chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several days after receiving 1st dose, at night her heart was really racing / heart palpitation; She had cough.; She had swelling in her feet.; Her left arm was really sore for 1 week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Several days after receiving 1st dose, at night her heart was really racing / heart palpitation), COUGH (She had cough.), PERIPHERAL SWELLING (She had swelling in her feet.) and VACCINATION SITE PAIN (Her left arm was really sore for 1 week) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Several days after receiving 1st dose, at night her heart was really racing / heart palpitation), COUGH (She had cough.), PERIPHERAL SWELLING (She had swelling in her feet.) and VACCINATION SITE PAIN (Her left arm was really sore for 1 week). At the time of the report, PALPITATIONS (Several days after receiving 1st dose, at night her heart was really racing / heart palpitation), COUGH (She had cough.), PERIPHERAL SWELLING (She had swelling in her feet.) and VACCINATION SITE PAIN (Her left arm was really sore for 1 week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's additional concomitant medications included other supplements. It was reported that the patient had fast heart beats.  No treatment information was provided by the reporter.
TSH  level was higher 12.92 and 15.8; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD THYROID STIMULATING HORMONE INCREASED (TSH  level was higher 12.92 and 15.8) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD THYROID STIMULATING HORMONE INCREASED (TSH  level was higher 12.92 and 15.8). At the time of the report, BLOOD THYROID STIMULATING HORMONE INCREASED (TSH  level was higher 12.92 and 15.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Blood thyroid stimulating hormone: 12.92 (High) High TSH. On 28-Jun-2021, Blood thyroid stimulating hormone: 15.8 (High) High TSH.         Patient had upcoming appointment with his doctor to discuss the findings. Concomitant medication was statin. No treatment information were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
10-21-10 patient called. Had local redness evening of Influenza vacc. In morning her hand was swollen (injec arm site).
Two days after the second vaccine I had to ophthalmic migraines one after the other. I was very tired after that and slept most of the afternoon. Prior to having the vaccine I may have had two or three ophthalmic migraines in a year I started keeping track of my migraines on May 18, 2021. As of today July 11. As of today July 11, 2021 I have had 29 ophthalmic migraines. I don?t have much of a headache afterwards but I do feel tired.
Swollen lymph node; pain on left side of throat; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 15Apr2021 at 11:15 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included inositol (MYO INOSITOL) for unknown indication and unspecified birth control pill; both from unknown date. 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 24Apr2021 at 03:00 the patient experienced swollen lymph node and pain on left side of throat. The clinical outcome of the events swollen lymph node and throat pain was recovered on an unknown date of 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a licensed practical nurse and refers to a 11 year old female patient. The patient did not has any medical history, concurrent conditions or drug reactions/allergies. On 19-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (route, lot # and expiration date were not reported), and on 23-DEC-2015, the patient received the second dose of GARDASIL 9 intramuscularly, lot # L011846 (expiration date not reported), also. No concomitant medications were reported. On 23-DEC-2015, shortly after the administration of the second dose, the patient experienced shaking and then fainted. The reporting nurse stated that the patient received 2 liters of oxygen via nasal cannula, her vital signs were taken (which were within normal range), an icepack was provided to the patient and was finally monitored in an office for some time prior to being sent home upon recovery. At the time of the report, the outcome of shaking and syncope was reported as recovered. The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Grandmother reported to me that after receiving immunizations on 10/20/06, sometime that evening, patient began to vomit and have fever, and developed a rash on her left thigh. On Saturday the 21st she developed dyspnea and was taken to the ER where she was treated for croup with an injection, name of medication unknown to grandmother. By today, she is much better, rash is going away, had no further vomiting or dyspnea and will return to Day Care tomorrow, per grandmother.
chills; fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (called on behalf of her father) reported for a male patient that, he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for Injection) via an unspecified route of administration on 27Mar2021 as a SINGLE DOSE of COVID-19 immunization. Approximately on an unknown date in 2021, the patient experienced chills and fatigue. The caller asked if how long the side effects will last. The outcome for the events was not recovered.  No follow up attempts are needed. No further information is expected.
Pfizer vaccine was administered outside - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  G51.0 LEFT FACIAL PALSY 6/16/2021 HTN (HYPERTENSION)
Soreness and stiffness in upper left arm Soreness and stiffness in left side of neck Fatigue and loss of appetite
Pt notes she received her 2nd Pfizer vaccine at 1040 am. Later this afternoon she started to feel heaviness around the left side of her cheek but thought it might be due to a wisdom tooth extraction that she had 5/17/2021. Then around 4 pm today while on a video conference she noticed that she was unable to raise the left side of her lips. She also feels a heaviness in the left parietal area of her head. Pt was referred to the ER for new onset of facial weakness.
Vaccines given at approx 9-10 am. That same evening around 7-8 pm c/o stiffness (entire body), chest pain, SOB, stomach hurting, light headed. Called poison control & told to go to ER. States her "shots for pain & to calm him down & meds to counter act affects of vaccine ".
