chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US024362, is an initial spontaneous report received from a nurse on 18 Nov 2015. This report refers to a patient of unknown demographics. Medical history and concomitant medication were not reported. The patient was vaccinated with a high dose influenza vaccine (manufacturer and batch number: not reported) intramuscularly on an unknown date. It was reported that before administration the vaccine was out of temperature range. No adverse event was reported following this maladministration.
Information has been received from a physician concerning a 24 year old female patient who on 13-JUN-2007, was vaccinated high into the shoulder with a third dose of Gardasil. Right after the vaccination, the patient's shoulder went numb. It was reported that the pain in her shoulder has been intermittent since she received the vaccine. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  i. 1/9/21 - none ii. 1/10/21 - vomiting, severe headache (not responsive to medicine) , fever (100.5 -101.0) relieved by Motrin, body aches (low back, shoulders, thighs, upper arms, neck) not relieved by Motrin. Started around 1p, Worse as day progressed iii. 1/11/21 - severe headache (not responsive to medicine- Motrin, Toradol, Phenergan tried) , fever (100.5 -101.0) relieved by Motrin, body aches (low back, shoulders, thighs, upper arms, neck) not relieved by Motrin. iv. 1/12/21 - severe headache, (not responsive to medicine- Motrin, Toradol, Phenergan tried) v. 1/13/21 - moderate headache
PT VACCINATED 1/04/21 (LOT 025J20A) + 2/01/21 (LOT 030L20A). S/O BEGAN 12/31/21, TESTED + 12/31/21
R arm extension, less than 1 minute, cyanosis at the lips and distal extremities, responsive at the time. Was febrile. Called EMS and was transported to local hospital. Keppra dose that patient was already on was increased. Patient was well appearing in the ER.
Fatigue with whole body muscle spasms (legs, arms...).  I have previous gotten muscle spasms like this when I had reactions to Remicade (used to treat neurosarcoidosis). Ever since I got this shot (2nd covid-19 moderna vaccine), my spasticity from my neurosarcoidosis has gotten worse. I am having chronic tightness and pain. The increase in pain initially lasted for 10 days. However, since then, the pain from spasticity in my muscles has resumed. And in April, I started seeing spots in my vision from the left side of my left eye. I don't know if it is related. I saw a neuro-ophthalmologist and he could not find a cause. He has been considering an MRI.
Nausea, body aches, severe migraine, chills started the next morning and lasted for 24 hours.
Mother reports mild-moderate redness & swelling @ injection site 2 days after vaccination. Treated with oral TYLENOL and cool compress to site.
No adverse reaction. Patient was given 0.2 mL Moderna Bivalent, should have received 0.25 mL of Moderna as it was his second vaccine in the series.
The client came into immunization clinic for his second Hepatitis B vaccine (ENGERIX-B) and after the second dose was administered and documented in both the clinic's EMR system and immunization registry was it discovered that client's first Hepatitis B vaccine was the new HEPLISAV-B. Therefore the second (and final dose when using HEPLISAV-B) should have been HEPLISAV-B as it is not interchangeable with ENGERIX-B or RECOMBIVAX. The error was revealed when the client produced a copy of his printed immunization registry record he obtained after the first HEPLISAV-B vaccine was administered and on the paper copy was hand-written adjustments to the dosing schedule and brand name. Immunization registry and the clinic's EMR have HEPLISAV-B in their inventory systems but for whatever reason, immunization registry has not adjusted it's dosing schedule nor indicates the brand name on the general viewing screen as it does for ENGERIX-B, etc. The clinic is aware of the error and encouraged to obtain second HEPLISAV-B vaccine 16 weeks from receiving the first HEPLISAV-B vaccine to achieve optimal protection, per CDC guidelines.
Pt arrived to outlying facility with fall and rib fractures. Pt has a PMH of COPD, obesity, and DM. He was found to be COVID positive and transferred to facility. He was admitted for hypoxia/hypercapnia and rib fractures 5-10.
pt recv vax 23SEP97 & itching devel 29SEP97;sx worsened to pox reported 5OCT97;reported sx to mom 11OCT & again 12OCT97;DPH given;
On or about 07/02/2005 patient started with a few bumps on face and then the next day broke out into a full fine body rash.  Patient had fever on 07/02/2005.
