chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Little warmness; Little body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, FEELING HOT, and MYALGIA in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039AZ14 and 036AZIA) for COVID-19 vaccination.     Concomitant products included VITAMINS for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS, FEELING HOT, and MYALGIA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS, FEELING HOT, and MYALGIA had not resolved. Not Provided.          Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 11-MAY-2015 the patient was vaccinated with PNEUMOVAX 23, administered intramuscularly. The patient received a 1.5 mL dose of PNEUMOVAX 23 instead of the recommended 0.5 mL dose. No adverse effects reported. Additional information has been requested.
Information has been received from a physician concerning a 54 year old white male business owner, who on 25-OCT-2007 was vaccinated intramuscularly with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 655765/0061U). Subsequently, the patient experienced pain, swelling, and red hot throbbing that spread down left arm to just above the wrist. The patient could not sleep. The patient recovered on an unspecified date. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # report as M012495, expiration date 09-OCT-2017). There was no adverse effect reported. The administrated dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
headache; potential fever; freezing cold; chills; body ache; felt lousy; Couldn't carry on normal activities; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on 15th October 2020 and had body ache and chills, for tolerance refer case US2021008377).   On 7th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th January 2021, less than a day after receiving Shingrix, the patient experienced headache, fever, cold, chills, general body pain, feeling bad and activities of daily living impaired. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever, cold, chills, general body pain, feeling bad and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the headache, fever, cold, chills, general body pain, feeling bad and activities of daily living impaired to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient for herself. The patient received 2nd doses of the Shingrix and had the side effects including headache, body ache, chills, freezing cold and a potential fever. The 2nd dose reactions started 3 to 6 hours after the injection and she felt lousy at 3 hours and by 6 hours she could not carry on normal activities due to the symptoms. Those reactions resolved after 24 to 36 hours. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008377:same reporter, 1st dose
pt reported what appeared to look like "cellulitis" day after receiving  shingrix shot. Pt did inform me, which was not known at the time, that she has history of lymphoma and lymphadenopathy, in her right arm. The shot was given in her left arm. Pt described site as red, warm to the touch. She requested me to call her doctor to request refills on antibiotics she has had in the past. I left the on-call doctor a message. The doctor sent in RX for the treatment but did not call me back. Called patient
Per patient's mother pt had hives for approx. 24 hours on and off after vaccine given. He was given PO BENADRYL with relief. He had the same type of Rx when he received his 1st varicella per mother but since has grown out of egg allergy so mom wanted vaccine given.
Pfizer BioNTech Bivalent COVID vaccine was administered 5 days after the 10 week refrigeration date. Vaccine expired on: 11/24/2022 and vaccine was administered on 11/29
Chest pain, abdominal pain and right flank pain 12 days after vaccination. Admitted to the hospital for a pulmonary embolism 13 days after receiving vaccine and discharged the following. Prescribed blood thinner and will be following up with my doctor in a week.
This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and AGEUSIA (loss of taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced ANOSMIA (loss of smell) and AGEUSIA (loss of taste). At the time of the report, ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant medications reported. No treatment reported.
Extremely sick-feeling; Chills; Sweats; Severe headache; Body ache; Wweakness; Dizziness; Nausea; Terrible nightmares; Sleep off and on; emotional feelings of dread and anxiety; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 08Apr2021 at 11:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine with aura. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), lorazepam (ATIVAN), gabapentin (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 18Mar2021 at 11:40 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 02:00, the patient experienced extremely sick-feeling side effects; including chills, sweats, severe headache, body ache, weakness, dizziness, nausea. she could only lie in bed, drink water, and sleep off and on. At 2:00 pm, the patient took one TYLENOL and went back to sleep. At 5:00 pm it lifted, and she was able to act normally. She also experienced terrible nightmares, and it took several days to shake the emotional feelings of dread and anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling sick, chills, sweaty, headache, ache, weakness, dizziness, nausea and poor sleep was recovered on 09Apr2021 at 17:00. The clinical outcome of the events lack of feeling emotions and nightmares was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Fever of 104 less than 24 hours if receiving VARIVAX. Had febrile seizure as well. Child had febrile seizure 03/18/08 which was not related to vaccines.
