chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Location: vaccine drive-up site. Pt received Pfizer vaccine @ 1505. Alerted that pt is feeling SOB and numbness/tingling in hands. Vital signs: SpO2 100% on room air, HR 75, BP 127/89. No complaint of throat swelling and no visible facial swelling. medical history obtained - hx of anaphylaxis 2 months ago during third ivig infusion. first allergic reaction. no issues with first 3 doses of Pfizer vaccine. NP called @1528- ordered 25 mg PO Benadryl & given @1529. Pt c/o slight difficulty with swallowing. Visible assessment remained the same and no other worsening of symptoms. VS @ 1535 spo2 100% on room air, HR 80, BP 134/83. Increase in difficulty swallowing and tingling in hands - visible assessment remained the same WNL. @1540 spo2 dropped to 90 and returned to 100, but increase in work of breathing noted. NP called @ 1541 - epi injection and call 911 ordered. @1543 spo2 dropped rapidly to 70s w/in 5 seconds w/ visible distress. Epi given in right thigh @1543. PT VS stabilized immediately w/ spo2 rapidly back to 100% on room air. 911 called and on scene @ 1547. VS @1545 are spo2 100% on room air, HR 73, BP 135/79. Transfer of care given @ 1548.
Information has been received from a nurse concerning a female patient who was vaccinated with the Gardasil on an unspecified date. Subsequently, the patient developed a rash. The patient unspecified medical attention. The patient's outcome was unknown. This report is one of two reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL on an unspecified date. Subsequently, the patient developed a rash. The patient sought unspecified medical attention. The patient's outcome was unknown.
Patient went to the emergency room with heart palpitations, chest pain, fever, chills, swollen arm ,vomiting, diarrhea, fatigue ,headache. Patent was also told by the doctor that her WBC was elevated.
Initial unsolicited report received from nurse on 14 May 2018. This was invalid case as no patient identifier reported. In this case expired dose of TENIVAC (Batch number was unknown, expiration date: 16 Mar 2018, dose, route and site of administration was not reported) on an unspecified date. It was an actual medication error due to expired dose administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Chest discomfort; Heart palpitations; Elevated heart rate; This is a spontaneous report from a contactable Consumer. This Consumer reported for a 43-year-old male patient (Husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7534) via an unspecified route of administration on 19Mar2021 at 11:00 hours (at 43-year-old) on left arm as dose 1, single for COVID-19 immunization. No prior vaccinations (within 4 weeks) and other products were received, no investigation assessment was done, no events were reported following prior vaccinations and no family medical history was reported relevant to events. The relevant tests and medical history were reported as none. On 20Mar2021 the patient had chest discomfort, heart palpitations and an elevated heart rate since receiving the first dose of the Pfizer Covid-19 vaccine. Caller reported that the patient was considering going to the emergency room since he had been experiencing side effects. Caller reported that the patient described the event as it feels like there was something weird in his chest and described it as a strange sensation. Caller reported that the patient had no history of heart problems and was not on any medications. The patient spoke with the callers cardiologist and urgent care. Caller reported that the physician and urgent care staff informed patient that if the chest discomfort, heart palpitations, and elevated heart rate continue to go to the emergency room. The patient did not require emergency room and physician office visit. The patient had not recovered.  No follow-up attempts were possible. No further information was expected.
hypothyroidism; This is a spontaneous report from a non-contactable consumer (patient). This 28-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 12:00 (Lot Number: EN6208) at single dose for COVID-19 immunisation.  Medical history included COVID prior vaccination.   The patient's concomitant medications were not reported. Patient did not have other vaccine in four weeks. The patient previously took cefdinir and experienced allergies.  The patient experienced hypothyroidism on 09Jun2021 10:30 with outcome of unknown.  Therapeutic measures were taken as a result hypothyroidism. Event was resulted in doctor or other healthcare professional office/clinic visit. Patient was not tested COVID post vaccination.  No follow-up attempts possible. No further information expected.
For all my other 3 shots I got Pfizer.  They did not have it at the time of my appointment so my 4th shot was Moderna.  I had a sore arm, chills, fever (101), and muscle aches from the night of the shot til about 24 hours later.  My worst symptoms were after my first Pfizer shot and this one was very similar (it was my first Moderna shot) compared to my 2nd Pfizer and the Phizer booster.
This spontaneous report as received from a physician refers to a patient of unknown age. On 01-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported) that was exposed to warmer temperature during shipment. No adverse effects were reported. Additional information has been requested.
Patient had a reaction 4 days after the 2nd Covid vaccination. She began to experience vomiting that lasted 24 hours, accompanied by extreme fatigue and dizziness. Fatigue and dizziness are still peristing in a mild manner.
Right upper arm swollen, red, firm and warm to touch. Ct c/o fever, aches 6hrs post administration. Continued to experience fever, aches to date. Have improved some since 3/17/2004 administration. Ct referred to MD at an outreach clinic.
ARM TINGLING; FATIGUE; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced arm tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 09-APR-2021, and had not recovered from arm tingling. This report was non-serious.
