chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my first vaccine my menstrual lasted 10 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 15:00 (Lot number: FC3184) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing); "Cesarean section", start date: 20Feb2003 (unspecified if ongoing), notes: Illness/AE: Cesarean section, Onset date: 27Sep2005, Onset date: 28Feb2007, Onset date: 15Nov2014. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID], start date: 2019 (ongoing); B 12, start date: 2021 (ongoing). The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 23Dec2021, outcome "unknown", described as "After my first vaccine my menstrual lasted 10 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding.  Additional Information: The patient concomitant medication also include Women multivitamin start from 2019, Route: P.O (Per Oral), ongoing. The patient family medication history relevant to AE(s) includeds: Mom: blood pressure, High cholesterol. Dad: heart disease. The patient did not have other vaccine in four weeks. The patient has covid prior to vaccination. The patient was not tested post vaccination. The patient does not have known allergies. The patient consider the Pfizer product had a causal effect to the adverse event.     No follow-up attempts are possible. No further information is expected.
dose_number=3; Fatigue; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 05Dec2021 (Batch/Lot number: unknown) 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, prev_dose_brand=Pfizer), for Covid-19 immunization; Bnt162b2 (prev_dose_brand=Pfizer, Dose:2), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "dose_number=3"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches". It was unknown if therapeutic measures were taken as a result of fatigue, headache, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; inadvertently administered an expired dose of the bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (1st dose, batch ; 025J20-2A) on 05-Jan-2021, MODERNA COVID-19 VACCINE (2nd dose, batch ; 011M20A) on 02-Feb-2021, MODERNA COVID-19 VACCINE (3rd dose, batch ; 007C21A, route: Intramuscular) on 02-Sep-2021, MODERNA COVID-19 VACCINE (4th dose, batch ; 033K21-2A and route: Intramuscular) on 11-Apr-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 25-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 25-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of the bivalent vaccine).    It was reported that there was no record of patient's medical history.    No concomitant medication was reported. The patient did not had any AE after the administration. No treatment medication was reported.
Vomiting Diarrhea Chills Fever - 101 from 1700 - 0300
inj site became red, hard also c/o fever, chills, stiffness in arm;
This spontaneous report was received from a pharmacist, and refers to a 60 year old non pregnant, female patient with hypertension. The patient had no known drug reactions or allergies. On 01-OCT-2016, the patient was vaccinated subcutaneously with ZOSTAVAX in the deltoid region of the right arm, lot # M001746 with expiration date of 07-APR-2017 (dose and frequency were not reported). Concomitant therapies included PRINIVIL. On 03-OCT-2016, the patient stated that her injection site was itchy. Additionally, the reporting pharmacist stated that the injection site was "swollen and larger than a golf ball" and the injection area was bumpy, "like a rash". However, the reporter was unable to state with certainty whether or not the patient appeared to have a zoster-like rash. Therefore, the patient stated she was planning to consult with her healthcare provider for treatment recommendations. At the time of reporting, the outcome of the events and their relatedness with the suspect therapy were unknown. Additional information is not expected as the reporter did not allow to be contacted.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-May-2021 contains no significant information.
1 of 3 pts recvd vax via lederject from the same lot which resulted in inj site rxn w/in 24 hrs rxn consisted of erythema, swelling, pruritus & pain from shoulder to elbow requiring MD visit;treated w/Atarax
Raised red rash all the way down to her elbow on same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Raised red rash all the way down to her elbow on same arm of injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Raised red rash all the way down to her elbow on same arm of injection). At the time of the report, RASH ERYTHEMATOUS (Raised red rash all the way down to her elbow on same arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
INHIBITORY DRUG INTERACTION; PSORIATIC ARTHRITIS AGGRAVATED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination, and psoriatic arthritis. The batch number was not reported. Per procedure, no follow up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported for psoriatic arthritis. Concomitant medications included prednisone. On an unspecified date, the patient experienced inhibitory drug interaction, and psoriatic arthritis aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was increased. The outcome of the inhibitory drug interaction and psoriatic arthritis aggravated was not reported. This report was non-serious.
