chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient fainted upon exiting the vaccine room and sitting back in her observation chair approximately two minutes after the vaccine was given. She was in and out of consciousness for about 10 minutes total, was sweating heavily, and eyes dilated and unable to track. We applied a cold compress and ice packs, and then laid patient down flat. Upon laying her down she quickly came back to consciousness and then the paramedics arrived. Paramedics recommended patient go to the hospital for fluids, but patient felt like she was okay. She went out to the ambulance for further observation and testing.
did not get second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This patient self-reported the case. The age at vaccination was not applicable for this report. The patient stated he/she did not get the 2nd dose of Shingrix within 6 months interval, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
pt recvd vax;according to mom had high pitched cry >3 hrs & not able to be consoled;both lt extremities red & swollen from thighs to below knees;mom called FMD who advised apap; mom did so & pt well today 3nov94;
Post vax, the pt presented to clinic with diarrhea and hematoemesis. Subsequent dx of c. diff. colitis on 11/12/00. Pt developed acute severe hypercarbic respiratory failure. 11/14/00, suspects respiratory failure from possible muscle weakness.
A non-serious spontaneous report of a 50-year-old male patient who experienced arthralgia and malaise subsequent to FLUMIST has been received from a physician (patient). No relevant medical and medication history was reported. The patient received FLUMIST on 18-Sep-2008. Two days after FLUMIST administration, the patient experienced malaise and general arthralgia which lasted for about four days. At the time of report, the patient had no symptoms.
Onset 1 hour after administration. High blood pressure: systolic over 167. Nausea and vomiting. She was sent home and took a nap. Her blood pressure improved to 155/79.
Light headed/dizziness, tachycardia,  nausea, muscle aches, fatigue/exhaustion, brain fog,  fever
Pt came in at 0715 with chest pains since 0530. Was evaluated at clinic and was transported downtown to ER. Pt returned to clinic with diagnosis of pericarditis. Pt was given Indomethacin and omeprazole for medications.
Cellulitis , one day after receiving the second dose of moderna. Also headache, fatigue, joint paint, nausea, vertigo body aches, fever, chills.
Post vax, the patient developed a temperature of 104F and was taken to the ER at 11:45 pm after the mother couldn't get his temperature down with medication and sponge baths. The patient was treated with Motrin, his fever broke and he was discharged at 3:00 am. The patient remained alert and active during the time his temperature was elevated. The patient's mother gave him Tylenol without additional problems.
got very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), 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 (Primary immunization series complete; Unknown manufaturer), for COVID-19 Immunization.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 14-year-old male with type 1 diabetes mellitus, no known drug allergies, and a family history of migraines (paternal grandmother) who on 05-AUG-2008 was vaccinated into the right arm with the second dose of MMR II (Lot number 659703/0666X), and into the left arm with the second dose of VARIVAX (Merck) (Lot number 660822/0338X). Concomitant therapy included HAVRIX (unspecified, lot number ahavb118ab, first dose, right arm), RECOMBIVAX HB (unspecified, lot number 1714U, second dose, right arm), MENACTRA (lot number U2605aa, first dose, left arm) and insulin. It was reported that at the time of the vaccinations, the patient had no known illnesses. On-06-AUG-2008, (the morning after the vaccines were administered), the patient presented to the emergency room with a severe debilitating headache and vomiting. It was reported that the patient also had abdominal pain, pain, nausea, anorexia and neck pain. On that same date, his blood sugar was 183. It was reported that the patient was treated with TORADOL 30 mg diluted with normal saline slow IVP. The patient improved, and he was discharged from the emergency room on 06-AUG-2008. The patient recovered on 07-AUG-2008. This is an amended report. The serious criteria of disabling for severe debilitating headache has been changed to yes. This is a corrected report as amended.
tested positive for COVID-19 after the vaccine; tested positive for COVID-19 after the vaccine; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: not reported), via an unspecified route of administration on 20Jan2021 (also reported as 18Jan2021, pending clarification) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive for COVID-19 after the vaccine. She queried if she still needed the second dose and when she can have it administered. The clinical outcome of "tested positive for COVID-19 after the vaccine" was unknown.  Information about batch/lot number has been requested.
Pt called 4 days later 06/16/23 that she got a yeast infection that afternoon after the vaccine.  Spoke with provider on 06/16/23
slight tingling; numbness on the left side of her face from the eyeball, high cheek bone down to the middle of her chin; A spontaneous report was received from a consumer who was a 55-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness on the left side of her face from the eyeball, high cheek bone down to the middle of her chin and slight tingling.  The patient's medical history was not provided. No concomitant medications were reported. The reporter states, the patient took diphenhydramine and ibuprofen prior to thevaccinet due to an allergic reaction from a previous flu vaccine.  On 30-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot# Unknown).   On 31-Dec-2020, the patient experienced numbness on the left side of her face from the eyeball, high cheek bone down to the middle of her chin. No treatment information was reported.  As of  05-Jan 2021, the patient reported that the facial numbness had subsided, however, she was still experiencing a slight tingling. No treatment information was reported.   The Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, numbness on the left side of her face from the eyeball, high cheek bone down to the middle of her chin, was considered recovered/resolved.  The outcome for the event, slight tingling, was considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fatigue, nausea, anorexia. Headache, body aches, temp 99.5 to 100.2 orally, chills, started 4 hours after shot and worsened over the next 12 to 13 hours. The side effects feel the same as flu. Had the same symptoms with injection #1 a d had to miss work.
