chrisvoncsefalvay/vaers-outcomes huggingface dataset:
is spontaneous report as received from a pharmacist refers to a 58 year old male patient. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown) (route, lot number and expiration date were not reported). On an unknown date, the patient experienced anaphylactic reaction to the unspecified hepatitis B vaccine, reporter stated RECOMBIVAX HB could not be ruled out. The outcome of anaphylactic reaction to an unspecified hepatitis B vaccine was reported as recovered (on an unknown date). Upon internal review the event of anaphylactic reaction to an unspecified hepatitis B vaccine was considered medically significant. Additional information is not expected, because the reporter did not want to be contacted.
excessive vomiting/extreme vomiting; lowgrade fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (excessive vomiting/extreme vomiting), PYREXIA (lowgrade fever) and MYALGIA (muscle aches) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood cholesterol abnormal (Cholesterol). Concomitant products included SERTRALINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (excessive vomiting/extreme vomiting), PYREXIA (lowgrade fever) and MYALGIA (muscle aches). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VOMITING (excessive vomiting/extreme vomiting), PYREXIA (lowgrade fever) and MYALGIA (muscle aches) outcome was unknown.            Patient was over 65 years old and wants to go get the Covid19 vaccine booster.  Reporter said his wife got excessive vomiting, extreme vomiting, low grade fever, muscle aches from the second primary Moderna Covid.  The patient took Pepto Bismol or Alka Seltzer for the side effects.   This case was linked to MOD-2022-640744 (Patient Link).   Reporter did not allow further contact
Patient developed bell's palsy on right side of face approximately 2 months after administration of SHINGRIX.
Arm is so sore that I can't lay on it or raise it above shoulder level. Feel achy, tired, nauseous  and have a headache.
Nausea; Joint pain; Joint tightness; Clinical flare up; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 13Apr2021 at 09:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), levocabastine hydrochloride (ZYRTEC), folic acid (MANUFACTURER UNKNOWN), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) and sambucus nigra fruit (ELDERBERRY) taken for unknown indication on unknown date, unknown if ongoing. No known allergies were reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. 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. On 13Apr2021 at 15:00 the patient experienced nausea, joint pain and tightness similar to an RA flare up and extreme fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events nausea, joint pain and tightness similar to an RA flare up and extreme fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, joint pain and tightness similar to an RA flare up and extreme fatigue was recovered on unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
weakness Narrative:  Patient presented to outside ED with EMS secondary to concerns of stroke like symptoms within once day of COVID Moderna shot. Patient was at normal baseline day of covid vaccine then next day woke up dizzy and weak; unable to stand without support and legs felt wobbly. Had extensive workup in the ED including Head CT, CT angiogram of head/neck, MIR of brain, and echocardiogram were completed. Non-clinic Neurology was consulted and reviewed imaging; stroke and TIA were ruled out. The profound weakness and dizziness were likely secondary to COVID vaccine which patient received the day before. Patient was discharged from the ED with recommendation of physical therapy.
Back pain in left scapular area from 4/8- to present. Pain was 10/10 on 4/12, has become less intense, now more mild. Took Advil and Tylenol , which helped but upset stomach. Called RN at PCP office to discuss 4/12/21. Called nurse Covid hotline 4/14 because had J+J vaccine 4 wks ago.
HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
fever 103.4, erythema and edema right thigh, lethargy, screaming
Covid Positive.  Severe coughing, severe body aches, severe headache, vomiting, complete loss of appetite,  severe chills
Missed dose; exceeded 35 day dosing window; sore throat with white pus, (strep negative); flu like symptoms; nausea; vomiting; headache; feverish; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceeded 35 day dosing window), PRODUCT DOSE OMISSION ISSUE (Missed dose), OROPHARYNGEAL PAIN (sore throat with white pus, (strep negative)), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat with white pus, (strep negative)), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache), PYREXIA (feverish) and DIARRHOEA (diarrhea). On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceeded 35 day dosing window). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. On 23-Apr-2021, OROPHARYNGEAL PAIN (sore throat with white pus, (strep negative)), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache), PYREXIA (feverish) and DIARRHOEA (diarrhea) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceeded 35 day dosing window) and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Amoxicillin was prescribed as treatment but patient did not use as prescribed.
