chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First shot felt like I had flu for 2 to 3 days; This is a spontaneous report from a contactable consumer (patient). An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 as dose 1, single for COVID-19 immunization. Medical history included post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD), depression, anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, caesarean section, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergies to amoxicillin, morphine, cantaloupe others unknown and experienced allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post 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. The patient received 3 other prescriptions daily in two weeks prior to the vaccination. The patient stated that after first shot felt like she had flu for 2 to 3 days on 30Mar2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient received Therapy and possible change in medication as treatment for the adverse events. The outcome of the event was not recovered.  Follow-up attempts are needed. Further information is expected.
Within a few hours, began to develop red, itchy, hot, swollen, tender  rash at injection site. Swelling and redness increased over the next few days, with maximum size 3 inch diameter on 10/8/2021. I recognized it as an allergic reaction on the first day and took Benadryl 25mg twice daily and style 500mg to treat.  On 10/7/2021 I contacted my primary care Dr. whose office provided the shot. Dr. instructed me to ice it, and continue to take Benadryl 25mg twice daily and take Tylenol as needed which I did.   I also spoke with  my allergist, Dr. by phone. Dr. office instructed me to use my allergy steroid cream triamcinolone 0.05% topically in addition to the Benadryl and Tylenol.  The rash and pain persisted for several more days but improved and was pretty much gone by a week later.
Pt. received 1st dose Pfizer vaccine and 30 minutes later experienced swelling of face/tongue, slight bilateral edema of face not extending to neck.  At ED expressed difficulty swallowing.  Resolved after steroid and antihistamine.
Moderna COVID-19 vaccine   18 hours after vaccine administered starting on 1-6-2021 pt had fever of 100.1,  chills and somewhat fatigued and then noticed his tongue slightly swollen.  All symptoms subsided by 1-7-2021
1500 Inj given. 1630 Symptoms started. 1800 Pt vomited / hives began immed. 1839 Emergency Room. 1900 Triaged. 2000 Given 3 inj. 2 doses of Epi, 25 mg BENADRYL, liquid dose of Prednisone. Pt is to take meds x 5 days.
shots worse than desease itself, kicked my behind; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient thought his/her Shingles shot was worse than the disease itself. The patient stated that it kicked him/her behind for days. Follow-up could not be possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR050244.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR050244:Same patient, different dose
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient came to the hopsital for Hip surgery, she initially had fever and mild cough. treated with antibiotics. Discharged home.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions.     On 11-Mar-2022 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 1:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's ethnicity was reported as white. It was unknown if the patient received any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. It was unknown if the patient received other vaccines given on the same day and it was also unknown if the patient received other vaccines within one month prior to Moderna vaccine. It was reported that, the vaccines went in to 2-8 C thaw state on or about 24-Dec-2021. It was unknown if the patient experienced any adverse events or not. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Mom states noticed (R) deltoid warm to touch with red inflamed area. No fever or pain. Notified PCP - who instructed her to come to Health Department. Staff notified.
This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient. The patient's pertinent medical history included high cholesterol. The patient's drug reactions and allergies included allergy to clarithromycin. The patient's concomitant therapy included rosuvastatin calcium (CRESTOR). On 09-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the left arm (lot # R012632, expiration date: 15-JAN-2020, dose was not provided) and FLUCELVAX in the left arm (lot # 252228, expiration date: 31-MAY-2019, dose and route of administration were not provided) for prophylaxis as the patient was over age of 65 and was due for second PREVNAR 13 on an unknown date in 2017 (reported as one year ago). On 10-OCT-2018, the patient experienced chills, fever and large red rash that was itchy and hot to touch on the injected arm and the patient was unable to move injected arm. The injection site reaction appeared to be stemming from where PNEUMOVAX 23 was injected. The patient received unspecified treatment for the events. The patient sought medical attention via coming to pharmacy. The outcome of the events was reported as not recovered. The relatedness between the events and suspect vaccines was not reported.
