chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Bell's Palsy; Stomach pain; Blurred vision; Severe headache; Slight fever; A spontaneous case was received from a 70 -year-old, female consumer, who experienced stomach pain, severe headache, slight fever, blurred vision and was diagnosed with bell's palsy. The patient medical history was not provided.  Concomitant medications were include metformin, gabapentin, lisinopril, celecoxib, atorvastatin,and glipizide.  On 14-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch no; 022M20A), intramuscularly in the upper right arm for prophylaxis of COVID-19 infection.  On 15-FEB-2021 , the patient experienced stomach pain, severe headache, slight fever, blurred vision.  On 23-FEB-2021 she was diagnosed with bell's palsy.  She had taken prednisolone and valacyclovir to treat bells palsy.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sudden pain in left calf. Tried treatments for pulled/upset muscle (heat, ice, NSAIDs, increasing magnesium and potassium, different pain creams) for a week with no success. Went to urgent care a week later. Muscle area was swollen larger than opposite side. Doctor concerned for clot. Ran bloodwork. D-Dimer in 1200s, went to ER for ultrasound. Clot found in vessels. Started up on Eloquis 10 mg twice daily for a week then 5 mg twice daily for another 3 months. Still in treatment.
Malaise; Body aches; Fever; This case was reported by a physician via sales rep and described the occurrence of malaise in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced malaise, general body pain and fever. On an unknown date, the outcome of the malaise, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the malaise, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine and experienced malaise, body aches, and a fever of 101 degrees.  All symptoms resolved within two day. The reporter was unable to provide any additional details.  This is 1 of 4 cases reported by same reporter.      Lab Comments: the patient's body temperature was 101 degree F on an unknown date
practically crippled me, suffering ever since; This case was reported by a consumer via interactive digital media and described the occurrence of immobile in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included decreased immune responsiveness.   In August 2021, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant). On an unknown date, the outcome of the immobile was not recovered/not resolved.   It was unknown if the reporter considered the immobile to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingrix vaccine last year. The patient had been suffering ever since and had practically crippled. The patients doctor did not know what it was and neither patient do. The patient wish he/she had never taken that shot. The patient think it was MS (Multiple sclerosis) but doctor says no.  The patient do had a very weak immune system. The follow-up could not be possible as no contact details were available.
Severe hives, rash on neck, Chest, and left arm with tiredness. CALLED DR. Advised BENADRYL, to come in if not improved. Not to get second shot.
PATIENT STATED THAT HIS ARM HURT SHORTLY AFTER RECEIVING THE VACCINE AND HAS CONTINUED TO HURT SINCE.
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Concomitant therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Additional information has been requested.
pt fainted within a couple of minutes and then appeared to have a seizure (brought arms towards body), this was witnessed by patient's mother. Vaccinator arrived and while talking to pt the same thing happened.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Lymph Node Swelling-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
pt recv vax-no rxn began w/tenderness, Sunday noted to be hot, red & indurated;redness 7" x 4 3/4" induration 3 1/2" x 3 1/4";
Redness and itching at injection site.  (Have photo if requested) "Covid Arm" or delayed cutaneous hypersensitivity.
Symptoms: large red itchy spot on arm, chills, fatigue, slight nausea, mild general headache that became piercing,painful and intermittent for several hours Symptoms lasted for approximately 36 hours ,arm remains red and slighty itchy 4 days later, slight headache  Treatment:tylenol,liquids,rest
This spontaneous report was received from nurse practitioner via a field representative regarding a 15 year old female patient (friend of the reporter's daughter). The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. In approximately 2015 (reported as approximately three years ago), the patient was vaccinated with one dose of GARDASIL (route, lot # and expiry date unknown) for prevention of human papilloma virus (HPV). On an unknown date, the patient developed juvenile rheumatoid arthritis after being vaccinated with GARDASIL. The patient sought medical attention with a physician. Treatment administered for the event was unknown. The patient underwent multiple unspecified tests on unknown dates for which the results were unknown. At the time of the report, the patient had not recovered from the event. Causality assessment was not provided by the reporter. Upon internal review, the event of juvenile rheumatoid arthritis was considered to be medically significant.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response code scanned. On 03 NOV 2021, vial was initially stored in the refrigerator. No temperature excursions was noted and patient did not experience any adverse event. Treatment medications were not reported.
This case was reported by a nurse via call center representative and described the occurrence of hives in a 56-year-old female patient who received Shingrix for prophylaxis. On 14th June 2018, the patient received the 1st dose of Shingrix. On 14th June 2018, less than a day after receiving Shingrix, the patient experienced hives (serious criteria other: As per reporter), painful rash (serious criteria other: As per reporter) and itchy rash (serious criteria other: As per reporter). The patient was treated with Benadryl. On an unknown date, the outcome of the hives, painful rash and itchy rash were recovered/resolved. It was unknown if the reporter considered the hives, painful rash and itchy rash to be related to Shingrix. Additional details were reported as follows: The health care professional (HCP) stated that, the patient reported a moderate to severe painful, itching rash with hives within an hours after vaccination with Shingrix. HCP stated patient was advised to take Benadryl for this reaction at that time. No further treatment was needed. Shingrix was administered at a local pharmacy, but did not have vaccine information for the adverse event.
severe chest pain; shortness of breath; severe muscle and  joint pain; severe muscle and  joint pain; Fever the next day; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 as dose 2, single for covid-19 immunisation. Medical history included hypertension (prolonged qt) from an unknown date and unknown if ongoing. Concomitant medications included fish oil, colecalciferol (D3), vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) and amlodi-pine;Olmesartan taken for an unspecified indication. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:00 as dose 1, single for COVID-19 immunisation. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vac-cine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 29Apr2021 patient experienced fever and on 30Apr2021 patient experienced second day was a severe chest pain and shortness of breath with severe muscle and joint pain. The patient did not received any treatment for all the events. The outcome of the events was recovering.  No follow up attempt are needed: No further information is expected.
