chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported vomiting and low blood pressure approximately after receiving the flu vaccine. Managed at home.
Night of chills, headache which resolved in 24 hours.  Starting April 11 through April 21, nausea, diarrhea, severe headache, severe vertigo and postural hypotension. I am a physical therapist with my single little clinic and I had to close for 2 week bc of symptoms. Self treated vertigo but would come back within an hour.
with both shots (But worse with this one)  got soreness at the site of injection,   body aches, headache, flushed, red  skin on face (hot to the touch) tiredness and feeling chilled.
headache; congestion; really bad allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. 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: HEADACHE (non-serious), outcome "unknown", described as "headache"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "really bad allergies".  Additional information: The patient had been having really bad allergies for the past 3 days, along with constant headache and congestion. The patient wanted to know if he should wait to receive second dose or if it would be okay to get the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was administered the Anthrax Vaccine the on 2 October 2006 due to the fact I was assigned to a foreign country.  Within 48 hours of receiving the first Anthrax vaccine dose of the series I began experiencing episodes of severe strong and rapid heart beats. This typically happened at night while I was trying to sleep.  Each episode would last for about 10 minutes at a time.  This continued for several months after I received the vaccine.  On 4 May 07 I saw MD about what was happening and he submitted a permanent exemption for me not to receive anymore Anthrax vaccine.  Although the cardiac symptoms I was having caused me the most concern, at the same time I began to experience fatigue and body aches.  These symptoms continued and became progressively more severe.  In March 2009 I was diagnosed with Systemic Lupus (S.L.E.) which I strongly suspect was a result of my receiving the Anthrax vaccine on 2 October 2006. 7/16/09 Brief report with Dx: Systemic Lupus Erythematosus.  No further records available as care was received out of the country.
Congestion 3/9. Fever 101F 3/11. Presently no fever.
First, I take several more Rx than space available to tell you. My reaction occurred 3 days after the injection. I had a fine all over body rash. It was quite red. Did not itch. Took 3 days to resolve; This is a spontaneous report from a contactable consumer(patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7533), via an unspecified route of administration on 31Mar2021 at 18:15(at the age of 61-years-old) administered in Arm Right as a single dose for COVID-19 immunisation at at Pharmacy or Drug Store. Medical history included HBP, a fib, 5yr s/p breast cancer, pituitary adenoma benign; allergies to Adhesive, contrast dye (all from an unknown date and unknown if ongoing). Concomitant medication(s) included bupropion; metformin; lamotrigine; modafinil; citalopram hydrobromide (PRAM) taken for an unspecified indication, start and stop date were not reported. The patient was not Pregnant at the time of vaccination. On 03Apr2021 at 15:30, it was reported that My reaction occurred 3 days after the injection. I had a fine all over body rash. It was quite red. Did not itch. Took 3 days to resolve. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Therapeutic measures were taken as a result of event and took 10 mg Zyrtec per day after the first day of the rash. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Shingles rash on mid back, left side of body, treated with valacylovir
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    Pharmacy intern reported that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information was available.  No concomitant medication reported. No treatment medication reported.  This case pertains to the 4th of the total 40 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
Swelling of (L) hand, urticaria and faint rash on (L) hand approximately 2 hr post vaccination. Urticaria and rash resolved with po BENADRYL-2 doses. Swelling initially improved but has returned.
After being vaccinated, he was crying a lot for almost 2 hrs. He developed fever, started vomiting, and  his left leg was swollen like a potato, from thigh down the leg. He was taken to the ED and  were informed that he had an "allergic reaction" more than expected.  REVIEW-> He was seen at ED on 8/13. Found to have left more than right thigh swelling, status post getting his 2-month vaccine today. No change in breathing and no body rash. On PE, vitals were normal. Mild localized swelling around the vaccination site on both thighs. Assessment was "No concern for allergic reaction, as expected post vaccine reaction," and discharged. In addition, there is a discrepancy in the chart in terms of where the vaccines were administered.   On chart review- received PCV and Td/HIB/IPV L thigh, R thigh HBV. However, parents recall and provide photos for me to review which demonstrate that he received 2 vaccines on his right thigh and 1 vaccine on his left.  Discrepancy in chart vs parent report regarding which vaccines were received in which thigh, however given that this was likely a site reaction and not an allergic reaction, largely reassured parents and will follow up regarding discrepancy of documentation of 2mo vaccines.
