chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took sumatriptan 100mg for migraine headache in 10 minutes began with 6/10 chest pressure/pain--lasted 1hr and went to ER with no relief of in ER still had 8/10 chest pain and new left bundle branch block on EKG-plus BP 180/92. (no hx of HTN). Echocardiogram with LV wall motion abnormalities. LV EjFx down to 32% (new) Given metoprolol and diltiazem and sent by ambulance to another hospital for stat heart catheterization. Result was totally clean coronaries but Takotsubo abnormality of heart. EjFx 45% during the cath. Stayed in hospital 24 hrs. Started on lisinopril and metoprolol. Interesting consideration is that patient (who had 4 prior doses of Moderna vaccine) had exposure to Covid 05/28/2022-received bebtelovimab post exposure prophylaxis 05/30/22 and tested PCR positive 06/03/2022. Had fatigue and sweats for 2 days and cleared to negative rapid Ag test by 06/09/2022. Patient had taken sumatriptan many times before (years) for migraine with only a slight brief sense of chest pressure for a few minutes. Is it possible that Covid 19 virus contributed to sensitizing the heart muscle to serious effect of sumatriptan? FYI I am reporting this event and I am the 71 year old female who suffered this event. There have been reports of Takotsubo with acute Covid 19 illness and one with post Covid-19--so I wonder if the preceeding infection with Covid 19 had anything to do with this adverse reaction. I have taken this exact sumatriptan 100mg from the same package in the past without this effect.
Within an hour of receiving the vaccine I developed a 2.5 inch welt at the injection site. Area was raised and itchy. After a week it isn't raised but is still red & itchy.
Patient hospitalized for overdose. Patient found to have potential myocarditis. Patient overdosed on antihistamines loratadine and doxylamine. Found to have rhabdomyolysis. CK levels have been trending downward. Patient found to have elevated troponin and ECHO showed decreased EF raising concern for myocarditis. Also with EKG changes.  Patient is asymptomatic without chest pain or palpitations.  Cannot differentiate cause of myocarditis, can be due to over dose and related to rhabdomyolysis or other causes.
Approximately 3 hours after receiving the vaccine pt started having muscle pain, fatigue, and diarrhea which lasted approximately 48 hours. Pt reported feeling fine before the vaccine was administered.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 14-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
-Pain in arm -Arm felt warm -Slight swelling of the whole left arm and underarm
Face got tingly like when your foot falls asleep Throat felt like it was swelling  Pharmacist administered Benedryl and monitored for additional 20-30 minutes
two doses administered on  07/20 and 08/17; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 17th August 2021, the patient received the 2nd dose of Shingrix. On 17th August 2021, unknown after receiving Shingrix and an unknown time 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 details were provided as follows: The nurse reported that, the patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
I contracted COVID-19 04/2022. I started having a sore throat on 4/4/2022. I was around a child that tested positive. I got PCR tested on 4/6/2022. I lost my voice and had extreme congestion.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, on 04Feb2021 at 01:30 as dose 1, single (Lot number: EN5318), in left arm, on 25Feb2021 at 11:15 as dose 2, single (Lot number: EL9264), in left arm and on 04Oct2021 at 13:45 as dose 3 (booster), single (Lot number: 2389) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: internal sulfas" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included pf-07321332, ritonavir (PAXLOVID).; Sender's Comments: The causal relation of reported events lack of efficacy with suspected vaccine BNT162B2 cannot be totally excluded based from temporal relation and potential varying immune response of individuals in relation to vaccines.  Case will be reassess pending investigation of this report.
HEADACHE Narrative: THIS IS A 54-YEAR OLD AFRICAN AMERICAN MALE WITH A COVID 19 VACCINE. PT HAD HEADACHE 2 DAYS AFTER SECOND INJECTION ON 2/19/2021. SELF LIMITING REACTION.
Patient developed painful genital ulcers and vaginal discharge. Was seen in the ER for pain, inability to walk and void. Provided pain control. GC/CT testing performed and was negative. Seen in Adolescent Medicine practice few days later for continued pain and symptoms. Treated with pain control and Valacyclovir. Subsequent HSV testing was indeterminate due to problem with lab. Also treated with Flagyl for diagnosis of bacterial vaginosis.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported.   This case was linked to  INC.-MOD-2021-122741,  INC.-MOD-2021-122781 (E2B Linked Report).; Sender's Comments:  MOD-2021-122781:crosslinked
Severe pain in right shoulder (same side as injection) with certain movements; Limited mobility without inducing extreme pain. Any minimal movement while sleeping woke me up. This just happened within 24hr of reporting so it is unknown as yet what the outcome will be.
Mother states in PM 03/16, child complained of pain and soreness left deltoid area. Erythema swelling noted. States child had temp, but did not take with thermometer. Was given Tylenol every 4-6 hours. Mother states took child to PMD 03/17, was told to ice arm and take with Tylenol. Presents today 03/18 for PPD reading. Noted 2 inch diameter raised area left deltoid area with erythema. Advised continued to ice and treat with Tylenol. Advised may also use Topical Benadryl. Child able to move arm with difficulty, child OK, mother was just concerned.
Patient presented to clinic for Pfizer booster with vaccination record.  Registration team followed CDC's recommendations for vaccination follow-up out of vaccine schedule.  Due to different spelling of Sinovac on the record, registration team made recommendation to receive Pfizer monovalent to complete primary series, when in fact patient was eligible for pfizer bivalent booster, which they came requesting that day.  Medical provider (myself) was consulted after vaccination was administered and determination was made that wrong vaccination was administered.  Patient was still in office and I spoke with them in detail, utilizing interpreter service.  Opportunity was given to ask questions and explained to patient that they may choose to receieve bivalent booster after 2 months, per CDC's errors and deviations guidelines.
fainted/seizure ?  loss of bladder control.  EMT called and assisted. Said all vital were normal and no signs of seizure.  EMT recc pt see primary MD for follow up.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported that his left arm feels tingly, as if it had fallen asleep and the sensation started minutes after injection while he was in the waiting room.
Information has been received from a nurse practitioner concerning a 9 year old female with no known allergies or pertinent medical history, who on 22-JAN-1999 was vaccinated with a dose of varicella virus live (Oka/Merck). There was no illness at the time of vaccination. On 29-OCT-2006 (also reported as 30-OCT-2006) the patient developed a questionable case of varicella. The patient's symptoms included a headache, achiness and 2-3 itchy maculopapular lesions on her abdomen, back and left arm (with no vesicles), the patient was also reported to be feeling sick. On 03-NOV-2006 medical attention was sought and the lesions were small, scabby and itchy at that time. There were no labs performed. On 06-NOV-2006 the patient recovered, No further information was provided. There was no product quality complaint involved. Additional information is not expected.
heel pain; This is a spontaneous report from a contactable consumer (patient). This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he had an appointment tomorrow (as of 05Apr2021) with a podiatrist for heel pain that his podiatrist said he could give him a shot for; the patient assumed it would be a cortisone injection. The patient inquired if he could take the steroid injection. The patient stated his second dose was due 14Apr2021 and that he would probably wait for the injection until after he'd received his second dose. The clinical outcome of heel pain was unknown.   No follow-up attempts are needed. No further information is expected
had swelling in elbows; Had swelling in ankles; Had swelling in knees; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 10Nov2020 at 09:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR) 10 mg for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 21Oct2020 at 09:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. On 12Nov2020 at 00:00, the patient experienced swelling in ankles, elbows, and knees. The swelling in the ankles discontinued. However still have the problems with his knees and elbows. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in ankles were recovered on an unknown date in 2021, while that of the events swelling in elbows, and knees was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: Patient developed a rash on most of body including arms and legs after receiving the COVID-19 vaccinations. She self-treated with Benadryl which seemed to improve the rash for a little bit and then it would return. She was given the OK to received the second COVID-19 vaccination after which the rash got worse.
This spontaneous case, initially received from a pharmacist on 10-Oct-2018, concerns a 64-year-old, adult male patient. The patient's current conditions included high blood pressure and chronic obstructive pulmonary disease (COPD) (reported as medical history). The patient's concomitant medications were not available. On 10-Oct-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). It was reported that the patient did not experience any adverse effects after vaccination. The reporter assessed this case as non-serious. This case 201804383 was cross-linked with the case 201804384 due to the same reporter. Non-significant follow up received from pharmacist on 30-Oct-2018: The reporter confirmed that the patient did not experience any adverse effects after vaccination. There was no further information available regarding the concomitant medications and case.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (lot number reported as L01248, expiration date 10-APR-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 50F and the time frame was 6 hours. There was no previous temperature excursion. It was stated that it was due to a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Painful raised red rash and bumps on left side of face, neck, scalp, and ear
Narrative: 68 year old male, received first dose of COVID-19 vaccine (Pfizer) 3/5/2021. Spouse called facility on 3/25/2021 to cancel second dose appointment scheduled for 3/26/2021. 4/2/2021 wife called to notify facility that patient was on hospice. Patient expired 4/6/2021.
Immediately after receiving covid vaccine, client felt light headed and nauseous.  BP 86/42 P 72 R 16 and regular. Pulse was "thready." Client complained of chills and feeling clammy.  She appeared very pale.  She spit up a small amount of mucous.  Nurse applied cold compress to neck and assisted her to lying down.  BP taken at 11:05 was 100/ 60. BP taken at 11:20 was 120/80. She drank two packets of juice.  At 11:15 she walked over to the observation area and waited an additional 30 minutes.  Color was pink an she said she was feeling better.  Her final BP was 120/70 and she left the observation room at 11:45.
Seen @ Sick call with headache after Small Pox Vaccine 4 wks ago and papular rash all over body x 6 days. No fever / chills. Ibuprofen for headache, BENADRYL for rash. Spoke with patient @ approx. 1355 7/30/09 and was informed that pt removed bandage per advisement from co-worker who told her to remove it.
The second dose of vaccine was inadvertently administered on 1/28/21, 22 days after initial dose on 1/6/2021. The patient was observed for 15 minutes following administration and had no adverse reaction.
I first felt symptoms of a painful headache on 06/21/2022, following that I develop a low grade fever. It was under 100 and over a week span it raised to 101 to 103. I was having a lot of fatigue that was unpleasant. I tested with an at home COVID-19 test the results were negative. On that Friday 06/24/2022 I went to a walk in clinic because I had a extreme sore throat and more fatigue. I was tested again and given a positive result and prescribed Paxlovid.  The sore throat went away on the next day. I developed a metallic taste due to the medicine I think. On that Monday following , I became very dehydrated and vomiting a lot. I went to the ER and was treated for dehydration  and pain from the headache that I was having on 06/27/2022.
I have had plenty of vaccines in the past, but this was administered EXTREMELY high up on the shoulder.  The pain in my left shoulder started around 3-5 days after the vaccine. I assumed that I had simply slept on it wrong and did not initially consider that my pain might be vaccine related. I have extreme loss of mobility in my left shoulder and it is extremely painful to move my shoulder in any direction. Pain or mobility are not improving with stretches recommended by physical therapist.
Arm became reddened, painful and swollen about the size of a golf ball.  Temp 101.2F.  She experienced a feeling like her heart was racing, and her hR was 120 at the walk in center.
1st Pfizer covid shot, gave me heart inflammation, Didn't seek treatment, because It's slowly getting better and it would be a waste of my time. Loss of Breath My heart Literally felt bigger in my chest, The size has decreased but bigger then normal. I think I'll skip the 2nd covid shot out of concern of personal health.
I21.4 ACUTE NON ST ELEVATION MI 1/29/2022 HTN (HYPERTENSION) J96.00 ACUTE RESPIRATORY FAILURE 11/24/2021 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/22/2021 HTN (HYPERTENSION) I21.4 ACUTE NON ST ELEVATION MI 1/29/2022 HTN (HYPERTENSION) J96.00 ACUTE RESPIRATORY FAILURE 11/24/2021 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/22/2021 HTN (HYPERTENSION)
slightly sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083986   Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comments: The patient self-reported this case via interactive digital media.  The patient received 1st dose of Shingles vaccine on an unknown date and experienced no effects other than slightly sore arm. The patient was so relieved that he/she got it. Much better than having shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR083986, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083986:Same reporter
Headache, 1" x 3" red rash at injection site, itching, 92 heart rate.
pt recvd vax & devel a rash 7 days later; No further details were provided
Within 90 seconds I had severe vertigo and a severe migraine.  In about 5 minute the vertigo subsided to a moderate enough level that I could walk to the observation room.  Over the subsequent 30 minute period I started itching and feeling generally awful like the flu and was a bit nauseous. My BP and Pulse were within acceptable limits though so I was released to go home.     As the evening wore on I developed a light rash down my arm. My PCP Dr. proscribed some different OTC medications to halt the allergic reaction I seemed to be having (based on its similarity to some of my food allergy reactions).    I took these treatments for 36 hours.   I woke the next morning with a severe autoimmune flare up that had me unable to get up without a cane for assistance.  I had no fever but felt feverish.  I was in a lot of pain all over. My injection site was very swollen and had a hives ring around it that lasted for about 5 days.   The total reaction from initial allergic reaction through the flare up lasted 8 days. Additionally, I take weekly allergy shots.  Prior to the vaccine I had to reaction to these shots (desired result).  Since then, I have a mild bout of vertigo after each allergy shot (indicating my immune over-response has been hyped up).
Pt recv vax on 12/11/98; on 12/12/98 pt exp pain at vax site (LA) to side of neck w/ swelling, redness, tingling- of left fingers, fever (100.3); tx=Tylenol
new onset sz disorder w/status epilepticus complicated by aspiration pneumonia (fever started 24h a/sz);
On beginning of November 2022 in the morning around 8:00AM. I had a severe cough, headache, loss of appetite, shortness of breath, and runny nose. I was tested for COVID-19 3 times 1 at my doctor's office and 2 home COVID-19 tests. They were all negative. On 11/03/2022 I went to my doctor office, and she prescribe me with antibiotics, and prednisone. On 11/23/2022 I had the same symptoms again. On 11/30/2022 I went back to my doctor's office this time she prescribe me with a different antibiotics and more prednisone.
Headache; Exhaustion; Fever; Chills; Nausea; Exposed to Covid at work; This is a Spontaneous report received from Pfizer sponsored COVAX US Support program by a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for Covid-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported that the patient experienced headache, exhaustion, fever, chills, nausea but then the next day felt fine on an unknown date. It was also reported that patient was due for second dose today but caller said she was exposed to covid at work. The health department called her and told her to quarantine until the 18th (as reported). The patient had undergone a covid test which resulted negative on an unknown date. The outcome of the events headache, exhaustion, fever, chills, nausea was recovered on an unknown date while for other event exposed to covid at work was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.