In the middle of the night I woke up with chest pain and extremely light headed. My blood pressure dropped to 97/63 and pulse went up to 164.  Since the shot I have felt dizzy and my blood pressure continues to drop.
got the second dose on 42nd day on 15 april 2021; due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021; serious cut injury; This spontaneous case was reported by an other and describes the occurrence of WOUND (serious cut injury), INTENTIONAL PRODUCT USE ISSUE (due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 42nd day on 15 april 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and lot#019B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included TETANUS VACCINE for Cut wound.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced WOUND (serious cut injury). On 01-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 42nd day on 15 april 2021). On 27-Mar-2021, WOUND (serious cut injury) had resolved. On 01-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 42nd day on 15 april 2021) outcome was unknown.            Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Contact details, second dose details and events were updated
NauseaVomiting LETHARGIC, INJ SITE PAIN Narrative:
s/p fall at home, reported fatigue, weakness, headache, neck pain. on 8/8/22, tested positive for covid on 8/9/22
I had covid 19 back in March of this year. I am experiencing similar side effects.  Headache Aches Chills Brain fog Tiredness Night sweats
2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023; The patients left injection site arm was sore the night after the vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023) and VACCINATION SITE PAIN (The patients left injection site arm was sore the night after the vaccination) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 1), PFIZER BIONTECH COVID-19 VACCINE (first booster) and PFIZER BIONTECH COVID-19 VACCINE (dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 11-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (The patients left injection site arm was sore the night after the vaccination). On 13-Apr-2023, the patient experienced SWELLING (2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023). At the time of the report, SWELLING (2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023) and VACCINATION SITE PAIN (The patients left injection site arm was sore the night after the vaccination) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patients left injection site arm was sore the night after the vaccination and then 2 days later the patient experienced puffiness and swelling in the space between the left shoulder and neck which the patient described as the spot where her bra strap would be located. No treatment information was provided by the reporter.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 89 and cause or notice of death not listed. On 8/7/2020 patient was admitted with aspiration pneumonia, Patient had chronic inflammatory demyelinating polyneuritis and was suffering disease progression with dysphonia and dysphagia. Death was likely caused by disease progression.
Swelling at the injection site from arm down to elbow; Redness at the injection site from arm down to elbow; A spontaneous report  was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling at the injection site from arm down to elbow/vaccination site swelling and redness at the injection site from arm down to elbow/vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, approximately two weeks prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced swelling and redness at the injection site from arm down to elbow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, swelling at the injection site from arm down to elbow and redness at the injection site from arm down to elbow was 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.
Rec'd 3rd dose rabies vax & 3hrs later developed h/a, nausea, gen shakiness, myalgia, no rxn to prior two shots; tx Advil, rest & observed x 3-4hrs;
That afternoon after vaccination, (the next day) child reports a swollen and red area on arm that is about 3 inches in diameter located in the back of the left arm where the varicella vaccine would have been given. So far, ice pack has been used, will see physician if there's a larger concern.