This non-serious spontaneous case, initially received from other non-health professional (consumer) on 07-Dec-2017, concerns a female patient of an unspecified age. On an unspecified date in Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported). It was reported that, the vaccine was not administered properly, which affected her shoulder and it had been more than 6 weeks. On 11-Dec-2017, at 02:45 pm, the patient's appointment was scheduled with the doctor. At the time of this report, the patient had yet not recovered from the event (shoulder discomfort).
Lt arm- orange size indurated erythematous area - progressed  X 3 days - tender - no systemic effects.
dizziness normal on day 2 after shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced dizziness (Verbatim: dizziness normal on day 2 after shingles). The outcome of the dizziness was not reported.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     It was unknown if the company considered the dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023. This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient was asking dizziness normal on day 2 after shingles shot.  The patient had no other symptoms. The follow-up could not be possible as no contact details were available.
Patient reported elevated heart rate and blood pressure, numbness of bilateral arms and legs, chest pain, neck pain, ear pain, pressure to top of head and neck, shivering, stuffy nose.  Went to Emergency Room on 3/5/21 at 2043 and discharged 3/6/21 at 0640.  Patient seen in administering provider's office on 3/8/21 for follow up.  Continued to complain of palpitations, tachycardia, chest pain along the sternum, burning pain on both sides of neck, pressure when taking a deep breath, redness and swelling to left arm vaccine site, feeling anxious, ringing in her ears.  She was referred to cardiology for further work up.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 18-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010754: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010761: US-009507513-1708USA010760.
Red bumps on the face, fever during the night. Child scratching, cannot sleep by morning of 06/03/2010, bumps are very red covering her neck, arms, back, legs. Now they are hard cluster like rash. Visited the doctor on Friday. They say its nothing she just caught a virus at the same time. Prescribe Zyrtec. Saturday its not clear if it's working she couldn't sleep Friday night with out rolling and scratching and whining. Saturday I decide to treat it like POX. I give her Aveeno Baby treatment bath and calamine lotion. Keep temp around recommendation of 70 degrees and cool mist blowing. No more fever. She slept that night. But the clusters have spread behind the ear and she scratches the back of her head. Sunday morning I call the insurance nurse hotline. She tells me to stop the 1/2tsp Zyrtec and give her Benadryl (1/2tsp every 12hrs). If not better by Monday morning take back to her doctor. Sunday night it seems the bumps aren't red and large. Monday, today they seem smaller and she slept. Called doctors office for answer, nurse/practitioner calls back. We talk advise me to keep the calamine, Aveeno and Benadryl going. Tells me only one vaccine was different from the 2month and 4month: PCV13 instead of PCV7. She has ran fever and snotty nose after the other 2 vaccines, but no rash or hives. Nurse practitioner states that it may take a week to stop the rash. She doesn't think it's the vaccine. But no one has tried to check either. I am basing this on the reaction after the vaccine.
red circle about 2 inches in diameter on their arm; the area was itchy; it was warm to the touch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle about 2 inches in diameter on their arm), VACCINATION SITE PRURITUS (the area was itchy) and VACCINATION SITE WARMTH (it was warm to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle about 2 inches in diameter on their arm), VACCINATION SITE PRURITUS (the area was itchy) and VACCINATION SITE WARMTH (it was warm to the touch). At the time of the report, VACCINATION SITE ERYTHEMA (red circle about 2 inches in diameter on their arm), VACCINATION SITE PRURITUS (the area was itchy) and VACCINATION SITE WARMTH (it was warm to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication includes blood pressure and cholesterol medicines. Treatment information was not provided.
Had flu shot she states high in arm & doctor says it hit nerve. Has been in pain since Sept 2010. Has been on DARVOCET and PERCOCET for pain. Does seem to be getting better.
sleepless night; dizziness; diarrhea; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless night), DIZZINESS (dizziness), DIARRHOEA (diarrhea), NAUSEA (nausea) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INSOMNIA (sleepless night), DIZZINESS (dizziness), DIARRHOEA (diarrhea), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, INSOMNIA (sleepless night), DIZZINESS (dizziness), DIARRHOEA (diarrhea), NAUSEA (nausea) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Patient had some flushing, sweating and headache. Patient also had generalized itching over entire body. no rash noted.
Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
H1N1 vaccine administered at 9 AM. Noticed feelings of itchiness and warm face, chest, neck, and arms at 10:00. About 2 PM-itchy on legs and trunk also. BENADRYL 25 mg PO at 2:30 PM and another 2:45 PM this afternoon. Also took CLARITIN 10 mg PO at 10:00 AM. Lips tingly. 4:00 PM-feeling better but still blotchy on face, chest, and arms. Next Am she reports some itching during night-hives gone.
