chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (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: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset Mar2021, described as "given the vaccine at the top of her shoulder, way up on her arm"; NEURALGIA (non-serious) with onset Mar2021, described as "vaccine may have hit nerve or went in to joint"; MOBILITY DECREASED (non-serious) with onset Mar2021, described as "unable to move her arm and not from soreness"; VACCINATION SITE JOINT PAIN (non-serious) with onset Mar2021, described as "extreme pain vaccine may have hit nerve or went in to joint". Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Reporter states that her mother received 1st dose of Covid vaccine about 2 weeks ago. She states that her mother was given the vaccine at the top of her shoulder, way up on her arm. After the vaccine her mother was unable to move her arm and not from soreness. Now 13 days later mother is in extreme pain. They are wondering if the vaccine was given in shoulder, will that decrease efficacy of vaccine and wondering if this pain will resolve itself or will this be a lifelong thing. Thinks vaccine may have hit nerve or went in to joint. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information was No. Information on lot/batch number has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case previously recorded as MA2009-6444. Initial case report received from a healthcare professional on 20 NOV 2009. This 1-year-old child was vaccinated for the first time with S-OIV FLUVIRIN (batch no. unknown) on an unknown date. No adverse event appeared. Reference no. NA09-008973.
Pt experienced inconsolable crying for 8 hours post vax. Pt also experienced a fever of 102.5.
The expiration date on vial was 10/27/2021. In the morning around 9 am we called CDC, The representative confirmed that the vaccine is good to use on 10/27/21. Upon confirmation we gave booster dose (0.25) to the patient. Later same representative called back after 30 minutes to inform that we CAN NOT use that vial on 10/27 as it expires on date written on the vial.
11/17/21 Tested (+) 2 days ago at bluewater. Wants to be tested again.  - Started with sx 3 days ago.  - Notes malaise, fever, congestion, mild cough. Temp 102.1 1 hour ago, took ibuprofen, normal now, in office. He has had some mild wheezing.  - Has been vaccinated with pfizer, due now for booster.  - Has friend he plays cards with that has COVID, girlfriend sx but rapid test was negative.  - Denies SOA, chest tightness, chest pain.
2/16/2023 I was feeling fatigued, body aches, bad cough and congestion. I tested with an at home COVID Test and it was negative. I tested again for COVID on 2/20/23 and it was negative. I had an appointment with the doctor on 2/20/23 and was prescribed steroids. I called back on 2/22/23 and was prescribed an antibiotic.  I was wheezing very badly. This lasted for four weeks.
He got immunizations on 4/24/03 10:30 AM. Mother noticed redness, swelling at 7:30 PM same day. Swelling has gotten worse on 4/25/03. Swelling, redness, fever noted on left upper anterior and lateral thigh.
pt recvd vax JAN94 & 2 wks later wife c/o SOB, fatigue, arthralgia, joint swelling & lymphadenopathy, lymph nodes biopsy showed granulomatous disease of the lymph nodes; atypical of but consistent w/dx of sarcoid; lymphoma was r/o;
Hives, itching began shortly after receiving flu vaccine on 10/1/14. Went to MD - took BENADRYL, received IM SOLU-MEDROL - later took dose pack steroids.
6cm area of erythema, edema and warmth to touch on right upper arm at injection site. Advised Benadryl Q 4-6 H.
patient fainted while walking down the aisle shortly after receiving vaccine. ambulance was called and patient was feeling better before ambulance arrived. emergency personnel allowed patient to leave with parents.  called patient 1/3/22 and she was feeling normal with no other adverse reactions since leaving the store.
On 9/19/07 patient c/o fever, chills, headaches, generalized rash and hives; redness, swelling and tenderness at puncture site left arm. Symptoms treated with Tylenol, Benadryl, rest, warm/cold arm compress.
Patient reported later in the evening fatigue, muscle aches, injection site soreness, and a low grade fever
No adverse events reported from patient/caregiver. Patient received dose appropriate for children 5-11 years old though he should have received adult dose due to age (12 years old at time of administration).
diagnosed with COVID today; diagnosed with COVID today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Dahloss" (unspecified if ongoing), notes: Ehlers Dahloss; "Stroke" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022 at 11:00, outcome "not recovered" and all described as "diagnosed with COVID today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. No covid prior vaccination and covid tested post vaccination was reported as yes. It was reported that, the patient became aware of the adverse events on 21Dec same day as the report was filed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted upon minutes after patient given vaccine. Pt was going by seat to sit down after getting vaccinated and brother was on deck for the vaccine. Before sitting down pt fainted and hit the floor. Patient was unresponsive for a few seconds and then recovered. Pt was complaining about headaches but reported to be okay. Asked pt and father multiple times if they were okay, they said they were fine. Pt sat for observation for 15 minutes and then left the pharmacy, fine.
