chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Briefly, This is a 35 y/o man with PMH of Multiple sclerosis, ADEM, Seizure disorder and TBI with left sided residual weakness  who presented with weakness, slurred speech and mild facial droop. In the ED he had extensive imaging including CT Heat, CT Angio brain perfusion, CT Angio Neck, MRI noncon that were all negative for acute abnormalities. Patient was also found to be COVID positive, and with resolution of fevers, symptoms significantly improved. He had recurrent fevers and neuro symptoms 1/8 pm, repeat head CT negative and sxs resolved with treating the fever. Patient initially requiring heavy Ax2 with worsened neuro sxs, now appears to be near baseline and stable for DC to home w/ support from Mother per PT. Recommended scheduling Tylenol for at least 3-4 more days to stay on top of fevers, then prn thereafter. Home PT/OT/SN ordered for DC. Discussed plan with mother, all questions answered. COVID-19 infection See above.   Multiple sclerosis + Hx TBI + Stroke-like Symptoms Hx Seizure disorder Cont all PTA Meds as below. No e/o seizure like activity this admission, neuro status returned to baseline w/ fever control as above.
Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant fullness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171), via an unspecified route of administration in the arm left on 28Apr2021 at 14:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously took bupropion for hives. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate 60 mg QD (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 for COVID-19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150), via an unspecified route of administration in the arm left on 07Apr2021 at 11:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 20:30 (after 6 hours of vaccination), the patient experienced inflammation/ feeling of significant fullness at site. On 29Apr2021 at 01:30 (after 11 hours of vaccination), the patient experienced insomnia, chills, headache and muscle aches. On 29Apr2021 at 08:30 (after 18 hours of vaccination), the patient experienced high temperature. On 29Apr2021 at 08:30, the patient underwent body temperature and the result was 100.4. The clinical outcome of the events headache and muscle aches was recovering; while the clinical outcome of the events inflammation at site, insomnia, chills and high temperature was not recovered.  No follow-up attempts are needed. No further information is expected.
On 10/6/10 received phone call from patient.  Vaccine given 8/23/10.  States arm "sore and irritated" (especially at night) for past 2-3 weeks.  States "Shoulder and arm go numb from time to time".  States this started "a week or two ago".  When questioned about time before he believes symptoms began, states can't remember any problems soon after the vacacine was given.  Patient poor historian.  Encouraged to follow-up with PCP.
Flu-like symptoms within 24 hours.  Itching, warmth and redness continues at 72 hours.
vaccinated at 31 weeks pregnant and 35 weeks; No adverse event; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccinated at 31 weeks pregnant and 35 weeks) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccinated at 31 weeks pregnant and 35 weeks) and NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccinated at 31 weeks pregnant and 35 weeks) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. The patient was vaccinated (Moderna) at 31 weeks pregnant and 35 weeks with her second daughter that was now 6 months old. The patient was breastfeed and hoped she was somewhat protected by her. At the very least. Her daughter would be exactly 30 months (2.5 years) in Nov-2021 (born on 5/01/19) . She had no health conditions, no known allergies, was up to date on all other vaccinations, stays at home with her. she just want to do everything I can to protect her children. No treatment information was provided. 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.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a female patient of unknown age, with no medical history, who experienced no adverse event. The patient received 2 doses of mRNA-1273 vaccine, with an interval of 4 weeks, on the third trimester of gestation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a female patient of unknown age, with no medical history, who experienced no adverse event. The patient received 2 doses of mRNA-1273 vaccine, with an interval of 4 weeks, on the third trimester of gestation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
After receiving IM DTaP and IM PREVNAR on 4/20/09 to (R) thigh, pt. developed red, warm area and temp described as "hot" per mom day after shots. Seen in office 4/22/09 and was given BENADRYL liquid 12.5mg/5cc 3ml QD
Rash occurred on left arm near injection site 7 days after first vaccine that seemed to grow larger in area each day.  Treated with Triamcinolone Acetonide Ointment USP, 0.1% for a few days and rash disappeared.  A couple days later, rash reappeared.  I contacted my PCP, who suggested that I use Claritin tablets.  I had Zyrtec available and used it.  The rash disappeared after about 3 days of use of Zyrtec tablets.  After 2nd shot, rash formed in same area about 30 hours afterward. Rash is not as itchy, but feels hard and warm to the touch.
