chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states that he had AVA#1 on 6/18/07 without adverse event. On 9/7/07 the pt was given AVA#2 in his left arm. On 9/8/07 he noted swelling and redness around the injection site (about 1/2 inches in diameter). He had no decrease in ROM or numbness in his left arm or hand. This lasted about 3 weeks. Additionally, he had dizziness which was constant, did not interfere with activities for 5 days. On 9/9/07 he had a severe headache (the top of his head), 8/10, for 48 hours. The headache then became intermittent; MOTRIN decreased the pain but did not completely alleviate the  pain; resolved in 2 weeks. 9/9/07 he noted that his heart was beating "hard", not rapid, "I could see the bed move with each heart beat". This symptom was constant for 5 days and has continued to present being intermittent, only occurring at night when he lies down or when he gets up to the BR to void. 9/9/08 he had the sensation that "my blood was hot and I could feel my blood pulsing through my entire body". The pt was not febrile. This sensation was constant for 48 hours and has occurred about 4 times since - occurring during the nite while lying down. On 9/9/07 he noted difficulty concentrating/focusing - it was like "being in a fog" which lasted one month. On 9/9/07 he also experienced fatigue ("I was tired all the time") which also lasted one month. On 9/15/07 the pt started to have loose, watery, frequent (3-4/day) stools which lasted about one month. He had no bloody stool, nausea, vomiting, abdominal pain or decrease in appetite. The pt received AVA#3 on 11/14/07 in the left arm. Immediately he had left arm swelling and redness (less severe than with AVA#2). He again experienced headache, N, cold sweats, diarrhea, pound heart beat, fatigue and difficultly concentrating lasting from 2 days to 2 weeks. Symptoms: Memory Loss, short term, Weakness, Diarrhea, Cognitive deficiency, Fatigue, Malaise < 60 days, Erythema, Edema @ injection site < 30 mm, Clamminess, Nausea w/o vomiting, Palpitations, Diarrhea, Headache, general, Clamminess, Pain, Nausea w/o vomiting, Palpitations, Cognitive deficiency, Fatigue, Malaise <60 days, Edema @ injection site < 30 mm, Erythema, Dizziness
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On  Jun 11, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On  Jun 11, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-363245, MOD-2021-363730, MOD-2021-363777, MOD-2021-364245, MOD-2021-364274, MOD-2021-364385, MOD-2021-364699, MOD-2021-364890, MOD-2021-365040, MOD-2021-363032, MOD-2021-363226 (patient link).
One day after receiving 2nd vaccine shot in left arm, I had tinnitus in left ear for about 10-15 seconds and the lymph nodes in my left underarm became swollen and painful. The following day, my underarm area is still swollen but less painful. Experienced tinnitus again at around 5 p.m. in my left ear for about 5 seconds.   I am reporting this because tinnitus is not listed as a common side effect.
Patient stated evening after vaccines - rash started.  Seen in office 9/24/08 for worsening rash - hives.  No signs of anaphylaxis - patient placed on Benadryl around the clock for 48 hours - if worsening to call.
Narrative:  Patient had covid pneumonia with bilateral PEs off isolation on anticoagulation. Was discharged 1 day after receiving covid vaccine on oxygen therapy and he PEA arrested in Ambulance going home from the hospital.
Approximately 10-15 mins after vaccination pt reports feeling nauseous, then dizzy and weak, when she attempted to stand she fainted. After approximately 10 min. symptoms resolved. Pt was diaphoretic A and O x 3 during possible reaction no LOC.
Swelling in throat. Transported self to hospital but sat in car outside. Took anxiety med. Fell asleep in car. When awoke felt better and returned home.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: 24 year old female post first immunization of Pfizer.  Advised to wait 15 minutes in the chairs in front of the pharmacy.  Shortly after, approximately 10 minutes she returned to the vaccination "area" and looked sweaty and flushed.  Immediately got weak, started to fall to the ground but was caught and assisted to the floor where she was placed on her back and started to regain color and consciousness.  Patient was given fluids, B/P taken 110/60, HR 58.  911 arrived, patient home with husband.
Patient received shot on 9/12/17 and is stating that her right arm is still very sore. It hurt to even lift arm.
sore arm; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case from non-health care professional.  This case involves patient (demographics unknown) who had sore arm (pain in extremity), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (high dose) produced by unknown manufacturer and  also had 13 and 23 shots (name unspecified) [lot number and expiry not reported] via unknown route in an unknown administration site for prophylactic vaccinations.  On an unknown date, the patient developed a non-serious sore arm (pain in extremity) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the of reporting, the outcome is unknown for sore arm.  There will be no information on the batch number to be requested for this case.
