chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Top of both wrists noticeably swollen/ A slight hump on each; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 Immunisation. Medical history included severe asthma. The concomitant medications included fluticasone furoate; vilanterol trifenatate (BREO ELLIPTA), mepolizumab (NUCALA) 100mg, bupropionXL (MANUFACTURER UNKNOWN) 300mg and ibuprofen (ADVIL) for unknown indications from unknown start date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 17:00 (day after the vaccine injection), the patient experienced swelling wrist from top of both wrists (where a wristwatch face would sit) were both noticeably swollen (swollen wrist). No redness, rash, itching or pain, but visibly swollen. A slight hump on each. The patient never experienced this before and it was strange. The patient did not receive any treatment for the reported event. The adverse event 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 event swollen wrists was not resolved (4 days after swelling was going down in one wrist but not the other) at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On an unknown date, the patient was were vaccinated with improperly stored GARDASIL lot # K008931, expiry date: 04-MAR-2017 (dosing details, route of administration were not reported) for prophylaxis. It was reported that, the vaccines were exposed to a temperature 30.9F for a time frame of 16 hours and 14 minutes. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. Data digital logger was involved. Follow up information has been received from the medical assistant on 21-DEC-2016 who stated that, she would fax the information with the letter. This is one of two reports from the same reporter. Additional information has been requested. Reporter address and narrative were updated.; Sender's Comments:  US-009507513-1610USA016261:, MERCK 1610USA014314:Mfr number.
Pt is experiencing itching, no visible rash. Feels like it is under the skin. Also feels like having allergies-stuffy nose/head.  Did not try any otc options. Advised to call MD if very bothersome or could try benadryl or claritin.  Does not think it was necessarily the vaccine that is causing this reaction but wanted to report. Followed up w/ patient 5/24/21- Pt reported that just took 1 dose of benadryl and it cleared up. Did not need to repeat dose.
No additional AE or PQC.; the patient and received his first dose of the GARDASIL 9 3-dose series about 11 months ago but has not received the remaining doses in the series; This spontaneous report was received from a male pharmacist of unknown age referring to himself. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.   On an unspecified date in November 2019 (reported as 11 months ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  0.5 milliliter as prophylaxis (concentration. anatomical location and route of administration, lot number and expiration date were not reported). The patient was not received the second and third dose at the time of this report, therefore he was wondering what was the timeline for series completion (inappropriate schedule of product administration). No adverse events were reported.
Patient felt flushed, a bit light-headed, and felt her heart racing.  Marble size hematoma present on left deltoid, injection site.  All symptoms resolved within a couple of minutes, except hematoma. She came to her PCM's office to alert us. Vital signs stable, afebrile.
Bloating, constipation, gassy/gastrointestinal pains, tiredness/fatigue, malaise, irritable.
0915 53 year old male  stated that his tongue was tingling after taking his vaccination. Pt has a history of hypertension. No known allergies. BP, 152/104, HR 71, RR 16. Patient will stay 30 minutes. Will recheck vitals before leaving. 0940 BP 147/100, HR 69, RR 16. Pt stated the tingling on his tongue has stopped. Pt stated he will go visit his doctor today concerning his blood pressure. Pt stated he felt good. Patient was released. LPN
My first symptoms were chills, nasal congestion, dry hacking cough, and exhaustion. I took 2 home COVID-19 tests and both tests were positive. I called my doctor's office to report my case and to request a prescription for PAXLOVID. I started PAXLOVID on the following Saturday, July 23rd. I had a very strong, horrible metallic taste from the PAXLOVID that continued the full five days I was taking it. The symptoms seemed to get better after two days. I had less chills, less chest congestion, and less cough. I never had a fever, sore throat, or a headache. I had a complete loss of appetite, but I think that was from the medicine. I finally tested negative after 10 days. The most overwhelming and long lasting symptom was a lack of energy.
Sicker than usual, cold or pains after vaccine, got sick with Flu and other symptoms, such as weakness, fatigue, continual coughing, mucus constant in throat, unable to recover for month (I am taking other medications)
I had a sore arm, fever, muscle aches, and then the next day I had an elevated resting heart rate of 120 for 24 hours. I have noticed that my SVT lasts longer and is more pronounced than before the vaccine. I used to get heart flutters once a month now its several times a week.
Information has been received from a pharmacist, referring to a 75 year old female patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On 21-SEP-2016, the patient was vaccinated with one dose of PNEUMOVAX 23 (0.5 ml; strength, lot # and expiration date unknown) intramuscularly for prophylaxis. On 01-OCT-2018, the patient was vaccinated with another dose of PNEUMOVAX 23 (0.5 ml, lot # R000692, expiration date: 09-SEP-2019; strength unknown) intramuscularly for prophylaxis. No adverse effect was reported.
