chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer booster shot; got infected with Covid; got infected with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer booster shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got infected with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: got infected with covid.  Clinical Course: Consumer reported the vaccine was a killer and was killing the people. Created 1 AE form because there was no patient's information gathered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101863868 same drug and patient, different event and drug dose;US-PFIZER_INC-202101863870 same drug and patient, different event and drug dose
nurse gave 1 children only the Dtap-IPV part of the Pentacel vaccine, ActHIB vials were not given; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with 2019SA192664.   This case involves one child patients of unknown demographics who was vaccinated with a dose only the Dtap-IPV part of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ123AAA and Exp. Date 29-Sep-2020) ACT-HIB part was not given via unknown route in unknown administration site on an unknown date.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  (DTap-IPV- lot number U6397AA and Exp. Date 09/29/2020 and ActHIB UJ123AA and Exp. Date 09/29/2020)  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
no adverse effect; received improperly stored PEDVAXHIB; This spontaneous report was received from a nurse refers to a 13 month old male patient. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On 06-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # S000353 and expiration date 09-OCT-2021 (strength, dose, frequency and route not reported) for prophylaxis (product storage error). Storage temperature was reported as above 47 degree Fahrenheit (F) (47.4 F) with timeframe of 23 hours. There was no previous temperature excursion. The call was made because of a data logger. No adverse effects reported. No product quality complaint (PQC) present.  This is one of three reports received from the same reporter.
PATIENT STARTING EXPERIENCING NAUSEA, VOMITING, AND CHILLS ALMOST 2 HOURS AFTER RECEIVING THE VACCINE.  PATIENT WAS NOT EXPERIENCING AN ALLERGIC REACTION.
Swelling and redness of face, swelking of lips, tongue, and throat.  Feeling of jitteriness.  Headache & fatigue
Experienced dizziness. Lasted about 1-2 mins. Felt nauseated and felt like vomiting but did not.
Fever (100 degF), severe headache, general malaise, pain and tenderness in area of injection site (approximately 6" diameter). Fever, headache and general malaise ymptoms lasted approximately 60 hours and resolved without treatment. Arm pain reduced, but still present at 96 hours post-injection.
In December I had shingles. I sought care from the doctor for the shingles and was prescribed medication.  In March I experienced a hypertensive episode.
Information has been received from a licensed practical nurse (LPN) concerning a patient who was vaccinated with PNEUMOVAX (lot # not provided). Subsequently the patient experienced injection site reactions. The patient had redness, swelling, pain and cellulitis at the injection site. The patient had sought medical attention. At the time of reporting the patient had recovered from injection site reactions. Follow-up information was received on 14-Jan-2009 from the nurse. The patient had the PNEUMOVAX vaccine administration in approximately 2008, "about a year ago." The patient had random lot number (lot number not provided). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX vaccine administration. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. Follow-up information has been received from the licensed practical nurse (LPN). It was reported that on 14-NOV-2008, at 9:00 am, a 60 year old white male was vaccinated SQ with the second dose of PNEUMOVAX (lot # 1295X). Subsequently, the patient developed cellulitis in given arm, edema shoulder to elbow, hot to touch, redness, fever. The patient was treated with the symptoms lasting 7-10 days. At the time of this report, the patient was recovered. This is one of several reports from the same source. The nurse requested a lot check. Additional information has been requested.
Pt recvd Engerix-B on 1MAY90, 1JUN90, & 24OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Headache & Fever fever 100.2, chills and extreme headache until 02/20/21.
24h duration polyarthralgias and fevers (tmax 102, recurrent despite taking Tylenol). I was 6 weeks pregnant at the time, estimated delivery date 9/6/2021. Symptoms completely resolved after 24h.
Paresthesias (L) peri-oral with (L) sided mouth droop and (L) eye tearing.
Received vaccine 10/7/13 - Developed severe pain numbness and tingling consulted PMD. Tx with pain meds/3 courses of steroids Lido patch - EMG 11/13/13 - symptoms worsening after 3 weeks steroids.
Fever to 38.5, abnormal behavior-Lip smacking, repeated emesis x5.
Fluzone and Flulaval on 2022 and another on 2023; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3K75S, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUZONE (SEASONAL INFLUENZA VACCINE)) and INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT VACCINE).   On 20th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, the dose was an unknown dose. On 20th January 2023, the patient started Flulaval Tetra Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving FLULAVAL QUADRIVALENT VACCINE, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments: A medical assistant reported that a male patient 1st received Fluzone on 18th November 2022, then Flulaval on 20th December 2022, and then another dose of Flulaval on 20th January 2023.  No symptoms reported. The reporter consented to follow up via email. Additional Supportive Information: the patient received flulaval vaccine again on 20th January 2023, which led to extra dose administered.
