chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) tablet for an unknown indication.    No Medical History information was reported.   On 01-Sep-2021, the patient started PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   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.
Pt walked to observation chair and passed out, losing consciousness  for 1 - 2 minutes and losing control of bladder. She felt strange  and faint. Vital signs taken 79/37  Pulse 43
Arm sore as expected after injection. First vaccine only sore arm.   Second dose on 2/11/20 very sore arm then around 1:30am i woke up with chills a fever of 100 and body aches which continued all day on 2/12/21. I still feel kind of blah but nothing I can?t handle at this time.
This spontaneous report was received from a Registered Nurse concerning unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates since 02-SEP-2015, the patients were vaccinated with GARDASIL (two doses from lot # J003727, expiration date 07-NOV-2015; three doses from lot K016966, expiration date 10-MAY-2017; unspecified number of doses from Lot K010215, expiration date 05-MAY-2017). No adverse effect was informed. Additional information has been requested.
Patient received Pneumovax 23 on 9/25/2020 .  She stated that the shot was painful when it was administered.  A week later, she stated she had a swollen gland underneath her armpit.  She went to the doctor who prescribed her antibiotics.  The swollen gland did not go away.  She states that it is still swollen 3 months after the fact.
Arm swelling; Arm rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling) and RASH (Arm rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078czia) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelling) and RASH (Arm rash). At the time of the report, PERIPHERAL SWELLING (Arm swelling) and RASH (Arm rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
No adverse effect; improperly stored vaccine administration; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient with unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 10-SEP-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, frequency and route were not reported) (lot # S002874, Expiration Date: 29-JAN-2021) for prophylaxis. There was no adverse effect. The stored temperature was 6 Fahrenheit (F) to 14 F (10.2 F, multiple) for 50 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The storage of sterile diluent was properly.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005223: US-009507513-1909USA005220:
Pt says she had rash below the shot site after 3 hrs of vaccination and it was itiching and burning sensation. Came to pharmacy on 02/3/2018 2 days later to show to rph. Told to take benadryl and suggested to opt dr care so she went urgent care and was given steroid shot and prednisone tabs and per pt md didnot say it is from pneumovax shot. Pt came to pick rx on 02/04/2018 and went to ER again as it was spreading to face and neck. So Er told her to continue the prednisone tabs and pt says she thinks this is from vaccine.
continues to experience arm pain or really bad soreness to her arm that has been ongoing for well over 10 weeks.; She also reports that the patient is now experiencing High blood pressure.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 27Jan2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE JOINT PAIN (non-serious), outcome "not recovered", described as "continues to experience arm pain or really bad soreness to her arm that has been ongoing for well over 10 weeks."; HYPERTENSION (non-serious), outcome "not recovered", described as "She also reports that the patient is now experiencing High blood pressure.".  Additional information: The patient experienced a side effect following administration of the covid vaccine. The patient went to her doctor who prescribed Physical therapy, but the pain has not been resolved. High blood pressure a side effect of the covid vaccine and are there any treatment recommendations that Pfizer provides to treat the arm pain this patient is experiencing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red, raised rash (wheel), warm to touch and measuring 2x2 1/4 inches
Pt reports feeling dizzy, light headed , and heavy all over after waiting in observation for 15 minutes. Pt. moved to another room to lay on stretcher with lights dimmed. Pt was provided a snack and observed by nurse. After 30 minutes of waiting she states she was feeling a little better and she refused further observation in ER. After 15 more minutes, patient states symptoms improved and patient was discharged home.
Onset of moderate-severe arm pain at site of injection. (Left deltoid) within 2 hours progressed to sense of swelling shoulder to fingertips left arm. Limited range of motion (L) shoulder (lateral and anterior movement). 2inch diameter induration without erythema.
