chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 03/03/22 at 1:15PM. Patient has not reported to Medical Clinic with symptoms at this time.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Janssen vaccine 3/22/21. Presented to ED Covid + c/b worsening gangrene of L foot. Recently d/c'd after hospitalization for osteomyelitis and dry gangrene of L foot. Admitted to ICU for severe sepsis c/b septic shock. Transfered to floor w/shock resolved, course c/b AHRF from mucous plugging, progressive weakness and cough. Failed nebulizer and chest PT s/p ICU transfer. Procedure was complicated by shock resulting in intubation. After extubation patient had worsening mentation and resp failure. Transitioned to DNR, expired on 9/29/22. Tx'd w/vancomycin, prednisone, and cefepime.
Onset of fever, approx 101-102 F; Lethargy in the evening; Tired.
SWEATS; CONGESTION; BLAZING HEADACHE; TEMPERATURE WAS 99.8; BODY ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced body aches. On 26-AUG-2021, the patient experienced sweats. On 26-AUG-2021, the patient experienced congestion. On 26-AUG-2021, the patient experienced blazing headache. On 26-AUG-2021, the patient experienced temperature was 99.8. Laboratory data included: Body temperature (NR: not provided) 99.8. The action taken with covid-19 vaccine was not applicable. The outcome of the sweats, body aches, blazing headache, congestion and temperature was 99.8 was not reported. This report was non-serious.
PATIENT CAME TO HEALTH DEPARTMENT FOR COLLEGE IMMUNIZATIONS. NERVOUS ABOUT SHOTS. DETERMINED NEEDED Tdap(FOR COLLEGE ENTRY), MENACTRA, AND GARDASIL (LAST 2 FOR COMPLETE IMMUNIZATIONS SERIES). EXPLAINED SIDE EFFECTS. TDAP GIVEN IN LEFT DELTOID AND GARDASIL GIVEN IMMEDIATELY AFTER IN LEFT UPPER ARM. PATIENT SAID THAT SHE DID NOT FEEL WELL, BECAME PALE AND FAINTED. LOWERED TO FLOOR FROM CHAIR. PALE, AND HAD WHAT APPEARED TO BE A SEIZURE. WITHIN SECONDS WAS TALKING BUT COMPLAINED OF BEING WARM. B/P 72/59 PULSE 84/MIN,NEVER STOPPED BREATHING. 911 CALLED AND RESPONDED B/P INCREASED AND PATIENT SITTING IN CHAIR AND SAYS FEELS BETTER. SHE SIGNED THAT SHE DIDN'T WANT TO GO TO ER AND THEY LEFT. WITHIN ABOUT 4 MINUTES SHE FAINTED AGAIN. LOWERED TO FLOOR AND PATIENT WAS TALKING BUT LETHARGIC. B/P WAS 112/ FIRST RESPONDERS RETURNED AND SITTING IN CHAIR B/P 108/ DRINKING SOME JUICE AND TALKING WITH 1ST RESPONDERS. AFTER APPROX 5 MINUTES WHILE FIRST RESPONDERS WERE STILL HERE SHE FAINTED AGAIN AND APPEARED TO HAVE A SEIZURE. FIRST RESPONDERS LOWERED HER TO FLOOR AND WITHIN SECONDS AGAIN SHE WAS RESPONDING AND TALKING. DECISION TO TRANSPORT TO ER.  7/24/09 ER records received DOS 7/17/09. Final Diagnosis: Vasovagal syncope. Patient reports receiving 2 shots today and passing out before receiving the 3rd. Total of 3 episodes syncope. Anxious. Presents for evaluation of syncope.  ICD-9 Codes: 780.2
TWO STROKES; This spontaneous report received from a patient via social media  concerned a patient of unspecified age, sex, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced two strokes and felt that people only told the good stuff and no one told the bad stuff. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) no covid (negative). The action taken with covid-19 vaccine  was not applicable. The outcome of two strokes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210950516.; Sender's Comments: V0-20210951067-Covid-19 vaccine - Two Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Information has been received from a registered nurse concerning unknown number of patients who on an unknown dates were vaccinated with doses of ROTATEQ (doses, routes and lot number not reported) which were stored at lower than recommended temperatures on multiple occasions. No adverse effect reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number and date of event.