Arm turned deep red purple after a few minutes, felt has ants all over me, felt Rush of cold freezing through stomach up through chest and back lower to upper back, felt as if cotton was being packed into my throat. After a few more minutes difficult to swallow. Dr.  administered Epi shot, was sent to ER where was administered IV meds, prescribed at home allergy meds. ER follow-up last Thursday with primary Dr. , extended prescribed allergy meds for additional month due to ongoing symptoms.
Severe pain to injection site at upper left arm. Injection administered very, very high on the arm. Pain increasing with intensity over the next few days. Bruising at site present withing a few days. Restricted range of motion of left arm. Unable to lift my arm due to severe pain. Pain increases at night and sleeping is hampered due to pain.
Report A0372956A describes autism in a 28 month old male who received hep B vaccine recombinant (Engerix B). The medical history included allergy to penicillin. At the time of vaccination, the vaccinee had been "sick" for two weeks. when the vaccines were administered, a diagnosis of otitis media had been made. The vaccinee had been taking amoxicillin trihydrate (Amoxil) "prior to receiving the vaccines." On 08/16/2000, 11/22/2000, and 02/08/2001, the vaccinee received his first (lot ENG3221A2), second (lot ENG3223A2) and (lot ENG3324C2) injections of Engerix B, respectively. Additionally, on 06/06/2000, 08/16/2000 and 08/17/2001, the vaccinee received his second (lot DTPA921A2), third (lot DTPA955A2), and fourth (lot DTPA997A2) injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Additional concurrent vaccines included Haemophilus influenzae type b conjugate vaccine (brand name unknown), and MMR II. On 02/12/2002, the vaccinee experienced a rash which resolved after an unspecified period of time. On 06/03/2002, the physician made a diagnosis of autism. The vaccinee was hospitalized for an unspecified period of time. As of 06/27/2002, the autism was ongoing.
Later in the day on 11-05-2021 day of shot I became very tired.  I felt very cold all over and started to shake with very bad headache.  I started feeling hot all over.  In the middle of the night I woke to being very hot, headache.  I put cold wash clothes on my head and on my arms and legs throughout the evening and morning.  Running fever at 100.3.  This morning feel very tired, headache temperature 97.3. Feel tired, weak and headache.
Patient has not experienced any side effects.; patient was accidentally administered their third dose of GARDASIL 9 three weeks after their second dose of GARDASIL 9.; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On 10-SEP-2022, the patient was accidentally administered their third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), three weeks after their second dose (inappropriate schedule of product administration).  At the reporting time, the patient had not experienced any side effects.
soreness in the arm and other symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm and other symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484818 Same reporter/product/event, different patient
This spontaneous report was received from an office manager and refers to a 46-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 07-SEP-2018, the patient was vaccinated with PROQUAD, subcutaneously for prophylaxis (dose, lot #, expiration date and therapy type were not provided). Vaccine was reconstituted with sterile diluent. No adverse effect was reported.
Mother noticed flat rash on trunk of body salmon in color, non papular, non-macular. Temperature of 101 degrees today.
product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 10:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 60 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 15May2023 to 20May2023.  Additional information: The patient received no other medications within 2 weeks of vaccination. No known allergies reported.
This spontaneous report received from a healthcare worker refers to a unknown number of patients of unknown age and gender. Since 23-MAY-2014 the suspect vaccines were improperly stored and on unknown date (in approximately May 2014) the patients were vaccinated with LIQUID PEDVAXHIB Lot #, dosage, anatomical localization and route of administration were not reported. Vaccines has been administered up to 8 patients. No adverse effects reported. This is one of the several reports of the same source. Additional information has been requested.
Standing, getting dizzy. She remembers drinking water and sat down and couldn't see and fell. When her mom found her she was pale. Took a long time to come back 15-20 mins. Approx 2 episodes of syncope. Diaphoresis, dizziness, headache.
contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days to be exact; This is a spontaneous report from a contactable other health professional (patient).  A 66-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL3246) at single dose at right arm on 14Jan2021 for covid-19 immunisation, administered at hospital.  Medical history included rheumatoid arthritis, allergies to morphine and related, PCN, sulfa, quinidine, Xeljanz. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: upadacitinib (RINVOQ), folic acid (FOLIC ACID), ropinirole hydrochloride (REQUIP). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Lot # EJ1685) at single dose at right arm on 26Dec2020 03:00 PM for covid-19 immunisation, administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced contracted Covid after her 2nd dose, muscle aches and fatigue 3 days to be exact on 17Jan2021 17:00, Covid test result positive on 22Jan2021. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): positive on 22Jan2021. No treatment was received for the adverse event. The outcome of Covid test result positive was unknown, of the other events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lack of efficacy cannot be excluded.  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, and Investigators, as appropriate.