pain; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EY0584, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 29Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were none. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0182 and Expiry Date: Unknown), via an unspecified route of administration, in arm left on 04Jun2021 11:00 as dose 1, single for COVID-19 immunisation and experienced with pain was excruciating, Chills and Fever, No appetite, Occasionally feels flushed and Neck, Upper Arm, Thigh Pain. It was reported that, she was scheduled to get her second dose of the COVID Vaccine on 25Jun2021. Due to her symptoms going on at that time she did not get it on that date. She felt well enough to get it on 29Jun2021. On 29Jun2021, patient experienced pain. The patient underwent lab tests and procedures which included full blood count normal was everything was fine, 2 Lyme tests on her was negative, resistance test with her arms and legs, CBS was everything was fine on these tests and SARS-COV-2 antibody test was positive on an unspecified date in 2021. Patient took Tylenol for the pain, but that Tylenol never helps her with pain anyway. She said that the doctor ordered Percocet (combination of Oxycodone and Acetaminophen), as one tablet every 6 hours on the 29Jun2021 to take around the clock for three days. She mentioned that there was a Product Complaint for Tylenol and Percocet, which did not help with pain. The outcome of events was not recovered.
pt recvd vax; pt exp pain in arm w/ 2nd dose of vax; pt exp more pain in eve & devel swelling in right upper extremity from her shoulder to her elbow;
2/4/03 three red raised pimple-like lesions around vaccine site-whitish center-noted by mom-c/o itch.
Patient was given an expired vaccine on 3/11/22. Vaccine was expired as of 9:24pm on 3/10/22 since it was first opened and punctured on 3/10/22 at 9:24am. Patient has not reported an adverse symptoms at this time.
After about 15-20 min of getting a flu shot, she felt dizzy & light headed.  She sat down on the chair and experienced tingling sensation all over her body.  Tremor in her hands & drowsiness.  I called 911 and have medics check her out as precautionary measure.  Later, they took her to the hospital for further tests.
This spontaneous report was received from the patient's mother concerning a 15 year old non-pregnant female patient. The patient had no concurrent conditions, medical history, drug reactions/allergies or concomitant medications. On 30-JUL-2018 at around 16:30, the patient was vaccinated with the first dose of GARDASIL 9 0 .5 ml, via intramuscular, for prevention of HPV (Strength, lot # and expiration date were not reported). On the same day at around 20:00 (reported as around 20:00 or 20:30), she complained of nausea and had fever of 100.6 F degrees. On 31-JUL-2018 by 07:30, her fever had reached 103.6 F degrees and by 12:30 her fever reached 103.5 F degrees. She received an unspecified treatment for the events and no laboratory diagnostic tests were performed. However, she seek medical attention with her physician. The outcome of nausea and pyrexia was reported as not recovered. The causality between the events and GARDASIL 9 was not provided.
Pt received J&J.  Pt tested COVID + on 8/26/21 and admitted to hospital for COVID on 8/26/2021. Pt received remdesivir x3 doses and dexamethasone.
ringing in the ear worse ( after 2nd dose); blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab; couldn't fall asleep; blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab; ringing in the ear worse; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear worse ( after 2nd dose)), CONDITION AGGRAVATED (ringing in the ear worse), PAIN IN EXTREMITY (sore arm), RASH MACULAR (blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab) and SCAB (blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009021A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced CONDITION AGGRAVATED (ringing in the ear worse), PAIN IN EXTREMITY (sore arm) and SCAB (blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab). On 18-Jun-2021, the patient experienced TINNITUS (ringing in the ear worse ( after 2nd dose)), RASH MACULAR (blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab) and INSOMNIA (couldn't fall asleep). At the time of the report, TINNITUS (ringing in the ear worse ( after 2nd dose)) and CONDITION AGGRAVATED (ringing in the ear worse) had not resolved, PAIN IN EXTREMITY (sore arm), RASH MACULAR (blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab) and SCAB (blood clot blotches on the back of both hands which one clot was ripped and resulted in a scab) had resolved and INSOMNIA (couldn't fall asleep) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided by reporter.   This case was linked to MOD-2021-248502 (Patient Link).
Headache, whole body ache,  could not eat for 2 days,  very dry mouth,  half sick to stomach had no fever,  had chills then get hot,  loose bowels
Initial report received from a health care professional on 12 October 2009. A 39 year-old male patient was vaccinated with H1N1 (sanofi pasteur, lot # UP001A) on 11 October 2009 and was previously vaccinated with  FLUZONE (sanofi pasteur, Lot # U3213AA) on 26 September 2009. The patient reported receiving the H1N1 vaccine in the morning, ate lunch at approximately 12:30 PM and at approximately 3:15 PM developed a left-sided occipital headache which was unrelieved by EXCEDRIN. The patient also had two episodes of vomiting that evening. The following morning, the patient reported that the headache was resolved, but reported feeling very rundown. Two days post vaccination, the patient was recovered and returned to work reporting that he was "feeling fine". The patient reported having seasonal allergies treated with ALLEGRA and NASACORT at the time of vaccination. No further information is expected. List of documents held by sender: none.
