chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an healthcare worker refers to some patients. On an unknown date the patients were vaccinated with PROQUAD (Merck) (lot#, strength, dose, route unknown). On 14-MAR-2014 the reporter reported a temperature excursion. Since the excursion that was reported, some of these doses of VARIVAX (Merck) (captured in MARRS 1407USA010231), PROQUAD (Merck) and ZOSTAVAX (captured in MARRS 1407USA010909) had been administered to patients. The healthcare worker did not report an adverse experience. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Red rash, slight itch, a little swollen (still have as of today). No treatment has been necessary  Also,  5 days after the vaccine I experienced a soreness on the left side of my ribcage area and it spread across entire ribcage area.  It hurt to take deep breaths or to try to reach upward.  It disappeared in about 24 hours.
FINGER TIPS WERE BLUE; PAIN IN FINGERS; FINGER ULCERS ON FINGERS; This spontaneous report received from a parent concerned a 25 year old of unknown race and ethnicity female. 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: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021, the patient experienced pain in fingers and finger tips were blue, and was hospitalized (date unspecified).  On Next day (JUN-2021), the patient experienced finger ulcers on fingers and had seen many doctors who couldn't help her because they had said it is from the vaccine and they don't know what to do. Every day the patient goes to work in pain, comes home in pain, goes to bed in pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in fingers, and finger ulcers on fingers, and the outcome of finger tips were blue was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210900251-covid-19 vaccine ad26.cov2.s-pain in fingers and finger tips were blue. 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).
WOKE UP IN THE MIDDLE OF THE NIGHT WITH SEVERE SWEATING; COULDN'T SLEEP; FEELS HUNGOVER THIS MORNING; PRETTY SIGNIFICANT CHILLS; PRETTY SIGNIFICANT FEVER; BAD HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, once a total administered on 07-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced woke up in the middle of the night with severe sweating. On 08-MAR-2021, the subject experienced couldn't sleep. On 08-MAR-2021, the subject experienced feels hungover this morning. On 08-MAR-2021, the subject experienced pretty significant chills. On 08-MAR-2021, the subject experienced pretty significant fever. On 08-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up in the middle of the night with severe sweating, pretty significant chills, and pretty significant fever on 08-MAR-2021, had not recovered from bad headache, and feels hungover this morning, and the outcome of couldn't sleep was not reported. This report was non-serious.
Sore arm; swollen lymph nodes in armpit and clavicle area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 09:00 (Lot number: FA7485) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=FA7484, lot unknown=False, administration time=09:00AM, vaccine location=Left arm, dose number=1), administration date: 26Jul2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 18Aug2021, outcome "not recovered", described as "swollen lymph nodes in armpit and clavicle area". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy. Additional information The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Adverse event: Sore arm and swollen lymph nodes in armpit and clavicle area,   No follow-up attempts are possible. No further information is expected.
pt says p/vax fever, went way up (did not take temp); had hallucinations & couldn't walk;also had terrible h/a;
body aches; flu like symptoms; she didn´t fell well; funny sensation in her throat; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced general body pain, influenza-like symptoms, feeling unwell and pharynx strange sensation of. On an unknown date, the outcome of the general body pain and influenza-like symptoms were unknown and the outcome of the feeling unwell and pharynx strange sensation of were recovered/resolved.   It was unknown if the reporter considered the general body pain, influenza-like symptoms, feeling unwell and pharynx strange sensation of to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received a dose of Shingrix in end of the August 2019. The patient had a funny sensation in her throat about an hour after the administration of the vaccine that resolved. The patient also experienced body aches and flu like symptoms. The patient did not feel well for a few days.
pt recv 2 doses of vax & failed to seroconvert based on lab values;
8AUG98 pain in bottom of feet that becomes sharper when walking;no marks on feet;was seen @ ER on Sunday & sent home;pt fine;
within 1 minute of administration pt felt dizzy and was helped to a chair.  He went pale and eyes rolled back.  He had trouble holding his head up, he continued to wobble his upper body around while seated.   Mom reported he shook/seized.   We gave him a bottle of water and monitored.  He continued to appear pale and his head rolled back, and onto a merchandise shelf.  911 was called.  In < 10 minutes from initial symptoms EMS arrived.  Pt sysolic bp was 80 per EMT.   pt was taken to ER for further evaluation
Broke her hip and shoulder; Broke her hip and shoulder; Fall; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had a fall and broke her hip and shoulder, which ultimately put her in a rehab facility. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
had increased temp & high pitched screaming for >2hr starting about 2hr p/vax given;
flu-like symptoms; Body Aches; Tiredness; arm was sore; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, fatigue and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fatigue and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fatigue and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in an unknown arm. The pateint expereinced flu-like symptoms which included body aches, tiredness but no fever. The reporter also stated their arm was sore.  All the symptoms began the following day of administration and lasted approximately a day.  The reporter did not consent to follow up.
