chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 63-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's comment: The case was self-reported by the patient. The patient had allergic reaction to Shingles Vaccine.
Swollen glands, tongue.  Red-bloodshot eyes.  Swollen arm - sore to touch.  Lasted about 24 hrs.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (fine after receiving the first dose on an unknown date.). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were recovered/resolved. It was unknown if the reporter considered the fever and feels awful to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Registered Pharmacist (RPh) for herself. The age at vaccination was not reported. In 2018 last year from the reporting date, the patient received a dose of SHINGRIX, and she felt terrible with fever and missed work for an entire day. The patient said, she patient did not feel that great prior to receiving the vaccine. The patient received a dose of SHINGRIX on Wednesday (date unspecified) and felt better by Friday (date unspecified).
HYPOXIA 1/15/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
administration of Shingrix after the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number H7AT2, expiry date 28-AUG-2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 22-NOV-2022, the patient received the 2nd dose of Shingrix. On 22-NOV-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: administration of Shingrix after the recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date:17-AUG-2023  A pharmacist called in to request information about the administration of Shingrix after the recommended interval and wished to know how to proceed.  Partial information was given about patient, event and vaccine. No follow-up consent. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
HEADACHE!!!!!! Fever 101.5, Chills, Muscle pain,  Weakness.
Severe tiredness/lethargy started on 01/28/2021. Died at home around noon on 01/29/2021.
Tue 28Jun2022 was my first positive test/Sun 26Jun2022 I started feeling a little off/Mon 27Jun2022 I developed a cough and fever.; Tue 28Jun2022 was my first positive test/Sun 26Jun2022 I started feeling a little off/Mon 27Jun2022 I developed a cough and fever.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 [booster], single (Lot number: 30125BA), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 28Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 28Jun2022, outcome "unknown" and all described as "Tue 28Jun2022 was my first positive test/Sun 26Jun2022 I started feeling a little off/Mon 27Jun2022 I developed a cough and fever.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: Tue 28Jun2022 was my first positive test; (03Jul2022) Negative, notes: Sun 03Jul2022 I tested negative; (04Jul2022) Negative, notes: Mon 04Jul2022 I tested negative; (08Jul2022) Positive, notes: I just tested positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient didn't received other medication in 2 weeks. Treatment start date-28Jun2022, Treatment stop date-04Jul2022. Other medical history reported as None.  No follow-up attempts are possible. No further information is expected.
covid test date=26Nov2021 / covid test result=Positive; covid test date=26Nov2021 / covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: el8987) at the age of 69 years as dose 2, single and administration date 29Jan2021 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: trees" (unspecified if ongoing); "Meniere's ear" (unspecified if ongoing), notes: 20 years ago. Concomitant medication(s) included: LEVOXYL. There was no other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "covid test date=26Nov2021 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive, notes: Nasal swab.
EXTREME DIZZINESS, NAUSEA, AND VOMITING. BEGAN A FEW HOURS AFTERWARDS. SYMTOMS IMPROVED ON THE MORNING OF 11/13/13. PATIENT SELF TREATED.
Ears swollen inside-no infection anywhere; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 08Mar2021 at 12:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, thyroid, and type 2 diabetes mellitus (controlled) from an unknown date. The patient had an allergy to dust and dog and cat dander. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included unspecified thyroid medication and metformin (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. On 14Mar2021 at 12:00, the patient had a loss of smell and taste. The ears were swollen inside and there was no infection anywhere. Other than the events reported, the patient actually felt okay and could exercise and live as normal. The patient could only smell or taste the dust. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with montelukast sodium (SINGULAIR). The clinical outcome of the events loss of taste and smell and ears swollen inside-no infection anywhere were not recovered at the time of this report.