At 09pm experienced a severe fever. (the type i experienced with Sepsis) No other symptoms.   It was a debilitating fever with chills and severe shaking.  I took acetaminophen with some crackers and plenty of water at 10pm.  Fever broke by 01am.  I followed with a more water and ibuprofen and fell asleep around 02am.   Following morning, I feel pretty good, slightly tired but other wise normal.   I have had no gastrointestinal or noticeable issues before or following.      The episode was near the point of going to ER.   It was something utterly unexpected and I've never experienced a fever with no cause.
administration of an adult Engerix-B dose to a 9 year-old female patient; administration of an adult Engerix-B dose to a 9 year-old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old female patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23-NOV-2023) for prophylaxis.   On 18-JUL-2023, the patient received Engerix B adult. On 18-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administration of an adult Engerix-B dose to a 9 year-old female patient) and adult product administered to child (Verbatim: administration of an adult Engerix-B dose to a 9 year-old female patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter called to report the administration of an adult Engerix-B dose to a 9-year-old female patient.  The reporter asked for safety information and recommendations on this situation. The reporter consented to follow up. The reporter called to report the administration of an adult Engerix-B dose to a 9 year-old female patient, which led to overdose and adult product administered to child.
Thyroid is out of control (thyroid number is fine but the marker for Hashimoto?s is the highest it?s ever been) Never had a flare or issues with RA, after the second shot had a massive flare up and have a positive Rheumatoid Factor now.  Neither were issues before the vaccine and no major lifestyle changes.
Later in evening 6/18/13 - Red rash increased up (RT) side (thigh), warm to touch, itching at site. Mildly pink erythematous on day ie exam 6/20/13.
had the flu for 2 weeks now; Initial information received on 11-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age male patient who had the flu for 2 weeks now after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for flu vaccination  On an unknown date the patient developed a non-serious event of has had the flu for 2 weeks now (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, My husband got his flu shot and has had the flu for 2 weeks now. I've never had a flu shot and have never had the flu. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is 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 (has had the flu for 2 weeks now).  At time of reporting, the outcome was Unknown for the event.
RECOMENDED AGE FOR FIRST ADMINISTRATION IS  12 MONTHS, PT RECEIVED DOSE AT 3 MONTHS OF AGE
went limp-blue around mouth; breathing funny sz; no temp-vomiting; 2 hrs p/brain swelling-from vax;
generalized maculopapular(>50) located over the neck/waist/B UE/B LE that developed 2 days after receiving the anthrax(#5) and smallpox vaccines, prescribed benadryl 50mg IM today, atarax 25mg q6h or hs prn, zantac 150mg bid, loratadine 10mg qam, and prednisone 60mg taper over 9 days.
Swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included nickel sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications and did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 18:00, the patient experienced swollen lymph node in left armpit. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for swollen lymph node in left armpit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node in left armpit was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling and redness of upper left arm extending to inside arm and down approximately 6 inches from injection site.  Resembling fluid under the skin around margins of redness.  Physician recommended one week treatment of Zyrtec and Tylenol or Ibuprofen.
Shoulder pain; This is a spontaneous report from a contactable consumer. A 85years male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Right on 08Feb2021 10:30 (Batch/Lot Number: EL9265) as single dose, dose 2 intramuscular, administered in Deltoid Left on 08Mar2021 10:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization.The patient Medical history included blood pressure measurement, blood cholesterol, urinary incontinence, benign prostatic hyperplasia, hypothyroidism. (All ongoing). The Concomitant medications included irbesartan (IRBESARTAN, formulation: Tablet) taken 150 mg for blood pressure measurement, start and stop date were not reported; lovastatin (LOVASTATIN, formulation: Tablet) taken 20 Mg for cholesterol, start and stop date were not reported; oxybutyn-in chloride (OXYBUTYNIN CHLORIDE, formulation: Tablet) taken 15 mg for Bladder control, start and stop date were not reported; doxazosin (DOXAZOSIN, formulation: Tablet) taken 2mg  for benign prostatic hyperplasia, start and stop date were not reported; levothyroxine (LEVOTHYROXINE, formulation: Tablet) taken 50 Mg for thyroid, start and stop date were not reported.  It was re-ported that Scheduled for second dose more than 21 days. The patient wanted to know it was okay that the 2nd dose is scheduled 08Mar, 4 weeks after the 1st dose. He enquired to whom he should talk to about getting his appointment changed. The patient took the second vaccination on 08Mar2021 on the left shoulder. Both vaccination shoulder pain after 8 hrs. No treatment was provided for the event. The outcome of the event was recovered by morning after injection on unspecified date.  No follow-up attempts are needed. No further information is expected.
