chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHEST SORENESS; OCCASIONAL COUGH; MILD LABORED BREATHING; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 or 1855018 - she cant tell, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on Right arm. No concomitant medications were reported. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 21-MAR-2021, the subject experienced mild labored breathing. On 21-MAR-2021, the subject experienced chest soreness. On 21-MAR-2021, the subject experienced occasional cough. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, occasional cough, body aches, chills, chest soreness, and mild labored breathing. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAXS HB (dose, route of administration, lot # and expiration date not reported). On 26-MAY-2015, the patient received another dose of RECOMBIVAX HB (lot # L035881, expiration date 26-JUN-2017 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-FEB-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II (rHA) (lot # K000738; 16-JAN-2016; route and dose were not reported). No adverse effect was reported. Additional information has been requested.
COVID-19; COVID-19; 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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 29 years 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 was not reported. Concomitant medication(s) included: TYLENOL, start date: 19May2022, stop date: 25May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took paxlovid for the treatment of COVID 19. Treatment start date 19May2022, Treatment stop date 24May2022.Patient had Adverse events foul, bitter/metallic taste for entire course of Paxlovid.
first dose: 2019, second: did not received; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose(0.5 ml) received on 2nd october 2019, batch number 3553N, expiry date 26th November 2021, by intramuscular route on an unknonwn arm).   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 provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details were reported for 1st dose.
White particulate matter in the product; White particulate matter in the product; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FF8006) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT QUALITY ISSUE (non-serious), PRODUCT CONTAMINATION PHYSICAL (non-serious), outcome "unknown" and all described as "White particulate matter in the product". Additional information: NDC number of Prevnar 20: 00005200010. The reporter went to open a box, then opened two boxes to check them both. She went to put the syringe on and noticed that the product has particulate matter in it. States that they all have the same Lot Number and have white particulate matter in them. Caller states that she called other stores and they said they haven't had that issue. No patients have received the affected vaccines. The reporter has 17 affected vaccines; all from the same Lot Number. A sample of the product available to be returned, if requested.   Follow-up attempts are completed. No further information is expected.
Left lower pulmonary embolism.  Will be on anticoagulants for the remainder of my life.
Moderna COVID-19 Vaccine  Stiffness, pain, and swelling at injection site Flare up in fibromyalgia pain Fatigue Nausea Delayed ovulation
Noticed flesh colored rash 9-23-9 in groin on forehead & behind ears. + itch Strep cx-
On January 19th I broke out into hives all over my body. I still have them today in February. I?ve never been allergic to anything.
3 days after my booster shot my right shoulder was extremely sore it progressed over the hrs. until I could no longer lift my arm without assistance. This lasted for about 4 days. 1 day after my right shoulder felt better then my left shoulder did the same as my right one had. It was extremely painful and from past flareups I recognized  the symptoms to be an RA episode.   Since then in the last  18 days I've experienced a flare of the Sjogren's  as well as lingering effects from the initial RA flare.  This morning on 10/23/2021 I woke up with the shingles on the right side of my ribcage. I've never had shingles before. Very, very tired.
Fever of 101 on following day at 5am spiking to 107 by afternoon. Treated with Tylenol 20 Ibuprofen. Seizures 3 times on following day; 1 generalized tonic clonic lasting 6 minutes, 2 focal seizures lasting 1 minute each. Emesis 3 times.  Medical record on 05/05/04 states: fever, seizure to atypical febrile seizure.
We gave 4 doses of expired Moderna Bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) 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 (We gave 4 doses of expired Moderna Bivalent vaccine).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. This case is reported for patient 4 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730166 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730166:Master Case - Patient 1 Case
Client received 2 shots (both seasonal and H1N1 injections) around 2 PM at the clinic. He stated he felt fine afterwards. He proceeded to go climbing around 4:30 PM same day. Soon after he got a "tickle in his throat, started coughing, his tongue started to swell and his eyes got red, itchy and his lips started to swell. He got nervous and went to a clinic around 8:00 PM as listed in report earlier. His eyes became a little worse (burning and photo sensitive). Treatment he received: He was put on Prednisone (oral) tabs for 4 days. The next morning the swelling had gone way down and he felt back to normal.
T 101.7 X 1 day. Erythematous, raised rash approximately 5 X 7cm, mild tenderness @ injection site of MMR, left arm. No treatment required except Ibuprofen.
