chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Moderna, Date: 27Feb2022, Dose Number: 4 / Pfizer, Date: 24Aug2021, Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9265), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 24Aug2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2022 as dose 4 (booster), single (Lot number: 026121B), in right arm and on 08Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer (in remission)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iv iodine, reaction(s): "Known allergies: IV iodine"; Clindamycin, reaction(s): "Known allergies: Clindamycin"; Zantac, reaction(s): "Known allergies: Zantac"; Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Feb2022, outcome "not recovered", described as "Moderna, Date: 27Feb2022, Dose Number: 4 / Pfizer, Date: 24Aug2021, Dose Number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: My COVID antigen test became positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix vaccine (1st dose received on 6th September 2019 from batch number TE493, expiry date 19th October 2021). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The VAERS details were reported for the 1st dose. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient called pharmacy on the day of reporting, to ask about receiving 2nd dose, but it had not yet been administered. The reporter consented to follow up.
Had 1+ pitting edema on left deltoid area. Arm was red and swollen 3 X larger than the right arm. Symptoms lasted X 4 days. Saw MD on 4/20/01. No treatment recommended.
Site surrounding DTaP developed redness, warmth, and swelling. RX: Claritin and oral Benadryl.
1 week post injection, injection site became itchy, red, hot, swollen. The redness spread & got larger throughout the day. Determined to be a cellulitis.  Required antibiotics.
Left shoulder pain, xray ordered, cortisone injections. Physical therapy ordered. Patient reports injection given quite high near the subacromial area.
Since the vaccine I have severe shoulder pain and limited range of motion.  Over the counter pain medications does not help at all and the pain has not improved at all.
Information has been received from a physician concerning a patient who on 08/12/1995 was vaccinated with a dose of varicella virus vaccine live.  on 01/20/1996 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Erythematous rash surrounding site of injection, right arm, central part of rash is indurated, tender, with itching Benadryl, cool compress to area.
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 16 years old female patient who received first and second dose of vaccine IMOVAX RABIES lot number not reported via unknown route in unknown administration site on an unknown date and missed third dose of IMOVAX RABIES. The patient's past medical history included patient was bitten in another country and did not come to the clinic till a month after the bite. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was reported that the office staff had ordered IMOVAX online to be overnighted to be at the office by noon today but they did not receive it. It was sent by regular mail. The patient was coming in at 4 PM to get her 3rd shot today. Caller said it is Pasteur's fault that they did not ship it overnight even though she paid for it. She was given the first 2 shots in the ER as their office did not have it in stock. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
A non-serious spontaneous report of administration of expired product was received from a pharmacist concerning a nine-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 02-Jan-2011. On 05-Jan-2011, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
A report has been received from a Physician concerning a 6 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Dec-2014. It was reported that patient received expired FLUMIST QUADRIVALENT which started on 02-Dec-2014. The outcome of the event of patient received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
July 19th-increased sleepiness-vomiting- decreased urine output taken to ER-see attached (1) Abd x-ray-showed multiple dilated bowel loops. US-sign. amt free fluid. Labs-increased WBC. 7/20/15 pt taken to operating room.
Date and time adverse event started:  03/21/2021 Evening- Body aches, chills, nausea- Still occurring 03/21/2021 Evening- Diarrhea- Resolved 03/22/2021 Morning Date and time of vaccination: (list both if they received both shots):   1st Dose- 02/21/2021 @ 09:30 2nd Dose- 03/21/2021 @ 09:30 Brand and lot of vaccine:  Moderna Lot # 00LA21A- 1st Dose                          044A21A- 2nd Dose
pt broke out in hives;pt was still in clinic;pt was immed given epi & decadran;hives worsened & pt was given another epi & DPH;pt was nearly clear of hives prior to leaving clinic;
Syncopal episode post HPV vaccination. B/P 105/71, P. 84 with possible brief loss of consciousness.
