chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a week after my first does, the injection site swelled more and was hard and warm to the touch and itchy. The next day the affected area was much larger and still hard and warm to the touch. That evening there was a dull, throbbing pain that radiated to my elbow joint and behind my shoulder. The discomfort made it a little difficult to sleep, but pain level about 4/10. I iced it that night and took some Tylenol. Today the pain isn't as bad 3/10 but the area is still swollen. The appearance reminds me of my allergic reaction to mosquito bites. I had a headache and took some generic Migraine medication.
They prescribe patient that medication (Clarified as Paxlovid) because patient had COVID; They prescribe patient that medication (Clarified as Paxlovid) because patient had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "They prescribe patient that medication (Clarified as Paxlovid) because patient had COVID ". The patient had COVID before and was worse than now because patient had a shot (clarified as Pfizer COIVD-19 Shot). Patient was reading the side effects that's very bad that medication and patient was scared to take Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Chills and blocked sinuses for one night; blocked sinuses for onenight; since then sore throat with mucus accumulation overnight and cough; sore throat with mucus accumulation overnight; since then sore throat with mucus accumulation overnight and cough; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 02Apr2021(at the age of 31-years-old) as a single dose for COVID-19 immunisation. The medical history were reported as none. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021, the patient experienced chills, blocked sinuses for one night and since then the patient had sore throat, mucus accumulation overnight and cough. On an unknown date, the patient underwent SARS-COV-2 test and the result was negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, blocked sinuses for one night, sore throat, mucus accumulation overnight and cough was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt tested positive 10/12/21, fully vaccinated with booster 9/29/21. Reporting asymptomatic, but also reports feeling tired. Unable to pinpoint date of fatigue onset. Pt quarantined at this time. Pt to update DOH and follow up with MD due to immunocompromised status.
Initial report was received from a consumer on 18 January 2013. A male patient (age and date of birth not reported) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date not reported) and an unspecified amount of time later fainted. No additional information was provided. Outcome was not reported. Documents held by sender: None.
clots in her legs; clots/clots in her lung; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (clots in her legs) and PULMONARY THROMBOSIS (clots/clots in her lung) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (arm sore). On 13-Mar-2021, the patient experienced THROMBOSIS (clots in her legs) (seriousness criteria hospitalization and medically significant) and PULMONARY THROMBOSIS (clots/clots in her lung) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 13-Mar-2021 due to PULMONARY THROMBOSIS and THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of 5 mg twice a day. On 27-Feb-2021, VACCINATION SITE PAIN (arm sore) had resolved. At the time of the report, THROMBOSIS (clots in her legs) and PULMONARY THROMBOSIS (clots/clots in her lung) outcome was unknown.            No concomitant medication was reported by the reporter. On 13Mar2021 she was in hospital with clots in her lung and legs.  Company comment: This is a spontaneous case concerning a 79 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, according RA, AESI of Thrombosis (LLT: thrombosis leg) and Pulmonary thrombosis. The events occurred approximately 16 days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and has been prescribed Apixaban. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 79 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, according RA, AESI of Thrombosis (LLT: thrombosis leg) and Pulmonary thrombosis. The events occurred approximately 16 days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and has been prescribed Apixaban. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
depression; chills; nausea; headache; Fatigue; cough that was really intense for a short period; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough that was really intense for a short period), DEPRESSION (depression), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0316201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (cough that was really intense for a short period), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced DEPRESSION (depression). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency. On 12-Feb-2021, COUGH (cough that was really intense for a short period), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, DEPRESSION (depression) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported.    This case was linked to MOD-2021-044613 (Patient Link).
Six days after receiving my second vaccine at a mass drive-thru site (on 2/25), I experienced plugged ears -- a feeling of congestion, pressure and mild pain. Then three days after that, on 2/28, I became dizzy and nauseous, causing vomiting and a feeling that I may faint. My husband took me to Urgent Care where I was diagnoses with BPPV and prescribed meclizine and ondansetron. I have been doing the Epley maneuver and my condition has improved somewhat, but I still feel fatigued and the pressure in my ears has not subsided. I cannot hear correctly out of my left ear. I am concerned that I now have Meniere's disease, which can be caused by "abnormal immune response" -- the vaccine? I have an appointment with an ENT specialist on 3/25 and hopefully can get some answers at that time.
Extreme upper abdominal pain (pancreatitis flare), severe headache and vomiting. This lasted for 2 hours. 36 hours later, the severe headache is still present as is the nausea.