Patient tested positive for COVID 19, Antigen 11/8/2021 Admitted to hospital on 11/7/2021 Complaint of gait issues for the last 2 days, weakness He also has report of temp up to 102, occasional chills, cough and congestion
Patient was vaccinated at a clinic on 7/11/2022. Mother noticed a rash on 7/13/22 and presented to the clinic on on 7/15/22 with a rash on arms, legs, face, and torso.
Within 24 hours of immunization, erythema noted. Within 48 hours swelling of upper arm past elbow with erythema from upper arm to elbow. Full ROM at elbow (Reaction to right arm).
Within (3) hrs of receiving vaccine I had an awful repellant like smell & taste, causing extreme nausea for about (5) hrs along with severe diarrhea with 99.9-101 fever for (3) days. The taste & smell of roach spray like was awful, scared my husband & I. To this date I have no sense of smell or taste & feel tired all the time. Haven't gone to ER being afraid to be among others who may have Delta variant but am considering going if symptoms persist. My 2nd vaccine is on July 24.
This spontaneous report as received from a nurse practitioner refers to a male patient in his 60's to 70's. The patient was vaccinated with a "standard first shot" 0.5 ml dose of PNEUMOVAX23 (Lot# and route not reported) on an unspecified date. There were no concomitant medications. The patient experienced swollen cellulitis after being vaccinated with PNEUMOVAX23, date unspecified. The nurse told the patient to take BENADRYL and TYLENOL for the reaction and if that didn't help to come back in for a follow up visit but the patient hasn't come back in the date so the nurse thought he was fine. At the time of this report the patient's status was not known. The nurse said that the patient should not get another dose of PNEUMOVAX23 because of the reaction. Additional information has been requested.
NOT EASY TO DESCRIBE EVEN AS NURSE, WEAKNESS , SWOLLEN GLANDS UNDER ARM PIT, LOSS OF APPETITE, FEELING OF HAVING A FLU OR FLU LIKE SYMPTOMS, JOINTS PAIN AND MORE FOR 2 DAYS
I had a sore throat, headache, fever, and loss of taste and smell. These symptoms lasted about 6 days. I went to the doctors about this. They did a COVID-19 test, positive results.
pt recv vax;cellulitis;very large area of redness(elbow to shoulder),inflammation&hardness dx as cellulitis;pt responding to massive doses of Ceftin;tx in ER;
Redness, warmth, swelling around the injection site in a 2in X 2in area. ?Firm? feeling to the deltoid muscle.
sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.
Received third dose  at Public Health Dane County vaccination clinic. Normal immunogenic response day of and after vaccine (headache, nausea, fatigue, aches, "felt under water" that went away normal function from time of booster 11/2-11/15- able to do cardio no problem  11/16 felt like I was going to faint during an EMDR therapy session - could be related to trauma processing.  11/17 headache/nausea in am. Was sitting in a meeting and all of a sudden my vision veered. Felt like I was going to faint around 1:30 pm. Then actually Fainted with shaking/fatigue - stayed in bed rest of day 11/19 shortness of breath started -unable to complete my daily half hour walk due to difficulty breathing, very high heart rate that wouldn't come down, dizziness since then have had on and off again headache, high heart rate that persistently stays higher than usual, dizziness especially down stairs, shortness of breath interfering with daily activities, extreme fatigue
Arm pain, soreness and knot in arm- all began day after vaccine and lasted for about 4 days, treated with Ibuprofen and ice pack. Headache began day after vaccine, lasted for three days on and off- treated with Ibuprofen.  Light headedness began on day 4 after vaccine, nothing helped, went away after 24 hours. Lymph node swelling occurred on day 5 after vaccine- in under arm and collar bone of the same side of body as injection.
I was feeling fatigue and had a fever and my arm was swollen and red at the injection site for about a week and a half and it was difficult to move my arm. I also had nausea and dizziness. I was driving and I got dizzy while driving. It lasted for about 3 weeks but I didn't drive for about 4 weeks because of the dizziness.
Outbreak of shingles behind left knee, treated at urgent care next day. Prescribed Valtrex and Zovirax.
RED AND ITCHY AT INJECTION SITE ON LEFT ARM WHERE RSV WAS GIVEN. FEVER WHICH RESPONDED TO TYLENOL. JOINT PAIN.
Redness / at the injection site; Swelling / at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (had COVID in September 2020).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 63 or 64 years. The patient received the first dose in either October or November of 2020. The patient had redness, swelling and pain at the injection site.  For tolerence with 2nd dose refer case US2021005929. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021005929:Same reporter
PATIENT FELT DIZZY AND FLUSHED WHICH PROCEEDED TO VOMITTING, DIFFICULTY BREATHING AND CHILLS AND SHAKING THE PATIENT WAS MONITORED WHILE PARAMEDICS ARRIVED.  PATIENT VITALS WERE NORMAL AND PATIENT WAS MONITORED BY PARAMEDICS AND PHARMACY STAFF FOR ABOUT HALF AN HOUR. PATIENT REFUSED FURTHER TREATMENT AND WENT HOME ON THEIR OWN AND WAS INSTRUCTED TO FOLLOW UP WITH THEIR DOCTOR, AN URGENT CARE CENTER OR CALL PARAMEDICS IF FURTHER CARE IS NEEDED OR THEIR STATUS CHANGES.
I went to the community church where they were offering the Covid-19 Vaccine. I had my 2nd shot, waited 30 minutes due to reactions to other vaccines. I went home and I was ok. Only pain in injection site and a bit cold. After a couple of days I started to feel a pain in my Right Armpit. It was throbbing, soaring pain I could not stretch or reach, painful to the touch. The pain subsided on its own after a couple days.
She reports that 2-3 days after vaccination she had some localized redness, warmth and swelling around the injection site. She didn't think much of it, took some ibuprofen for her menstrual periods and found that symptoms were not terribly bothersome. About 9/2/11 she started to notice some generalized paresthesias starting around the area of her biceps distally. No localized patterns of paresthesias. No weakness. No color changes, swelling or warmth. She is right-hand dominant, no recent injury or overuse. She denies any systemic or respiratory symptoms. She's never had a vaccine reaction though her mom told her that she tends to be "sensitive to vaccinations". Patient is unsure what this means. Symptoms were much more bothersome for the past 3 days. She describes the paresthesias as being uncomfortable, a level 7/10 on the pain scale. Today for some reason they're much better. She describes a 4/10 discomfort.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 11:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.51.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, and 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Booster; Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. , "Primary Immunization series complete but unknown manufacturer"), for COVID-19 immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. , "Primary Immunization series complete but unknown manufacturer"), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 14Dec2021, outcome "unknown" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Felt lightheaded and dizzy.; Felt lightheaded and dizzy.; skin pale; very fatigued; she was currently breastfeeding; she was currently breastfeeding; This is a spontaneous report from a contactable health care professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 (at the age of 34-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccination. It was unknown if the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. On 18Dec2020, the patient felt lightheaded and dizzy and was brought to the observation area, ambulatory. She denied shortness of breath, itching or difficulty swallowing. No rash was noted, but the skin was pale. Water was provided to the patient. It was reported that the patient was currently breastfeeding, was very fatigued, probably dehydrated and had not eaten breakfast. She stayed in the observation area until 10:37, drank a total of 3 bottles of water and was up to the restroom ambulating on her own. Her blood pressure was 131/83, heart rate was 83 and "100% on RA" as reported. She left ambulatory to drive home and was informed to notify the appropriate person of this episode prior to a second dose of vaccine. It was unknown if treatment was received for the events "felt lightheaded and dizzy", "skin pale", and "very fatigued". Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient recovered from the events "felt lightheaded and dizzy", "skin pale", and "very fatigued" on an unspecified date in 2020, while the clinical outcome of "she was currently breastfeeding" was unknown.   No follow-up attempts are possible; information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504266 mother/baby case, same reporter /drug , different patient
Patient was given a Pfizer vaccine for 2nd dose when Moderna was given as first dose. As per CDC and Moderna manufacturer guidance, additional dose not indicated.