chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I may have a blood clot in my leg.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on 20Jan2021 and is going to visit his doctor because they think that he may have a blood clot on his leg on an unspecified date. He wanted to know if it was okay if they give him a shot of something like contrast to see the ultrasound. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Information has been received from a licensed practical nurse concerning a 75 year old male patient who on Nov 03 2004 was vaccinated with 0.5 dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy included trandolapril (+) verapamil hydrochloride (Tarka), fluticasone propionate (+) salmeterol xinafoate (Advair), levothyroxine Na (Levoxyl), doxazosin mesylate, Pletol and folic acid. On Nov 04 2004 the patient experienced erythema of upper arm. Unspecified medical attention was sought. No further information is available.
About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99%, RR 17, HR 68). no wheezing, SOB, swelling, chest pain, dizziness, abd pain, NV. about 15 minutes later, lip tingling improved but began c/o generalized urticaria with mild erythema to left upper chest.   patient well appearing at that time, A&Ox3, no increased WOB, SOB, hives, facial swelling, facial redness. Patient reports she experienced same urticaria about 24-48 hours after 1st COVID vaccine dose, treated at home with po benadryl with improvement. Placed on continuous monitoring and administered 25 mg Benadryl po with improvement in symptoms. About 30 min after benadryl administration symptoms resolved. Offered ER evaluation to which patient declined. She works within hospital and agrees to seek emergency medical care should symptoms return or worsen. can continue to take benadryl at home and monitor closely.
heart palpitation; irregular heart beats/irregular beats that happening and seems like it's like every 20 minutes; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ER2613, expiration date was not reported) via an unspecified route of administration in the left arm on 02Jun2021 (at the age of 46-years-old) at single dose for covid-19 immunisation. The patient medical history and concomitant therapy were none. The patient was fine on the weekend and he didn't get any adverse side effect things, so he was noticing some heart palpitation, the heart was not regular pattern, irregular heart beats, he was noticing some irregular beats that happening and seemed like it was like every 20 minutes, he wanted to know this was normal or not and the only thing he took over the counter was some Advil (Ibuprofen ) just because of this irregular heart beat thing. No treatment received for the event heart palpitation. The outcome of the events was unknown.
Initial report received from a health care professional via Health Authority on 02 Mar 2010: This patient was vaccinated with Influenza virus vaccine H1N1 (manufacturer unknown) for immunization at an unspecified dose on 24 Nov 2009. She was pregnant since an unspecified date. She had experienced pyrexia on 01 Dec 2009. Also stillbirth was also reported which occurred on 01 Dec 2009. The outcome of events was not reported. The seriousness criteria of the events were reported as serious and no further information was provided at the time of report.
At approximately 12:08 pm on 10/17/2016 patient received the MENACTRA vaccine. She was fine after shot with no complaints. While mother was paying patient became dizzy and fainted. Paramedics were called because she hit her head. Her vitals were fine and refused further medical treatment.
Information has been received from a medical assessment referring to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of improperly stored VARIVAX (lot # L045955, expiration date 17-NOV-2017, strength and route were not reported). The vaccine had been stored under temperature of -10.8 degree Celsius for 48 minutes before back in range. There was no previous temperature excursion and data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; Headache; Muscle aches all over his body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches all over his body) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was  provided by the reporter.  Concomitant products included PRAVASTATIN for Cholesterol, LOSARTAN for Hypertension.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 6:30 PM, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches all over his body). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 11-Mar-2021, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches all over his body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I received the first dose of Shingrix at 2:00 pm on 10/31/2020. Pain at the injection site and a headache started that evening. At 2:00 am on 11/1/2020, I woke up with chills, fever and throwing up, in addition to a bad headache. By 10:00 am, the fever, chills and throwing up stopped. The headache and tiredness throughout the day, but went away by 11/2/2020.