Low blood sugar; felt a little warm; Headache; Sore arm; This is a spontaneous report from a contactable consumer (patient).  This 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9809), via an unknown route, on 19Feb2021 (at 13:45) at a single dose on the right arm for COVID-19 immunisation, administered at hospital. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318) administered on right arm on 29Jan2021 at 12:30 PM. Relevant medical history includes type II diabetes. No known allergies. Relevant concomitant medications included metformin, insulin detemir (LEVEMIR) and insulin lispro (HUMALOG).The patient did not receive any other vaccines within 4 weeks prior to the COVID 19 vaccine. On 19Feb2021 (in the evening), the patient had a bit of a sore arm and slight headache, she took 2 ibuprofen before bed. She took medications as normal, food intake nothing unusual.  She was woken up at 2:00 am by her continuous monitor which she kept at the side of her bed alarming her of low blood sugar. She never got that. Sugar level was 40. She had a glass of milk and some candy and it reversed. The monitor saved her. On 20Feb2021, she just had a slight headache, felt a little warm and she took Ibuprofen. The event low blood sugar was considered a life-threatening condition. The remaining events were assessed as non-serious.  Post-vaccination COVID test was not performed. The patient was recovering from the events.
Day after vaccine - red welt, tender, sore, itchy. Took Benadryl and applied ice to area. Pain subsided after 5 days. 3 weeks after vaccine - large area around site is discolored  ( 1 inch bruise in center and redness extends 3 inches around bruise) and itchy.
Patient was supposed to receive Moderna bivalent booster 0.5 ml - no symptoms or adverse reactions, just vaccine administration error
After the second dose I got my usually very regular period 10 days early. I also had breast soreness for about 3 weeks, starting a few days after the second dose.  I think it is important for you to look into what about the vaccine could trigger women's periods to change.
Pt. C/O post Shingle injection of upper right arm with redness/constant burning and itching with welting and producing heat.
This case was reported by a pharmacist and described a patient who received hep-B vaccine and tested positive for hep-b antigen.    The patient's medical history included renal failure (cause not specified) requiring hemodialysis.    On an unspecified date, the patient received a dose of Energix-B.  "A few hours" after the administration of Energix-B, a hep-b surface antigen was "positive".
This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot # L004740, expiry date 16-NOV-2017 (dose and route were not reported). There was no concomitant medication provided. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client described feeling "flushed.  And my heart is racing."  VS at the time of incident were 104, 18, 138/78 and 96% pulse ox.  Client denies throat or tongue swelling, denies SOB.  Denies nausea or dizziness.  States she had hives reaction that lasted less than 24 hours with vaccine #1.  She states she pre-medicated with 50mg of Benadryl prior to today's vaccine, on advice of her doctor.  Client additionally states that she was very anxious about potential reaction today.    After 10 minutes, her VS are 88, 16, 130/76. and 99% pulse ox.  She states she feels much calmer walking around the room, and we walked together several laps.  Client has no hives, and continues to deny SOB or throat/tongue swelling for the duration of her time in  the recovery room.  After 30 minutes she continues to state she is "totally fine", denies flushing, heart racing, or other adverse symptoms.  Patient was driven today by a friend, and left with the same friend.
Information has been received from a physician concerning a 7 year old male with asthma and no allergies who on 28-JUN-2007 was vaccinated SC with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 653435/0561F0. Concomitant therapy included steroid medications. In August 2007, 3 to 4 months post vaccination the patient was found to be seronegative. No symptoms were reported. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested. It was reported that patient's sister WAES # 0801USA04742 experienced a similar adverse event following vaccination with varicella virus vaccine live (Oka/Merck). This is one of several reports received from the same source.
p/vax pt devel swelling to upper left arm which extended to under arm up to neck area. c/o pain, treated w/ibuprofen & lodin
Itchy rash on neck, back, front of trunk and forearms. Not hives.
severe pain @ the site of inj (lt deltoid) & gen aching-started next morning & lasted 10 days;
2nd vaccine given in right forearm with 0.5 ml dose.  Experienced itching at site, a red welt at injection, puffiness in area and red circle approximately 2 inches in diameter.  Redness is fading, but still present. Swelling is generally getting better.
unconsolable crying for 4 hrs w/in the 1st 24 hrs p/vax;
My ears have felt like I was underwater for a few months with sharp pain that would come and go. One day it got so bad I couldn?t go to work. I finally decided to go to my doctor after being refused at urgent care for not having my booster. I was prescribed ear drops and told to try a decongestant. After my appointment with my doctor and discussing this is a side effect of the Pfizer vaccine, she told me to report it here. It?s been months. I?m being sent for a hearing test by referral. This has been very miserable.
Patient was given first dose of Covid Pfizer vaccine 21 days past the beyond use date. Pfizer was contacted about it. Patient was contacted. Patient report no side effects following  administration.
