chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had second dose Pfizer COVID-19 vaccination 06/01/2021. Then developed central chest pressure. Treated at Hospital.  Found to have abnormal ECG and positive troponin. Cardiac MRI confirmed myocarditis.  He improved and was discharged. Now feels fine. Remains on Metoprolol and losartan, with plan to discontinue in time.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EWO183) at the age of 56 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "COPD" (unspecified if ongoing), notes: COPD. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". Therapeutic measures were not taken as a result of dizziness, fatigue. Additional information: Report was not related to a study or programme. Patient Ethnicity information is available, the patient was the reporter. Reporter consent was contact given. The COVID-19 Vaccine was a Pfizer product. Consumer stated, "He just has a question. He took the Pfizer first vaccine earlier today and He want to know, how long does the symptoms last from the vaccine. Consumer was informed about Pfizer Medical Information department and provided with the number LOT#: Consumer stated, "EW0183, it looks like a O, EWO183." Other medications: Consumer stated, "Yes, but He don't have all of it with me, He don't know". Treatment Consumer Stated, "No, He haven't took anything." No follow-up attempts are possible. No further information is expected.
I began having pain in my lower left leg later on Sunday (felt like a pulled muscle) but by Monday it was more painful. Since I had surgery (see above) my doctor sent me fir an ultrasound where a clot was found. Went to emergency room to further evaluate and get treated. Was given elequis and am taking for 3 months. Was told clot was likely related to immobility from injury, but wanted to report just for your consideration
This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 (lot R28321, expiry date Mar2018) via an unspecified route of administration in the arm on an unspecified date in 2017 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and warmth at the injection site on an unspecified date in 2017. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017108573 Same reporter/product/events, different patient.
Flu shot reaction, "loss of feeling in right hand" Visable skin irratation and bruising ongoing since 1/7/21 noted on 1/28/21 in medical chart. Patient seen again on 3/9/21 - "Has noticed ongoing numbness/tingling in R arm, specifically in R hand in a glove distribution. Intermittent and less frequent than it was before. Pins and needles in R hand after surf trip last week." Is improving so will wait and see.  Home PT prescribed along with NSAIDS.
Fever, chills, fatigue,  nauseated, dizziness,  loss of balance, thristy, no appetite. 2 1/2 days
Received Hep B #2 on 1/7/05 at well check and presented 1/9/05 to ER, Respiratory Arrest. Unable to resuscitate. Discharge Summary received on 2/14/2005 states unresponsive, choking, breathing stopped, difficulty breathing, loss of blood pressure and cardiac arrest. 3/4/05 Autopsy report received which revealed COD as undetermined and manner of death as undetermined.
P/receiving vax, pt wouldn't eat or drink; About 0400 21AUG91, pt awoke both legs & feet were slightly swollen, t103, bad dry heaves; No rash, SOB, crying spells were not continuous; cry was rigorous & normal; pt alert;
Pt with 18 YO special needs, came into clinic with 2 parents.  Parents said pt does not do well with shots and will try to run away.  Pt holding Elmo doll.  Famly states pt will not sit down for shot,  Pt given shot standing up with parent standing closely on each side of pt. Injection almost given and pt started to flail arms and try to walk away.  Needle removed quickly and intact.  MA reports that about 80% of dose was given.  Underdosing.  Per guidelines, Moderna does not require repeating.  No harm to pt.
The ADE began on day 10 after the immunization and is still ongoing at this present time; total duration for symptoms was about 5 months. It is a fine tremor, non-disruptive to ADLs.  It is exacerbated by caffeine and the intensity is alleviated with rest. No treatment received, as it should be self-limited. No fever at onset or throughout the duration. Tremor is the only symptom.
That night my fever 102 took Tylenol to bring it down, shakes, chills , nausea, muscle aches and swollen lymph nodes (right armpit).The symptoms lasted to Sunday. My estimated date of delivery was Sept.14 I miscarried at 5 wks.
According to the mother on April 26,2013 patient woke up with hives all over body and the right arm swollen and red.  She applied ice in the vaccine site.  This happened after receiving the MENVEO and varicella vaccine.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: advised patient to use ice pack and take tylenol. and to follow up with a doctor if symptoms do not improve or persists
ADMINSITERED PAST THE CURRENT REFRIGERATION BEYOND USE DATE AS LISTED IN EUA
Within first 24 hours developed large area of erythema, warmth changed induration around injection site. Lasted ~ 72 hours
Her shot was expired and had turned into water; Dehydrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EW1062) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing), notes: Caller says that it has been diagnosed for years, maybe 40 years ago., ; "Blood pressure high" (unspecified if ongoing), notes: Caller says that it has been diagnosed for years, maybe 40 years ago., . The patient's concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset Apr2021, described as "Her shot was expired and had turned into water"; DEHYDRATION (non-serious) with onset Apr2021, described as "Dehydrated".  Additional Information: Speakerphone recording notification given. Consumer calling about the Pfizer COVID-19 vaccine who said she got her first dose at Walgreens 3 weeks ago and sat there for 15 minutes, then when she was going out the door they said her shot was expired and had turned into water and she should take it again. She says she just went to a clinic to get one and was told she has got to talk to her doctor first, but no one has ever heard of something like this, that if it is expired that it would turned into water. Caller says that her vaccine card information was handwritten, and they did not provide the NDC/EXP of her dose. Caller says that the date the dose was given was hard to read the way it was written, it could have been either 11Apr2021 or 17Apr2021, it was two weeks ago. She says the dose was injected into her left arm around 11:00-11:30AM. Caller says that she did not get any other vaccinations the day. she got the Pfizer COVID-19 vaccine or start any new medications recently. Caller said that she tried to get labs done the other day but they could not get a vein and said that she was dehydrated, they weren't able to get blood .Is there a Product Complaint: Yes.  No follow-up attempts are possible. No further information is expected.
About 8 hours after the injection I passed out standing in my kitchen.  My head hit the tile floor and cut my scalp and it bled.  Lost consciousness for a moment.  Never had this happen before.  Wife called 911 and I was transported to hospital trauma center.  CT scan showed no injury from fall.  Admitted to hospital with low pulse rate Bradycardia.  Pulse rate was traditionally low due to training as a runner.  4 days later a heart pacemaker was implanted as a precaution
patient describes dull achy pain in injection arm continuing  at the 2 month after injection point
Pt recv vax on 11/17/98; on 11/26/98 pt exp febrile illness w/ fever (104.5) x 3dy; 11/27/98 exp cough, coryza, sore throat; 11/29/98 pt exp erythema, maculopapular rash from head to extremities
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 at 16:00 as dose 1, single (Lot number: ER8730), in left arm, on 18Apr2021 at 16:00 as dose 2, single (Lot number: EW0162), in left arm and on 06Dec2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01May2022 at 12:00, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient had not received any other medication in 2weeks. Patient had received anti-viral Paxlovid as a treatment medication for the event COVID-19 from 16Apr2022 to 21Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I got a red rash on the top of my hands a few hours after getting my second dose of the vaccine. The same thing happened to me after receiving my first dose, however, I did not get the rash until a week or two after.
There was no adverse event. However it came to attention that the patient is 15 years old instead of 18 as recommended.
Joint aching. Muscle aching. 7/10 headache behind eyes. Chills. Fatigue.
Patient reports the day vaccine was administered prior to administration she had mild nausea and diarrhea. Rabies vaccines was administered 1/31/13 at 10:30AM. On 2/1/13 about 4pm developed itching of feet, hands, torso and jaw. Noted "large welts" "hives" on torso. Redness of feet and hands. Took BENADRY. Resolved in about 30 minutes.
Varicella disease - fever (subjective low grade) x 2 days then rash multiple stage lesions.
After receiving both vaccines, patient immediately stated he felt dizzy and began to lose consciouness. Pt started midly shaking and moaning. Technician called 911. My intern and I monitored the patient as he regained consciousness. Once he regained consciousness, we gave him water and glucose gel (patient stated he had not ate that morning) and had him lay on floor with with feet elevated. I checked blood pressure which was around 90/50mmHg but was unable to get an entire accurate reading bc of position patient was laying in. Patient laid on ground with cold pack on his forehead until 911 arrived and took over. Patient was taken out in stretcher but eventually refused to go to hospital as 15 minutes later patient patient came back into pharmacy to retrieve paperwork. Patient left feeling fine and stated he didn't like needles.
First night awoke 3am with muscle pain and fever. By morning also had sinus congestion/headache/eye ache; fatigue.  Temp continue to rise throughout day, reaching 100.8 by 5:30pm.  All symptoms began to dissipate by 9pm, awakening normal by morning..
Bump in the arm of the injection; In less than a month she has lost 5 pounds of weight; Arm of the injection quite itchy; Red in the arm of the injection; Pain at the injection site as if someone had hit her there and it started to spread to the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump in the arm of the injection), WEIGHT DECREASED (In less than a month she has lost 5 pounds of weight), VACCINATION SITE PRURITUS (Arm of the injection quite itchy), VACCINATION SITE ERYTHEMA (Red in the arm of the injection) and VACCINATION SITE PAIN (Pain at the injection site as if someone had hit her there and it started to spread to the whole arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: BABY ASPIRIN. Concurrent medical conditions included Bronchiectasis (it is controlled). Concomitant products included VITAMINS NOS, CALCIUM, MAGNESIUM and FISH OIL for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Bump in the arm of the injection), WEIGHT DECREASED (In less than a month she has lost 5 pounds of weight), VACCINATION SITE PRURITUS (Arm of the injection quite itchy), VACCINATION SITE ERYTHEMA (Red in the arm of the injection) and VACCINATION SITE PAIN (Pain at the injection site as if someone had hit her there and it started to spread to the whole arm). At the time of the report, VACCINATION SITE MASS (Bump in the arm of the injection) and VACCINATION SITE ERYTHEMA (Red in the arm of the injection) had resolved, WEIGHT DECREASED (In less than a month she has lost 5 pounds of weight) and VACCINATION SITE PRURITUS (Arm of the injection quite itchy) outcome was unknown and VACCINATION SITE PAIN (Pain at the injection site as if someone had hit her there and it started to spread to the whole arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       At the time of reporting, the patient had a lot of pain in the injection arm, from the wrist to the shoulder, and the pain was as if she had arthritis.  The patient stated that she needed strength in her arm for her job and it hurt her more when she rose something up. Treatment details included medication from urgent care visit and an unspecified medication for 4 days.
eczema deteriorated/his excema began to get worse after the first shot; itch; thyroid levels have increased; he also developed thyroid whereby his Tsh levels shot up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "eczema deteriorated/his excema began to get worse after the first shot"; PRURITUS (non-serious), outcome "unknown", described as "itch"; THYROID HORMONES INCREASED (non-serious), outcome "unknown", described as "thyroid levels have increased"; BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "he also developed thyroid whereby his Tsh levels shot up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of thyroid hormones increased, blood thyroid stimulating hormone increased.  Additional Information: My son, 14 years old, eczema deteriorated, and he also developed thyroid whereby his Tsh levels shot up after taking both the Pfizer COVID shots. Have you received similar feedback from other parents whose children's have taken these shots. Successful outbound callback made at 3:47 PM on 14Feb2022. Caller also reports that his excema began to get worse after the first shot. The urge to itch has increased specially between the hours of 2AM - 5AM, prior to vaccination he was sleeping well at night. His thyroid levels have increased. Caller also reports patient takes thyroid medication.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
The patient is not 18 so should not have received Moderna. Did not have any adverse reactions during the 15 minute waiting period.
Bruising at injection site accompanied by pain and swelling. Red rash with or red patchy skin that burns. No raised bumps, appears more like a ?sunburn? an inch and a half south of injection
This spontaneous report as received from a nurse refers to a 5 month old patient of an unknown gender. On 21-JAN-2015, the patient was vaccinated with improperly stored, oral ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer.    A 37-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 as single dose and received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/Lot Number: EN6203), via an unspecified route of administration on 24Feb2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid virus, after being fully vaccinated (vaccination failure) on 01Aug2021. The patient underwent lab tests and procedures which included NAAT COVID test which was positive on 01Aug2021. Outcome of the events was unknown.  The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/eevnt, differnt patients
the patient had not manifested any side effects; administered the VARIVAX that had expired on 22Sep2022; This spontaneous report was received from a nurse and refers to a 34-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).  On 24-SEP-2022, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T032322, expiration date: 22-SEP-2022, route: subdermic, for prophylaxis (anatomical location, and dose were not provided) (expired product administered). The reporter stated that varicella virus vaccine live (oka/merck) (VARIVAX), hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) were administered by medical assistant (MA) to the patient. When the patient's vaccine record card was printed, the MA discovered the varicella virus vaccine live (oka/merck) (VARIVAX) had expired on 22-SEP-2022. As of the time of the call, the patient had not manifested any side effects. There were no adverse events reported (no adverse event).
Within a month after I received the vaccine I started having tremors in both my feet and weakness in my leg muscles which interferes with my being able to walk any appreciable distance or to stand for longer than 5 minutes. I now walk with a cane and need to use a riding cart to do my food shopping and am unable to work and am now on SSDI.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 57-year-old female patient who received SHINGRIX (batch number BN9L9, expiry date 26th March). Concomitant products included LEXAPRO and lisinopril. On 29th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. The patient was treated with BENADRYL. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the pain in arm was recovering/resolving. The reporter considered the erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were reported as follows: No medical history was reported. The patient received the vaccine on the right arm. The expiration date of the vaccine was mistakenly reported same as date of birth of the patient. However, no clarification could be obtained. The patient experienced soreness in her right arm and also redness on upper underside of her right arm. The pharmacist reported that no physician visit was required but stated that the patient was counseled to use cold compresses on site. The pharmacist reported that the redness began within a day or two and resolved by the time she spoke to the patient over the weekend. The pharmacist stated that she was 100 percent certain that the patient's experiences were caused by SHINGRIX.
2nd dose 2 weeks after 1st dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a elderly male patient who received Herpes zoster (Shingrix) (batch number 4H5MY, expiry date 11th May 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022  Reporter's comment: The nurse reported that the patient received second dose of Shingrix in 2021 only two weeks after the first dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Skin reaction at injection site.  Red, itchy, swollen and warm to the touch.  Approximately the size of a softball.  Treated with hydrocortisone cream, ice and heat.  Redness faded after six days.
This spontaneous report was received from a physician who refers to a 22 year old female patient. It was reported that the patient received her first dose of GARDASIL (dose, route and lot # not reported) in November 2012 (reported as "a year ago") and on 20-NOV-2012 the patient received intramuscularly her second 0.5 ml dose of GARDASIL (lot # reported as 0629AE, exp. 16-DEC-2014). No adverse reactions reported. Additional information has been requested.
The patient received the vaccine on 06/1/21 and claimed that a bump formed later which remained for 4 days at which point he claims that it had moved from his injection site to the left side of his neck under the surface of the skin where it still remains.  He said that it wasn't painful at all, there was no visible redness or swelling upon visual inspection but he claimed that he could feel it.  He was instructed to go get the lump checked at the local hospital on 6/20/21, the day the event was reported to the pharmacy.  The patient has no primary provider that he sees.