chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Aching; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and PAIN (Aching) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (Nausea) and PAIN (Aching). At the time of the report, NAUSEA (Nausea) and PAIN (Aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Employee reported that patient and mother were leaving the patient area and at the counter paying the visit bill. Patient felt weak then blacked out and proceeded to fall, mother caught her, and assisted to chair. Care team was called, Dr., RN, and MA. After Dr. and MA arrived, patient was observed stiffening and arching back, eyes rolled back, and then went limp. Very difficult to arouse. Non responsive.  O2 given. RN arrived. BG done- 124. Vitals were taken, BP of 74/42, HR 58-80. O2  99-100 % RA. Pt just had  Tdap, HPV and MCV.  Came to after about 20 min. Became alert and oriented x 3 after 20 min.   Ambulance arrived  and transported to ER. Assessed Dystonic Reaction (likely dt HPV) vs Seizure episode as comment only
Several days after injection, patient experienced vaginal bleeding (spotting) very dark blood - atypical for this patient. Spotting continued for approximately 10 days. Over the next 3 months patient experienced menopause like symptoms, including irregular cycles and spotting (dark blood), hot flashes. These symptoms stopped approximately 3 months after receiving vaccination and since then patients cycles have become regular again, with normal flow, red blood and 28 day cycle - hot flashes have also stopped.
Confusion that appeared to be a stroke but turned out to be swelling in the brain; caused memory loss/confusion, weakness of muscles, bladder retention issues treated with antibiotics/ 8 day stay in the hospital currently needs PT and OT to try to get back to her baseline
1 hr post vax first dose experienced restlessness, lightheadedness, dizziness, vomiting, severe headache & "felt like she was crawling out of her skin".
Weakness, chills, fever, emesis day after shots. So went to emergency room. After leaving emergency room, local reaction, edema & erythema left arm.
Headache, fever, weakness, and hallicunations from 12 to 36 hours after receiving vaccine.  Weakness, shortness of breath, spaciness, and body aches from day 2 to 6 after receiving vaccine.  Chest pain, back pain, and indigestion beginning around 2 weeks following vaccination and continuing until present day.
suspected vaccination failure; developed Shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the In 2019, the patient received both the doses of Shingrix vaccine and the patient now developed Shingles although it was painless. The reporter consented to follow up. No further details provided via web form. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was not reported.
After receiving the flu shot at a workplace flu clinic, she experienced prolonged arm pain. After being seen by a physician she has stated she had nerve damage from the administration of the flu shot.
Patient presented to the ER with a severe headache on 3/30.  CT found subdural hematoma as well as intra-axial hemorrhage in the left axial lobe.  The patient was life flighted from our facility.
This case was reported by a consumer and described the occurrence of erythema in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included FEMARA, LIPITOR, LEVOXYL and Antihistamine. On 10 November 2008 at 10:00, the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 10 November 2008, less that one day after vaccination with FLULAVAL, the subject experienced erythema, itching, swelling and black & blue marks on skin. The subject planned to follow-up with her physician on an unknown date. At the time of reporting the events were improved.
Marked decrease in circulation of L and R 2nd and 3rd toes when exposed to cool temperature that did not previously cause same Sx.  Experienced waxy white digits that resembled Raynauds like Sx that was initially refractory to worming and lasted 15 min or longer.
headache on and off, nausea, nonproductive cough, runny nose, sneezing starting on 12/31/21
Patient developed redness, heat, pain, and swelling at injection site. Did not seek any medical treatment and tolerated the effects on her own.
Patient woke early the morning after vaccination feeling very itchy, upon looking in the mirror he realized he was covered in hives - breathing was slightly hindered, but not a lot. His face was also swollen.  He went to the ER where they administered benadryl and pepcid and was sent home with prescriptions for those as well as a medrol dose pack.  Time frame to reaction would have been about 14 hours later.
Flu symptoms, ache, fever, very tender, red arm for 2 days after shot, bad cough, and cold.
lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen/numbness to his hand went up to his shoulder and his arm; lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen/ hand became so swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. The patient concomitant medication which includes Fish oil and Vitamin D3, both taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Feb2021, reported as 7 days later (not specified exact date), patient was sitting in his room when his lips and the right side of his face and his right side fingers became numb and swollen, reported as all on the right side. Patient stated that 30 minutes later after washing his hands and walking the symptoms went away. And this happened again another 3 days later, on an unspecified date in Feb2021, the right side of his face, his lips and right fingers became swollen and numb, and 1 hour later again it went away. After 2 days, on an unspecified date in Feb2021, while sitting on the couch, same thing, face lips and hands, swollen on the right side, patient wash his hands, exercise and walk. It happened 4th time, on an unspecified date in Feb2021, the numbness to his hand went up to his shoulder and his arm and hand became so swollen that patient could not move his hand to his body. Then they came fast and 2 hours later and it was gone again. Patient reported that he went to the ER, had an IV and a scan, x-ray with unknown results, the doctor said it may be a stroke but then not a stroke it was likely a reaction or allergy. Patient stated that he never had this before and he only take fish oil and vitamin D3 over the counter. Patient also reported that he cancelled the second dose that was due to on Tuesday. The outcome of the events was unknown.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-DEC-2017 the patient was vaccinated with one improperly stored dose of PROQUAD (dose, frequency and route of administration were not reported) lot # N015621 and expiration date: 15-NOV-2020). The vaccine vas reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degrees Celsius (C) to -10 C for 1 hour and 15 minutes and between -9 C to 8 C for 4 hours and 25 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002263:
This spontaneous report as received from a pharmacist refers to a 44 year old male patient. On 08-DEC-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported) indicated for their first dose of VARIVAX (Merck). No adverse effects reported. Additional information has been requested.
