chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; This spontaneous report received from a consumer concerned a 55 year old male. The patient's weight was 135 to 140 pounds and height was 67 inches. The patient's concurrent conditions included: diabetes (diagnosed in 1995). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1, suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 12-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included insulin for diabetes.  On an unspecified date, the patient experienced blurred vision in his left eye. On an unspecified date in AUG-2021, the patient subsequently experienced a stroke. The patient started stumbling after the stroke and the  patient has not regained full mobility. It was reported that patient was confused and took time to respond to answer questions. Patient's motor skills were not back to 100 percent. Patient was prescribed Plavix 5mg once a day after his stroke. It was reported that patient was having therapy sessions to improve his motor skills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211266078.; Sender's Comments: V0 20211266112-COVID-19 VACCINE AD26.COV2.S- stroke. This event(s) is considered unassessable. 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).
Very low grade headache behind the eyes. Momentary high grade shooting pain (8 on scale of 10) when sneezing, coughing or bending down forward.
Rash on upper body, chest, torso, back, arms, looks like shingles but spread out.  Not itchy. Joint pain. Started Saturday morning, used hydrocortisone 1% blotches subsided but still there a little bit.
started feeling bad about 30 hours after injection, gotten worse; after the Moderna booster shot, she's feeling ill; Pain across the shoulder, up to back of her head. Pretty bad headache; Pain across the shoulder, up to back of her head / Pain in the shoulder started 16 hours after the injection; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad about 30 hours after injection, gotten worse), MALAISE (after the Moderna booster shot, she's feeling ill), HEADACHE (Pain across the shoulder, up to back of her head. Pretty bad headache) and ARTHRALGIA (Pain across the shoulder, up to back of her head / Pain in the shoulder started 16 hours after the injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21H) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Last year had heart stent installed) in 2020. Concurrent medical conditions included Heart disease, unspecified (she was on some other heart medication) and Blood pressure abnormal. Concomitant products included GLYCERYL TRINITRATE (NITROGLYCERIN) for Chest pain, CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN 81) and ATORVASTATIN for an unknown indication.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced FEELING ABNORMAL (started feeling bad about 30 hours after injection, gotten worse), MALAISE (after the Moderna booster shot, she's feeling ill), HEADACHE (Pain across the shoulder, up to back of her head. Pretty bad headache) and ARTHRALGIA (Pain across the shoulder, up to back of her head / Pain in the shoulder started 16 hours after the injection). At the time of the report, FEELING ABNORMAL (started feeling bad about 30 hours after injection, gotten worse), MALAISE (after the Moderna booster shot, she's feeling ill), HEADACHE (Pain across the shoulder, up to back of her head. Pretty bad headache) and ARTHRALGIA (Pain across the shoulder, up to back of her head / Pain in the shoulder started 16 hours after the injection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the patient was on heart medication blood thinner and blood pressures pills. Not taken any treatment.   This case was linked to MOD-2021-423760, MOD-2021-423679, MOD-2021-423761 (Patient Link).
got her first dose of COVID-19 vaccine last 25Feb2021 and tested positive for COVID-19 on 17Mar2021/lost smell and got a head cold; got her first dose of COVID-19 vaccine last 25Feb2021 and tested positive for COVID-19 on 17Mar2021/lost smell and got a head cold; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 25Feb2021 (Lot Number: EL3247; Expiration Date: May2021) as dose 1, single for COVID-19 immunization. Medical history included ongoing Factor V Bleeding Disorder from an unknown date, diagnosed in the 2000s (as reported) and had a blood clot diagnosed at age 18 and one blood clot diagnosed in 2000. There were no concomitant medications. The patient previously received a flu shot on an unknown date but reported that it had been more than 4 weeks before the COVID shot for immunization. The patient got her first dose of COVID-19 vaccine last 25Feb2021 and tested positive for COVID-19 on 17Mar2021. Her husband got COVID and they wouldn't let her get tested for seven days. She went to Urgent Care and got rapid test on 17Mar2021. She was shocked that she had COVID, so she believes the shot works. She got a mild case. She lost smell and got a head cold. She was due for second shot on 16Mar2021. She reached out to Pfizer to say she potentially had COVID because her husband had COVID. She got the positive results of COVID on 17Mar2021. The patient had not received her second shot because she waited for her quarantine period to be over before she could get her second dose but when it was time for her to get the second dose, she mentioned that her dose is no longer available at their company. The patient added that she read in a journal that she has more antibodies since she got the shot and got COVID and mentioned that her medical doctor advised her not to get the second shot since she would have many antibodies from the first dose and her COVID-19 infection. She wanted to know if she should still get the second dose of the vaccine or if the information provided to her by her doctor and the journal she read were true. The patient added that Pfizer said they had no idea where her second shot went. She tried to get her second dose of the Pfizer COVID-19 vaccine after her quarantine period but it was no longer available. They told her she missed the opportunity and they didn't have any more shots. Now they are doing kids and she doesn't qualify to come in with the kids. She doesn't know where her shot went. The outcome of the events was unknown.
