chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(injection administered intramuscularly in upper left arm) Left side of lower lip affected with Herpes breakout - grew to size of quarter - down on face w/blisters, etc. (Residue still remains) 1 1/2 hrs after vac. had episode of extremely Hi B/P - lite headed, faint.
SWELLING, WARMTH, TENDERESS AT INJECTION , UNAGLE TO RAISE THE AFFECTED ARM Narrative
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Started aching and that it was painful), MYALGIA (Soreness/started aching) and FATIGUE (Tiredness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Amlodipine Besylate; Buspirone HCL; Paroxetine HCL for an unknown indication. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PAIN (Started aching and that it was painful), MYALGIA (Soreness/started aching) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Started aching and that it was painful), MYALGIA (Soreness/started aching) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included AZATHIOPRINE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK CF. In 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            No medical history was reported by the reporter.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
My first affects hit me 2 hours and 15 minutes after the vaccine. It was like 3 days of bad flu compressed into 6 hours-high fever, body aches that were unbearable, and terrible chills. After 6 hours it was gone. I was weak from those affects for one day afterwards. The next day I was perfectly fine. I got my second dose today-04/03/2021-and have had no side effects. My arm doesn't even hurt.
Severe chills and fatigue, headache began about 12 hours after the injection.  Chills and fatigue lessened after 48 hours but continued daily for two weeks.  Chills continued for two months, several times per week until May 2021 when it stopped.  Then I began experiencing chills again in the first 2 weeks of July, when I made an appointment with my primary care physician.  Chills have recurred almost daily beginning September 5 to present.
Injection site pain, dizziness, fatigue, mental confusion, problems discerning reality, pain in left arm pit which is spreading to left shoulder muscles
This spontaneous case was reported by a patient and describes the occurrence of MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp) and STOMATITIS (Sores in her mouth) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma, Dust allergy and Allergy NOS (General allergies).    On 10-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Sep-2022, the patient experienced MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp), STOMATITIS (Sores in her mouth) and ORAL PIGMENTATION (Her mouth got all white.). At the time of the report, MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp), STOMATITIS (Sores in her mouth) and ORAL PIGMENTATION (Her mouth got all white.) had resolved.              No treatment medications were reported.
No adverse event; Bivalent booster vaccine administered instead of Monovalent booster; Bivalent booster vaccine administered to 17 year old patient instead of Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent) and NO ADVERSE EVENT (No adverse event) in a 17-year-old female patient 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.    In September 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. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent).    No concomitant medication was reported.   Pharmacist reported that 17 year old patient received a Bivalent Moderna COVID-19 vaccine about 1 week ago from the day of reporting instead of the Monovalent booster and stated that all previous doses of COVID-19 vaccine for this patient were Moderna.  Reporter did not remember if it was the patients first booster or 2nd booster.  No treatment medication was reported.
Pain to left underside of arm, travels from armpit down left wrist, centralizes in elbow, difficulty moving left arm above head, feels like pulling sensation. Pt. tried warm compresses, showers, exercises, motrin all started on Sunday 2/7/21 with some relief. Pt. states that she has been taking one dose of motrin ever since with some relief. Pt. denies numbness and tingling in fingers.
Booster; developed fever after receiving the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Lot number: 30135BA, Expiration Date: 28Feb2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "unknown", described as "developed fever after receiving the Pfizer COVID-19 vaccine".  Additional information: Caller wants to clarify if the lot number reflected on his vaccination card for his booster dose which has different format as compared to his first and second dose of the Pfizer Covid-19 vaccine. He would like to know if the booster dose he got was not fake and he want to verify if the lot number of his booster dose is authentic or not. And in response It was confirmed that the lot number 30135BA was authentic
She has experienced hair loss after she took the third vaccination. She noticed it a few months after; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (She has experienced hair loss after she took the third vaccination. She noticed it a few months after) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 006B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Barrett's oesophagus (diagnosed with Barrette's esophagus 7 months ago). Concurrent medical conditions included Penicillin allergy (Allergy to Penicillin,( all -cillin's)).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-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 experienced ALOPECIA (She has experienced hair loss after she took the third vaccination. She noticed it a few months after). At the time of the report, ALOPECIA (She has experienced hair loss after she took the third vaccination. She noticed it a few months after) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested positive for COVID-19: Never.         No concomitant information was provided.  Patient  has experienced hair loss after the third vaccination. Patient noticed it after a few months. Patient did mention it to the nurse practitioner. when Patient went to the doctors and the nurse said the the vaccine is causing some people to lose their hair. Nurse did not specify which COVID-19 vaccination. It was  reported in case MOD22-010200. The reporter does not know if this is from the Moderna shot and should go for dermatologist consultation patient mentioned.  No treatment information was provided.
Day 1-Patient had injection site reaction, with arm swelling (size of a tennis ball) when she woke from a nap , hot to touch and pain.   Day 2(07/18) the swelling was less at injection site but redness spread from deltoid to forearm.   Day 3 (07/19) Redness/ swelling subsided in upper arm but moved down to /worsening around elbow thru' the forearm -all the way down to the wrist. Pain better but still tender.  Day 4(07/20) -"not getting worse, redness / swelling from forearm to wrist started to resolve.  Day 5 (07/21) Swelling/ Redness significantly better. 70% of symptoms improved.  Day 7 (07/23) Swelling/pain/redness is gone.   Pharmacy followed up with family daily and recommended support treatment-- and daughter continued to apply ice, massage, moving of extremities and gave ibuprofen.
A contactable consumer reporting on behalf of her mother reported that a 82-year-old female patient received PREVNAR 13 on 21Dec2015, in right arm, at single dose. Medical history included heart problem. The patient concomitant medications were not reported. the patient experienced immobile right arm on 21Dec2015 with outcome of not recovered, could not move her arm past her head on 21Dec2015 with outcome of not recovered, she occasionally had spasms on an unspecified date with outcome of unknown, swollen arm on 21Dec2015 with outcome of not recovered, muscle contraction on an  unspecified date with outcome of not recovered, did not have any feeling in her right arm on an unspecified date with outcome of unknown, she could not use her right arm since then on 21Dec2015 with outcome of not recovered. She was still having pain at injection site since 21Dec2015. Treatment received included BENADRYL 75 mg  tablet, steroids, pain medications, muscle relaxers. the pain medication and muscle relaxers were not doing any good. Some fluid was withdrawn twice out of the big knot (swelled part) but did not find any bacteria in that. the patient went back to the doctor who gave the vaccine. She had also been to the orthopaedic doctor and cardiologist.
1 Week after vaccination patient developed fever, a macular rash and conjunctivitis. Patient also has a concurrent Otitis Media with perforation.
Pt received flu shot on 10-9-19. Reported sore arm as of 12-22-19
pt recvd vax & exp inc in the severity & frequency of migraine h/a; pt treated fever w/APAP; had no liver enlargement or jaundice; No further details were provided;
Came to the hospital for outpatient laparoscopic surgery. Became hypoxic post-op and required re-intubation. Developed ARDS and repeat COVID test  on 11/10/2021 was positive. Patient was accepted for ECMO at another hospital and was transferred 11/10/2022.
Patient is an 87 year old  male with a history of Atrial Fibrillation/LBBB, CAD, HFrEF, Alzheimer's Dementia, who presented to hospital 8/24/23 with shortness of breath and new onset fatigue. Found to be hypoxic with fever per EMS with COVID-19 testing positive in the ED.    1. Acute Hypoxemic Respiratory Failure: Reported per EMS, 70% on RA but unclear if accurate. CXR in ED with densities noted in lung bases with bilateral pleural effusions. Goal sat to keep greater than 92%, currently on supplemental Oxygen since morning of 8/25/23. Restarted decadron, promote IS, wean as able. 2. COVID-19 infection: COVID-19 positive in ED 8/24/23. Symptoms of dyspnea, cough, fevers. Initially deemed hypoxic by EMS but no re  . Initially deemed hypoxic by EMS but no requirement on admission. Decadron initiated X10 days. Evaluated by ID, deemed a candidate for Remdesivir and so ordered, started 8/26/23.  3. Age related debility: PT/OT followed, noted reduced mobility with recommendations for rollator walker at discharge. 4. Chronic HFrEF: Known history with ischemic Cardiomyopathy. LHC with LV gram Nov 2021 noted EF 20-25% with severe diffuse hypokinesia of the LV. CXR in ED with pleural effusions noted similar to May 2023. Other than this, he clinically appeared dry on admission. NT Pro BNP 5501. Betablocker continued with hold parameters. ARB and diuretics at discharge. 5. Atrial Fibrillation: per history. CHA2DS2-VASc (5). Continued home Eliquis and Betablocker/ 6. CAD: Extensive ASCVD with history of CABG and prior intervention to RCA. Home ASA, statin, Betablocker and Eliquis continued.  7. LBBB: Known history  of this, ECG on admission re-demonstrated.  8. Primary Hypertension: per history, home meds at discharge. 9. Alzheimer's Dementia: per history. A/Ox2 on admission. Continued home meds.  10. Seizure Disorder: per history, continued home meds.  11. Code status: DNR CC per son's request, but continue current level of care.
Pt. experienced facial droop next day or night after first COVID shot. Pt. Had right face weakness, could not close right ee or wrinkle right side of forehead. Pt. was treated  with prednisone 20 mg bid for 7 days, and tylenol 325 mg bid for 5 days; was wearing eye patch. Had same symptoms when was seen by this writer on 5/21 Pt. was transferred to another facility on 6/30/21.
she had the first dose 22JUN2021 /The caller would like to know if she could get the second dose; Hurt a lot/really bad; Didn't sleep for two days because it (rash) hurt so bad; Rash all over body except face; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt a lot/really bad), INSOMNIA (Didn't sleep for two days because it (rash) hurt so bad), RASH (Rash all over body except face) and PRODUCT DOSE OMISSION ISSUE (she had the first dose 22JUN2021 /The caller would like to know if she could get the second dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002546) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced PAIN (Hurt a lot/really bad), INSOMNIA (Didn't sleep for two days because it (rash) hurt so bad) and RASH (Rash all over body except face). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she had the first dose 22JUN2021 /The caller would like to know if she could get the second dose). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALTIFEX) in July 2021 for Rash, at an unspecified dose and frequency. At the time of the report, PAIN (Hurt a lot/really bad) and INSOMNIA (Didn't sleep for two days because it (rash) hurt so bad) outcome was unknown, RASH (Rash all over body except face) had not resolved and PRODUCT DOSE OMISSION ISSUE (she had the first dose 22JUN2021 /The caller would like to know if she could get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The caller would like to know if she could get the second dose. Concomitant product use included Birth Control Pills.
Information has been received from the mother of a 17 month old male who on approximately 07/17/2001 was vaccinated with varicella vaccine. On 11/21/2001, the pt's mother thought her son had a "zit" on his back. It was red, dark and crusted. then a dot appeared behind the pt's right arm. Within 24 hrs, the pt had 8-10 vesicular cluster like groupings on his right arm. The pediatrician indicated that the vesicular groupings could be impetigo but it looked like herpes zoster. Additional info has been requested.
"covid arm", itchy localized rash around injection site that began a couple of days ago.   Also noted elevated heart rate and mild flushing the day of the vaccine, appx 10 minutes after injection.  Symptoms quickly cleared.
Muscle pain in shoulders and neck, worsened; Joint pain in shoulders and neck, worsened; Typical pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, 72 hrs after receiving Shingrix, the patient experienced pain. On an unknown date, the patient experienced muscle pain and arthralgia multiple. On an unknown date, the outcome of the pain, muscle pain and arthralgia multiple were not recovered/not resolved.   It was unknown if the reporter considered the pain, muscle pain and arthralgia multiple to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient had his/her Shingrix vaccine and encountered typical pain and some manageable other side effects for about 72 hours after. However, muscle and joint pain in his/her shoulders and neck had continued and even worsened during since the last two weeks. The patient asked if side effects continue one month later, if it was normal.
sore arm more than before with previous doses/arms were sore (more than with previous doses)/sore arm; sore arm; felt tired; The mother called and said that her kids were overdosed with Pfizer covid 19 Bivalent last 28Oct which was not diluted; The mother called and said that her kids were overdosed with Pfizer covid 19 Bivalent last 28Oct which was not diluted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  An 8-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (orange cap; booster), single (Batch/Lot number: unknown) at the age of 8 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (Dose 3; MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "The mother called and said that her kids were overdosed with Pfizer covid 19 Bivalent last 28Oct which was not diluted"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "sore arm more than before with previous doses/arms were sore (more than with previous doses)/sore arm"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm"; FATIGUE (non-serious), outcome "not recovered", described as "felt tired". Additional information: The patient's mother reported that two of her kids received the Covid 19 orange cap Bivalent booster on 28Oct2022, it was not diluted. The kids had a sore arm more than before with previous doses and felt tired. It has seen on the news that this happened to other kids. The mother was wondering why Pfizer is not doing the single dose of the vial already diluted. She wanted to make sure her kids have no adverse effect from that. The HCP told her that it should be fine; just more reactogenicity. They got in touch with the CDC.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300442 same reporter, events and suspect product; different patient;
Swelling of lower face and lips. Numbness in same location as swelling. Difficulty swallowing. Discomfort
Increase in episodes of bradycardia and desaturations. Recovered within 12 hours. Pre vaccination/bronch OA's, 1B, 1D, immediate post 1A, 6B and D; post 0 As, Bs, Ds (A-Apnea, B-Bradycardia, D-desats)