chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; This solicited report received from a patient via JS2021-30756: COVID 19 Consumer. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and died was not related.  This report was serious (Death). This case, from the same reporter is linked to 20210941085 and 20210941906.; Sender's Comments: V0: 20210947994-COVID-19 VACCINE AD26.COV2.S -Died. This event(s) is considered not related. The event(s) has an unknown/unclear 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
swelling; her arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (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, SINGLE), for Covid-19 Immunisation. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "swelling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm is sore".  Additional information: reporter wants to know if there is something to worry about with his wife's condition since her arm is sore and swelling after getting the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 11/18/94; on 3/26/98 pt exp invasive haemophilus infection group B sepsis.
This is another reaction I experienced. My  left arm started to be sore again  8 days after vaccination, on 1/7/21 (I originally had sore arm on left the first 3 days of vaccination but then it was recovered).  I also feel there is some weakness on my left arm as well.  I wonder if this is a delayed reaction and if it would be permanent? I previously filed  an report on early adverse events-left arm soreness within an hour of vaccination, then spread  across shoulder, in the middle of night, I woke up with whole body muscle ache that lasted till next morning. The next day of vaccination, I was tired , yawning frequently and very sleepy. I slept for 11 hours on the second night of vaccination which was unusual for me. The sore arm disappeared after about 3 days. But 8 days later it occurs again with some weakness on upper left arm.
Decreased appetite; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was COVID positive.) in January 2021.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DECREASED APPETITE (Decreased appetite), FATIGUE (Tiredness) and NAUSEA (Nausea). In March 2021, DECREASED APPETITE (Decreased appetite), FATIGUE (Tiredness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.   This case was linked to MOD-2021-233495 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
1 hour after receiving the 1st vaccine, I felt as if my throat was closing off which lasted 30-45 minutes, after 15 more minutes I was then shaking uncontrollably approx 30-35 minutes, then heat flash throughout my body which lasted 30-45 minutes, then my eyes started strobbing which lasted about 30 minutes, then a rash broke out on my arms and became sick to my stomach.  The next day I was sick to my stomach all day and had headaches.  Today is Monday 8/9/2022 and I have soar throat and severe headache.
Repeat dose of Boostrix given 6 months apart; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18th March 2024) for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 2nd May 2011) and Boostrix (received 2nd dose over a 9 years later on 23rd June 2021).   On 22nd December 2021, the patient received the 3rd dose of Boostrix. On 22nd December 2021, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that the patient received a repeat dose of Boostrix given 6 months apart, which led to extra dose administered. The health care professional had given consent for safety team to follow up.
patients left are has a red hot and itchy. started the day after the injection. patient also had a fever that resolved 24 hours after shot. patient claimed knots were felt in the arm where injection was.
tightness in the chest; felt tired when she went up the stairs; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in the chest) and FATIGUE (felt tired when she went up the stairs) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (No Medical history reported.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHEST DISCOMFORT (tightness in the chest) and FATIGUE (felt tired when she went up the stairs). On 18-Mar-2021, CHEST DISCOMFORT (tightness in the chest) and FATIGUE (felt tired when she went up the stairs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received PREVNAR 13, (unknown lot number and expiration date), via an unspecified route of administration on 12Jan2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient got the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 12Jan2019 and had some redness at the injection site which spread down his arm. He then had a rash on his arms, back, stomach, chest, legs, over 70 % of his body. He was given BENADRYL and fluocinolone cream and IV prednisone. It started getting better for a little while on the medication but it was back. They are going to see a dermatologist today. They wanted to know if there is an antidote. The patient had not recovered from the events. Information on the batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Crohn's disease (bad bout last year, currently in remission) and small intestinal resection (had about 2 feet removed). Concomitant products included Vitamin B12 and ENTYVIO. On 7th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, stomach pain and gas. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved and the outcome of the injection site erythema and stomach pain were recovering/resolving and the outcome of the gas was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, stomach pain and gas to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. At 9 AM, the patient received SHINGRIX. The next day after receiving SHINGRIX, the patient had pain, redness and swelling at the injection site. The patient also experienced stomach pain which might be related to gas. The stomach pain lasted about 12 hours. On 9th August 2018, on the reporting date, the stomach pain was much better and the injection site was less red, but it was still tender and swollen. The swelling was greater than 2 inches in diameter. This case is 1 of the 4 cases reported by the same reporter.
