chrisvoncsefalvay/vaers-outcomes huggingface dataset:
respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program  from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a
Gardasil-induced autoimmune disorder; premature ovarian failure; secondary amenorrhea; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient had no autoimmune diseases prior to vaccination. On 15-FEB-2013, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) following her primary care physician's advice, for the prevention of cancer. On 29-JUN-2016, during a visit to the Clinic, her doctor noted that her last menstrual cycle was in December 2015 and referred her to an endocrinologist. On 28-JUL-2016, the patient was evaluated for secondary amenorrhea. During the evaluation, it was noted that her menses were normally until 8 months ago. She was diagnosed with secondary amenorrhea. On 04-AUG-2016, she returned to the Clinic and was diagnosed with premature ovarian failure. According to the reporter, the patient's Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection caused her to develop serious and debilitating injuries, including but not limited to autoimmune disease, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) induced autoimmune disorder (onset date not provided). The outcome of the events was unknown. Causality assessment was considered related.  Upon internal review, the event of autoimmune disorder was considered medically significant.
very painful stomach pains; a really sharp pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (very painful stomach pains) and PAIN (a really sharp pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Drug allergy (montelukast). Concomitant products included ESTRADIOL, NORETHISTERONE ACETATE (ACTIVELLA), LOSARTAN, MONTELUKAST, MULTIVITAMIN & MINERAL, FISH OIL (OMEGA 3 FISH OILS), UBIDECARENONE (COQ10 [UBIDECARENONE]), VITAMIN C [ASCORBIC ACID] and COLLAGEN for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (a really sharp pain). On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (very painful stomach pains). At the time of the report, ABDOMINAL PAIN UPPER (very painful stomach pains) and PAIN (a really sharp pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
12 hours after the vaccine around 3:30am I got up to us the bathroom and was a bit unsteady but after peeing I was walking back to my bed I grabbed the door and my wife woke up and helped me Collapse to the sitting position, about 3 minutes later completely passed out. I was out for 30-40 seconds then startled awake. I laid in the floor for about 10 minutes and my wife helped me get back to bed. The rest of the week I was kind of dizzy and off balance On Saturday 27th I almost passed out again and again on Tuesday March 30th.
Spreading pruritic rash starting 8/31/15, initially on trunk, now neck, auricular areas, axillae, and proximal extremities. Received PROQUAD 12 days prior to rash.
chest tightness; prickling in her eyes; cough; Initial information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional  This case involves a female patient (age unspecified) who had tightness in her chest (chest discomfort), prickling in her eyes (eye pain) and cough, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious tightness in her chest (chest discomfort), prickling in her eyes (eye pain) and cough (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was recovering.  There will be no information available on lot number
Skin rash. I began having a skin rash since my active duty around 2000.  Everytime I wear a necklace, watch or wrist bands, I break out.  If the climate is too hot or humid I break out as well.  Until this day.
Red rash from around 1&1/2 inches below shoulder to around 1 inch above the crease of the arm at elbow; painful to touch and hot; pain at resting and active states.
4 hours, post vax, the pt began developing hives on arms. Benadryl was given. Upon waking on the following day, 8/8/01, she was covered with hives, eyes were swollen shut and she had difficulty breathing and swallowing. Rushed to ER and medicines were given and then medications increased after 3 days. Hives lasted 7 days.
DEATH; This spontaneous report received from a pharmacist through reports (from other doctors and nurses) concerned 6 or 7 patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter stated that, on an unspecified date 6 or 7 patients died due to unknown cause of death after receiving the Janssen covid-19 vaccine around the time of the food and drug administration (FDA) pause of vaccine. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210943888-covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sore throat at 6PM, worse overnight. Nausea next day 8AM, Cough (productive ) 3PM lasting for two weeks plus. Weakness 8AM also next day, continuing for two weeks plus.
A non-serious spontaneous report of accidental exposure and tight dry cough has been received from a health professional concerning an adult female. Neither relevant medical history nor concomitant medications were reported. The patient did not receive FLUMIST. The patient experienced tight and dry cough within a week of starting to give FLUMIST to patients each year. The patient never had cough any other time of the year. The outcome of both the events were recovered; tight dry cough resolved on 05-Sep-2011.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211009653, 20211006668, 20211006798 and 20211006371.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that on an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported) that had been expired by a month. He was enquiring if there was any health risk the patient needed to worry about as well as do they need to be revaccinated. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR, via an unspecified route of administration, on an unspecified date, as single dose. Medical history and concomitant medications were not reported. The patient experienced cellulitis like reactions on an unspecified date, with outcome of unknown.
REDNESS ON LEFT ARM; SWELLING ON LEFT ARM; LEFT ARM PAIN; ITCHING ON LEFT ARM SIMILAR TO ALLERGY; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced itching on left arm similar to allergy. On 23-JUN-2021, the subject experienced left arm pain. On 29-JUN-2021, the subject experienced redness on left arm. On 29-JUN-2021, the subject experienced swelling on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on left arm, redness on left arm, swelling on left arm, and left arm pain. This report was non-serious.
