chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
After about 8 hours after the injection, I began to experience slight muscle pain at the injection site. About 1-2 hours after, I began to fever and experience a migraine and intense body aches. During my night, my fever went as high as 102.8F, at which point I took some Tylenol. My fever stayed above 102F for the next 12 hours or so, after which the fever went hovered between 100-101F. The migraines and body aches also persist.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient has history of fainting when given shots, getting blood taken, or being at a doctors office/eye doctor. Patient fainted after getting her second dose of pfizer. She fainted sitting down during monitoring pd and mom said it was normal and was going to wait until felt better. I took her blood pressure and it was at 104/69. She refused any food/candy. However, she fainted again within 10 minutes so 911 was called and taken to the emergency room since she hit her head on the chair.
I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 03May2021 at 14:30 (at the age of 48-years) as 2nd dose, single dose in the left arm for covid-19 immunisation. The patient medical history included chronic lymphocytic leukaemia. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included rivaroxaban (XARELTO). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route on Apr2021 at 14:30 as 1st dose, single dose in the left arm for covid-19 immunisation. On 28May2021, the patient experienced facial numbness and Paralysis. As per doctor it's bell's Palsy. The patient received treatment for events with prednisone and valacyclovir. The patient visited physician office. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is requested.
Mom described this: started at 2:15pm on 06/24/02. Child stiffened up extremities, curled toes up, abdomen turned blue and then legs were blue. No fever but warm to touch. Screamed/cried. Mom called doctor and told to stop FE+ and take child to ER. Seen at ER 3:30pm by ambulance-was asleep and pickup. At ER-child normal. Sent home. No subsequent events.
Hives all over his body where his lymph node is located for the last couple of days; arm pits and groin area were not feeling great; arm pits and groin area were not feeling great; Muscle cramps; Headache; Has been in bed; terrible pain in both feet; This is a spontaneous report from a contactable Consumer or other non-HCP (mother of patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 08Aug2021 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced terrible pain in both feet on an unspecified date in Aug2021, muscle cramps and headache on 09Aug2021, arm pits and groin area were not feeling great on 12Aug2021 and hives all over his body where his lymph node is located for the last couple of days on 13Aug2021. The patient had been in bed since Monday 09Aug2021. The clinical details of the events as follows: Caller stated her son who is 26 years old got first Pfizer Covid vaccine on Sunday, 08Aug2021 and has big hives near all lymph node areas of his body, and complaining of terrible pain to both his feet, he was also having other side effects and wanted to know if this was normal after the vaccine, knows they said that the major side effects would occur within 24 hours of the vaccine. Caller stated the patient noticed yesterday, 12Aug2021 his arm pits and groin area were not feeling great, noticed the hives today. Got the vaccine at Walgreens and stated her son has been in bed since Monday, stated he has had a headache and muscle cramps since Monday, 09Aug2021. Unknown anatomical location of injection stated she assumes it was on the left side since he is right-handed. Caller wanted to know if these are side effects reported after taking the Pfizer Covid vaccine and also asked how long these side effects supposed to last: response: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days. There was no Investigation Assessment provided. The patient outcome of the events hives near all the lymph node areas on the body, terrible pain in both feet, Headache and Muscle cramps was not resolved and the outcome of the other events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax, the pt developed an itching rash on hair line and arm. She was treated with calamine lotion. Symptoms resolved after two weeks.
1/18/2013: stomach ache, eye pain, lesions on left arm, lesions in mouth. 1/20/13: eye drainage, swelling. 01/21/13 taken to ER given Rx Acyclovir, Z-pak; 01/22/13 condition worsened unable to swallow, taken to Hospital ER. Admitted to PICU. Hospitalized for 15 days (11 ICU; 4 ward). PICC line, IV TPN. Dx: Stevens Johnson Syndrome.
5-6 cm area of induration with erythema around vaccine site 8 days after vaccine improved. Pt developed about 10-12 erythematous papular lesions on face, RUE, torso and right leg, no vesicles no pustules.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was given as a treatment for Covid-19 from 21Jul2022 to 25Jul2022. Patient does not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
hallucinations; left sided temporal seizures; fevers; This is a spontaneous report received from a contactable other-HCP. A 66 years old male patient  received BNT162B2 (lot number unknown) at single dose for COVID-19 immunisation on unknow date. Relevant medical history included: Type I Diabetes, CKD III (Chronic kidney disease stage 3), Hypertension and Heart failure.   Relevant concomitant drug was unknown. Patient reported of fevers since 22May2021 two days after the vaccine. Two weeks later he reported to have hallucinations per son and also left sided temporal seizures, both since 22May2021. The patient was independent and living alone before this episode. Antiepileptic medication was received as treatment.  The patient was hospitalized due to the events. The outcome of event was resolving. The patient had Covid-19 NAAT (Nasal swab) test on 22May2021 with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on temporal association and profile of the product, the events were considered related to suspect product BNT162B2 (lot number unknown).
