chrisvoncsefalvay/vaers-outcomes huggingface dataset:
macular degeneration; an allergic reaction; unable to read tiny print; unable to read tiny print; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 98-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MACULAR DEGENERATION (medically significant), outcome "unknown"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "an allergic reaction"; VISUAL IMPAIRMENT (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown" and all described as "unable to read tiny print".  Clinical course: Caller was asking for a list of Paxlovid ingredients compared to the ingredients of the Pfizer covid 19 vaccine. Caller reported that she experienced an allergic reaction about 1.5 years ago after her first dose of the vaccine and wants to know if any ingredients of the vaccine are present in Paxlovid, in case she were to ever catch covid. Caller noted she also had macular degeneration and was unable to read tiny print. Caller said she received an email from Pfizer listing three ingredients in the vaccine that might have caused her allergic reaction. Caller explained she was able to access emails but was not able to look things up well or read tiny print.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bad cough; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced FATIGUE (Tired). On 14-Jun-2021, the patient experienced COUGH (Bad cough). At the time of the report, COUGH (Bad cough) and FATIGUE (Tired) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.
Shoulder surgery/ Shoulder operation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4401105-00 (Abbvie).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Batch/Lot number: unknown), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Jun2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Shoulder surgery/ Shoulder operation". The action taken for adalimumab was unknown.  The reporter considered "shoulder surgery/ shoulder operation" related to BNT162b2.  The reporter's causality for the event of shoulder surgery/ shoulder operation with HUMIRA (ADALIMUMAB) was not related. The reporter causality for the event of shoulder surgery/ shoulder operation with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event shoulder operation and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
pt recv vax 29OCT97 & devel an inj site rxn that consisted of a red & swollen arm that was itchy for a week & hot to the touch;30OCT97 pt exp bruising & swelling from elbow to shoulder;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAY-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, Patient did a standard COVID-19 virus test which came back negative. On 31-AUG-2021, He did COVID-19 rapid POC test that tested positive. He experienced suspected covid-19 infection and was sick for one day. Laboratory data included: Pyrexia (NR: not provided) 102 F. In SEP-2021, he experienced suspected clinical vaccination failure. He took Tylenol and slept through it and fever broke next morning. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 01-SEP-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20211021024-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
5aug 1st dose, 14 aug 2021 positive for covid, 27 aug2020 out quarantine. didn't hold off. The pharmacy got my second dose 2 September 2020. You mentioned fever and mentioned that I was out off quarantine. next day 105 fever, chills, couldn't walk and couldn't get out bed. doctor on 4sep2021, bad reaction on the arm. Supposed to wait 90days. My teeth was rattling, my fingers were cold, I couldn't open my eyes and couldn't feel my knees. Been going to Psychical Therapy. I cant work right right . Pins and needles in my body
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 12Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Sep2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Negative; (21Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient previously received a COVID-19 Vaccine. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 12Sep2022 to 16Sep2022. Rebound of symptoms and positive COVID test on day 11 days after initial diagnosis, 6 days after finishing nirmatrelvir; ritonavir, 4 days after testing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days after my second shot I started my menstrual bleeding violently and two weeks early.  That night I woke in the middle of the night and my ears were ringing and my vision blacking at the edges and I was loosing a lot of blood. I started shaking so hard my teeth chattered, and was unable to get out of bed without feeling like I was going to pass out. My husband brought me juice and crackers, and it lessened within a half hour.
Utilizing the ancillary supply needle/syringe combo - while administering vaccine, vaccine noted to leak out between the needle/syringe connection.  Amount that leaked out unknown, client reported, "feeling a drop run down his arm".
