chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fatigue; I just felt warm and I felt achy as my arm; I have too much potassium in my blood; my arm was hurting; I went as low as 99.1 and as high as 100.2; Took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 82-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL8982; Expiration Date: May2021), via an unspecified route of administration on 17Feb2021 15:30(age at vaccination 82Years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, gastroesophageal reflux disease from an unknown date and unknown if ongoing, vascular graft from an unknown date and unknown if ongoing, coronary artery bypass from 2016 to an unknown date. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; ranolazine (RANOLAZINE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took potassium pill. The patient experienced fever on 17Feb2021, chills (on an unspecified date, fatigue on an unspecified date, I went as low as 99.1 and as high as 100.2; took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5 on 17Feb2021, I just felt warm and I felt achy as my arm on an unspecified date, I have too much potassium in my blood on an unspecified date, my arm was hurting on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 99.5 fahrenheit on 18Feb2021, body temperature: 100.2 fahrenheit on 18Feb2021 at 4pm, body temperature: 99.3 fahrenheit on 19Feb2021, body temperature: 100.4 fahrenheit on 20Feb2021, body temperature: 99.1 fahrenheit on 21Feb2021, body temperature: 99.1 fahrenheit on 22Feb2021, body temperature: 99.6 fahrenheit on 22Feb2021, body temperature: 99.6 fahrenheit on 23Feb2021. Therapeutic measures were taken as a result of fever, chills, fatigue, I went as low as 99.1 and as high as 100.2; took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5, my arm was hurting was Tylenol.The outcome of the events pyrexia was not recovered, the outcome of the events chills, fatigue, pain, blood pressure increased, pain in extremity was unknown.   No follow-up attempts are possible. No further information is expected.
Pt arrived @ ER on 11/4/16 @ 17:40. Husband reports pt seizing and unresponsive prior to calling 911 5 minutes earlier. Work up benign. d/c ER 11/4/16 @ 1900. Diagnosis: reaction to vaccine.
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent. A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "got omicron Covid"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died". The patient underwent the following laboratory tests and procedures: Oxygen saturation: Unknown results, notes: Hospitalized on oxygen; SARS-CoV-2 test: Positive for omicron. Therapeutic measures were taken as a result of Covid-19. Clinical information: Patient consider the Pfizer product had a casual effect to adverse event(s). P.S Son (Name withheld) - had same two Pfizer vaccine and 3rd booster and got omicron Covid and hospitalized on oxygen and almost died. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information. Based on available information and the drug temporal relationship, the causality between the event "near death experience" and the suspect drug "BNT162B2" cannot be completely excluded. 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.
Initial report received on 24 May 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL on 08 June 2012, 31 July 2012 and 01 October 2012 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 07 April 2013, approximately 6 months after the last dose. On 23 April 2013, the subject developed a cough and paroxysmal cough on 01 May 2013 with a whoop. The subject also experienced post-tussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 06 May 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 07 May 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 21 May 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
On 5-20-22 i began to feel like i had a sinus infection and began mucinex, advil, gargling with salt water, and nasal saline wash.  I had a negative home test for covid on 5-22.  started feeling much worse: harder to breathe, coughing, sinus pressure, headache.  then on 5-23-22 i started having fever and chills all night and morning on 5-24 and did a home test, which was +covid.  i continued to use mucinex, advil, salt water, drinking fluids and resting.  i began either throwing up or pooping out any food or water i ate.  coughing got much worse and my MD refused to give me the new antiviral medication, despite me having asthma.  she did prescribe me perles drops for the coughing, which helped, and a new asthma inhaler.  i ached all over, every muscle and bone, and was sleeping a lot because i was so exhausted, and the other symptoms from the beginning continued.  My eyes had so much pressure on them and were sore.  i had trouble breathing or walking down the street a block to put in my recycling.  i felt like there was something heavy sitting on my chest and it was tight.   the only symptoms on the list for covid that i didnt have were the loss of taste and smell.  i was sick for 3 weeks and still have a lingering cough. it wasnt until the 3rd week that i thought i might be coming out of it.  (FYI:  i have had both of the original moderna covid vaccines and the 2 booster vaccines.)
Vaccine went under temperature excursion; No adverse event; Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant medications were reported.  It was reported that due to lost power in the middle of the day at 12:00 PM, vaccines were placed into a frozen bag. Booster vaccines were then transported to another clinic.  On 02-MAR-2023 to 28-MAR-2023 vaccines were administered to 26 patients. No symptoms were reported. No treatment information was provided.  This case was reported for patient 18 of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:patient no. 01 (Master case)
Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, fever of 101 Narrative:
08/24/04: Phone call from mother. States child woke this AM with "bumpy rash" at injection site. Concentrated-clustered around site until this afternoon.  Now spread to both upper extremities and trunk. Afebrile-in no acute distress.  08/25/04: Office visit, mother states prescription and Zyrtec yesterday. Rash disappeared.  No signs and symptoms today.
On Feb 22nd I was diagnosed with DBT clout in my right leg, on Feb 26th I was diagnosed pulmonary embolism in your left lung, I am in medication until the end of May and then the doctor will evaluate me. Ultrasound
Information has been received from a health professional concerning a 7 year old male with no past medical history, no known allergies, and no concurrent medications who on 12/04/1995 was vaccinated with a dose of varicella virus vaccine live. On 02/24/2002, the pt showed his first chicken pox marks. Unspecified medical attention was sought. Additional info has been requested.
Hematoma located several inches lower than where shot was given. Hematoma extended to approx 1/2 of pts arm. Pt has muscle pain extending to her elbows.
pt recv vax 12AUG97 & on 1SEP97 pt exp a rash 10 to 15 lesions;
given beyond use date of 25 hours after punctured time (recommended 12), has muscle soreness and dizziness within 6 hours of having vaccine
After 15mins in observation, patient reported having palpations, and dizziness. Vital signs taken, and EKG performed. Medical Provider examined the patient.
First dose given 01/11/2021, employee now requesting 2nd dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose given 01/11/2021, employee now requesting 2nd dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose given 01/11/2021, employee now requesting 2nd dose.). On 02-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose given 01/11/2021, employee now requesting 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications were not provided.  Treatment medication was not provided.
After receiving my first shot 2-3 weeks later I started having very heavy long period. I have a birth control implant for 2yrs now and it stops me from having regular periods. Now they come every 2-3 weeks and last 6 days I?ve never had that happen to me before.
Arm and breast aches, bleeding, sharp pain near right ovary, back pain, right kidney pain and bruising.
Developed a fever early 7/30 (about 12:30 AM). Vomited after waking up 7/30, continued to have a fever that day (highest temperature was 101 F), was lethargic with little appetite. Fever was gone by the middle of the night 7/30. Vomited 2 times after waking up on 7/31, remained lethargic through mid-day but improved in the afternoon and began to eat more. Resumed usual activities on 8/1.  Reached out to pediatrician for consultation on 7/31, but did not have an office visit.  Thanks for reviewing ;)
pt recvd vax 15SEP95 & 26NOV95 pt devel approx thirty draining lesions & had a 101.0 fever;2wks prior to vax pt had been exposed to natural chicken pox;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: About 5 minutes after giving the Pfizer vaccine, patient stated he felt like he was going to pass out.  Wife let us know and when I got to patient he was tremoring, arms locked and fist clinched (supected seizure).  Patient's eyes were rolling in the back of his head and then he passed out for about 30 seconds.  When hew came to we moved him to the floor and an ambulance was called.  Patient refused to go with the EMT's.  Monitored him for 30 minutes and he had no more sypmtoms.
Systemic: BRUISING ON LIMBS (NOT AT INJECTION SITE)-Mild
"Half-dollar" sized local reaction at injection starting 24 hours post injection, lasting 3 days.  Seen in office on 10/25/2007 (6 days later for 3 days of pharyngitis (strep negative),and a 3 mm apthous ulcer above uvula on physical exam, as well as some increase anterior nodes.  No fevers.  Had some self-limited vomiting 10/19 - 10/20.  No prior history of oral ulcers.  Child is not toxic appearing.  No cutaneous vesicles.  Local reaction has resolved.
First came down with a soar throat, then took a test and was positive for covid. I went to urgent care I was prescribed paxlovid, few days he had a fever. After few days I was feeling better and tested negative. 5 days later he started to feel sick with body aches and re -tested and I was positive again for covid.
late in receiving the 2nd dose/ late for 2nd dose coming in today to receive it; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 6th October 2020, batch number: 3Y7NL, expiry date: 24th May 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this case. The patient was late for 2nd dose and was coming in on the day of reporting to receive it. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter wanted to know when could they get their 3rd dose how long can it spaced. The reporter did not consent to follow up.
got shingles from the vaccine a side affect they don't tell you/Suspected Vaccination failure; got shingles from the vaccine; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter stated that the patient got shingles from the vaccine, a side effect that they did not tell you. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Severe chills/shaking for 18 hours with the inability to walk unassisted during this time.  Extreme lethargy including inability to care for self or others.  Sweating, fatigue, headache.  Loss of appetite.    18-53hours post shot: chills not as severe, headache, lethargy lessen but still inhibit patient from normal daily functioning.  54 hours post injection:  chills diminished, headache gone, Pt able to resume normal function except for worsened injection site pain and also vision disturbance onset similar to two previous episodes of optic neuritis.
A nurse reported that her 6 month old daughter received Prevnar, Hib-Titer and DTAP vaccines on 5/19/00. The next morning, the pt developed diarrhea which persisted and the pt was seen by the physician on 5/21/00. He reportedly dx'd "the stomach flu" and prescribed no treatment. Hourly episodes of diarrhea persisted on 5/22/00. Follow up info received from the vaccine provider on 6/13/00 indicated that a stool culture was negative. The infant recovered.
Dull pain in left thight and hand.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Dull pain in left thight and hand.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Dull pain in left thight and hand.). At the time of the report, PAIN (Dull pain in left thight and hand.) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 10:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:23 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 36.17 for dose administered on 13-Feb-2021 and 36.27 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Feb-2021.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Felt sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt sick). At the time of the report, ILLNESS (Felt sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitants medications were not reported no treatment medications were not reported