chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved.            Concomitant medications were not reported.  Company Comment ; Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR)  upgraded case to serious, new event added, action taken updated; new reporter added.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Massive heart attack
103 temperature Body Aches Chills fatigue Nausea injection site swelling joint pain
Extra dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received HAV (Havrix) (batch number BE554, expiry date 1st August 2021) for prophylaxis.   On 8th November 2019, the patient received the 3rd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were received as follows: Nurse practitioner reports the patient received three doses of Havrix instead of two, which led to extra dose administered.  The reporter consented to follow up.
2/2/09 11 PM Tongue "thick and hard". Difficulty breathing and swallowing. 2/3/09 12 Noon (L) arm sore. (L) hand/fingers tingling. 2/3/09 Family called "doctor". Advised swallowing H2O. 2/6/09 All symptoms resolved.
chills; Headache; body fatigue and aches; body fatigue and aches; Moved on next day to same symptoms I had with covid; Started off as allergy reaction; Scratchy throat; sinuses closed off; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), via an intramuscular route of administration (at the age of 47-years), administered in arm left on 22Mar2021 14:15 as dose 1, single for COVID-19 immunization. Medical history included allergy from only pollens, pet dander, covid-19, allergies from an unknown date and unknown if ongoing. Concomitant medications included cetirizine taken for allergies route: pill from an unspecified start date and ongoing. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient took other vaccine within four weeks which included allergy shot on 17Mar2021. On 23Mar2021 07:00, the day after both shots I had serious body fatigue and aches, chills and a headache. Symptoms lasted the entire day and eventually subsided the next morning. On 22Mar2021 17:00, the patient stated that he started off as allergy reaction, scratchy throat, sinuses closed off and moved on next day to same symptoms I had with covid. No fever though. The treatment was received for the adverse events included flonase spray for allergies and tylenol. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Dec2020, sars-cov-2 test: negative on Jan2021. The vaccination facility type was reported as public health clinic/veterans administration facility. The clinical outcome for the events body fatigue and aches, chills and a headache was reported as recovered on 24Mar2021 while for other events reported as recovering.  Follow-up attempts are completed. No further information is expected.
Developed chest pain 2 days after first dose of covid-19 vaccine. Pain when trying to breathe deep, pain when moving right side of torso.
Patient has three bruised/blood filled areas at and surrounding the area of injection. She noticed this within 24 hours after vaccine administration. There is a knot at the injection site along with pain. She does not take blood thinners or aspirin so she normally does not bruise or bleed easily with injections in the past.
Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022; expired doses of Moderna COVID-19 administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 administered beyond the beyond use date) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022). At the time of the report, PRODUCT STORAGE ERROR (Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 administered beyond the beyond use 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.  The patient had received total 4 doses. Total, 22 doses were administered from a few different vials.  The vial did not undergo any temperature excursions. Treatment medications were not reported.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX vaccine (lot number not provided). Subsequently the patient experienced fever of 101 Fahrenheit and swollen arm. The outcome was unknown. Follow up information was received from the physician by phone indicated that out of 12 patients who received PNEUMOVAX from the same lot, 3 of the patients experienced adverse events. Follow up information was received from a physician by phone on 06-MAY-2009 provided the identifier and date of birth for the patient. It was reported that the 58 year old female patient was vaccinated with a dose of PNEUMOVAX (lot # 662744/1085X) in 29-APR-2009. Concomitant therapy included BENADRYL and TYLENOL. On 30-APR-2009 the patient called the office with fever (102F) and swelling of the arm. On an unspecified date the patient recovered. This is one of several reports from the same source. No further information is available.
Typical pain and  tenderness at injection site with redness and some swelling.  Fever for 2 days at times reaching 101.9 (without Tylenol) Persistent headache  lasting into the fourth day before subsiding. Body Ache especially around  chest and left and right rib cage.  lingering pain today at the right ribcage with occasional stabbing pain .  There is pale redness at the injection site with occasional itching sensation.
