chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia; Intermittent palpitations; Low grade fever/fever; muscle aches; This is a spontaneous report from a contactable physician. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in unknown arm on 17Dec2020 at single dose for routine mass immunizations (covid-19 immunization). The COVID-19 vaccine was administered at Hospital. Not a military facility. The patient's medical history was reported as none and concomitant medications was none (he was on no other medications). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tachycardia, intermittent palpitations, low grade fever/fever all started somewhere in the morning of 18Dec2020 and muscle aches on 17Dec2020. Physician assessed tachycardia and intermittent palpitations as serious due to medically significant. Physician stated that one of his workers had the vaccine and proceeded to have tachycardia and low grade fever. He would like to know if patient should get the second dose. The patient had mostly tachycardia with some intermittent palpitations. Patient was seen in his office on 18Dec2020, and got the COVID vaccine on 17Dec2020. He also reported fever and muscle aches, although the fever was subjective and was not documented. Tachycardia improved and sent him to cardiology on 21Dec2020. It was not life threatening and they did an Electrocardiogram (EKG). His initial heart rate was 130. When he was seen again in their office on 21Dec2020, it was 93, which was baseline. It improved. He never got his temperature. The highest in office was 99.5 degrees Fahrenheit. He had some muscle aches. The physician just sent patient to cardiology because he was having intermittent tachycardia and intermittent palpitations. Two visits to physician office. He was seen on 18Dec2020 and again on 21Dec2020. Relevant tests: they did testing for tachycardia but not related specifically. They did thyroid and EKG in office and he did not know if test were back. EKG was ok. The Thyroid, Complete blood count (CBC) and lipid (all were on an unknown date in Dec2020) were not back and were just done to make sure there were no cardiac issues. The outcome of the events was recovering. The lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tachycardia and palpitations cannot be excluded. This case will be reassessed once additional information becomes available. 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.
1st dose a year ago, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. No more information provided by the reporter. The reporter consented to follow up.
Patient received dose of ZOSTAVAX and had also had this same vaccine 1 year ago, this is to be a one time vaccine. Injection site itchy, swollen.
Aggressive Outbursts Syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 05May2021 (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: INTERMITTENT EXPLOSIVE DISORDER (non-serious), outcome "unknown", described as "Aggressive Outbursts Syndrome".  Additional information: The patient's mother stated that appointment for second dose was scheduled on 26May and asked for assistance to set the second appointment for him at their house as he has Aggressive outburst syndrome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On the day after shot, starting at 2am, I ran a fever of 100.3.  Headache, soreness, and really tired.  Tylenol seemed to keep symptoms at bay, but felt very lethargic, and needed to sleep.  By day 2, fever had diminished. But had swollen lymph nodes (lymphodemenopothy) in left arm pit.
4 days after receiving the Tdap vaccination I began having pre-term contractions (28 weeks gestation). I was sent to the hospital at 5pm where I received medication to stop contractions and was sent home later that evening. The following morning around 6am the contractions started again and I went to the hospital where doctors were again able to control and cease contractions with medication. I was prescribed Nifedipine, taken orally every 4 hours to further control my contractions, which I was experiencing daily. I took Nifedipine from 28 weeks to 37 weeks gestation in order to control contractions and delay delivery of the baby. Up until the Tdap vaccination, my pregnancy was healthy and without complications. My actual delivery was a 8 lb. 15 oz. baby. This was my first pregnancy.
intense headache, fatigue followed by intense muscle and joint pain in both legs; fatigue lasted only briefly (about  6-10 hours), pain lasted two days; legs no longer in pain but upper legs feel weak
lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (lightheadedness). At the time of the report, DIZZINESS (lightheadedness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: decreased. (Low) Decreased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
Severe chills and body aches.  Unsure is fever present. Severe chills lasted for 4 hours followed by body/muscle aches and fatigue for 24 hours.
increased intracranial pressure (pseudotumor cerebri) with irritability and bulging fontanelle7/29/08-records received for DOS 7/12-7/15/08-DC DX: fever and bulging fontanelle with irritability. Idiopathic intracranial hypertension secondary to vaccinations.Presented with fever times 3 ago after vaccinations. Irritability and listless, intermittent fever.
Hospital Course and Significant Findings: Patient is a 70 Y male with history of DM2, HTN, recent hospitalization for MDR UTI who presented with increased leg swelling, found to have COVID-19 and admitted with acute CHF. He was diuresed below his dry weight to 177lb. On room air. He did not want remdesivir treatment for covid. He is stable for discharge home with primary care physician follow up.