second dose was administered this past March/ A few weeks age we both contracted the virus; second dose was administered this past March/ A few weeks age we both contracted the virus; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for himself and his wife. This is 2nd of two reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that both reporter and his wife received the Covid vaccines. The second dose was administered this past March. It was reported that a few weeks ago on an unknown date in 2021, reporter and his wife both contracted the virus (COVID-19). The reporter was not aware he had the virus and infected one of his friends. The reporter could have infected other people. Luckily, reporter got out the alarm and they were all self-isolated. He doesn't remember ever hearing the virus could be disseminated by a vaccinated person. The event outcome was unknown at the time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101419659 Same reporter/vaccine/event, different patient
Within 3 minutes of getting the Janssen shot I started feeling really sick, lost my vision and all feeling in my hands. I sweated through all of the clothes and soaked the chair I was sitting in.  That night around 7 pm I got a migraine and felt really fatigued I couldn't stay awake and I was really sore. My chest hurt and so did my head. I was nauseated to no end The next day was worse. All day I couldn't stay awake. I felt so sore and sick to my stomach and I coint move too much because I was super dizzy. The next day I was still sick and dizzy  By day four I felt fine just dizzy.
The patient had rotavirus vaccine #2 on 8/5. On 8/10 - had a documented intussusception that was reduced by an air contrast enema.
Pt. was given zoster vaccine 7/10/09. She presented 7/23 w/ bilateral blisters on 1st & 2nd digit of hand. She was referred to derm. Will be seeing 8/14/09.
No adverse event: Bivalent doses administered after the BUD to patients 12 and up. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, 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 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported.  No treatment information was provided.
Patient received COVID-19 vaccination.  Patient reported to RN that she may have vagal response.  Mother was prepared with juice.  Patient received injection and then slumped back in chair and RN assisted her to the floor.  A cold compress was placed on her head, patient was conscious the entire time.  Mother gave her juice and patient did throw that up.  Sat with patient for about 10 minutes.  NP did respond to assess the patient.  Patient then reported she was feeling better.   We then got patient put back in chair and after about another five minutes she was placed in a wheelchair and taken to an empty room with her mother.  Patient left with mother in the wheelchair and was escorted out to the car. Patient had no complaints at discharge.
Myalgia, Fever, chills, injection site pain red, itchy, swollen and hot, symptoms lasted until 11/1 Narrative:
A forceful feeling of the brain going back and forth, a feeling of a head concussion, loss of balance, faint feeling.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The date when the vaccine initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  No treatment medications information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included non-significant information.
Fever, seizures taken to Hosp status epilepiticus transferred to another Hosp admitted 12MAY90-14MAY90; "complex febrile seizure, OM";
Developed a small lesion right anterior cervical region and 2 lesions just under the right eyebrow.
1 hour after vaccine left arm and hand swelled up. 2 hours after systematic swelling in body. Pants were tight, right hand also swelled and feet sweliing and discomfort. 4 hours after vaccine knee joints swelled and legs wanted to give out upon standing from sitting position. Also, moderate headache. Blood Pressure was normal.
Sore arm; Heart fluttering; Discomfort; More extreme exhaustion; A spontaneous report was received from a consumer, concerning a 39-year old, male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced extreme exhaustion, sore arm, discomfort, and heart fluttering.  The patient's medical history was not provided. Concomitant was not provided.  On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 015M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient began to experience extreme exhaustion, sore arm, discomfort and heart fluttering.   There was no change planned to the dosing schedule of mRNA-1273 in response to the events. The patient received their second dose on 12 Mar 2021.   The outcome of the events, extreme exhaustion, sore arm, discomfort,  and heart fluttering, were unknown/not reported.; 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.
