chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt bad; didn't feel like getting up; back hurt really bad; Diarrhea; across her hips hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ARTHRALGIA (across her hips hurt really bad), FEELING ABNORMAL (felt bad), DYSSTASIA (didn't feel like getting up) and BACK PAIN (back hurt really bad) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Reflux gastritis and Arthritis. Concomitant products included MELOXICAM for Arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ARTHRALGIA (across her hips hurt really bad) and BACK PAIN (back hurt really bad). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad) and DYSSTASIA (didn't feel like getting up). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 29-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ARTHRALGIA (across her hips hurt really bad), FEELING ABNORMAL (felt bad), DYSSTASIA (didn't feel like getting up) and BACK PAIN (back hurt really bad) was resolving.            Concomitant medications included blood pressure, reflux and preservation eye medication. Treatment information included Imodium.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non-significant follow up. Patient declined to give email address and any further FU, states she believes she had a virus instead of adverse events to vaccine
Dizziness- nausea - vomiting - tingling in arms lite head. Approx 6 to 8 hours after all symptoms resolved 10/12/15 - pt started WELLBUTRIN same day 10/10.15.
Pt recvd 3 doses of Engerix-B & titers were checked 6 months p/last dose; titer result was neg;
Information has been received from a Registered Nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 11-OCT-2007 was vaccinated with the first dose of GARDASIL (lot number not provided) and on 06-FEB-2008 was vaccinated with the second 0.5 ml dose of GARDASIL (lot number not provided) and is now pregnant.  There was no concomitant medications.  The patient was not experiencing any known symptoms.  Medical attention was sought in the practice.  Patient outcome was unknown.  No product quality complaint was involved.  Follow-up information was received from another health professional who reported that on 06-FEB-2008 a PAP test showed atypical squamous cell of undetermined significance s/o HPV.  She had the second dose of GARDASIL the same day.  On 13-MAR-2008 the patient underwent colposcopy and was diagnosed with cervicitis, focal HPV changes.  The patient received MACROBID 100 mg, twice a day for the treatment of urinary tract infection from 07-MAY-2008 to 14-MAY-2008.  On 02-JUN-2008 an ultrasound was performed which was within normal limits and showed a fetal anatomy scan at 19 weeks.  An MSAFP was declined.  Patient declined genetic screening.  This was the patient's first pregnancy.  On 15-AUG-2008 (at 28 weeks) because she was Rh negative the patient received globulin, RHOGAM intramuscularly.  The outcome of cervicitis and urinary tract infection was unknown.  On 08-NOV-2008, at 40.5 weeks from LMP, the patient gave birth to a liveborn female infant weighing 5 pounds, 5 ounces, length was 18 inches, head circumference was 12 inches.  Apgar score was 8.  There were no complications during delivery.  The infant was normal.  There were no congenital anomalies or other complications or abnormalities.  No further information is available.
THE DAY AFTER VACCINATION PATIENT DEVELOPED BLISTER FILLED WITH LIQUID AT THE SITE OF ADMINISTRATION.  PATIENT WAS ADVISED TO KEEP EYE ON IT.  IF THE BLISTERS ARE SPREADING ALL OVER HIS BODY OR THE BLISTER THAT ALREADY  EXISTS IS GETTING WORSE PATIENT WAS ADVISED TO CONTACT THE MD IMMEDIATELY.
A few minutes after the shot, she heard ringing in her ears, saw a ?swirly? rainbow circle, felt her ears were clogged, and  felt her head getting hot. After a few minutes of sitting, the circle went away, and then a few min more, she was back to normal.
Mild Headache, general muscle soreness and aches, general feeling of malaise. Sore shoulder where injection occurred.
Varicella vaccine storage temperatures were noted to be outside of recommended range. Due to inconsistencies in temperature documentation, the vaccine was deemed possibly ineffective. Patients have been notified.
Information has been received from a nurse practitioner concerning a 70 yr old female pt who on 11Oct05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (650331/0749P). On 11Oct05 she experienced a cellulitis like reaction which was characterized by swelling, redness and warmth from the deltoid injection site to the knuckles. The pt was treated with levofloxacin (Levaquin). It was noted that the adverse event improved after the levofloxacin and the pt is recovering. There was no product quality complaint reported. The reporter considered swelling, redness and warmth to be other important medical events (OMIC). Additional information has been requested.
