chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He came down with COVID Disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He came down with COVID Disease) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, 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. In February 2023, the patient experienced COVID-19 (He came down with COVID Disease). At the time of the report, COVID-19 (He came down with COVID Disease) 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 medications was reported. It was reported that the 64-year-old retired lab worker received 3 Moderna Covid-19 vaccine in 2021 and 4th dose on 1-Dec-2022. She stated that her boyfriend who was the patient also received the same shots as her at the same place. Caller was not 100% sure that he had the Moderna COVID-19 Vaccine. She states that he probably did have Moderna because he was vaccinated at the same time as her. Since 2 weeks ago he has been having fatigue, he is lethargic and has diarrhea. No treatment drug details was reported.
Feels dizzy; Extreme fatigue; Nausea; Diarrhea; Headache on right side of head; Fatigue; Injection arm developed soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feels dizzy), PAIN IN EXTREMITY (Injection arm developed soreness), DIARRHEA (Diarrhea), HEADACHE (Headache on right side of head) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Injection arm developed soreness) and FATIGUE (Fatigue). On 14-Mar-2021, the patient experienced DIARRHEA (Diarrhea), HEADACHE (Headache on right side of head) and NAUSEA (Nausea). On 18-Mar-2021, the patient experienced DIZZINESS (Feels dizzy) and FATIGUE (Extreme fatigue). In March 2021, PAIN IN EXTREMITY (Injection arm developed soreness), DIARRHEA (Diarrhea), HEADACHE (Headache on right side of head), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, DIZZINESS (Feels dizzy) and FATIGUE (Extreme fatigue) outcome was unknown.            Concomitant product used was reported as glaucoma eye drops NOS Treatment information was not provided by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-049766 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049766:crosslink
Began with heavy feeling in limbs, progressed to painful joints and muscle weakness. Extreme fatigue, headache, and fever and chills throughout the day 3/7. Woke up feeling better on 3/8.
mom reports high pitched crying greater than 3 to 4hrs p/1st tetramune;
Headache severe Headache and chills x 2 days Narrative:  Other Relevant History:
Dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter confirmed that patient reported no adverse events. No treatment details were reported.
Patient tested Positive for COVID 19 by PCR on 4/17/21.  Had received 2nd Pfizer dose on 3/19/21. Patient admitted to hospital due to fall, tested for COVID d/t hospital admission. Patient admitted to non-productive cough for approximately 1 month but denied other COVID symptoms. Did receive monoclonal antibody infusion on 4/22/21.
Patient who is 10 years old received Pfizer Bivalent Booster (12 and up). Nurse verified the correct patient, D.O.B, and primary series was completed but did not realize patient was 10 years old by D.O.B. Spoke with parents notifying them about the incorrect vaccine being administered to the child. Parents stated child was experiencing no symptoms.
pt recv vax 2APR97 & the same day pt devel a swollen, red area 1.5 inch x 1.5 inch @ the site of inj;by 6APR97 pt recovered;
Patient developed a full body rash after waiting the first 15 minutes after injections. Patient mother states that patient developed the  rash after the injections were given after about 10 minutes. Patient waited an additional 15 minutes, total of 30mintes, and rash did not worsen. Patient was sent home and advise to keep an eye on the rash.
6 days after vaccination, upper arm became hot, red, itchy, tender, with raised edges.  Tentative diagnosis on day 7 was cellulitis.  Prescribed Clindamycin 300 mg 4 x daily for 10 days.  (Occurred when earlier [within 1 day after vaccination] reaction of a hardened area under the skin and sharp pain upon using that muscle in the immediate vaccination area had nearly dissipated.)
On 16Nov2021 and in Jul2022 patient had COVID twice.; On 16Nov2021 and in Jul2022 patient had COVID twice.; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4512552-00 (Agency).  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1160069), oral for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Nov2021, outcome "recovered" and all described as "On 16Nov2021 and in Jul2022 patient had COVID twice.". The patient underwent the following laboratory tests and procedures: COVID-19: (16Nov2021) positive, notes: On 16Nov2021 and in Jul2022 patient had COVID twice; Magnetic resonance imaging neck: (16Nov2021) ??-MAR-2022, notes: Disc damage. The action taken for upadacitinib was unknown.  Clinical course: Solicited report from a consumer of a 34-year-old female with events of non-serious pain, two bulging discs in neck/cervical spine, COVID and magnetic resonance imaging showed disc damage with Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced pain, two bulging discs in neck/cervical spine and magnetic resonance imaging showed disc damage. On 16Nov2021, the patient experienced COVID. In Jul2022, the patient experienced COVID. On an unknown date, COVID resolved. Pfizer BioNTech COVID-19 VACCINE (Tozinameran) was also considered suspect. On 16Nov2021 and in Jul2022 patient had COVID twice. She was feeling pain. She had two bulging discs in her neck and cervical spine. In Jan2022 She had started physical therapy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq (Upadacitinib) provided as the reporter's causality for the event(s) of pain, two bulging discs in neck/cervical spine, COVID onset 16Nov2021, COVID onset in Jul2022 and magnetic resonance imaging showed disc damage was not provided. Drug pfizer bioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), unknown daily dose booster (1 in 1 Once). Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "on 16nov2021 and in jul2022 patient had covid twice." related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
A nurse reported that a 34 year old male now 36 years of age, received an injection of Flu Shield '99-'00 formula, in 10/99. Approx. 1 week later, he was dx'd with Guillain-Barre Syndrome. The pt was hospitalized and recovered. No further information was available at the date of this report. This report of a serious, labeled event is being submitted in a 15 day time frame.
Looks like sprain in my right arm; Thursday my left arm started kind of itching a little bit/it was like couple of bumps/last night it felt kind of itchy little bit and then this morning could see there is tiny bumps; Thursday my left arm started kind of itching a little bit/it was like couple of bumps/last night it felt kind of itchy little bit and then this morning could see there is tiny bumps; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination 37-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left at three weeks before the second one, on unknown date in Mar2021 (Batch/Lot number was not reported) (age at vaccination 37-year-old) as dose 1, single for covid-19 immunisation. The patient was like a little bit over weekend, a couple of days before that. The patient experienced thursday her left arm started kind of itching a little bit/it was like couple of bumps/last night she thought was like all over her body it felt kind of itchy little bit and then this morning could see there was tiny bumps, It's not over her face but it's all over everywhere on her body on 20Apr2021 and looks like sprain in her right arm on 22Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of thursday my left arm started kind of itching a little bit/it was like couple of bumps/last night i thought was like all over my body it felt kind of itchy little bit and then this morning could see there is tiny bumps included some antihistamine foam in case of Benadryl after better. The outcome of the event looks like sprain in my right arm was unknown and other event recovered on Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
have the flu now and it's horrible; Initial information received on 02-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced have the flu now and it's horrible after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious have the flu now and it's horrible (influenza) (unknown latency) following the administration of influenza vaccine. Nothing like the flu we used to get.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
After administration of vaccine, we were notified that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  As of this report, the patient has not come back for revaccination.  She declined revaccination when contacted by the nurse from our clinic.
Pt received immunization of polio (IPV) and Pediarix on same date; should have received Prevnar instead of polio; no adverse affects known.
Mother reports 24 hrs after injection right thigh (Dtap). Noted redness and red rash 4-5 inches from site. Noted swelling upper thigh from knee to groin. No warmth c/o itching and soreness. Benadryl and Tylenol. No previous reaction to any vaccine. Not seen by MD 5/10/06 no swelling or redness per mom.
sore left arm after the second Moderna Covid-19 vaccine; headache after her second Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm after the second Moderna Covid-19 vaccine) and HEADACHE (headache after her second Moderna Covid-19 vaccine.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced VACCINATION SITE PAIN (sore left arm after the second Moderna Covid-19 vaccine) and HEADACHE (headache after her second Moderna Covid-19 vaccine.). At the time of the report, VACCINATION SITE PAIN (sore left arm after the second Moderna Covid-19 vaccine) and HEADACHE (headache after her second Moderna Covid-19 vaccine.) outcome was unknown.            No Concomitant medication were reported.  The patient received her second Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle.  No treatment medication were reported.   This case was linked to MOD-2022-482637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up document received contains no new information
memory loss; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced AMNESIA (memory loss). At the time of the report, AMNESIA (memory loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Little bit of dizziness; Sleeping during the day; Extreme Fatigue / really tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Little bit of dizziness), HYPERSOMNIA (Sleeping during the day), FATIGUE (Extreme Fatigue / really tired) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Little bit of dizziness), HYPERSOMNIA (Sleeping during the day), FATIGUE (Extreme Fatigue / really tired) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Little bit of dizziness), HYPERSOMNIA (Sleeping during the day), FATIGUE (Extreme Fatigue / really tired) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-032452 (Patient Link).
