chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had uncontrolled vomiting and was unable to keep water down, had severe muscle cramps, and blacked out.  Pt was treated at ER and called use to report this
day after the injection the patient was tired/down for the count that day; nausea; pain in her injection site arm; swelling in her injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm), VACCINATION SITE SWELLING (swelling in her injection site arm) and FATIGUE (day after the injection the patient was tired/down for the count that day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm) and VACCINATION SITE SWELLING (swelling in her injection site arm). On 27-Feb-2021, the patient experienced FATIGUE (day after the injection the patient was tired/down for the count that day). At the time of the report, NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm), VACCINATION SITE SWELLING (swelling in her injection site arm) and FATIGUE (day after the injection the patient was tired/down for the count that day) outcome was unknown.            The patient received her first vaccine in her left arm shoulder deltoid muscle and no adverse reactions reported.   The patient down for the count that day and the day after the injection on 26 Feb 2021.  No treatment information was reported.   This case was linked to MOD-2022-544226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow up contains no new information.
A few days later, I developed psoriasis outbreak on my right elbow and right knee.  I hadn't had an outbreak at all in over 2 years.  I still have the outbreak as of today.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), via an unspecified route of administration, administered in left arm on 03Feb2021 09:15 as (at the age of 55-year-old) DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included overweight and psoriasis. The patient reported known allergies to penicillin, bactrim, tetracycline, erythromicin, and benzoyl peroxide. The patient's concomitant medication(s) included colecalciferol (VITAMIN D COLECALCIFEROL]), acetylsalicylic acid (ASPRIN), cyanocobalamin (B12 [CYANOCOBALAMIN]), ascorbic acid, glucosamine sulfate (MOVE-FREE), and levocetirizine dihydrochloride (XYZAL). No other vaccine in four weeks. On a few days later, 07Feb2021, the patient developed psoriasis outbreak on the right elbow and the right knee. The patient did not have an outbreak at all in over 2 years. And still have the outbreak as of today. Patient did not have any treatment for an event. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event not recovered.    Follow-up attempts completed. No further information expected.
Horrible itchy rash over the entire body, including back of neck, scalp, torso, legs. Lasting for days.
Had SHINGRIX shot 3/4/19 (1st of 2) and arm became swollen immediately. One week later it is still slightly sore. Fever began 3/6/19 as well as occasional feelings of nausea. Fever was kept under control for three days by use of acetaminophen.
I have had two incidents of AFIB 10/21/21 and 11/7/21. I do not have a history of AFIB. My PCP made a referral for me to have an appointment with a cardiologist. I have had one consult with the cardiologist so far. I am in the process of having further an evaluation, in the interim I have been prescribed some medication (metoprolol sulfate) to take while waiting on some more answers.
I woke up with a fairly large lump in my left armpit. It is painful to the touch.
Received the Moderna shot then immediately after became delirious, dizzy, and could not breathe. B/P was 105/74 and resting heart rate was 48. This led to them recommending that I go to the hospital to have blood taken due to them being uncomfortable with my results to make sure I was okay.
Prior to pt receiving her second dose of Moderna she had a relatively regular menstruation cycle occurring about every 28-38 days with the last date of menstruation occurring in May 2021. Pt did not have another menstruation until July 2021 and since then has had her cycle roughly about every month and a half on a regular basis.
Light-headed, mouth irritated. BP 152/96 (pulse 78), O2 sat 100%. Benadryl 25 mg PO given, crackers, and water.
4-5 inches big rash at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (4-5 inches big rash at the site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Latex allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE RASH (4-5 inches big rash at the site of injection). At the time of the report, INJECTION SITE RASH (4-5 inches big rash at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Patient woke up on 12/20/19 with swelling, pain, itching and tactile warmth to right upper arm at injection site.
After patient received HPV injection  became diaphoretic and nauseous/vomiting.  After about 2-3 minutes was examined by health care provider  and VS normal .  Patient was observed for 10-15 minutes  and stated that he was feeling better.  Patient was then walked back to class, school nurses notified of the event  and parent was called about this.
6hrs p/vax pt temp went to 103+ came down w/APAP but then would go back;
5 days after booster an flu shot while coming out of my house I stopped to talk with my wife when I got dizzy and a horrible headache, I grabbed the railing  just before falling   BP was low but pulse was 184. Hospitalized for 3 days and found nothing obvious to cause this
Patient was taken by ambulance to E.R. 3 days after injection with bleeding from the nose and blood in stool. Spent 10 days in hospital. Returned to ER a few days later with fluid leaking from arms and legs. Diagnosed with congestive heart failure. Sent home under Hospice. Returned to ER, by ambulance, 36 hrs. later.  Still weeping from skin and placed in ICU. on Bipap machine . Transferred that evening to medical Care Center where she passed away on March 3, 2021.
Patient started with a fever about 4 hours after vaccine administration. Fever continued daily for 7 days. Rash was reported about 48 hours after vaccine administration. Dark colored urine was reported about 96 hours (4 days) after vaccine administration. Hospitalized 4 days after vaccine administration. Blood work done daily.
Patient alerted myself today that she was experiencing severe numbness and tingling in her left arm.   She stated that she is light headed and has an extremely swollen arm.   This was brought on after she got her covid shot.    She mentioned that she did not have any insurance and was concerned about potential cardiac issues associated with the vaccine.   I advised her to be seen at the local emergency room.
Larger than expected red raised area at site of immunization. Four days post injection warm to touch, not resolving. Pt referred to NP at primary care for evaluation.
patient is stating that she felt like I hit her bone when I administered the injection and she said she's now experiencing a headache.
Case number PHEH2014US000919 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 02 FEB 2014. This reprot refers to a 14-year-old female patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A, expiry date: JUN 2014) intramuscularly in to the left deltoid on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 02 FEB 2014: updated site of administration of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 02 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Horrible headache and eye pain 1 day after second vaccine. On second day, Shingles developed on left forehead and scalp, and in left eye.  14 days PO Valtrex, zirgan opththalmic ointment 12 days, Lyrica, nortriptyline, Tylenol, Tramadol on-going. Still have slight rash with few new blisters everyday, burning/itching/tingling and fatigue.
a child received an expired Daptacel/no AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to case 2020SA053839 (same reporter).  This case involves a 24 months old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that a child received an expired Daptacel/no AE (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 24-Feb-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA and expiry date: 07-Feb-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event at the time of reporting.  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.
About 10 minutes after injection my heart started fluttering and chest got very tight, in a very odd and unfamiliar way.  This persisted for a long time, even several hours later, during which I experienced considerable numbness in my left arm.  I have tightness also in my head feeling like fluid pressure on the top of my head.  In the last year and a half, this vaccine made me feel the worst I have felt from any sickness and most concerned I have been for my health.   I am otherwise a fit person, rarely drink, never smoke or do other drugs, and have no known health issues.  I am deeply unhappy with the effects of the vaccine and thought that there was a chance I would end up in the hospital.  It doesn't feel safe.
Pt received DTAP on 4/27/06. Woke up with red, swollen sore arm at site. Cellulitis was treated with warm compresses and Augmentin.
Feeling lousy; Not been feeling well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling lousy), MALAISE (Not been feeling well) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 006B21A and 042B21-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX), LEVOTHYROXINE SODIUM (SYNTHROID), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), BREXPIPRAZOLE (REXULTI), BUSPIRONE HYDROCHLORIDE (BUSPAR), TRAZODONE, METOPROLOL, CLONAZEPAM (KLONOPIN) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced FEELING ABNORMAL (Feeling lousy), MALAISE (Not been feeling well) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Feeling lousy), MALAISE (Not been feeling well) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment was not specified.
Patient presented to After Hours clinic with moderate redness, swelling, and warmth to the right deltoid area, just under injection site.
woke up with very itchy rash to arms and legs the next day after receiving flu vaccine. Immediately after receiving the vaccine, he felt a little light headed.  Used atarax x 2 doses; triamcinolone cream, allegra x 1. It has helped someone. But still had symptoms when he presented on 9/23/19 for evaluation.  On exam he had multiform wheels, papules/macules to lower arms and legs. No angio edema or HEENT sx. No nausea/vomiting.  Rx provided for benadryl 25mg 1-2 tabs qid for the following 2 day then prn. rtc 2 days for recheck. Did not follow up as of report date
08-14-08 fever- no temp taken- phlegmy cough started- 08-25-08- breastfeeding ok- coughs at night & vomits at night- today runny nose started- client never went to MD- still has not gone to MD- I encouraged client's mother to go to MD
Developed fever on 7/21/12 at 0100 which lasted 3 days. In addition, vomiting x 2 on 7/21/12 severe headache on 7/21/12.