Gave 3rd dose of COVID vaccine and gave 0.3 mL bivalent
shot administered after the vial being punctured for over 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (shot administered after the vial being punctured for over 12 hours) 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.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (shot administered after the vial being punctured for over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (shot administered after the vial being punctured for over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
pt had an adverse rxn of tongue swelling & pruritus of tongue d/t flu vax;
Facial swelling; hives; This case was reported by a consumer and described the occurrence of facial swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling and hives. On an unknown date, the outcome of the facial swelling and hives were recovered/resolved.   It was unknown if the reporter considered the facial swelling and hives to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received dose of shingrix and experienced facial swelling and hives for over a year. The patient inquired would it be safe to have any of the Covid vaccines and were there any components of Shingrix that would be in the Covid vaccines. The information regarding consent to follow was not reported.
Information has been received from a registered nurse concerning a 11 year old female with peanut allergy who on 27-SEP-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 658178/1013U). On 21-AUG-2007, the patient was vaccinated subcutaneously in the left thigh with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck), a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA, lot # 62391BA, mfr. Sanofi Pasteur) "in the same thigh but many inches apart", a dose of GARDASIL vaccine (yeast) (lot # 0469U), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot# AC52B024AA, mfr. GSK) and hepatitis A virus vaccine (unspecified) (lot# AHAVB186AA, mfr. GSK). The registered nurse reported that within 20 minutes post vaccination the patient experienced an injection site reaction with redness 1 to 1.5 inches in diameter. The patient sought unspecified medical attention. No treatment required. There was no product quality complaint involved. Follow-up information was received on 05-SEP-2007. Follow-up information was received via a telephone call with a registered nurse who stated she did not know if the patient had recovered. Follow-up information was received on 13-SEP-2007. Follow-up information was received via a telephone call with a registered nurse who updated the varicella virus vaccine live (Oka/Merck) lot number (658178/1013U). Follow-up information was received on 25-SEP-2007 from a registered nurse concerning a 11-year-old (also reported as 12 years old) white female with a peanut allergy who on 27-SEP-1996 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) and her second subcutaneous 0.5 ml dose administered in her left thigh on 21-AUG-2007 (lot # 658178/1013U). There were no illnesses at the time of the report. Concomitant vaccines administered on 21-AUG-2007 (lot # 658178/1013U). There were no illnesses at the time of the report. Concomitant vaccines administered on 21-AUG-2007 included a first intramuscular dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) administered in her left thigh (lot # U2391BA), a first intramuscular dose of GARDASIL vaccine (yeast) (MSD) administered in her right thigh (lot # 0469U), a fifth intramuscular dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) administered in her right thigh (lot # AC52B024AA) and a first intramuscular dose of hepatitis A vaccine (inactive) (HAVRIX) administered in her right thigh (lot # AHAVB186AA). On 21-AUG-2007 (immediately following injection) the patient experienced an injection site reaction with redness 1 to 1.5 inches in diameter, knot in center of site, extreme pain at injection site, hard raised swollen area the size of a half dollar with total induration 6-8 inches in circumference. On 26-AUG-2007 the patient recovered from all adverse experiences. Additional information is not expected.
pt recv vax 16DEC98 & pt devel a macular papular rash w/a mild temp;
she experienced redness around her neck; got itchy; itchy eyes; itching on the head; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, PRURITUS, EYE PRURITUS, and PRURITUS in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TOPROL, LOSARTAN, LEVOTHYROXINE SODIUM, and LEXAPRO for an unknown indication.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA, PRURITUS, EYE PRURITUS, and PRURITUS. On 16-Mar-2021, ERYTHEMA had resolved. On 17-Mar-2021, PRURITUS, EYE PRURITUS, and PRURITUS had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment details reported.   This case was linked to MOD21-070112, MOD21-055367, US-MODERNATX, INC MOD-2021-068792.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: F/u received on 12 may 2021, reporter contact information updated. Sender's Comments:  MOD21-070112: MOD21-055367: US-MODERNATX, INC MOD-2021-068792.
Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored PEDVAXHIB (lot# M036058, expiry date: 19-MAY-2019) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000376: US-009507513-1703USA006087: US-009507513-1703USA006085.
Td vaccine administered 11/4/19. Patient called 11/7 to discuss ongoing pain. Reports sharp pain @ site to finger tips. F/U call to pt. on 11/11, reports inability to lift arm over head, pain still present.
The injection site on her left arm had developed a dollar coin size that is itchy with red bumps and felt hot.
