chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got Covid-19 in June 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got Covid-19 in June 2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (Patient got Covid-19 in June 2022). At the time of the report, COVID-19 (Patient got Covid-19 in June 2022) outcome was unknown.            It was reported that patient was senior. No concomitant medications were reported. Patient got all Moderna shots, the 2 regular and 2 boosters. It was reported that patient want to get the new Moderna bivalent booster but none of the pharmacies around her have it. They said there was a shipping day and would not get it until OCT-2022. No treatment information was provided.  Company comment-This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred unspecified days after fourth dose of mRNA-1273 vaccination in covid-19 vaccination series. Patient had received two primary and two booster doses of same vaccine on unknown dates. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events and details pertaining to the previous doses was available in the report. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement   This case was linked to MOD-2021-089267, MOD-2021-049548 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred unspecified days after fourth dose of mRNA-1273 vaccination in covid-19 vaccination series. Patient had received two primary and two booster doses of same vaccine on unknown dates. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events and details pertaining to the previous doses was available in the report. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
I got my second shot on Friday and it is now Sunday and I am still experiencing severe side effects, I?ve been puking none stop (yellow color) bile is what it looks like. I have a head ache the chills and sweats at the same time, shortness of breathe and I feel like I?m dying
The pt developed a fever, chills one day post vax with watery diarrhea 2 days post vax. Seen by MD on 7/26/00, treated with Imodium AD.
pt recvd vax;T 104;apap given & brought fever down to 102;to MD on 4apr95;MD advised advil & tepid bath;MD felt rxn to pertussis;during time of high fever,lips blue & became not very responsive;T down to 100.9;
Fatigue and headache at 6 pm chills and fever by 8:30 pm body aches over night Felt normal again by 2 pm on 2/4
Initial case was received from a health care professional on 07 October 2013. A 06 patients (gender and sex unknown) had no medical history reported, received a dose FLUZONE intramuscularly on an unspecified date in September (year not reported) (site, batch number not reported). Patient had no reported concomitant medication. It was reported that on an unspecified date in September (year not reported) 06 patients felt that they developed redness and swelling at the injection site. Prednisone (route, dose, site not reported) was given as a corrective treatment. At the time of report the outcome of event was unknown.
Arm pain/Leg pain; Coughing up mucus; Arm was itching; arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain/Leg pain), PRODUCTIVE COUGH (Coughing up mucus), VACCINATION SITE PRURITUS (Arm was itching) and VACCINATION SITE PAIN (arm Pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain/Leg pain), PRODUCTIVE COUGH (Coughing up mucus), VACCINATION SITE PRURITUS (Arm was itching) and VACCINATION SITE PAIN (arm Pain). At the time of the report, PAIN IN EXTREMITY (Arm pain/Leg pain), PRODUCTIVE COUGH (Coughing up mucus) and VACCINATION SITE PAIN (arm Pain) outcome was unknown and VACCINATION SITE PRURITUS (Arm was itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter  No treatment was 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.
Chills, tired, short term memory loss.  Couldn?t remember eating dinner then went to bed at 7 pm.  Woke up in the morning at 6:00 am, still couldn?t remember having eaten dinner but felt fine.
Patient got the 5-11 y/o formulation for a booster dose after getting this formulation for the first 2 primary doses. patient turned 12.
After the shot my left arm was sore. Around 10am the  next day I started to have chills but no fever. I was also fatigued for the whole day. I took an Advil to help with the headache as well.  At night I also had the chills until the next day.
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:10 for prophylactic vaccination. Concomitant medications included naproxen. On 12-APR-2021 13:15, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious.
Severe fever, shaking, chills, aching, headache, pain in arm. Fever lasted 3 days on and off with Ibuprofen and cool towels to help. Aching body lasted one week. Headaches lasted 2 weeks.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; DEATH; This spontaneous report was received from literature. This report concerned multiple patients of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: inflammatory bowel disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date 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.  The patients with inflammatory bowel disease who received at least one vaccine dose prior to diagnosis of COVID-19 were included, among which 12 were hospitalized and 1 died. On an unspecified date, the patients experienced suspected covid-19 infection, (suspected clinical vaccination failure) and was hospitalized on an unspecified date for unspecified number of days. On an unspecified date, one patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case was associated with product quality complaint.; Sender's Comments: V0-20220225916-covid-19 vaccine ad26.cov2.s-Death, Suspected covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220225916-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Severe headache lasting 18 hours.  Pain and swelling in the axillary lymph nodes that persists at the time of this report.  Joint pain in the hands and elbows that occurs in the evenings since receiving the vaccine.