Patient exhibited symptoms for myocarditis.  She also had chest pains, and a crushing sensation in her chest.  These symptoms began in the middle of the night on  June 30, 2021. Worsened in the morning and patient went to E.R. Patient received toradol and i.v. fluids and was monitored.  Symptoms resolve after approximately 4 hours.  Today she is feeling fine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # K010016, expiration date 05-AUG-2015 (route and dose not reported). On an unknown date, 24 to 48 hour after being administered PNEUMOVAX 23, the patient experienced hot and painful injection site reaction. The patient sought medical attention and was diagnosed with cellulitis at the injection site. At the time of the report the outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Adult dose given to a 18 years-old  Inappropriate age at vaccine administration; Adult dose given to a 18 years-old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult 1 ml. On an unknown date, unknown after receiving Engerix B adult, the patient experienced inappropriate age at vaccine administration and overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and overdose were unknown.   Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comment: The pharmacist called to ask for information about the administration of adult dose 1 mL (20 mcg) Engerix-B to a patient.  The reporter mentioned that this was the first dose and asked if the patient had to complete the schedule of 2 more doses with the adult dose (20 mcg) or if the vaccination had to start over with the 0.5 mL (10 mcg) dose. The reporter consent to follow up. Additional supportive information: The 18 years old patient received 1 ml Engerix-B 20, which led to inappropriate age at vaccine administration and overdose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6738) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 19Jul2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Salmon" (unspecified if ongoing), notes: known allergies: Salmon; "Osteoarthritis" (unspecified if ongoing); "Cutaneous Lupus" (unspecified if ongoing); "Obstruct Sleep Apnea" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Nsaids, reaction(s): "lichen planus".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2023 at 08:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2023) Positive, notes: I tested positive 13Jan2023 took the 5 days medication; (21Jan2023) Negative, notes: Retest on Saturday 21Jan2023 w 2 tests negative; (22Jan2023) Positive, notes: Then 22Jan2023 Sunday got positive test and negative test with one kit; (22Jan2023) Negative, notes: Then 22Jan2023 Sunday got positive test and negative test with one kit; (22Jan2023) Positive, notes: Follow up same day 6 hrs later and got 2 positive tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.
sick with flu like symptoms; Initial information was received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a male patient (demographics unknown) who was sick with flu like symptoms (influenza like illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In 1992, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient was sick with flu like symptoms (influenza like illness) (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE.  In the fall of year 1992, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient was deathly sick for several weeks with flu like symptoms (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE. He reported that he will never take another one.  Normally he does not get sick. He decided not to take another one for several years and just as always he did not get very sick. He had a heart valve replacement surgery in Aug-2006 and had to go back and repair it in Jan-2007.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Pink substance coming from mouth in saliva started few weeks after vaccine, stopped  at end of July, went to ENT 7th October 2021,  had a camera put in nose and started having this pink substance again. Chronic head sensations,  blocked nose,  now cleared but developed tightness around both my eyes, and still having head sensations.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 08-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. . Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Aproximately 5 minutes after injection, pt felt burning type pain at injection arm which spread to chest area and up neck.  HR 110. Anxiety noted.  Pt escorted to ED for possible treatment but symptoms dissipated over the next 10 minutes without further intervention or provider review.  Pt was NOT seen by ED provider.  She felt she was ok to go home
Erythema with tenderness at R tricep-where anthrax administered. Pink rash to arms/trunk.
All body itching and rashes, pain on site exterior. Headache, some nausea. Unable to sleep.   Prescribed medications Zantac, benadryl extra strength(generic), cortisone cream.  Symptoms still continue less intense for rashes and itching after bowel movements specifically.
L upper arm swelling and erythema 4 x 4 1/2 in area erythema and swelling. Rx with ibuprofen, Benadryl.
low grade fever, vomiting seen @ ER (12 hrs later) for vomiting & dec urination output; seen by MD states it was an ear infect; given ATB;
Patient woke up that morning screaming and crying. He stated that he hurt really bad and it initially seemed like it was possibly his stomach bothering him, he was hunched over holding his stomach. As the day progressed the muscle in his right shoulder was obviously tightened and he could not turn his head to the right. His screaming lessened throughout the day, but the muscle in his neck became increasingly drawn up, he could not hold his head straight up, and his right arm was drawn up to his chest. Took him to the doctor and he stated that it was an episode of acute torticollis. It took 5 days for the symptoms to resolve.
After the 3 IM shots, she became pale/stood-up and feeling faint and dizzy. Pale, HR decreased 50, sweaty, vomited. After while rested on a chair, laid on the exam table gradually improved - pinked-up HR above 80 strong. Exam NL after 20-40 min observation.
Upset stomach; Very weak; Headache; Fever; Chills; Nausea; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Blood pressure high.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigued). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Taking care of woman who had COVID-19 and was exposed; Took a Home COVID-19 test and was positive; Went to an Urgent Care and they sent me to an ER where they took blood work; Was given an infusion of Remdesivir; and told to come back in 24 hours to have another infusion; Had a total of 3 Infusions; Currently recovering.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years 11 months old male patient who received an expired 0.5 mL dose of vaccine ACTHIB lot UI207AAA, expiry date: 02-Oct-2018 via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUARIX for Immunisation; KINRIX for Immunisation; and PROQUAD for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
7 1/2 hrs post inject fever 104, high pitched cry, chills/tremor, irritable (4AUG94 5PM); 29 hrs post inject fever 104 irritable-referred to pvt MD for f/u care 5AUG94 230Pm;
Since 12 years old my period has been clock work every 28 days, on or off birth control was supposed to get my period on April 7 did not receive until April 25. No chances of being pregnant, no changes in my life style or medications. Just almost 3 weeks late to the date, had not happened ever in 19 years!
Phizer covid vaccine sn FA7484 9/8/21. symptoms began on 9/16/21. Intermintant fever and chill with and without profuse sweating (most began on 9/20 - 9/23), loss of energy (9/17- current), sore muscles (9/19- current), sore joints (919-current) with swelling. Joint problems are still continuing. GI upset on 9/19
1st Shingrix 26Jun2019, never had second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th June 2019).   On an unknown date, the patient received 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: 13-June-2022 Reporter's comment: The pharmacist reported that a patient had her 1st Shingrix  and never had a second dose. The Vaccine Administration Facility is the same as Primary Reporter. The VAERS details reported for 1st dose. The reporter forgot to ask about follow-up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.