I took another rapid COVID-19 test and it was negative. Didn't believe the results so I scheduled a PCR test with the pharmacy and it returned positive on 11/7. Spoke with PCP over phone and was prescribed PAXLOVID it needed but I never needed it. Symptoms improved consistently after 11/7. Cough lasted 3-4 weeks but is gone now.
This spontaneous report was received from an employee at pharmaceutical company who came across an article on a social media news feed and refers to a male patient of unknown age. The article from News Network and was posted 29-MAY-2017. On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (MMR) vaccine (manufacturer not specified). The article indicated that the governments conceded or the court ruled that vaccines had caused brain injury. In turn, this injury led to an autism spectrum disorder (ASD) diagnosis and MMR vaccine was the common denominator in this case. The outcome of the event was unknown. Causality was assessed as related. Upon internal review, autism spectrum disorder was considered medically significant. This is one of several reports from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA012166.
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 REACTION (magnetic at the injection site/ messed around with their name badges and anything that was magnetic, and it would stick to the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced VACCINATION SITE REACTION (magnetic at the injection site/ messed around with their name badges and anything that was magnetic, and it would stick to the injection site). At the time of the report, VACCINATION SITE REACTION (magnetic at the injection site/ messed around with their name badges and anything that was magnetic, and it would stick to the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No Treatment information were reported. They messed around with their name badges and anything that was magnetic, and it would stick to the injection site, not the whole arm.
SYNEOPAL EPISODE HAPPENS WHEN SHE GETS SHOTS. PATIENT STATES SHE WILL BE FINE.
Started thirteen hours after vaccination with Fever, Migraine, fatigue, chills, aches. 37 hours after vaccination threw up and prior symptoms continued. Swelling and rash started around 48 hours. Still having fever, headaches and chills at over 48 hours post vaccination.
GENERALIZED "MILD ITCHING" Narrative:  @1050: Employee reported generalized "mild itching", BP 136/86, HR 72, SPO2 97%RA. @1102: BP 144/82, HR 67, SPO2 97% RA. Juice/Water was given. @1125: BP 137/81, HR 67, SPO2@ 96%RA, symptoms resolved and employee released
runny nose, scratchy throat, headache, cough. starting 1/5/22
pt recv vax 3MAY94 & the following day devel redness, swelling & warmth-eventually had redness extending to elbow;exam on 8MAY96 showed tenderness to mild bruising @ inj site;redness/recurred that noc;tx w/DPH
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
TD vaccine given in right deltoid and it hurt and swelled up. The next day, had a 3" X 3" welt that had fever and was very tender, lasting for 6 day and even today, 8/26, there is a knot at the injection site.
Information has been received from a physician concerning a 12 year old female with diabetes and eczema who on approximately 07-JAN-2007 was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) concomitantly with a dose of an unspecified vaccine. On approximately 07-JAN-2007, later in the night, the patient developed hives all over her body, mostly on her legs.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Hives; This non-serious case was reported by a consumer and described the occurrence of hives in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included CellCept (received CellCept on 6th October 2008) and Tacrolimus (received Tacrolimus on 6th October 2008).   On 13-APR-2023, the patient received the 1st dose of Shingrix. On 15-APR-2023, 2 days after receiving Shingrix, the patient experienced hives (Verbatim: Hives). On 18-APR-2023, the outcome of the hives was resolved (duration 3 days).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt date: 18-APR-2023 The case was self reported by the patient. This case was submitted by public reporting reference via the online direct entry reporting system. The patient received first dose of Shingrix and had hives. The patient asked should she got the second shot of Shingrix. The patient reported that symptoms were treated. The reporter did not consent to follow up.