Pt received vaccination after the manufacturer expiration date. Stability data from the manufacturer supported the stability and efficacy through 10/19/2022 therefore pt did not need to be notified or revaccinated.
Pt reported sensitivity, soreness, redness, and swelling at and around the injection site on her right deltiod. Symptoms appeared on the first day after vaccination, and have subsided significantly but are still present now 48 hours post vaccination.
pt given vaccine that had expired 12 hours prior, vaccine was refrigerated, no temperature excursions, manufacturer contacted.
Rigors x2 hours approximately 12 hrs after the vaccine; Low grade temp to 101 for 24 hrs post injection; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 24Mar2021 at 11:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. Concomitant medications included insulin (MANUFACTURER UNKNOWN), ethinylestradiol; norgestimate (ORTHO TRI-CYCLEN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date. The patient previously took AUGMENTIN for an unspecified indication and experienced allergy. The patient previously 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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 23:45, the patient experienced rigors for 2 hours approximately 12 hours after the vaccine and low-grade temp to 101 (units unspecified) for 24 hours post injection. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the events rigors for 2 hours approximately 12 hours after the vaccine and low-grade temp to 101 for 24 hours post injection were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FELT FAINT, LAID FLAT COOL PACK TO CHEST. STATES AFTER SHOT ALWAYS PASSES OUT. ANXIETY ISSUES PER MOM ALSO PASSED OUT WHEN IV INSERTED IN PAST, ABOUT 1 MTH AGO. FOLLOW UP PHONE CALL 4:45 PM 5-17-11, DOING WELL NO PROBLEMS.
Since injection (L) deltoid, pt experiencing shoulder/elbow pain. Treatment:now given Medrol dosepack
pain; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and VACCINATION SITE RASH (injection site rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (pain) and VACCINATION SITE RASH (injection site rash). At the time of the report, PAIN (pain) and VACCINATION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: follow up received on 08-feb-2021,Email address updated, 1st shot on 21-jan-2021 updated, batch no of drug updated , concomitant medication baby aspirin, vitamin d updated ,event rash from forage to forage of left arm site of injection on 7-feb-2021 updated On 09-Feb-2021: follow up recived on 9-feb-2021,Caller called to provide the correct date of vaccine administration which is 27Jan2021 instead of 21-jan-2021, On 21-Apr-2021: followup received on 21-apr-2021,Contact information updated
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. The patients were vaccinated with doses of improperly stored ROTATEQ with lot # L000568 (expired date 10-JUL-2106, oral, dose unknown) on 05-APR-2016, 03-MAY-2016, 04-MAY-2016 and 09-MAY-2016 and ROTATEQ with lot# L033693 (expired date 31-MAY-2017, oral, dose unknown) on unknown dates. The vaccine with lot # L000568 was exposed under 46.3 Fahrenheit (F) for 9 hours on 01-APR-2016, 46.5 F for 70 hours on 04-APR-2016 and 46.6 F for 56 hours on 11-APR-2016. The vaccine with lot# L033693 was exposed under 46.6 F for 144 hours on unknown dates. There was no previous excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 74 year old female patient with no known drug allergies, elevated blood pressure, hyperlipidemia, and a pacemaker who on 10/21/2004 was vaccinated with a dose of pnuemococcal 23v polysaccharide (lot 649694/0386P).  On 10/22/2004 the patient developed injection site soreness, redness, swelling and itching.  The symptoms began two to three hours post vaccination.  The nurse measured the clients arm from the injection site down to the end of the swelling which was 15 inches; but the actual swelling began 3 inches below the injection site.  The patient was treated with oral diphenhydramine (Benadryl), heat or ice pack, and acetaminophen (Tylenol).  It was reported that another female patient had a similar experience.  Additional information has been requested.
Red, swollen, itchy patch at injection site that happened about a week after injection.  On Saturday 1/16/2021 it was about the size of a quarter and Monday 1/18/2021 it is about the size of a silver dollar.  The swollen area is also hot to the touch.
Patient was seeking for new bivalent booster, given with patient's sign consent form on 10/6/2022. Found on the immunization registry that patient previously had the same vaccination given to him on 09/20/2022.
Started feeling fatigued at about 6:15pm. Developed a headache shortly thereafter, and a fever at about 8:30pm. Fever, headache, body aches, and nausea continued through the night. Finally started taking acetaminophen at about 2:30am. Symptoms lessened after that until acetaminophen dosage started to wear off. Continued with 2 more courses of acetaminophen. All symptoms resolved by about 8pm and use of acetaminophen was discontinued.
This spontaneous report was received from a Nurse practitioner referring to an unspecified number of patients of unknown ages and genders. No concurrent or medical condition was reported. On an unknown date the patients received improperly stored doses of (Oka/Merck) VARIVAX lot # L007225, expiration date: 22-OCT-2016, dose, route, frequency and anatomical location were not reported. No concomitant medication was reported. No adverse event was reported. No further information was provided. No product quality complaint reported. This is one of several cases received from the same source (MARRS numbers 1508USA005092, 1508USA005093). Additional information has been requested.