130PM 17NOV94 pt devel urticaria, wheals, varying in size from 1 cm to 4 cm were present to face, arms, legs & front & back torso; swelling also present to facial features; back torso also red from neck to buttocks;
I feel like crap; she was in bed all day, she felt like she had the flu or something; fever; soreness with every shot she has had; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 06Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Additional Information for Other medicines cholesterol pill: started years ago. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Lot/Batch no: EM9810), administration date: 04Feb2021, when the patient was 74-year-old, for COVID-19 IMMUNIZATION, reaction(s): "Pain in extremity"; BNT162b2 (DOSE 2, Lot/Batch no: EN6200), administration date: 24Feb2021, when the patient was 74-year-old, for COVID-19 IMMUNIZATION, reaction(s): "Pain in extremity"; BNT162b2 (DOSE 3, Lot/Batch no: FF2589), administration date: 08Oct2021, when the patient was 74-year-old, for COVID-19 IMMUNIZATION, reaction(s): "Pain in extremity". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Jun2022, outcome "recovered" (Jun2022), described as "soreness with every shot she has had"; FEELING ABNORMAL (non-serious) with onset 07Jun2022, outcome "unknown", described as "I feel like crap"; PYREXIA (non-serious) with onset 07Jun2022, outcome "recovered" (Jun2022), described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Jun2022, outcome "unknown", described as "she was in bed all day, she felt like she had the flu or something". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported her weight to be 126lb and was administered with dosage of a 2nd covid booster. After administration patient reported that, "I feel like crap, she was in bed all day, she felt like she had the flu or something". She reported that, she and her husband (210 lb) got the same dosage covid, but her symptoms were much worse outcome than her husband. The patient reported that, about 2am she was felt pretty ragged and she felt more ragged as the day wore on and she laid around most of the day. The patient also took half a sleeping pill as she needed to get some sleep and she took 2 Tylenol during the day and again night. She also added that her husband is "twice her size" and it "doesn't make sense that they both received the same dosage and wanted to know how was the dose  for the Pfizer Covid 19 vaccine adjusted as per weight.
The nurse injected the booster into my bicep on the side and not tricep. The area became red, indurated and after 24 hrs a cellulitis developed with intense pruitis all along the arm. I used an antihistamine for 4 days, no anitibiotics were required
This spontaneous report as received from a nurse refers to a unspecified number of patients. On an unknown date, the unspecified patients were vaccinated with improperly stored VARIVAX (Merck) (lot# J013733 and expiry date: 30-OCT-2015, lot# L007226 and expiry date: 03-MAR-2015, Lot# K002047 and expiry date: 10-FEB-2015) (dose, frequency and route were not reported). No adverse effects were reported. Additional information has been requested.
PAIN IN LEFT ARM, UNABLE TO LIFT ARM UP TO FULL RANGE ANY LONGER.
The patient came with her father and received her first covid-19 vaccine on 05//05/2021 around 11:00 am in our pharmacy, but we found out later that her actual age was 15 years, not 16 upon contacting her pharmacy insurance.  We called her father to verify her date of birth, and he admitted he knowingly gave us wrong information on her daughter's birth year in order to have her vaccinated.
patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer 1st dose lot#EW0183) on 08-Jun-2021 and Pfizer (Pfizer 2nd dose lot#EW0180) on 29-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 01-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported stated that the patient had not reported any side effects.
Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). Concomitant medications were not reported. No treatment information was provided by the reporter. That case contains information for the 14th adult patients out of 15 adult patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-658139 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 14.
Information has been received from a physician, concerning a female patient, who in July 2008 was vaccinated with 0.5ml GARDASIL IM. A few minutes post vaccination, the patient got very pale and fainted. While the patient was still unconsciousness her body jerked several times, and then she regained consciousness. The patient was fully recovered on an unknown date. The patient sought medical attention in the office. There was no product quality complaint. Additional information has been requested.
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in the left arm on 19May2021 at 12:00 PM (at the age of 74-year-old) as single dose for COVID-19 immunization. Vaccination facility was a pharmacy or drug store. The patient medical history included heart surgery in Dec2018 and allergy to Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included metoprolol, avorstatin, Omeprazole (PROTONIX), Acetylsalicylic acid (ASPIRIN) and TALAFAD (as reported) - all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 28Apr2021 02:30 PM as single dose for COVID-19 immunization. On 15Jun2021 at 04:45 PM in the emergency room, the patient was diagnosed with Bell's Palsy. A computed tomogram (CT) scan was performed (result unspecified) and the patient was prescribed prednisone and Valtrex (calaciclovir). Reporter considered event as serious (Disability or permanent damage). Outcome of the event was not recovered.  Follow up attempt possible. Information on lot/batch number has been requested.
Pediatric  dose administered to Adult; Pediatric  dose administered to Adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 42-year-old male patient who received HAV (Havrix pediatric) (batch number 95EG7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 2-Nov-2022 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: A pediatric dose of Havrix was administered by mistake to an adult patient, which led to underdose and adult use of a child product.
Flu-like symptoms including body aches, chills, headache, stuffy nose, extreme fatigue. Symptoms lessening 24 hours later.
Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023; No adverse event; HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Oct-2022, 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 18-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023) 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 EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023).    Concomitant medication was not reported. Vial size was 2.5 ml.  The vial did not undergo any temperature excursions. Treatment drug was not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-725148 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Significant follow up contains patient details and dose information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725148:Patient 1 out of 4 patients