Patient developed redness/swelling in left arm within 24 hours of administration, swelling has extended to left wrist.  No systemic symptoms.  Patient provided NSAID and topical steroid therapy.
Vomiting; Abdominal pain; Headache; Aches; Fever; Dizzy.
Rash, pruritic: neck and upper back. Rash began day of flu shot (9-8-16). Went away after 1 wk.
fever day of shots- temp never taken- week later coughing- still has cough- lots of phlegm- almost vomited, but did not- did not go to MD- still has not gone to MD- I encouraged client's mother to go to MD
pt. had dizziness , emesis x 1.  Denies headche difficulty breathing and itching.  pt. was given water to drink.  VS Bp 105/69, P 70; R-18, O2Sat 98%.  pt. symptoms got resolved after 10 mins.  Drove self home from observation area in no distress.   advised pt. to reach out to PCP if symptoms re-occurs.
almost immediate sore throat.   next day fever, nauseous, sore at injection site., and tiredness.     I took two OTC Tylenol and DayQuil and went to sleep for three hours.    I was back to normal within four hours after feeling ill.  The sore throat lasted through the second day.
28JAN94 mom in clinic & informed us that pt had react to DTAP given in JULY93; mom states w/in 1 hr of inject of vax pt had fever & was very lethargic; pt was taken to hosp; throat infect
Reports usual administration site pain but on third day post vaccine developed bone pain in arm at elbow and shoulder. Pain increases with position change of arm or with increased movement of arm. Has not declined with time.
pt recv vax 16JUN97 & 25JUN97 pt exp rash on lower extremities consisting of approx 15 painful, bruised lesions, diffuse arthralgias in both wrists & neck & erythema nodosum;A MD other than the reporting MD conducted mult blood tests;
1st fever x 2 days (fever max 102), WBC;s 32.3, bands 10, mono 17 crp 19.5 from 10/26/07, 2nd shots given 1/11/07. Fever started 1/11/07 at 1600, fever max 102 WBC's 33.5.
DTaP given on 4/27/04. Patient's mother called 4/29/04 stating patient had a cyanotic episode with a possible seizure. Seizure work up done on patient. Patient placed on seizure medication and placed on apnea monitor.  Nurse follow up on 07/20/04 states: "Complete."
This spontaneous report as received from a pharmacist refers to a 67 year old male patient with no pertinent medical history or drug reactions/allergies. On 21-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, (lot number of K007985, exp. date 03-SEP-2015) subcutaneous. No concomitant therapies were reported. On 23-OCT-2014 (two days after vaccination), the patient experienced the injection site was red and swollen, and he was "feeling tired". She reported that the patient was at his doctor's office for "routine blood work". The pharmacist stated that the patient reported to her that diagnostics studies were performed. The outcome was reported as recovering/resolving. Additional information has been requested.
Started as a grapefruit sized swollen, red, hot, hard, itchy welt-started taking benadryl-continued to get worse and spread Switched to ibuprofen and ice-reduced swelling, hardness hotness. 1/27/21 - Woke up to a very large welt, approximately a melon size.  Red, itching, warm.  Went to urgent care and they prescribed an antibiotic and steroids. 1/29/21-Still same size, but now purple splotchieness.
Pt reported a very red warm arm after getting the flu shot and PNEUMOVAX 23 shot both in her Left deltoid the previous day. Pharmacist on 10/21 told her to take Benadryl and advil and go to urgent care on 10/22 in the morning if it was still red and and warm.
dramatic arm pain; stiffness; Headache; chills; fatigue; jaw tension; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Feb2021 at 08:30 hours as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine in four weeks. Concomitant medication(s) in two weeks included rizatriptan taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19, post vaccination. On 09Feb2021 at 11:45 hours, patient had dramatic arm pain, stiffness, headache, chills, fatigue and jaw tension. Patient received no treatment for all the events. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been rec'd concerning a pt who was vaccinated with hepatitis B vaccine recombinant. It was noted that the pt  serocoverted, but then had a waning titer. No other info was provided. Additional information has been requested.
Initial report received from healthcare professional on 31 July 2014. A female patient had received a dose of FLUZONE ID (batch number, dose in series, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the vaccine, the patient developed major swelling in arm and armpit after injection. The patient's corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from health care professional on 08 September 2014. A 49-year-old female patient had received a dose of FLUZONE ID on 30 September 2011 at 4.53 pm. Patient had received minocycline (100 mg daily) as a concomitant medication on an unknown date. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical condition was reported as none. It was reported that patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 01 October 2014 i.e. one day after vaccination patient had experienced major swelling in arm and armpit after injection. It was reported that swelling began within first 12 hours and continued for 24 hours then slowly improved for next 3 days. No laboratory investigations were done. On an unspecified date patient outcome was recovered.
PT stated her heart felt like it was racing, hot, tingly, and lightheaded. Moved PT to the floor and monitored vitals with initial BP of 180/80, HR 115, RR 12, SpO299% Continued to monitor PT as BP returned to normal and PT felt better.
Pt was inadvertently given a vaccine that was 2 days beyond it's expiration date. Patient's mother was informed. Patient had no signs or symptoms of a adverse reaction.
Was given a full dose 0.5mL instead of 0.25mL as a booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Was given a full dose 0.5mL instead of 0.25mL as a booster) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Was given a full dose 0.5mL instead of 0.25mL as a booster). On 17-Dec-2021, ACCIDENTAL OVERDOSE (Was given a full dose 0.5mL instead of 0.25mL as a booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
vaccine given on 10/25/2021, vaccine expiration on 10/1/2021. Patient has experienced no adverse reactions.
Screaming began approx 4-5 hrs p/vax & screaming became uncontrolled & lasted about 5 hrs; had sl fever; APAP given; called MD & was instructed to watch pt; was fussier than usual next day; @ next immun MD stated no DTP;
Pt received H1N1 in L deltoid at public clinic Saturday Dec 5, 2009. He noticed on December 7, 2009 generalized edema L arm (LUE). No erythema or adenopathy in the axillary cervical or upper extremities. Good circulatory perfusion. Bowel and kidney fxn. No medication changes. Normal appetite. Consistent sleeping posture. Mentally alert. Impression: Apparent post Imm. Reaction. Tx: observe closely and notify if any changes. Expect diminution of swelling and return if no better in one week.
The area felt a little bit hard; developed a rash around the injection site; red; itchy; warm; a little bit of a sore arm day of and after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (a little bit of a sore arm day of and after the shot), VACCINATION SITE INDURATION (The area felt a little bit hard), VACCINATION SITE RASH (developed a rash around the injection site) and VACCINATION SITE ERYTHEMA (red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy (Allergy to IVP dye.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm day of and after the shot). On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (The area felt a little bit hard), VACCINATION SITE RASH (developed a rash around the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at a dose of 1 dosage form. On 13-Jan-2021, PAIN IN EXTREMITY (a little bit of a sore arm day of and after the shot) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (The area felt a little bit hard), VACCINATION SITE RASH (developed a rash around the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that after 25JAN2021 the injection site got lighter and lighter until it faded away  No concomitant medication was provided.  Treatment included applying  ice pack for 20 minutes.   This case was linked to MOD-2021-022231 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up updated with reporter's email. On 09-May-2021: Follow up contains No new information. On 07-Jul-2021: Follow up received on 07-JUL-2021 included  no new information..
This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, several days after receiving SHINGRIX, the patient experienced tingling and appetite lost. On 23rd August 2018, the patient experienced headache and sinus headache. On 24th August 2018, the patient experienced taste metallic, numbness oral, swollen mouth, fever, facial flushing and fatigue. The patient was treated with ibuprofen. On an unknown date, the outcome of the headache, fatigue, sinus headache, tingling and appetite lost were unknown and the outcome of the taste metallic, numbness oral, swollen mouth, fever and facial flushing were recovered/resolved. It was unknown if the reporter considered the headache, taste metallic, numbness oral, swollen mouth, fever, facial flushing, fatigue, sinus headache, tingling and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she experienced headache which started on the first day post vaccination. On the second day, the patient experienced metallic taste in the mouth, numbness and swelling in the mouth, fever, flushing of the face, and fatigue. Later at night, the patient visited the emergency room and kept there for couple hours, monitored and then discharged. The patient was mentioned that she took an ibuprofen before going in to the emergency room. Couple days later, the patient noticed that she had loss of appetite. Approximately about three days ago from the date of reporting, the patient had tingling on the left side of the face and the neck in the evening. The patient had recovered from everything except fatigue and loss of appetite. The patient had a sinus headache on the left side on the date of reporting.
A pharmacist reported that a subject of unspecified age and gender became hepatitis B positive prior to completing the hepatitis B vaccine recombinant (Engerix B) immunization series. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date, the subject received an injection of Engerix-B; the number of previous injections of Engerix B was not reported. Prior to completing the immunization series, the subject became hepatitis B positive. The subject was hospitalized. As of 11/7/02, the event persisted.
Injection site turned black and blue. Arm was swollen and Wednesday 2/11/15 arm was swollen and red almost down to my elbow.  Whole arm and hand was swollen.  When had lab work done on Friday 2/6/15 white blood count was high enough for doctor to call and have me report to immediate care. I was told it was Cellulitis and given an antibiotic.  However by Friday 2/6/15 the three fingers on that left arm are so painful and unable to make a fist are painful to touch and painful to use them.
Patient called pharmacy to report of pain "where the bra line is" and "throughout the back area". She also listed the pain as "around her rib area and around the back". Patient said pain has been continuing for 3 days since receiving the vaccine.
4 days p/inject had hives; was seen @ urgent care; many tests including CAT Scan were performed; given dx of Bell's Palsy & hives; taking DPH;
Patient presented to the ED with NSTEMI and was subsequently admitted, within 6 weeks of receiving COVID vaccination.