This spontaneous report as received from a physician is also the patient in this case of unknown age reported to the representative regarding himself/herself. Medical history and current conditions were not reported. On 02-OCT-2014, the patient was vaccinated with 1 single shot of ZOSTAVAX vial, via an unknown route. Concomitant medications were not reported. On 02-OCT-2014, the patient experienced huge red reaction at the injection site. Lab diagnostics were not performed. The outcome of huge red reaction at the injection site was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
SEVERE LETHARGY/ KNOCKED HER OUT; TIREDNESS THROUGHOUT THE DAY; MILD GASTROINTESTINAL (GI) SIDE EFFECTS SUCH AS CRAMPING; TUMMY UPSET; This case (PVX2019-2187) was received from a pharmacist on 27-Aug-2019. It described a 36-year-old adult female consumer who reported "severe lethargy/ knocked her out" (PT: Lethargy), "mild gastrointestinal (GI) side effects such as cramping" (PT: Abdominal pain upper), "tummy upset" (PT: Abdominal discomfort), "tiredness throughout the day" (PT: Fatigue), during therapy of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took Vivotif doses on 23-Aug-2019, 25-Aug-2019, and 27-Aug-2019, respectively. She reported that after taking each dose it "knocked her out". She had severe lethargy in the morning. She experienced mild GI side effects such as cramping, after taking each dose. Also, she had tiredness throughout the day, for which she consumed caffeine. It was reported that her tummy was getting upset. She denied any other reactions such as swelling or rash. She took oral Pepto Bismol (bismuth subsalicylate) for stomach cramping.   Past medication included Hepatitis A and B vaccines, which were taken on 22-Aug-2019 for Hepatitis A and B prophylaxis, respectively. She also took oral typhoid in the past. She did not have any medical conditions or allergies.  Concomitant medication included oral Lutera (levonorgestrel; once a day) for birth control.  Action taken with Vivotif with respect to the reported events was dosage maintained.  The consumer was recovered from the events of "mild gastrointestinal (GI) side effects such as cramping" and "tummy upset", while the consumer was recovering from the events "tiredness throughout the day" and "severe lethargy/ knocked her out ".  Company's Comment: In this case, it was reported that the consumer experienced "severe lethargy/ knocked her out", "mild gastrointestinal (GI) side effects such as cramping", "tummy upset" , "tiredness throughout the day" during therapy of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "severe lethargy/ knocked her out", "mild gastrointestinal (GI) side effects such as cramping", "tummy upset" , "tiredness throughout the day" during therapy of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Pt recvd flu vax on 18NOV91 between 11AM & 2PM; that night pt "arrested" @ home; EMS were summoned, but pt died; pt suffered an asthma attack; no autopsy was performed; Prior to vax survey form pt didn't indicate allergy to eggs;
Had shot on 3/12/21 @ 6:20 pm, felt fine. Went to bed and woke up on 3/13/21 @ 1:15 am vomiting.  Took it easy, on 3/13/21 and 3/14/21 eating soup, drinking Powerade. Felt fine by the evening of 3/14/21.
were the shot is, but it's still red; were the shot is, but it's still red and swollen; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on 21Feb2021 (age at the time of the vaccination 71-year-old) as dose 2, single for COVID-19 immunization. Medical history included allergy to penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration on 30Jan2021 (age at the time of the vaccination 71-year-old) as dose 1, single for COVID-19 immunization had little reaction to the first shot but her heart doctor changed her cholesterol levels. On an unspecified date in 2021, the patient had to take Benadryl all three days after the second vaccination. The patient placed a sore bean junior were the shot was but it was still red and swollen. The outcome of all events was not resolved.  Follow-up attempts are completed. No further information is expected.
?Moderna COVID- 19 Vaccine EUA? After 15 minute monitoring time, patient complained of metallic taste in mouth. She described it as similar to "the taste you get after a saline flush".
Infantile spasms, myoclonic jerks (3 days). Bronchiolitis and diarrhea (1 week and continuing).
pt recv vax 1995 & exp myalgia;pt devel deep muscle pain in hips, legs, calves & sometimes the pain goes to the arms;
1.3x3"circular, red, warm to touch on left upper thigh. Treated with Benadryl po, cold compress. 2. 1.5x1.5" circular red spot on right upper arm.
Twenty minutes after injection, patient and father were leaving building.  Patient had orthostatic hypotension, syncope with collapse in elevator.  Developed diffuse rash with some pruitis. Administered 25mg of oral Benadryl and oral hydration.
Directly after administration of the vaccine, the patient started to feel like he was going to faint and became nauseous. I got him some water and when I returned he was slouched in his chair. His leg and arms started to twitch for at least 10 seconds and he was incoherent. After the twitching stopped, he seemed to not have full recollection of the past minute and asked if he had passed out. His shoulder muscles were tight, he felt very warm, and soon after become nauseous but did not vomit. We gave him an ice pack to cool him down in addition to the cold bottle of water. We waited for a friend to come pick him up and during the wait he recovered and was able to hold a conversation, not feel dizzy, and stand up on his own. After 30 minutes of observation, the friend arrived so I walked with him out of the pharmacy to the car.