some of them become crusty for first, she thought they were the shingles; but they would not burst or anything was reported as worsened; bumps on her head, almost like a block blind pimple but they would not burst or anything; This is spontaneous report from contactable nurse (the patient).  A 63 years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, solution for injection, lot number: not reported, expiry date: unknown), via an unspecified route of administration, administered in arm right on 18Mar2021 as dose 2, single (age at the age of 63 years) for covid-19 immunisation. Medical history included ongoing multiple sclerosis from an unknown date and ongoing neuropathy peripheral from an unknown date. Concomitant medication included natalizumab (TYSABRI) for multiple sclerosis from unknown date to unknown date and gabapentin (NEURONTIN) for neuropathy peripheral from unknown date to unknown date. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, solution for injection, lot number: not reported), via an unspecified route of administration on 19Feb2021 as dose 1, single (age at the age of 63 years) for covid-19 immunisation. On an unspecified date in 2021, probably, about a week after, she got her second shot, the patient experienced bumps on her head, almost like a block blind pimple but they would not burst or anything, some of them become crusty for first, she thought they were the shingles, but they would not burst or anything was reported as worsened. The reporter stated that the first two shot and last one was on 18Mar2021 and after that, she started getting all these bumps on her head. She never had it before. She did not know if, it was from that or not. The patient started to see bumps all over her head and they were almost like a block blind pimple but they would not burst or anything but then she wake up in the morning, some of them become crusty for first, she thought they were the Shingles. She went to doctors twice, they warned Shingles and they had ordered antibiotic Prednisolone and it seemed to surprise a little bit this was 2 doses of antibiotics 2 doses of Prednisolone, she had it all over her head again and she did not know it was because of vaccine or not. Therapeutic measures were taken as a result of the events. The patient took an antibiotic called Clindamycin and Prednisolone 2 doses each for the events because events came back. The patient just went for ADC. The patient was still experiencing the event. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I was laying down on the sofa the second day of the vaccine when I was feeling and itch on my roght arm and a saw  a bump and a rash on my left arm. My lip was getting swellen. I took benadryl 100 mg and went to the hospital to the ER. Doctor evaluated me giving me pepcid and solumedrol and made CMP, urinalisis and a cbc. After a few hours bumps dissapered, and labs came normal. The same day I was discharged.
Edema Quincke's; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-NC20214076) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021.    This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA (Edema Quincke's) in a 53-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Aug-2021,  after starting mRNA-1273 (Spikevax), the patient experienced ANGIOEDEMA (Edema Quincke's) (seriousness criteria hospitalization and medically significant). At the time of the report, ANGIOEDEMA (Edema Quincke's) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient has a past medical history of HTA.  No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This case concerns a 53 year old female patient with medical history of HTA who experienced the unexpected event of angioedema. The event occurred on the same day after the first dose of the Moderna COVID-19 vaccine.. The rechallenge is not applicable as it is the first dose. The event is considered related to the product per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 53 year old female patient with medical history of HTA who experienced the unexpected event of angioedema. The event occurred on the same day after the first dose of the Moderna COVID-19 vaccine.. The rechallenge is not applicable as it is the first dose. The event is considered related to the product per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.
My feet and toes swelled with inflammation, formed into bunions on eah side of my foot?? even my toes and the bottom of my feet was really swollen I've been very careful of what shoes I wear.   Also my hands, thumbs and fingers swelled with inflamation (R. & L. hands) mostly in all in the fleshy part of my hands and knee and mostly all on the righ side of my body swelled. Two months later and THERE IS STILL SWELLING AND PAIN. I'M STILL DEALING WITH IT WITH MY ORTHOPAEDIC & G.P. DOCTOR'S.   It's as if the vaccine put my body in early arthritis mode and did'nt have any of those symtoms before the vaccine. I'm still going throught this month later.
70-year-old female with past medical history of hypertension presenting with feeling of swollen salivary glands and temporomandibular jaw pain after receiving the second dose of her Covid vaccine earlier this afternoon.  Patient states that 4 minutes after she received her Covid shot, she bent down to grab something inside her bag, and when she sat back up felt that her face was flushed, and felt swelling in her submandibular salivary glands as well as in her bilateral TMJ areas.  No rash, throat pain, voice changes, or oropharyngeal swelling.  No shortness of breath.  Symptoms improved after drinking water.  Exam overall reassuring.  Low suspicion for anaphylaxis.  Given ibuprofen for TMJ pain.  Recommended continued symptomatic management at home.  Stable for discharge home at this time.
Reporting per Moderna COVID-19 requirements  n/v/d abdominal pain, elevated white count: appendicitis
Headache Narrative: For 2 days after #1 dose pain at site, for 2 days after #2 dose pain fatigue headache
site pain, sore arm, fever, chills, fatigue, body aches, headache  Narrative: