chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 COVID-19 (1st dose) and MYALGIA in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 039D21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included GABAPENTIN and MELATONIN for an unknown indication.   On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced COVID-19 (1st dose). On an unknown date, the patient experienced MYALGIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (1st dose) and MYALGIA outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case concerns a 27-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 9 days after the first dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-370418 (Patient Link). This case concerns a 27-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 9 days after the first dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
A non-serious spontaneous report of received expired vaccine was received from a health professional concerning a 12-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2012. The patient received the expired FLUMIST on 30-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved. The reporter stated that the patient did not experience any late occurring adverse events.
08/26/22 presents to ED for "Fatigue, abnormal labs". PMHx of " hypertension, hyperlipidemia, sick sinus syndrome status post pacemaker, bladder cancer and CKD 3"
Moderna COVID-19 Vaccine EUA: Chills, fever, headache, muscle & joint pain, nausea, and fatigue. I was in bed the entire next day. I had been diagnosed with COVID-19 on November 13, 2020 and was in the hospital for 3 days.
Hives, redness, swelling to legs, left more severe than right, vomiting
Injection given 6/17/02 that evening noted redness 82x45mm. Hot and itchy. Took Benadryl. Next morning (06/18/02) redness measuring 120mmx80mm. Continues hot and itchy with pain and tenderness. Seen by Dr. Treated with Solumedrol 80mg. IM, Benadryl, and Prednisone (40mg PO decreasing to 10mg). Pt experienced complete recovery.
Information has been received from a physician concerning a male who was vaccinated in 2000 with a dose of varicella virus vaccine live. On 13-Oct-2003 the patient experienced breakthrough disease on both arms and the nape of his neck. No fever was noted. Unspecified medical attention was sought. There as no product quality complaint involved. Additional information has been requested.
Pt arm was red, swollen, and hot to the touch. Per pt, arm was in pain and also had body aches that did not improve with time or treatment with ice or MOTRIN. Pt was advised to continue to treat w/MOTRIN, ice, and also add on BENADRYL as well as see MD asap. Pt said she will see MD in the afternoon the day after.
After shot administered pt developed nodule in arm (R). No other reaction noted. Pt left coherent.
Severe skin reaction. We were told it was eczema but she never had it before the shots. She has severe outbreaks constantly. She is now 24 and still has reactions to everything.
9/7/23: Patient reports seeing a "wavy rainbow out of side of left eye". She closed her eyes for a few minutes and it subsided. 9/8/23: Patient reports feeling as if she was "moving through jello" as she went to stand up. She claims she did not experience any dizziness, but as if things were moving in slow motion. She laid down to nap and felt better when she got up. 9/12/23: Patient reports feeling as if she was "moving through jello in slow motion" again. She tried to get up but felt very unsteady, as if she didn't have real control of her legs. She felt better after some rest, and no episodes were felt after.
18 hours post injection I started with body aches and chills. No fever. Body aches continued for 12 hours. Tylenol and Advil taken with some help.  Headache continued off and on for a week.
Vaccination site warmth; Tiredness; Vaccination site rash; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), FATIGUE (Tiredness), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 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) (unknown route) UNK, CF. In 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), FATIGUE (Tiredness), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), FATIGUE (Tiredness), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            No concomitant and treatment medications were reported. It was reported that daily dose of Humira was citrate free. 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.
Could not raise arm higher than 2 inches - started about 5-6 hours after shot was administered. Pain has continued throughout this time period (as of 4/1/21 5pm) although range of motion has increased. Sometimes felt like pins and needles when muscle was used. Joint soreness intermittently in elbow and shoulder.  Ibuprofen every 4 hours was not enough to take the pain away.
Nausea; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 03Feb2021 at 10:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced nausea, headache and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, nausea and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
She got first dose and it hurt for 3 days/her arm hurts for 3 days after the 1st dose; She got first dose and it hurt for 3 days/her arm hurts for 3 days after the 1st dose; This is a spontaneous report from received from program. A contactable consumer, the patient, reported a female of unspecified age received COVID-19 immunisation with the first dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 05Feb2021 and the second dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 26Feb2021. There was no history, concomitant medications or past drug history reported. The patient inquired as to why the needle has to go that far into the muscle. The patient explained that she got her first dose and it hurt for three days. The patient commented that when she went for her second dose, they did not put it that deep in the muscle and it did not hurt much after second dose. The patient also inquired about a yearly booster for the vaccine. Treatment details, if any, were not reported. The outcome of the event got her first dose and it hurt for three days was recovered on 08Feb2021 and the outcome of the event did not hurt much after second dose was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
On 12/24/2021, I developed symptoms of sore throat, cough, fever, and achy muscles. The next day around 6 or 7 AM, I fell and dislocated my knee and was transported to the ER. When I got to the ER I had a fever of 102. I was tested for COVID and was positive. I was treated for my knee. I was transported to another hospital for my knee in the trauma center then was placed in the COVID unit for 2 weeks. I developed viral pneumonia and was treated. After 2 weeks after COVID, my blood work came back abnormal. My kidney functions were low right at the point of failure and magnesium levels were so low that I was put on supplements. I had diarrhea a week after supplements, which could have been from the supplements. Within a week my kidney functions went back to normal.