Narrative: Vaccinated x 2 patient presented to the hospital for pain in L shoulder thought to be osteomyelitis, incidentally found to be COVID positive. Hx of prior COVID infection in 2020.
w'/in 30min of vax pt w/rash on torso-front & back starting from inj site & travelling upwards;rash thick & coarse;parent took pt to MD & was told rash not d/t vax;
Fever that lasted for roughly 24 hours  Headache that lasted for 3 days  Nauseous for a week Low energy for a week
Seizure. Stopped talking and walking. Started high pitched screaming within hours of immunization.  He was later diagnosed with severe autism and chianti malformation when a brain scan previously did not show chiari. He tested at 24 months the day of vaccination, he was 15 months old at the time.
Headache; nausea; vomiting; body aches; red mark appeared around injection site 3 days after being injected.; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches) and INJECTION SITE ERYTHEMA (red mark appeared around injection site 3 days after being injected.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches) and INJECTION SITE ERYTHEMA (red mark appeared around injection site 3 days after being injected.). At the time of the report, HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches) and INJECTION SITE ERYTHEMA (red mark appeared around injection site 3 days after being injected.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Fever, increased pain at injection site, general malaise in the evening on 08/15. Came back to hospital the evening of 08/16 with a temp of 40.1. He was given IV fluids, antibiotics (clindamycin and vancomycin) and received a CT scan of his right arm to rule out a necrotizing skin infection.
Headache, Arthralgia, severe fatigue, severe headache, left arm pain, pain in left trunk, axilla and nexk Narrative:
Nursing staff at patient's long term care facility was unaware that client had previously received a complete series of Pfizer monovalent vaccine back in 2021. Moderna monovalent dose administered today, 12/8/2022, to client to start her series. Database revealed that client completed a full series and should not have received the Moderna monovalent vaccine today. Nursing home notified that patient should not receive the bivalent booster for 2 months. No adverse events reported from client or nursing staff.
1116 pt c/o of numbness in lips and tongue, pt denies SOB, difficulty swallowing, swelling in throat, dizziness, itching or HA, assessment of pt revealed no swelling of the face, mouth, or extremities, no presence of rash or hives, no facial drooping noted, per protocol 25mg oral Benadryl administered 1125 Pt assessed, pt states no change in c/o, pt denies new onset of symptoms, 25 mg oral Benadryl administered 1130 Pt states she is able to feel parts of her lips and the tip of her tongue, POC continue to monitor patient for 15 minutes 1145 pt reports improvement of symptoms, per pt she is able to feel her lips and tongue, pt denies new onset of symptoms, pt informed to monitor for any change in symptoms at home, follow-up with her PCP recommended, ER precautions provided, pt verbalized understanding 1150 pt left vaccination site with  no signs of distress and no c/o
PATIENT CAME IN ON 10/23/20 WITH REDNESS AND SIGNIFICANT SWELLING FROM SHOULDER DOWN TO ELBOW, AND PAIN. HE WAS REFERRED TO URGENT CARE
their immune system was off track; get sick all the time; their immune system was off track; get sick all the time; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "their immune system was off track; get sick all the time".  Additional information: The reporter was speaking to a doctor and the doctor made a statement in regard to the COVID vaccine. The doctor didn't specify if she was referring to Pfizer's Johnson and Johnson's or Moderna's vaccine. The doctor just made a brief comment. Again, The reporter states she does not know which manufacturer the reporter was referring to. The doctor mentioned the COVID vaccine and said she had three patients who had a bad immune system, she finally got the patients on track and states after the patients got their shot, their immune system was off track. The reporter asked the doctor if she reported this in VAERS or with Pfizer if it's Pfizer's vaccine, and the doctor didn't respond. The reporter asked the doctor which of the three manufacturers she was referring to and the doctor didn't clarify between the three manufacturers. The doctor only said the patients got off track and get sick all the time. The reporter mentions the patients did have comorbidities, but the reporter did not ask for any patient details. She believes that is a HIPAA violation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200402704 Same product and event, different patient;US-PFIZER INC-202200402705 Same product and event, different patient
swollen lymph node above left clavicle- no pain   Denies any other symptoms- fever, chills, body aches, headaches
Report adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Report adverse event) 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 VACCINATION COMPLICATION (Report adverse event). At the time of the report, VACCINATION COMPLICATION (Report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided
Pt recvd 2-1cc injects of Recombivax 21NOV90 & 1JAN91; 23MAY91 recvd Engerix-B; pt "did not develop immunity";
Rash developed at injection site (left arm) ONE WEEK following vaccine injection, with some itching. Rash approximately 3 cm in diameter.
