chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008831: US-009507513-1707USA008799: US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008819: US-009507513-1707USA008862: US-009507513-1707USA008863: US-009507513-1707USA008793: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008839: US-009507513-1707USA008864: US-009507513-1707USA008865: US-009507513-1707USA008794: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008840: US-009507513-1707USA008866: US-009507513-1707USA008867: US-009507513-1707USA008795: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008841: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008826: US-009507513-1707USA008827: US-009507513-1707USA008828: US-009507513-1707USA008842: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008843: US-009507513-1707USA008798: US-009507513-1707USA006643: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008845: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008834: US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008853: US-009507513-1707USA008789: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008854: US-009507513-1707USA008855: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836.
Extreme muscle pain covering full body lasting full day after second injection.  Swelling at injection site.  Bruised feeling at injection site.  Tylenol did not help alleviate the pain.  Aleve taken and seemed to help the pain, but not relieve it entirely.  Muscle pain completely gone the second morning after injection.  Still redness, swelling and slight "bruised" pain at injection site.
Neuropathy after vaccine; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy after vaccine) (seriousness criteria disability and medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy after vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEUROPATHY PERIPHERAL (Neuropathy after vaccine) to be possibly related.    No concomitant medication was reported.  No treatment medication use was reported.  Company comment: This case concerns a female subject of unknown age with a history of autoimmune disorder, who experienced the unexpected event of neuropathy peripheral. The event occurred on an unknown date, patient also received the Moderna Covid-19 vaccine on an unknown date. The rechallenge is not applicable since no other data is provided. The event was considered possibly related to the study drug per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a female subject of unknown age with a history of autoimmune disorder, who experienced the unexpected event of neuropathy peripheral. The event occurred on an unknown date, patient also received the Moderna Covid-19 vaccine on an unknown date. The rechallenge is not applicable since no other data is provided. The event was considered possibly related to the study drug per the reporter's assessment.The benefit-risk relationship of the vaccine is not affected by this report.
Treatment of COVID-19; Treatment of COVID-19; Moderna-Dose 1, Dose 2, Dose 3; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 at 16:00 as dose 1, single (Lot number: 025L20A), in left arm, on 20Feb2021 at 15:00 as dose 2, single (Lot number: 031L20A), in left arm and on 09Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 004f21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergie: Shellfish" (unspecified if ongoing), notes: Known allergies : Shellfish; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: METFORMIN ER, start date: 05Sep2022; LISINOPRIL, start date: 08Jun2009; VITAMIN C [ASCORBIC ACID], start date: 03Oct2022; VITAMIN D3, start date: 18Jun2007; VITAMIN B12 [CYANOCOBALAMIN], start date: 15Jun2020. Past drug history included: Iodine, reaction(s): "Known allergies :  Iodine", notes: Known allergies :  Iodine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22May2022 at 16:00, outcome "unknown", described as "Moderna-Dose 1, Dose 2, Dose 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Interchange of vaccine products, Drug ineffective and COVID-19 cannot be excluded for the suspect drug BNT162B2. the case will be reassessed once new information is available.
As to be expected several hours after vaccine my arm become sore. Then at 12:30am I woke to severe chills, slight headache, sweats as well, body aches all over my body and I took my temperature and it was 103.4.  I don't think I have ever had a fever that high before.  I took some Tylenol extra strength  and tried to go back to sleep but I couldn't I was afraid.  This went on for several hours and my temp ranged from 102.3-103.6.  I tried to drink liquids too.  I called off of work.  That day I laid around hot and cold, body aches, my chest hurt a little to take a deep breath, fatigue and weakness were unbearable at sometimes. My fever spikes probably that high 3-4 times yesterday.  I had fluids and soup.  I alternated Motrin and Tylenol all day.  I tried to rest and maybe sleep but just couldn't close my eyes despite being tired/weak.  By 7-8pm I was still weak but felt better  My temp was around 99-100.  I went to be around 10pm and woke up at 2am with really bad heartburn that I couldn't lay down I had to sit in my recliner chewing 4 Galvascon tabs. Sipping water and felt my chest hurt and wondered if I was having a heart issue. But i relaxed and finally by 5 am when my alarm went off.. I took my temp it was 100.2.  I called off work again today and I laid down to sleep a few more hours.   Now  I feel better and still weak  My temp has gone down.