Sharp burning stinging pain in right upper thigh laterally - 2 days post injection of SHINGRIX. Initial pain at site of injection for 2 days.
At first I was ok then after a few hours  I started to have light pain in the left leg where I was diagnosed with neuropathy. The pain continued to increase until 11 PM where I was crawling in pain in bed, on the left side from the SI joint to my feet all my muscles were hurting, my leg was getting numb with pins and needles down trough my foot. It was clearly related to the vaccine as there was no traumatic event. It started to subside early morning.  I kept the "heavy leg sensation for more than a week. The SI joint and muscles pain have decreased from a 9 to a 5,6 in 36 hours day  stbutayed at that level until the 15th. My left foott was numb until 2 days ago. I had to take iburpofen 600 every 8 hours for more than a week now I am at 1 or 2 times a day and I had to increase by 25 mg my pregabalin intake 2 times a day. I would like to know if it safe to get my second dose given the fact that usually the immune system response is stronger with the second shot. The pain in my left leg was so high and so intense and the numbness was so strong  that I thought I will loose the use of it
This spontaneous report was received from a consumer and refers to her 12-month-old daughter. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On an unknown date, the patient passed away due to an unknown cause. It was not reported in an autopsy was performed. The relatedness between the event and M-M-R II or diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was not reported.
I had a digestive issues after dinner the night of the vaccine.  I had nausea and gastric pain. It continued such as I could not eat much but a bland diet.  My stomach felt that after I had ate anything  my stomach felt full.  About an a few hours after eating I felt nausea. The symptoms continued from March to the end of May.   I lost several pounds due to not eating.  I felt not myself, I also felt afraid to eat due to feeling sick afterwards.  I now feel like myself again and I can eat regularly.  I also had a rash that itched that went away after a week.   I did go to the doctor the last week of March.  The second time I went to the doctor was the 14th of April.  The following week on the 22nd I went to my gastroenterologist, he prescribed a stronger medicine for my stomach.  I took the medicine for a few weeks and I still felt bad.  He advised to take the medicine another week which helped.
The night after I received the shot, I felt very cold the whole night. I woke up at 6am, went to get a glass of water and went to the bathroom. After, I was walking through the hallway when I lost consciousness and collapsed on the floor. I don't remember falling. I woke up on the floor, went into my room, threw up a few times and was sweating  profusely. This lasted an hour until I went back to sleep. I felt light-headed and weak the whole day, as if I could pass out again. I had low blood pressure. I slept a lot and was very weak for two days. On the third day I started feeling better.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M037770, expiration date 01-JUN-2019 (dose and route of administration were not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact. Sender's Comments: US-009507513-1705USA009556: US-009507513-1706USA003430: US-009507513-1706USA003431: US-009507513-1706USA003432.
Within 5 minutes of administration of third vaccine. Pt complained of dizziness: positioned patient in lying position. Became cool/clammy. BP(s) 54: never lost consciousness. Just very week. Doctor assessed order 1 liter hydration. Within 30 minutes pts BP returned to normal and symptoms disappeared.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (vaccine expired on April 17, 2022; given to patient) and product storage error (vaccine stored in refrigerator on Apr 1, 2022, expired on Apr 17, 2022 and administered on Apr 20, 2022) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016J212A) for COVID-19 immunization. No medical history reported. On Apr 20, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2022, patient administered expired product (vaccine expired on April 17, 2022; given to patient). On an unknown date, patient experienced product storage error (vaccine stored in refrigerator on Apr 1, 2022, expired on Apr 17, 2022 and administered on Apr 20, 2022). At the time of the report, administered expired product (vaccine expired on April 17, 2022; given to patient) and product storage error (vaccine stored in refrigerator on Apr 1, 2022, expired on Apr 17, 2022 and administered on Apr 20, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received 2nd booster. The vial initially stored in the refrigerator on April 1, 2022. Vial did not undergo with any temperature excursions. This case linked to MOD-2022-545248 (patient link).
Patient received his flu shot on 10/30/19 and his arm has been hurting since. Patient says the pain radiates down to his forearm but is not sharp or tingly. He also feels like he loses control with tight grips or heavy weights. Patient saw his PCP and the PCP said the shot was given too high. Patient will follow up again in about a week or so for further evaluation. He said there has been slight improvements from the past few nights. He has been taking Tylenol but was advised to try an NSAID to help with the pain.
pt recv vax approx 930AM & father reported pt had been screaming for 45min & rt thigh lateral aspect was red & swollen;pt had been given APAP 1/2hr prior to visit;pt had fallen asleep on the say MD prescribed DPH;
pt broke out in varicella rash 23MAy;pt was seen in office 24MAY w/pox, probably 20 lesions;temp @ home 104.5;
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Peanuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no other medication in 2 weeks. The patient received Paxlovid as treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ lot # M042172, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage, no adverse event and circumstance or information capable of leading to medication error. The outcome of incorrect product storage, no adverse event and circumstance or information capable of leading to medication error is unknown. The reporter considered incorrect product storage, no adverse event and circumstance or information capable of leading to medication error to be not related to ROTATEQ.  Additional information is not expected.
red raised rash 7x6, burning & itchy, left arm; left shoulder pain mild in degree
Fatigue, chills, aches and pains, increase in appetite, lethargic
This clinic was at the Shelter for the homeless. This patient was checked in under wrong vaccine. One paper said first dose vaccine the Covid card said Booster vaccine. This patient was checked in the system before registering to check his eligibility for the vaccine. Therefore, I assumed the covid card was correct since the registering person was also doing the Covid cards. When I asked the patient how have your other Covid vaccines been, he responded with " just fine". I confirmed he was to receive Moderna Bivalent, and he responded with "yes". I proceeded to give the vaccine and he said he had gotten over his fear and finally did it. I then looked at the initial paper and compared with Covid card and asked if this was his first dose ever. He responded with a "yes". I then went to my manager to notify of the situation, and we proceeded to look again into system. We realized that he had gotten 1 dose of Pfizer Monovalent and was due for his second Pfizer Monovalent. He received incorrect vaccine Moderna Bivalent; he was monitored for the remainder of the clinic. No reaction to vaccine was noted.
This spontaneous report as received from a female patient of unknown age regarding herself. Patient's concurrent condition and medical history was not reported. On an unknown date in November 2013 the patient was vaccinated with first dose of GARDASIL (strength, dose and frequency were not reported) by the physician. On an unknown date she received the second dose and in May 2014 she received the third dose. Concomitant medications were not provided. On an unknown date the patient experienced headaches, joint pain in knees, hips, hands and ankles. In addition she experienced loss of memory, excessive urination and weight gain and loss. The patient stated the pain became more severe after vaccinations. Furthermore, she stated that she can't do things. The patient also experienced cravings. The patient did not seek medical attention. The patient was not treated for the events. The outcome of the events were unknown. Causality assessment was not reported. Additional information has been requested.
Patient contacted her employer 2 days after vaccination with complaint of new onset rash.  Was seen by her PCP  and was reportedly being treated for Shingles.  Missed work week of 8-12 March for same.  When didn't report to work today (3/15/21), supervisor went to home to conduct a safety check and found the patient dead in her home.
Pt came in with a large area on deltoid that is red and itchy.  States it didn't appear until a few days after the vaccine.  No mass.  No fever.  No pain.  Advised to watch area and see physician if it doesn't resolve in a couple days or gets worse.
1st dose, arm swollen. SECOND DOSE: Extremely painful blisters on forehead, eye with pustules, styes, and nerve pain on right eye. All on right side of face. This happened on 8/18/2022. Went to urgent care. Given prednisone. On 8/29 went to eye doctor after my doctor determined I had shingles around eye and eye lids. Was prescribed Valacyclovir 1gm tablets and Erythromycin opth ointment 3.5gm.
Pain at site with 10cm of hot erythema and central 4cm vesicular cluster.
potentially has blood clot; stomach pain; severe abdominal pain/like severe menstrual cramping abdominal pain/it's more like achy cramping; tingling; burning on the collar bone area; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 04Aug2021 at 19:15 (Batch/Lot Number: EW0168) (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none. There were no concomitant medications. She received her first dose on 04Aug2021 at 7:15pm and during the 30-minute wait time, the patient experienced some tingling and burning on the collar bone area and then it subsided. Then at 04Aug2021 at 23:00, she had severe abdominal pain, it is still there today but has improved some. It felt like severe menstrual cramping abdominal pain, like somebody was stabbing her with knives in the stomach. She stated that it lasted about 45 minutes to an hour, the severity of that, then throughout the whole night off and on she was waking up and it was cramping on and off.  The morning she woke up, the cramping is not as severe, it's still there, it's more like achy cramping. When she called her doctor, they said to just take some Tylenol and if it gets worse go seek urgent care. She did just have her menstrual cycle.  She is concerned about her stomach pain (started on 05Aug2021, as reported) because on the Johnson and Johnson vaccine website, stomach pain is listed as a potential sign of a blood clot. Patient was asking if Pfizer have any information available like this. She has little kids at home and is worried about not going to the ER if she potentially has a blood clot. She reports her main concern is when she started having symptoms, she started looking online, and the abdominal pain is not a common symptom after getting the Pfizer vaccine so after reading about it, it sounds like it could be an adverse reaction. She reports with the J&J, that could mean blood clotting issues so she just needed to know if she needed to go to the emergency room. She reports she did call her family physician and he wasn't very helpful. Outcome of tingling and burning on the collar bone area was recovered on 04Aug2021, abdominal pain was recovering, while rest of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The association between the event "potential blood clot" with BNT162b2 can not be fully excluded based on the close temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was fully vaccinated with a booster but tested positive for Covid on 06Jun2021; Patient was fully vaccinated with a booster but tested positive for Covid on 06Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient was fully vaccinated with a booster but tested positive for Covid on 06Jun2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jun2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.