swollen lymph nodes; swollen tonsils; body chills; body aches; the tonsil on the opposite side of injection is far more swollen noting it is blackish red; she woke up in the middle of the night; my tonsil is completely swollen and inflamed; a lot of discomfort; bloody tonsils / when she spits, it is bloody / dry blood; bloody tonsils / when she spits, it is bloody / dry blood; headache; sore arm; low grade fever of 99.6/ fever is not breaking 100.5; Fatigue; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Aug2021 (lot FC3182), as the first single dose, in right arm (shoulder), for COVID-19 immunisation. Medical history included problems with her tonsils when she was in her teens and had mono. Concomitant medications were not reported. On an unspecified date in Aug2021, reported as the first two days, she experienced typical side effects mentioning headache, sore arm, low grade fever of 99.6, fatigue and were tolerable. All of a sudden, on 27Aug2021, she had swollen lymph nodes and swollen tonsils. For the following 4 days she had swollen lymph nodes on the opposite side of the vaccine. She also reported bloody tonsils, body chills and body aches. The tonsil on the opposite side of injection was far more swollen noting it was blackish red. When she spitted, it was bloody, it was dry blood. She had to take deeper breaths because of the swollen tonsils. Since an unspecified date in Aug2021 she woke up in the middle of the night where her tonsil was completely swollen and inflamed. It was causing her a lot of discomfort. She has never had problems with her tonsils except when she was in her teens and had mono. Her throat was not sore, just her lymph nodes and tonsils. She was taking Tylenol and Advil around the clock. The fever was not breaking 100.5. The fever was worse now then when she received the vaccine. On 30Aug2021 her tonsils were swollen and getting worse, the lymph nodes on both side of her neck were swollen and specially her left tonsil was just getting bigger. She got the vaccine in her right arm, and that tonsil on her left side was actually bleeding, spitting of blood and everything too. And she still had headache and the fever. She also went to her Doctor. She stated this was way too much of a coincidence and did not know if this was the norm. She stated she did not want to get the vaccine but had to for work because she was a healthcare. The final events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Day After Starting at 2 AM: Fever: 104 for 3-5 hours, 100 for 12 hours after Cold Sweat/Chills: All day Extreme Headaches: All day Nausea/Vomiting: 3-5 hours Fogginess: All day  2 Days After (Today): Minor Headaches Cold Sweat/Chills Fogginess
Mild headache and flu-like light-headiness for approximately 12 hours. No other symptoms.
Within 24 hours of Fluzone quadrivalent vaccine administration, he developed severe hives, swelling, some fullness of the throat. No resp or GI. Hives have continued daily since then (4 months). Seen by allergy 12/3/13. To ER 12/8/13 for "heart pains," swelling and throat closing. Ruled out for myocardial infarction. Allergist rx Prednisone 12/9-14, Zyrtec, Zantac.
Friday - Arm soreness at site of injection Saturday - Wednesday : Fatigue Numbness in fingers b/l -- > entire body? -- > increased sensation and twitch in b/l legs and feet Change in sleep habits Sensitivity to bright lights/sounds Symptoms began to improve Thursday and Friday.
No adverse event; Expired product administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered) and NO ADVERSE EVENT (No adverse event) in a 6-decade-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered) 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 (Expired product administered).    No concomitant medication was reported. It was reported that patient was in 50s.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-736678 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736678:female patient case
This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. The patient' medical history and current conditions were not provided. on an unknown date in 2015 (reported as "between 01-MAY-2015-09-SEP-2015"), the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (dose and route were not reported) lot # K018960, expiration date 13-MAY-2017 and lot # K018960 expiration date 15-OCT-2016. On an unknown date in 2015 (reported as "between 01-MAY-2015"), the patients experienced redness at the injection site. There was no treatment given for adverse event. The outcome of redness at the injection site was unknown. The relatedness between redness at the injection site and suspected therapy was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
I had minor arm pain after my shot.  About twelve hours later I had severe body aches, headache, intense chills with full body shaking.  I could hardly move and felt an ache in all my muscles and bones.  It was very intense pain.  The entire next day I had severe body pain and severe fatigue.  I tried to go for a short walk and felt dizzy.  Everything hurt.  I took Tylenol regularly all day and mostly slept.  48 hours later I was feeling better.  Slowly regaining stamina and pain is now diminising.