I received the shot at about 3 pm on April 2nd. That night my arm was very sore. Took a couple ibuprofen. On Saturday my arm was still sore so took some more Ibuprofen. Sunday I was feeling fine until about 8 pm when I started to get a little dizzy.  On Monday when I woke up I could barely raise my head. Everything was spinning. I was very dizzy and my mouth was dry. I had no concept of time. 2 mins would feel like 2 hours and 2 hour could feel like 2 mins. I started to feel a little better around 4 pm. Today I still feel a little hazy in the head.
dizziness; difficulty of talking; rash at the injection site; Rash on her arm/round, dot, like a quarter size rash; rash has a little bump or a minimal bump and that it wasn't that big but not a flat one and that it was like a "red dot."; This is a spontaneous report from a contactable consumer (Husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 03Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Jul2021, the patient experienced dizziness, difficulty of talking, on an unspecified date in Jul2021 rash at the injection site, rash on her arm/round, dot, like a quarter size rash, rash has a little bump or a minimal bump and that it wasn't that big but not a flat one and that it was like a red dot. Patient received the first dose of the Pfizer Biontech COVID19 vaccine on 3 Jul 2021. Caller said that his wife experienced dizziness and difficulty of talking that lasted for seconds or a minute or two. Caller mentioned that when he was with her, he did not notice anything. Caller also added that his wife had a rash at the injection site which lasted longer. Caller described the rash as round, dot, like a quarter size rash on the arm. In addition to that, caller said that the rash has a little bump or a minimal bump and that it wasn't that big but not a flat one and that it was like a red dot. Caller stated that it took a couple of weeks to fade out. Caller was asking if his wife can still get the second dose of the Pfizer Biontech COVID19 vaccine since her first dose was on 3 Jul 2021 and has been more than 21 days. The event dizziness and difficulty of talking was recovered on 03Jul2021 and all other events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a health care worker refers to an unspecified number of number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with PEDVAXHIB. Concomitant medications were not reported. On an unknown date the unspecified number of patients received PEDVAXHIB doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received PEDVAXHIB doses that were stored at 34F for 7 hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot number information was ava liable. This case is linked to 1406USA003227, 1406USA003839, 1406USA003840 and 1406USA003842 (same reporter link). Additional information has been requested.
Approximately two weeks post vax pt developed a pruritic rash with less than 100 small red papules and vesicles on legs, arms and trunk.
VERTIGO IN AM ON 03/16, 17, 18, AND EXTREME VERTIGO ON 03/19 ALL DAY..  TAKEN TO DOCTOR ON 03/19/2021
I felt awful; I just felt weak; Nauseous; Arm hurt really bad; I felt awful; I just felt weak; Headache; My chest felt really heavy, not super short of breath, just a heavy feeling; It could be the anxiety of not being sure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 07:00 (Lot number: FE3590) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 13Oct2021, outcome "recovering", NAUSEA (non-serious) with onset 13Oct2021, outcome "recovering" and all described as "Nauseous"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2021, outcome "recovering", described as "Arm hurt really bad"; CHEST DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "My chest felt really heavy, not super short of breath, just a heavy feeling"; ANXIETY (non-serious) with onset Oct2021, outcome "unknown", described as "It could be the anxiety of not being sure"; ASTHENIA (non-serious) with onset 13Oct2021, outcome "unknown", described as "I felt awful; I just felt weak"; HEADACHE (non-serious) with onset 13Oct2021, outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of dizziness, nausea, pain in extremity, chest discomfort, anxiety, asthenia, headache.  Additional information: Regarding treatment medication, Consumer stated, No, just like Ibuprofen kind of stuff. (Further Clarification Unknown). Prior vaccination (within 4 weeks): Consumer stated, No. There was no lab test done. Patient asked since she had side effects, should she get the second dose, she was answered when scheduling, that if she had the second one the side effects could be worse. As noted in the Fact Sheet for Recipients, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Pfizer refer patients to speak to their healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider knows the health situation.  Follow-up (14Oct2021): This is a follow up spontaneous report from a contactable consumer. Updated information included Reporter Information. Patient Characteristics. New Events added.  No follow-up attempts are possible. No further information is expected.
bit of a reaction; spike fever(101.5); nauseous for 2 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (bit of a reaction), PYREXIA (spike fever(101.5)) and NAUSEA (nauseous for 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No medical history was provided by the reporter.     On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (bit of a reaction), PYREXIA (spike fever(101.5)) and NAUSEA (nauseous for 2 days). At the time of the report, VACCINATION COMPLICATION (bit of a reaction), PYREXIA (spike fever(101.5)) and NAUSEA (nauseous for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.
