chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an approximately 73 years old female patient with unspecified medical history, who "about one or one and a half years ago" in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). In June 2009 the patient developed an excruciating pain under both breast and extending into the arm pit. Three weeks after the pain began she developed blisters under both breasts that have resolved into "skin tabs". On an unknown date the patient was admitted to the hospital because of the pain that she was experiencing. The patient stated that she was hospitalized a second time due to a reaction to NEURONTIN that she was given for the pain. The patient mentioned that shingles went undiagnosed for a while and physicians believed that she may have had pleural effusions or "fluid in the lungs" but they could not find fluid. The patient mentioned that she was admitted to the hospital a third time since her physician wanted to get immediate diagnostic studies performed, results were not reported. The patient stated that now she is consulting a dermatologist and that has been taking VALTREX. At the time of reporting the patient had not recovered. No further information is available.
Mom stated that patient woke up in the AM of 2/24/21 with her legs red and swollen that then became bruised. Mom stated that the swelling was the size of a soft ball. Mom stated that patient was stumbling, patient had lost sensation in her legs, was fatigued and had cold sweats. Mom stated that patient's temperature was 96.8. Mom was informed that Dr. requested to have patient be evaluated in the ER. Unknown at this time of patient's outcome.
Cold; Flu; being achy; a little bit of fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for Covid-19 immunisation. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; INFLUENZA (non-serious), outcome "unknown", described as "Flu"; PAIN (non-serious), outcome "unknown", described as "being achy"; PYREXIA (non-serious), outcome "unknown", described as "a little bit of fever".  Additional information: Caller wanted to know if her son should have the second dose or not. Caller said that the rest of them did not experience anything like that, the first dose was fine, then for the second they had the regular symptoms of like cold or flu, being achy, a little bit of fever; but her son of course had to be different.  No follow-up attempts are possible. No further information is expected.
redness on her arm at the injection site; patient was administered one dose or improperly stored PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's current conditions, pertinent medical history, drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) of lot number S021740, expiration date was reported as 31-MAR-2021 but upon internal validation it was established as 25-MAR-2021 (dose, strength, frequency, route of administration were not reported) for prophylaxis (product storage error). On an unknown date, the patient experienced redness on her arm at the injection site (injection site erythema). There was no product quality complaint (PQC) present. The lot underwent the temperature excursion of 70 degree Fahrenheit in 16 hours time frame. There was no previous temperature excursion. The call was placed due to data logger. Outcome of the events was unknown. The reporter's causality assessment between the event injection site erythema and the suspect therapy was not provided.
Patient reported loss of feeling in her legs and felt numb. She went pale and could not stop shaking 15 minutes after the vaccination. We called for EMS and they evaluated her further.
Severe flushing approximately 2 hours after shot given.  Lasted about 18 hours and no treatment necessary.
Right arm pain of site of injection followed with redness which has increased daily since vaccination.  This is day 3.  Redness has migrated down the arm approx. 1 inch and is the size of a golf ball or slightly larger.  Hot to touch.  No red streaks.  Tender to touch but no swelling
Vomiting x1, followed about 1 hour later by large 17cm x 10cm hive at injection site. Hive still present at time of report (14 hours) but improving. Rash was painful and itchy.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history and drug allergies or reactions were reported. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. This is one of the many reports form the same source. Additional information has been requested.
Flu-like symptoms approximately 8 hours after 2nd dose of Moderna vaccine. Fatigue, fever, heart palpitations, nausea, back pains, headache, pain in left arm.  Symptoms cleared up 80% after 24 hours of symptoms, cleared up 100% after 48 hours.
SORNESS AT INJECTION SITE 4 DAYS FEVER 2 DAYS CHILLS 3 DAYS NAUSEA 1 DAY VOMITING 1 DAY CONFUSION 3 DAYS SIGNIFICANT HEADACHE 4 DAYS SIGNIFICANT MUSCLE ACHES 3 DAYS MALAISE 3 DAYS DIZZINESS 2 DAYS  MY WORST REACTION TO COVID VACCINATION EVER
recently died from covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter had a good friend who was fully vaccinated and didn't know which vaccine he got, who recently died from covid. The reporter knew nothing was 100%.  The patient died on an unspecified date in 2021.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: recently died from covid
Approximately 5 minutes after receiving flu and pneumonia vaccine pt began hollering, "Oh, Oh my neck is hurting. Feels like a knot in my throat, a medicine taste." Complained of chest pain moving to back and leg numbness.