Fever, chills, body aches, headache, nausea for 20 hours
ARM SORENESS; BUMP/KNOT; WARMNESS TO THE TOUCH; ARM REDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced arm soreness. On 12-MAR-2021, the subject experienced bump/knot. On 12-MAR-2021, the subject experienced warmness to the touch. On 12-MAR-2021, the subject experienced arm redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and warmness to the touch, and had not recovered from bump/knot, and arm redness. This report was non-serious.
The reason I came to this site to fill out adverse events is for lower right lip numbness that started about 30 hours after the shot, but I also did have other side effects starting the first day that I will list as well.  I have never experienced anything like this numbness  before in my life, and I am 99% positive it is due to receiving the Moderna vaccine.  I did not find facial numbness as a possible side effect of the vaccine listed, so I searched ?facial numbness COVID vaccine? and was able to find that only  4 of the 30,000 participants in the Moderna trials experienced facial numbness, and that only 3/4 received that active vaccine over the placebo, and so was not considered to be a side effect of the vaccine. I also read that they appeared to be cases of Bell?s Palsey, which I do not believe to be what I am experiencing, because I do not seem to have any symptoms of drooping, just a numb sensation. I woke up around 4:30AM on Wednesday (got vaccine on Monday at 2:30pm) with my lower right lip completely numb. The lower left lip had full feeling, as did my entire upper lip. Friday afternoon (2 days later on the 15th) I finally started to get some feeling back on the inside on my lower right lip. Over the next week (it?s been 12 days now since I first woke up with my lip numb), I have slowly regained a little more sensation each day. While I have about 95% of my feeling/sensation back in my lower right lip, there is still some numbness. Also important to note that while this symptom has been annoying, it has not been painful in any way.   An adverse side effect that happened immediately after getting the vaccccine was that my arm started to itch around the injection site, spanning about 3 inches out in every direction. My arm also got very slightly puffy (only right at the injection site), and moderately pink/red in the same area. They kept me just a little longer than the 15 minutes, but I had no breathing issues, and stated that I felt fine, and was able to leave.   Adverse side effects that started day one of getting the vaccine and lasted 2-3 days: -Severe cotton mouth/dry mouth and throat that started on my drive home about 40 minutes after receiving the injection  -Severe fatigue that started about 2 hours after receiving the vaccine (could not even keep eyes open the first day, and had to call out of work for the next two days) -Moderately severe arm numbness at the site of injection that I noticed around 6 hours after injection.  This symptom bothered me less than others due to lifelong chronic pain, but it was still very difficult to raise my arm to grab things (moved slow like a sloth to be able to push past the soreness).
Information has been received from a consumer who is the father of a 9 year old female who in 1997 was vaccinated with a dose of varicella virus vaccine live. On 06/18/03, the pt "developed about 15 chickenpox sores". It was noted that the pt was away on vacation at this time and had not seen her doctor. It was also noted that the "pt's friend had chickenpox about 2 weeks ago, and was also already vaccinated". The pt's father had no additional information to provide. There was no product quality complaint involved. The caller also reported on another pt who had been vaccinated with varicella virus vaccine live and developed chickenpox (WAES # 0306USA02707).  Additional information has been requested.
Fever 3-4 days with 104.2 rectal temp checked at home being the highest according to FOC  Maculopapular rash on face, chest and abdomen area  Doctor visit 09/10/2019. Vital signs WNL. Temperature 97.9 F, route: ear
pt recv vax 24MAY95 & in MAY95 pt exp fever, vomited 3x & devel a gen rash & fluid filled vesicles; exp required a visit to a MD; No further details were provided;
"My muscles tightened up, I took a BENADRYL and relaxed" - "Never had to leave work for this reaction"
Red, swollen, hot to touch, arm immobile, extremely painful, headache, nausea, fatigue.
12/24/12 burning under skin, on back. No rash. On right hand side. 12/31/12 symptoms. 12/26/12 MD diagnosed patient with shingles. Symptoms are subsiding quickly.
Pt recvd flu shot 4NOV & rash started on arms, spread to legs & abdomen, by 7NOV91 & 8NOV91 itchy, dry, red tiny bumps, became mottled;
1 of 5 pts who exp an inject site react w/in 24 hrs p/vax; react was the size of a quarter, hard, raised & warm to touch; afebrile; no tx initiated;
Extreme pain in shoulder where vaccination administered.  Admitted to ER, spent 2 days in hospital, primarily to determine if heart condition involved (it was not).
Vaccines were stored after beyond use date and CDC expiry date; Vaccine was administered after beyond use date and CDC expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The BUD date and CDC expiry date was reported as 02-Apr-2022.  The vial was stored in standard freezer for the lot 068H21A with 2 degrees F high -1 degrees F low on 14-Jan-2022. No treatment medication were reported. This case contains information for the thirty fourth of 45 patients described by the reporter.
