chrisvoncsefalvay/vaers-outcomes huggingface dataset:
atrial fibrillation; Systemic inflammation; headache; fatigue; stuffy nose; joint pain; nerve tingling; irregular heart rhythm; high blood pressure; diarrhea; nausea; insomnia; anxiety; stress; panic; This is a spontaneous report from a contactable consumer (Patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 44 years). The patient's medical history included High blood pressure, atrial fibrillation, inflammation, sensitive to animal foods, gluten and dairy. The concomitant medications were not reported. It was reported that he did not took other vaccine in four weeks prior COVID vaccine. Other medications in two weeks included anti-Inflammatory supplements. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 01Sep2021 at 20:00, the patient experienced atrial fibrillation, systemic inflammation, headache, fatigue, stuffy nose, joint pain, nerve tingling, irregular heart rhythm, high blood pressure, diarrhea, nausea, insomnia, anxiety, stress and panic. Patient did not receive any treatment as a result of events. the seriousness of the event atrial fibrillation was considered always serious and medically significant and for all the other events was non-serious. The outcome of the events was recovering.   Follow-up attempts have been completed and no further information is expected.
Pt recvd MMR vax as a child & pt currently exhibited a lack of response to mumps; No further details were provided;
Patient came in requesting Pfizer COVID vaccine, stated he had never received before, had lost his wallet so provided passport as an ID, didn't have insurance (but was able to run an online eligibility check to obtain info), no record of COVID vaccines on .  Upon processing at end of the day, got a rejection from the insurance "Max 2 fills in 300 days."  Confirmed with the insurance and pharmacy that 2 doses were already given on 3/2/21 and 3/23/21.  We are unsure of possible outcomes of receiving a 3rd dose of Pfizer COVID-19 vaccine at this time.
Amenorrhea since vaccination. Prior, menses was regular, monthly. No other symptoms or behaviors appear to be contributing to amenorrhea.
I began experiencing fast heart rate when standing. The symptoms were exacerbated by heat, so I had to stop going to the sauna. I also started experiencing Raynaud's phenomenon in three fingers on my right hand, when exposed to colder temperatures. In the fall of 2021, my tachycardia symptoms worsened and I was sent to the emergency room and given saline (which improved my symptoms). I was referred to a cardiologist and finally diagnosed with Postural Orthostatic Tachycardia Syndrome in February of 2022.
severe tinnitus developed approximately 72 hours after receiving vaccine. No prior history of tinnitus. Has not resolved.
Pt states  had vaccine 8/08.  Sincew 10/27 has had sore neck and head on Rt.  This AM awoke with vasicular leisons on Scalp where pain is.  Some mild tingling of Rt Eye.  No pain at this time.   Prescribed Valtrex 1000mg BID X 7 days.  Told if she gets any pain in eye she must go to ER or return here or her PCP as soon as possible.
GI upset, spiked fever after the first shot. Was ten days before I could leave the house.  After second shot had flu like symptoms( 2 days after) Had hives and had angioedema event.
Blisters on his chest again on 04/08/2021 which have not resolved; This case was reported by a consumer via call center representative and described the occurrence of blister in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included oral herpes. Concomitant products included acyclovir.   On 10th February 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, 57 days after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix on 10th February 2021 on his left arm and experienced blisters on chest on 18th February 2021, which was resolved on 3rd March 2021. The patient again experienced blisters on chest on 8th April 2021. The outcome of blister was not resolved yet. Till the time of reporting patient did not receive the 2nd dose of Shingrix . No further information reported. The reporter Consented to follow up This case has been linked with US2021086464, reported by same reporter for other event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086464:Same reporter
Redness swelling at 1/2 inch diam - knot appeared at 1-2 hours after administration right thigh outer aspect.
product complaint; She got her first dose on 05Mar and then she got COVID on 11Mar; This is a spontaneous report from a Pfizer sponsored program.  A contactable Other HCP reported that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Mar2021, the patient experienced she got her first dose on 05Mar and then she got covid on 11Mar. The patient received vaccine at the health department. It was reported that reporter was calling because patient who got the vaccine the Pfizer COVID19 vaccine in Mar. So the first dose would be on 05Mar2021 and after the vaccine, the first dose vaccine, she developed COVID 19 she got COVID on 11Mar2021 she received he mentioned antibody therapy (treatment). now she is wanting to get her second dose now, its on Jul. I was calling to get the information on if it was okay to get her second dose or what do we need to do". The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Mar2021. Patient was received treatment for event.  Patient There was a product complaint. The outcome of event was unknown.  Information about lot/batch number is requested.