No adverse symptoms aware of. Patient was stuck twice by provider. 1st injection was with an empty syringe. 2nd injection was with the medication.
Information has been received from a physician concerning an 8 year olf male who in 1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  On 05/17/2004 the patient developed chickenpox with about 300 lesions on his body.  Unspecified medical attention was sought and the patient was treated with acyclovir and diphenhydramine.  Subsequently, the patient recovered.  No product quality complaint was involved.  Follow up correspondence received from the physician reported that there is no additional information.  It was also reported that a female patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox.  No additional information is expected.
he has had a lot on his mind the last couple of weeks; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program . A 75-year-old male patient received the first dose of bnt162b2 via unspecified route of administration on 22Mar2021 (also reported 11Mar2021) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he has had a lot on his mind the last couple of weeks and he got his 1st shot on 22Mar2021 and he was calling back because he has no return date. The patient stated he called and was told he would get a call back and hadn't heard from anyone for a while. The patient stated he was seeing if there is an explanation about going to get the 2nd shot. The patient stated he called the number on the sheet that was given to him for the 1st shot. The patient stated it is a Pfizer number and clarifies he is calling to set his 2nd shot appointment. The patient stated he had no other problems with the first shot. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Non-length small nerve peripheral neuropathy through skin biopsy.  No other symptoms such as muscle weakness, dizziness, brain fog, unsteadiness.  Primary symptoms include extreme burning in toes in the evening, numbness on left forearm, and occasional sharp pain on outside right hip.  Treated with IVIG back to back for 2 days for 2 months, Duloxetine.  Neither has worked.
Became pale and diaphoretic after 10 minutes observation after vaccine. Assisted to W/C and transported to Facility for assessment. No LOC observed.
L arm slightly red, warm to the touch, measured 25 mm x 20 mm. Returned 5-11-07 for recheck very little redness, no swelling no warm to touch.
Fever, body pain, joints pain, diarrhea, swelling and redness on injection site
Vaccine participant received Moderna dose 2 fewer than 24 days (Moderna) after  the first dose. Moderna dose 1 received on 02/04/2021.
3OCT95 pt recvd vax & 2OCT pt has broken in large welts on back each evening & temp as high as 103;mom states it was the pts 3rd Hep B vax & the pt had no problems w/1st shot;referred to MD
On 07/08/2022, donor stated the he developed a reaction on 07/08/2022 lasting until 07/09/2022. Donor's symptoms on 07/08 consisted of headache, fever of 102.5 degree Fahrenheit, fatigue and weakness; with first symptoms starting around 12pm and progressing to a fever later in the day. On 07/09, donor's symptoms had resolved with the exception of a fever, which had lowered to 99.8F. Donor stated all symptoms were resolved by 7/10 and donor felt 'normal again.' Donor did not report any localized reaction at  the immunization site.
no adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation. All doses were given as 0.2 ml dosage form instead of 0.25 ml; This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.), UNDERDOSE (All doses were given as 0.2 ml dosage form instead of 0.25 ml) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and UNDERDOSE (All doses were given as 0.2 ml dosage form instead of 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.), UNDERDOSE (All doses were given as 0.2 ml dosage form instead of 0.25 ml) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and UNDERDOSE (All doses were given as 0.2 ml dosage form instead of 0.25 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 9th out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:1st patient case (Master case)
pt recv 4SEP97 & SEP97 the pt devel chickenpox;
Pt developed rash on face that traveled down to abdomen and lower extremities over the next few days.
The Moderna COVID Vaccine was administered to this 17 year old because his mother put her own DOB (not his) in the system while registering him for an appointment; for this reason his underage status was not flagged. He attended a COVID vaccination clinic as he works for the Fire Department. No side effects or adverse reactions were reported by patient/family. This was recognized when he could not register for his 2nd dose appointment.
administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 6 months patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 01-JUL-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(dose 2 ml, lot # 1660946, expiration date 10-APR-2021; exact dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to temperature excursions of 9.6 degree Celsius (C) for 2 hours and 1 minute. It was reported the vaccine was previously exposed to temperature excursions of 10.5 C for 40 hours and 5 minutes on 04-JUN-2020. A "data logger" was involved. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011564: US-009507513-2008USA013131: US-009507513-2009USA002369: US-009507513-2009USA002370:
Baby had a seizure: staring, teeth chattering, stiffened body, post dictal state afterwards.
Vaccine 1 given 2/5/21. On 2/24/21 was running a fever and not feeling well. On 2/25/21 - I went to the doctor. See attached office visit forms.
pt recvd vax & 10 days following vax pt devel a rash, arthralgia, myalgia & cervical adenopathy; No further details were provided;
Arterial clot in radial artery of left wrist, symptoms began on 1.05.21, 6 days after first vaccine dosage. Symptoms presented initially as numbness and tingling in the left thumb, index and middle fingers and progressed to being cold to the touch and purple in color. Numerous attempts at initial diagnosis were inconclusive until a hand CT scan was conducted on 1.15.21 with hospital admission later that day. Patient was transferred on 1.16.21 to Hospital to consult with a vascular surgeon. Clot was treated with heparin and warfarin, with 7 days in total for the hospital stay. Subsequent testing for clotting disorders found none.
No adverse affects; patient received their third dose of GARDASIL 9 sooner that what is recommended; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R017624, expiration date 17-MAR-2021, dose and route not reported) for prophylaxis. The patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) sooner than what was recommended (Inappropriate schedule of product administration) (onset date was reported as 27-AUG-2019). No adverse effects were reported.
Suspected Subacromial?subdeltoid bursitis following COVID?19 vaccination.  Onset approximately 1 week post second dose.  Severe internal shoulder pain and surrounding scapula and clavicle muscle groups.  Natural anti-inflammatories, therapy.  Following up with orthopedic.
After 7 hours I developed numbness in my arm and hand as well as   left back. The numbness lasted several days.
This spontaneous report as received from a physician and a licensed practical nurse refers to a 72 year old female patient. On approximately 03-MAR-2013, "1 month ago", the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). The physician and nurse reported that the patient got shingles and on 02-APR-2013, the patient was seen in the office and was admitted to hospital due to a rash on the face. The outcome of shingles was unknown. Additional information has been requested.
pt. recvd. vax & developed measles rash,cough,conjunctivitis,& Koplik spots.
Extreme headache, dizzy - can't walk without support. This is 3 days after. Low BP 82/59, low grade fever. Difficulty with urination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) positive, notes: on day 8; (Jun2022) Negative, notes: on the day after treatment completion; (unspecified date) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events Drug ineffective , covid 19 and the suspect drug cannot be excluded.
Pt states he received 3 immunizations on 2/23/06. He thinks rash developed 1 wk after involving both underarms, chest, back, waist, behind left knee, and slightly on r calf, itchy, red, seen by PCP, dermatologist and allergist. Treated for sackies and scrapings, neg allergy testing. Treated allergy to Neomycin. Not known prior to this event. Rash remains. Told to call by allergist, calls to manf and AP.
Lot number 300046A, received vaccine 15 Jul 2020 - Approximately 6 hours later, joints started to ache and throb, became very fatigued, with a lot of body aches. Joints continued to hurt for approximately 2 months.   Lot number 300133A, received vaccine 04 Aug 2021 - Approximately 6 hours later, joints became very painful to move, became very fatigued and body aches. This time joint pain and fatigue continued through Dec 2021 and was so severe that life became impacted negatively. Could not run, lift, hike, or play sports due to pain.
Swollen arm, red and very sore to touch and with movement on the right arm injection site. I had fever that afternoon, night and next day of 100-102 degree F. Went to ER on 10/04/19 and diagnosed with sepsis. Went to ICU, then critical care, now on 10/05/2019 I went to general care. Edema found with MRI on right arm.
This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced vision loss the day after being vaccinated. The event resolved completely within that day. Following the second dose of the vaccine and no events were reported. The information on the lot number has been requested. Sender's Comments: the patient experienced vision loss that resolved completely within that same day. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Developed Tinnitus some time after the second.  I cannot recall the exact date but it was within a month of receiving the second dose.
Pt recvd vax 7OCT92 & 5 mins following vax exp pruritus @ the inject site & 30 mins later the pruritus spread to include entire body;
A report was received from a health care professional on 12/11/03 concerning an 3.5 year old vaccinee of unknown gender who inadvertently received 0.5ml Fluvirin vaccine on 12/10/03. On 12/10/03, the vaccinee received Fluvirin vaccine. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee was female and inadvertently received Fluvirin SC on 12/10/03. No adverse events were reported at the time of the report. Follow up pending.
Pt given vaccines DTaP, IPV, MMR. Nasal drip right onset turned to cloudy in a few minutes. Rash, swelling of face, flushing, dyspnea rhinorrhea approx 15-20 minutes after vaccine administration.