chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On 10-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dosage and lot# unspecified). On 16-JAN-2014, the patient experienced long list of adverse events. The outcome of the event was unknown. No further information provided as the pharmacist was too busy to answer questions for the report. Additional information has been requested.
Round 3inches diameter Red, swollen, itchy, site, raised Live one large hive. Hot to the touch. Treatment was ice applied to site. Swelling is down but site still red. I did not see a physician about this reaction.
For 3 weeks following receipt of the vaccine, patient exhibited fatigue (required naps when she previously did not), exercise intolerance, decreased appetite, and sudden insatiable desire for sweets when she previously did not ask for sweets. Symptoms resolved after 9/14/22.
REDNESS, HEAT, WELTS. PT INSTRUCTED TO TAKE BENADRYL AND SEEK MEDICAL ATTENTION IF WORSENING.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 02-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005164: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Mild welts on face; sore arm; mild headache; This is a spontaneous report from a non-contactable consumer. A 41-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on 26Feb2021 as 1st dose, single for COVID-19 immunization. Facility type vaccine was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient did not had known allergies. Medical history was reported as no and concomitant medications were not reported. The patient experienced mild welts on face on 3rd day after first shot In addition to sore arm and mild headache on 28Feb2021. The patient did not received treatment for the events. The outcome of the events was reported as recovered on an unspecified date. No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Nose bleeds; This is a spontaneous report from a contactable health care professional (patient). A 56-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 24Feb2021 at 08:30 (Lot Number: EL9267) as dose 1, single for COVID-19 immunization.  The patient did not have any medical history and had no known allergies. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccinesin four weeks. The patient was not tested for COVID-19 post vaccination. On 01Mar2021 at 12:00 the patient experienced nose bleeds. The patient did not receive treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
5 patients out of 100 complained of persistent pain lasting approximately 2-3 weeks from shoulder to elbow, across the arm after they received Fluzone (lot unknown, date not reported). Follow up information received on 30/Jan/2006. Per the reporter, the orthopedic evaluation and the MRI indicated that the patient had an impinged nerve. The symptoms became noticeable at the time of the vaccination, but was not directly caused by the vaccination.
expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  On 12-Nov-2021, all vaccines were administered within 2 hours.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up information received on 18 Nov 2021 included suspect administration date. On 19-Nov-2021: Follow-up information received on 19 Nov 2021  included about patients details On 19-Nov-2021: Significant Follow up received on 19 Nov 2021 appended (Second reporter Information was updated)
Patient received Moderna COVID vaccine at 1926. She completed standard 15 min observation time and was dismissed from clinic. Patient returned to clinic at 2000 with redness at injection site, itching, chills. BP 126/90 and pulse 86, patient able to speak comfortably.  Diphenhydramine 25 mg given orally. Patient observed for 36 minutes. All symptoms resolved and observed redness to left deltoid completeely resolved. No complaints of shortness of breath or difficulty breathing. Patient discharged from clinic to another facility with appropriate follow up instructions. Patient texted ahead to her preceptor that she is en route.
No adverse event; Improperly stored PROQUAD was inadvertently administered; Information has been received from a medical assistant concerning to a 11 year old male patient. No medical history nor concurrent conditions were reported. On 31-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S012536, exp. date 20-OCT-2020) (rHA) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Pt received 2nd Gardasil; Tdap, Hep A on 3/29/07 and 3rd HPV on 1/21/08, 2nd Hep A, and flu vaccine. Pt had syncope spell in office after vaccines given. On 1/21/08 - went to dance class x 3 hours after left office. Pt has not had dizzy spells and sore throat since 1/21/08.
Racing heart rate 100-150 for three hours paired with fatigued. Heart rate elevated compared to normal when resting afterwards
04/04/14 client reports that by evening of vaccination day she was feeling achy with a mild, continual headache. She did not have a fever and did report taking ADVIL helped. Encouraged client to continue taking ADVIL if she was able to, drink fluids and get some rest. If symptoms continued enc. client to seek medical care. 04/07/14 follow up call to client. Reports not a lot of change. Low grade fever of 99 degrees F. Has appt to see her primary care provider. 04/11/14 follow up call client reports provider thought it was a prolonged reaction to vaccination. Cont. with ADVIL. Reports though that 04/09/14 evening she developed aphasia x2 nights (Wed and Thurs) and was taken to ED. Stayed the night and had various tests performed: MRI, USounds, etc. to r/o stroke. All tests came up inconclusive. She was told that it was possibly TIA. Is following up with ophthalmologist today. No longer has body aches and has less of a headache today.
