chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via pediatric medical records concerning a 2 month old male (birth weight 6 pounds 7 ounces) with no known drug allergies who on 10-JUL-2008 (1 month old) was vaccinated with the first dose of RECOMBIVAX HB (lot # 655871/057OU). On 11-AUG-2009 the patient was in the office for well child check. The physician's impression was thrush, constipation with lots of crying and irritability. Nystatin, 100,000/dose, 2 dose daily PO was prescribed. Formula changed and guided stools for 3 times. On 11-AUG-2008, the patient was vaccinated with TRIPEDIA (lot # C2935AA) and IPOL (lot #A0127) into the right thigh; the first dose of PREVNAR (lot #C80884) into the left thigh; the first dose of ROTATEQ (lot #660289/1888U) PO. On 29-SEP-2008 the patient was in the office with complaint with increased irritability, decreased appetite, cranking, fever (temp 101 degree), running nose and cough. The patient was fed Tylenol. The physician's impression was upper respiratory infection (URI).  Treatment with Tylenol, 100/package every 4 hours and Amoxicillin, 250/package, 1 package BID for 5 days was prescribed. On 10-OCT-2008 the 4 month old patient was in the office and was noted teething, drooling, a rash on head and scalp with several erythematous patches. On 10-OCT-2008, the patient was vaccinated with the first dose of PEDIARIX (lot #AC21B150AA) IM into the right thigh; the second dose of ACTHIB (lot # UF454AA) and the second dose of PREVENAR (lot# C65046) IM into the left thigh; the second dose of RECOMBIVAX HB (lot # 660880/0923X) PO. On 17-NOV-2008 the patient was in office with complaint with coughing for 3 days and irritability. The physician's impression was cough and probably teething. Tylenol was prescribed as necessary. On 14-JAN-2009 the patient was in office with complaint with discharge from left eye for 5 days. pulling left ear and no fever. The physician's impression was conjunctivitis. The physician prescribed Amoxicillin suspension, 250mg/5ml, 3ml q12h PO for 10 days and Tylenol PRN. On 24-FEB-2009 the patient was in office and vaccinated with the second dose of PEDIARIX (lot #AC21B150AA) and the third dose of PREVENAR (lot # D03124) IM into the right thigh; the third dose of ACTHIB (lot # UF505AB) IM into the left thigh; the third dose of ROTATEQ (lot # 661579/0899X) PO. It was reported previously that when the patient's mother was pregnant, she was vaccinated with HPV (WAES # 0711USA02981). Additional information is not expected.
The adverse event occurred the next morning when the pain from the injection sight on the left upper arm felt like it moved into my armpit and left side lymph nodes.  Very painful accompanied it.  The day after that the lymph nodes in my left collarbone area became swollen and painful with an increased fever, chills, headache that lasted for a week.  I got the vaccine on a Thursday (3/4/21) and went to my doctor on Monday (3/8/21) to get checked out.  This was only my first vaccine.  I had a bad case of Covid-19 in June-July 2020 and my husband passed from Covid-19 at that time.  I still have swelling in my left collarbone lymph nodes today.
sinuses just started and her sinuses are really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: EW0169) as dose 1, single for covid-19 immunisation. Relevant medical history included: "has sinus issues because she just moved " (ongoing). The patient's concomitant medications were not reported.  The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "sinuses just started and her sinuses are really bad".  Additional information: Caller states her sinuses just started and her sinuses are really bad and she took the 1st dose of the Pfizer shot and has an appointment to take the 2nd dose of the Pfizer shot on the 11th of the month. does not have permission to do that and she herself is just sick with her sinuses and that has nothing to do with the vaccine and she has sinus issues because she just moved; States she herself is in otherwise good health and this is just her sinuses and she thought she was calling the location of the facility that gave her the Pfizer COVID vaccine and wanted to ask them how to go about her situation and did not know she was calling Pfizer.   No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA 4:30am 1/30/21 Vomiting about 3 Hrs. Chills for about 6Hrs. Body aches started around 10:30 on 1/30/21  lasted about 3.5 Hrs. Started get a fever of about 101 around 3:00 pm used Tylenol by 10;00 pm 1/30/21 symptoms seem to be gone.
A non-serious spontaneous report of H1N1 Mist went into the patient's eye was received from a registered nurse concerning a 30-year-old male. The patient's medical history and concomitant medications were not provided. On 19-Oct-2009, the patient received H1N1. During administration of the first half of the dose some of the vaccine went onto the patient's glasses and some got in his eye. The second half of the dose " was administered to the other nostril appropriately." There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
soreness at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2018, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the physician for his wife. The patient received the 1st dose of the Shingrix and only experienced soreness at the injection site. At the time of this call the representative was unable to obtain additional information, because the call was disconnected. Hence the representative called back and left message. The physician did not give consent to follow up. This case has been linked to the US2019087006, reported for the dose 2 of the same patient by the same reporter.