Pt was vaccinated at 10:02 and @10:16 patient reported severe itching tochest, neck, and BUE. Patient appeared to be anxious and hypervigilant upon assessment. Patient stated "I sometimes get itchy when I am exposed to the cold." Patient stated she was unsure if the itching was due to the vaccination or due to the exposure to the cold.   Patient reported she was nervous getting the vaccination due to the side effects and as a result have delayed signing up for an appointment until today. Patient scratching at skin. Mild dermatographia on skin which appears to mostly be contributed to patient itching at skin. No visible hives or any uniform raised bumps on patient's skin. Scratch marks/dermatgraphia and erythema/edema visible on left axilla, right forearm, and surrounding neck area. Patient denies any SOB or chest pain/tightness. Denies any angioedema, edema in in the throat, tongue swelling, throat itching. VS as follows    10:20 154/108, HR 85, RR 19, 97.0F, Sp02 99% on RA. LSCTA.   10:21 25mg PO Benadryl was administered to patient's reports of purititis on skin.   10:30 145/85, HR 75 RR 17, 97.9F, 99% on RA. LSCTA   10:40 Patient reports less symptoms at this time, stated she felt good enough to go home.   10:45 143/85, HR 75, RR 17, 98.2F, 97% on RA.   Patient advised to receive J&J for second COVID vaccination in 28 days. Patient was advised to follow up with PCP due to SBP of greater than 140 and family history of HTN.  Patient verbalized understanding. Patient advised to seek immediate medical care if itching worsens or persists or any other symptoms manifest. Educated patient on S/S of allergic reaction including: hives, continued itching, SOB, throat itching, facial swelling, chest pain. Patient given written discharge instructions. Patient stable at time of discharge. Patient voiced no further questions or concerns at this time.   Time of discharge: 1050   1758 Called to F/U with patient. Patient reported she was feeling better and did not have any further questions at this time.
rash on arms, stomach, waist, upper thigh, intense itching.  Treated with hydrocortisone, ketoconazole, Benadryl, Allegra.  Rash spread
On March 28th had severe stomach cramping. Felt like I was going to have diarrhea but only blood, mucas, and bloody tissue came out. The cramping was severe until Tuesday. I almost went to the emergency room. When it stopped I would feel fine until I had another attack. This lasted from Sunday morning until tues afternoon
fever of 103; chills; lung discomfort; shooting pain down nerves; migraine; nausea; dizziness; soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced fever of 103 (unspecified unit), chills, shooting pain down nerves, lung discomfort, migraine, soreness, nausea and dizziness. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. On 20Apr2021 the patient checked her body temperature and it was 103(unspecified units). Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 103(unspecified units), chills, shooting pain down nerves, lung discomfort, migraine, soreness, nausea and dizziness were recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received smallpox vaccination on 5Jan08 and became pregnant approximately 2 days later.
Red Circular Rash measured 2X6, hot to touch, itchy, sore, headache
COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for husband.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 10Jan2021 for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 19Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 19Jan2021. He was scheduled for the second dose on 31Jan2021.  Information on the lot/batch number has been requested.
not feeling well; mild cold; This is a spontaneous report from a contactable consumer. This male consumer (patient himself) reported for himself.  A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number: not reported), dose 1 via an unspecified route on 17Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. He was scheduled to receive his second dose of the vaccine on 07Feb2021. He cancelled his appointment for the second dose because he was not feeling well and states he had a mild cold on an unspecified date in 2021. He has rescheduled his appointment for this Friday, 12Feb2021. The patient wanted to know If patient does not feel totally well, how long can he postpone between first and second. He was already one week over because he was supposed to have it two days ago and now is scheduled for 12Feb2021. He feels much better, but he wants to be covered. If he does not feel well by Friday, he will have to postpone. The outcome of evenst was unknown.  Information on the lot/ batch number has been requested.
16-18 hour after receipt- "deathly ill" - cold sweats, "stomach convulsions" ie vomiting, eyes would not stop rotating. eyes couldn't focus, blurred vision. Eyes still blurry, stomach still upset.