Injection site not hot, but warm; Injection site swollen, 1x3inches in size; Injection site not red, but medium pink; slightly tender when touches it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swollen, 1x3inches in size), VACCINATION SITE ERYTHEMA (Injection site not red, but medium pink), VACCINATION SITE WARMTH (Injection site not hot, but warm) and VACCINATION SITE PAIN (slightly tender when touches it) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Cholesterol and Acid reflux (oesophageal). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), CORTICOSTEROIDS for COPD, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Cholesterol, ERGOCALCIFEROL (CALCIFEROL VIT D) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen, 1x3inches in size), VACCINATION SITE ERYTHEMA (Injection site not red, but medium pink), VACCINATION SITE WARMTH (Injection site not hot, but warm) and VACCINATION SITE PAIN (slightly tender when touches it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Injection site swollen, 1x3inches in size), VACCINATION SITE ERYTHEMA (Injection site not red, but medium pink), VACCINATION SITE WARMTH (Injection site not hot, but warm) and VACCINATION SITE PAIN (slightly tender when touches it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
about 6 hours after first shot started having bad abdominal pains, burning sensations in hands feet and face. Eyes started burning, horrible tastes in mouth. Joint pains  hands feet hips  ,diarrhea. What felt like allodynia in face really bad for close to a week. Pains in rib cage feels like costochondritis. Headaches im sure i am forgetting a few   many of these are still a problem
COVID 19 virus positive on 11/9/2021. Admitting dx:  abdominal pain, AKI, COVID infection.  Patient presented with acute respiratory failure and diarrhea. Patient is status post started on remdesivir and IV hydration correction of electrolyte imbalance and patient condition continued to be worsening.   Patient diagnosed with COVID and started on the COVID treatment but the patient continued to be worsening status post into patient with acute kidney injury. Family opted for the patient to be transitioned to hospice care and comfort care and plan for the patient to be taken off the ventilator with gradual wean. Positive D dimer.   Treatment:  remdesivir, decadron, albuterol nebulizer, inbulation and sedated on full vent support.   Septic shock:  Levophed, ICU management, IV antibiotics.  Afib with rapid ventricular response:  IV Cardizem drip, IV heparin, metoprolol.  Normocytic anemia requiring 2 units of blood for HG less than 7. Pt expired.
This spontaneous report was received from a pharmacist and refers to a 62-year-old male patient with none pertinent medical history, concomitant medication and none drug reactions or allergies. On 15-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, lot number L031273 with expiration date 19-NOV-2016 (dose and anatomical location were not reported) for zoster vaccination. On approximately 29-MAR-2016 (reported as about 2 weeks after the ZOSTAVAX injection), the patient complained of joint pain, all over and had worsened over the 3 years. The patient sought medical attention with a pain specialist and no treatment was given for the event. None laboratory diagnostics were performed. At the time of the report, the patient did not recovered from the arthralgia. The relatedness between the event and therapy with ZOSTAVAX was not reported.
hives on trunk after 1st dose recurring with second dose; This is a spontaneous report from a contactable other health professional. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers and expiry dates not reported), via unspecified routes of administration, on unspecified dates as dose 1, single and dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives on trunk after first dose recurring with second dose on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mouth so dry; pain on his lungs; sore arm; loss of sense of taste; loss of sense of smell; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), AGEUSIA (loss of sense of taste), ANOSMIA (loss of sense of smell), DRY MOUTH (mouth so dry) and PLEURISY (pain on his lungs) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication.     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 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell). On 30-Jan-2021, the patient experienced DRY MOUTH (mouth so dry) and PLEURISY (pain on his lungs). At the time of the report, PAIN IN EXTREMITY (sore arm), AGEUSIA (loss of sense of taste), ANOSMIA (loss of sense of smell) and DRY MOUTH (mouth so dry) outcome was unknown and PLEURISY (pain on his lungs) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication was not  provided by reporter. treatment information was not provided.
Patient received second dose of Moderna rather than Pfizer dose that was due.  Received the second dose at day 22.
knee problems, Not sure if it's arthritis as per caller; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 29Jan2021 (age at vaccination was unknown) at a single dose for Covid-19 immunisation. Medical history and concomitant medication were not reported. The patient had the first shot yesterday and wanted to know if she can take Tylenol. She was experiencing knee problems, not sure if it was arthritis as per caller. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I started having migraine headaches on 3-19-2021 , this lasted for 3 days. On 3-23 started coughing up blood , that progressively became worse. Went to emergency room and was admitted  CAT scan of lungs showed that I had 3 blood clots.
Approximately 8 hours after injection, I woke up experiencing severe nausea, chills, body aches, vomiting, fatigue, and lightheadedness. I also experienced an anxiety attack. After several hours, these symptoms began to resolve. I experienced body aches, injection site pain, fatigue, headache, and mild anxiety for the next 9-10 hours. After that fatigue and muscle soreness were very mild until the time of this submission.