fell asleep her tongue on the left side; headache; muscle pain; dizziness; This is a spontaneous report from a non-contactable consumer (herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. Medical history was not reported. Concomitant medication included cresol (LYSOL [CRESOL]), via an unspecified route of administration from an unspecified date on an unspecified date, for unspecified indication. A Consumer called for information about the efficacy of Pfizer's COVID-19 vaccine if she accidentally inhaled some Lysol aerosol. The Consumer reported on 09May2021 that she accidentally inhaled some Lysol aerosol and fell asleep her tongue on the left side, which was the side where she was given the first dose of Pfizer's COVID-19 vaccine. The Consumer reported that she received the first dose of the vaccine yesterday and after administration of the first dose she suffered from headache, muscle pain and dizziness. The consumer response that today she has good health. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial was place in refrigerator on 01-Mar-2022 and vial did not undergo any temperature excursion.  It was reported that patient did not experience any adverse event.
dizzy 30hr post vax hip & spine pain;could barely walk;could not focus properly;extremely tired could not get out of be x 2 days;eyes are still sensitive;unconscious for 12 hrs & in & out of consciousness for the entire day & following nigh
Sore arm near the injection site; This is a spontaneous report from a contactable consumer. A 33-years-old Non pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247,expiration date was not reported), dose 1 via an unspecified route of administration, administered in Left arm on 05Feb2021 14:00 (age at vaccination is 33 years) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON). The patient previously took morphine, sulfa drugs and experienced drug hypersensitivity. On 05Feb2021 18:00 the patient experienced sore arm near the injection site Soreness started approximately four hours after vaccination and has persisted at least 24 hours. Outcome of the event was recovering.    Follow-up attempts are completed. No further information is expected.
Rash, UrticariaPruritus, pain and inflammation at injection site Narrative:
My whole body started feeling sunburned about 8 hours after getting the vaccine. My skin was very tender all over. There was no rash.
Pt. states 04/09/2021 @ 8:30am started experiencing symptoms from injection site (paralysis), numbness in the face (Left) droop 30mins-45mins, 05/18/2021 numbness in the face/difficulty speaking 2-3hrs, 06/12/2021 again numbness in the face05/20/2021 diagnosed with male Breast Cancer. Breast tissue removed. 06/27/2021 severe facial droop, whole numbness left-side of body, Admitted for observation. 06/28/2021 discharged TIA. Currently experiencing numbness.
This spontaneous report as received from a pharmacist refers to a healthy 59 year old female patient. Medical history and drug reactions or allergies were not specified. On unspecified date in 1993 (also reported as since 1993) the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route, lot # not reported). On approximately 1998 (also reported as every 5 years since 1993), the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route, lot # not reported). On approximately 2003 (also reported as every 5 years since 1993), the patient was vaccinated with the third dose of PNEUMOVAX23 (dose, route, lot # not reported). On approximately 2008 (also reported as about 6 years ago), the patient was vaccinated with the fourth dose of PNEUMOVAX23 (dose, route, lot # not reported). Concomitant medications were not specified. The pharmacist reported that a patient had been receiving PNEUMOVAX23 every 5 years since year 1993 because she worked in public. No adverse effect was reported. Additional information has been requested.
Pt given PREVNAR vaccine - indication age > 65. 3 days later developed urticarial abdominal pain no anaphylaxis - went to ER improved with steroid injection. Diagnosed as allergic reaction - steroid taper, BENADRYL given no other obvious cause of allergic reaction noted.
Swelling of lymph node under left armpit after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph node under left armpit after covid vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling of lymph node under left armpit after covid vaccine). At the time of the report, LYMPHADENOPATHY (Swelling of lymph node under left armpit after covid vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   It was reported that Humira was not effective.  The reporter's causality for the event(s) of Humira was not effective was not provided. The reporter's causality for the event(s) of Swelling of lymph node under left armpit after COVID vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Dizziness following vaccination, swelling of eyes, slight facial swelling around cheeks and eyes. without resp distress. BP 138/94, 76, 18, 98%, BS 135
Rash, itchy (not painful). Lidocaine, Valacyclovir given to patient by MD. Confirmed case of shingles per MD.
Left deltoid area with swelling. Approximately 7cm in diameter, also mild fever the night before.
EXTREME SWELLING IN LEFT ARM & DEBITATING PAIN Requiring  continuous.ice packs for 24 hours
Breakthrough COVID-19 case. Symptoms: pharyngitis, nasal congestion, fatigue, fever > 101ºF, chills, cough, difficulty breathing, bronchospasm. Most symptoms resolved after 2 weeks, with lingering cough and fatigue remaining to 4 weeks. Treated symptomatically at day 8 for bronchospasm with albuterol HFA inhaler.
Fairly severe chills and muscle ache in lower back. Body temperature was normal and no local irritation at injection site or any other symptoms. Treatment was (1) covered myself with an electric blanket on high and (2) 600 mg of ibuprofen which resolved both problems within 1 hour. To date, no return of these symptoms or any other problem.
