chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a female, with no history of allergies, who was vaccinated with Gardasil.  Subsequently the patient experienced coughing, sore throat and fever.  No additional information was provided.  Additional information has been requested.
Low grade fever, Headache, Severe Injection site muscle pain, Chills, Low back pain
Patient received vaccine and reported approximately 5 minutes later that he needed help. Within just a few seconds following him calling for help he was not able to talk and his eyes had rolled into the back of his head. His body was rigid but he did not lose consciousness. A technician called 911.  He was sweating profusely so his jacket was removed and a cold rag applied to his head. He finally came to after approximately 1-2 minutes and reported that he was feeling very dizzy. His blood pressure was 118/80 and temperature was 98.5 degrees Fahrenheit. He was examined by an EMT, and they found a very similar blood pressure.  Patient reported feeling much better and was fine to go home. Treatment occurred over a 15 minute window.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 52-year-old male patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FS4991), at the age of 52, in left arm, on Apr 6, 2022, single dose, for COVID-19 immunization. Vaccination history included the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EE3590), left arm, on Oct 11, 2021, the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0151), on Apr 8, 2021, left arm, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), left arm, on Mar 18, 2021; all single dose, for COVID-19 immunization. Medical history included multiple sclerosis (unspecified if ongoing). Concomitant medications not reported. The patient experienced ineffective drug (medically significant) and COVID-19 (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19; negative, notes: COVID-19 symptoms during treatment with negative test two days after completion of treatment; negative, notes: COVID-19 symptoms during treatment with negative test two days after completion of treatment. Therapeutic measures were taken as a result of COVID-19. Clinical course: No other medication in 2 weeks. No follow-up attempts possible. No further information expected.
5/5/08 4:45 PM Pt. into clinic reported redness and swelling with tenderness to R.arm. Received Tdap in R.arm 4/30/08. Pt. states arm became swollen on 4/30/08. Pt. has been taking Tylenol. Arm is swollen, minimal redness to area. Advised to contiue Tylenol, Cold compression today followed by warm compression tomorrow. See MD if needed.
My mother fainted on the night she was vaccinated, early in the morning. She had gone to the kitchen to get a heating pad and felt faint while standing  She didn't make it to a chair, but fell and broke her hip.   While this could have been due to another health problem, my mother had never had a fall or a near-fall. it is concerning that very old adults are not warned to have someone with them after receiving the vaccine (for instance, overnight),  I realize that the vaccine has not been studied specifically in geriatric populations, but it is realistic to assume that there are substantial numbers of very old people living on their own, particularly in cities where there is no need to drive, and where food and other necessities can be delivered. There should be a warning to people that they should not be alone after receiving the vaccine.
Also diagnosed with AFIB; Rash broke out all over body within 7-10 days of vaccine; Atopic dermatitis; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:15 (at the age of 75-year-old) (Batch/Lot Number: EN6198) as single dose for COVID-19 immunisation.  Medical history included high blood pressure, mild heart attack-stent, high chlolesterol. The patient had not experienced Covid-19 prior vaccination. Concomitant medication(s) included metoprolol tartrate (manufacturer unknown); atorvastatin calcium (manufacturer unknown); ramipril (manufacturer unknown); amlodipine besilate (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously took terbinafine hydrochloride (LAMISIL) orally for foot fungus and experienced ageusia 30 years ago.  No other vaccine in four weeks. The patient experienced rash broke out all over body within 7-10 days of vaccine (non-serious) on 03Mar2021 with outcome of not recovered, atopic dermatitis (non-serious) on 03Mar2021 with outcome of not recovered, also diagnosed with AFIB (non-serious) on 29Apr2021 with outcome of unknown. Event rash broke out all over body resulted in Doctor or other healthcare professional office/clinic visit. The course of events was as follows: On 03Mar2021 rash broke out all over body within 7-10 days of Vaccine. He had 6 visits to Dermatologist. He received 2 series of Prednisone 20 mg, steroid ointment/creams. He had skin biopsy, blood work and no definite conclusion (atopic dermatitis). Also diagnosed with AFIB 29Apr2021 (emergency room--cardioversion) not sure or origin but, still fighting this skin rash. The patient underwent lab tests and procedures which included biopsy skin: unknown results on 21May2021 No definite conclusion (atopic dermatitis), blood test: unknown results on 21May2021 No definite conclusion (atopic dermatitis), Sars-cov-2 test: negative on 21May2021. Therapeutic measures were taken as a result of rash broke out all over body within 7-10 days of vaccine, atopic dermatitis.  Follow-up attempts are completed. Lot/batch number has been requested. No further information is expected.
