chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to 4 patients of unknown age. On an unknown date the patients were vaccinated with improperly stored PROQUAD lot # M044718, expiration date 07-MAY-2018 for prophylaxis. Concomitant therapies included properly stored sterile diluent (MERCK STERILE DILUENT). Administered doses of vaccines experienced the temperature excursion of 32.5 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA000794:
15 minutes: Throat closing via growing "lump in throat", numbness in neck muscles, light-headed , at 4 hours: vomit, at 12 hours chills; at 40 minutes given shot + Benadryl; take home methlyprednisolone descending dose pack
Patients received two doses of Sinovac in another country, his last dose was on 9/23/21. Patient received Pfizer as a booster on 1/11/22.  Booster was suppose to be given 5 months after last dose.  Patient did not report any adverse reaction after receiving the Pfizer booster.
Early Menses; Fibroids that were protruding from her uterus; feeling tired.; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (Early Menses), UTERINE LEIOMYOMA (Fibroids that were protruding from her uterus) and FATIGUE (feeling tired.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MENSTRUATION IRREGULAR (Early Menses), UTERINE LEIOMYOMA (Fibroids that were protruding from her uterus) and FATIGUE (feeling tired.). At the time of the report, MENSTRUATION IRREGULAR (Early Menses), UTERINE LEIOMYOMA (Fibroids that were protruding from her uterus) and FATIGUE (feeling tired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient will now require surgery.  No concomitant medications were provided.  No treatment medications were provided.
fever 100.4 degrees, chills,  aching joints lasting about 12 hours.  Treated with Ibuprofen.
After first dose, experience chest pain,  discomfort from left side of neck on top of shoulder into arm, sore arm for 4 days, red and swelling. High Heart rate for a day, chest pain/discomfort for two days.  After second dose,  same reaction as first with pain on left side, even though administered in right arm this time. Sudden fullness in ears as if I was on a plane. Increase heart rate and resting pulse-current. Headache, swelling of right foot, chest pain intermittingly.
Info has been received from a health professional concerning a 53 year old female who in 2/2002, was vaccinated with a dose of Hep-B (lot not reported). Post vax, the pt had an "anaphylactic-like reaction", where she reportedly passed out and turned white. The pt was treated with epinephrine and "everything seems okay". Unspecified medical attention was sought. Upon internal review, anaphylactic-like reaction was determined to be an "Other Important Medical Event". Additional info has been requested.
Blistering rash (Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Blistering rash (Second Dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (hospitalized due to Covid19 in December for a week). Concurrent medical conditions included Fibromyalgia, Blood pressure high and Sleep loss.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH VESICULAR (Blistering rash (Second Dose)). At the time of the report, RASH VESICULAR (Blistering rash (Second Dose)) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-295024, MOD-2021-295772 (Patient Link).
Pt presents to ER with fever, cough, diarrhea, and headache.  Onset 3 days prior.
No additional AE reported; a patient received a dose of VARIVAX intramuscularly; This spontaneous report was received from a registered nurse referring to a 14-month-old patient of unknown gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions/allergies was not reported.   On 04-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly (strength, dose, lot# and expiration date were not provided) for prophylaxis (incorrect route of product administration). The reporter had no additional information regarding the adverse event (AE). No additional AE reported.
received 1st dose on 21Jul2019, it is unclear if a 2nd dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st July 2019, batch number 5JX9Z).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The medical assistant did not have record of the expiration date of vaccine. The second dose was not administered at same facility and it was unclear if a second dose was ever administered.  The patient might have received 2nd dose out of state, records had been requested and were pending. The reporter consented to follow up. This case was linked with case US2021238416, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238416:same reporter
Information has been received from a health professional concerning a 30 year old female who was inadvertently vaccinated with a double dose of pneumococcal vaccine 23 (1ml). Subsequently, the pt experienced a severe asthma attack. She was referred to the ER for treatment. The pneumococcal vaccine 23 polyvalent had expired in May 2000. The severe asthma attack was considered a "Significant Medical Event".
Extreme Debilitating Dizziness for 4 days so far as well as fatigue. Muscle pain that comes and goes in left arm, neck , upper back and both legs.  Wheezing on days 1-3.
Left arm swollen stopping at elbow with pain; treated with Ibuprofen 600 mg x qd and Vicodin
This spontaneous case was initially received on 03-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 33 years old male patient. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 09-OCT-2015 - 09-OCT-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 09-OCT-2015, the patient received an IM dose of expired AFLURIA (non serious, outcome: Unknown). (Medication error) (non serious, outcome: Unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered.  For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
On Dec 21 got  covid vaccination   2 days after left eye was bothering her/dry            Then Saturdays Dec 26 was eating a bowl of cereal and then spilling the food and was drooping                  No headache, no fever.                      Has  Bell?s Palsy          She has chronic urticarial and  Because of Hives from Sulfa and NSAids               Prednisone 20 mgs BID x 5 days before the shot.
Marked local swelling, redness, pain, malaise and low grade temp 37.9.
A few days after the Singrex vaccine I developed a sore throat and swollen glands. It has persisted for 4 days now. The pharmacist told me to take vitamin C for a few days which I did but she did not tell me why.
Information has been received from a physician concerning a patient who on 08-APR-2008 and on 18-AUG-2008 was vaccinated with the first and second dose respectively of ROTATEQ vaccine live (human-bovine). No adverse effect were reported. It was unknown if patient sought medical attention. A product quality complaint was not involved. Additional information has been requested.
Fever of 101 degrees for 2 days post injection. Redness, warmth, swelling at injection site. "Equilibrium" off.
Immediately upon getting the dose, I fainted and felt as though my ears were popping. This feeling has only gotten worse and it feels as though my ears have too much pressure in them (like I?m underwater)
headaches/sometimes the pain feels intense; feel like a squeezing sensation; neck muscles also sometimes feel very stiff; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:00 (at the age of 76-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 10Feb2021 at 2PM as DOSE 1, SINGLE for covid-19 immunization. No vaccine was administered within 4 weeks. The patient's medical history included left elbow surgery after traumatic fall in May2018 from an unknown date, physical therapy for neck stiffness from an unknown date and unknown if ongoing, skin allergy to nickel and allergic to ceclor from an unknown date and unknown if ongoing and covid was tested prior vaccination on an unknown date and covid was not tested post vaccination. Concomitant medications included levothyroxine, atorvastatin, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 at 03:00 AM the patient reported that for the past six weeks after her second vaccine, she was experiencing daily headaches (which began 12-24 hours after her vaccine) on both the top and back of her head, varying in intensity and duration. She feels like a squeezing sensation, sometimes the pain feels intense. Neither Tylenol nor Ibuprofen really help. Her neck muscles also sometimes feel very stiff when the headache is coming on. No treatment was received for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Red hot, itchy rash on entire neck, ears, and two spots on the forehead, extreme body fatigue and muscle pain, extreme sleepiness until Monday at 2 p.m.
Patient admitted on 04/04/2022 due to seizures.  Patient was initially admitted to neurostepdown unit, was found to be NCSE, he was transferred to the NSICU for higher level of care and was intubated for airway protection.  Patient was placed on ketamine infusion, versed infusion, Propofol infusion, which did not stop his seizures.  He was placed on a ketogenic diet while adjusting antiseizure medications and this improved his seizures.  He remained on clobazam, lacosamide, keppra, fycompa, depakote and phenobarbital which was not suppressing his epileptiform discharges.  He was also tried on empiric solumedrol for possible autoimmune encephalitis, this did not resolve seizures.  Patient was transitioned to palliative level of care.  Patient expired 04/28/2022.
Information has been received from a pharmacist concerning a 73 year old female with myasthenia gravis who on 26-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). The reporter indicated that the PI was reviewed, but "this" was not mentioned (?myasthenia gravis). The patient has been evaluated by a doctor. No further information was provided. Additional information has been requested. Attempts are being made to obtain additional information regarding the extent of the patient's myasthenia gravis and treatment at the time of vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 07Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of 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.
This spontaneous report as received from a pharmacist refers to a now 76 year old female patient with no drug reactions or allergies. The patient's medical history included "some type of orthopedic surgery". On an unknown date the patient was vaccinated with a dose of pneumonia vaccine (manufacturer unknown). Concomitant drugs included "several medications" (not specified). On an unknown date the patient experienced arm swelled up after receiving the pneumonia vaccine. It was not known if the patient sought medical attention. The outcome of arm swelled up was unknown. Additional information is not expected.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left 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: "CHF (Congestive heart failure)" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had not taken any other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient had taken Paxlovid as COVID-19 treatment from 27Mar2023 to 31Mar2023. Paxlovid immediately lessened symptoms of sore throat, aches, sneezing. Cough  had also decreased to some extent till last Paxlovid date. Symptoms of sneezing, runny nose, congested nasal passage and some chills began on day 9 (05Apr2023 at 04:00 PM) of treatment start.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147047 same reporter/patient, different product/AE;
My reactions were :  Mild Injection Site Pain, Tiredness, Headache, Severe Muscle Pain, Some Chills, Feverish, feeling Unwell, Sinus issues and Coughing.  Very Erratic and disrupted sleep for Days. The Major Adverse effect is that these Reactions are within the Range of Published and known Effects. I treated them at home with Rest and Some Tylenol, but was not really capable of normal functioning or to be Employed.. But they were Persistent for 6 1/2 Days....   I have spoken to No One who have had the symptoms last this long. It seemed and felt like descriptions  of Real Covid or past Influenzas but the symptoms seemed more severe and longer. I have spoken with many who have had real Covid who's symptoms and length of illness were milder... I did contact my Physician to advise of this event.
Patient presented with themp of 99 F and lacey rash from about the site of the Tdap injection to the finger tips on the left arm.  States he started feeling unwell last evening.  He was not aware of the rash.
Patient was confused. He could remember what he had for breakfast, and he may have been seeing things. He was admitted to hospital and stayed overnight.
fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years).  The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.
Really doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix. On 11th June 2021, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and was not feeling well. The patient wasn't expecting any side efeects and she would like to know how long would this side effect last. No further information was provided. The reporter did not consent to follow up.
Vasovagal reaction, pale, did not faint, but very light headed. Threw up.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received FLUARIX QUADRIVALENT. On 31st August 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In September 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: 2 to 3 days after receiving (on an unknown deltoid) the patient experienced injection site pain and cannot lift arm due to the pain. The patient required an emergency room visit due to the events and no overnight hospitalization was required.
Patient received Pfizer covid-19 vaccine and was not of age for the said vaccine.  on 04-03-21  patient did receive 2nd dose to complete the series  on 04-24-21
The following is transcribed from a report submitted by Paramedic on a 72 yo female who received 2nd Pfizer COVID vaccine (Lot# EN 6203, exp 6/2021) in right arm at approx 10:45am: "At 10:45am, I observed an elderly female with increased respiratory effort, flushed skin, appearing to be in mild distress, sitting in the 15 min. observation area. I approached patient and asked if she was doing okay, and she stated "yes." Patient's skin was flushed, diaphoretic, and warm. Pupils equal and sluggish. Patient denied any other complaints but claims she felt lightheaded prior to vaccine. Patient was moved to 30 min. observation. Patient was able to stand up and ambulate without assistance. EMTs took vital signs as another patient arrived. 11:05am baseline vital signs obtained: blood pressure 124/80, respiratory rate 16, heart rate 100, alert and oriented to person, time, place, and situation. At 11:12am, patient's vital signs were re-assessed and radial pulse palpated which was strong, regular with occasional PVC's felt. Blood pressure 130/82, respiratory rate 16, heart rate 108, alert and oriented to person, time, place and situation. C/C reassessed and she reported no change. It was advised that due to her physical appearance not improving with skin flushed and diaphoretic, ALS would be contacted to further evaluate; patient obliged. At 11:27am 911 contact made with a 6 minute response time with fire department on scene. Patient turnover report given and care transferred. Patient AMA'd (left against medical advice) with fire department. Patient ambulated with steady gait and without assistance.