Narrative: Patient has received 3 Pfizer COVID vaccines on 2/25/2021, 3/18/21, and 10/2021. Patient comes to the ED 6/3/22 for increased SOB and found to be COVID positive. Patient still currently hospitalized and receiving IV remdesivir for COVID treatment.
Violent headache for 48 hours. Other symptoms such as fever 101, joint pain, nausea persisted for upto 3 days.
blood clot in between muscles; huge pain in his left leg (same side where he got the vaccine shot); This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 51 years (as reported) on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 for Covid-19 immunization. 10 days after getting the second dose of the Pfizer BioNtech Covid-19 Vaccine, patient felt a huge pain in his left leg for a week (same side where he got the vaccine shot) and when he went to the doctor, he was told that he had a blood clot in between his muscles. Patient was about to have his booster dose by tomorrow and was concerned if it would be a contraindication for him. Patient wanted to know if the blood clot and leg pain that he experienced after getting the second shot of the Pfizer BioNtech Covid-19 vaccine would be a contraindication for his booster shot tomorrow. Seriousness was reported as no. The outcome of the event Leg pain was recovered with duration of 7 days, other event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Redness about 4 inches in diameter, Swelling, Lump, Pain in area, Flu like Symtoms Stated 08/07/2014 8:30 AM
Presented 4-19-10 at office c/o itchy rash. Open vesicles on face and extremities. Had fever over weekend.
The patient had her Moderna COVID booster on 12/18/2021.  The next day she developed persistent chest discomfort.  An ER visit shoed normal troponin levels and nonspecific ST findings on the EKG.  When I first saw her 12/28/2021, she had persistent chest discomfort consistent with pericarditis.  An echo was normal.  I am treating her with ibuprofen and colchicine.   As noted, her presumptive diagnosis is post vaccination pericarditis.
Within 15-minutes of vaccination, the patient reported feeling near-syncopal. EMS evaluated the patient on-site. The patient was hypotensive (93/63) and bradycardic (56bpm) with a FSBG of 91mg/dl. EKG demonstrated sinus brady, rate 50bpm, no ST elevation. EMS administered 4mg Ondansetron PO. EMS transported the patient to Hospital Emergency Department. In the ED, the patient reported they felt weak, dizzy, and briefly lost consciousness. The patient was not in any acute distress, but was hypertensive (141/78). The patient left AMA without a diagnosis after "waiting too long" and was informed of the risks of leaving the ED prior to complete evaluation.
patient experienced severe aches and tingling in the entire arm, high fever ranging from 102-103°F  after receiving the second dose of GARDASIL 9 on July 13, 2019; patient experienced severe aches and tingling in the entire arm, high fever ranging from 102-103°F  after receiving the second dose of GARDASIL 9 on July 13, 2019; patient experienced severe aches and tingling in the entire arm, high fever ranging from 102-103°F  after receiving the second dose of GARDASIL 9 on July 13, 2019; Therapy start date: "July 12, 2018" / second dose of GARDASIL 9 on July 13, 2019; This spontaneous report was received from patient's mother referring to her 12-yearold daughter.  The patient did not have concurrent conditions, medical history, previous drug allergies, reactions or concomitant therapies.  On 12-JUL-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in her left arm (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for Human Papilloma Virus (HPV) prophylaxis.  On 13-JUL-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  in her left arm (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On 14-JUL-2019, she experienced severe aches and tingling (paraesthesia) in the entire arm. Additionally, high fever ranging was reported (102-103 Farenheit degrees (°F) (pyrexia). The patient sought medical attention, unspecified routine blood work was performed on an unspecified date (results not provided), and treatment with ibuprofen was given for the events. At the reporting time, the patient had not recovered from pain in extremity (severe), paraesthesia (severe) and pyrexia.  Relatedness between pain in extremity (severe), paraesthesia (severe), pyrexia and  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was not reported.
sore throat, cough, diarrhea, runny nose, chills. starting on 1/2/22
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 34-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.   This case was linked to MOD-2022-501575 (Patient Link).
9 days after 2nd dose, I am still experiencing headache, dizziness, fatigue, light headedness.
Thrush infection; breakthrough COVID infection 18 days after second vaccine in March; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough COVID infection 18 days after second vaccine in March) and CANDIDA INFECTION (Thrush infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (breakthrough COVID infection 18 days after second vaccine in March). On an unknown date, the patient experienced CANDIDA INFECTION (Thrush infection). At the time of the report, COVID-19 (breakthrough COVID infection 18 days after second vaccine in March) had resolved and CANDIDA INFECTION (Thrush infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication information were provided.  No treatment information provided.   This case was linked to MOD-2021-317852 (Patient Link).