Sore arm after the 1st dose; Headache after the 1st dose; General tiredness after the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the 1st dose), HEADACHE (Headache after the 1st dose) and FATIGUE (General tiredness after the 1st dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after the 1st dose), HEADACHE (Headache after the 1st dose) and FATIGUE (General tiredness after the 1st dose). On 10-Apr-2021, HEADACHE (Headache after the 1st dose) and FATIGUE (General tiredness after the 1st dose) had resolved. On 12-Apr-2021, PAIN IN EXTREMITY (Sore arm after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Approximately 10 minutes after administration of vaccine, child developed a fine red rash on both sides of face, none anywhere else.
pt had booster dose on 11/18/21 and complained of area being puffy and red. resolved now 11/23/21.
Information has been received from a nurse concerning a patient who was vaccinated with the first dose of MMR II when he was a child. On 05-AUG-2008 the patient received the second dose of MMR II. The nurse reported that the patient failed to respond to MMR II vaccinations. The measles and mumps titer was drawn last week and the result of the titer came back as negative. At the report time the outcome was unknown. Follow-up information has been received from the patient: The patient reported that he did not have an adverse experience. He just had a question about protocol. Additional information has been requested.
Swelling , redness and lots of itching at shot site, more so than i had with my 1st and 2nd injection. i applied ice packs and that has helped.
p/vax arm swelled, had pain & itching; went to ER recv cortisone & antihistamines; better for several days then devel n/v, dizziness, fever; still not feeling well, weak & tired;
needle breaking during administration of her second dose; Accidental exposure of skin to vaccine; The Dr who was administering the shot was unaware of how much of the vaccine went into her arm; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (needle breaking during administration of her second dose), ACCIDENTAL EXPOSURE TO PRODUCT (Accidental exposure of skin to vaccine) and UNDERDOSE (The Dr who was administering the shot was unaware of how much of the vaccine went into her arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     No medical history provided by the reporter. .  Concomitant products included AMLODIPINE, SIMVASTATIN, LEVOTHYROXINE and METFORMIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (needle breaking during administration of her second dose), ACCIDENTAL EXPOSURE TO PRODUCT (Accidental exposure of skin to vaccine) and UNDERDOSE (The Dr who was administering the shot was unaware of how much of the vaccine went into her arm). On 10-Mar-2021, ACCIDENTAL EXPOSURE TO PRODUCT (Accidental exposure of skin to vaccine) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (needle breaking during administration of her second dose) and UNDERDOSE (The Dr who was administering the shot was unaware of how much of the vaccine went into her arm) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment received. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 6-Apr-2021 and contains non-significant information. Contact information updated. HCP information provided.
With both this third Pfizer shot and then with the fourth shot which was Moderna shot, I was sick with high temperatures for 3 or 4 days and then exhaustion for a couple of weeks. I still don't feel I've recovered from these shots. I don't have my normal energy and have even been diagnosed with sleep apnea. I never snored before these shots.
PATIENT RECEIVED COMIRNATY AND FLUZONE VACCINE. PATIENT PROCEEDED TO CHAIR IN WAITING ROOM AS HER FATHER WAS THE NEXT PATIENT FOR VACCINATION. PATIENT PASSED OUT IN CHAIR. I WENT BACK INTO THE PHARMACY FOR ADDITIONAL GAUZE. I WAS NOTIFIED OF A PATIENT SLUMPED OVER IN THE  CHAIR. I ABRUPTLY TAPPED HER SHOULDER AND ASKED WAS SHE OKAY. SHE AWAKENED, BUT DID NOT REALIZE WHAT HAPPENED. PATIENT'S FATHER SAID SHE 1) HAD AN EMPTY STOMACH, 2) HAS HAS SIMILIAR REACTION WHEN GIVING BLOOD.
This case was reported by a pharmacist via call center representative and described the occurrence of painful rash in an adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced painful rash and rash vesicular. On an unknown date, the outcome of the painful rash and rash vesicular were unknown. It was unknown if the reporter considered the painful rash and rash vesicular to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up.
This spontaneous report as received from a physician refers to a 2 month old (at the time of second vaccination) and currently 18 years old non-pregnant female patient. On 15-NOV-1994 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 10-OCT-1995 and the third dose was administered on 31-AUG-1995. The reported stated that on an unknown date a titer for Hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of Hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
scales and itching on head and both arms; scales and itching on head and both arms; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12May2021 (Age at vaccination 59 years), as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2, solution for injection via an unspecified route of administration on unspecified date as single dose for covid-19 immunization. In May2021, the patient experienced scales and itching on head and both arms, scales and itching on head and both arms. Flare began approximately 2 weeks after injection and still has scaling. The outcome of event scales on head and both arms was not recovered, itching on head and both arms was unknown.  Information on the lot/batch number has been requested.
pt exp shooting sensation in lt hand @ time of inject since that date intermittent aching & soreness w/o erythema @ inject site; Aches @ end of day & during noc; Seen by MD week of 27APR92;
Within 3 weeks of 2nd Moderna dose on 4/23/21 by RN (1st Moderna dose was 3/18/21 who ran out for 2nd dose) I noticed something different in my head at top and back of head - a foggy void sensation.  Lethargic and shortness of breath to this day.  I have a chronic blood clot disease - Pulmonary Thrombo Embolic Disease and on medication for that since 2007.  I know my body and something changed after the 2nd Moderna dose.  Head feels the same way in the same areas with Nexus in time to 2nd dose.
burning in throat, pain in R arm/shoulder, weakness in R arm/shoulder to the extend pt cannot work out like he used to.