he experienced dizziness described as a balance issue and when standing up, he was unstable; he experienced dizziness described as a balance issue and when standing up, he was unstable; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN9581 and expiration date not reported), via an unspecified route of administration, administered in left arm, on 05Feb2021 12:00 (at the age of 73-years-old), as dose1, single for Covid-19 immunization. The patient's medical history included Type 2 diabetes mellitus from 2016. Concomitant medications were not reported. No prior vaccinations within 4 weeks. Patient stated that, when he got up this morning (09Feb2021), he experienced dizziness described as a balance issue and when standing up, he was unstable. Patient experienced something for the first time. He woke up feeling like he never has had before. He was not dizzy. He was imbalanced and was not stable. The room was not spinning but when he stands, he has to get his balance. No relevant lab tests reported. Outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
102.7 fever for 24 hours - 100.3 for 14 hours Severe nausea Extreme tiredness - slept 34 of 36 hours Migraine Site swelling
Starting 12-10-10 noticed discoordination, followed by tingling in fingers, symptoms progressed to admission at hospital, with diagnosis of GUILLAIN-BARRE Syndrome. Spent 8 days in hospital and received immune-globulin.
Symptoms began 2 days after vaccine and progressed: spasms/burning in testicles, bladder, thighs, legs; numbness in buttocks, penis; frequent urination and urinary retention; hoarseness; sexual dysfunction; neuropathic burning in legs, feet, palms.
~ 10 minutes after vaccine, patient started c/o chest tightness and SOA.  Pulse ox was 95%, BP 204/79, P-83.  Patient stated that she experienced same symptoms when she went to ED for chest pain and was given Morphine.  At 10:04 AM Patient was given Pepcid 20 mg, Benadryl 25 mg, and Zyrtec po.  She had difficulty swallowing those pills.  Lung sounds clear. Oriented X3.  EKG was normal.  After about one hour of observation with no relief, she was transferred to UKED.  BP was 131/50, P-97 and Pulse ox 98% just prior to transfer.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers xx of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Acute liver failure w/in 36 hours of vaccination.  6-month-old FT male with no significant PMHx.  01/07/2010: Pt was at 6-month WCC in AM.  Rec'd HIB and FLU vaccines at approx 10:00 AM.  Unusual fussiness, gassiness, difficulty sleeping in evening.  01/08/2010: Unusual tiredness in PM.  Emesis x 2, listlessness from 5:30 to 7:00 PM.  Mother called pediatrician. Pt fell asleep at approx 7:30 PM.  At approx 10:00 PM mother heard pt make unusual high-pitched screams, found pt limp and unresponsive w/ hypothermia (rectal 93 F), diaphoresis, shallow breathing, and blue around the lips.  Hypoglycemia and GI bleeding confirmed in ER.  Dx: Acute liver failure of unknown etiology.  Presumed sepsis.  Coagulopathy.  GI bleeding.  Hypoglycemia.  Hypothermia.  Acute hepatitis.
Low fever, body aches, chills, exhaustion.  I took one acetaphetamine tablet and slept. Fever broke overnight. Body aches continued into the next day.
Pt was given pediatric dose of Pfizer. Pt had turned 12 the day before vaccine was given. Should have received a  Pfizer 12+ dose.