patient's right thigh has some mild erythema and swelling less than a centimeter diameter around the central injection site, and to the medial aspect there is an erythematous outline of the Band-Aid, then lateral to the central injection site there is a larger area of erythema and induration also where the Bandaid was but more extensively erythematous with wheal and flare reaction, including the injection site the involved area measures 6-1/2 cm in width horizontally by 3-1/2 cm in length vertically, the plaque was outlined with a skin marking pen.  There is no confluence to the erythema and there is no significant warmth to touch.   Provider believes that she has had a mild reaction to the vaccine, however it does not appear to be a secondary cellulitis.  It may be a minor allergic versus localized reaction. Unaware of outcome, was just evaluated. Given topical hydrocortisone to use to area as needed.
- "Usual" side effects with most recent COVID19 vaccine and previous COVID vaccines (with exception of very first one ever, which had none):  pain and swelling at COVID19 injection site for about a week, pain in underarm in same arm as injection site, body aches throughout body, chills and sweating, headache, fatigue, random increases in resting heartrate throughout next 2 days, changes in menstrual cycle (previous COVID19 vaccines - regular monthly menses  was a day or 2 longer, heavier, more intense cramps, migraine. Now that I have the Nexplanon implant, I don't have a regular monthly menses, and have barely had any bleeding in the past year.  The most recent COVID19 vaccine caused me to unexpectedly have bleeding similar to my natural period without the implant - heavy bleeding a day or two longer, intense cramps, migraine.  Hopefully this will return to previous state next month, as with previous COVID19 vaccines).  - "Unusual" new effect - unexplained bruises on L foot and R calf, 8th and 9th days after COVID19 vaccine.  L foot - about 1"x1" purpura bruising.  R outer calf - about 3"x4" dark purple, round bruise.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, ROTATEQ was stored under 32 F for 39.5 hours. Then on 11-DEC-2015 the patient was vaccinated with the improperly stored dose of ROTATEQ (lot # K007246, expiration date 17-MAR-2016, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.
p/vax pt devel induration; warm to touch; area size of 50cent piece; also blotches on hands & feet;
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot # not reported, expiration date 17-AUG-2012) on 25-SEP-2012. No adverse event was reported. Additional information is not expected.
Initial literature report received on 25 Oct 2010: Authors presented a case of optic neuropathy following influenza vaccination in a patient with rheumatoid arthritis. This patient with long-lasting rheumatoid arthritis undergoing regular supported treatment was vaccinated with influenza virus vaccine (manufacturer and batch number unknown). Three days after influenza vaccination, the patient noted an inferior altitudinal defect in the visual field of the left eye (OS). The fundus study revealed 2-3 diopters oedematous optic disc, worsened segmentally superiorly OS. A diagnosis of optic neuropathy was made. Despite intravenous application of methylprednisolone, her vision progressively worsened over several days to 20/300 OS. Ten days later, OS started to improve and after one month, neuro-ophthalmological examination showed partial visual recovery (20/70 OS). One year later after vaccination, visual acuity was 20/40 OS with pale optic disc in the affected eye. Authors speculated that present case suggests a possible link between ischemic optic neuropathy and influenza vaccine in an immunocompromised by rheumatic disease or this patient's treatment.
was lethargic for like a week; Initial information received on 11-Jan-2022 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who was lethargic for like a week after receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "was lethargic for like a week" (lethargy) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (was lethargic for like a week).  At time of reporting, the outcome was Unknown for the event was lethargic for like a week.
running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CHANTIX. The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "running nose". Additional information: It was reported that the patient has been experiencing running nose, when she keeps her head down she has to keep wiping it; she does not feel bad but her nose keeps running. Patient was querying if that was okay. The patient also wanted to know if the running nose she was experiencing was due to Pfizer COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "unknown", described as "Sore arm".  Additional information: On 12Sep2022, the patient hoped to receive bivalent vaccine. The sticker on the card did not mention as bivalent. It was stated that Pfizer COVID-19 Vaccine with Lot: GH9694. The patient asked whether it could be a bivalent vaccine. After receiving vaccine the patient had no side effects except a sore arm.