Nauseous; Dry-heaved; Feels weak; Low grade fever; Fever cause her eyes to burn; General aches; Trouble falling asleep and kept waking up; Restless night; This case was reported by a consumer via call center representative and described the occurrence of trouble falling asleep in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included thyroid disorder and palpitation. Concomitant products included liothyronine sodium (T3 (Liothyronine)).   On 5th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, 1 days after receiving Shingrix, the patient experienced nausea, dry heaves, weakness, fever, burning in eyes and general body pain. In November 2020, the patient experienced trouble falling asleep and restlessness. On an unknown date, the outcome of the trouble falling asleep, restlessness, nausea and dry heaves were unknown and the outcome of the weakness, fever, burning in eyes and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the trouble falling asleep, restlessness, nausea, dry heaves, weakness, burning in eyes and general body pain to be related to Shingrix. The reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient stated that she was started on T3 and they have been playing with thyroid for 3 to 4 months and every time she eats she will have heart palpitations. The age at vaccination was not reported. The patient received her 1st Shingrix shot in the left deltoid. and she reported that she had trouble falling asleep and kept waking up last night, had a restless night, but was not nauseous. When she woke up she was nauseous and dry-heaved.  The reporter asked her if the nausea had resolved now and she at first said yes but then said no and added that she feels weak (perhaps due to not eating). She also reported that she believed she had a low grade fever. She does not have a thermometer but she would estimate that her fever was probably less than 101. She says that the fever cause her eyes to burn. She says the eye burning had gotten better but has not fully resolved. She also reported that she was having general aches.  The patient was calling to see how long these side effects would last.  The patient was unable to locate the lot number on the paperwork provided but she did provide the contact information for the doctor's office where the shot was administered. The reporter consent to follow up.
About 7.5" are of edema and erythema to PST aspect of left arm. No vesicles or pustules. Two days s/p vaccination.
pt recvd vax & devel rash, fine red; 12.5 benadryl given to pt;
Information has been received from a RN concerning a 5 year old white male with no past medical history and no known drug allergies who on 04/13/99 was vaccinated SC on the right arm with a first dose of varicella virus vaccine live (Lot # 628697/1838H).  There was no illness at the time of vaccination. Concomitant therapy that day included a first dose in the left arm of MMRII (Lot # 627184/1580H) and a first dose of tuberculin purified protein derivative (Batch # 25110-11). There were no problems following vaccination. On 05/14/03 the pt was seen in the office with midly pruritic lesions in the underware area and on the head. It was noted that the rash was in four stages: tiny papules, larger papules, watery blisters, and scabbing and scabbed over lesions. No prescription therapy was required. It was not known if there was a known exposure. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 05/13/03 the pt developed less than 50 lesions. There was a small amount of itching. No fever was reported. Diagnostic tests and lab work was "not done". It was noted that the pt recovered. No further information is expected.
Information had been received from a healthcare worker referring to a patients of unknown age and gender. Information of pertinent medical history and drug reactions/allergies of the patient were not reported. On 25-JUN-2015 the patient was vaccinated with expired M-M-R II (dose, strength and route unknown), lot # H016132 with expiration date of 31-AUG-2014. Concomitant medication was not reported. The outcome of the event was unknown. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
February started having abnormal heart beat in chest, associated with activity. It continued to occur and so I wore a heart monitor for 30days, it showed Ventricular Ectopy- VTach, PVCs and Ventricular Bigeminy.  It occurs when exercising. I was worked up thoroughly, my Calcium Cardiac Score was "0", my Stress Test showed the ventricular bigeminy. The echocardiogram was normal. The Cardiac MRI was normal. I was a marathon runner, the only thing different is that I had the vaccines. I am a healthcare provider, I am now also seeing similar ECTOPY in my own patients who are otherwise healthy. They all had Moderna.