nauseous; headache; fever; felt tired; The problem is the rash on his arm, he has a rash going down his arm.; it is all red and itchy; it is all red and itchy; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry date are not Provided), via an unspecified route of administration on 12Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as single dose for covid-19 immunisation. Investigation assessment was not provided. The Reporter was calling about Pfizer vaccine, second dose. Clarified as covid 19 vaccine. He got his second dose on Friday, 12Mar2021. He has had reactions. On an unspecified date, the patient experienced felt nauseous, had a headache, had a fever and felt tired. The problem is the rash on his arm, he has a rash going down his arm. He is not sure if he should do something about it. The rash started at the shoulder and it is going down his arm. He clarified the rash is not going down the elbow, now it is inside of the elbow and it is all red and itchy. He stated he was calling to see if Medical Information would maybe advise him to take Prednisone for the itching, but if they are not able to provide medical advice, he will just call his doctor. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Janssen COVID-19 Vaccine EUA Extreme fever, chills, nausea, headache, aches
Increase in her rheumatoid arthritis symptoms; She probably felt things with the first two doses but just did not relate it to the vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4342179-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Increase in her rheumatoid arthritis symptoms"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "She probably felt things with the first two doses but just did not relate it to the vaccine". The action taken for upadacitinib was unknown.  Clinical course: On unknown dates, the patient experienced bursitis, osteoarthritis and rheumatoid arthritis symptoms increased with Rinvoq (Upadacitinib). In 2021, the patient experienced inflammation with covid booster. On an unknown date, rheumatoid arthritis symptoms increased resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient experienced inflammation with the Covid booster and it also caused an increase in her rheumatoid arthritis symptoms which lasted for about eight weeks. She thought she probably felt things with the first two doses but just did not relate it to the vaccine. She had Osteoarthritis that affects many areas. She had been doing very well for about a week. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of rheumatoid arthritis symptoms increased was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Upadacitinib) Causality as per reporter (Drug/Vaccine): Probable  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported events Rheumatoid arthritis , Feeling abnormal and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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
Pt recv vax on 10/30/98; pt was injected w/ empty needle, then recv vax.  Post vax pt exp swelling & pain at vax site; tx=Trovan
He has a heavy, dry cough a couple of weeks after receiving his vaccine. Days after that, he started having hives on his arm and really bad itching like something was irritated him. I contacted his doctor about it and they informed me to put hydrocortisone cream on it to see if it would reduce the itch and hive outbreak. They told me if the coughing and hives persist to wear he can't breathe to take him to the emergency room. He still does his normal daily activities, but the cough won't subside since receiving his vaccine. When he's having a breakout, the pediatrician told me to give him an allergy medication (I alternate between BENADRYL and ZYRTEC to help the breakout as well).
sweating real bad, 102 temperature, bad rash head to toe, eyes swelling shut, lips swelling, headache  ER visit on 5/1/21 - hospital gave a steroid and suggested taking Benedryl (have been and continuing to do so) visit with PCP 5/3/21 - prescribed prednisone for 5 days
Woke up with muscle aches,shivering, fever,headache, nausea,very tired.  Took tylenol and all symptoms got better
Swelling, lump at site of immunization, pain spread down arm, now unable to lift arm over head w/out antinflamatory.
Severe Preeclampsia. Born 35weeks 5days due 3/28/22. 5lbs 9oz. 18 days in NICU due to prematurity. Magnesium needed for 36 hours.
itching, 6cm circular area of pink/red skin and subcutaneous nodule to injection area
Patient stated that he fainted with the first two doses of his Pfizer vaccine in the past.  Immediately after his booster shot of Pfizer, he fainted in his chair and started to have convulsions.  We slowly lowered him to the ground and he began to recover within one minute.  He wanted to sit back into his chair and he was extremely confused and scared.  He looked pale and we took his blood pressure and pulse.  His vitals were normal and we gave him water to sip and had him remain seated for another thirty minutes.  He was with his mother and they refused us to call 911.   When he felt better, he left with his mom and she said that they will call his Dr. and look into seizure precautions.
pt recv vax 15JUL96 & pt exp a hive described as raised & erythematous about 1/2inch above the inj site;
I started having symptoms on 4/18/2022 that kept worsening over the next couple of days, and I tested positive for COVID on 4/20/2022. I started having shortness of breath and tightness in my chest so I went to my Dr. at the dr.'s office. I don't remember the name of the Dr., but she gave me an albuterol Inhaler to use and I'm still using it now.
Sensitive skin, everything that touched me hurt. Clothes, air, water, etc. 9:00am  Aching bones, 5pm, knees, arms, shoulders. Everything felt like i was a 90 year old man. I?m 23.
45 min. after vaccination started having trouble swallowing. Progressed to severe throat swelling and inability to swallow. Eyes started burning and itching with erythematous conjunctiva and green discharge. Tx with Solumedrol IM, and BENADRYL.
facial swelling and hives; hives to right arm - zyrtec and prilosec taken.  Ice administered.  subsided by next day.
Headache, poor sleep, abdominal pain, nausea, near syncopal, dry mouth.