1st dose on 12Oct2022, 2nd on 12Nov2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17th June 2023) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX), HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS B VACCINE (ENGERIX B).   On 12th November 2022, the patient received the 2nd dose of Havrix. On 12th November 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.       Additional Information: GSK receipt date: 01-DEC-2022 Reporters comment:  The reporter reported that patient received the 1st dose of Havrix and an early 2nd dose of Havrix. The patient also received the 1st and 2nd dose of Engerix on the same dates. The reporter consent to follow up. Additional Supportive information: The patient received 2nd dose of havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. This case had been linked with US2022180223 same reporter. Note-As per source document Engerix B coded as concomitant vaccine.; Sender's Comments:  US-GSK-US2022180223:Same reporter
Tightness in chest, started 12 hours after injection and occurred only at night until 5 days after injection, then became persistent  Chest pain, started 12 hours after injection and occurred only at night until 5 days after injection, then became persistent  Shortness of breath, started 12 hours after injection and occurred only at night until 5 days after injection, then became persistent  Spikes of abdominal pain Started 12 hours after injection Faintness, Started 5 days after injection
pt recvd 3 doses of Engerix-B & had lack of seroconversion;
3x4 swelling, redness, tenderness, erythema, fading today 4/14/05 3PM, site tender and swollen.
pt recvd DTP/OPV vax 1145AM 9JUN92 approx 5-10 mins p/vax pt fussy & appeared as if was going to vomit; tried once but didn't; pale, blue around the mouth, did not appear to be fully responsive; diarrhea, achy, cold & clammy;
Patient is 6yo and was accidentally given a maroon cap pfizer dose of .2 which is meant for 6m-4yo patients. Patient should have received a 5yo-11yo pfizer orange cap vaccine due to her age group
Non-serious case received from a health care professional (pharmacist) on 16 October 2009. A 50-year-old male patient with history of diabetes and hypertension reported having problems with "blood sugars running low at night" since receiving a FLUZONE vaccination (lot number unknown; route/site of administration not reported) on 08 October 2009. Patient outcome was unknown. The reporter indicated that the patient had received the FLUZONE vaccination at his physician's office. No further details were provided. Documents held by sender: None.
Positive PCR COVID test on 16Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Dec2021 19:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. List of any other medications the patient received within 2 weeks of vaccination: daily multi-vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The following information was reported: COVID-19 (medically significant) with onset 16Dec2021 16:00, outcome "recovering", described as "Positive PCR COVID test on 16Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive, notes: Post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I received my 2nd dose of covid vaccine from pfizer on March 13,, 2021, I was warned  already  because the nurse who gave it to me said  that since I had slight S/E from the first shot the second one would be a little more sore in site.  I went home felt fine, the symptoms started around 1-2 am in the morning when I got up to use the bathroom went back to the bed shivering , I had to get me additional cover, then  I woke in that morning feeling the flu symptoms such as joint and muscle ache as if beaten up, and low grade fever.  I manage the ache by just drinking water and tea. The next morning (Monday) I felt fine my joint and muscle ache and fever were gone. Such weird symptoms of flu.
Flu like symptoms for 30 hours. Severe in that it affected how I could take care of myself. I was so fatigued I could not move
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ANXIOUS; STRESS; This spontaneous report received from a physician concerned a 73 year old female. Initial information was processed along with the additional information received from central complaint vigilance on 01-JUL-2021 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's concomitant medications included unspecified medications for blood pressure. It was reported that, the patient's partner was not using mask and going out to multiple high risk areas and this was causing a lot of tension and stress for the patient. On an unspecified date, the patient was tested negative for SARS-CoV-2 IgG antibody test spike, Semi QN (SARS-CoV-2 IgG) antibody test, and regular antibodies SARS CoV 2 SEROLOGY (COVID19) AB (IgG, IgM) SARS-CoV-2 IgM (IA SARS CoV 2 AB) antibody test (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxious, stress and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184427. The suspected product quality complaint has been confirmed to be voided (does not meet criteria) based on the evaluation/investigation performed.; Sender's Comments: V0: 20210665609- COVID-19 VACCINE AD26.COV2.S- Suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Fever with shaking chills at night. Headache. Fever was gone by 10:00a the next day.
This spontaneous report was received from a office manager referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9 lot# M009173 (lot# M009173 is an invalid lot number for GARDASIL 9) with expiration date 20-NOV-2019, or lot# N009801 with expiration date 20-NOV-2017 (dose number, route of administration and anatomical location were not reported) were administered to the patients. The doses were stored in temperatures from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 5 minutes. Digital data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007202: US-009507513-1708USA007201:
No additional adverse event; Pharmacist calling reports expired dose of PNEUMOVAX 23 was administered to a patient. The vaccine did not experience any temperature excursions.; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The subject's medical history, historical drugs, concurrent conditions, known allergies, and concomitant medications were not provided  On 15-MAR-2022, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (dose, strength, frequency, route of administration and anatomical site of application were not reported); lot # T020639 had been verified to be valid with an expiration date reported and established as 13-MAR-2022 (Expired product administered).  The vaccine did not experience any temperature excursions. No additional adverse event (AE) details were available.