chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date between 08-OCT-2016 and 11-OCT-2016, the patients were vaccinated with improperly stored unspecified dose of GARDASIL 9 injection (dosing details were not reported) (lot # M016193, expiry date: 24-APR-2018) for prophylaxis which was stored at temperature of 1 degree centigrade for 4 hours as worst. There were no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Follow up information has been received on 30-NOV-2016, it was reported that a call was placed to the medical assistant, but he/she was unable to provide any further information. Additional information has been requested. Sender's Comments: US-009507513-1610USA007903: US-009507513-1610USA007902: MERCK 1610USA005738: Mfr number.
Per patient, he started to feel mild nausea after vaccine once he was home on 01/05/21. Starting 01/06/201 patient nausea has worsened and has vomited multiple times and has lost appetite. He also reports a dry cough and slight tightness in airway but patient unsure if it is due to vomiting or cough. Patient able to speak complete sentences and able to ambulate independently with no shortness of breath.
shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019 03:30, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 23rd July 2019 03:30 pm the patient had a vaccine and within 48 hours developed shingles which was confirmed by a visit to Urgent Care.
Vaccine was accidentally drawn up from an undiluted vial, so patient received 0.2ml of vaccine without diluent added.
Mom reported seeing swelling on Friday night, 6/25/21 and gave 1 dose of Benadryl.  Then noticed the following morning that it was bigger so she gave more Benadryl and used a cool compress on it.  Monday 6/28/21 she called to have him checked today.  Swelling is down and we advised to continue Benadryl
Received Moderna vaccine under 18 yrs of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 yrs of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 yrs of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 yrs of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-207585 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant Follow up appended
arm at the injection site was swollen and hard; arm at the injection site was swollen and hard; a little fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING, and PYREXIA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 012M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION SITE INDURATION, VACCINATION SITE SWELLING, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at a dose of 2 TYLENOL. On 31-Oct-2021, VACCINATION SITE INDURATION, VACCINATION SITE SWELLING, and PYREXIA had resolved.            No Concomitant medications were provided by the reporter.
Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both arms. At 11 pm went to bed with large lump in my throat, felt like I was breathing thru a straw plus whole body freezing from inside out. Could not get warm. Added layers of clothes and blankets and laid like that all nite, no sleep. 7am called nurse, advised to remove some of the layers, drink hot liquids and Tylenol every four hours. By mid afternoon the cold was gone but severe achy bones, even the bottom of my feet hurt. Next day hot and cold and ache. Fourth day dripping sweat all day and flu like symptoms. Took three showers to get sweats down plus the entire time had been taking Tylenol every four hours. Day five just drained, felt like I'd been through the wringer.
1. mild fever, body ache, lethargy for 36 hours after immunization 2. high fever 102F, body ache lethargy for 48 hours. 3. no fever. sore arm body ache 36 hours
This spontaneous case reported by a consumer, describes the occurrence of alopecia (hair loss) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced alopecia (hair loss). At the time of the report, alopecia (hair loss) outcome: unknown. No concomitant medication or treatment information provided. Reporter wanted to know if hair loss was side effect of the Moderna vaccine. Most recent follow-up information incorporated: On Jan 27, 2022: Follow-up received contained no new information.
I am currently 21 weeks pregnant. Due April 28, 2022. I weigh 132 lbs. Hives breakouts on neck, scalp, shoulders, shoulder blades, groin, and lower abdomen began on Tuesday, 12/14/2021. I have treated them with 10mg of Zyrtec and Sarna topical cream. The hives are very itchy and hot to the touch. Scratchy throat. Irritation when I urinate.
itchy skin especially in cheeks; This is a spontaneous report from a non-contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9267) via an unspecified route of administration in left arm on 22Mar2021 at 07:45 (at the age of 49-years) as a single dose for COVID-19 immunisation. The medical history of the patient included diabetes mellitus type-2 and the patient was allergic to erythromycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced itchy skin especially in cheeks on 22Mar2021 at 07:45. The patient did not receive any treatment for the reported event. Event didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Swelling  of left armpit extending to neck, face and head. Extreme headache (missed work for 6 days) fever of 102.5, loss of hearing on injection side for one week. Nausea. Extreme muscle aches. Right dude upper abd pain under right rib cage.