Initial report received from a pharmacist on 14 November 2012. A 31 year-old female patient had received a dose of FLUZONE (lot number UH718AB) on 27 August 2012 and about 1 week later experienced cold symptoms and continues to have respiratory symptom of wheezing. The patient required doctor visit; however it was not reported whether treatment was required. The patient had no illnesses at time of vaccination. Medical history included allergies to sulfa. The patient has not recovered. Documents held by sender: None.
moderate body ache; Fever; chills; This is a spontaneous report from a contactable consumer.   This 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not provided), on 03Apr2021 as single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient had received the first dose on 03Apr2021, and he had no symptoms at all for the past 3 weeks. He has as of this morning (Apr2021) some moderate body ache, fever and chills. He hasn't been sick in years. He is very diligent about keeping a mask on wherever he goes. He just wanted to get clearer when I was getting the vaccine administered that sometimes symptoms will show up a week to two weeks, but he couldn't recall if he said 3 weeks. The outcome of the events was unknown.   Information about lot/batch number has been requested.
severe naseau and dizziness fainted 2xs  out 2 minutes injured chin and jaw from falling face first on bathroom tile floor
Redness/erythema; itching/pruritus; swelling of left lymph node; still some swelling on the arm; welt around the injection site; rash spread to the front and back of her whole upper arm/bullseye type of rash.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welt around the injection site), PERIPHERAL SWELLING (still some swelling on the arm), ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced URTICARIA (welt around the injection site) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.). On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (still some swelling on the arm). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and LYMPHADENOPATHY (swelling of left lymph node). On 19-Mar-2021, URTICARIA (welt around the injection site) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.) had resolved. At the time of the report, PERIPHERAL SWELLING (still some swelling on the arm) had not resolved and ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and LYMPHADENOPATHY (swelling of left lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment medication included a steroid cream for rash.  Follow-up received on 04-AUG-2021 included no new information   This case was linked to MOD-2021-276028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non Significant information. The patient was assuming that she will need a booster as she had underlying conditions. On 04-Aug-2021: Follow-up received contains non- significant information
Oral lesions; Blisters; Altered taste; Mouth burning; Raw mouth; Sore throat; Swollen tongue; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration on 06Sep2021 at 08:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Sep2021, the patient experienced oral lesions, blisters, altered taste, mouth burning, raw mouth, sore throat and swollen tongue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events oral lesions, blisters, altered taste, mouth burning, raw mouth, sore throat and swollen tongue was not resolved at the time of the report.
Headache, Myalgia, Fever, NaueaVomiting, Site pain, redness, swelling, lump present, fatigue, chills Narrative:
Blotchy skin around her wrist; Skin tightening; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy skin around her wrist), SKIN TIGHTNESS (Skin tightening) and SWELLING (Swelling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH MACULAR (Blotchy skin around her wrist), SKIN TIGHTNESS (Skin tightening) and SWELLING (Swelling). At the time of the report, RASH MACULAR (Blotchy skin around her wrist), SKIN TIGHTNESS (Skin tightening) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Onset 3/26/03 evening. Redness and swelling, 50 cent hard red area surrounding area. Red about 3 inch circle and swollen. Fever at home.
7 days after injection there is a raised patch that is hot, itchy and firm under the skin.  The patch is approximately 3 x4 and is spreading on upper left arm at injection site.
On day 4 I started to feel like I was feverish. I did have an elevated temperature but only 99.1. It did not go higher. It lasted for about 12 hours and the next morning I felt normal. I did break a sweat.
Feeling weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 13Jan2021 (14:45) at single dose for Covid-19 immunization. The patient's medical history included anxiety and known allergy to Grapefruit. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced feeling weak on 16Jan2021 (23:00). There was no treatment received for the adverse event. The patient has been tested for COVID-19 post vaccination on 16Jan2021with Unknown result. The outcome of event was recovering.
Patient arm is red, hot and swollen. Patient went to the doctor and was given an antibiotic and a pain medication.
About 4cmx3cm area of erythema on thigh just distal to injection site. Began about 24 hours after immunization. Treated with Keflex, Bactroban, and warm compresses.
No diluent used, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine was administered)
I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?
Slightly swollen 3x3 rash in area where shot was given. Outer edge of rash red.
diagnosed positive for COVID on 8/31/21; presents to ED on 9/8/21 with c/o SOB, productive cough, weakness and leg swelling; Hx of CKD III-IV, CAD, lupus, HTN, Gout; states has not taken any polyclonal antibodies; started on dexamethasone and remdisivir; on O2 4-6L and High Flow; DNR/DNI; placed on BiPAP for short period of time but unable to tolerate; pt's condition declined and she was placed on comfort care; she died in the hospital
Patient said a lump formed at reaction site.  Site was red and itchy.  On 7/6/13 injection site was just red and swollen.
Nausea, malaise, headache, fever since 10/05/06. Patient took Tylenol. Physician perscribed NSAIDS, warm compresses.
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patient had Astra in May, BionTech in July and Moderna before Christmas.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Astra in May, BionTech in July and Moderna before Christmas.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Astra in May 2021 and PFIZER BIONTECH COVID-19 VACCINE in July 2021. Past adverse reactions to the above products included No adverse event with Astra and PFIZER BIONTECH COVID-19 VACCINE.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Astra in May, BionTech in July and Moderna before Christmas.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Astra in May, BionTech in July and Moderna before Christmas.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.