Severe abdominal cramping, nausea, headache, body aches, fever of 101+, weakness
Days after vax starting to develop circular itching random bug bite looking blotches but bigger than a mosquito bite. Pretty sure it started on the same side of my body as where the shot was placed right side.. Start on my leg then arm after a few days started on the other side.  Maybe 10 isolated 5-7 mm lesions total. Today I had a similar legion at the site of a nickel snap touching my skin but nickel was not involved in the origin of the other lesions
10/15: flut shot given, patient developed pain and a knot at the injection site 10/16: knot resolved however pain continued 10/17: knot and pain resolved 10/18: pain returned with an intense throbbing sensation 10/24: sought medical care
Swollen arm and pain: 1 hour later. Nausea, fever, chills: 2 hours later. Slurred speech, lethargic: 2.45 minutes later. Hypersensitivity to touch: 5.45 min later.
headache; tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (tenderness at the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Feb-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 HEADACHE (headache) and VACCINATION SITE PAIN (tenderness at the injection site). At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that three days after vaccination, the patient developed 40 lesions. Additional information has been requested.
20 minutes after receiving vaccine patient reports paresthesia in bilateral feet traveling up legs to bilateral arms and hands. Patient reports fatigue and headache. Patient able to hydrate with water. After 1 hour of observation, patient reports symptoms improved significantly. Patient informed to take Acetaminophen/Ibuprofen, to consume food/fluids and rest. Advised to follow up with primary care physician. Advised to call 911 if symptoms persist or respiratory distress. Patient declined transportation to hospital for evaluation. Patient reports able to drive home safely which is about 10 minutes away. Patient was ambulatory upon discharge. BP 118/80. HR 82.
Patient presented with redness, rash, and itching. Mild allergic reaction to patients chest and neck area. Patient received 25mg of benadryl IM @ 1600.  No change in patients condition. Vital Signs: 1. 13:55 - 178/102 Pulse 102 - RR 18 - SpOz 98% 2. 14:10 - 164/107 Pulse 109 - RR 20 - SpOz 98% 3. 14:20 - 144/95 Pulse 120 RR 18 - SpOz 98% 4. 14:35 - Patient condition improved, rash and redness decreased.  Itching stopped.  Patient stated "I feel much better."  Patient denied c/p, SOB, NV, ABD Pain, itching
Pt vax 3 doses; did not achieve titers.  03Apr91 titer indicated none detected.
terrible tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 15:15 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrobid, reaction(s): "Drug allergy", notes: Known allergies-Macrobid; Cipro, reaction(s): "Drug allergy", notes: Known allergies- Cipro; Bactrim, reaction(s): "Drug allergy", notes: Known allergies- Bactrim. The following information was reported: TINNITUS (non-serious) with onset 19Feb2021, outcome "recovering", described as "terrible tinnitus". Therapeutic measures were not taken as a result of tinnitus. The patient experienced terrible tinnitus after 9 days of first vaccine on 19Feb2021. It was reported that it got somewhat better. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Prior to 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 vaccine within 4 weeks prior to COVID-19 vaccine. The patient received other medications (unspecified) within two weeks of vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
68 yo F with history of food allergies, including multiple types of berries and lavender oil presented to the COVID-19 Vaccination Clinic on 02/20/2021 for her second dose of the Pfizer COVID-19 vaccine. An hour after her first dose at 1841 on 1/28/21 (Lot #EL9263), patient had developed a headache and hives which she treated with 25 mg diphenhydramine.  Since that time, she develops hives around her face, inside her lips, down her neck and onto her chest daily.   Her headache lasted approximately 1 week after the first vaccine. She consulted her PCP about this reaction and was advised to pre-medicate with 25 mg of Benadryl before the second vaccine. Based on this information, CMA agreed to allow her to have  her second vaccine.   Vaccine given at 1419 with Lot EN6201 in her left deltoid.  Approximately 5 minutes after receiving the second vaccine today, she reported that she could feel her lips tingling and that she was developing bumps on the inside of her lips. She was given 25 mg of diphenhydramine IM to her right deltoid.  Vitals monitored and were stable.  Patient denied development of any other symptoms during this time and also denied any worsening of bumps on the inside of her lips. She reported that she was feeling drowsy from the Benadryl. Patient had a driver.  Patient had denied any prior history of allergic reaction to injectable medications, but then later reported that she did not tolerate the shingles vaccine well and had a swollen arm, so she never received the second dose.   This reaction was not documented in her medical record.  Per chart, PMH includes Allergic rhinitis, Chronic neck pain  GERD (gastroesophageal reflux disease), and Hyperlipemia.