The patient that contracted COVID, 19 days after the first dose; The patient that contracted COVID, 19 days after the first dose; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reporter for himself. A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient that contracted COVID 19 days after the first dose and want to know what guidance offer for that situation. The outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19  and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
experiencing induration 6 inchs long on her arm  for about a week; swelling, hardness and pain at the injection site; swelling, hardness and pain at the injection site; This spontaneous report was received from a nurse practitioner via company representative refers to a 43-year-old female patient. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 28-MAR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosing details, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in March 2019, the patient reported that for the past one week she had experienced induration 6 inches long on her arm. On an unknown date in 2019, she also had swelling, hardness and pain at the injection site. The symptoms lasted an extra week beyond 05-APR-2019. The outcome of vaccination site induration, vaccination site pain and vaccination site swelling was unknown. Reporters causality assessment was not reported. There was no product quality complaint associated with this report.
Pt states sore arm for three weeks but could not move for one week says it stings like getting a shot. Still feels does not have full range of motion.
sick; Initial information was received on 29-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who experienced sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed got sick (illness) (non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, patient did shuffle for two weeks and then got the flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Hives at COVID-19 vaccine injection site. Vaccine received 01/02/2021. Hives began 01/12/2021 8pm. Took Benadryl and symptoms subsided.
A territory representative reported that a pt received vaccine and subsequently developed a severe injection site reaction characterized by swelling and redness.
Fever of 102+ from 1:00 PM on 1/14/2010 until Friday, 01/15/2010.  Severe vomiting, high fever, paleness, shallow breathing and incoherent at 09:00 PM on 01/15/2010. Emergency room visit 01/15/2010 at 10:00 PM requiring saline IV, Tylenol to get the temperature of 103 down. Chest X Rays performed, Blook and Urine tests performed. Pediatric physician on duty determined a viral illness with reacation from the Varicella vaccination.
Presented with 3 months of unint weight loss, malaise, jaundiced, diagnosed with ampulla cancer needing surgery
Booster; Nose bleeds; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single (Primary Immunization series complete but unknown manufacturer)), administration date: Apr2021, for Covid-19 immunization; Covid-19 vaccine (dose 2, single (Primary Immunization series complete but unknown manufacturer)), administration date: Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Booster"; EPISTAXIS (non-serious) with onset Nov2021, outcome "unknown", described as "Nose bleeds". Additional information: The patient had nosebleed 2 days after the booster dose, really bad. The patient does not know if the vaccine caused this nosebleed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After first dose of Shingrix NDC: 58160-0823-11. At 2:30AM following day (8/11) Developed hives on Right thigh. Lasted for 1 1/2 hours. Took Benadryl. Next night, at 11PM developed hives on Left thigh. Lasted under two hours. Third night, hives on right arm, and behind both knees, PLUS severe nerve pain (burning and stinging) up and down both legs. Called my physician and was prescribed prednisone 20 mg/da for five days. No further problems.
TOOK 4 DOSES OF EXPIRED VIVOTIF; This spontaneous case report (PVX2019-1843) was received from a consumer on 16-Jul-2019. It describes a female consumer who "took 4 doses of expired Vivotif" (PT: Expired product administered), while being on oral Vivotif (one dose every other day) (expiry date: Apr 2019) for typhoid fever prophylaxis.  Case report: The consumer took 4 doses of expired Vivotif. The last dose was taken on 14-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 4 doses of expired Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 4 doses of expired Vivotif" was considered as not applicable.
At the time of administration it was obvious the injection was given high into my shoulder and not my deltoid.  About 2 hours later I couldn't lift my arm to drive. I obtained care and with little improvement over the last couple weeks I was sent for an MRI which shows I have subacromial-subdeltoid bursitis as a result of inappropriate injection location. I am scheduled for a steroid shot next week.
Right arm ich that has lasted 2 years now; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2), on 29Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "copd" (unspecified if ongoing); "stroke" (unspecified if ongoing). The patient has no known allergies. The patient has no COVID prior to vaccination and was not tested positive for COVID post vaccination. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 15Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Oct2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PRURITUS (disability) with onset 29Oct2021 at 15:00, outcome "not recovered", described as "Right arm ich that has lasted 2 years now".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Redness, swelling, tender to touch pt given triamcinolone acetonide cream.