Positive COVID test after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID test after receiving vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLLAGEN for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID test after receiving vaccine). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; VITAMINS NOS (MULTIVITAMINUM) at an unspecified dose and frequency; MELATONIN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID test after receiving vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, COVID-19: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Vitamin C, Multivitamin, Melatonin, Aspirin   This case was linked to MOD21-088505, US-MODERNATX, INC.-MOD-2021-116365 (E2B Linked Report).; Sender's Comments:  MOD21-088505: US-MODERNATX, INC.-MOD-2021-116365:
allergic reaction; dizzy/lightheaded; blood pressure and heart rate skyrocketed; blood pressure and heart rate skyrocketed; fever; sweats; This is a spontaneous report from a contactable consumer reporting for him/herself.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date the patient experienced a mild allergic reaction with unknown outcome. About an hour after getting the shot the patient got dizzy, lightheaded, and her blood pressure and heart rate skyrocketed. She was given 50mg of diphenhydramine hydrochloride (BENADRYL) in the ED and still felt bad. On unspecified date the patient had a fever and sweats but the day after she was feeling good. The patient wanted to know if she could get the second dose.    Information on the lot/batch number has been requested.
Pt presented to the ED on 1/10 with CC of abdominal pain. Pt was seen in ED a month ago for similar abd pain and had CTA that showed endovascular leak.  Pt was discharged home at that point.     Pt having RUQ pain radiating to his back.  Pain is sharp, stabbing.  He reported it was the worse pain he ever had.  Has had cholecystectomy in 5/2020. He reported some N/V with this.   In ED pt with VS of temp of 98, heart rate 69, respiration rate 18, blood pressure 132/72, and sats 97% on room air.  Labs with hemoglobin low at 12.4, albumin low at 3.0, direct bilirubin elevated at 3.0, total bilirubin elevated at 3.6 alk-phos elevated at 292, AST elevated at 251, ALT elevated at 420, lipase of 36, lactate is 0.7, CRP elevated at 6.67, iron level low at 32, serum ethanol level less than 3, UA negative, COVID-19 PCR positive . Ultrasound abdomen was negative.  MRCP with no evidence of biliary obstruction or compelling evidence of hepatic parenchymal disease.  A left simple renal cysts noted.   Pt was placed in observation.  He got 1 L of normal saline, thiamine IV, Solu-Medrol IV, Dilaudid IV, and IV benadryl.  GI was consulted and ordered MRCP that was negative for any choledocholithiasis.   Recommended follow up in 2-4 weeks to discuss endoscopy.  Felt abdominal pain may be related to COVID as well.   As COVID 19 test came back positive pt was admitted for further workup. Troponin x 3 negative. CXR with no acute process.
Symptoms started with numb left side of tongue and progressed in to numbness and drooping of L side of face. Diagnosed with Bell's Palsy 10/30/15.
pt recv vax; devel a vesicular rash; was noted that pt old sibling also recv vax & devel vesicular rash;
This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 81-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), at the age of 81, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# and expiration date not reported) via an unspecified route of administration, both doses on an unspecified date, both single doses, for COVID-19 immunization. Reportedly, on Sep 14, 2021 (after patient took the booster shot), she experienced side effects of slight headache and fatigue; with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 19-AUG-2016, the patient was vaccinated with improperly stored dose of M-M-R II lot # L029266, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
the incorrect diluent was used . no adverse reactions or symptoms following the administration of the vaccine with the incorrect diluent.