second dose of vaccine 14 days after she would be tested negative for Covid.; SARS-CoV-2 test; a fever that came and went; fatigue; loss of appetite; a cough; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), COUGH (a cough), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine 14 days after she would be tested negative for Covid.), SARS-COV-2 TEST (SARS-CoV-2 test) and PYREXIA (a fever that came and went) in a 95-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.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DECREASED APPETITE (loss of appetite), COUGH (a cough), PYREXIA (a fever that came and went) and FATIGUE (fatigue). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine 14 days after she would be tested negative for Covid.) and SARS-COV-2 TEST (SARS-CoV-2 test). On 20-Jun-2021, PYREXIA (a fever that came and went) had resolved. At the time of the report, DECREASED APPETITE (loss of appetite), COUGH (a cough), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine 14 days after she would be tested negative for Covid.), SARS-COV-2 TEST (SARS-CoV-2 test) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Updated reporter email . Event COVID 19
A metallic taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (A metallic taste) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (A metallic taste). At the time of the report, DYSGEUSIA (A metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medication were provided.  The patient heard about a metallic taste after Moderna Covid-19 Vaccine.  No treatment medication were provided.   This case was linked to MOD-2021-369093, MOD-2021-368867 (Patient Link).   Reporter did not allow further contact
June 5th i got a fever, June 7 i recovered, June 12 i relapsed. June 15-17 i was hospitalized. I was relapsed the 17th spent the next recovering. Went to Vegas 24-25, The 29th resumed normal exercise did a morning via zoom and noticed i had a runny nose, fatigue, loss of hunger. Around 9pm i did a COVID-19 test i was positive. on the 30th mostly in bed body ache chills, fever. By the morning of the 1st i was back to work and yesterday the 6th i felt well enough to get back on my bike and did a mile and half walk with my wife.
Wheezing, several bloody noses, mother stated that she did not inform us previously of asthma diagnosis when asked at vaccination visit because they had not needed to use any medication for more than 2 years.  Wheezing continued for several days started using inhaler immediately.
Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am.  Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f.  Family states a "scan" was done and came back with nothing.  P was treated for UTI and sent home.  Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed.
Patient reported pain, swelling, bruising, redness, warm to touch and headache. Started Wednesday night.
p/vax pt collapsed immed;no one else in co recv flu vax x/this pt;
Booster; some blood pressure changes/blood pressure is a little higher/ around 123/89.  The other day I checked it and left arm readings were 199/93, 199/97/ blood pressure increase was noticed not too long after my Pfizer Covid 19 booster dose; tired; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 20Oct2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; tafamidis (VYNDAMAX), via an unspecified route of administration from an unspecified date to an unspecified date, at 61 mg, 4x/day for an unspecified indication. Medical history included pacemaker and defibrillator both before tafamidis, ongoing stress; Patient lived with cousin who was hospitalized and passed away from COVID about 3 weeks ago (as of 02Nov2021). Patient took a COVID test after cousin passed away and it came back negative. The test was done approximately a week before COVID booster shot (Oct2021). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included 1st dose of BNT162B2 on 23Mar2021 (age at vaccination was 52-year-old) and 2nd dose of BNT162B2 on 14Apr2021 (age at vaccination was 53-year-old), both for Covid-19 Immunization. Recently, patient had noticed some blood pressure changes based on blood pressure readings taken on an at home wrist monitor. The pulse was OK but blood pressure was a little higher. Typically, it was around 123/89 (2021). The other day patient checked it and left arm readings were 199/93, 199/97; right arm was lower but still high. It's never been over 200.Patient had been under a lot of stress this last month and blood pressure increase was noticed not too long after Pfizer Covid 19 booster dose. Patient just got a Pfizer covid 19 booster shot on 20Oct2021. He was tired but as days went on, he fought it off. Patient preferred not to report since he did not think the blood pressure changes were related to the medications but probably due to stress since patient had been on tafamidis for over a year and did not notice blood pressure changes then. All this was probably related to stress. Action taken in response to tafamidis was unknown. Outcome of tired was recovering. Outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Event hypertension is considered intercurrent and unrelated to BNT162B2 and tafamidis.