About 15 hours after receiving the shot I started to experience nausea, headache, heavy sweating & freezing chills (at the same time), and then this morning about 36 hours after the shot, itching. Took Zomig nasal spray and oxycodone aspirin for the headache.
Dry, scaly rash on back and abdomen. Described as mild.  Lasted a couple days then got better.  Rash came back 1-2 days from today.  Now also on face and described as worse.  Eczema-like rash.  Doesn't itch but client states that it is sore.
pt recv vax 4APR97 & on 15APR97 pt exp rash;
Within an hour of vaccination, he experienced rapid onset discomfort in his left wrist, right arm, and shoulders. By the time he arrived home, he felt pain throughout his arms, hands, back, and legs and had significant difficulty moving due to the pain. He saw Rheumatology on 12/16 and was referred to the ED given the rapid onset of his multiple joint pains.  Admission was negative for infection. Migratory joint pains persisted for 5 weeks, requiring narcotics for pain relief, but ultimately resolved with steroid treatment (initially 40 mg followed by taper). Rheumatologist's ultimate diagnosis was a vaccine reaction/reactive arthritis/serum sickness like illness.
minor pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3247) via an unspecified route of administration administered in left arm on 12Mar2021 (at 52 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included migraines and latex and penicillin allergies; all from unspecified date. The patient previously took neomycin and experienced allergies. Concomitant medications included gabapentin and omeprazole both from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced minor pain at injection site, which was non serious on 12Mar2021. No treatment received for the event. Outcome of the event was recovered on unspecified date in Mar2021.    No follow-up attempts are possible. No further information is expected.
pt recv vax 14FEB96 @ 9:30 by 1100-1200 felt weak,lightheaded w/tunnel vision & chills;pt fainted co-workers witness some shaking of upper extremities + bladder incontinence
Raised, red bump at site of injection, almost like a bug bite.  Feels hard to the touch.  The spot is itchy and sore.
Vaccine adminstered 12/7/06 in the evening.  On 12/9/06 am noticed 3 to 4 inch long by 2-1/2 to 3 inch bright red area indurated to approx 1 inch with warmth at injection site.  Denied pain at sight.
Arm swelled up, red, inflamed. Started following day of shot. Still slightly swollen and red 5 days after
PATIENT PRESENTED WITH SYMPTOMS OF "COVID ARM" A RASH WITH SOME FEVER AND SWELLING AT THE INJECTION SITE ALSO STATING THAT THE AREA WAS ITCHING, SECOND DOSE WAS GIVEN ON 5/5/2021, PATIEN CALLED PHARMACY ON 5/14/21 SAYING THAT SYMPTOMS STARTED ON 5/13/2021 IN THE EVNING, PATIENT WAS INSTRUCTED TO TAKE TYLEONL AND ANTIHISTAMINE AND COULD ALSO USE A COLD COMPRESS AND TOPICAL STEROID ON THE AFFECTED AREA
passed my / booster timeframe; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient just realized that he/she had passed Shingrix booster timeframe, which led to incomplete course of vaccination. The reporter asked what he/she could do. The follow-up would not possible as no contact details were available.
Dizziness, light-headedness, unsteadiness in walking, paleness, nausea.
contacted facility 8/2/22 states on vacation out of state, developed headache, temp and body aches today and tested positive for covid on a home test
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated intramuscularly with a 0.5mL dose of GARDASIL (LOT# not reported). On an unspecified date, after vaccination, the patients experienced "2 episodes of syncope and dizziness"> The patient was sought unspecified medical attention and no outcome was provided. No further information is available.
Extreme stomach discomfort, liquid diarrhea that lasted more than 45 days. Systemic full body hives that lasted 6 days a week following second Pfizer dose. Extreme biliary dysfunction. Extreme anxiety, panic attacks.
had high pitched shrill cry 3-4 hrs p/shot; would cry until mom got pt to sleep & would start crying again if laid pt down; lasted for 3 days; given APAP q 4 hrs;
patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window; Blood pressure elevated; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure elevated) and OFF LABEL USE (patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038-K20A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure elevated) and OFF LABEL USE (patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure elevated) and OFF LABEL USE (patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications: Taken but not listed Patient was told by her primary care provider not to get second dose as scheduled due to her blood pressure being elevated but has given the patient permission to receive it now.
redness - 3"x4" oval down tricep. can still see injection site injection site on arm warm pain - feels like a bruise when touched. can't sleep on that side started 2 days after vaccination (9/24), called pharmacy to report on 9/25 upon follow up with patient on 9/26, area is not as big/red/warm, but just as painful. pt took ibuprofen 200mg twice with some relief
Pt devel t104 3hrs post vax; Temp 107 27 hrs post vax;
p/vax pt arm was sl uncomfortable, swelling grapefruit sized from shoulder to almost elbow & redness;pt upper arm was sl swollen w/redness;half dollar sized area @ inj site & was hardened & warm to touch;
Patient stated she experienced redness, firmness, and pain around injection site and it hasn't gone away since then. Still hard to move her arm. It has improved but still not that much as of 10/25/2019.