Dry mouth; Joint pain; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Tired) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Tired). At the time of the report, DRY MOUTH (Dry mouth), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
I had heightened senses after waking up in the middle of the night.  I went to the bathroom thinking I was going to get sick.  A short time later I blacked out falling to the ground striking my face.
pt recv vax & devel a red rash from the inj site, across the chest, & over to the opposite arm;pt was treated w/DPH & Epi & recovered;
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent two separate temperature excursions. In the first excursion the vaccine was exposed to temperature between 46 to 77 degrees Fahrenheit for 4 hours. The second temperature excursion details were unknown. There was no adverse effect reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter. Sender's Comments: US-009507513-1701USA013510: US-009507513-1701USA013514.
Pt recvd vax on 15OCT93 & has had a sore arm since then sought care from MD who gave exercises to do;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition was not reported. On 25-MAY-2016 (also reported "20-MAY-2016") the patient was vaccinated with a dose of ZOSTAVAX (lot # L036823, expired on 24-DEC-2016) (dose, frequency and route unknown). No concomitant therapy was reported. On an unspecified date of May 2016 the patient experienced a large red itchy spot at the injection site, upper arm swelling. The pharmacist had instructed the patient to apply BENADRYL cream or hydrocortisone cream for the itching and oral ibuprofen for the swelling. The patient had recovered from all the events in 2016. The causality was not reported. Pharmacist had requested a lot check. This is one of 4 reports received from the same reporter. Additional information has been requested.
Patient is a 29 y.o. female who received the Janssen COVID Vaccine Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate   of observation: Dizzines Diaphoretic  Patient was treated/managed as follows:  Pt was given Gatorade  VS are as follows:    10:20: BP 108/76 HR: 76 RR: 18 O2: 98% 1034: BP 116/64 HR: 80 RR: 18 O2: 99% Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor. Pt escorted to car
Pinpoint rash started 5 hours later, lasted 4 days. Did not recur with second dose.
No adverse effcet; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 06-year-old female patient. on 11-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Janssen COVID-19 Vaccine EUA  I have been married with my female spouse for over thirty years and we have two adult children.  We still have an active sexual life, but I am now having difficulty having an erection.   I exercise every day, I have a very balanced and healthy diet and I can't think of anything else that could have created this adverse effect.  I  sent the message to my doctor's office today.
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: EMT and paramedics came
started to sweat quite a bit; really weak for 2 days; had body aches; trouble breathing; a pretty bad reaction; had nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (started to sweat quite a bit), ASTHENIA (really weak for 2 days), PAIN (had body aches), DYSPNOEA (trouble breathing) and ADVERSE REACTION (a pretty bad reaction) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal, Cholesterol total abnormal NOS and Thyroid disorder NOS.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HYPERHIDROSIS (started to sweat quite a bit), ASTHENIA (really weak for 2 days), PAIN (had body aches), DYSPNOEA (trouble breathing), ADVERSE REACTION (a pretty bad reaction) and NAUSEA (had nausea). On 15-Feb-2021, ASTHENIA (really weak for 2 days) had resolved. At the time of the report, HYPERHIDROSIS (started to sweat quite a bit), PAIN (had body aches), DYSPNOEA (trouble breathing), ADVERSE REACTION (a pretty bad reaction) and NAUSEA (had nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications as medications for blood pressure, thyroid and cholesterol No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: No specific follow-up information recorded.