Shingrix to patients under 50; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles before).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not applicable for this report. The pharmacist reported that that Doctors have been prescribed  Shingrix to patients under the age of 50, which led to  intercepted drug prescribing error. The pharmacist reported that they did not have patients information, she was looking for general information about Shingrix in patients under 50. The health care professional mentioned that Shingrix was administered to a female patient but she was not sure if the patient was immunocompromised, the patient had shingles before. The reporter consented to follow-up. The has been linked with US2021AMR210277, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210277:Same reporter US-GLAXOSMITHKLINE-US2021209480:Same reporter
Patient received flu shot approximately 12:00 noon on 3/10/08.  First noticed systemic rash last PM - Presented into hospital after overall symptoms "burning rash" at 11:45AM 3/11/08.  Seen by N.P. - advised to take over the counter 50mg Benadryl and go to ER if difficulty breathing or swallowing.
No adverse reactions to report, just that I noticed when entering the information  that the patient had received the Moderna covid 19 vaccine on 2/14/2021 .
Presented to emergency room 12/19/20  with back pain and leg weakness.  He was diagnosed with Guillain Barre Syndrome and hospitalized from 12/19/20 to 1/3/21 and discharged to skilled nursing facility for rehabilitation. per discharge summary" Guillain Barre Syndrome  -Deficits:quadriparesis, legs more affected than arms and LE sensory impairment with resulting functional deficits, sensory deficits, neurogenic bladder, neuropathy  -Pt reports receiving the Flu Vaccine 1 week prior to onset of LE weakness -S/p IVIG x 5 days with improvement"
No additional adverse effect reported; VARIVAX that underwent a temperature excursion was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number: S031497, expiration date: 07-OCT-2021; dose and route of administration not provided). The vaccine was stored in temperature 0.6 degree Celsius for 30 minutes. There was previous temperature excursion in temperatures from -10 to 8 degrees Celsius (-4.5 degrees Celsius) for 2 hours and 20 minutes. Digital data lodger was involved. No adverse event was reported.   This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2107USA004652:
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported). On unknown date the reporter called to the physician's office to find out the results of unspecified specimen that she had sent on 19-AUG-2014 due to an unspecified adverse reaction that the patient developed on unknown date after receiving an unspecified product. The reporter declined to provide any information and ZOSTAVAX was documented. The outcome of the unspecified adverse reaction was unknown. Addition information is not expected due to the reporter declined to provide further information.
Local redness and swelling at injection site developed 1-2 days following vaccine administration; by day 4 less erythema without any intervention. Diagnosed with cellulitis of arm and given KEFLEX 250 mg/5ml 2 tsp PO BID x 7 days.
Dizzy; heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and PALPITATIONS (heart palpitation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13A2A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizzy) and PALPITATIONS (heart palpitation). On 02-Mar-2021, DIZZINESS (Dizzy) and PALPITATIONS (heart palpitation) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment Medication was available. No Concomitant Medication was available.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees Fahrenheit (F) for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees Fahrenheit (F) for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004551: US-009507513-1801USA005336: US-009507513-1802USA004550:
A spontaneous report of serious event of shortness of breath, and non-serious events of "received first dose of H1N1 on 18-Nov-2009 and second dose of 15-Dec-2009", hives, itching and rash has been received from a physician concerning his seven-year-old daughter, subsequent to H1N1, Intranasal. There was no family history of drug or food allergies. The patient also had no history of drug or food allergies, no medical history, and was not taking any concomitant medications. On 18-Nov-2009, the patient received the first dose and on 15-Dec-2009, patient received the second dose of H1N1, Intranasal for an unknown indication. On 16-Dec-2009, twenty four hours after receiving the second dose of the vaccine, the patient broke out with hives, itching, rash, and shortness of breath. The patient was treated with cetirizine hydrochloride, which relieved the symptoms other than rash, which was present at the time of reporting. Over the past two weeks, the events of rash, itching, and hives returned and came back at various intervals with no temporal relationship to anything that could be new. The patient was being treated with oral diphenhydramine hydrochloride 25 mg on an as needed basis (PRN) whenever the events of rash, itching, and hives returned. The outcome of the events of shortness of breath, "received first dose of H1N1 LAIV on 18-Nov-2009 and second dose on 15-Dec-2009", was recovered, while that of rash, itching, and hives was not recovered at the time of reporting. Additional information was received on 04-Jan-2010 and incorporated into the narrative: patient's medical history; concomitant medication confirmed as none; event description and outcome of the events.