Client presented to vaccination site on 2/24/22. The client reported she received a 1st dose of Pfizer COVID vaccine on 2/3/22. Client reported feeling chest soreness localized to the same side of vaccination, her left side. She stated she felt the soreness four times in intervals with the symptoms lasting seconds each time. She also reported, a little bit of back pain. Client reports taking ?Tempra? a medication she said is ?like paracetamol?. The client reported her symptoms were relieved with this medication. Client followed up with primary care provider via telephone after developing symptoms and was informed by her provider that the decision was hers to make if she wanted to decide to get the second dose of COVID Pfizer vaccine. RN gave client water bottle before client got vaccinated. Client was not seen drinking the water.  RN submitted a medical consult via text message to clinical project coordinators requesting to proceed with the Pfizer COVID vaccine. Per Dr, approval to proceed with Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FK9895 on 2/24/22 at 1058 by  LVN. The client did not report any symptoms during the 30-minute observation period.  RN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1132 unassisted and with a steady gait.
Body started changing a bit; Sore arm; Sex drive started increasing; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Body started changing a bit), PAIN IN EXTREMITY (Sore arm) and LIBIDO INCREASED (Sex drive started increasing) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 30-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 FEELING ABNORMAL (Body started changing a bit), PAIN IN EXTREMITY (Sore arm) and LIBIDO INCREASED (Sex drive started increasing). At the time of the report, FEELING ABNORMAL (Body started changing a bit), PAIN IN EXTREMITY (Sore arm) and LIBIDO INCREASED (Sex drive started increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The consumer stated that he uses blood pressure medication.  No treatment medications were reported.   This case was linked to MOD-2021-313131 (Patient Link).
Numbed feelings on my hand; Pain all along my arm all the way to the tips of each finger; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st December 2021, the patient received Shingles vaccine. On 4th December 2021, 3 days after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the patient experienced numbness in hand. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the numbness in hand was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and numbness in hand to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that by the 4th December 2022 ,he/she was in so much pain all along his/her arm all the way to the tips of each finger. The patient was much better now, but still had numbed feelings on his/her hand.
I had returned from a trip, I noticed I started scratchy throat and headache on Wednesday. I took a several home COVID-19 test that came back negative. I still felt feverish, was coughing, my throat was hurting and scratchy, so I went to the local Urgent Care and did the drive-up test for COVID-19 and flu A and B. All tests came back negative. I was advised to get plenty of rest and stay hydrated.
Case number PHEH2014US018323 is an initial spontaneous report received from a medical assistant on 11 Sep 2014. This report refers to a 70 year old elderly male patient. His past medical history and concomitant medications were not reported. In Oct 2013, he was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly. On the same day, after the patient went home after vaccination, he had a local reaction; the site of administration was red and swollen. The outcome of the events was not reported. The seriousness and causality of the events was not reported.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients was vaccinated with unspecified doses of improperly stored (Oka/Merck) VARIVAX lot # J013905, expiry date 30-OCT-2015 and lot # K021932, expiry date 10-NOV-2016 (route was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Bell Palsy to right side of face starting 10/4/09. No treatment. Improving spontaneously. 12/2/09 Medical records received for date 10/7/09. DX: Bell's palsy. Presenting SX: c/o cannot close rt. eye or smile w/ rt side of mouth x3 days w/ gradual improvement. Pt received flu shot x2wks ago. Assessment: rt eyelid not able to close completely, rt side mouth not able to abduct completely.
I got extremely sick; had a reaction to the vaccine; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got extremely sick) and IMMUNISATION REACTION (had a reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 ILLNESS (I got extremely sick) and IMMUNISATION REACTION (had a reaction to the vaccine). At the time of the report, ILLNESS (I got extremely sick) and IMMUNISATION REACTION (had a reaction to the vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. This case contains information for the 12th of 63 patients described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Arm got very hot; Arm rash; Arm itching; Hives on arm; Arm got sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Arm got very hot), RASH (Arm rash), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE URTICARIA (Hives on arm) and VACCINATION SITE PAIN (Arm got sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm got very hot), RASH (Arm rash), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE URTICARIA (Hives on arm) and VACCINATION SITE PAIN (Arm got sore). On 28-Jan-2021, VACCINATION SITE WARMTH (Arm got very hot), RASH (Arm rash), VACCINATION SITE URTICARIA (Hives on arm) and VACCINATION SITE PAIN (Arm got sore) had resolved and VACCINATION SITE PRURITUS (Arm itching) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to urgent care but didn't received any treatment.  Concomitant products were not provided/unknown. Treatment medication includes Witch hazel for itching.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 3:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:06 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.61. . Concomitant products were not provided.  On 28-Feb-2021, Excursion time were 9 AM and 1PM, temperature were 27 and 26  respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35 respectively, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The patient arrived with a separate vaccination record than what was recording in Immunization Information System. Vaccine records reviewed by another nurse. Needed vaccines were not double checked by administering nurse. Vaccination given and then history recorded in vaccination administration record. It was noticed by a clerical staff member when entered the vaccinations into Immunization Information System that an extra dose of Hepatitis A was given.