Menstrual cycle changed from regular 5 day periods to 15 day periods.  No other changes to medications.
Patient has presented with a swollen left supraclavicular lymph node measuring in 1 cm several days after flu shot. Dr unsure if related.
Woke up the next morning with shivering and 99.7 fever, headache. Left armpit swollen, possibly lymph nodes. Fever reached 103.5 by afternoon. I contacted my primary care who recommended Tylenol and Ibuprofen plus fluids. Fever lessened by night, swollen armpit and headache continues
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBICAX HB (which has the lot number of L044707, expiration date 06-OCT-2018, L0044917, expiration date 05-OCT-2018 (dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Numbness in the legs Numbness in the hands Pain in the left and right arms Pain in the arms with difficulty in using them. Extreme pain in the lower and central back, asphyxia 5, demyelinating lesions in my head, Fatigue Extreme, tiredness, High blood pressure, Sleep problems. Fluid in the lungs, Pain throughout the body, Burning on the skin, with just a touch Sensitivity to temperatures, Pain in the fingernails, Dizziness, De-concentration, Numbness on the left side of the face.
Approx 8 hours after the shot, 12:30am, I started to have chills.  The chills prevented me from sleeping well.  Also when I laid down for the night, I was accutely aware of my heartbeat, which according to my smartwatch was beating at a rate of 71.  The next morning, I still was experiencing chills, and felt achy/stiff/sore muscles - possibly from tensing up and  shivering all night.  Pain at the injection shot also started the morning after the shot.  By bedtime the day after the shot, the symptoms had eased up.  The next morning the symptoms were gone, except for a little residual injection site discomfort.
I have red itchy spots that are raised on the back of my calf; I have red itchy spots that are raised on the back of my calf; I have red itchy spots that are raised on the back of my calf; This is a spontaneous report from a contactable consumer (patient).  An unspecified age and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unknown date as 2nd dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an 07May2021 as 1st dose, single dose for COVID-19 immunisation and experienced nausea, had no appetite, little bit tired, little red welt, started developing little red welt or greyish circular spot-on patient neck and on the back of patient calf on patient right leg, it was very itchy and red and grey. It was reported that the patient went on last Friday to have second vaccination done and it was the same as the first dose has now (at the time of reporting) worst, Patient had red itchy spots that are raised on the back of the calf and did not know what to do about it, patient did not know what to put on it and need somebody to tell what to put on it. The reporter did not specify the seriousness. The outcome of event was unknown.  Information about lot/batch number has been requested.
Pt. was accidentally given varicella immunization instead of PENTACEL immunization. Pt. has had no ill effects from varicella immunization.
I had regular bowel movements-each morning-normal consistency until I had the H1N1. Now, I have bowel movements, about 3 or more per morning from 7AM to 10AM. It is incredibly difficult to do anything before 10AM unless it is on the occassional day when I am not realy suffering from the symptoms. I had a colonoscopy yesterday. The doctor said it showed redness likely from and infection. I am awaiting test results, but no growths seen.
Patient was scheduled to receive Regeneron Infusion for COVID diagnosis. Upon initiation of the infusion patient was anxious, however during the infusion patient's blood pressure elevated to 236/113 and patient stated "I feel like there is a tight band aroudn my waist and it keeps getting tighter."
196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No Concomitant medications were provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine  No treatment medications were provided..   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received, updated I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
SORE THROAT, FATIGUE AND DIZINESS AND COUGHING. I went to the urgent care and they ran blood work and TCR and X-ray. The doctors said I had Covid ammonia and they gave me a couple of medicines and antibiotics. I was nauseaus and achy and the doctor told me that I can't take the second dose
(L) arm redness and swelling below vaccine site. Redness on chest and face, mild dyspnea. Elevated temp, no fever.
accidentally administered the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (accidentally administered the booster dose) 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 19-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (accidentally administered the booster dose). On 19-Jan-2022, ACCIDENTAL UNDERDOSE (accidentally administered the booster dose) had resolved.            Concomitant drugs were not reported. Treatment details were not reported. Reporter states that patient came in for 2nd dose of Moderna and they accidentally administered the booster dose.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), on Mar 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), single dose, for COVID-19 immunisation. The patient had a slight headache, onset Mar 11, 2021, with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.