This spontaneous report was received from a registered pharmacist concerning a 72 years old female patient. Concurrent conditions included hypertension, hypothyroidism and hypercholesterolemia. On an unknown date, approximately in November 2007 (reported as 4 to 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route unspecified). Concomitant medications included simvastatin (manufacturer unknown), metoprolol and levothyroxine sodium. In approximately November 2012, the patient experienced shingles and she sought an unspecified medical attention for shingles on 13-NOV-2012. She was treated with acyclovir, Methylprednisolone dose pack and Nortriptyline. The outcome of shingles was reported as not resolved. Additional information has been requested.
Pt developed a fine macular-papular erythematous rash on 8/6/01.
Headache, body ache, perspiration, tiredness, nausea, vomit, continuing to 8/3/2018.
Patient ended up going to the hospital and staying overnight after their second covid vaccination. Patient was experiencing more robust then expected reactions of feeling malaise, heart palpitations, fever, and nausea. Patient was held in hospital for obversation overnight and is feeling fine as of reporting.
For the past two days, my blood sugar numbers have been too low. I've lowered my insulin dose 3 units. This has never happened before and while not an "adverse" reaction, it is an odd one.  Last night my arm started itching about one inch below and one inch to the left of my injection. There is a rash about 2 1/2 inches wide and 4 inches long. It is slightly swollen, red and itches like crazy! Just documenting it.
Patient was given 5-11yo Bivalent Booster instead of 12+ Bivalent Booster. Patient is 12 years old.
inital delayed reaction to injection site - puritic rash - 6 cm x 5 cm after day 11 patient developed upper and lower lip angioedema
Fever; Sore throat; Cough; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, adhd (attention deficit hyperactivity disorder) and depression. The patient did not have allergies to medications, food or other products. Concomitant medications included lamotrigine (LAMICTAL) from unknown date for unknown indication and quetiapine fumarate (SEROQUEL) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced fever, sore throat, cough, fatigue and headache. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, sore throat, cough, fatigue and headache were not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling/redness at injection site within hours of injection. Flulike symptoms with myalgias, malaise, more swelling/pain/redness, lymphadenopathy (axillary, supraclavicular) within 24 hours.  4 days postinjection:  10 x 7 cm induration, heat, redness at injection site.  Treatment with dicloxacillin 500mg qid for cellulitis.
Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 301ssba) at the age of 68 years, in left 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: "High cholesterol" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as treatment from 29Jun2022 to 03Jul2022.
This initial spontaneous case, was received on 21-Sep-2017, from a nurse, concerning a 12-year-old male adolescent patient. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch number: 179002 (as reported), expiry date: May-2018, route of administration: intramuscular, anatomical location: not reported). On the same day, FLUAD was administered to the patient of 12 years age (aged less than 65 years) (explicitly coded as inappropriate age at vaccine administration) and had sore at the site of injection. The treatment measures were not reported. At the time of the report, the outcome of the event injection site pain was recovered on the same day and for the event inappropriate age at vaccine administration was not reported. The reporter assessed the event as non-serious. Follow-up report received on 28-Sep-2017: Event pain at injection site was added. Route of administration was updated as intramuscular. Amended narrative accordingly. Follow up report received on 13-Oct-2017: The outcome of the event injection site pain was changed from not reported to recovered. The start date was updated for the event injection site pain. The narrative was amended accordingly. Non-significant case correction received on 13-Oct-2017: Narrative changes were amended.