chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fell a day prior to receiving the vaccine on 3/18/21. Patient takes  Eliquis daily. About one or two days after receiving the vaccination, the patient's skin became a blotchy red all over.  His legs had a "honeycomb" like appearance. His mental status was altered slightly. Patient was admitted to the hospital 3/23/21.
The next day 3 of them had called out sick from work.; itching; The site of the injection, the redness has widened; fever; headaches; chills; very sore at site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever) and HEADACHE (headaches) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Nov-2023 at 10:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever), HEADACHE (headaches), CHILLS (chills) and INJECTION SITE PAIN (very sore at site of injection). At the time of the report, ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever), HEADACHE (headaches), CHILLS (chills) and INJECTION SITE PAIN (very sore at site of injection) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that five other employees that were given shot same morning all having had adverse side effects, three of the employees had to call out sick next days with several symptoms ranging from fever, extreme headaches which still haven't subsided, chills, itching, very sore at site of injection. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748215, US-MODERNATX, INC.-MOD-2023-748404 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live significant follow up received: Batch/lot number, new events and reference numbers were added. On 06-Nov-2023: Non-significant information received: Reporter details and reference numbers were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748342:Patient 2 out of 3 US-MODERNATX, INC.-MOD-2023-748352:Patient 3 out of 3 US-MODERNATX, INC.-MOD-2023-748215:Reporter's case US-MODERNATX, INC.-MOD-2023-748404:Patient 5
This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (she started having cardiac issues (a rapid heart beat)), MALAISE (not felling well for 24 hours), FATIGUE (tiredness) and ACCIDENTAL OVERDOSE (Full 3rd dose without being immunocompromised) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 026L20A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy, Allergic reaction to bee sting and Osteopenia. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia. On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Full 3rd dose without being immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (she started having cardiac issues (a rapid heart beat)), MALAISE (not felling well for 24 hours) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and METOPROLOL SUCCINATE (TOPROL) for Cardiac disorder, at a dose of 12.5 milligram once a day. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (she started having cardiac issues (a rapid heart beat)) and FATIGUE (tiredness) had not resolved, MALAISE (not felling well for 24 hours) had resolved and ACCIDENTAL OVERDOSE (Full 3rd dose without being immunocompromised) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had allergy to scalps. The patient was not tested or diagnosed with COVID. The patient had no acute and chronic illnesses at the time of vaccination. The patient had no history of cardiac issues and the events were ongoing at the time of report. This case was linked to MOD-2022-527368 (Patient Link).
He was laughing and suffered from sudden onset OD central retinal artery occlusion with persisting deficits from it.
patient developed "Lymphadenopathy in the right groin"; This spontaneous report was received from a registered nurse referring to a 15 month old female patient with dermatitis atopic. The patient's concomitant therapy included desonide.   On 07-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R029513, expiration date: 14-OCT-2020) subcutaneous as routine vaccination. On 12-JUL-2019, the patient developed "lymphadenopathy in the right groin". The patient was taken to the emergency room and was prescribed with clindamycin and received an ultrasound of her right groin (results not provided). The reporting nurse mentioned that the patient's right groin was "purple, discolored and swollen." At the reporting time, the outcome of lymphadenopathy was reported as not recovered. The causal relationship between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the event lymphadenopathy was not provided.
March 17 2021- Dizziness and high blood pressure. 3/19/21- Went to Urgent  care late evening for the worsening symptoms above.  Prescribed with Meclizine for Vertigo. Order Lab works which was done the day after. 3/23/21- Sent to ER via 911 due to B/P 193/101, pressure headache, dizziness and weakness. Laboratory work ups done, all normal. Sent home with no prescription. 3/25/21- Went to Urgent with same symptoms, prescribed with blood pressure medication. Received my second dose on 4/1/21, still with daily dizziness and headache. I have future appointments with my primary doctor.
Patient was pregnant at time of vaccination. Pt evaluated on 17Feb2015 and was 6weeks/6days pregnant.
Large welt appeared 6 days after injection. Injection site is bright red (sunburn looking) and extremely hot to touch. Arm stiffness and soreness with occasional ?dead arm? feeling. Unable to lift objects over 20 lbs with ease.
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose 5: 08Sep2022/Pfizer Dose 4: 15Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2021 at 10:00 as dose 1, single (Lot number: EK9231), in left arm, on 27Jan2021 as dose 2, single (Lot number: EL8982), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 as dose 5 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "h/o atrial fibrillation" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "unknown", described as "Moderna Dose 5: 08Sep2022/Pfizer Dose 4: 15Apr2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelligibly.  I also had trouble with balance and fine motor skills.  Had some personality changes too: became very moody with erratic mood swings. The next day I slept all day because of exhaustion and aches. When I woke up on Wednesday (36hrs later) I was literally screaming in pain because of how bad my arm and shoulder hurt. It hurt to move it, and hurt not to move it.  It was excruciating and ibuprofen didn't seem to help at all. Throughout Wednesday I could hardly move my left arm. Getting dressed or washing my hair was very difficult and very painful.  I was also still very uncoordinated. My left armpits lymph nodes were so swollen that (1) it filled in my entire armpit so there was no more pit, just a very soft bulge, and (2) the fluid extended all the way to my chest and it looked like I had one breast and one pec.