After 1st shot; Patient developed multiple blood clots (lungs and legs) about 10-11 days afterwards. All tests for cause of clots were inconclusive.   Patient received his second dose and with in 48 hours was hospitalized for appendicitis.   If it was a reaction after just one shot, I would normally think it was a coincidence. With him have severe reactions after both shots, it seems very suspicious!
This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (I was totally deaf in one ear) in a  patient of an unknown age and gender 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 04-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOACUSIS (had mild hearing loss in the other) and HYPOACUSIS (problems with my hearing). On 07-Apr-2021, the patient experienced DEAFNESS UNILATERAL (I was totally deaf in one ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (I was totally deaf in one ear), HYPOACUSIS (had mild hearing loss in the other) and HYPOACUSIS (problems with my hearing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication was reported. SD narrative:  I received my second Moderna shot on April 4th.  By April 6th I was having problems with my hearing.  By April 7th I was totally deaf in one ear and had mild hearing loss in the other.  Went to a ENT and" No Treatment was reported. Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events seriousness per IME list; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events seriousness per IME list
Feeling fine. About 9 PM arm started to really really hurt and she cannot move her arm. About 12 Midnight, she started profusely sweating and she couldn't see well, as if there was a black laced curtain in front of her and couldn't see well. Fee were sweaty, whole body was soaking wet w/sweat, went to deck got air, iced arms. Couldn't sleep all night long, real week and shaky, next day feels exhausted but can see better, arm not quite as sore. Recovering as of reporting time. Pt has hx of autoimmune disorder, lichen pleura.
Extreme headaches, dull pain and dizziness frequently. Limited vision and hearing during dizzy spells along with black vision spots - POTS  Gastro problems - cramping, inability to go to the bathroom, bloating, mood swings  PCOS - Hormone dysregulation, low progesterone Major food sensitivities to common foods  Sleep and energy probelms  - low energy and difficulty sleeping  Hair loss  Painful periods with extreme cramping, bloating, flow and headaches  Hypoglycemia - Blood sugar dysregulation   Leaky Gut and endotoxins  Candida/Mycoplasma bacteria/Protazoa/Hyplori  Inflammation with endotoxins  Small and Large Intenstine Stress Expoure to shedding  Toxicity from being backed up  Hair loss/Intestinal Inflamation/SIBO/Hormone Dysregulation
Red welt like covering the entire right deltoid, no report of pain or fever, seems like cosmetic only per patient. It is subsiding gradually.
fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In July 2019, less than a month after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The batch number of Shingrix was reported as 465HX, which was corrected to 4G5HX as per sales data sheet.  After 1st Shingrix dose, the patient had fever of 103 degree F for 2 days.  The reporter consented to follow up.
slight discoloration of the skin on the upper thigh like a birthmark; child will need cosmetic surgery due to the event; skin started to dimple and became a concave area; doctor stated the vaccine was given in the fatty tissue in error; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old female patient who experienced slight discoloration of the skin on the upper thigh like a birthmark (Skin discolouration) and will need cosmetic surgery due to the event (Skin cosmetic procedure), skin started to dimple and became a concave area (Skin reaction), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 25-Nov-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AAA via unknown route in unknown administration site for prophylactic vaccination .  On an unknown date, The patient developed a non-serious slight discoloration of the skin on the upper thigh like a birthmark (skin discolouration) and skin started to dimple and became a concave area (skin reaction) 1week following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient will need cosmetic surgery due to the event (skin cosmetic procedure).   The patient developed a non-serious doctor stated the vaccine was given in the fatty tissue in error (vaccination error) <<Unknown latency>> following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was also of actual medication error due to vaccination error. Doctor stated the vaccine was given in the fatty tissue in error.  No lab test reported.  Final diagnosis was skin discolouration, skin reaction, skin cosmetic procedure.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported.  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.
Within 15-18 minutes  minutes of receiving dose experienced : scratchy throat, then coughing, tongue swelling, lips numb, and bilateral  itching of ears.
pt w/approx 1 min began to turn pale; body & limbs jerking; sweating profusely; pulse 76; lip purple; pt immed laid on floor applied ammonia salts & wet towels to face & neck;
Flu; Initial information received on 02-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of an unknown age and gender who experienced flu after receiving vaccine influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Saturday 313 am, chills, 400am extreme sweats ended by 630am - 718am unable to breathe, It felt like right lung collapsed. I was able to pull up breath, however light chest pain persists at this time, 12;12pm.
