chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling muscle aches; FEBRILE; SORE THROAT; HEADACHE; This is a spontaneous report received from a contactable nurse. A 21-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscularly in her left arm on 19Jan2021 (age at vaccination 21-year-old), at 07:15 for COVID-19 immunisation. On 09Feb2021, the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in her right arm. The patients medical history was not reported. Concomitant medication included loratadine (MANUFACTURER UNKNOWN) 10 mg, ESTARYLLA 0.25mg/0.035mg, calcium supplement (MANUFACTURER UNKNOWN) 500mg, multivitamin (MANUFACTURER UNKNOWN), FLONASE for an unknown indication from an unknown start date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021, the patient experienced muscle aches, sore throat and she was febrile for 2-3 weeks until second dose, regular symptoms like headache happened for first 48 hours. The patient did not receive any treatment for the events. The clinical outcome for the events headache (happened for first 48 hours), muscle aches, febrile and sore throat was resolved on an unknown date (2-3 weeks until second dose).   No follow-up attempts are needed. No further information is expected.
At approximately 7:00pm I received the Moderna vaccine for COVID-19 on 5/3/21. 17 hrs. after injection: headache,   19 hrs.: fever and bad headache, 20 hrs. 103.00 fever/ TERRIBLE headache/ body aches. I took Ibuprofen (200 mg. softgels) at 21 hrs, 23 hrs. 25 hrs and 27 hrs. after injection. Finally, by 29 hrs. post injection the fever started to go down and the pain was more bearable. I slept for 3 hours, then again and again. By 36 hrs post-injection the headache  was more mild and that next day I was tired and weak but without fever and body pain.
Tested positive after taking the 1st dose; Tested positive after taking the 1st dose; This is a spontaneous report from a contactable physician via a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received the first dose of bnt162b2 (lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient tested positive after taking the 1st dose and about to get the 2nd dose on 12Jan2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "test positive after taking the 1st dose".
Pt experienced subarachnoid hemorrhage secondary to aneurysm s/p r craniotomy and clipping of R MCA bifurcation aneurysm.  She made a complete recovery.
Inadvertently administrated an expired dose of Menveo; Patient is 77 years old; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 77-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 31st August 2021) for prophylaxis.   On 10th September 2021, the patient received the 1st dose of Menveo. On 10th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter stated that they had inadvertently administrated an expired dose of Menveo to the patient on the reporting date, which led to inappropriate age at vaccine administration. The vaccination was meant to be first dose. The lot number of the vaccine was not asked. The reporter consented to follow-up.
Blood pressure was also a little elevated  on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as "none". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms.  Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine.  She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
per mom's report, pt had unconsoleable crying for 6 hrs beginning 6 hrs p/shot;
Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored ZOSTAVAX (batch number # reported as M011665, expiration date 17-MAY-2017, dose not provided), subcutaneously. No adverse reactions were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Syncope/Fainting after vaccine administration...also watched parents get vaccinated and said that it freaked her out.  Quickly recovered and feeling fine with normal blood pressure/respiratory rate just minutes after syncopal episode.  Patient remained sitting for 10 minutes for monitoring then had her walk around store to make sure no more syncope episodes before going home with parents.
Developed COVID-19 and was hospitalized. Symptoms were cough and shortness of breath.
His left eye started looking funny on Thursday night, 2/25/21. Friday morning the left side of his face wasn?t able to smile. Took him to medical center where, after CT scan and blood work, he was diagnosed with Bell?s palsy. Unfortunately the treatment for this is a steroid and antiviral medication. By Sunday night he was exhibiting signs of mania.
19Jun87 20 wk /p vax, 2wk hx sore throat,T,aches,dizziness,d;DX:acute infectious illness;8aug87 pain dorsum lt foot that cont;14sep87 tenderness lt 4th& 5th metatarsal heads& swelling lt foot;30Mar89 knee pain& pain/stiff ankles,ANA&RF-neg
Pt says after a few hours after receiving shot, he noticed stiffness in arm at injection site. Next morning he developed redness and swelling around the area. Pt took antihistamines and anti-inflammatories for next 3 days that helped reduce symptoms.
A physician reported the occurrence of encephalopathy and neuropathy in a subject of unspecified age and gender who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. The subject's past medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received an injection of LYMErix; it was not known if the subject had received previous injections of LYMErix. At an unspecified time post-immunization, the subject developed "neuropathy and encephalopathy complaints." The reporting physician stated, "We are not certain whether the pt developed these conditions from the vaccine or possibly from Borrelia burgdorferi infection." As of 10/17/02, the outcomes of the events were unknown. Encephalopathy is considered medically serious (OMIC).
The vial was initially stored in the refrigerator on 10-FEB-2023; No adverse event; Dose administered after 30-day Use By Date and after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) had not resolved and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023).    No concomitant medication details was reported. It was reported that Intact carton inside refrigerator, but placed in a bag in the cooler to transport to the site and maintained at 2-8C the entire time. Vial size was 5.5ml red cap. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Patient developed hives, cough post receiving Varicella, Dtap, IPV, MMR and Influenza (Fluzone) vaccines. Symptoms began at home -> transferred by ambulance to Hosp where he received Rx
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 18-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
infection of the prostate; fasciitis; stomach got kind of bloated; prostatitis flare up; This is a spontaneous report from a Pfizer-sponsored program regulatory authority. A contactable consumer (patient) reported that a 78-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration in Feb2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his second dose of the Pfizer BioNTech COVID 19 vaccine in Feb2021, and two weeks later developed a prostatitis flare up and his stomach got kind of bloated. At the time he didn't think much of it but "now" thinks it may be correlated. The patient was having fasciitis or infection of the prostate. He is receiving his booster dose later the day of reporting; he will have the booster shot "now". He wants to know about the adverse reaction or side effects, if there have been any reports of prostatitis or stomach bloating after receiving the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-JUN-2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # N000238 for prophylaxis. On 23-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to LIQUID PEDVAXHIB.
SWELLING OF AIRWAY; FEELING OF SUFFOCATION; SWELLING OF ENTIRE BODY; SHORTNESS OF BREATH; RASHES THROUGHOUT BODY; HIVES THROUGHOUT  BODY; WATER RETENTION; GI PAIN; This spontaneous report received from a consumer concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non-smoker, and seasonal allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the Patient experienced water retention, gi pain, rashes throughout body and hives throughout body. On 20-MAR-2021, the patient experienced swelling of airway, feeling of suffocation, swelling of entire body and shortness of breath. Treatment medications included: epinephrine and antihistamines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of airway, and feeling of suffocation, had not recovered from swelling of entire body, water retention, gi pain, rashes throughout body, and hives throughout body, and the outcome of shortness of breath was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210350470-covid-19 vaccine ad26.cov2.s- Rashes throughout body, Hives throughout body. This events are labeled and is therefore considered potentially related.  20210350470-covid-19 vaccine ad26.cov2.s-Swelling of airway, Shortness of breath ,Swelling of entire body ,Feeling of suffocation, Water retention ,GI Pain. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
has terrible pressure on her spine.; inflammation of spine; Difficulty breathing, no throat closing; Coughing; Kidney pain; Tiredness; Muscle pain; Headache; injection site really, really sore; slept most of time; This is a spontaneous report from a contactable consumer. This consumer (patient friend) reported for a 25-year-old female patient that:  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0177 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm right on 19May2021 17:30 (age at vaccination was 25-year-old) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder/ for mental health, 30mg, 1 tablet by mouth twice daily, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior or the same day and no problems with the vaccines in past. On 19May2021, it was reported on behalf of his friend, who got the first Pfizer BionTech vaccine yesterday and since then has been having most of the symptoms read about but had one that was not heard of. Has had terrible pressure on the lower spine, it feels like she got an epidural. Clarifies most symptoms patient experienced as inflammation of the spine, difficulty breathing, but no throat closing, more coughing, kidney pain, tiredness, muscle pains, headache, and the inject site was really really sore. When she first got it she was kind of tired and slept most of the time afterwards and this morning the spine pressure/inflammation started getting worse and worse as time goes by. Everything has gotten worsened. The patient did not visit Emergency Room and Physician Office. The outcome of the events was not recovered.  Follow up needed, further information has been requested.
This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016 ), the patients were vaccinated with improperly stored GARDASIL 9 lot # M011840, expiry date: 01-FEB-2018, lot # M013636, expiry date: 15-FEB-2018 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003199.
Rash & UrticariaPruritus Narrative:  delayed onset localized urticarial rash reaction around injection site.
joint pain; Itchy skin on scalp and all over the body; Brain fog; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), PRURITUS (Itchy skin on scalp and all over the body), FEELING ABNORMAL (Brain fog), HEADACHE (headache) and PYREXIA (fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (joint pain), PRURITUS (Itchy skin on scalp and all over the body), FEELING ABNORMAL (Brain fog), HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain), PRURITUS (Itchy skin on scalp and all over the body), FEELING ABNORMAL (Brain fog), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   Reporter did not allow further contact
This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JUL-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M046008, expiration date 29-JUN-2018, 1 dose, orally for prophylaxis (exact dose and dose number were not reported). No adverse effects were reported in the patient.
Immediate nausea ~24 hours later nausea, vomiting, pain along entire body of side injection, fever 101.2, severe fatigue-slept for 20 hours ~48 hours all resolved except fever fatigue
This spontaneous report as received from a 76 year old female consumer refers to herself. The patient's medical history included asthma and keratocones. In June 2012 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # K000995, exp date 16-MAR-2015 (also reported as 06-MAR-2015) in her arm. Concomitant therapies included atorvastatin and levothyroxine sodium (manufacturer unknown). On 25-SEP-2014 the patient experienced: being tired, headache, nerve pain, itching, burning, big red clusters on her back, a 'full blown case' of shingles, and feeling irritated after ZOSTAVAX. She also stated that she had not been able to sleep since she developed shingles. The patient had sought medical attention. No lab diagnostics studies were performed. Treatment was given: acyclovir 400 mg and LYRICA 50 mg capsule. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Pt returns, 1 day, post vax, with a half dollar-sized red, raised lump at injection site.
The patient experienced extreme fussiness, vomiting and diarrhea a few hours after the vaccinations. The patient had a rash from head to toe the next day.
Pt developed acute fatigue and shortness of breath. pt was bed bound and after about a week or so contacted our office due to persistance of symptoms, along with weight loss  and decreased appetite. Covid test was negative. He was severely weakned and both I and cardiology were very concerned that with his underlying conditions the degree of debility was potentially hospitalization worthy or life threatening, fortunately he seemed to stabilize and treatment and follow up was able to be done out patient.
Flu symptoms- severe headache. Stayed prone for 2 solid days. Could hardly move- recovery- 4 days