Rash on left arm that spread to chest, trunk, back. Rash is maculopapular confluent. Treated with Medrol dose pack rash began day after TD given.
MEMBER RECEIVED IMMUNIZATION ON 5 JUNE 04.  ON 7 JUNE 04 HE STARTED TO EXPERIENCE SHORTNESS OF BREATH LIKE FEELINGS.  CONDITION WAS CONSTANT DURING REST AND EXERTION.  ON 8 JUNE 04 MEMBER STARTED TO EXHIBIT CHEST COLD LIKE SYMPTOMS.  MEMBER CONTACTED ME ON 9 JUNE 04 @1430.  WILL GET FOLLOWUP TREATMENT ON 10 JUNE 04.
blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a female patient of an unknown age 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot) (seriousness criterion death). The reported cause of death was Clot blood. It is unknown if an autopsy was performed.            The reporter stated that his wife had recently passed away from a blood clot after receiving a second dose of the Moderna COVID-19 vaccine. Treatment information was not provided. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Clot blood
Arm tender for two days, ran a fever, body aches and headache for 12 hours. Blood pressure went up to 187/101.
This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (red and swollen patches on elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck), FATIGUE (tiredness) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PANTOPRAZOLE, ATORVASTATIN, LISINOPRIL and DICYCLOMINE HYDROCHLORIDE for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (tiredness), HEADACHE (headache), CHILLS (Chills) and PYREXIA (fever (up to 100 degrees Fahrenheit)). On 07-Mar-2021, the patient experienced JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck). The patient was treated with TRIAMCINOLONE (topical) on 20-Mar-2021 at a dose of 0.1%  30 g; AVENA SATIVA (EUCERIN ECZEMA RELIEF) on 25-Mar-2021 at a dose of 1 dosage form; SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) on 25-Mar-2021 at a dose of 1 dosage form; LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form; GLYCEROL, NAPHAZOLINE HYDROCHLORIDE (CLEAR EYES REDNESS RELIEF) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 01-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (tiredness), HEADACHE (headache), CHILLS (Chills) and PYREXIA (fever (up to 100 degrees Fahrenheit)) had resolved. At the time of the report, JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 100 degree f (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included health pill over-the-counter. This case was linked to MOD-2021-101978.
This spontaneous report was received from a 66 years old male consumer with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) about three months ago (approximately in September 2012). No other co-suspects were reported. Concomitant medications included CELEXA and pantoprazole. The consumer reported that he developed a case of shingles. On 03-DEC-2012 (also reported as 04-DEC-2012) he noticed a small rash on the inside of his left thigh, near his groin. The area started to itch and burn. By 06-DEC-2012 the rash got worse and started to blister. He saw his healthcare professional (HCP) on 07-DEC-2012 and the HCP confirmed it was a case of Shingles. The patient was put on antibiotic and a pain pill (manufacturer unspecified) as treatment for the event. No lab diagnostic test were performed. The outcome of shingles was reported as not recovered. The relatedness for the reported event was not provided for ZOSTAVAX. Additional information has been requested.
Client stated she felt lightheaded after receiving her vaccine.  Vital signs obtained by EMS.  BP 116/77, HR-81, O2 sat99%. Client states she is feeling better. Client discharged home by EMS.
58y.o. female who presented to Hospital on 8/9/22 N/V & Diarrhea. She was seen at Facility 8/8, given fluids, dx with dehydration, subsequently discharged home. Pt states PCP sent her To EC for further evaluation due to chronic N/V x two years. Pt states she had a fundoplication Feb 2022. Pt was recently COVID+ at end of July.The patient is complaining of headache for couple months. The headache describe as pressure/throbbing in type and located across the R temporal head region and base of the head and graded 10/10. The past week, the headache comes lasts all day. The headache is associate with neck stiffness, photo-phonophobia, tinnitus, nausea, vomiting, and dizziness. At home, patient stated that rest and Tylenol help the headache. Fioricet helps bring the headache to +2-3 out of 10. There was no history of head injury, fall, trauma, nasal or ear discharge, blurring vision, diplopia, dysarthria, facial or extremities numbness or weakness. The patient is also complaining of hands tremor for 1 month.  The patient stated that the tremor has been progressively worsening and gets worse with moving the hands include holding the phone. The hand resting tremor is worse over the left hand.  The pt states she has hallucinations. There is family hx of Parkinsons (sister).
The patient is only 17 years old. He was mistakenly given the Moderna Vaccine at a different location and his mother asked us to complete his series with either Pfizer or Moderna. We looked into what we should give and I was told to give Moderna as his second dose.
12 hours after vaccine given at 5:00 a.m. woke tobeing  Dizzy, Nausea with vomiting,  and headache; dizzy, headache and nausea continued all day, vomiting again three times between 7:00 p.m. and  7:30 p.m. with slight fever:  dizzy and headache continued for the next week; started to disappear but  I still have periods of dizziness and it has now been three weeks.
Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-contactable nurse. A 40-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 12:00 to 28Dec2020 12:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported.  The patient previously took chlorhexidine and experienced allergies. The patient experienced Fever to 99.8 body, muscle aches, Headache and sore arm for days, felt like being punched repeatedly in the arm; all on 28Dec2020. The outcome of the event was recovered on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports feeling dizzy, lightheaded. No shortness of breath or flushing. Cleared by EMS.
On 10/21/22 I had a very normal day of work, at about 5pm I was getting ready to go out of town to see family when all of a sudden I had really intense chest/upper abdomen pain, I went and laid down to see if it would go away, it improved slightly so we got on the road around 630 or 645 pm.  At about 930pm I felt some itching around my waist band, and did not think much of it. At about 10pm I again had very intense chest pain and felt like I was going to die. I was having difficulty breathing. We were 4 miles from Hospital and so I drove there. They did a cardiac work up and cleared me of cardiac problems and sent me on my way. About 30 minutes after I left I was covered from head to toe with hives, the palms of my hands, the bottoms of my feet and everything in between. At the same time I have sever chest pain. I arrived to my sisters around 1am and took some motirn for pain and benedryl for itching. I let up a little but 2 hours later the hives and pain were back even worse. For all day on the 22 I took motrin 200mg and benedryl 25 mg every 2 hours, i was vomiting about every 2 hours and did not keep anything down. On Sunday morning I got on the road and headded home to go to urgent care. On the way my hives returned and my bottom lip became swollen. At clinic they started me on 60 mg of prednisone, pepcid and zyrtec. On 10/24 at 7am I went to the ER at regional hospital for severe abdominal/chest pain. They did a ct, gave me IV fluids and Iv pain medication and then discharged me. The following day I followed up with my PCP, no changes were made at that time but I was set up to the the immunologist on 10/27, Dr. who reports that it could be a delayed reaction to the flu vaccine. Symptoms of hives continued until the morning of 10/26 with occasional chest discomfort. The prednisone, zyrtec and pepcid were tapered and completed on 11/5/22. Today I still have an unusual discomfort in my upper abdomen/chest but nothing painful. Still have occasional chest/upper abdominal discomfort
Weird feeling; Never had a temperature; temperature went up to 102.2; Chills; Eyes started getting hot aches and pains; Eyes started getting hot aches and pains; Back ache; hot, flush cheek; hot, flush cheek; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the second dose of BNT162B2, intramuscularly on an unspecified date at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC). Concomitant medication included riboflavin/thiamine hydrochloride/ursodeoxycholic acid (URSO). Patient previously received first dose of BNT162B2 for COVID-19 immunization. The second shot she got around 1:30 on Friday and came home and a kind of feel weird an hour later about she figured it out whatever. She came home, she went, took rest, what happened was around 1:30 was it the same day she was losing track. She got this temperature and it started going up pretty fast and she was one of those people who had normal temperature was like 97 it went up to 102.2 and she called the "(company name)" (not clarified) advisor just to ask recommending paracetamol (TYLENOL) or acetylsalicylic acid (ASPIRIN) because she didn't want to take the wrong one. She said paracetamol wasn't recommending it was very pretty common that was for having no symptoms but the ones that were 24-36 hours afterwards. So, she was having the temperature she took the paracetamol which helped but she had chills, her eyes were like hot, flush cheek, she pushed fluids. Next day she felt it came again after 8 hours her eyes started getting hot, eyes got hot again so she kept pushing fluids and then she started getting aches and pains and then she just took more paracetamol and been resting the whole time. She took the Pfizer one just an "FYI" (not clarified) everyone at work saying you should have waited work for "Mondera" (not clarified). They said it had less side effects it started protecting you immediately after the injection where Pfizer took 3 weeks to second one to protect you. From the second vaccine, she didn't want to really tell anybody at work any one about her high temperature, her flush cheeks, her chills, her all the above right because she was scared that wouldn't take the second vaccine. Patient never had a (temperature) she was one of those people that "sudden" normal "Fumida" (not clarified) send bed for 2 day and just drink water and some "jellies" you know it was something that was why she was calling. Patient got vaccine on Friday and came home about 11:50 in the morning. She started experiencing around 10 am and I got this shot the second vaccine around 1:30 ish-1:15-1:30 in the afternoon till the next day. Patient felt better at the time of the report. She only felt like aches in her back she didn't know what that was and that was about it and obviously she felt better because she was talking on the phone, she couldn't have done that yesterday if she wanted. Yesterday all she wanted to do was sleep, rest and try to get the fever down. Outcome of the events was resolving.  Information about batch/lot number has been requested.
Patient was given a Moderna COVID 19 booster dose that has expired; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a Moderna COVID 19 booster dose that has expired) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a Moderna COVID 19 booster dose that has expired). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient was given a Moderna COVID 19 booster dose that has expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.