Information has been received from an administrator, who also worked as a medical assistant, referring to an unknown number of patients of unknown age and gender. Information about concurrent condition, concomitant therapies, drug reactions/allergies and medical history was unknown. From 02-JUN-2017 to 22-JUL-2017, the patients each was vaccinated with improperly stored VARIVAX (dose, route and lot # were unknown) for prophylaxis. The reporter stated that if the VARIVAX were to go over 14 Fahrenheit (F), the patients who were administered the vaccines would need to be revaccinated (It was also reported that "no doses were administered" (conflict information)). No adverse effect was reported. The vaccines were under the temperature in the range of 6 F to 14 F: 6 F for 1 hour and 30 mins, 8 F for 5 hours, 5.6 F for 45 mins, 8 F for 7 hours, 8 F for 3 hours, 6 F for 1 hour, 9.7 F for 30 mins, 6.4 F for 5 hours. There was no previous temperature excursion. A data logger was used.
PATIENT C/O NAUSEA AND MIGRAINE POST INJECTION OF MODERNA VACCINE. SHE HAD THE SAME RESPONSE TO THE FIRST DOSE.
Redness left quadriceps area where prenar injection was given on 3/15/06. Local reaction to inj. Dr. saw the patient on 3/17/06. Cephalexin 125 mg.
she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering.  No follow-up attempts are possible. No further information is expected.
Initial misuse report received from a healthcare professional on 13 May 2013. A child was administered the 5th dose of DAPTACEL at 23 months of age because the 4th dose was administered less than 6 months after the 3rd dose. No adverse event was reported. List of documents held by sender: none.
Pt stated that she had a metallic taste in her mouth and felt dizzy. She also stated that she had right sided headache.
Patient reports feeling light headed with headache. denied shortness of breath, dyspnea, hives or itchiness. Patient educated to lay flat with feet up. Also encouraged to drink water to stay hydrated. after few minutes symptoms subsided.
Advised patient to sit for 15 minutes after vaccination to watch for allergic reactions. Patient left room and fainted while seated. Later learned patient had not eaten or had drink, and was nervous.
her daughter received a dose of Daptacel on 10Nov2021 that was expired when it was administered with no reported adverse event; Initial information received on 16-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 months old female patient who received a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 10-Nov-2021 that was expired when it was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 10-Nov-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (form and strength not reported, lot number: C5643CA, expiry date: 17-Jul-2021) at a dosage of 0.5 mL via unknown route at an unknown administration site for immunization.   On 10-NOV-2021 the patient received a dose of daptacel that was expired when it was administered with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  Outcome: Unknown   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.
4 hrs after taking the vaccine she fainted in home while taking a shower. Mom thinks she had a brief seizure. She was taken to the local emergency room. She was discharged. Continues with headache and pain at the site of injection.
While at COVID Clinic on 1/29/2021 the first dose of vaccine was administered outside of CDC guidelines to someone less than 16 years old.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with drug reaction/allergies to penicillin and unspecified thyroid disorder. Patient medical history include oral thrush from penicillin. On 13-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K009809, expiration date 16-MAY-2015, intramuscular in arm (dose was not reported). Other suspect therapies included influenza virus vaccine (unspecified) on the same date, in the same arm that PNEUMOVAX 23, separated by one inch (dose and route were not reported). Concomitant therapies included SYNTHROID. The pharmacist reported that on 14-OCT-2014, the patient went back to the pharmacy in which she noted that the patient's arm where she received the PNEUMOVAX 23 and the unspecified flu vaccine was swollen and looked as if it was infected. The pharmacist reported that patient visited her primary care physician who prescribed her clarithromycin. On 15-OCT-2014, the patient's arm had gotten worse and patient visited the emergency room at a hospital in which she was admitted. Patient was treated with an unspecified intravenous antibiotic while in the hospital. Patient was discharged on 16-OCT-2014 with a prescription for AUGMENTIN. The outcome was reported as not recovered. Unspecified blood labs were performed (on an unknown date in October 2014, result were still pending). Additional information has been requested.
Migraine headache started 1 day later and persisted for ~5 days. Also developed body aches, chills, and low grade temperature.
Got redness and itch for 11 days in my arm; Got redness and itch for 11 days in my arm; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: not reported) via an unspecified route of administration, on an unknown date as dose 1, single for covid-19 immunization). The patient's medical history and concomitant medications were not reported. On an unknown date, patient got redness and itch for 11 days in my arm. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.