pt recvd vax 23FEB96 & 6hrs later devel nausea & vomiting which persisted until 25FEB96;still nauseous on 26FEB96 w/some muscle soreness;no rash, hives or breathing or swallowing;
7/13/07 Mother called states had Tdap and Varivax 2 days ago and patient's arm is swollen on a circular area around the site. At the present time child is c/o of pain to site is warm to touch. Child is afebrile. Daycare has started putting warm compresses, instructed mother if does not receive relief from compress and/or notices changes like red streaks on arm to go to PMD or ER for evaluation. Notified supervisor and MD director.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), administration date: 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient felt abnormal/felt bad, onset 2021, with outcome of unknown. Additional information: The patient was supposed to at 11:00 am (unspecified date) get the second vaccination, but the night prior felt very bad and wondered if they should not go in. It has been three weeks at the time of the report. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient complains of headache (pain- 3/10) and mild dizziness @ 1540.  Patient states that she is asthmatic and chronically hypertensive.  Confirms that she has eaten today and taken her medications as prescribed. RN notes that patient is donning a N-95 mask under a three-ply cloth mask.  Instructed to remove outer cloth mask and educated on proper use of N-95.  RN offers oral hydration, continues to assess and monitor.  At 1550 patient states that dizziness has resolved.  At 1600 she states that she is feeling better and would like to go home.  RN advises patient to seek medical attention for any escalation of symptoms, and to call 911 with any emergent issues.  Verbalizes understanding. Ambulates from facility alone 1605. Initial vitals @ 1540: HR 92, BP 136/95, SpO2 97 Repeat vitals @1603 HR 88, BP 140/94, SpO2 99 Recorded by  RN
The patient had redness, swelling, pain and warmth of the left arm, possible cellulitis.
Fever 100.7 overnight; Fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 13:15 (lot number: P220395-0060L; expiry date: unknown) as dose 2, single for Covid-19 immunisation. Medical history included known allergies to penicillin. The patient was not pregnant at the time of vaccination. The vaccine was administered in doctor's office/ urgent care. The patient did not receive other vaccines at the time of vaccination. The patient was not diagnosed with Covid-19 prior vaccination. The patient was not taking concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 at 14:00 (lot number: p220395-DD74L) at the age of 60 years old, in left arm, for Covid-19 immunisation. On 09Mar2021, at 11:45 PM, the patient experienced fever 100.7 overnight (approx. 12 hours after vaccine for about 12 hours), fatigue, and headache. The patient did not receive treatment for the events. The patient has not been tested for Covid-19 post vaccination. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
28 yo woman who started having chest pains after Moderna COVID vaccine.  Dose #1 was 5/28/2021 (027C21A); dose #2 was 6/23/2021 (027C21A).  Both given through clinic.  She says she had to get the vaccine in order to work with employer.  She said that the same evening after the 2nd dose she had a severe headache, soreness all over, nausea.  Chest pains started the next day, worse with laying on her back.  She says the chest pains have continued, and are at their worst later in the day and when she lays back.  Says she noted some areas of freckling on her hands in the days after the vaccine, and that under her armpits she also got some small areas of freckling.  She says she also feels palpitations, and an overall heaviness in her chest.  Pain is worse with deep breaths also, so she avoids deep breathing.
Vomiting, paleness, cold sweats, fever.  Vomiting began 3 days after immunization.  Increase in secretions, loss of appetite, desat/bronchospasm.
