chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Certified Medical Assistant refers to an approximately current 33 year old male patient. On an unknown date the patient was vaccinated with VARVIAX (Merck), 1350 U (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. It was reported that the patient on an unknown date had an equivocal varicella titer result and was not sure if he had received VARIVAX (Merck) in the past. The outcome of the event was unknown. Additional information has been requested.
Chills; Fever; This is a spontaneous report from a contactable consumer or other non-health professional (patient boy friend). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 14Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 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. The patient experienced chills and fever on 15Mar2021. Reporter stated that patient had the shot yesterday and she got a fever next day and we are wondering what we can do about it. She had gotten chills with fever and he was calling to see if there was something they should do about the fever, was there something patient should take, what should patient do with it and want to know what steps patient should take. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable consumer. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on an unspecified date (Lot Number: EW0153) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that he was not in pain or anything but he had about, he wanna said about half dollars size bump where the injection was and it's just red, it's kind of itchy. It's almost like he got the bite like mosquito or something but it's a big bump, so there was no pain he can still move arm it didn't hurt to touch or anything it's just itchy but he figured better safe then sorry and perhaps he should go ahead and at least get that reported to may be if that's just the normal thing. Event started within a week he got the vaccine. He wanted to know if he is going to loose an arm or if he is going to die from his reaction to the vaccine. The redness hasn't gone away, the bump was still there. The outcome of the events half dollars size bump where the injection was and it's just red was not recovered, of the other event was unknown.  No follow-up attempts are needed. No further information is expected.
On the right thigh inferior and medial to actual injection site was a circular area of mild erythema which is slightly indurated.  1.5 inches from injection site. no vesicules or pustules are noted
I had the Pfizer vaccine here at the hospital on 12/29/20. I had no immediate reaction, however, within 12 hours I had some major joint swelling. My joints in my hands were so swollen I had trouble gripping my phone, holding a glass, writing, etc. Swelling and aching in my knees, hip pain that caused me to avoid using the steps. I assumed this may be a normal reaction, therefore treated with anti inflammatories. The following week I returned to work and on Jan 7th was still having bad joint pain from the vaccine. Graciously, doctor gave me a steroid pack to help me get back to baseline. I did as advised by my manager and contacted a department were I was asked several questions, etc. and I thought nothing of it. It was very scripted as if she were reading from something. I assumed I would be provided documentation. Unfortunately, I did not keep a record of who I spoke with to which I now regret. Things were so ?urgent? in healthcare at the time, I had faith the correct measures were being taken. Obviously, I did not get the second dose. When completing the vaccine exemption form, it required uploaded documentation. I physically went to this department 8/17/21 and spoke with the manager. She has no record of the event. She said that sometimes it just gets reported to the VAERS system. I was given their contact info. She says all cases are to be reported to them but that our facility does not have access to those records. They only make the report. I called the number for VAERS and it was never reported.
Dizziness, Patient reported history of hypertension and dizziness. BP: 160/80 Pulse: 62 RR: 19 After 15mins BP went down 128/74, Pulse 64, RR 18. Patient reported no more dizziness. Patient stable went home accompanied by wife.
Moderna COVID 19 VACCINE EUA  A BAD RASH ALL OVER MY BODY
fever, cold sweats x 2 days, swelling @ inject site w/wheel 2 3/4 x 3 1/2 cm;
large red, hard area on rt deltoid where DTAP given; area about 6 1/2CM & 1 3/4CM raised;
Passed out; This serious case was reported by a other health professional via call center representative and described the occurrence of passed out in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 30 min after receiving Shingrix, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant). The outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Shingrix.     It was unknown if the company considered the passed out to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter reported that the patient received Shingrix vaccine and experienced passed out. The reporter wanted to know it appropriate to administer the second dose of Shingrix vaccine. The reporter did consent to follow up.
Received COVID vaccine on 1/6.  On 1/7 had body aches and chills, which resolved.  On 1/13 had nausea and diarrhea which resolved.
UNUSUAL RASH. TRIGGER FINGER IN RIGHT THUMB FOLLOWED BE TRIGGER FINGER IN LEFT THUMB.
About 17 minutes after the administration of the vaccine the patient refer that she started to feel  dizziness, tremors, daze and weakness
Pt recvd vax 4NOV92 & w/in 2 hrs of vax pt devel fever, arthralgia & myalgia; sx persisted for 2 days; No further details were provided;
When Pt came for 2nd dose of Moderna vaccine on 4/21, she reported to staff that beginning the day following dose 1, she experienced 2 straight weeks of migraine which resolved after two weeks. Did not report any other associated symptoms.  She did not seek medical care. She did opt to received the second dose om 4/21
Headache, Sedation, Myalgia, Arthralgia, Fever & Diarrhea Narrative:
pt recvd vax;fever,swelling on lt thigh,vomited x 3; stomachache,lt leg painful, unable to walk on it; T  101.4;referred to MD
Patient experienced vasovagal syncope. Became lightheaded almost immediately and then passed out shortly after while still sitting in chair. Was in and out for a few minutes. Had her lay on ground until she felt well enough to get up (approx. 10 minutes)
Information has been received from a consumer concerning an approximately 5 - 12 year old child who in approximately 1996 - 2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced a mild case of chicken pox. Unspecified medical attention was sought. The patient subsequently recovered. There was no product quality complaint involved. Additional information has been requested.