This spontaneous report as received from a registered nurse refers to an unspecified 17 year old female patient. The first dose of the GARDASIL, injection was given on an unspecified date in 2008, the second dose in the series was administered on an unspecified date in 2010 and the third dose in the series was given on an unspecified date in 2012. No adverse effect reported. Additional information has been requested.
couldn't get up; my whole body was shaky; weakness; Her feet and legs were screaming in pain, both legs; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (Her feet and legs were screaming in pain, both legs), DYSSTASIA (couldn't get up) and NERVOUSNESS (my whole body was shaky) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergic to Penicillin, Latex, Sulfa and all Cephalosporins. Patient stated that she has a blood disorder Idiopathic Thrombocytopenic Purpura and has no spleen. Patient is also a diabetic.  The patient's past medical history included Allergy to antibiotic, Idiopathic thrombocytopenic purpura, Diabetic, Latex allergy and Penicillin allergy. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot Number EW0202 ) in July 2021 and Moderna COVID-19 Vaccine (Lot Number 055A22A ) on 24-Aug-2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 31-Jan-2023, 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 31-Jan-2023, the patient experienced ASTHENIA (weakness) and PAIN IN EXTREMITY (Her feet and legs were screaming in pain, both legs). On an unknown date, the patient experienced DYSSTASIA (couldn't get up) and NERVOUSNESS (my whole body was shaky). At the time of the report, ASTHENIA (weakness) and PAIN IN EXTREMITY (Her feet and legs were screaming in pain, both legs) had not resolved and DYSSTASIA (couldn't get up) and NERVOUSNESS (my whole body was shaky) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
No adverse event; Moderna Bivalent vaccine was administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2023, 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 19-Jun-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date).    Pharmacist called to report that Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.  He stated that he wanted to wait on the assessment as it was just 1 day after expiration date.  Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry  The vial size was 2.5 mL  The date the vial was initially stored in the refrigerator was 19Jun2023 , 22Jun2023, and 23Jun2023  The vial did not undergo any temperature excursions. This case was for patient 1 out of 5. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730721, US-MODERNATX, INC.-MOD-2023-730757, US-MODERNATX, INC.-MOD-2023-731657, US-MODERNATX, INC.-MOD-2023-731671 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730721:patient 2 US-MODERNATX, INC.-MOD-2023-730757:Patient 3 US-MODERNATX, INC.-MOD-2023-731657:patient 4 US-MODERNATX, INC.-MOD-2023-731671:Patient 5
Pt received Pfizer as a first dose.  Pt needed his 2nd dose of Pfizer, but it was not available.  Pt received Moderna as a 2nd dose.  Pt did not have and adverse events with this vaccination regimen.
Legal report of a patient who experienced toxic exposure to mercury coincident with Certiva. On an unreported date, the patient was exposed to Certiva therapy. On an unreported date, the patient experienced toxic exposure to mercury, which led to permanent neurological injuries. It was noted that the patient was exposed to mercury from continually inhaling and ingesting mercury emissions. Pertinent laboratory test, diagnostic procedures, medical history or concomitant medication information was not provided. The patient was a child. The event of toxic exposure to mercury was considered serious (OMIC).
Acute chest pain, onset 30 minutes prior to ED arrival and after exercise. Associated symptoms include shortness of breath, dizziness and sweating.
Received a call from pt's father. On the way home, the pt had facial swelling, lip swelling, drooling, and said his "throat felt funny." Pt sent to local hospital E. There he received Epinephrine, Benadryl and oral steroids.
rash on chest and back; rash on chest and back that is tender when wearing clothes; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than 2 weeks after receiving Shingrix, the patient experienced rash and tenderness. On an unknown date, the outcome of the rash and tenderness were unknown.   It was unknown if the reporter considered the rash and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient has had rash on chest and back for 5 days that was tender when wearing clothes.