chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date in 2014, the patient was vaccinated with unidentified Merck HPV vaccine (dose and route unknown, therapy type: unidentified Merck HPV vaccine). In September 2016 (reported as last month, prior to 11-OCT-2016), the patient received the second dose of unidentified Merck HPV vaccine (dose and route unknown, therapy type: unidentified Merck HPV vaccine) (Inappropriate schedule of vaccine administered). No adverse effect was reported. The nurse inquired whether the patient could be administered the third dose of unidentified Merck HPV vaccine on 11-OCT-2016. It also could not be determined whether the third dose was actually administered on 11-OCT-2016. Additional information is not expected as the reporter was unable to be reached for follow up information.
No additional AE reported.; expired PROQUAD administered to patient.; This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was not provided. Concomitant therapies included sterile diluent (manufacturer unknown).   On 10-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot #U010743, expiration date: 03-OCT-2022, administered for prophylaxis (route of administration and anatomical location were not provided) (product storage error).  The reporter stated that the product did not experience any temperature excursions through date of administration. No additional adverse event was reported.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever) and CHILLS (Chills). At the time of the report, PYREXIA (Slight fever) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. This case was linked to MOD-2022-524348 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow up received contain no new information.
I developed full-body hives with intense itching, burning and dermatographism that turned into chronic urticaria that lasted ~5 months thereafter.  The intensity slowly waned after the 5 month period, however I will still have more mild hives on a daily basis
Pt received both doses of the Pfizer COVID-19 vaccination, on 1/10/2021 and 2/6/2021.  On 3/1/2021 (greater than 2 weeks post completion of vaccine series), pt tested positive for COVID-19 via PCR.  Mildly symptomatic, only reporting diarrhea.
Pt developed rash at the injection site and possible herpes outbreak under the nose. Pt reports having history of herpes. Pt concerned because she was in contact w/ grandchild.
This patient's mother called at 8 PM on 02/12/2001, stated that the baby had welts on his left thigh 30 minutes after the immunizations. Given on 02/09/01. By 12 noon on 02/10/01, the baby broke out with hives all over his body. The baby developed a croupy cough, a temperature of 103F, and difficulty breathing. Went to the ER on 02/11/01 AM and was given Benadryl and sent home.
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) which was exposed to temperatures outside the prescribing information. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. This case is linked to case number 1403USA007008 and 1403USA007007. On 19-MAR-2014 a phone call was placed to the Licensed Practical Nurse. The receptionist, transferred the phone call to Licensed Practical Nurse. The Licensed Practical Nurse stated no doses were administered. It was reported that the lot number of GARDASIL was J011272 and expiry date 21-APR-2016. No further information was available at this time. Additional information has been requested.
pt recv vax 17OCT95 & exp redness & swelling @ the inj site shortly p/vax;MD was not aware of the event;
autism spectrum disorder  (looked at her all he saw were black eyes, like something was living inside her body, other than his daughter / she had behavioral issues); This spontaneous report was received from a consumer via other pharmaceutical company, referring to a 26 month old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).          On an unknown date, the reporter stated when he looked at her all he saw were black eyes, like something was living inside her body other than his daughter.  She had behavioral issues and was diagnosed autism spectrum disorder.   The reporter said "the lights were out for almost 2 years" and that MMR (manufacturer unknown) vaccine changed the patient's life.  The reporter stated his daughter was a smart lady now and he was concerned over the covid 19 vaccine.    The outcome of the event and the causal relationship between the event and therapy with MMR vaccine (manufacturer unknown) were not reported.  Upon internal review autism spectrum disorder was determined medically significant.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date after receiving the mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was reported as resolving. Patient received 1st and 2nd doses of mRNA-1273 vaccine 28 days apart. On unknown date, patient received co-suspect Adalimumab for rheumatoid arthritis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date after receiving the mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was reported as resolving. Patient received 1st and 2nd doses of mRNA-1273 vaccine 28 days apart. On unknown date, patient received co-suspect Adalimumab for rheumatoid arthritis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Streptococcal pneumonia with acute hypoxic respiratory failure -Urine antigen positive for strep pneumo, patient needed supplemental persistent oxygen to maintain saturations above 90%, patient initially treated with IV Rocephin, her oxygen requirement decreased with time and now she has not qualified for home oxygen.  Will give a week of Augmentin post discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Pt had actual Covid 8/2020  (loss of taste/smell--mild/long resolved--no respiratory sx).  Received Moderna vaccine (first dose) 1/7/21--24 hours later had typical symptoms (HA/fatigue/chills) but also SOB--SOB continues to linger in isolation currently.