Exactly, 1 week from receiving 2nd dose of Pfizer vaccine, I suddenly had excruciating stomach pain, went to the hospital with pancreatitis and the following Monday while still in the hospital had my gallbladder removed!  Not positive this was caused by vaccine but definitely feel strongly that i was, as I had no previous issues...Just thought it should  be reported somewhere to someone.
Patient contracted Covid, despite being double vaxxed; patient contracted Covid, despite being double vaxxed; Fatigue; Fever; Loss of taste and smell; Nausea; Loss of taste and smell; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Patient contracted Covid, despite being double vaxxed"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "patient contracted Covid, despite being double vaxxed"; FATIGUE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown". Therapeutic measures were taken as a result of fatigue, pyrexia, ageusia, nausea, anosmia, dizziness.  Clinical information: Patient was a 48-year-old female, around 130lbs, and 5'3 in very healthy condition due to regular exercise and healthy diet. The patient is double vaccinated with Pfizer Covid 19 vaccine. The patient contracted Covid, despite being double vaxed, and is experiencing intense symptoms - significant fatigue, fever, loss of taste and smell, nausea, and dizziness. Patient was healthy 48-year-old female with no underlying conditions and was typically resistant to taking any medication, including OTC analgesics. Currently taking ibruprophen to treat symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was given the incorrect booster dose. - She was administered 0.5ml instead of the recommended 0.25ml
5 minutes after vaccines pt standing and became pale and fainted. Vomited x 2. Patient laid down elevated feet drank 8 oz carbonated soda. Waited 20 minutes Dr checked pulse which was normal.
Pt with history of migraines (using Topamax for prophylaxis) developed severe migraine within 13 hours of receiving flu shot.
Information has been received from a registered nurse concerning an 8 year old white female pt with no pre-existing medical conditions and no illness at the time of vaccination, who on 11OCT1996 was vaccinated in the left arm with a first dose of varicella virus vaccine live. On an unspecified day in November 2003, the pt was exposed to chicken pox and came down with the disease. The pt recovered on an unknown date. There were no laboratory or diagnostic tests performed, and the pt did not have adverse events following prior vaccinations. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Rash on arm at the end of vaccination day. Painful, hard lump started on right collar bone on day two
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 22-JUL-2017, the patient administered an improperly stored dose of PROQUAD (dose, frequency and route unknown, lot # N012490, expiration date:17-OCT-2018) for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown)(dose, frequency, route, lot # and expiration date unknown,) which was used to reconstitute improperly stored PROQUAD.  The temperature excursion was at 6 Fahrenheit degree to 14 Fahrenheit degree for 156 hours(incorrect product storage). The previous temperature excursion was 6 Fahrenheit degree to 14 Fahrenheit degree for 4 hours and 15 Fahrenheit degree to 46 Fahrenheit degree for 1 hour. Data logger was not involved. No adverse effect was reported. This case was cross referenced with case 1708USA012173; Sender's Comments: US-009507513-1708USA012173:
developed a localized pustular rash of RUE 2 days after administration of the vaccine. Rash self resolved after 3 days.
Pt stated that yesterday (12-3-01) late night arm had red streaks appearing on lower arm than noticed swelling came back 12-4-01 @ 8:30. To be seen today. Had redness and swelling on upper right arm associated with pain. Pt received pneumovax yesterday (12-3-01). Pt was seen 12-4-01 by doctor. Treatment: Claritin 10 mg and Medrol dose pack. Was treated today.
sweaty; heart rate became rapid; not to feel well; his arms and legs got tingly; This is a spontaneous report from a contactable consumer. This consumer (patients Grandmother) reported for a 13-year-old male patient (reporters Grandson) that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: EW0181 and Expiry date was not reported) via an unspecified route of administration in the right arm on 30Jun2021 (age at vaccination was 13-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 30Jun2021 reporter stated on behalf of her 13-year-old grandson who received the Pfizer COVID-19 vaccine yesterday and did not experience any side effects until 7 pm that night when he went to an exercise class. She states that he started not to feel well, and his arms and legs got tingly, he became sweaty and rapid heartbeat for a short period of time. She states that by the time he got home he was feeling better. The patient took couple of tylenol and went to sleep and seem to be fine. Unspecified treatment received for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow up information has been requested.