Chills, fever, headache, body aches, unable to lift arm above head. Lasted around 24 hrs
Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and CT of head all negative. Kept overnight and had MRI 3/9/2021 in AM revealed "mini stroke" TIA per neurology. She was discharged with Plavix and Lipitor. Has follow up appointment with neurologist 4/8/2021 and cardiologist 4/1/2021. Patient states she was on Amiodarone and Bystolic prior to having this TIA. Patient is scheduled for second dose of vaccine 3/19/2021 and wants to receive it. She is cleared to receive from our stand point. Please reach out via email or phone if you guys disagree.
NEEDING TO HOLD ON TO THE WALL WHEN WALKED; BLOOD PRESSURE WAS LOW AT FIRST; FELT FAINT/DIZZY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies to bees, and other pre-existing medical conditions included the first symptom patient had as a rare allergic reaction was an intense headache. The patient felt numbness in lips and it spread, symmetrically from the center. The tip of tongue began growing numb. The patient felt some swelling in mouth. That slow ramp up was not typical of an allergic response, but it was precisely what happened the last time the patient was stung by an itsy bitsy baby bee hiding in a bushel of plums and the patient was in the emergency room. The patient experienced rare allergic reaction when treated with bnt 162 for drug used for unknown indication, and terrifying side effects when treated with tetanus vaccine for drug used for unknown indication. The patient received benadryl unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. 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 needing to hold on to the wall when walked, blood pressure was low at first, and felt faint/dizzy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with benadryl unspecified was not reported. The outcome of the blood pressure was low at first, felt faint/dizzy and needing to hold on to the wall when walked was not reported. This report was non-serious.
Pt. is experiencing joint pain in left shoulder, arm (severe pain) - also numbness in arm and wrist.
10 days after receiving the shingles vaccine, I broke out with shingles rash. Was treated with valacyclovir HCL 1 gram tablet 3 times a day for one week. Prednisone 3 5mg tablets for 3 days, then 2 5mg tablets per day.
A nurse reported that a 37 year old female received an injection of Pnu-Imune 23 on 11/16/00. Within hours, post vax, she developed an injection site reaction characterized by swelling, redness and a "softball-size" knot. The pt was treated with Atarax (hydroxyzine) and Medrol (methylprednisolone). This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 474939.
Child was given vacc. on 11/21/06....ran a fever started on 11/21/06 until 11/25/06. Noticed small red bumps on neck 11/22/06, red bumps on face 11/24/06 started to spread to upper body noticed 11/25/06. spreading to vagina/anal area 11/26/06. spreading to lower body fast. vomiting, loss of appetite, sleep disturbance.
Dose 1: on that day, headache  and sore arm. Within a week of Dose 1, tingling in hands began.  Daily headaches.  Sore left deltoid and biceps.  Then pain on bottom of both feet began, came and went. After Dose 2, got much worse: tingling, burning, prickling in hands, arms, shoulders.  Nerve issues. Tingling in feet.  Sore left shoulder continues. Random joint pain (wrist, elbows).  Random shooting pain in muscles (forearm, quad)   Tingling and burning and numbness on left side has continued daily for five weeks.