Vascular occlusion; Area blanched; Bruising; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, in Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included gastric bypass and rheumatoid arthritis. The patient's concomitant medications included botulinum toxin type A haemagglutinin complex (DYSPORT; Lot Number: T18469, Expiration Date: Aug2021), hyaluronic acid (RESTYLANE; Lot Number: 17763, Expiration Date: Sep2022), and durapatite (RADIESSE) (lower half of the face), all three from 17Feb2021; epinephrine/ lidocaine as premedication; and an unspecified multivitamin. The healthcare professional premedicated the patient with epinephrine/lidocaine. As the healthcare professional was injecting around 0.25 mL of hyaluronic acid in the right cheek, with a cannula, she noticed that the area blanched (unspecified date). The healthcare professional immediately withdrew and applied warm compresses to the area. The patient was experiencing a vascular occlusion. The healthcare professional injected 5 vials of vorhyaluronidase alfa (HYLENEX) into the area. The patient only experienced bruising which eventually resolved. All events have resolved. It is unknown if the patient has history of fillers or toxins. Almost exactly 4 weeks prior to the injection, the patient had the COVID-19 vaccine, but the healthcare professional is not sure which one the patient received (pending clarification). The healthcare professional assessed that COVID-19 is the suspect product. The patient had not had any dental procedures in the last 4 weeks leading up to injection. The healthcare professional did not know if the patient had any other vaccinations or any illness or sickness leading up to injection date. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the very close temporal association, the reported vascular occlusion with pallor and bruising seems more likely an adverse effect of hyaluronic acid injection and is deemed unrelated to BNT162b2 vaccine.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
A non-serious report was received from a consumer concerning a 33-year-old female, who experienced head congestion, cough and sore throat one day after receiving FLUMIST.  No medical history and concomitant medications were reported.  The patient received one dose of FLUMIST on 07-Dec-2007 in a military clinic.  On 08-Dec-2007, the patient began to experience head congestion, cough and sore throat.  On 13-Dec-2007, the patient reported that the symptoms were somewhat better and indicated that she will be followed up by a military doctor.  The patient did not experience a rechallenge while receiving the suspect vaccine.  The reporter did not provide a statement of causality for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006287, which is the adverse event report fort the above patient's son.
Information has been received from an emergency medical technician, for GARDASIL a Pregnancy Registry product, concerning an approximately 26 year old female smoker patient with allergy to BENADRYL. The patient had a miscarriage in 2001 (reason unknown). In 2003 the patient delivered a male baby of low birth weight, otherwise healthy. In 2008 the patient delivered a baby boy of low birth weight (6 lbs, 8 oz), the delivery was induced at 38 weeks due to decreased fetal movements. Decreased fetal movement was note throughout the pregnancy in 2008. The patient also had documented poor maternal weight gain during the 2008 pregnancy. Family history included down syndrome and sister had cerebral palsy. On 03-NOV-2008 the patient was vaccinated IM with a 0.5 ml first dose of GARDASIL (660616/0570X). On 02-JAN-2009 the patient was vaccinated with the second dose of GARDASIL (lot number 661531/1311X). Concomitant therapy included LOESTRIN. The reporter stated that the patient returned to the office in May for her third dose and it was discovered that she was pregnant. The third dose was not given. Her LMP was on 17-FEB-2009. Expected date of delivery is approximately 24-NOV-2009. The reported stated "the patient is a seriously unhealthy person. She is a smoker and has been smoking throughout the pregnancy". The patient was seen in June 2009 for complains of left flank pain and first trimester bleeding. In July 2009 she complained of abdominal pain. She was now experiencing third trimester spotting and was having decreased fetal movements that was due to the smoking. Again she had poor maternal weight gain. Laboratory tests included: prenatal blood work completed results: iron was low; ultrasounds: "measuring smaller than dates". At the time of the report the status of the patient was unspecified. The patient sought medical attention by office visit. Follow up information has been received from an emergency medical technician who reported that the patient's LMP was more than one month after she received her second dose of GARDASIL. The reporter stated that the patient's last menstrual period was "not even in February, it was later than that" and that the patient had a history of irregular periods. The patient had not taken all her birth control pills and that the patient had some other prior health related problems and was a heavy smoker. Because of the dates of her LMP the patient was not enrolled in the Pregnancy Registry as she did not meet the dating criteria. No further information is available.
woke up with a subconjunctival hemorrhage in right eye; This is a spontaneous report from a contactable consumer reporting for himself   A  67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 23Jan2021 at 01:00 a.m.  at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included diabetes. Concomitant medications included empagliflozin (JARDIANCE), lisinopril, rosuvastatin, tamsulosin hydrochloride (TAMULOSIN). On 24Jan2021 the patient woke up with a subconjunctival hemorrhage in right eye. No Treatment was given for the event.