Elevated blood sugars into the 300's. Started next day and have persisted for 4 days requiring me to contact my physician.
body ache; joint ache; low grade fever; sore throat; This is a spontaneous report from a contactable consumer. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 13Mar2021 16:00 (age at vaccination 41-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included penicillin, cyclosporin and shellfish an unknown date and unknown if ongoing. The patient concomitant medication was not reported. On 14Mar2021 09:00, patient experienced body ache, joint ache, low grade fever, sore throat. Patient has not taken any other vaccine with in four weeks and no other medication in two weeks. No treatment was received for AE. Patient was test for COVID prior vaccination and not been tested since post vaccination. Outcome of the patient was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Rash 1-3 mm pink blanchable macules and papules trunk and back, no extremities. no open sores, no pruritic. On set 11 days after MMRV vaccine and two days after completing 10 course of Omnicef.
I had extreme burning when I received TDAP. She administered in it in top of arm and I don't remember her pinching skin. Soon after, I had reduced mobility in left arm and could not move shoulder well. I still have the reduced mobility and pain in arm, down to forearms, with achiness and discomfort.
Mom reports around noon the Sat. after childs vaccinations the child started having pin-prick size bumps all over body. Reports by 4:00 PM there were patches on chest, arm, legs. Reports went to walk in clinic. Reports 20-30 min while being there at clinic they had spread all over body. Mom reports they tested her for strep and it was neg. Reports they gave her BENADRYL and oral steroid. Mom reports took 3d before went completely away. They told her it was prob. allergic reaction to flu shot.
Fever; body aches; chills; headache; rash on left upper arm/shoulder area; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169), via an unspecified route of administration in the left arm on 26Apr2021 at 11:00(at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 11:00(at the age of 47-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 11:00, the patient experienced fever, body aches, chills, headache and rash on left upper arm/shoulder area. The clinical outcome of the events fever, body aches, chills, headache and rash on left upper arm/shoulder area was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
swelling and soreness at the injection site; soreness at injection site; red, and a little swollen at the injection site; felt itchy at the injection site; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular on the right arm near shoulder on 19Jan2021 09:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. There were no other vaccine received within 4 weeks prior to COVID vaccination. After she got a tetanus shot (probably needs another since it had been ten years) her arm/ muscle was sore. Patient had typical swelling and soreness at the injection site on Jan2021that went away within a couple of days and then did not have any symptoms. Then today all of a sudden it felt sore, red, and a little swollen at the injection site again. It has been more than a week since the symptoms initially resolved and now they have reemerged. It felt itchy at the injection site, it had a raised red area that was itchy on Jan2021. She did go running this morning and has been running several times, she went running the day after she got the vaccine. Events did not require emergency room nor a visit to the physician's office, and no treatment was given. Outcome of the events was unknown.
Parent called in evening after immunizations were given, reporting that child could not be roused,was "unresponsive", "catatonic", "floppy" and "breathing shallowly".  Instucted by Dr to go to ER. Told in ER that child suffered from reaction to immunizations.
1 day, post vax, in the left arm, pt had swelling and violatous discoloration at site of shot plus surrounding erythema and induration.
heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a 54 years old and unknown gender patient who had heart attack while receiving vaccine INFLUENZA 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 an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as Immunisation. Information on lot number was requested.  On an unknown date the patient had heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart attack).  At time of reporting, the outcome was Fatal for the event heart attack. It is unknown if an autopsy was done. The cause of death was reported as Heart attack.; Sender's Comments: Sanofi Company Comment dated 04-Feb-2022. This case involves a 54 years old and unknown gender patient who had heart attack while receiving vaccine INFLUENZA VACCINE.. Based upon the reported information, the role of a vaccine cannot be assessed  Further information regarding time to onset, autopsy results,concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.; Reported Cause(s) of Death: heart attack
This spontaneous report was received from a registered nurse concerning an approximately 73 year old female patient with no drug reactions or allergies. The medical history of the patient included adhesive capsulitis of the right shoulder, cholecystectomy and rotator cuff tear (everything resolved on an unknown date). On 17-MAY-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as J001180 and 18-AUG-2014 respectively), intramuscularly. The patient received ZOSTAVAX (lot number, expiry date, dose and route unspecified) as well on the same day as the PNEUMOVAX23 (on 17-MAY-2013). Concomitant therapies included vitamins (unspecified) (reported as multivitamins). On 17-MAY-2013, the patient experienced swelling of the arm, arm was warm to touch, large reddened area at injection site about 10 centimeters (cm), chills and a temperature of 102 or 103 (units unspecified) after receiving PNEUMOVAX23. The patient sought medical attention (called to doctor office on 20-MAY-2013). Patient was told by the physician to take some ibuprofen and to put ice on the area. No lab tests were performed. The patient was recovering from all the events. The relatedness for all the events was unknown for PNEUMOVAX23 and ZOSTAVAX. Additional information has been requested.
Breakthrough period 2 days after 2nd dose of vaccine and headache on my lower back right side of my head (right posterior scalp)  Also got a breakthrough period 1.5 weeks after first dose.
REDNESS/HIVES ON THE BODY COMES AND GOES, BUT NOT AT ONCE. EVERY TIME IT'S IN A  DIFFERENT SPOT, IT CAN BE ROUND OR LONG (UNDER THE BREAST AS WELL) THEY ARE AS LARGE AS A QUARTER, NICKEL, DIME OR PENNY. IT CAN BE A "BOTCH" IN THE "CREASE" AS WELL; SWELLING IN THE LIPS; INJECTION SITE BRUISING; INJECTION SITE MILD DISCOMFORT; INJECTION SITE REDNESS (2-3INCH); This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 237 pounds, and height was 61 inches. The patient's concurrent conditions included penicilline allergy, and other pre-existing medical conditions included high sensitivity to many things (hcp is aware of the situation). The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 19-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced injection site bruising. On 19-MAR-2021, the subject experienced injection site mild discomfort. On 19-MAR-2021, the subject experienced injection site redness (2-3inch). On APR-2021, the subject experienced redness/hives on the body comes and goes, but not at once. every time it's in a different spot, it can be round or long (under the breast as well) they are as large as a quarter, nickel, dime or penny. it can be a "botch" in the "crease" as well. On APR-2021, the subject experienced swelling in the lips. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness/hives on the body comes and goes, but not at once. every time it's in a different spot, it can be round or long (under the breast as well) they are as large as a quarter, nickel, dime or penny. it can be a "botch" in the "crease" as well, and the outcome of injection site bruising, injection site redness (2-3inch), injection site mild discomfort and swelling in the lips was not reported. This report was non-serious.
Soreness and swelling at the sites. Fever over 102 (with Tylenol and Ibuprofen). Inconsolable screaming. Hives appeared on day 4. Lethargy. No appetite. Very few barely wet diapers. Writhing in pain. Will barely latch on to nurse, while nursing, will only pacify for a moment then cry again. Clammy. Hard to keep asleep.
Client presented to the vaccination site on 12/20/2021 and received a booster dose of Moderna COVID vaccine lot #069H21A at 16:05. Client reported feeling dizzy 5 minutes into her observation period. RN's assisted client into anti-gravity chair and took vitals: BP - 125/80, HR - 95, SpO2 - 99%, RR - 14. Lead RN had client take off face mask and drink water at 16:24. Client reports no health history or allergies, client states "I have a history of fainting with blood work". Client declined another set of vitals to be taken but allowed HR and SpO2 to be checked: HR- 88, SpO2 - 99%. Lead RN educated client on possible adverse reactions, when to seek medical care and to register with V-Safe. The client left the vaccination site at 16:34 A&Ox4 with a steady gait.
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022.  No treatment information was provided.  This case is reported for 18th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-665494, US-MODERNATX, INC.-MOD-2022-665704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665494: US-MODERNATX, INC.-MOD-2022-665704:Same reporter
Administered the wrong vaccine, was mistaken for a tdap vaccine  Patient has nausea, headaches, dizziness and body aches
potential side effects after taking a Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (potential side effects after taking a Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-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 an unknown date, the patient experienced IMMUNISATION REACTION (potential side effects after taking a Moderna vaccine). At the time of the report, IMMUNISATION REACTION (potential side effects after taking a Moderna vaccine) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Non Significant Follow-up received.
Hives and severe itching all around the injection site down to the elbow of right arm.