Pentacel dose was expired on 10/12/2023 and patient received it on 10/23/2023.  We noticed about an hour after administration. Sanofi was contacted, no need for special treatment but dose needs to be repeated.
Left arm pain; redness; swelling of lymph nodes; swelling of lymph nodes with pain; chest pain; mild trouble breathing.; This is a spontaneous report from a contactable other hcp. A 36-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FF2589) via an unspecified route of administration, administered in Arm Left on 15Sep2021 12:15 (age at vaccination:36-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't had covid-19 prior to vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications Lamotrigine, Loratadine, Ibuprofen, Tylenol within 2 weeks of vaccination. Medical history included epilepsy from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported; loratadine (LORATADINE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183) via unspecified route of administration on 24Aug2021 03:30 in as DOSE 1, SINGLE for covid-19 immunisation. Patient previously took optivar and experienced drug hypersensitivity. On 16Sep2021 12:00 the patient experienced left arm pain, redness, swelling of lymph nodes, swelling of lymph nodes with pain, chest pain, mild trouble breathing. Patient had physician office visits for the events. Therapeutic measures were taken as a result of left arm pain, redness, swelling of lymph nodes, swelling of lymph nodes with pain, chest pain, mild trouble breathing was antibiotics. Patient was not tested with covid-19 to post vaccination. The outcome of the events pain in extremity, erythema, lymphadenopathy, lymph node pain, chest pain, dyspnoea was unknown.  Follow-up attempts are completed. No further information is expected.
Arm still feels like the needle is still in; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm still feels like the needle is still in) 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.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm still feels like the needle is still in). At the time of the report, LIMB DISCOMFORT (Arm still feels like the needle is still in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
THE DAY AFTER THE SHOT WAS GIVEN THE SITE BECAME LARGE AND INFLAMED, IT IS HOT TO THE TOUCH AND THE SITE SKING VERY TIGHT.
Right Unilateral Cranial Nerve 7 Paralysis, 6 hours after administration of vaccine, associated symptoms included diarrhea, emesis Treatment included prednisone and valacylovir
I received my 4th dose on 04/09/2022 and my adverse event started about 4-5 weeks later on 05/6/2022. Scratchy   throat; Sore throat, body aches, head cold, head fog; fever 102 before going to the urgent care; stuffy nose; fatigue. Cough; short of breath from coughing. 05/9/2022 Monday, tested positive for Flu but negative for COVID-19. I always get flu shot. I get flu but it's never a big deal but after my 4th dose my flu symptoms are moderate this time instead of mild. I am more tired than usual. My doctor prescribed me ZITHROMAX; TAMIFLU; oral steroids for 5 days.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 31Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Copd" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). No known Allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Elevated temp 104.2 after 2 hours, 102 48-72 hours, lethargic, fussy, screamed 72 hours, vomited x 3.
I began to have extreme headache (occipital neuralgia distribution and intensity) 10 hours after shot, which worsened over the next day.  During that next day I had some word-finding impairment and dulled thinking.  34 hours after shot, I experienced a transient Bell's palsy like episode with right-sided facial drooping (eye ptosis, cheek muscle flattening) and impaired speech, which lasted about 1-2 hours and self-resolved.  I called doctor who put me in contact with on call doctor who said symptoms sounded like a complicated migraine with neurological involvement.  I have had a migraine once or twice in the past, but nothing chronic and nothing like this episode.  The next day (Thursday 1/21/21) I had fatigue, and by Friday 1/22/21 all symptoms had resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, oral, from 18Apr2023 to 23Apr2023).; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Seen at Clinic on 4-20-19 (L) arm with induration approximately 4 cm below the vaccination site- surrounding erythema approximately 6 cm around site, right arm with induration about 2 cm below vaccination site, erythema about 2 cm around site, both areas red to touch.
105f fiever for 24h; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 04Apr2021 11:45 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included COPD, Covid-19 from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took penicillin and had drug allergy. The patient experienced 105f fever for 24h. The patient underwent lab tests and procedures which included Body temperature: 105 fahrenheit on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore and swollen underarm on left arm (vaccine administered)  Lacy rash on left side of chest  Fatigue  Wrist pain on right side