Acute shock and syncope. Pale and diaphoretic, low BP. Resolved after about 10 min with lying flat with feet elevated.
pt was given/reviewed and verified questinaire prior to getting the vaccine.   after administration about 2-3 mins after stated was filling a little dizzy.  we assisted patient,  provided her with necessary aid,  patient  was asked if she wanted paramedic, she denied any heart issues, denied wanting paramedic or ambulance. stated was just dizzy. upon further investigation from her company she was not eaten anyting today.  pt after given orange juice and something to eat was fine and left.  we asked if anything else we can do, she said no that is fine and left
This case was reported by a health professional and described the occurrence of fever in a 20 year old pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not reported. On 7/24/03, the pt received the first dose of Engerix B (5371A4). In the afternoon or evening of 7/24/03, the pt developed a fever. She was febrile when seen by the physician on 7/25/03.
Mother called On 4/30 stating patient had a ping pong sized lump in area where injection was given.  It was warm and red.  Mom states she did not notice any reaction on Mondau or Tuesday.
Patient came to clinic with complaint of rash and pain near injection site. SHINGRIX was given 3 weeks ago, left deltoid. Symptoms include red band of discoloration around arm-approximately 3" below the site of injection. Warm to touch, burning-sharp pain. Continues with symptoms at time of visit.
Pt developed red, hard lump 6 in x 6 in. Pt states that it was hot to touch, these symptoms lasted 5 days.
Vomiting at 1am, 1:15am, 1:46am, 2:10am and 3:02 a.m. No fever (97 degree via ear) on May 29. At 8 am 5/29, fever of 99 degrees via ear.
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis.  It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 11 years. It was also confirmed that on 28-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1708USA001768: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739:
Fainting, followed by seizures all within a ~2 minute timeframe. Regained consciousness but patient had no memory after feeling dizzy.
Some red rash on arms, back, legs, itching on these rashes. (minor inconvenience)
Systemic: Mensus (bleeding)-Medium, Additional Details: Patient started bleeding and feeling run down after injection for several days.  She had previously had an ablation and not had a \"period\" since and was concerned.
Per mother, child had fever of 102.8 nine hours after vaccination, then 101.7 two-three hours later, then 100.0.  This was with giving Tylenol every 4 hours.  Mother describes swelling in both legs the size of a golf ball.  Mother felt child was lethargic.
Pt was given Pfizer vaccine on 04/29/2021. After vaccine was administered, it was discovered that Pt's immunization records indicated Pt received Janssen vaccine on 04/08/2021. Pt was not showing any signs or symptoms of adverse reaction. No treatment was required. Pt and her son were notified to seek medical treatment if Pt began having adverse effects.
SM reported that he was vaccinated with AVA # 1, Hep B # 1, and Typhoid on 12 Aug 08. He reported taking ibuprofen prior to vaccination. Later that pm he reported abd cramping followed by loose stools. He also reported a couple episodes of nausea but no vomiting. He denied diarrhea, blood in stools, fever, chills, headaches or joint or muscle pain. He denied eating any foods that may cause diarrhea, and no one else around him was sick. He reported that he was under stress because he just found out about his deployment and had to do combat training the following week. He reported that the loose stools lasted approx 3-4 days and he currently feels fine. He will be deploying next week. Received AVA # 2 on 26 Aug. No problems. Symptoms: Abdominal Pain, Diarrhea, Nausea w/o vomiting.
Starting on 2/9/2021 patient experienced symptoms of dizziness, body aches, fevers, headaches, and weakness. After taking Tylenol patient's symptoms improved.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information regarding current condition, historical condition and concomitant medication was provided. In 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Woke up early next morning feeling weak and feverish.  (no Fever) Developed rash on injection arm that lasted better part of a week.