No adverse events noted. Patient vaccinated with vaccine licensed for 3 years and older, and he is only 2 years old.
Time of vaccination was 11:34 onst of symptoms 11:50. Patient feel dizzy hot sweaty.  Skin  was   Clammy Diaphoretic.   Pt all so c/o diarrhea.  First set of vs bp 80/43, sp02 98% ra, 20 reps,hr 56.  Bgl 143. Epi pen given 0.3 im . Right deltoid. At 1215 pm.  Vs after epi 104/ 58 spo2 95% reps 18 hr 78 skin color improved  . Pt sent out by ems
Pt was administered 2 pediatric doses of Hep. B Engerix B 10 mcg/0.5 ml. 1st dose 5/4/07. 2nd dose 5/29/07 instead of an adult dose. No adverse events noted
5 days after the first dose I had a lump in my left arm pit which was sore.  It lasted about 4 days.
Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022; Patient received the vaccine on 08-Apr-2022 but it had got expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 08-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 08-Apr-2022 but it had got expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 08-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The pharmacist thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. Date the vial was initially stored in refrigerator 04-Apr-2022. The vial did not undergo any temperature excursions.  Treatment information was not provided.
9 min post injection pt felt her heart rate increase, was pale and diaphoretic.  Vitals signs were taken  with BP being 183/113, HR 103 and respirations 22.  Pt was sat down, given cool water and apple juice.  She reported having not eaten much for the day.  Her symptoms began to subside within 10 min and she required no further  intervention.  She was observed for a total of about 1 hr post injection .  Her BP was 136/ 98, HR  83 and respirations 17 when she left for home with her husband.
voice wasn't right; couldn't stand; felt wiped out/ had to lie down; positive for COVID; felt really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (positive for COVID), DYSSTASIA (couldn't stand), DYSPHONIA (voice wasn't right), ILLNESS (felt really sick) and FATIGUE (felt wiped out/ had to lie down) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (positive for COVID) and ILLNESS (felt really sick). On 22-Oct-2022, the patient experienced DYSSTASIA (couldn't stand) and FATIGUE (felt wiped out/ had to lie down). On 23-Oct-2022, the patient experienced DYSPHONIA (voice wasn't right). At the time of the report, COVID-19 (positive for COVID), DYSPHONIA (voice wasn't right) and ILLNESS (felt really sick) outcome was unknown and DYSSTASIA (couldn't stand) and FATIGUE (felt wiped out/ had to lie down) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) took a home Covid test which was positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient had received 2 primary doses and 2 booster doses of the Moderna vaccine followed by a dose of the Bivalent vaccine. The next morning she went to work where her symptoms continued, and she was encouraged by occupational health to go home. She came back to work the following day, but her voice wasn't right. She did not have a fever at that time. She saw her primary doctor on Thursday who stated her voice would start to come back.  Friday she felt really sick, and wiped out, so she went home. Saturday she had a problem and wanted to get a test. She took a home Covid test which was positive. Saturday night she took a downhill turn where she had to lie down. She woke up yesterday with nasal issues and congestion.  She took antiviral medications for 1 day, and felt a headache the day after that. She has an appointment with her doctor after this call today.
Client presented to Health Dept. for second dose of Hepatitis A vaccine. Client had no contraindications or risk on vaccine screening sheet documented by clients mothers. Client was given Hep A vaccine and left clinic with no issues. 24 hours after receiving the vaccine clients mother called Health Dept. stating she took client to ER for angioedema. Client was given steroids and prescription for an epi pen and sent home without admission to the hospital. According to mother client played out side after receiving vaccine and the morning that angioedema started. Mother denies client had any adverse reactions to first dose of Hep A. VAQTA Hepatitis A vaccine lot: T023914 pulled from vaccine stock as a precautionary measure.  I, RN contacted clients mother today, 8/5/21, who states client is doing better. Furthering that client still has angioedema present, but states she has not given client prescribed steroid since his first dose yesterday. No site reaction reported by clients mother. Angioedema only symptom reported.
have a headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (have a headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced HEADACHE (have a headache). At the time of the report, HEADACHE (have a headache) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
I had the Moderna vaccine at 6:35 PM on June 21st, 2021. Pins and needles/tingling on the left side of my face began the following morning at 10 AM on June 22nd, 2021. The tingling goes from in front of my left ear, along my cheek and jaw into my bottom lip. The pins and needles on the left side of my face has been constant since it began, and has NOT resolved as of 06/25/21.  Occasionally tingling is felt on right side of face and down into both of my arms/hands. I had aching/tenderness down the left side of my neck/throat, down into my left shoulder blade on 06/24/21, but no injection site pain.  I had a doctors appointment on 06/23/21 and they were unable to diagnose me, but told me to follow up if the problem persists which it has. I had no pre-existing health conditions and am an active healthy woman.
Pt reports next day after her 1st vaccine she felt fatigue, lethargic and her whole body was burning up - by 3rd day the the symptoms cleared up. With 2nd vaccine, pt reports the next day she felt the same way as the 1st dose symptoms along with having congestion, coughs and mucus production. Pt reports feeling better on 5/15/2021, but today she is still congested, coughing, producing mucus and when she blew her nose her ears popped.  Pt reports she took Tylenol and took off her clothes and that helped with the burning sensations.
Patient received Moderna Covid-19 vaccine at age 16; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16). On 30-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) had resolved. Not Provided      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.   Concomitant medications were not provided. treatment medications were not provided.   This case was linked to MOD21-085818, MOD21-085846 (E2B Linked Report). This case was linked to MOD-2021-262812 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up added and addition of second dose detail given. On 29-Jul-2021: follow-up received and contains no new information.; Sender's Comments:  MOD21-085818: MOD21-085846:
got COVID after vaccination; got COVID after vaccination; had a bad sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 13Jun2021 (Lot number: EW0180) at the age of 56 years as dose 2, single and administration date 23May2021 (Lot number: EW0182) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got COVID after vaccination"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "had a bad sore throat".  No follow-up attempts are possible. No further information is expected.
Itching, local swelling, and redness around the injection area for 1 day.
Pt is complaining of sore arm. No redness or soreness at injection site, but sore inside. She says it is sore or hurts when she moves it or lays on it. We suggested heat/ice to help. She said her Dr has recommended PT.
This spontaneous case reported by a pharmacist, describes the occurrence of product administration error (2nd dose shot given too high on the top of the shoulder), vaccination site movement impairment (shoulder motion limitation) and vaccination site pain (severe pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 009C21A and 041C21A) for COVID-19 immunization. No medical history reported. On Apr 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 23, 2021, patient experienced product administration error (2nd dose shot given too high on the top of the shoulder), vaccination site movement impairment (shoulder motion limitation) and vaccination site pain (severe pain). At the time of the report, product administration error (2nd dose shot given too high on the top of the shoulder), vaccination site movement impairment (shoulder motion limitation) and vaccination site pain (severe pain) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD21-097288 (patient link).
Information has been received from a physician concerning a 12 year old female patient with no drug reactions or allergy who on 14-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # not reported). There were no concomitants medications. On 15-JAN-2009 the patient experienced high fever, weakness and nauseated. The patient sough unspecified medical attention. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic sclerosis pulmonary (Scleroderma with interstitial lung disease (systemic sclerosis)) and Autoimmune disorder. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Scleroderma.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with CELECOXIB for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event, sore arm was not applicable.
fatigued; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 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: FATIGUE (non-serious), outcome "unknown", described as "fatigued". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RASH ON LOWER RIGHT HIP; BURNING PAIN FOLLOWING A NERVE; SLIGHT FEVER JUST BEFORE OTHER SYMPTOMS
felt like she just had a fever; very nauseous; sick for 10 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "felt like she just had a fever"; NAUSEA (non-serious), outcome "unknown", described as "very nauseous"; ILLNESS (non-serious), outcome "unknown", described as "sick for 10 days".  Additional information: On 25Oct2022, it was reported that a patient started treatment on Apr2021 with Pfizer BioNTech COVID-19 Vaccine at dose 2 for COVID-19 immunization and got very sick for 10 days. The patient was very nauseous and felt like she just had a fever. The patient also had a booster on Aug2021 which was really bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine given 4/1/15 in pm - by late afternoon fever 99.0, red, warm, firm area site of injection. 4/3/15 area still red, soft, warm - 11cm-10cm.
Pain, redness at injection site - the redness spread distally (as opposed to proximally) on the arm and was blotchy; also felt ill and reported low grade fever. I ran into her at the pharmacy two days after the injection (she was seeing the NP at the clinic who she says told her that she had not seen this type of reaction) and then at my office on May 8. The reaction had improved compared to what she showed me in the pharmacy.