It was reported that a pt (1 of 13) received a Fluzone SV '00-'01 vaccination on  17Oct2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
under the weather; had a sore left injection site/sore left arm; tired; The patient received his third Moderna Covid-19 booster dose on 15OCT2021; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site/sore left arm), FATIGUE (tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his third Moderna Covid-19 booster dose on 15OCT2021) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site/sore left arm), FATIGUE (tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his third Moderna Covid-19 booster dose on 15OCT2021). On 15-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his third Moderna Covid-19 booster dose on 15OCT2021) had resolved. At the time of the report, MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site/sore left arm) and FATIGUE (tired) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.  It was reported that Symptoms were more pronounced than the first two vaccinations on 15-OCT-2021   This case was linked to MOD-2021-369380, MOD-2021-369381 (Patient Link).
Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.
Pain at injection site, upper arm redness and swelling.  Decreased appetite, shin hypersensitivity.  Had spontaneous resolution within 4 days.
half of her face and neck got swollen along her jawline and down her neck; her neck got swollen; face was touchy/tender; neck tender; jaw tender; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIOTECH COVID-19 VACCINE), dose 1 at vaccination age of 72-year-old via an unspecified route of administration in the left arm on 19Feb2021 (Lot Number: EL9267) as dose 1, single for covid-19 immunisation. Medical history included blood pressure abnormal (not sure if high or low blood pressure). Concomitant medication included hydrochlorothiazide for blood pressure abnormal with start (reported to be maybe about 4 years ago) and stop date not reported and unspecified vitamins. On 19Feb2021 at 12:45, the patient experienced her face and neck got swollen. It was further reported that the patient reported that approximately three hours later (19Feb2021 at 12:45), half of her face and neck got swollen along her jawline and down her neck. She measured the swelling to be about 4.5 inches long. She added that the left side of the patient's face, and jaw, down into her neck, about 4 and a half inches long, was swollen and tender and hard. She went back downstairs to see the paramedics because the paramedics were still there in her building and the paramedic looked at the patient's face and said he could see that it was swollen and hard, and when he touched a certain spot on the patient's face, it was touchy. The paramedic wanted the patient to go to the emergency room, but the caller said no. She was monitored, but not taken to the ER. The paramedics monitored her for 20 minutes after that, and then they sent her back home. She used an ice pack on her face after that. She still has some mild swelling left today but it's definitely improving. The next day (Saturday, 20Feb2021), the swelling had gone down some, and yesterday it was down even more (21Feb2021), and today (22Feb2021), it is just a small little spot. The patient stated that she is thinking it will be gone in the next day or two, but she just wanted to report it. She also mentioned that she has also called and reported the event to her primary care doctor. She inquired if she could get the second shot. A nurse told her that if you have a reaction to the first vaccine you won't have one to the second. So, she inquired if it was true. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
No adverse reaction. Patient was informed that she has been given nasal vaccine instead of IM. 12/8 and 12/11/2009 OB-GYN records note patient is pregnant, given nasal vaccine instead of IM, no side effects noted.
AT 9:30 AM HAD SYNCOPE EPISODE AND FELL AND HIT BACK OF HEAD.  SKIN FLUSHED, WARM, BP.130/60, AP. 98 RRR, MONITORED AND CONDITION RETURNED TO NORMAL.
Her arms were slightly sore; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDEM22-02829 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 02Nov2020 as dose 1, single (Lot number: EK4244244) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Inhaler: Asthma; "Medication for fibromyalgia" (unspecified if ongoing), notes: Medication for fibromyalgia. Concomitant medication(s) included: COCODAMOL; MORPHINE. The following information was reported: HEADACHE (non-serious) with onset 02Nov2020, outcome "recovered" (03Nov2020); PAIN IN EXTREMITY (non-serious) with onset 02Nov2020, outcome "recovered" (03Nov2020), described as "Her arms were slightly sore". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201201534 same patient/drug, similar event, different dose number.
CONTRACTED COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CONTRACTED COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (CONTRACTED COVID). At the time of the report, COVID-19 (CONTRACTED COVID) outcome was unknown.            Concomitant Drugs Not Reported. No treatment information was provided. 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 is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Follow-up added-received updates to event information.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient received Pfizer COVID vaccine on 2/27/21 and 3/25/21. On 12/8/21, patient admitted to our facility for acute left descending colitis (related to his diverticulitis disease). During this admission, he's also tested positive for COVID on 12/8/21 ( and was also diagnosed about a week ago using home test kit). During hospitalization, patient does not currently have any signs of hypoxia or dyspnea. Patient is still admitted for the colitis as of today 12/9/21.