This spontaneous case, initially received on 20-Aug-2018 was reported by a physician and concerns a female patient of an unspecified age. On an unspecified date, the patient received last year's FLUAD (TIV) (batch number: 179201, expiry date: 30-Jun-2018, dose, route of administration, anatomical location: not reported). The reporter assessed the case as non-serious.
I experienced tingling in my throat and tongue, as well as swelling in my tongue 10 to 12 minutes after my vaccination. I took a Benadryl for my symptoms and they resolved with the swelling resolving first.
Per receipient: The pain in my arm was immediate upon vaccination and progressively got worse in the first 12 hours post injection.  In addition to pain, I have the following symptoms: numbness in the arm from the shoulder down to my lower arm, a feeling of coldness throughout my arm down to my fingers, inability to move my arm as I was able to before injection, significant limited range of motion and pain in my arm in any direction while doing everyday things (such as putting on/removing a jacket, scratching my head, etc). All these symptoms are persistent when my arm is at rest, and increase significantly when I move my arm.  Pain and discomfort is persistently at a level that affects my daily routine and my sleep. It started immediately upon vaccination and is still occurring. I have modified my daily routine as a result of the symptoms. My medical provider wrote a prescription for Prednisone on October 11, 2019, which I began taking as directed the morning of October 12.  Prior to that, I took OTC Advil, 200 mg the morning after the injection and stopped Advil as directed when I began the Prednisone. I have no history of any issue with my left arm prior to the vaccination on October 8, 2019.
Thigh swelled and redness spread over more than 3/4 of her leg warm to touch.
high pitched ringing in  ears; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant adult female patient of unspecified age received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0164) via an unspecified route of administration in the right arm on 21Apr2021 at 08:45 as a single dose for COVID-19 immunisation. Patient had no medical history and past drug history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced a high-pitched ringing in ears for large parts of the day. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events high-pitched ringing in ears was not recovered.   No follow-up attempts are needed. No further information is expected.
mom called clinic stating pt recv vax 22MAY96 2PM & by 3-4PM had hives on face & body;no diff breathing or fever;mom called MD & MD ordered DPH;
Interstitial cystitis, worsening of urinary frequency despite no UTI or other explanation after diagnosis of Pelvic Inflammatory Disease. COVID-19 vaccine exacerbated any potential for interstitial cystitis or caused it. No other potential cause.
pt recvd vax & area 1st became pink & 2 days later became dark red; pt also c/o that the area around the inj became hot & swollen;
went blind for two weeks after receiving the COVID vaccine; This is a spontaneous report from a contactable consumer or other non health care professional (Patient's friend). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as UKKNOWN DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient went blind for two weeks after receiving the covid vaccine. The event was medically significant. Reporter stated that her vision came back but the patient did lose it for two weeks. The outcome of the event was recovered on an unspecified date.  Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.  Information on the lot/batch number has been requested.
Day after injection: stepped from shower, left side of: head, neck, chest, and hip was red, "scalded" appearance, and had tingling  sensation in left ear.  This lasted the day. Area where shot was given was very sore and developed a pain that "shot" down the left arm to the wrist when doing heavy work with that arm. This pain lasted about 2 months. Low back pain, day after injection that lasted for 3 to 4 weeks.
I have a rash about two inches in diameter on my left arm. It is raised and is itchy and hot. I am also experiencing fatigue.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male 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) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) Patient had fever of 103.5 F after receiving Moderna COVID 19 vaccine.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
more tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. 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 FATIGUE (more tired). At the time of the report, FATIGUE (more tired) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported   This case was linked to MOD-2021-035175, MOD-2021-221118 (Patient Link).
Patient was administered Adacel vaccine on 9/20/21, Product had expired on 9/17/21 with no reported adverse event; Initial information was received on 20-Sep-2021 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves an unknown age male patient who was administered with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 20-Sep-2021, which had expired on 17-Sep-2021 (expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 20-Sep-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (same day).  It was unknown if the patient experienced any additional symptoms/events.   At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  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 the 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.  There will be no available information on lot number for this case.
Redness and swelling at injection site, warm to touch and itchy. Came in to show pharmacist on 1/17/2016 and pharmacist instructed use of hydrocortisone cream and Zyrtec or Claritin. Unknown outcome at this time.