This is a spontaneous report from a contactable consumer via  non-clinical study program. The consumer reported the same event for two patients, this is the first of two reports. A 12-month-old female patient received,  a single dose of PREVNAR 13, MMR, varicella vaccine and hepatitis A vaccine, all on an unspecified date for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient's IgE increased. Patient's clinical course was the following: at 8 months-old, her serum IgE values (in IU/mL) were total 61.4, peanut 13.6, almond 4.04, milk 3.84, egg 2.01, soy 1.6, and wheat 0.98,  compared to total  44.1, peanut 11.2, almond 1.54, milk 2, egg 1.71, soy 1.62, and wheat 2.2 at 12 months-old. After the 12 month-old laboratory tests were drawn, she received the vaccines pneumococcal 13-val conj vac (dipht crm197 protein) , measles vaccine/mumps vaccine/rubella vaccine , varicella vaccine and hepatitis A vaccine. Three weeks later, at 12.7 months , her IgE values were total 75.6, peanut 16.5, almond 2.18, milk 5.06, egg 3.4, soy 3.64, and wheat 3.75. The outcome of the event IgE increasedwas unknown. One or more of these four suspect vaccines could have contributed to the increase in peanut IgE. However, the patient already was sensitized at 8 months. Since hepatitis A, measles vaccine/mumps vaccine/rubella vaccine and varicella were only administered at 12 months, the sensitization was most likely due to pneumococcal 13-val conj vaccine. Per CDC vaccine schedule, by 8 months, the patient likely already received 3 shots of pneumococcal 13-val conj vaccine. The pneumococcal 13-val conj vaccine at 12 months boosted the peanut IgE levels already induced by the previous shots. Follow-up (30Jun2016): Follow-up attempts are completed. No further information is expected. Follow-up (07Oct2016): New information received from contactable consumer via program includes: comment/causality. Follow-up attempts are completed. No further information is expected.
Swollen, painful, red over 10x12 cm below/ inferior to injection site.
PATIENT STARTED ITCHING WITHIN 15 MINUTES OF BEING VACCINATED AND DEVELOPED HIVES.  SHE WAS GIVEN BENADRYL IM AND WAS ADVISED TO TAKE BENARYL LATER IN THE DAY IF NEEDED.  SHE STATES SHE TOOK MOVE BENADRYL LATER IN THE EVENING.   SHE STATED SHE WAS WEAK, DEVELOPED A LOW-GRADE FEVER, AND OTHER FLU-LIKE SYMPTOMS.
I received my first Moderna booster for COVID-19 on 10/26/2021. On the afternoon of 11/9/2021, I was walking my dog. I began to get pains in my chest. The chest pains became constant. At one point, I dropped his leash. I went to pick it up, and the pain just hit really hard and really fast. It was so extreme that it hurt to breathe or to move. I came home and told my husband. I waited for the pain to subside, but it never did, so I went to the ER. I was at the ER for several hours. While there, I underwent a CT scan and lots of bloodwork. After the pain finally subsided, they let me go home and told me I needed to see my PCP. When I saw her, she referred me to a cardiologist and a gastrologist. The gastrologist determined that my issue wasn't with my esophagus; I had previously been diagnosed with Barrett's esophagus, but he didn't think my symptoms were caused by that. When I saw the cardiologist, I underwent a stress test and no anomalies were detected. However, he did prescribe me nitroglycerin, which would work on either esophageal spasms or on a heart attack. In the subsequent months, my symptoms decreased and I only had to take the nitroglycerin periodically. However, when I received my second booster on 4/18/2022 (Moderna, lot number 005M21A), the chest pains returned. I finally got to see the cardiologist in July 2022. By that point, I had been taking the nitroglycerin more often, which helped. However, I didn't think I should have to continue taking the medicine without having the answers regarding the cause of the issue. I then began searching for the answers and wondered if my COVID-19 boosters were related to the symptoms. When I saw the cardiologist in July 2022, he prescribed me diltiazem. For the most part, the diltiazem seems to help, though I did have to take nitroglycerin a few times in September 2022. However, I have not had to take any nitroglycerin in October 2022. In August 2022, my cardiologist had me undergo a nuclear stress test. The cardiologist said that everything looked good on the test, so we're still not sure what the cause of my chest pains is. I am scheduled to see the cardiologist again in January 2023, and he has advised me to hold off on getting any more boosters until after I see him.
Fainted 3-5 seconds, VItal signs taken BP 109/66, Pulse, 74, O2 98%, Head to toe assessment done, no injury, no head hitting noted. Patient transferred to gurney and given sips of water. Mother states patient has history of fainting and he skipped breakfast today. He had not eaten anything for the morning. Snack provided. Patient stayed 30 minutes for observation. Patient feels better. Advised mother to contact PCP of patient and give more fluids. No dizziness or pain reported. Vitals after 15 minutes BP 110/78, Pulse 66