Upon waking 11/21/2003 parents noticed left thigh to be significantly larger with localized swelling and redness. Diameter of left thigh 34 cm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EH9899), in left arm, on 10Feb2021 as dose 2, single (Lot number: EK4176), in left arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Gold" (unspecified if ongoing), notes: Allergies: Gold; "known Allergy: Manganese" (unspecified if ongoing), notes: known Allergy: Manganese. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: followed by positive antigen test; (Jul2022) Positive, notes: positive COVID test; (Jul2022) Negative, notes: Two negative antigen tests day 8 and 9; (Jul2022) Negative, notes: Two negative antigen tests day 8 and 9. Therapeutic measures were taken as a result of covid-19. The patient received other medication that was anti-viral product Paxlovid (start date: 17Jul2022 to stop date: 22Jul2022) for treatment of covid-19 and Claritin D (details unspecified) within 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe new persistent Left sized chest pain, severe persistent  left sized lung pain, nausea, chest fluttering, abnormal fatigue, inability to lay on left side due to lung pain, shortness of breath, muscle ache in left arm , generalized severe joint pain and pain in hands like being sliced with razor blades.
Edema, pain, fever take Ibuprophen and Benadryl, ice arm.
Patient was admitted for treatment of UTI, antibiotics and fluids were given.  Was found to be COVID + on admission, no treatment required.
RN removed vial of what was thought to be a new box of COVID bivalent vaccines, which was in fact COVID monovalent box in the "COVID Bivalent" bright yellow bin. COVID box was not labeled "Monovalent" as it has been in the past when received from pharmacy, which indicated to RN that it was the bivalent, as it was also placed in the bivalent bin. RN pulled up all 6 doses up, and put them in the appropriate area for MA distribution. All COVID doses were distributed to patients. Alternate RN was notified that the clinic needed more bivalent doses, and went to the fridge to grab a vial of COVID bivalent vaccine to pull for distribution. Once at her desk, RN noticed that the vial stated "COVID Vaccine", Not "COVID Bivalent". RN went back to verify that the box was also monovalent placed in the wrong bin. RN discussed with administrator RN that it might have been monovalent distributed, administrator RN confirmed that the vial used this morning for vaccines was pulled from the monovalent box that was labeled without "monovalent" and put in the COVID Bivalent bin.  RN and administrator RN went to nursing supervisor to report the incident. PRIVATE was onsite who was the previous Nurse Supervisor. PRIVATE contacted IT in pharmacy to obtain a list of the patient's administered vaccines today. List retrieved. Administrator RN notified patients on 1/19 Per MD infectious disease head, 2 months until patients can receive bivalent dose.
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 001B21A), in left arm, on 18Apr2021 as dose 2, single (Lot number: 041B21A), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 037C21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION HCL. Past drug history included: Augmentin, reaction(s): "Drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
DEVELOPED RASH IN ARMS, BACK AREA AND EXTREMITIES, SWELLING OF WRIST AND BOTH HANDS, KNEE PAIN, MUSCLE PAIN, SORE THROAT, WEAKNESS, FAST HEART BEAT FOR 3 DAYS AFTER VACCINE ADMINISTRATION.
This spontaneous report was received from a physician via company representative refers to a 17 year old male patient. On 06-AUG-2013, the patient was vaccinated with first dose GARDASIL, (lot # H020002, expiry date was 08-AUG-2015, route was not reported). Other suspect therapies which were also administered on 06-AUG-2013, included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE), meningococcal conj vaccine (unspecified) (MENINGOCOCCAL CONJ VACCINE (UNSPECIFIED)) and chickenpox vaccine (unspecified) (VARICELLA VIRUS VACCINE LIVE (UNSPECIFIED)). On 06-AUG-2013, the patient fainted. The patient had not eaten all day. The patient was given oxygen as a treatment. There were laboratory diagnostics provided. The outcome of fainted was reported as recovered on the same day. It was stated that the patient planned to continue with the series. The patient sought medical attention. Additional information is not expected.
Patient notified pharmacist of severe pain in arm two days after the injection. She stated she could not sleep on that side. She did not take anything for the pain and it resolved without issue.
This spontaneous report as received from a consumer refers to a 73 year old male patient with no pertinent medical history. On 22-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 and a dose of influenza virus vaccine (manufacture unknown) in the same arm (dose number, dose, frequency, route and lot# not reported). On the same day, the patient received his allergy shots (manufacture unknown) in his other arm (dose number, dose, frequency, route and lot# not reported). After receiving PNEUMOVAX23 and influenza virus vaccine (manufacture unknown) in the same arm, on an unknown date in 2013 the patient experienced pain and swelling at the injection site. The patient also experienced some itching after receiving allergy shots (manufacture unknown). The patient did not receive any treatment and any lab diagnostic studies. The patient also did not seek any medical attention. On an unspecified date, the outcome of all events was reported as recovered on therapy. The patient was not reintroduced. The patient reported TYLENOL, OXYCONTIN and oxycodone did not work for him and he was allergic to them. The patient was also allergic to heparin. Additional information has been requested.