Pfizer BioNTech COVID 19 Vaccine EUA Had a high fever of 102.7, extreme headache and body aches, nausea, and extreme vomiting that led to dehydration. Extreme dizziness. Four days later on Saturday, my arm swelled badly and broke out into hives in a six inch radius around the injection site.
COVID 19 Treatment; COVID 19 Treatment; 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: after days of testing negative; (11Jul2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Anti-viral details included: Product: COVID 19 Treatment, Brand was Paxlovid. Treatment start date was on 02Jul2022, Treatment stop date was on 06Jul2022, Indication was for Treatment of COVID-19. 6 days after completing course of Paxlovid, patient feel sick and tested positive again, after days of testing negative.  No follow-up attempts possible. No further information expected.
pt felt dizzy and had a red face, no vasovagal symptoms, anxiety reaction resolve,  VS AT 12:49 170/103 P 79 02 97 VS AT 12:54 BP 155/87 P 70 02 98 VS AT 12:59 BP 156/91 P74 02 98 VS SITTING 1301 BP 164/109 P 76 02 96 VS STANDING BP161/92 P 82 02 97; PT WAS GIVEN WATER AND WAS ESCORTED BY STAFF TO GO HOME
Sx onset 7/21/21 with cough. Visited son, his wife & newborn. Son and DIL are both + cases. Tested on 7/26/21 which resulted as positive.
Intensification of muscle/body pain in neck and left shoulder (vaccination was given in left arm, that is not painful) starting more than one week after the vaccine.  Ongoing diarrhea that seems to be worsening, not getting better. MIld nausea beginning one week plus one day after vaccine (today)
Patient who received his primary smallpox vaccination on November 21, 2003. At that time he also received anthrax #1, Hepatitis B #1, typhoid, and influenza. On day 6, November 27,2003, he developed axillary lymphandenopathy and axillary pain. On day 10, November 30, 2003, he developed a fever, maximum 101.4F, along with chills. During this time, he also reports that he experienced a headache especially when coughing, he felt achy, and nausea. He went to a local Emergency Room and was given Motrin 800MG TID and told to report to Immunizations Clinic on December 1, 2003. He reports that he found the Motrin to be effective meaning that he was able to sleep. Upon arrival to Imms clinic, he was found to be afebrile. He states that he feels much better today, although his axillary is red, edematous, and painful, especially when touched or with movement.
Blood sugar monitored every mealtime at home.  The evening mealtime reading on vaccine day was 350.  Patient did not report any dietary changes that would have resulted in this high reading.  Her typical reading is in the mid 100s.  No other known acute illness at the time.  This sugar level reading was very unusual for her.
Received PREVNAR in left deltoid on 4/21. Per MD at end of day she noticed swelling to elbow and by next AM to wrist. Had modest pruritus and papillary rash over entire arm. Pt said took BENADRYL PO and used steroid cream. MD just prescribed prednisone x 9 day. Still being treated w prednisone.
red itchy rash to right upper arm approximately 6cm wide x 3 cm long at site of 2nd COVID injection.
Vaccination site cellulitis; redness; Swelling; neck pain; arm  pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), PAIN IN EXTREMITY (arm  pain), VACCINATION SITE CELLULITIS (Vaccination site cellulitis), ERYTHEMA (redness) and SWELLING (Swelling) in a 70-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.  Concomitant products included PANTOPRAZOLE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced NECK PAIN (neck pain) and PAIN IN EXTREMITY (arm  pain). On 25-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Vaccination site cellulitis), ERYTHEMA (redness) and SWELLING (Swelling). The patient was treated with CEPHALEXIN [CEFALEXIN] for Cellulitis, at a dose of 1 dosage form. On 18-Jan-2021, NECK PAIN (neck pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm  pain), VACCINATION SITE CELLULITIS (Vaccination site cellulitis), ERYTHEMA (redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication Pantoprazole Treatment provided was Cephalexin. The patient had no further issues.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up was received on 28- Apr-2021 included no new information On 07-Jul-2021: No new information was received.