Evening of shot severe pain in rotator cuff area that lasted at least 36 hrs, It is still a bit sore there but, liveable..Rapid heartbeat along with blood pressure of 200/100, Fever reaching 102 degrees, chills, nausea. The nausea, chills lasted about 36 hrs. The fever which was eventually brought down by extra strength Tylenol around the clock after 12 hours. The increased hypertension which lasted for about three weeks was controlled by increased dosages of Vasotec at times to 20 mg. This required constant contact with Dr by text and phone.. Forgot to mention no black and blue or bruising at injection site but also pain at injection site for about one week.
BLOOD CLOTS; ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative via social media concerned a female of unspecified age, race and ethnic origin. 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, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient reported that "My youngest daughter's best friends mother died right in front of my daughter and her friend after getting the same one I got by J&J that's the main reason she refused and still refuses to be vaxxed. I'm okay with that as I had adverse reactions to it myself including blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and adverse reactions was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220349106.; Sender's Comments: V0: 20220349128-COVID-19 VACCINE AD26.COV2.S- blood clots. The event(s) has a 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). Therefore, this event(s) is considered unassessable.
The patient fainted immediately after receiving the vaccine.  The patient was fine within a few minutes.  Patient was sweaty and anxious for about 10 minutes total.  Patient remained in immunization room for a total of 30 minutes and was fine before he left.  Patient has previously fainted when receiving other vaccines as note on his informed consent paperwork and as discussed with pharmacist.
Information has been received from a nurse concerning a 14 year old female with no medical history or known drug allergies who on 20-FEB-2008 was vaccinated IM in the left deltoid with a first dose of GARDASIL (lot # 659437/1266U).  On 29-APR-2008 the patient was vaccinated at 4 PM with a second dose of GARDASIL (lot # 660391/0063X).  Later that day she started her period.  She took naproxen.  On 30-APR-2008, at 4 AM the patient was diaphoretic, pale, and experienced cramps.  The patient took 3 tablets of ADVIL.  The mother of the patient, who called the office on 30-APR-2008 at 9:10 AM, also reported that the patient fell on the floor, her eyes rolled back and "came to", the patient continues to be extremely diaphoretic, dizzy, weak, pale with body aches and pains, and her symptoms are similar to the flu.  At the time of reporting, the patient had not recovered.  The mother was advised to take the patient to her primary physician if symptoms did not improve.  No product quality complaint was involved.
had a little bit of swelling but no fever; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 78-year-old female patient received second dose of bnt162b2 (COMIRNATY COVID 19 Vaccine, mRNA, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose 2, single for COVID-19 immunization. Medical history included two autoimmune situations (but not immunocompromised) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date in Jan2021 for COVID-19 immunization and flu shot (Patient usually gets the Fluzone high dose. Patient usually gets her flu shot at the end of September). On an unspecified date in Feb2021, the patient experienced had a little bit of swelling but no fever. In (withheld) the booster dose is available after 5-6 months. Here in the US they are stating they're going to start the booster dose for non-immunocompromised people at 8-9 months. Doesn't the vaccine lose a lot of efficacy after 6 months. What are the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine. Is there a specific test I can take to check my antibody titers. Patient, female, aged 78, with two autoimmune situations but not immunocompromised is calling about the Pfizer BioNTech Covid 19 vaccine's booster dose. Patient received the first two doses in January and Feb2021. Afterwards she just had a little bit of swelling but no fever or anything else. Patient sees in (withheld) people are getting booster shots after 5-6 months after the two dose series. Is the vaccine booster the same as the original two or is it a new formulation to give better protection against delta and lambda. Or is it the same old dose as the first two doses. Were the immunocompromised patients in the original study. Are the studies for the 8-9 month boosters on the original study participants or a separate study. Patient declined transfer to DSU about the swelling side effect after the vaccine, patient stated it was no big deal. Patient declined to provide PCP information. What was the efficacy in people over the age of 65. How many participants were over the age of 65. Is Pfizer working on a new formulation booster to cover delta and lambda variants. How do they test for the efficacy against delta. Patient is scheduled to have surgery on 22Oct2021, patient is wondering when she should time her flu and COVID booster vaccine. Should she wait 2-3 weeks. Should she get the flu vaccine first. Patient usually gets the Fluzone high dose. Should she wait until after she receives the Pfizer booster. Patient usually gets her flu shot at the end of September. Outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 10/21/02 parents present with toddler for evaluation of "hives." Hives noted "on and of" since 10/18/02. No other sx's. Parents deny environmental changes (clothing, soaps, etc). urticaria are distributed over entire body. (+) pruritis, no distress.
Vomiting; Headache; Lightheaded; Chills; Body aches; Insomnia; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 07Oct2021 at 07:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was type 2 diabetic, and was allergic to latex, shellfish, kiwi and pine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included metformin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY) and ertugliflozin pidolate (STEGLATRO); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 07Oct2021 at 11:00, the patient experienced vomiting, headache, lightheaded, chills, body aches and insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events vomiting, headache, lightheaded, chills, body aches and insomnia was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.