4/13/2021 - FEVER, ABDOMINAL PAIN, VOMITING, CHEST PAIN, DIARRHEA
Lt arm lg welp, hot and swollen. Also c/o itching all over , sore throat.
Possibly next day pt. arm got infected, (red/swollen). Antibiotics were prescribed
This spontaneous report was received from a medical assistant regarding an 8 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 25-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Had soreness and decreased range of motion in shoulder- started approx. 2 hours after immunization.  Ongoing soreness and decreased ROM when crossing midline, worse in the morning.  Reports feeling "much better" as of 10/24/17.  States it felt "like a pinched nerve." No problems with previous IM vaccinations. Did not see any healthcare provider for evaluation or follow up. Has been taking OTC motrin at home and states it is effective.
left injection arm soreness; Felt dizzy; Ear pain; Covid arm; chills; Tiredness; headache; lymph node under the left injection arm was swollen; fever of 103F; sore left arm at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included IBD (Microscopic Colitis) since 01-Jan-2021. Concomitant products included ATORVASTATIN for Hypercholesterolemia, BIFIDOBACTERIUM INFANTIS (ALIGN) for IBD, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Vertigo, VITAMIN D3 for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen), PYREXIA (fever of 103F) and VACCINATION SITE PAIN (sore left arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at a dose of 500 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Rash, at an unspecified dose and frequency. On 19-Apr-2021, PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen) and PYREXIA (fever of 103F) had resolved and VACCINATION SITE PAIN (sore left arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 103 (High) High.         The patient alternated between Advil and Tylenol for reducing fever.   This case was linked to US-MODERNATX, INC.-MOD-2021-089677 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Updates concomitant product use and treatment medication use. Updated event start date and stop date.Updated patient's medical history.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089677:Crosse linked
After the injection on 9.25.2023 my arm started itching and was pink below the injection site. At 2:00 am on 9.26 the itching as so bad I had to put cold compresses on it and noticed the swelling. Went to pharmacy to show them the sight and was told it was allergic reaction and the only thing I could do was to take Benadryl. I took the Benadryl once because I have glaucoma. The swelling spread but the itching lessened and I put ice compresses on the sight. The swelling continued to spread for a few more days and the itching was minimal. Swelling started going down 9.29.2023, but developed into a bruise and the itching would flare up suddenly then go away. As of Oct. 6th the bruise is gone but a blemish is visable where all the swelling was and the itching is still present at times.
Injection site itching; Injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) outcome was unknown.            This case was linked to MOD-2021-030074 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR added. Patient updated e-mail and confirms the evens for first and second dose. No further FU required.
Fever, SkinRash, hives, itching received epi-pen at time off vaccine then sent to ER for tx
I have been getting real bad migraines which makes me feel nauseous. I have started feeling this symptoms days after getting my first vaccine dosage.
Patient presented to ED on 10/10/21 with one week of recurrent fevers and persistent dry cough after recent admission for covid PNA on 9/5. Patient's PCP instructed the patient to come to the ED after fever didn't resolve with antibiotics. Patient was appropriately treated and was discharged on 10/16/21.
Fussy immediately after immunization, screaming, not sleeping well, diarrhea off and on, off and on fever, stomach pain; Lasted 12-13 days, was tired all the time. Rash in day 13. Loss of appetite.
Within hours of my first Shingrix shot (Zoster recombinant), my right ear started ringing.  For almost 10 months later, the ringing still persists.   It is a constant tone (sounds like an auditory exam signal) though the volume fluctuates.  I've said average is 4-5 on scale of 1-10 pain scale...and has gone as high as 8.  Location doesn't matter: in my apartment; at summer beach home; on trips.  Still persists.
Patient states she feels tired, loopy as is she has taken a BENADRYL. BP 104/60 P 64. AAOX3. Instructed to see dr. if worsens or doesn't improve.
All I've felt is a little fatigued; little aches pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "All I've felt is a little fatigued"; PAIN (non-serious), outcome "unknown", described as "little aches pains". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received second dose of Pfizer vaccine on 4-2-21. Patient wife wasn't able to get the vaccine yet as she became very sick and then tested covid positive on 4-20-21. Patient has been with her almost 24 hours a day and even sleep in the same bed. Patient felt was little fatigued and a little aches pains. Patient has taken two tests, and both are negative.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.