Two minutes post-vaccination, mother noticed redness on patient's neck, and "side vein slightly bulging". Five minutes after vaccination, mother noticed the patient was pale on forehead, followed by "overall paleness" a minute later. Patient reports feeling slightly light-headed five minutes post-vaccination. He said he also felt warm and slightly sweaty. Eight minutes post-vaccination, his mother said his earlobe "lost color". The patient reported feeling cool and sweaty around this time and still light-headed. 19 minutes post vaccination (at 10:06 AM), patient informed me of how he was feeling, and I checked his blood pressure. It was 93/47, with a pulse of 55. He felt very hot to the touch, but his temp was 96.8 degrees. He brought a water bottle to sip water as needed, and he was given a cool cloth for his neck/forehead. At 10:10 AM, patient reported feeling weak and didn't want to talk. At 10:13 AM (~25 min post vaccination), patient reported feeling a "bit better", and his BP was 104/57 (checked by other RPh). 34 minutes post-vaccination he reported feeling much better and was much less light-headed/able to talk. At 10:26 AM (~39 min post-vaccination), BP was 137/75, and his pulse was 60. 42 minutes post-vaccination, he said he was "mostly back to normal; ~90%". Then, 46 minutes post-vaccination, he said he was 95% better, and he said he was "good to go" 51 minutes post-vaccination.
Approximately 1 week after receiving my COVID Moderna Booster (3rd dose) I began to break out in hives.  Hives began on approximately 10 Dec 21 and continue to date (7 March 22).  I have been diagnosed with Chronic Idiopathic Urticaria.
5 hours later after the 2nd dose of vaccine. I had aching pain at the injection site and throughout my left arm, radiating to my chest (like squeezing or feels heavy) as well as nausea. On Sunday morning around 330 am, I had bad chills and temperature of 100.5 and had taken Tylenol prior to having chills. Later in the day, I had severe headache and fatigue.
Patient got the first dose 8-10 years ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix with an associated reaction of no adverse event (patient got the first dose 8 to 10 years ago).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: Web request form submitted afterhours and retrieved by Medical Information at start of business. The age at vaccination was not reported. The patient received first dose 8 to 10 years ago and did not receive 2nd dose, which led to incomplete course of vaccination. The reporter wanted to know do they need to restart the cycle and receive a second dose. No further details provided via web form.
DIFFICULTY TURNING HEAD FROM LEFT TO RIGHT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty turning head from left to right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of difficulty turning head from left to right was not reported. This report was non-serious.
c/o nasal congestion & body aches 8-10 hrs sp/ inj;sxs lasted 24-48hrs;denied having fever @ any time
I had a couple of episodes where I felt like I swallowed something and couldn?t catch my breath after the shot during the day.  Then I woke up about 3am and had a hard time breathing and felt like I was having an asthma attack. I have not had any issues with my asthma since I was child unless I was around environmental factors like smoke, perfume, air fresheners, etc. The next day I went to work and had a few more of those episodes throughout the day. Then after giving report at 7:00pm I felt like I was choking on something and couldn?t catch my breath. Maybe 15min of trying to cough and catch my breath, I was finally able to breath, but I felt like there was something in my throat. I felt like I was breathing through a straw. I ended up driving home and having another episode where I couldn?t breath, but I was also having left sided numbness and weakness. My left hand acted like I had a contracture and it was stuck like that. I also had numbness around my mouth and my jaw felt like it was hard to move. I ended up going to the ER  They said I looked like I was having a stroke. They worked me up for a stroke, which was negative. Despite telling them I couldn?t breath, they decided I was having a panic attack for no reason. I begged for a breathing treatment and finally got that and an inhaler which helped. I also reported that I had just got my vaccine and no one would listen to that.
Signs of measles or rubella. Morbilliform, bl circling, pink rash from head to toe including palms and soles. No fever.
Headache, Myalgia, lost time from work Narrative:  Other Relevant History:
Pt was given the Moderna bivalent booster instead of the flu shot, no symptoms were seen at time of incident, pt previously recieved two doses of pfizer with last dose adminstered more than 2 months ago.
Didn't feel good; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), CHILLS (Chills) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MALAISE (Didn't feel good), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, MALAISE (Didn't feel good), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported.    This case was linked (E2B Linked Report).; Sender's Comments:  same reporter, different patient and event same reporter, different patient and event
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-AUG-2011, at age 66, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a hospital for the following injury resulting from his ZOSTAVAX use: herpes zoster ophthalmicus. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster ophthalmicus is unknown. Upon internal review, herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.