Information has been received from a licensed practical nurse concerning a child between the age of 4-6 years who in first week of May 2007 was vaccinated SC with second dose of ProQuad (Lot # 657262/0259U). It was reported that within 5 minutes to 12 hours after vaccination, the patient developed swelling, redness and warmth at injection site. The child was treated with cool compress. At the time of report the patient recovering. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
JYNNEOS vaccination error no wheal. Patient revaccinated 0.5SQ
Injection site is red, hot to the touch, itches, sore when pressed on. Visible ?red? rash like patch below injection site. Has gotten larger and moved down the arm towards the Left elbow. Started 24hrs after second dose. Treating with ibuprofen, diphenhydramine and ice.
0.5 ml Moderna Covid booster was given instead of the CDC recommended 0.25ml dose
Information has been received from a Nurse Practitioner concerning a 64 year old male who on 12-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). The nurse Practitioner reported that on 13-OCT-2007 the patient came back to the office with a full outbreak of shingles. It was also reported that the patient had lesions and itchiness but it was not painful to the patient. Additional information has been requested.
Pt recvd 1st dose of Hep B vax on 21JUL92; approx 1 hr following vax exp severe pain @ the inject site & in the arm radiating from elbow to shoulder & into neck; also exp stiff neck, nausea, malaise & felt tired; sx lasted for approx 4 hrs
Now five days after vaccination - Am experiencing severe joint pain in hands, chills, headache, nausea.  Am worried because did not have anything like this before.  I took two Moderna vaccines and one booster in 2021
I don't know exact day/times. When I first noticed it, I had two red blotches maybe two to three inches in diameter and they were itchy and red and warm. The next day they were still warm and grew to the size of an index card. The swelling of the area was firm with distinct edges. I contacted my DR probably after they had grown together, upon looking at my photos on my phone that was Feb 19th 2021. On Feb 20th I have more photos of the spots. I only had a phone consultation by the way.
Admitted 3/29/2021 with acute on chronic heart failure, Cytomegalovirus liver failure
Fatigue in all over the body; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue in all over the body) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06EZ1A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOL +PHARMA) for GERD, DOMPERIDONE and ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for Gastric disorder, VALPROATE SEMISODIUM (DIVALPROEX) for Seizures, DIMETICONE (DIMETHICONE) for Skin disorder, PARACETAMOL (TYLENOL).   On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced FATIGUE (Fatigue in all over the body). At the time of the report, FATIGUE (Fatigue in all over the body) outcome was unknown.            Concomitant products included Tylenol is used to treat the symptoms.
Really really dizzy like walking on a boat; A spontaneous report was received from a 53-year old female patient concerning herself who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced really really dizzy like walking on a boat.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately 3 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 02 Jan 2021, after receiving the first dose of  mRNA-1273, the patient started to feel dizzy, when she gets up and walks, she feels really, really dizzy, like walking on a boat. She denied nausea, and reports that she was good when she sits down.   On 03 Jan 2021, the patient went to the emergency room but all tests were normal. Treatment for the event included cleaning out ears, Dramamine and oral Pedialyte.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, really really dizzy like walking on a boat, was unknown.; Reporter's Comments: This case concerns a 53-year-old female who experienced NS events of unexpected dizziness.  Event onset occurred on Day 4 after the first dose of mRNA-1273. Treatment with dramamine. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient developed hives that blistered and began oozing. She developed redness around the site the day following her influenza vaccination. She reported this to me on 9-15. I referred her to her primary provider. She stated she had already notified them a few days prior and they advised her to take Benadryl. She did report that her symptoms were resolving, but she wanted to make us aware of the event.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of (Merck) VARIVAX (lot # not reported) that were exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were reported. Additional information has been requested.
2nd dose of Fluarix to adult patient; This case was reported by a pharmacist via Regulatory Authority and described the occurrence of extra dose administered in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number H32SG, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix Quadrivalent 2021-2022 season with an associated reaction of no adverse event (the patient received the first dose of the Fluarix vaccine on 22-September 2021).   On 2nd December 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season. On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was a Pharmacist. The reporter reported that the patient received first dose of Fluarix on 22nd September 2021 and second dose on 2nd December 2021, which led to extra dose of Fluarix vaccine. The Fluarix vaccine was for 2021-2022 season and mentioned batch number and expiry date was for second dose. The reporter consented to follow up.
got Covid early January/taking Paxlovid; got Covid early January/taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown(booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "got Covid early January/taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: The patient has had all the Pfizer shots and boosters, just got Covid early January.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.