Initial report received from a health care provider on 14 October 2009.  A 42 year-old male patient was vaccinated with a first dose of IMOVAX (Sanofi Pasteur, Lot number unknown) on 16 September 2009 and reported headache, arthralgia (left elbow) and abdominal pain post vaccination.  The patient received the second dose of IMOVAX on 23 September 2009 and reported arthralgia (bilateral knee and left elbow) and abdominal pain post second vaccination.  On 07 October 2009 the patient was examined by a physician and had a "normal exam" as per the physician.  The patient was prescribed NAPROSYN, PROTONIX, LORTAB and Hyoscyamine for pain, which were not effective.  The patient reported no improvement on 14 October 2009 with continued bilateral knee pain, confusion and irritability.  The patient's physician decided not to administer the third dose of the pre-exposure series due to the patient's adverse events.  The outcomes of the events were not reported.  No further information is expected.
Abscess of deltoid muscle-incised & drained by MD 23MAY91-30cc drainage; Redness, swelling, inc temp;
Per Medical, Client c/o dizziness, headache, and chest pain. vitals taken. The pt. took self prescribed Nitro and requested transport. Client transported to hospital.
Information has been received from a practice manager concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patient experienced hives at the injection site. It was unknown whether the patient sought any medical attention. The outcome was unspecified. No further information is available.
Information has been received from a registered nurse concerning a 65 year old female patient with no pertinent medical history or drug reactions/allergies, who on an unspecified date was vaccinated with a dose of PNEUMOVAX. There was no concomitant medication. Within 1 and 1/2 hours of vaccination the patient was very lethargic, very dizzy and flushed. The PNEUMOVAX was given by an unspecified primary care physician. The nurse felt patient given BENADRYL was intervention to prevent serious criteria. The patient recovered the same day of vaccination, but later in the day. No laboratory diagnostics studies were performed. The patient sought medical attention (office visit). Very lethargic, very dizzy and flushed were considered to be disabling, immediately life-threatening and other important medical events. A lot check has been initiated. Additional information has been requested.
Rhabdomyolysis; This is a spontaneous report from a contactable pharmacist. This pharmacist reporting same events under the same suspect product for 3 patients. This is the first of three reports.  A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3180, expiry date: 16Sep2021), via an unspecified route of administration, administered in Deltoid Left on 15Sep2021 (at the age of 14-years-old) as dose 2, 0.3 ml single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3180, expiry date: 16Sep2021,) via an unspecified route of administration, administered in deltoid left on 14Aug2021 (at the age of 14-years-old) as dose 1, 0.3 ml single for covid-19 immunization. The pharmacist was calling about the Pfizer covid 19 vaccine and went out to a facility yesterday on 15Sep2021, gave second dose and experienced Rhabdomyolysis within 20 minutes of the vaccine. It was a mild case of rhabdomyolysis and the patient did not have to stay in the hospital. The patient went to the emergency room but was never admitted as a patient. This event happened with the patients second dose. This patient was not a foreign exchange student. The pharmacist wants to know if Pfizer has any information on this. No Serious was reported. The patient had her CPK levels checked yesterday, on 15Sep2021, but did not have the results listed yet. The outcome of the event was not recovered.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between event Rhabdomyolysis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58yo f developed sensation of enlarged cervical lymph  nodes 5/12/19, also mild inflamed throat, dizziness  and head cold sxs.
Chills, Fever, Muscular Aches and Pain, Coughing, Nausea, and Feeling Tired.
As occurred  when I got the 1st shot, I experienced 48 hours of a 102* fever, significant headache, chills, and severe whole body pain after the 2nd shot.  This began exactly 5 hours after receiving the shot.  I also had significant injection sight pain for 4 days.
This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and fever. On an unknown date, the outcome of the influenza-like symptoms, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Flu-like symptoms (body aches with temperature). This case has been linked with case US2018GSK106051, reported by the same reporter for same patient for the events experienced after receiving 2nd dose of SHINGRIX.