pain in hips; pain in hands; pain in neck; pain in back; Her right hand has not healed, it feels swollen and tight; She felt weak; lethargic; She had diarrhea as well; felt like she got hit by truck; She felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back) and PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), FEELING ABNORMAL (felt like she got hit by truck) and FATIGUE (She felt very tired). At the time of the report, MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), FEELING ABNORMAL (felt like she got hit by truck) and FATIGUE (She felt very tired) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19-May-2021, Contains No New Information
Acid Reflux: Right-sided chest pain Narrative: Patient has been seen in the ER twice. Treated for acid reflux during 1st visit. 2nd visit: DIAGNOSTIC IMPRESSION: odyophagia, suspect esophagitis; PLAN: Continue omeprazole. Will add Maalox for a few days Referral for endoscopy by GI. Return to ER for any worsening/concerns.
At 6pm the day vaccine was administered, patient developed chills (no temperature was taken) and achiness. The following day the patient still did not feel well with chills and achiness. He remained at rest the entire day. By 11/25 symptoms completely resolved.
Patient experienced more injection site pain than usual with this injection; This spontaneous report was received from a consumer (patient's mother) via company representative and referring to a 12 (units not provided) female patient. The patient's pertinent concurrent conditions, ,medical history and previous drug reactions or allergies were unknown by the reporter. The patient concomitant medications included influenza virus 3v reassortant vaccine live intranasal (cold adapted ann arbor master strain) (FLUMIST (INFLUENZA VIRUS 3V REASSORTANT VACCINE LIVE INTRANASAL (COLD ADAPTED ANN ARBOR MASTER STRAIN))).      On 23-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration, lot number and expiration date were unknown by the reporter).   On the same day, the patient experienced more injection site pain than usual with this vaccine (vaccination site pain). It was unknown by the reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if any treatment was given to the patient.    At the time of this report, the outcome of vaccination site pain was unknown by the reporter.   The causality assessment between suspect vaccine and the aforementioned event was not reported.; Sender's Comments:  US-009507513-2009USA010652:
Moderna COVID-19 vaccine was mistaken administered to a patient who is 13 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was mistaken administered to a patient who is 13 years old) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was mistaken administered to a patient who is 13 years old). On 21-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was mistaken administered to a patient who is 13 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
This case was reported by a nurse via call center representative and described the occurrence of vasculitic rash in a 76-year-old male patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received in 2012 without reactions as per healthcare professional). On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 3 days after receiving SHINGRIX, the patient experienced vasculitic rash, injection site erythema and injection site rash. On an unknown date, the outcome of the vasculitic rash, injection site erythema and injection site rash were recovering/resolving. The reporter considered the vasculitic rash, injection site erythema and injection site rash to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient experienced a vascular rash around the left upper arm (localized to the injection site and it did not radiate) and erythema around the same area as well. On 26th May 2018, the patient went to the convenient care clinic. It was stated that, the reaction was improved but it had not fully resolved at the time of reporting.
Client states everything getter dark, head went back, pale. hot, unconscious not responding to verbal stimuli, body got stiff, took V/S, layed on floor, gave Sprite, 911 called parents/client refused to go to ER.
I had the COVID-19  in June 2020; I had the COVID Vaccinations on in January 2021; I tested positive for COVID-19 on April 1,2020 through a rapid test and on April 2, 2020 in a PCR test.
I feel little cold, I know that it's my eyes, my nose, my throat, my body hurts; I feel little cold, I know that it's my eyes, my nose, my throat, my body hurts; Really bad allergies; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported), dose 1 via an unspecified route of administration on an unspecified date in May2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient had like really bad allergies for the past few days, felt little cold, eyes, nose, throat, body hurts. Patient was supposed to go for the second vaccine on the day of reporting but had like really bad allergies so patient wanted to make sure if patient would do it anyway. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
no adverse event thus far.    Vaccine administered past expiration. Batch FL8095 was also manufactured on 28-Sep-21. The current expiration date is assigned 12 months from the last day of the previous month it was manufactured in, so the batch was assigned an expiration date of 31-Aug-22. We have stability data to support the use of the vaccine for 18 months from the date of manufacture plus seven days. Any doses administered on or before 04-Apr-23 are supported by stability data. Pfizer cannot authorize storage or use of any product outside the approved labelled conditions. Additionally, Pfizer cannot make any disposition decisions for product stored outside Pfizer?s control. Any decision to use, release or dispose of the impacted products is the responsibility of the health care provider.  per Pfizer