Information has been received from a medical assistant referring to four patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number, dose and route were unknown). No adverse events were reported. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated by a physician and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of swelling face (facial swelling), swollen tongue (tongue swelling) and pyrexia (low-grade fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. Mar 20, 2021, patient experienced swelling face (facial swelling), swollen tongue (tongue swelling) and pyrexia (low-grade fever). On Mar 20, 2021, swelling face (facial swelling), swollen tongue (tongue swelling) and pyrexia (low-grade fever) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
About two weeks after my first shot I got a very large slightly itchy rash on the arm where I received my injection. It never prevented me from doing daily activities, just a little annoying.
Employee complains of headache and dizziness. Donor laid in office and received no medications.
Patient vaccinated 10/17/03 11 AM. Patient presented to ER 11/02 with back pain; was sent home only to return to ER with more pain 11/4. Sent home again. Returned to ER with  numbness and tingling in legs on 11/6. Was admitted to hospital where developed paralysis and on 11/10 had to be intubated. The medical record received on 2/5/04 states tracheal bronchitis and dysphagia. GBS follow up survey states Guillain Barre Syndrome. Follow up 2/09/05: Patient states she is 100% recovered. She spent 3 months in the hospital. Has occassional numbness in hands and feet. Has consistent tingling in hands.
1. Within 30 minutes of injection, I felt somewhat dizzy. This lasted on and off for several hours. 2. Within 30 minutes of injection, I experienced pain at the injection site (left arm). This lasted approximate 1 week. However, there have been two times since the injection that the site suddenly felt sore again like I had just received another injection. It only last a day or so, but very strange to feel it again after the pain had previously subsided. 3. Approximately 2 hours after injection, I became very tired, got a headache and my full body ached like I had the flu. This lasted approximately several days (with headaches on and off). I took general pain meds (Tylenol/Advil) and got to the point of getting very nauseous and dry heaving about 2 days after getting injection. Finally all symptoms resolved 4-5 days after the injection. 4. On and off since injection, I feel like I am getting heart palpitations.  5. On December 1st, I had my annual gynecology appointment and my blood pressure was very high when vitals were taken. They took bp 4 times throughout the appointment to see if it changed and to ensure the bp cuff wasn't an issue (used two different cuffs and took manually) and it was very high all 4 times (diastolic over 100), although it did go down a bit each time. They recommended I monitor it and make a doctor appointment. After my appointment I went to pharmacy and took my blood pressure again at the pharmacy and purchased a cuff to monitor at home (see readings over the last week below). I have never had high blood pressure previously, and had not had my bp taken since approximately July, so unsure if it was elevated prior to injection. I am trying to get a doctor appointment and will continue to monitor.   a. 1-Dec 4:36pm (bp: 137/91; pulse: 99)  b. 2-Dec 8:20am (bp: 138/97; pulse: 75)  c. 2-Dec 9:40am (bp: 145/107; pulse: 82)  d. 2-Dec 11:15am (bp: 144/105; pulse: 85)  e. 3-Dec 7:45am (bp: 123/88; pulse: 82)  f. 3-Dec 10:27am (bp: 139/100; pulse: 83)  g. 4-Dec 12:17pm (bp: 128/92; pulse: 91)  h. 8-Dec 8:12am (bp: 117/83; pulse: 79)  i. 8-Dec 10:30am (bp: 115/88; pulse: 97)  j. 8-Dec 12:05pm (bp: 105/81; pulse: 72)  k. 8-Dec 1:10pm (bp: 134/97; pulse: 68)  l. 8-Dec 10pm (bp: 143/99; pulse: 76)  m. 8-Dec 10:40pm (bp: 140/90; pulse: 74)  n. 9-Dec 7:05am (bp: 134/99; pulse: 80) 6. Since getting the injection, I have had trouble sleeping. Going to sleep at night is difficult. I typically toss and turn many times and it can take hours to get to sleep. I generally get 7 hours of sleep at night, but since getting the injection there have been many nights where I only got 4-6 hours of sleep, which affects my work and other activities.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with GARDASIL and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Pt was shaky and light headed when she attempted to stand up after receiving vaccinations. Pt vomited. Took pt blood pressure and set with her until she felt better. Felt well enough to continue shopping after 10 - 15 mins.
Pt reported coolness in both arms and hands, and also felt like her shoulders were swelling.  She then said she felt as though her wrists and lower forearms were getting swollen.  No trouble breathing or swallowing. No swelling of mouth lips or tongue. No hives or rash. No redness or warmth at injection site.
