chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1245AM - woke with severe chills/rigors (ambulation difficult), temp taken temporally at 100.3, 1g Tylenol taken.  1:00AM - Chills subside, fever spikes to unknown lever but very high by touch/feel. + headache,  +body ache 7:00AM - 400mg Advil taken All day with + malaise, + body ache, +high pain at injection site 1:00PM - 500mg Tylenol taken 6:00PM - Fever = 101 + headache and all other SX remain 10:00PM - 1g Tylenol taken 7/11/19 12:45AM - awoken with cold sweat multiple times throughout night 8:00AM - Woke up with only site injection pain. No other SX present, not further medication taken.
Information has been received from a physician and a certified medical assistant concerning a approximately 18 week old male with dermatitis from 02-OCT-2008 who on 30-DEC-2008 was vaccinated with a first 2ml dose of ROTATEQ (lot# 662735/1101X) orally. The patient also received RECOMBIVAX HB (MSD, thimerosal-free, lot# 661596/0919X) into left thigh, PENTACEL (lot# C3240AA) into left thigh and PREVNAR (lot# DD01075) into right thigh at the same day. Other concomitant therapy included topical hydrocortisone. In February 2009, the patient experienced bronchiolitis, from which he recovered. On 15-MAY-2009, the patient developed nausea and vomiting, dehydration, report of one tarry stool and abdominal pain. On 18-MAY-2009 the patient presented to the office, the physician palpated an abdominal mass in the lower left quadrant (LLQ) and sent the baby to the emergency room. There the baby was admitted on 18-MAY-2009. A KUB X-ray was performed on 18-MAY-2009 and showed that the baby had intussusception. At the same day, Barium/air contrast enema was done, but the patient developed a perforated bowel. Partial colectomy and appendectomy were performed on 18-MAY-2009. The baby was discharged on 24-MAY-2009. On 29-MAY-2009, the baby was readmitted with vomiting. An ultrasound was done that day and showed no evidence of recurring intussusception. There was no fever and the baby was discharged the next day. At the baby's last office visit on 08-JUL-2009, there were no gastrointestinal issues. The patient did not get the second or third dose of ROTATEQ. Additional information is not expected. 7/30/09 Hospital records received DOS 5/18/09 to 5/24/09. Assessment: Bowel perforation, intussusception. Patient presents with moderate intermittent vomiting, hard black tarry stools, decreased oral intake, decreased urine output. Decreased activity and sleeping more. Anterior fontanel sunken. Dehydrated. Small mass in left abdomen. Laparotomy with reduction of ileocolic intussusception, excision of colonic perforation, and appendectomy. ICD9: 560.0, 569.83, 553.1, 466.19, 692.9
joint pain; tired; congestion; body aches; Runny nose; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received first dose of BNT162B2 (Pfizer Covid Vaccine, solution for injection, Lot# unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 14:00 (at the age of 51 years-old) as single dose for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 at 14:00, patient experienced joint pain, tired, congestion, body aches, runny nose. The patient had no known allergies. The outcome of all the events was recovering.  Information on Lot/Batch number has been requested.
Severe muscle aches, chills. Low grade fever. Vomiting and diarrhea. Also soreness on arm and not able to move left arm as much.
2 hours after injection I had a large hard lump 2" below injection site, about 3" in diameter that went away within 3 days.  9 days after injection I had a large area in same place as lump break out into massive hives, painful, itchy, hot.  Went to Dr next morning, pictures were taken of arm. Went back to Dr 3 days later.  Rash resolved 8 days after it started.  Took Benedryl internally and topically.
High fever, extreme chills, body aches, numbness in my arms and legs, nausea, difficulty breathing lasted for 4 days after second dose. After the second dose I am still missing my period and my hair is falling out in large clumps.
given the less than the prescribed dose of the vaccine; A spontaneous report was received from a pharmacist concerning 13 patients who received less than the prescribed dose of Moderna's COVID-19 Vaccine (mRNA-1273).   There were no medical history or concomitant medications reported.  On 03 Feb 2021, the patients received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The pharmacist reported patients were given less than the prescribed dose of the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, given the less than the prescribed dose of the vaccine, was considered resolved on 03 Feb 2021.; Reporter's Comments: This case concerns 13 patients with no patient identifiers who received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events after the study drug was administered in this case of given the less than the prescribed dose of the vaccine.
Several hours post vaccine, pt experienced GI upset, headache, fever, progressed to nausea, vomitting, resolved with sleep of approximately 20 hours.  No generalized anaphylaxis.