This spontaneous report as received from a consumer refers to a 13 year-old female patient. On an unknown date, the patient was vaccinated with GARDASIL 9, one unspecified dose (dose number, exact dose and route of administration were not reported; lot # L036245 with the expiration date of 09-FEB-2018), for prophylaxis. The patient's mother did not authorize the physician's office to vaccinate the patient with GARDASIL 9.
1-dose on 2021, not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received first dose of Shingrix on 22 November 2021).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 23-JAN-2023 Reporter's comment: The pharmacist had reported that, a patient had received first dose of Shingrix, and had not received a second dose yet at the time of reporting. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: Additional supportive information: until the time of reporting, the patient did not receive the second dose of Shingrix, which had led to incomplete course of vaccination. The provided corresponded to the first dose of Shingrix as the second dose was not administered yet.
March  2021: Developed Genital Psoriasis as diagnosed by GP. Prednisone injection and 10 day treatment was required to clear it. Previously 2 rounds of treatment for yeast infection had not been successful. (under stress with preparations to move, sell house and furnishings as possible precursor to this condition ).   May 2021:  Developed skin tear on left arm that would not heal and diagnosed with cellulitis.  Prescribed doxycycline monohydrate and worsening of the area after 3 days. Prescribed sulfameth/trimethoprim with some improvement.   Another round  of sulfameth/trimethoprim June 23 after my  move to another city  July 16, prescribed clindamycin for 10 days and much improvement  July 29 - significant itching on right arm with extensive bruising. Also hardness and pink skin on left breast. Had immediate mammogram and ultrasound finding no unusual lumps and probable diagnosis of mastitis and cellulitis.  Prescribed sulfameth/trimethoprim again for mastitis but after 3 doses there was increased itching behind knees, inside arms, back so I discontinued that medication.  Took antihistamines for the itching. Non-drowsy claritin during the day and alternating again at night with benadryl for about a week.   Also developed overall tiredness, headache, coughing, sneezing and variety of symptoms of cold or allergies or covid. Had a negative covid test at Urgent Care on August 3, 2021.  Symptoms continued for about 10 days and beginning to get better with twice daily lotions and otc medications:   August 19  - Appointment with Dermatology for increased itching, rash, welts on legs, arms, back, chest Diagnosed Prurigo Nodularis   Additional blood work taken Prescribed NAC - 600 mg twice day may increase to 1200 twice daily  CeraVe Anti-Itch Lotion and Cream  (use morning, night, sometimes late afternoon also)  Fluconazole 150 mg 1 time each for 2 weeks   Protopic  (Tacrolimus Ointment .1%) under breast (improved)   Lyrica - Generic Pregabalin - prescribed 25 mg 1x per day for 14 days. Started this on Aug. 27  and gradually to increase to 100 mg per day  Some relief at this time but itching and welts are on-going. May 29: biopsy of fluids on skin around left skin tear regarding infection vs cellulitis  - negative June 23  blood work for potential concerns regarding infection/cellulitis  - all levels were in normal range July  16 biopsy of skin on right arm regarding infection vs infection vs cellulitis  - negative  July  29  mammogram and ultrasound regarding the hardness and redness of left breast - negative for cancer concerns, identified mastitis  August 19 blood work required by dermatologist for other issues that might identify the sudden occurrence of itching, welts and skin concerns - results were within normal range and nothing in addition was recommended
not severe pain on her arms, shoulders and neck; not severe pain on her arms; not severe pain on her arms, shoulders; This is a spontaneous report from a contactable consumer (husband) via Pfizer-sponsored program . A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration as single dose for COVID-19 immunization. Patient medical history included Parkinson's disease. The concomitant medications were not reported. On an unspecified date, the patient experienced not severe pain on her arms, shoulders and neck after receiving the first dose of Covid-19 vaccine.  The outcome for all the events was unknown.  No follow-up attempts are Possible. No further information is expected.
Patient reported to pharmacy to receive shingrix vaccine, but instead was given a Covid-19/Pfizer vaccine.  At this time, no adverse events have been reported by the patient.
Erythema, swelling at site of injection.  Area of erythema 3" X 4.5".
Vaccination received on 10/21/21. On 10/24 resident developed sudden change in mental status with hypertensive crisis requiring transfer to the Emergency Department.