underside of tongue began to tingle and feel strange and then went numb; simultaneously my lower lip began to tingle, go numb and swell to double its size  This happened in vehicle after leaving pharmacy. I received the vaccine at a small pharmacy which is 3-1/2 hours from my home, there are no nearby hospitals. I purchased benadryl at the next small town and took two capsules. Approximately 1 hour later the numbness and swelling began to subside. It took about 12 hours and two separate doses of benadryl for my mouth to feel normal again. I have had prior anaphylactic reactions, this felt like a much weaker beginning to an anaphylactic reaction. I have had a reaction to an epipen in the past because there is a sulfite preservative used in the epipen.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 20-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Patient came By the store on 3/12/21 And complained ABout Frozen  Shoulder pain
congestive heart failure; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) and DYSPNOEA (short of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (short of breath) (seriousness criteria death, hospitalization and medically significant). The patient died on 28-Aug-2021. The reported cause of death was Congestive heart failure and Short of breath. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: elevated (High) elevated. On an unknown date, Brain natriuretic peptide: elevated (High) elevated. On an unknown date, Fibrin D dimer: elevated (High) elevated. On an unknown date, Hepatic enzyme: elevated (High) elevated.         No concomitant medication details was provided. No treatment medication details was provided.  Company comment: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Reported Cause(s) of Death: congestive heart failure; short of breath
Fever; Chills; Headache; fatigue; Fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. I had a recent blood test confirming the presence of antibodies & I believe that my; stomachache; Sore arm; Insomnia; Tachycardia; Throbbing teeth; Body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 09Mar2021 at 12:00 pm (age at vaccination was 65 years) as dose 2, single for COVID-19 immunization. The patient's medical history included hypertension from an unknown date and COVID-19 from 04Apr2020 to an unspecified date (patient's positive COVID test was almost a year ago on 04Apr2020). The patient did not have any known allergies. Concomitant medications the patient received in 2 weeks included candesartan, atorvastatin, hydrochlorothiazide (MICROZIDE [HYDROCHLOROTHIAZIDE]), clonazepam (KLONOPIN) all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 16Feb2021 at 13:00 pm (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient underwent lab test which included Sars-cov-2 test: positive on 04Apr2020. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 16:30 pm, the patient experienced fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. She had a recent blood test confirming the presence of antibodies & she believed that her severe reaction was intensified due to their presence. She took Acetaminophen & Ibuprofen round the clock for the next 48 hours. The patient received treatment with over the counter medications. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Red rash start on face, and then spread to the entire body. Child was not fussy, no fever, no loss of appetite. No signs of discomfort or distress. Did not report to Health department until 11:00 a.m. on 5/17/2010. Did not seek medical care over the weekend. Mom has been giving Tylenol.
Temperature of 101.6; Pulse oximeter reading is 91; Heart rate is 101; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on 04Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Jan2020, had a temperature of 101.6, pulse oximeter reading was 91 and heart rate was 101. Patient wanted to know what specific side effects have been noted  with the vaccine  Information on the lot/batch number has been requested.
sore arm; little rash around the injection site; the area became itchy; A spontaneous report was received from a (consumer) concerning a 78yr old female patient who received Moderna's COVID-19 vaccine (Mrna-1273) and experienced events like arm was sore and a little rash started to appear around the injection site. The area became itchy The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On unknown date, the patient experienced the events list sore arm, little rash around the injection site, itchy.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was unknown.
high fever started around 6pm day of vaccine and continued through next day red, swelling, and hardening of tissue at site of vaccine was noticed the morning after vaccine and continued for 3 days
Flu like symptoms appeared 1 hour for 24 hours after shot. Swelling, itching, red rash at injection site 9 days after shot. Over the counter medication hasn't worked on any of the disconfort.
Woke me up in middle of night - severe pain in hips and shoulders; same severe headache that causes nausea. I had muscle fatigue and overall general fatigue for 48 hours.  Injection site - starting 2 inches down from it - I had red blotchiness (about 24 hours after) - grew (to not quite down to my elbow)and swelled and was hot to touch for 72 hours. It itched a little bit.  The Monday (11th) following I had Dr. visit - to Primary Care Physician - large allergic reaction. He told me to draw a border around it. It continued to spread but not severely and no streaks down my arm. Applied heat to increase blood flow to the area.  The heat helped. It took about seven days to fully go away (the swelling and redness on my arm).
EMS was called, because patient began to feel dizzy and extremely nauseous within about 1 minute of being vaccinated. She stood up to walk, but did not get more than 10 feet away before returning to sit down. Her face became flushed. Her BP was high at 177/87 with a pulse of 108, and she complained of having blurry vision. Her blood pressure lowered to 132/90 with a pulse of 82. Her final readings were BP 139/75 and pulse 77 when EMS took them. EMS was called at 1:22pm and arrived at 1:32pm. Pt was given some water and advised to get some rest at home. She refused to ride to the hospital with EMS, and claimed to feel better after another 10-15 minutes or so. EMS thought it was just an anxiety attack.
Immunizations (flu and pneumococcal 13) given on 12/29/2014. Came in to clinic on 1/2/2015. L deltoid region with erythema, swelling and warmth. Area measures 10cm by 8cm. Treated with Prednisone 40mg for 3 days, Benadryl 50mg at bedtime, and tramadol for pain.