Patient states feeling anxiety.  Patient states she felt nausea.  No vomit and rapid heart rate.  HR 88, RR 22. 6:25pm Patient left accompanied by aunt. was walking c/1 steady gait with vitals within normal limits.  Patient recommended to seek medical attention if any other adverse reactions arise.
pt recvd vax & started convulsing in upper and lower extremities & was not responsive & w/in several mins had another sz; taken to ER for eval; encephalopathy;
Low fever; Big hard lump and rash at injection site; Big hard lump and rash at injection site; Itcy at inejction site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site), VACCINATION SITE PRURITUS (Itcy at inejction site) and PYREXIA (Low fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site) and VACCINATION SITE PRURITUS (Itcy at inejction site). On 31-Jan-2021, the patient experienced PYREXIA (Low fever). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site), VACCINATION SITE PRURITUS (Itcy at inejction site) and PYREXIA (Low fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swelling of R side of tongue beginning 8 hours post vaccine administration (Heplisav-B, seasonal influenza).  Sxs started at the front tip of tongue around 5pm on 12/28 and progressed to entire R side of tongue today (12/29).  Upon evaluation at employee health, R side of tongue looks red, irritated, swollen with some canker sore like areas.  No swelling in throat noted.
On 12/16/99 the pt broke out in chickenpox with a fever, runny nose, sore throat, and a "strong case of lesions too numerous to count all over he face and everywhere else." On 12/17/99 she was seen in the physician's office and noted to be afebrile, with her sore throat and runny nose resolved. It was noted that the child had been exposed to chickenpox on numerous occasions over the last four years without previously developing any symptoms. No further information is available.
TSH levels 6x higher than what they had been for 7 years after first dose of vaccine. Medication adjusted and TSH levels went to a normal range. After receiving the second dose, my TSH levels rose again to 6x higher than previous normal range. Follow up in April for next round of labs.
WOKE UP WITH HOARSENESS IN VOICE AND LABORED BREATHING WEAKNESS IN HANDS, ARMS, LEGS & FEET.
Client became dizzy and fainted right after receiving HPV vaccination. Client became unresponsive for about 4 secs, but immediately became responsive after laid on floor with feet elevated.
Started having severe migraine with aura after 1st and 2nd dose of vaccine.  First time it lasted 24-36 hours.
Patient came to clinic with mother to get COVID 10 Vaccine. Patient received vaccine at 1515 and stated she felt nervous and asked for water and she vomited right after and was trembling. NP was notified. Patient was then escorted by nursing to another room to have her lay down. Patient was assisted to bed and VS were take BP LA Laying 122/89 HR 132 Oxygen Saturation 99% RA appeared pale. Patient awake and answering questions. BP at 1530 105/79 HR 101 Pulse Oxygenation 100% RA. VS at 1542 102/74 LA Laying HR 95 Pulse Oxygenation 99%. NP cleared patient to leave at 1545 stable vital signs patient stated she felt better no pallor noted no difficulty walking left with mother.
This is a spontaneous report from a contactable consumer reporting for herself. This female patient of unknown age and race/ethnicity received in Nov2017 a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. On an unknown date, patient has been on LYRICA for an unspecified indication and broke out in hives. In Nov2017, next day after she received vaccination, she didn't feel well and came down with a really bad cough. Outcome was not recovered. Information on the batch number has been requested.
Developed itching at site and then in 24 hrs red area 9sunburn appearing color approx.  4 inch diameter circle  below the injection site, reddened area spread to part of deltoid and into antecubital at its maximum.   used ice packs and Ibuprofen initially and then took 1 dose Benadryl on 3rd day which has helped subside the spread and caused fading from sunburn red to very light red color.  itching milder
Caller reported having a fever with the second vaccine; 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 74 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6206) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; GABAPENTIN; LOSARTAN; LEVOTHYROXINE SODIUM; AMLODIPINE BESILATE. Vaccination history included: Bnt162b2 (1st dose, Lot #: EM98809), administration date: 20Feb2021, for covid-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Caller reported having a fever with the second vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient also received booster (LOT-30145BA) in Left arm on 26Sep2021 and experienced fever about 100 Degrees and kind of chills, Achy (ache) and wanted to know if this was common problem or not. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.