About 20 minutes after the shot was given to me, I got a bad pain in my lower back. It has been 6 days  since it was given to me & I still have the back pain.
About 2-3 days after my second COVID-19 Pfizer vaccine shot, the middle finger of my right had began to swell, turn slightly purple, and become painful, and this pain and swelling worsened as the week progressed. I also experienced unusual redness and itching on both my hands, especially the palms and writsts, but this has been only mild, and occasional. The pain in my fingers, however, seems to wax and wane, sometimes spreading to my pointer finger and most of my third finger, and other times receding just to the top inch or two of my middle finger. Everything I do with my hand--write, type, wash, etc.--has been hampered by the pain and swelling, and the discomfort has occasionally kept me awake at night. It has now been about a week since this symptom became noticeable. It is slightly less painful than it was in the first 2-3 after the onset of symptoms, and the swelling is mainly restricted to the top inch of my middle finger (approximately up to the first joint) but it is still painful enough to hamper my everyday life. I hope and pray sincerely that it will resolve soon.
pt recvd vax & exp burning & swelling @ inject site which required tx w/ice; w/in several hrs of vax sx subsided; The nurse then switched to a different lot# of vax & the sx did not recur; No further detail were provided;
As soon as patient got shot he complained of tingling feeling in cheek and lips. Within a few minutes he said it felt numb. Upon taking his mask off, his cheek looked slightly puffy, but not severely.   I asked if patient had any adverse events after the first two vaccines, and he said no. However, he did state he had taken an antihistamine before each of the first two vaccines due to seasonal allergies. He recently moved and said since he hasn't had to take an antihistamine daily, so he didn't this morning.   I gave him a bottle of water and offered benadryl. He took 1 25mg tablet of benadryl and stated he felt slightly better within a few minutes. He chose to go home. I told him if he got worse again to go to urgent care or ER immediatly.  This all was within approx 15 minutes.
pt became pale & weak w/in min p/vax;pt did not feel very good, BP 120/90 usually 110/70;felt hot inside;taken to MD stated rxn to flu vax;
aches; fever; queasy stomach; headache; A spontaneous report was received from a Consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events aches, fever, headache, queasy stomach.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date (approximately four weeks ago from the day of reporting), the patient received their first of two planned doses of mRNA-1273 (lot batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date (reported as yesterday on the day of reporting),  prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, 1 day after administration of second dose of mRNA-1273 , the patient experienced the events aches, fever, headache, queasy stomach.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events include, aches, fever, headache, queasy stomach was considered as unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and the known safety profile of mRNA-1273, a causal relationship with the event cannot be excluded.  Fever, nausea and  headache are consistent with  the product safety profile.
This spontaneous report was received from a health professional refers to a 7 month old female patient. On 29-DEC-2014 the patient was inadvertently vaccinated with one dose of VAQTA (dose, frequency, route, lot # and expiry date unspecified). No adverse effects were noted. No product quality complaint (PQC) was involved. The reporter considered adverse event, drug administered to patient of inappropriate age to be not related to VAQTA. Additional information has been requested.
severe myalgias of hamstrings bilateral . Initially unable to stand but subsided over a couple of days but persists.
After vaccination Flu shot Pt experienced feeling dizzy, pale, clammy, diaphoretic. Pt screened by paramedics & released. Pt states feeling better & declined hospital visit.
DTAP - HIB - COMBO given before 15 months of age no side effects reported
Myalgia, Fever, Palpitations & Angina Narrative; Went to see cardiologist-had EKG, abnormal, then had ECHO done and will have holter monitor done
Patient came into the pharmacy today to report that 3 days after receiving  Pneumovax-23, her are because sore at the injection site and the pain extended down to her elbow and up to her neck.  Patient states she is still hurting today over 1 month after the vaccine.
My son began to shake/shiver violently.  Skin was pasty and his lips were bluish.  These were all given to him. I didn't know how to add this list on page..  VaccineDate AdministeredIMMUNIZ ADMIN; 1/COMBO VACCINE/TOXOID01/09/2020IMMUNIZ ADMIN; 2/> SING/COMBO VACCINES/TOXOIDS01/09/2020IIV3 VACC NO PRSV 0.25 ML IM01/09/2020PNEUMOCOCCAL VACC 13 VAL IM01/09/2020DTAP-HEP B-IPV VACCINE IM01/09/2020
PATIENT FAINTED AFTER ABOUT 8 MINUTES OF WAITING UNDER OBSERVATION. PATIENT UNCONCIOUS FOR ABOUT 3 MINUTES THEN TOOK SOME TIME TO COME OUT OF IT .