This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB lot # M022077 and L048236 for prophylaxis. Temperature was reported as 52.6 FR, timeframe: 2 hours 32 minutes. There was no previous temperature excursion. No adverse effects were reported. This case is linked to case 1707USA006122 and 1707USA006520 (same reporter link). Additional information has been requested.
would not walk, temp measured up to 105 and fluctuated for about 10 days;
Approximately 10 minutes after second dose, left side of face felt numb. Similar to first dose, facial numbness peaked around day 4. Facial numbness slowly improved, but mild form persists. Primary care doctor suggested it may be Bells Palsy.
Feeling of elevated heart rate, tired. BP 148/77, HR 98, O2sat 96. Denies chest pain, shortness of breath, headache, dizziness. Palpitations resolved. Discharged in stable condition.
Woke up the next morning with a "hard" knot on my left arm.  Fever, aching and lethargy.
she had symptoms of a stroke; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) first dose, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Initially, it was reported that the patient experienced symptoms of Bell's palsy before getting the second dose. It was further reported that the patient stated it was not true that she experienced Bell's palsy. She mentioned she had symptoms of a stroke on an unspecified date. She wanted to confirm that her appointment for next 20Feb2021 has not been cancelled. Consumer refused to continue with the survey. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
3cm circular erythematous edema at injection site, accompanied by nodularity and edema. Pt also reports sore throat and fever. All occurring within onset 12 days after vaccine administration.
Rash at site of injection, Redness on left thigh, benadyl by mouth
Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09243, -09245, -09246, -09247, -09248, -09249 and 2011-09250. An unidentified patient (infant/child, age not reported) had received a DTAP vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and within three days of vaccination, the patient died. Cause of death was pulmonary hemorrhage (onset not reported) although pathogenesis of the hemorrhage remained undefined. No CNS lesions were identified. Documents held by sender: None.
DVT (blood clot) left calf Eliquis prescribed resolved after 2 weeks
Itchiness at site, some itchiness on face, malaise, mild headache. Symptoms started within 3-4 hours of vaccination.
after the second shot I was very very sick/symptoms after the second vaccine hung on for a while; Fatigue; high fever; headache; Chills; Body ache; Severe Nausea; Diarrhea; stomach is just not right; heart burn and acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (stomach is just not right), GASTROOESOPHAGEAL REFLUX DISEASE (heart burn and acid reflux), ILLNESS (after the second shot I was very very sick/symptoms after the second vaccine hung on for a while) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (stomach is just not right), GASTROOESOPHAGEAL REFLUX DISEASE (heart burn and acid reflux), FATIGUE (Fatigue), PYREXIA (high fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and NAUSEA (Severe Nausea). On an unknown date, the patient experienced ILLNESS (after the second shot I was very very sick/symptoms after the second vaccine hung on for a while). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM HYDROXIDE (ROLAIDS [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (high fever) had resolved. On 12-Mar-2021, DIARRHOEA (Diarrhea), CHILLS (Chills), MYALGIA (Body ache) and NAUSEA (Severe Nausea) had resolved. On 15-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (stomach is just not right), GASTROOESOPHAGEAL REFLUX DISEASE (heart burn and acid reflux) and HEADACHE (headache) had not resolved and ILLNESS (after the second shot I was very very sick/symptoms after the second vaccine hung on for a while) outcome was unknown.            No concomitant medications were reported.   Action taken with mRNA-1273 in response to the event was not applicable.          This case was linked to MOD-2021-059889 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021, contains non-significant information.; Sender's Comments:  MOD-2021-059889:First Dose of Vaccine case for same patient.
irritated seborrheic keratosis; This spontaneous case was reported by a nurse and describes the occurrence of SEBORRHOEIC KERATOSIS (irritated seborrheic keratosis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and M012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high, Rosacea and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), ATORVASTATIN for LDL increased, METRONIDAZOLE (METROGEL) for Rosacea, MULTIVITAMINS [VITAMINS NOS] and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEBORRHOEIC KERATOSIS (irritated seborrheic keratosis). On 29-Apr-2021, SEBORRHOEIC KERATOSIS (irritated seborrheic keratosis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-032767, MOD-2021-032767 (Patient Link).
ASMA TARQUICARDIA,PAIN ON INJECTION SITE,HEADACHE,CHILLS,FEVER,SICKNESS,ALERGIC ACTIVE PAIN ON CHEST AND REFLUX 2 DAYS OF SINTOMES.
Patient reported can't lift arm that had Flu and PNEUMOVAX 23 injections, tense back, neck, shoulder, chills, aches, hives. Had immunizations at 10am 9-9-16 felt bad at 3:30 same day, reported to Pharmacy 9-10-16, saw doctor 9-12-16.