Woke up with swollen, runny, reddened bilat eyes with itching, with some blurriness.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 24-Oct-2021. The vial did not undergo any temperature excursions. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old.. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment.  Update1. 12/10/2002:  A follow up report from a health care professional indicating that a 1 year old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/18/2002. The vaccinee experienced no adverse reactions. Cross Reference with:PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200805, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP20000875, PJP200200876, PJP200200877.
Breakthrough COVID-19 case with unknown symptom onset date: shortness of breath/difficulty breathing. Hospitalized 8/21/2021 for unknown duration
Soreness and swelling at injection site,fever 100.2, chills, dry heaves, headache, body aches, fatigue, thirst. All occurred the same days as vaccination - lasted the rest of the day and the next day.  All gone by the third day.
pt recvd vax & exp migraines; seen by MD; This file is considered to be invalid;
This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX, lot # L027287, expiry date 21-JUL-2017, lot # L018002, expiry date 19-MAY-2017, lot/batch # L021612, expiry date 10-SEP-2016. Concomitant medication were not reported. No adverse event were reported. There were no Product Quality Complaint (PQC) involved. Temperature at which the vaccine was stored was 6.5 degree Centigrade, for a time frame of 3 hours There were no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Nausea, muscle pain, headaches, fever, fatigue, and lymph nodes.
Pain around injection site; Swelling around injection site; rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (rash around injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (rash around injection site). On 11-Feb-2021, VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (rash around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product  was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-207669 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR form received on 04-MAY-2021 and  does not contain any new information.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient may have been vaccinated with an improperly stored dose of VAQTA 25/0.5 (units not provided) (dose, frequency and route were not reported) lot # M027879 with expiration date of 24-JAN-2018, for prophylaxis. No adverse effects were reported. The temperature excursion of the VAQTA was between 32 F and 36 F, for a time frame of 72 hours. No previous temperature incursion was reported and no data logger was involved. No product quality complaint was involved (PQC). This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000334: US-009507513-1703USA000331.
Patient began itching about 5 1/2 hours after receiving shot.  Redness ocurred immediately after first signs of itching.  Hives over arms, truck and oper body.
"Pfizer-BioNTech COVID-19 Vaccine EUA". Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The local clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. (This VAERS writer assigned to form completion was not the administrator of this vaccine). Outcome: As of the date of this form completion, contact attempts x 3 and letter mailed by health dept. staff to vaccine recipient.
Lightheaded, low heart rate, low blood pressure, blacking out with no vision the first hour of the vaccine.  Could not walk without being held.
This case was reported by a physician via call center representative and described the occurrence of fainting in a 72-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness. On an unknown date, the outcome of the fainting, fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness were recovered/resolved. It was unknown if the reporter considered the fainting, fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's neighbor who himself was the physician. The age at vaccination was not reported. About 4 days after vaccination, the patient experienced fever, muscle ache, flu symptoms, palpitations, cough, fainting, trembling and sick for about 2 weeks. The patient did not receive the vaccine from the reporter. This reporter was just calling on behalf of her neighbor.
I was fine just had some discomfort in my arm and I took some Tylenol and I was fine. My husband also had the same reaction/just a little soreness in his arm; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's husband). This is second case out of the two cases.  A 77-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021 as unknown, single dose for COVID-19 immunisation. Medical history included myocardial infarction : Mild heart attack , blood pressure abnormal from an unknown date. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced discomfort in the arm, had a little soreness in the arm. Additional Information was reported by the reporter that patient had Mild heart attack last Sep but now he is fit as fiddle and also reported that her husband, I don't know if it's same. Yes his is same, it says lot number, product name, EN5318. Reporter also stated that "Well because we are old. Outcome of the event was recovered on an unspecified date.    Follow up (04Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a 77-year-old patient (Reporter's husband) that included patient's weight, height, medical history, product batch no, product start date, event with outcome.  Follow-up attempts are completed. No further information is expected.
started to itch on back of head, and then on my torso; later I had a rash on groin area and under my arms and the back of my head which formed into hives; this disappeared about 24 hours later with no other problems
NERVE DAMAGE TO THAT ARM; FELT LIKE IT WAS FALLING OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced nerve damage to that arm, and felt like it was falling off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nerve damage to that arm and felt like it was falling off was not reported. This report was non-serious.
Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021; Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021; This is a spontaneous report from a contactable consumer.    A 15-year-old female patient (not pregnant) received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers not reported), on 20May2021 (first dose, at 15 years) and on 12Jun2021 (second dose, at 15 years) , both as single doses for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19.Patient's brother tested positive via PCR test on 30Sep2021. Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021. Symptoms of nasal congestion and headache subsided within a few days. No treatment given. Patient recovered on an unknown date in Oct2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Low fever, chills within 8 hours of shot lasting 10 hours, swelling, upper arm turned red, pain tenderness, could not lift arm above 2 inches without extreme pain, could not put on sweater or blouse without pain or help for 5 days (stiffness in arm).
redness below injection site; upper arm at injection site feels heavy and tight; This is a spontaneous report from a contactable consumer (reported on herself).  The 77-year-old female patient received BNT162B2 (Solution for injection, Lot number: EN6200 expiry date: unknown) via an unspecified route of administration in left arm on 23Feb2021 9:58 am, as a single dose for Covid-19 immunization. Medical history included Diabetic since in her 30's or 40's, and problems with her spine. Concomitant PIOGLITAZONE HYDROCHLORIDE (ACTOS) 15mg daily Ongoing for Diabetes has been taking for over 10 years, HYDROCHLOROTHIAZIDE, TRIAM-TERENE (TRIAMTERENE/HCTZ) 37.5mg/25mg daily Ongoing had been taking for over 10 years for high blood pressure, LISINOPRIL 40mg daily ongoing for Blood pressure taking for over 10 years, ALENDRONATE SODIUM 35mg every Saturday from 2018 Ongoing) for bones. She would receive injections (unspecified) for back. She had one just before Covid but has had none since. She had problems with her spine. She had inflammation of the spine. She was unable to pronounce the name. On 23Feb2021, everything went ok. She waited for 15 minutes after she received the vaccine. When she got home there was a big red spot the size of a nickel down below the injection site. It had faded. She does not recall hitting her arm. The paper that they gave her mentions redness and a rash. This was down below the injection site. The redness had gone away. It looked like a bruise that had changed back to her skin tone. She could see blotches of the redness. It was a dark color but not bruised. Her upper arm felt heavy and tight. She did not have history of previous immunization with the Pfizer vaccine considered as suspect or additional Vaccines Administered on Same Date of the Pfizer Suspect. Events did not require to visit Emergency Room/ Physician Office. She did not receive prior vaccinations (within 4 weeks) and no relevant tests were performed. Outcome of the event of redness below injection site was recovering, however outcome of the event of upper arm at injection site feels heavy and tight was unknown.    No other information was reported.
Vaccines given at 0949, mom called stating pt is screaming. Did eat & nap after vaccines. Came back to clinic at 2pm. Doctor dx with allergy to Pertussis and ear infection.
Patient reports around midnight the day of 1st covid vaccine that she felt a sensation in her face, and began to get swelling and rash on right side of face. She states that it progressively got worse. Upon waking patient took a Benadryl tablet, and came to the pharmacy to get further direction. Initially on 3/17/21 she was directed to call primary care doctor (who is located about an hour from home) and if symptoms worsened or she started having issues around mouth or trouble breathing seek an urgent care or emergency room.  Patient reported on 4/3/2021 that she had contacted doctor and they wanted her to continue the benadryl until resolved but did not believe that the reaction warranted a steroid and instructed that she could get second dose of vaccine.
Developed a rash that looks like dermatographism that has been ongoing since. I have taken antihistamines, and cortisone treatment. I saw my PCP and she referred me to dermatology.
During waiting for 15 minutes after vaccination, patient felt dizziness and did not feel right .  We could not be able to obtain blood pressure and 911 was called.
p/vax had local swelling; warmth; itching; & pain @ inj site; referred to ER; in ER also described having tightness in throat; erythematous & selling 10x6cm area in posterior & proximal LUE; tx: motrin; ice pack
Pain at injection site, diarrhea, fatigue, nausea. 10/2/22 was my worst day. I'm getting better but I am not well yet.
Headache fatigue, low grade fever Narrative:  missed one day work following second dose due to above symptoms
Information has been received from a medical assistant referring to an unknown number of unspecified patients. On unknown dates starting on or after 12-MAY-2016 the patients were vaccinated with VARIVAX lot # L049536 (expiration date 08-DEC-2017), which was improperly stored at 14 F for 1400 minutes. There was no previous temperature excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Pain in her arm; Developed little and itchy bumps on her arm and legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain in her arm"; RASH PRURITIC (non-serious) with onset 2021, outcome "unknown", described as "Developed little and itchy bumps on her arm and legs".  Additional information: She reported that after getting her first 2 doses she experienced pain in her arm and then 5 months later she mentioned that she developed little and itchy bumps on her arm and legs. But she is not particular if this has been caused by the vaccine per se. The reporter wanted to know if she did not had any severe AEs on her first 2 doses. Is it possible that she will not have any AEs on the 3rd dose too. The reporter wanted to know how long does she need to wait to get the shingles/flu vaccine after she got the booster dose and vice versa.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.