This spontaneous report as received from a pharmacist refers to a 22 year old patient. Patient received dose 1 of VARIVAX (Merck) 0.5 ml, subcutaneous at the age of 1 years old in 1992. Lot number was not provided. In 2013 (reported as recently and at the age of 22 years old) the patient was vaccinated with VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous. Lot number was not provided. The pharmacist reported that the reason the patient received the dose of VARIVAX (Merck) was for nursing school. No adverse effect reported. Additional information has been requested.
pt in HCF after a stroke; had a positive COVID test on 1/24/22; on 2/1/22 pt was lethargic and hard to awaken; low BP; poor po intake x 4 days; refusing medications; pt passed away in the HCF on 2/8/22
Patient said he had high fever (he did not measure it) for several days, general body aches, and a sore arm. He took Tylenol for the fever.
11:20AM-Pt was given 3 vaccines. 1st)Influenza-L Deltiod. 2nd)MMR-L upper arm,SQ 3rd) Adacel (Tdap)-R Deltoid. Within 3 minutes after Adacel injection, pt c/o extreme itching to R upper arm. On inspection, the area around the Adacel injection site was reddened and swollen, from approx 1 1/2 inches below the site up and over her shoulder.  Pt took a Benadryl, then stated this isn't going to work. The rash was spreading quickly to her neck and face.  I drew up a dose of Epinephrine (0.5cc) and injected it into the pt's L upper arm.  About 90 seconds later, the pt stated "It isn't working." I drew up a 2nd dose of Epinephrine, (0.5cc), and gave it to her in her R upper arm. Then, immediately after, a co-worker began to transport pt to the Emergency Dept.  The total time spent from initial injection to leaving for the ED was less than 5 minutes.  The pt cored on the way to the ED, approx 3 minutes after leaving the office.  The pt was taken directly to the ICU, where she was intubated.  1/19/07 Received medical records from hospital which reveal patient admitted 11/10-11/13/06 for anaphylaxis & SOB s/p vax. Required intubation due to unstable airway.  Treated with high dose steroids & Benadryl.  Extubated following day but had bronchoscopy & was re intubated due to labored breathing & edematous soft tissue above the vocal cords.  Successfully extubated on 11/12 & remained stable for 24 hours prior to d/c home.  Patient was to obtain a PCP & get appointment ASAP. FINAL DX: Anaphylaxis, secondary to vax; vocal cord dysfunction; history of depression. Followup 3/30/2010. We are almost certain it was the Tdap (adacel) vaccine that caused the reaction.
Additional information provided updated outcome of events and event details, patient demographics and laboratory data. Information regarding PREVNAR was received from a healthcare professional regarding a 6 month old female patient who experienced rash all over body and fever. At 6 months of age, the patient received the third dose on 02 Feb 2010. Reported as "healthy". The patient noted no reaction occurred with the previous 2 doses of PREVNAR butt noted a sibling experienced rash following administration of MMR vaccine. Indication for PREVNAR was immunization. Product was administered on 02 Feb 2010. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced rash all over body on 02 Feb 2010 and fever on 03 Feb 2010. Treatment included BENADRYL. The patient was referred to an allergist who attributed the events to PREVNAR. The patient recovered from the events. Physical examination (results: birth weight 4395 kg, head circumference at birth 36.5 cm, length at birth 51 cm, normal birth) was done on 27 Jul 2009. Physical examination (results: weight at event 18lbs, head circumference 16.5 inches at event, length at event 70 cm, all developmental milestones normal) was done on 08 Apr 2010. No additional information was available at the time of this report.
typical sore arm; did not feel 100 percent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, single (Lot number: EN6201) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing), notes: MS; "Immunosupressed" (unspecified if ongoing), notes: has an underlying condition and is immune suppressed. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 25Jan2021, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "typical sore arm", "did not feel 100 percent".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "typical sore arm"; MALAISE (non-serious), outcome "unknown", described as "did not feel 100 percent".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300215077 Same product, patient, different event, different dose;US-PFIZER INC-202300215225 Same product, patient, same event, different dose;US-PFIZER INC-202300215227 Same product, patient, same event, different dose;US-PFIZER INC-202300214232 Same product, patient, different event, different dose;
Uncontrollable Shanking, Severe Headache, Rapid Heart Rate, Body Aches, Hot swollen tissue at the injection site, fever of 102F, Dizziness, trouble breathing.  This happened over a 48 hour period.
first two doses she had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (first two doses she had a sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LOSARTAN and BUPROPION HYDROCHLORIDE (BUP) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (first two doses she had a sore arm). At the time of the report, PAIN IN EXTREMITY (first two doses she had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provided.   This case was linked to MOD-2021-433312, MOD-2021-433313 (Patient Link).
Child developed low grade temp on 5/17/04 at 9PM then had vesicular rash eruption on 5/19/04. Was seen by MD on 5/20/04 and Rxbl Benadryl Elixir, Tylenol, Aveeno baths. Eruption of rash was to face, arms, abdomen.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). In 2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. In 2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Patient reports swelling, tenderness, redness at site of injection with headache and body aches within 24 hours of receiving the varicella vaccine.