headache/nausea/flushing/chest tightness/paroxysmal breathing within 5 minutes of vaccine administration
Patient reported that on the day he was vaccinated, in the evening when he laid down, he felt heart attack-like symptoms. His chest was very tight, he had trouble breathing and began convulsions for about 10 minutes. He called 911, and EMTs arrived quickly and checked vitals. By then, the convulsions  had stopped and he reportedly had a normal 12-lead ECG. He stayed at home, but went to the ER the following morning and had normal ECGs, X-rays and labs. He continued to feel nauseous, had chest tightness, and then had a D-Dimer checked at another facility which was normal. He gradually felt largely better, then went to on vacation over the weekend of 10/15/2021, and developed nausea, vomiting, and temperature of 100F. He also complained of fatigue and chest pain. He feels better again 10/19/2021, but still notes chest discomfort. He is scheduled to see cardiology later this month.
Breakthrough case admission after 2 vaccines Moderna 10/24/21 Lot# 017F21A;  Moderna 11/21/21 Lot# 034F21A
IT WAS UNKNOWN AT TIME OF ADMINSTRATION PATIENT HAD RECEIVED 2 DOSES OF MODERNA ALREADY, SO PATIENT WAS ADMINISTERED A 3RD DOSE ON 3/2/21.  UPON BILLING IT WAS DETERMINED PATIENT HAD ALREADY RECEIVED 2 PRIOR DOSES ON 1/14/21  AND 2/10/21
No adverse reaction observed.  Patient signed off on consent forms for Pfizer booster. She did not have her vaccination card, so opened her profile. 2 doses of Pfizer visible from Jan and Feb 2021. Showed patient her profile and she confirmed that it was her. MA also verbally confirmed that she was about to administer a Pfizer booster, to which the patient verbally consented.  Patient in reality has 3 profiles, apparent only after the event when charting.  (Charting in EHR had to be done after as this was an outdoor vaccination event).  Patient had received 3 Pfizer and 1 Moderna vaccine prior to 11/20/2021.
Moderna COVID-19 Vaccine EUA  On 1/11 around 7:30PM, My left arm was very sore at the injection site.  I started to have aches throughout my body and chills.  I woke up at 1AM with a fever of 100.6.  I took Tylenol and drank liquids.  When I woke up the fever was gone so I went to work.  As the day progresses at work, I had chills and body aches.  I felt like I had a fever, so I went home sick at 12:30PM.  When I got home, I took my temperature and it was 101.  From that point until about 10PM, my fever flcutuated fgrom 99.9 to 101.  This morning (1-13-2021( when I work up at 7AM, I felt fine.  No fever or aches.
excruciating headache lasting for 2 days and waking me up at 3am day after shot; vaginal bleeding/metrorrhagia beginning morning after shot and still ongoing; feet burning & tingling starting day 3 after shot and waking me up at night
moderate flu-like sx-fever, hot/cold; 3APR95 rash located hands/chest; swelling, soreness, nodule, discoloration (black/blue) @ site of inj (lt arm);
Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.
SEVERE BODY ACHES; RUNNING FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced severe body aches, running fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, running fever, fatigue, and headache. This report was non-serious.
Patient developed eye swelling, itchy ear, and itchy throat approximately 1 hour after vaccination.  Patient was at home when this happened, so she called into our ER department where she works and was advised to take benadryl.  She took allegra 180mg daily for 2 days which resolved itchiness in throat and ear, but upper eyelids remain swollen today (day 3 post vaccination).
Metabolic Alkalosis; Lethargy; Sleep16-18 hours per day; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route administration in left arm on 11Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included total thyroidectomy, idiopathic intracranial hypertension (IIH), depression, ehlers-danlos syndrome, post cardiac ablation, AV-nodal reentrant tachycardia (AVNRT) on unknown date. The patient previously allergies to sulfanamide. It was unknown if the patient had diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included NEURONTIN, ATENOLOL, LEVOTHYROXINE from unknown dates for unknown indication. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 12Mar2021, the patient underwent lab tests  which included blood urea nitrogen (BUN) 17, sodium (Na) 142, potassium (K) 4.5, chloride Cl 101, carbon dioxide (CO2) 31, creatinine 1.28, anion gap 10, calcium 9, glomerular filtration rate (GFR) non-AA 50 and diagnosed with metabolic alkalosis. On same day, the patient developed lethargy and sleep 16-18 hours per day. The patient did not receive any treatment for events. The clinical outcome of metabolic alkalosis, lethargy and hypersomnia was not resolved.    No follow-up attempts are needed. No further information is expected.
skin inflammation near the armpit, near the chest; This is a spontaneous report from a contactable pharmacist. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Reporter mentioned that patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine and experienced a skin inflammation near the armpit, near the chest when he got vaccinated and was told to wait until 4 weeks. It was unknown what kind of skin inflammation, only that the inflammation can be visually seen and this did not go away after a month. Patient went to the Doctor's office, went to order an ultrasound but said it would interfere with the vaccine. Upon checking, doctor said that it was nothing internal, only outside inflammation. Reporter stated that over the weekend, the inflammation got worse. Patient went to urgent care and was told that this was a common reaction. Patient was advised to wait 3-6 months. Reporter asked how long the skin inflammation would last, since they have been advised to wait for months for it to go away. The outcome of the event was not recovered.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Patient c/o pain from shoulder to elbow left arm, states it hurts to move it.