Also immediately after the shot Patient was very lethargic, irritable, loss of appetite and formed a lump on his leg at the injection site. That night a fever started, which quickly rose to 103.9 the following morning. Treated with Tylenol every 3-4 hours and cool baths, the fever persisted around 102 for 2 days. Meanwhile he was lethargic, motionless and no appetite. Saturday night he had a convulsion! This continued for four days, shot was given on Friday 6/11, Monday the fever finally subsided. That same day he broke out in a horrific rash all over his face, scalp, neck and trunk, injection site was still bruised and a lump. Treated the rash with Benadryl, epson salt baths and aloe. Rash finally completed went away a week later, energy and appetite returned.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Significant follow up received, contains Reporter address and Dose information
tightness in the chest similar to when she has reactions to shellfish or peanuts; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 65 years old female patient who experienced tightness in the chest similar to when she has reactions to shellfish or peanuts, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included allergy to shellfish and peanuts, tightness in the chest . The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunization.  On 16-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ232AB and Exp. Date 10-Apr-2020) via unknown route in the upper deltoid.  On an unknown date, the patient developed tightness in the chest similar to when she has reactions to shellfish or peanuts (chest discomfort) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  The patient had a hospital visit.  Details of lab data not reported.  Final diagnosis was tightness in the chest similar to when she has reactions to shellfish or peanuts.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from event.  List of documents held by sender: none.
Diarrhea; This is a spontaneous report from a consumer (patient). A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on 18Feb2021 with outcome of unknown. The patient asked how long should patient tolerate diarrhea? What was the next step? When offered the contact number for Pfizer Medical Information, the patient stated "I would be dead by then, you don't know?".  The information on the batch number has been requested.
sore are at injection site of deltoid muscle post 6 hours for 48 hours a few stabbing headaches post12 hours for 1 hour fever of 100.1 post 12 hours for 36 hours fatigue post 12 hours for 36 hours
Swollen shot location, 2 inches in diameter, warm, but doesn't hurt to the touch other than feeling swollen.
Child cried non stop 3 hours after immunization and continued for about 5-6 hours. Urinated 2 times, and legs were slightly purplish after 3 hours for a few minutes.
Pt presented to ED on 8/12/2021 for shortness of breath, cough with white sputum, and chest discomfort.  Pt tested positive for COVID-19 via PCR test and was ill enough to be admitted.  He lives in another state , but was in town to visit family.  Pt discharged from hospital on 8/15/2021. Pt was fully vaccinated with 2 doses of Pfizer (4/8/2021 and 4/29/2021)
Headache CHILLS, HEADACHE, TIREDNESS Narrative:  CHILLS, HEADACHE, TIREDNESS
headache; felt nauseous; felt weak; body pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172), via an unspecified route of administration in the left arm on 12May2021 at 16:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13May2021 at 09:30, morning after the day of vaccination the patient experienced headache, felt nauseous, felt weak and experienced body pain. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, felt nauseous, felt weak and body pain was recovered on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The reporter stated that, Shingles vaccine did not prevent shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
first vaccine in 2019, pharmacy would not administer 2nd; Large 15 cm local reaction; Swelling; Chills; Myalgias; This case was reported by a physician via call center representative and described the occurrence of local reaction in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number NZ4ZJ, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis. Concomitant products included secukinumab (Cosentyx).   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced local reaction, swelling, chills, myalgia and incomplete course of vaccination. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the local reaction, swelling, chills and myalgia were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the local reaction, swelling, chills and myalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a patient and also pediatrician. The reporter reported that she received Shingrix vaccine. The reporter stated that the patient had large 15 cm local reaction and swelling associated with chills and myalgia for 2 days. The patient received Tylenol and Benadryl as a treatment. The patient returned to receive the 2nd dose the pharmacy was not administered the 2nd dose because of her symptoms. The patient primary care provider was also advised to not receive the 2nd dose. The patient stated that she was concerned as she was not fully protected and she was interested to receive the second dose. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Received Moderna for dose #2 but received Pfizer for dose #1 only 22 days between doses.
The next morning  I got Tinnitus and it is still with me. I went to a doctor and there is no treatment.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years 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's relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE, start date: 01Jun2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.