Patient reported generalized urticaria and b/l orbital swelling >24 hours after 1st dose, no systemic effects. Seen by allergist and cleared to receive 2nd dose, advised to take cetirizine 10 mg twice daily starting 2/3.  Received vaccination under close observation by clinic staff, reported about 10-15 minutes later the following symptoms: foggy/spacey, itchy (tongue, oral mucosa, posterior pharyngeal), increased saliva output, throat clearing, new globus sensation, & bilateral tingling. RN administered epinephrine 0.3 mg IM x 1 dose, IV line w/ normal saline @ 125 mL/hr, EMS called and patient transported to ED for further observation.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:06 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:06 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 02-Apr-2022 at 10:06:18.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Patient tested positive for Covid-19 on 1/12/2022, was transferred to hospice facility with diagnosis of HTN, Hyperlipidemia, Scoliosis, GERD, Hx of femur fracture, overactive bladder, chronic pain, and Covid.  Patient expired on 1/24/2022.
This spontaneous report as received from a nurse refers to a 5 year old female patient. On 19-AUG-2013 the patient was vaccinated with PROQUAD (lot # J002304, exp 22-AUG-2014). On 20-AUG-2013, the patient experienced local reactions, large, swollen, red area, about size of an egg on the thigh after receiving PROQUAD. Patient was seen in the office on 21-AUG-2013 and received BENADRYL 25 mg as treatment. The outcome of the adverse event was unknown. Additional information has been requested.
A taste in my mouth you wouldn't believe, affected my taste; Parosmia, a rancid smelling aftermath of COVID-19, affected my smell; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (A taste in my mouth you wouldn't believe, affected my taste) and PAROSMIA (Parosmia, a rancid smelling aftermath of COVID-19, affected my smell) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included POTASSIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced TASTE DISORDER (A taste in my mouth you wouldn't believe, affected my taste) and PAROSMIA (Parosmia, a rancid smelling aftermath of COVID-19, affected my smell). The patient was treated with CALCIUM LEVOMEFOLATE (METHYL FOLATE) at an unspecified dose and frequency and THIOCTIC ACID (ALPHA LIPOIC SUSTAIN) at an unspecified dose and frequency. At the time of the report, TASTE DISORDER (A taste in my mouth you wouldn't believe, affected my taste) and PAROSMIA (Parosmia, a rancid smelling aftermath of COVID-19, affected my smell) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication included unspecified medications for hypertension and cholesterol.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-JUN-2021. TCR received: all the events updated to not recovered.
2/10/21: sore arm, body aches, nausea, fatigue, chills, fever (100.5) and headache.  2/11/21: sore arm, headache (mild)
One day after getting the vaccine, I started to develop hives on my abdomen. Within a few hours of this happening, the hives continued to spread to my upper torso and arms. A colleague prescribed me a medrol pack and Benadryl but even with multiple doses, the hives would come and go consistently. The next morning, on 1/7/2021, I went to the urgent care and received a solu medrol injection to more aggressively treat my issue. I was also recommended Zyrtec daily for the next two weeks.
Injection site reaction: Warm to the touch Red circle (rash) 2 1/1 inch diamter Slight swelling Bruise                   Ongoing and getting worse at 12th day after injection
- Blurred vision  - Viral illness  - Acute non intractable tension-type headache
Gradually enlarging area of erythema, induration, warmth & tenderness at injection site.
11/24/14 345 throat pressure, pain, hoarse voice, painful red eyes, nasal congestion, cracking ears. 445 increased above sx; 830 PM seen by urgicare MD. Sx; decreased.
Vaccine administered 8/15/14 - Friday evening patient noted: fever 102 degrees F, weakness, nausea, dizziness, chills/sweats, shortness of breath, loss of appetite. Redness and swelling on arm with lymph nodes under arm and neck. All symptoms except swelling ceased by Sunday 8/17/14 evening.
15 min after receiving vaccine felt "a wave" move up through my body to my head like a bubble rising and exploding; lasted less than 10 seconds with no other episodes - ended as abruptly as it started.
Large rash left deltoid area still present. Much itching.  4x6 inches.
Temp to 101, headache and eye pain.  Then vomiting, body pain, redness and swelling at site of vaccine on left arm.  Seen at Urgent Care 12/22.  No treatment.  Seen Wed 12/23 with temp 100.1 incr warmth/redness on left arm same side as vaccine site.  Also swelling, pain, and warmth in RIGHT hand, and more body aches/pain.