I developed Alopecia Areata in January 2022. I've been seeing a dermatologist and getting shots in my head, but the bald patches are growing very rapidly.
Severe headache chills sweats dizziness  body aches chest pain stomach ache elevated temperature
The public health nurse administered the vaccine intramuscular rather than subcutaneous.  She reported it to the clinic lead who, in turn, sent an e-mail to manufacturer   They responded that there is no need to revaccinate the patient.
As noted in VAERS for dose 1, I had issues with my heart rate, and they continue. After dose 2, I felt awful and began to have an unscheduled menstrual cycle that lasted 5 days.
patient  fainted right after he was give his vaccine, he seemed very stiff. It took 2 minutes for hi  to regain conscious. he mentioned that he sometimes faints when he gets injected by a needle. he was observed for 30 minutes offered water, and left the pharmacy in good shape
top of head felt like when you hand falls asleep, needles felt every hair. it went away after about 20 min.  Ten stood up and was disoriented, joints felt like knives stabbing me, fibro peaked, felt like every nerve ending was on fire. Could not think or remember what I was doing.
Patient complained of severe pain and weakness of her arm and shoulder after receiving vaccine from our pharmacy intern a week after she received it.  After a second week of rest, she continued to complain of pain and weakness that is worse at night and morning and gets better during the day.
Vial was mixed with the merck diluent intended for varicella/mmr/mmrv. Administrator mixed it, drew up .5mL and administered that instead of the correct method of defrosting and administering just the contents of the vial.
Pt's right arm with swelling and pain, less than 24 hours, post vax. No fever or rash. Treated with Benadryl and ice prescribed.
2ndo dose yesterday and now i have  fever 100.7; My arm is so sore; my arm is red; headache; feel nauseous; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (2ndo dose yesterday and now i have  fever 100.7), VACCINATION SITE PAIN (My arm is so sore), ERYTHEMA (my arm is red), HEADACHE (headache) and NAUSEA (feel nauseous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No Medical History information was reported.   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 an unknown date, the patient experienced PYREXIA (2ndo dose yesterday and now i have  fever 100.7), VACCINATION SITE PAIN (My arm is so sore), ERYTHEMA (my arm is red), HEADACHE (headache) and NAUSEA (feel nauseous). At the time of the report, PYREXIA (2ndo dose yesterday and now i have  fever 100.7), VACCINATION SITE PAIN (My arm is so sore), ERYTHEMA (my arm is red), HEADACHE (headache) and NAUSEA (feel nauseous) outcome was unknown.            No concomitant medications were provided.  No treatment medication were provided.
vomiting x 1, upper resp congestion & cough, irritable no rash noted;
Information has been received from a nurse, referring to a male patient of unknown age. Concomitant therapy included sterile diluent (lot # M028330 and expiration date 24-FEB-2019). Information of concurrent condition and medical history was not provided. On 26-NOV-2018, the patient received an expired dose of PROQUAD (recombinant Human albumin) (strength was unknown; lot # N014950 and expiration date 11-NOV-2018) subcutaneously for prophylaxis (expired product administered). No adverse effect reported.
Rash, but it was hardly a rash at all; This spontaneous case was received on 13-Jan-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00170) and concerned a female patient of an unspecified age.  The patient's concurrent conditions included many allergies and eczema. The patient's concomitant medications were not reported.   On an unspecified date in Jan-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose; 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On an unspecified date in Jan-2021, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced rash, but it was hardly a rash at all.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  This case as assessed as non-serious.  Company comment: The event of 'rash' is considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'rash' is considered as related to Flucelvax Quadrivalent.
Pt to ED 5/28 for SOB, generalized weakness and fatigue. COVID+ 5/28 not requiring oxygen or meds. 5/30 pt with no complaints of pain, vitals are stable,  denies pain, no acute CR distress. 5/31 pt on room air with no complains of pain or discomfort at time. 6/1 pt received alert and oriented x4 with some agitation, on room air still. 6/2 no new complaints, no sob, cough, had a soft normal BM. Pt discharged 6/3.