chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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.  Clinical course: Patient no received any other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11/16/99 received vax. Post vax, 11/20/99, temp 100. 11/21/99 temp in PM 105. Taken to the ER where he was administered IV fluids for dehydration, given rectal suppository, injection of antibiotic, discharged. 11/22/99 seen by MD had a rash and joint redness - knees, ankles, elbows, hands and feet. Saw physician 11/26/99 - blamed symptoms on MMR and started pt on Claritin.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, when the vaccine lot received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However the correct expiry date for lot was 01-Apr-2022.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
Pt stated she couldn't breathe the next day after administration of vaccines.  Was put in hosital for 4 days.  severe soreness in arm/shoulder - swollen and red (not extending beyond the joint).  Pt had brain fog and was severely dehydrated.  Pt does not know if she was running a fever.  doesn't remember first few days in hospital.
1 day after Tdap T increased 100.3 pos local 3 cm swelling at the (L) site Tdap (R-HPV)
Immediate syncope after application of GARDASIL with less than 3 sec. tension of body. Immediate spontaneous recovery.
Three days after vaccine,case reported blurry vision, hands and legs numbness and tingling, near syncope.  Ten days after vaccine case reported near syncope while riding bike.
immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 28-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Patient returned to clinic with parent about 48 hours after administration requesting provider/nursing to advise. It is unclear when exactly the reaction started. SubQ site did not have any visible abnormalities. Both IM injection sites were red, swollen, and warm. R deltoid is documented at 6cm annular erythema, no induration. Left deltoid IM inj site documented at 4cm annular with erythema- no induration. Provider visualized. RN and provider educated parent on localized reaction to vaccination. Ice/Cold therapy and NSAIDs recommended for swelling and pain reduction. Return to clinic if not improved.
This spontaneous report was received from a nurse, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ with lot # N009962 and expiration date on 15-NOV-2018 (strength, and dose were not provided); administered orally for prophylaxis. The storage temperature of the vaccines was reported as below 32 degrees Fahrenheit (°F) (24°F to 31.6°F) for an unspecified time frame. There was a previous temperature excursion of 31°F or colder (23.7°F) for 45 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
C/O rash on forehead and forearm sonce small erythematous bumps, some with white serous fluid on top. State he feels lousy, bodyaches.  Also, hx of diarrhea.
heart palpitations, shaky, weakness/sluggish, waited 15 minutes, cleared
Patient developed muscle tightness, pain, and stiffness in entire body starting 4 days after and lasting 4 days with only ongoing symptoms being pain at Hep B site.
headache; dizziness; Initial information was received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Elderly and unknown gender patient who experienced headache and dizziness while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site (strength, form, expiry date: unknown) for flu.  On an unknown date the patient developed a non-serious event of headache and dizziness (latency: unknown) following the administration of influenza vaccine.  It was reported, "Some needed it, some don't, it'll just give the headache and dizziness, no, I don't need it for 77 years."  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.
The morning of January 11th, I woke up with a scratchy throat, hoarse voice and body aches. I had fevers, chills, I was coughing. My lungs were burning, diarrhea, fatigue, dry cough. Exertional shortness of breath. I just wanted to stay in bed. I did a home test and it was positive. I scheduled a visit  telehealth on January 14th, retested (positive) and was prescribed Sotrovimab; IV infusion. I started feeling better 12 hours after infusion, but because I am immunocompromised I continued to have low-grade fevers and fatigue for 3 weeks later.
Roughly 22 hours after receiving the vaccine, I had to leave work because I felt as if I was going to throw up. That was followed by extreme dizziness. I went home and laid on the couch for 8 hours. During that time, my heart rate rose to 160 beats per minute at any time I stood up. My resting heart rate was 140 bpm. I was hot and cold and felt like my chest was getting full/tight. At one point I contemplated going to the emergency room but did not as the nurse who administered my shot said that you?ll feel terrible in about 24-hours but you?ll be fine. I was incapacitated for nearly 16 hours. I?m concerned I have long-term damage to my heart.
27Sep89 pt vax 2nd hepta B; exp severe h/a, n/v, chilling, achiness, + low grade fever. 05Oct89 noted arthritis, pain, + stiffness w/ fatigue + cycles of h/a, nausea, chills, and/or too hot, weakness, lightheadedness, + rt upper quad pain.
Approximately 4-5 minutes post flu injection, patient became faint and stumbled into table.  His mother caught him and helped him into a chair.  Nurse provided ice pack to place on the back of his neck.  Patient also layed down on a couch in the office. Patient's BP was 100/56.  After approximately 20 minutes, patient drank some lemonade, regained the color in his face, and said he felt better. 2 days later, patient's mother reported to the writer that patient was lethargic and light-headed for the rest of the evening on the date of the injection but was fine the next day.
patient was not experiencing any effects; no additional AE; PROQUAD from unknown prior temperature excursion case was administered to patient; Improperly Stored/Expired PROQUAD was administered to patient; Previous excursion had changed expiration to 10/26/2020 from 10/17/2021; Improperly Stored/Expired PROQUAD was administered to patient; This spontaneous report as received from a pharmacist refers to a 4-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 28-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: T013539, expiration date: 17-OCT-2021; dose and route of administration were not provided) (improper storage of product in use). Excursion parameters were unknown. The temperature excursion changed expiration to 26-OCT-2020 from 17-OCT-2021 (expired vaccine used). Digital data lodger was not involved. No adverse event was reported.
started with fever/chills on 7/10/19, then spent number of weeks feeling low/eyes burning/miserable/brain fog, then hives started in clusters-would go away, then come back for about 3 weeks (very itchy), then strange large spot (2-3 inch) on left breast (skin textures stringy and molted, buns and aches).
Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adverse event.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
4x2 inch warm and erythematous  induration on anterior upper thigh (where Kinrix was administered)
temp of 100-101-104.5 broke out in rash suspected to be chickenpox broke out all over trunk;temp dropped gradually spots faded gradually;
On March 5th, the day after receiving the vaccine there a large firm lump where the injection site was. The lump was itchy, red, warm, and tender to touch. The arm injected was also stiff and inflamed entirely around the lump.  On March 6th I experienced a fever of 102.5 accompanied by chills and muscle weakness. On March 7th, I was evaluated by my PCP, who upon seeing the arm and injection site, stated it could be cellulitis because of the bright red color and warmness. She stated that inflammation is normal with Covid-19 vaccine reactions so we agreed to watch it closely for the next 24 hours. On March 8th, the redness has spread very largely across the arm. The arm was getting stiffer and more painful to move each day. My PCP placed me on Amoxcillin to try and treat what she believes is cellulitis.
Reaction to Pneumovax with the sweeling, induration,erythema, warthm  and pain in the R arm and forearm
Pt recvd vax 22JUN93 & on 27JUN93 began to feel drained & hips & back hurt, had chest tightness; pt was treated w/Flexeril, APAP #3, PCN;
Patient was admitted to Hospital for COVID-19 related symptoms. This is considered a break through case.
Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 30-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
back pain; Stomach swell; out of sorts; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), ABDOMINAL DISTENSION (Stomach swell), MALAISE (out of sorts) and VOMITING (vomiting) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), ABDOMINAL DISTENSION (Stomach swell), MALAISE (out of sorts) and VOMITING (vomiting). At the time of the report, BACK PAIN (back pain), ABDOMINAL DISTENSION (Stomach swell), MALAISE (out of sorts) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sudden onset severe, constant  epigastric pain at 1:30, no other symptoms but severe pain. I went to the ER at 4:30 Emergency Room work-up showed inflammation in small section of small bowel near jejunum/duodenum. Received pain medication Tramadol at 12 noon on 5/20/21. Pain continued but started to resolve. Noted pain resolved by night 5/20/21 except with palpation. I slept all night and when I woke up 5/21/21 pain was completely resolved.
Woke up with a rash over stomach, back, thighs and arms that were like goosebumps and itchy. They would get red and were painful and that would come and go. on the 25th the rash was constant, The rash was not relived with multiple doses of Zyrtec, Allegra or hydrocortisone cream and has persisted and worsened through the weekend. Prednisone was started on Sunday the 27th which seems to have helped however still itchy and the goosebump like rash is still on stomach, back and thighs.
Customer came in today to show me her arm which was warm to the touch & rash at injection site.  ZOSTAVAX was administered 6/2/08.  I told her that BENADRYL may help & I called her physician to let her know.
Information has been received from a registered nurse concerning 2 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 09-AUG-2016, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M006726, expiration date 08-FEB-2018; strength, dose and frequency were unknown), subcutaneously, which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. Previous temperature excursion was 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of dizziness in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 18 September 2012 at 14:45 the subject received dose of FLUARIX (details unknown, left deltoid). On 18 September 2012, 45 minutes after vaccination with FLUARIX, the subject experienced dizziness and double vision. The healthcare provider reported that FLUARIX was given to the subject on 18 September 2012 at 2:45 PM at her work and 45 minutes later, the subject experienced double vision and dizziness. The subject went to her doctor's office to get treated for the double vision and the dizziness. The healthcare provider stated the subject has received flu vaccines in the past and has not experienced any type of reactions previously. No further information was provided. At the time of reporting the outcome of the events was unspecified.
Reported hives after receiving Flu Mist followed up with PCP (unknown). No respiratory symptoms or any other involvement reported by school nurse.
44 y.o. AD SM presents with 30 mm x 300 mm area of local redness, swelling, and warmth upper left arm S/P AVA #2 1/19/08, accompanied by <96 hours of constitutional malaise, HA, body ache, and muscle 'spasms/twitching' left upper arm and thighs.  Symptom: Headache, general.  Start: 01/19/2008.  Comment: No visual disturbances, N or V.  '5-6' on pain scale of 10.  Symptom: Edema at injection site 30-50mm.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area of swelling, redness, warmth left upper arm S/P AVA #2.  Symptom: Erythema.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area erythema, palpable margins left upper arm S/P AVA #2.  Symptom: Fasciculation.  Start: 01/19/2008.  Comment: 'Twitching' left upper arm and and left upper antero-lateral thighs S/P AVA #2.
Hurt really bad, hurting in arm, bothering in arm; dose was more painful and it felt like she may have pinched a nerve; It was not in the shoulder but felt higher than her previous dose of the vaccine or her previous flu shots/She stated the vaccine was administered high up on arm, in shoulder. not in the deltoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 11:00 (Lot number: ER8731) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot# EN6198, Anatomical location:  left arm , Time 11:40am), administration date: 02Mar2021, for covid 19 immunisation, reaction(s): "This dose was more painful". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, described as "Hurt really bad, hurting in arm, bothering in arm"; NERVE COMPRESSION (non-serious) with onset 24Mar2021, described as "dose was more painful and it felt like she may have pinched a nerve"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Mar2021, described as "It was not in the shoulder but felt higher than her previous dose of the vaccine or her previous flu shots/She stated the vaccine was administered high up on arm, in shoulder. not in the deltoid". Therapeutic measures were not taken as a result of vaccination site pain, nerve compression.  Additional information: The patient received second dose of Pfizer BioNTech Covid 19 vaccine a week ago and she feels as though they put it too high in her arm . It was not in the shoulder but felt higher than her previous dose of the vaccine or her previous flu shots. This dose was more painful and it felt like she may have pinched a nerve. She stated it was not in the deltoid. She stated her arm was still hurting her, bothering her. No investigation assessment. Treatment: Not provided.  No follow-up attempts are possible. No further information is expected.
Patient lost sense of taste. Felt like she had burned the inside of her mouth. Sensation was most severe starting the afternoon after the vaccine and continues until now. Sense of taste is returning but the side effect is still noticable.
Development of welps over trunk, arms, legs, onset within 12 hours. Seen in ER 10/21/2005.
I became aware of a deterioration in my hearing probably iin April. My hearing has been somewhat impaired for several years but not to the level that I wanted to use hearing aids. I responded to a commercial offer of a free hearing test. I visited the clinic but had to delay the testing for another week. When I did get the test, the hearing in my left ear was makedly inferior to that in my right ear. The audiologist was concerned they may be some blockage. I made an appointment to be seen. The hearing test confirmed the far greater hearing impairment in the left ear. There was no blockage of the canal.
platelets have gone up, really high; Second dose after more than 36 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after more than 36 days since the first dose) and THROMBOCYTOSIS (platelets have gone up, really high) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041521A and 053E4A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Sickness with Flu vaccine.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after more than 36 days since the first dose). On an unknown date, the patient experienced THROMBOCYTOSIS (platelets have gone up, really high). On 21-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after more than 36 days since the first dose) had resolved. At the time of the report, THROMBOCYTOSIS (platelets have gone up, really high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: normal (normal) four hundreds, about 445 Normal and high (High) High.         She has bloodwork done every 6 months and they used to be in the four hundreds, about 445, which could be normal. No concomitant medications were reported. No treatment medications were reported. Patient was concerned will they platelets come back down and anything close to 600 is a problem.
Pt stated that he felt pain at the injection site the next day and it just continued to get worse. He mentioned having vaccines at this site prior and not having problems.