Hospitalization for syncope, COVID-19, bradycardia and hypotension on dates 7/30/2023-8/2/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Redness on arm; Tenderness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 1st May 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix in the right deltoid and had experienced red and tender to touch area the size of the palm.  The reporter has been gathered the patient information.
This spontaneous report was received from a physician via a company representative concerning herself, a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date (reported as "in the summer"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, anatomical location, lot number and expiration date were unknown). The reporter stated that, on an unknown date within 2-3 days after receiving the vaccine, her tricep area turned red. No product quality complaint was involved. The patient was recovered from erythema on an unspecified date. The causality between ZOSTAVAX and erythema was not provided. Additional information has been requested.
shipment of Flublok received, out of range and it was administered to patient, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA281957 (same reporter).  This case involves a 59 years old female patient who received 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via intramuscular route in the left arm on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was an actual medication error case due to incorrect product storage.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Information has been received from a nurse concerning an 18 year old female who on 17-DEC-2008 was vaccinated with IM with the first 0.5ml dose of GARDASIL (Lot #661703/0651X). On 23-FEB-2009 the patient was given IM the second 0.5ml dose of GARDASIL (Lot #661841/0653X). On 23-JUN-2009 the patient was given IM the third 0.5ml dose of GARDASIL (Lot #658271/0558X). Concomitant medications included prenatal vitamins (unspecified) "just started" and tetracycline (unspecified) during pregnancy but now stopped. The patient was pregnant at the time of report. Her last menstruation period date was 07-DEC-2008 and her estimated delivery date was 15-SEP-2009. The lab diagnostics studies performance included ultrasound. There were no known symptoms reported. The patient had sought medical attention, office visit. At the time of report the patient's status was unknown.  Follow-up information has been received from a registered nurse concerning 18 year old female patient with no previous pregnancies, deliveries, abortions, elective terminations or fetal deaths and with no concurrent medical conditions or family medical history who was vaccinated with the first, second and third dose of GARDASIL respectively on 17-DEC-2008, 23-FEB-2009 and 23-JUN-2009. Concomitant therapies included prenatal vitamins (unspecified) (manufacturer unknown) and tetracycline (manufacturer unknown). The patient was pregnant. The last menstruation period date was 07-DEC-2008, the estimated delivery date was 15-SEP-2009 and the estimated conception date was 26-NOV-2008. The patient delivered a healthy normal male infant with no congenital anomalies weighting 7.13 pound on 01-OCT-2009. The weeks from LMP were 41 6/7 weeks. The apgar score was 3/6. The length of the infant was 53.5 cm and the head circumference of the infant was 35 cm. There was no complication, diagnostic test or infection or illness during pregnancy. There were complications during delivery: first, cord avulsion which required manual extraction of placenta; second, vacuum assistance; third, episiotomy; fourth, shoulder dystocia and fifth, stage III placenta. The following lab prenatal tests were performed: on 30-JUN-2009 the ultrasound was normal and the amniocentesis test was normal.  Additional information is not expected.
Pain right arm along with a rash on thighs; Pain right arm along with a rash on thighs; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 09May2021 at 12:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) for unknown indications from unknown date and unknown if ongoing. On 11May2021, the patient experienced pain in right arm along with a rash on thighs. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in right arm along with a rash on thighs were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
As previous - took Covid 19 vaccine approximately 3:00 pm.  Everything was fine. Woke up at between 11 PM and midnight shivering. Could not get warm kept turning up the heat it kept getting worse. Was so sick almost called an ambulance but since out in the country decided to tough it out.  Took my temp next afternoon (Wednesday) and was over 101 degrees. First time taken temp.  Woke up Wednesday night sweating- fever broke.  Thursday started feeling  better but was worn out.  Friday kept to bed just in case but was feeling a lot better.