Softball sized lump at injection site on Right arm. Discomfort at injection sites on both arms. Decreased with ice and ibuprofen temporarily through the evening. States just as bad on morning of 02/11/2015 as it was the day before.
This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 04-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter.  Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
Fluzone high dose is packaged with 2 vials which causes a safety concern. Administers are unsure whether to use both vials or 1.
Next day about 3 pm sat down and got very dizzy. Was off and on /off for next 7 days like vertigo, swirling sensation. Had vertigo before. Worse in morning when getting  up.. Didn?t work much. Might have overworked the day after injection. Has gone away  but was  very much like vertigo effects
20MAR given immun woke fr nap vomiting & temp 103.7(ax); Parent unable to bring fever down w/tylenol; vomiting cont; To ER temp 104 (ax) & irritable;
Rash still after almost 2 weeks, spreading, very itchy.; Felt run down; Stomach issues; Anxiety; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) via an unspecified route of administration on 20May2021 at 10:30 in right arm as a single dose for COVID-19 immunization. Medical history was not reported. The patient previously took naproxen for allergies. The patient did not received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Concomitant medications included Alprazolam, Zoloft and Atenolol. On 21May2021, the patient experienced Rash still after almost 2 weeks, spreading, very itchy. Felt run down and having stomach issues and anxiety. The patient did not receive any treatment medication. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing consciousness. It lasted for a few seconds and then the feeling went away. I called 911 because I didn't know what was happening and other than a bit of an elevated heartrate I was ok so I deferred the option to go to the hospital. At the time that the paramedics were checking on me, one of them noticed a red area on the inside of my right elbow. I hadn't noticed it until then, but it could have been there and I just missed it. After about 2 days the rash appeared on my left inner elbow. It didn't really itch but it was painful and felt very dry and irritated. I was told it looked like eczema so I began using eczema cream. It has seemed to help a little. I have never had eczema prior to this. I contacted my doctor and he said he had no way of really knowing if it was an allergic reaction.
Severe hives; Sleep of one hour a day; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe hives) and INSOMNIA (Sleep of one hour a day) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 06-Jan-2022, the patient experienced URTICARIA (Severe hives) and INSOMNIA (Sleep of one hour a day). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Severe hives) and INSOMNIA (Sleep of one hour a day) outcome was unknown.            No concomitant medications reported by reporter  Patient stated that last Thursday, he experienced severe hives and added he only gets one hour of sleep a day. He went to a walk-in clinic for a check-up and he was given Prednisone and Famotidine.
Vomited some blood; Vomited profusely; Spontaneous report received on 14FEB2020.  A nurse reported that a female consumer vomited profusely (PT: Vomiting) and also vomited some blood (PT: Haematemesis) after receiving first dose of Vivotif for immunisation. The consumer took first dose of Vivotif on 12FEB2020 and 3 hours later, she started vomiting profusely as well as she vomited some blood. She did not receive any treatment but was hydrated for her symptoms. The nurse reported that she did not continue with Vivotif after her first dose. Her symptoms were resolved at the time of report.  Concomitant medication included antidepressant Wellbutrin SR (bupropion; 300 mg daily) and birth control medication (10 mg) for menstrual cycle.  Company Comment: A consumer took first dose of Vivotif and after three hours she started vomiting profusely, and she also vomited some blood (Haematemesis). The consumer was hydrated in response to these events, and both events were resolved. The consumer did not take the next doses of Vivotif. Profuse vomiting might have led to some blood in the vomit of the consumer. Considering the potential of Vivotif to cause vomiting and the case information, the causality of vomiting and haematemesis is assessed as possible. The case is considered serious due to the medical significance of haematemesis. Vomiting is listed and haematemesis is unlisted as per CCDS.; Sender's Comments: Company Comment: A consumer took first dose of Vivotif and after three hours she started vomiting profusely, and she also vomited some blood (Haematemesis). The consumer was hydrated in response to these events, and both events were resolved. The consumer did not take the next doses of Vivotif. Profuse vomiting might have led to some blood in the vomit of the consumer. Considering the potential of Vivotif to cause vomiting and the case information, the causality of vomiting and haematemesis is assessed as possible. The case is considered serious due to the medical significance of haematemesis. Vomiting is listed and haematemesis is unlisted as per CCDS.
Vaccine was administered outside of proper storage conditions. Vial was at room temp for >2 hours but <6 hours at the time of dose being drawn up. Manufacturer did not have stability information for these storage conditions so it was recommended that this dose be considered invalid and to re-administer. Patient will be coming in to get dose in near future. Patient had no unusual adverse events. He only experienced a sore arm and was tired for a few hours afterwards.