c/o of bilateral wrist ache and pain following injection.  Also pain in R side of spine, midway.  No SOB, or other signs of allergy
Double polio dose/the patient received another dose of polio; 2-year-old patient that was supposed to receive DTap and polio doses received Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9PZ, expiry date 24-NOV-2023) for prophylaxis.   Co-suspect products included POLIO VACCINE for prophylaxis.   On 18-OCT-2023, the patient received Pediarix and POLIO VACCINE. On 18-OCT-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Double polio dose/the patient received another dose of polio) and wrong vaccine administered (Verbatim: 2-year-old patient that was supposed to receive DTap and polio doses received Pediarix). The outcome of the overdose and wrong vaccine administered were 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: 18-OCT-2023 The reporter called to inform that earlier that day, a patient was supposed to receive DTap and polio doses received Pediarix. However, shortly after the administration of Pediarix, the patient received another dose of polio, from the manufacturer Sanofi, which led to overdose and wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Narrative: The patient received two doses of Pfizer COVID 19 Vaccine in April 2021 and Jan 2022. The patient tested positive for COVID 19 on 12 Jan 2022. The patient was admitted to a community hospital with dizziness and confusion due to COVID 19. The patient left the facility against medical advice and ended up admitted to another hospital on 19 Jan 2022 with covid pneumonia. The patient was treated with dexamethasone and discharged on 1 February 2022 in stable condition. Reported per EUA.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-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: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result; Negative, notes: 3 days after I tested negative; Positive, notes: I started to fill ill again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had other unspecified medical history. Concomitant medications information: pantoprazole, hydrochlothiazide. 3 days after, patient tested negative, patient started to feel ill again and tested positive. Patient had Paxlovid for COVID 19 Treatment from 30Jun2022 to 05Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them; This spontaneous case was reported by a consumer and describes the occurrence of DRUG EFFECT LESS THAN EXPECTED (all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG EFFECT LESS THAN EXPECTED (all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them). At the time of the report, DRUG EFFECT LESS THAN EXPECTED (all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.  Company comment: This spontaneous case concerns a male patient of unknown age with relevant medical history of Liver transplant and immunocompromised reported, who experienced the unexpected non serious event of Drug effect less than expected in the context of unspecified dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported that as all of the mRNA vaccines (including the Moderna bivalent), but mRNA does not work well for them. No further information on clinical course, investigations, treatment of the event, details of previous doses was available in the report. The outcome of the event was unknown. Relevant medical history may remain as confounder to the event. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with relevant medical history of Liver transplant and immunocompromised reported, who experienced the unexpected non serious event of 'Drug effect less than expected' in the context of unspecified dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported that as all of the mRNA vaccines (including the Moderna bivalent), but mRNA does not work well for them. No further information on clinical course, investigations, treatment of the event, details of previous doses was available in the report. The outcome of the event was unknown. Relevant medical history may remain as confounder to the event. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.
Received immunizations in left arm 1/30.  1/31 complained of arm soreness and noticed enlarged left supraclavicular node plus achiness.  2/2 fever and cold symptoms develop.
I developed a macular type of lesion in the medial aspect of left axilla( about 3-4 mm in diameter) 3 days ago. It is a single lesion which has now developed into a papule.  Before that I developed mild flu-like symptoms with muscle aches and slight fever(which lasted a few hours) The papule itself is mildly tender and it had a reddish base which has disappeared now. The constitutional symptoms are gone now.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021).The location of the vaccination site were Mixmed pharmacy. It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed. No concomitant medications were reported No treatment medications were reported
white circle appeared around the injection site.; There is no pigment in my arm in that 1/2" diameter circle.; The soreness is the same as a bruise; The soreness is the same as a bruise; Dizziness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; AZITHROMYCIN. Past drug history included: Albuterol, reaction(s): "Known allergies: Albuterol"; Penicillin, reaction(s): "Known allergies: Penicillin"; Duricef, reaction(s): "Known allergies: Duricef"; Steroids, reaction(s): "Known allergies: Steriods". The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "white circle appeared around the injection site."; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "There is no pigment in my arm in that 1/2" diameter circle."; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious), outcome "unknown" and all described as "The soreness is the same as a bruise"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Additional information: Patient was not pregnant at the time of vaccination. Patient was not patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient neither diagnosed with covid-19 prior to vaccination nor after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an office manager and a physician, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female who on 25-OCT-2007 was vaccinated with a 0.5 mL first dose of GARDASIL (Lot # 658488/1264U). On 22-JAN-2008 the patient was vaccinated with a 0.5mL second dose of GARDASIL (Lot # 659657/1487U). At the end of January the patient had a positive pregnancy test (LMP: 15-Jan-2008, EDD: 21-OCT-2008) and is now two months pregnant. The patient sought unspecified medical attention. Follow up information was received from a healthcare worker who reported that at the time of reporting the patient had not "actually" delivered her baby, although, "everything was fine now." Upon internal review, implied pregnancy loss was considered as an other important medical event. Additional information has been requested.