Swelling and soreness at injection site, stiffness in shoulder and neck of same side as injection.
Bad headache/migraine 3rd day, generally feeling bad from 3rd thru 5th day
the sinus pressure started the 1st two days then this week about 10 days after vaccine the symptoms were getting worst saw my GP and was told i had an ear infection and given 2 antibiotics. ear drops which i have started to take  and Zithromax but have not used it yet.
BLOOD SUGAR INCREASE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced blood sugar increase. Laboratory data (dates unspecified) included: Blood glucose increased (NR: not provided) more than 400. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar increase was not reported. This report was non-serious.
Extreme muscle aches; fever; chills; headache; vomiting; This is a spontaneous report from a contactable healthcare professional reporting for herself.  A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 29Jan2021 17:15 (at the age of 42-years-old) at single dose for COVID-19 immunization in the workplace clinic. Medical history included endometriosis, acid reflux, and history of blood clots. The patient had no known allergies. The patient was not pregnant. The patient did not have COVID prior to vaccination. Concomitant medication included methyldopa hydrochloride (ALDOMET [METHYLDOPA HYDROCHLORIDE]), omeprazole (PROTONIX [OMEPRAZOLE]), probiotics (PROBIOTICS), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and vitamins. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the left arm on 08Jan2021 at 06:15 PM (at the age of 42-years-old) for COVID-19 immunization. The patient did not receive other vaccines in four weeks. The patient experienced extreme muscle aches, fever, chills, headache, vomiting on 30Jan2021 at 11:00 AM. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The outcome of the events was recovered in Jan2021. Information on the Lot/Batch number has been requested.
I can't carry anything with that left arm; Persistent itching in that injection site arm; Nausea; Arm was sore that day at the injection site; Left upper arm pain; felt very weak/ wanted to lay down all the time; heartburn/burning in my stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), DYSPEPSIA (heartburn/burning in my stomach), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm) and VACCINATION SITE PRURITUS (Persistent itching in that injection site arm) in a 44-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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), DYSPEPSIA (heartburn/burning in my stomach), VACCINATION SITE PRURITUS (Persistent itching in that injection site arm), NAUSEA (Nausea) and VACCINATION SITE PAIN (Arm was sore that day at the injection site). On 23-Jul-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm). On 22-May-2021, PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), VACCINATION SITE PRURITUS (Persistent itching in that injection site arm) and VACCINATION SITE PAIN (Arm was sore that day at the injection site) had resolved. At the time of the report, DYSPEPSIA (heartburn/burning in my stomach), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm) and NAUSEA (Nausea) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.    This case was linked to MOD-2021-265816 (Patient Link).
R Arm: Heaviness, itching, localized swelling.  Tx: Hydrocortisone Cream TID.
cold sore; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed a cold sore immediately after getting first Shingrix vaccine. The reporter consented to follow up.
Vasovagal reaction of c/o dizziness with nausea. bradycardia, hypotension. color pallor. Vital signs- 126/66  P-51 R-20 Temp 98.3 reaction subsided within 30 minutes. intervention required observation of s/s
1hr p/vax pt devel 3 episodes of migraine h/a sx;sx included jagged lines in vision & no peripheral vision, & waves of numbness started in hands & going through to feet;pt has hx of migraines;
Localized raised, reddened area. Warm and tender to touch. Took Benadryl-did not remedy the area but no worse. No systemic reaction. No further swelling of arm  I have reacted this way to previous vaccines (tetanus being worse than this one. ----
Narrative: Symptoms:  & INJ SITE SWOLLEN RED , HOT TO ELBOW Treatment:  METHYLPREDNISOLONE DOSPAK MG Unknown
I'm not sure what the specific flu vaccine was but I received it and within about 24 hours I was in extraordinary pain. I wasn't able to even pick up my infant daughter. This went on for about 3 to 4 months. It was excruciating and I would've much rather had the flu then the reaction that I had from that flu shot. I contacted the pharmacy, and they just told me to go to my doctor. I didn't see the point since my doctor wouldn't have any kind of solution for me. I just had to wait it out. When I went online, I discovered that other people had the exact same reaction. And it took anywhere from 4 to 12 months to get over. For me, it was probably a good six months before everything was out of my system.