Muscle soreness 4 days following. Heat, anti-inflammatories. 11/18/2002, Muscle relaxant 10/26
Patient is 17-years-old; Irritability; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17-years-old), IRRITABILITY (Irritability) and FATIGUE (Fatigue) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17-years-old), IRRITABILITY (Irritability) and FATIGUE (Fatigue). On 06-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17-years-old) had resolved. At the time of the report, IRRITABILITY (Irritability) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product used was not provided by reporter. Treatment for events was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: follow up information received it does not contain any new information.
Consistent muscular pain in site and area of injection. Pain eventually lessened but never waned. Eventually becoming more pronounced and debilitating. Arm (Left) is now almost useless. Unable to grasp, carry or raise.
The pt experienced a reaction to the hepatitis injection which included dizziness with an episode of vomiting, small ecchymosis and induration at the injection site. The pt was afebrile.
sore and swollen throat; sore and swollen throat; runny nose; after 10 days I am still in pain; I can not eat because of the pain in my throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 22:00 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MACROZIT. The following information was reported: OROPHARYNGEAL PAIN (non-serious), PHARYNGEAL OEDEMA (non-serious) all with onset 24Aug2021 01:00, outcome "not recovered" and all described as "sore and swollen throat"; RHINORRHOEA (non-serious) with onset 24Aug2021 01:00, outcome "not recovered", described as "runny nose"; PAIN (non-serious) with onset 24Aug2021 01:00, outcome "not recovered", described as "after 10 days I am still in pain"; ODYNOPHAGIA (non-serious) with onset 24Aug2021 01:00, outcome "not recovered", described as "I can not eat because of the pain in my throat". Therapeutic measures were taken as a result of oropharyngeal pain, pharyngeal oedema, rhinorrhoea, pain, odynophagia.  Additional information: The patient did not know if she could take anything other than Ibuprofen. Ibuprofen because it only eliminated the pain for a short time. The patient had Macrozit medication in two weeks. Facility type vaccine was pharmacy or Drug Store. The patient did not have Covid prior vaccination. The patient has not been tested Covid 19 post vaccination. Patient did not have known allergies. The patient did not have any other vaccine in four weeks. All the events started on the fifth day after her vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started having chest pains today around 3:30pm.  When I came home from work, I decided to take my blood pressure since it feels like my heart is overworking itself.  I checked three times, and all times my blood pressure was in the Stage 1 HTN range.  Decided to take a break and try to relax.  Took my blood pressure again and it is still in the Stage 1 HTN range.  I have no history of HTN.  My blood pressure has always been normal.  The only other notable symptom after the vaccine is an odd feeling at the frontal part of my head.  Not necessarily a headache, but my brain has a weird tingly feeling in the frontal area.  My chest still hurts and feels like it is overworking itself.
2 patients were administered doses post excursion with no reported adverse event; Temperature excursion at 48.91 Fahrenheit for 838 hours and 59 minutes since June 2022 with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 2 unknown age and unknown gender patients who were administered doses post temperature excursion at 48.91 Fahrenheit for 838 hours and 59 minutes since June 2022 with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Jun-2022, the suspect was exposed to a temperature excursion at 48.91 Fahrenheit for 838 hours and 59 minutes since June 2022 with no reported adverse event (product storage error).  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength and dose not reported; lot UJ878AA) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the 2 patients were administered doses post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, temperature excursion of unknown cause, reporting not due to human error. Caller reports they are still investigating the cause, either due to malfunction with the refrigerator, data logger malfunction, or not enough circulation with their refrigerator. FLUZONE QIV MDV at a high of 48.91 Fahrenheit out of range for 838 hours and 59 minutes since June 2022, one opened MDV and multiple boxes of unopened product. Caller reports she thinks 2 patients were administered doses post excursion. The FLUZONE QIV MDV that was administered was received on 02SEP2022 and administered the week of 05SEP2022-09SEP2022, at that time the high was 48.91 Fahrenheit out of range for 192 hours.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 09:00 as 1ST DOSE, SINGLE (at the age of 67-year-old) for covid-19 immunisation. Medical history included ongoing heart, GERD and blood thinner. Concomitant medications included carvedilol (CARVEDILOL) 125 mg twice daily taken for heart taking a couple of years, ezetimibe (ZETIA) 10 mg once daily taking for a long time, omeprazole (PROTONIX [OMEPRAZOLE]) 20 mg once daily taken for GERD, rivaroxaban (RIVAROXABAN) 20 mg once daily taken for blood thinner taking for 5 years or more. Patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 09:00AM in an unknown site. He noticed later that day that he had headache. It is unknown if the headache has resolved. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021137831 same reporter/drug, different patient/event
I broke out in a severe full body rash. I called my pcp was prescribed steroids in 3 days it had subsided.
Crying inconsolably greater 1 hour, temperature greater 101.  Red, raised, swollen rash top of head down to buttocks (? hives).
Patient began to experience dyspnea on exertion approx 7 days post-vaccination.  She waited 3 days before seeking care as symptoms worsened.  She was diagnosed with a saddle pulmonary embolism. She was treated for 3 days in-patient and released on Eliquis.  She has had 1 other thromboembolic event in 1985 immediately after the birth of a child.
Pericarditis. Not sure if it's because of the vaccine, but I read reports online and decided to submit this form.