3JUL92 8AM eyes rolled back, trembling, stiff, curled up, not responsive to verbal stimuli lasted 30 seconds drooling @ mouth;nausea, tired, not feeling good, sz, vomiting, feeling bad, tonic clonic sz activity, post-ictal period;
headache plus side of neck (left side) very swollen and sore (got vaccine in right arm).  started night of 3/24 and much stronger this morning 3/25.
No rash reported, felt sick after injection for several months, many MD visits, many lab tests and many meds including antibiotics, and antihistamines.
Itchy rash. I went to a dermatologist and told me to take Allegra. Eventually the itchiness went down, but then the nerves in my fingers and in both hands began to swell and tingle. It was hard to move my fingers. There was pain and sensitivity. I am still experiencing these symptoms. I am going to multiple doctors to find out what is the cause of this. One doctor put me on Celebrex and another one put me on something else which name I can't remember but it helps with nerve pain. But neither of the medications helped me.
Narrative:  Hands and legs not working right, had terrible dreams, could barely make it to the bathroom, so weak he essentially fell onto the commode, vision was off
This is a spontaneous report from a non-contactable consumer via a nurse. A 59 (units not provided) female consumer received a single dose (0.5 ml) of PREVNAR 13, intramuscularly for immunization. Relevant medical history and concomitant medications were not provided. On an unspecified date post-vaccination, the patient experienced a swollen and painful injection site. Treatment was not provided. The patient recovered from the events on an unspecified date. The reporter noted a probable relationship between the event and PREVNAR 13. Follow-up (10MAY2012) Follow-up attempts completed. No further information expected.
pt exp 24hr of extreme irritability;onset was just a few hr p/vax;
Extreme discomfort in middle upper back and neck which seemed to wrap around to front of chest and caused anxious breathing.
Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient)  A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID).  The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days.  The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
2 hrs p/vax pt turned completely white & slept for 45 mins & woke w/t012; color returned to nl; upon waking;
COVID vaccine clinic for third dose held for residents at the HCF on 10/4/2021. Facility Director of Nursing took Public Health Staff around to resident's rooms to administer vaccine. Director of Nursing had already completed the paper forms ahead of time. This resident was inadvertently given a fourth dose of the pfizer covid vaccine and it wasn't discovered until entering the information into the immunization registry. No adverse effects reported at this time. Physician ARNP notified of incident.
pt recv vax; abrupt onset on truncal ataxia & arm tremor on 14may95; pt hosp for 2 days; spinal fluid nl; MRI of head nl; dx of viral cerebellitis;
Delayed period by 2 weeks. Fever of 102- 2 days Chills- 2 days Body Aches 2 days
The entire left side swelled up (shoulder down to hips). Remained swollen for 10 days.
Very swollen knee.   I thought this was a coincidence with with April 1st shot and April 30th shot but it happened with my booster.  I have gone to ortho doc, rheumatoid doc, family doc and had 100?s of cc?s of fluid removed from April to August as well as steroid shots and here I go again.   As soon as my knee is drained it fills right back up within two days - so swollen I can?t walk and causes great pain.
pt recv vax 20FEB98 & noted red splotches on forehead & immed notified MD;
[Pfizer COVID Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Acute hypoxic respiratory failure in setting of advanced IPF, with evidence of NSTEMI, pulmonary edema and pneumonia . Patient received vaccines on 1/26/2021,2/10/2021 , and 11/19/2021
This spontaneous report as received from a registered nurse refers to six patients (ages and genders not specified). The patient's concurrent conditions, medical histories and concomitant medication use were not provided. On an unspecified date one patient was vaccinated with M-M-R II, (lot # unknown, expiration date 25-MAY-2016). The nurse reported that this patient was vaccinated with an expired dose of M-M-R II. No adverse effect was reported. The nurse also reported that on 02-JUN-2016 three patients were vaccinated with expired doses of PROQUAD (lot # K023861, expiration date 25-MAY-2016). A fourth patient was vaccinated with an expired dose of PROQUAD (lot #K023861, expiration date 25-MAY-2016) on 14-JUN-2016 and a fifth patient was vaccinated with expired dose of PROQUAD (lot #K023861, expiration date 25-MAY-2016) on 30-JUN-2016. No adverse effects were reported. The outcome of the expired products administered was unknown. Additional information has been requested.
Tinnitus in both ears onset approximately two hours after vaccination. Treated with 30mg prednisone for 10 days and symptoms did not resolve.
I very quickly started having neurological symptoms. Profound weakness; I dropped my 7 pound newborn. This became progressivly focal and eventually lead me to go to the emergency room.
R eye flashes then became fuzzy on 11/25 at 11:00pm2/3 Shingles L side ofbody(5am) prior to 2nd vaccine shot on 2/3 7:30am Narrative:   Other Relevant History: