chrisvoncsefalvay/vaers-outcomes huggingface dataset:
paralysis of the hand; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer COVID-19 Vaccine Call Center. An unspecified age male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first dose of bnt162b2 on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, patient had paralysis of the hand. He received both Pfizer covid 19 vaccines in the middle east. He was informed the spike protein test was not going to show covid or any antibodies in the system; he was told there is no way to check if he is protected after getting the vaccine. Caller is wondering if this information is true. The event was serious (medically significant). The outcome of the event was unknown.  Information about batch/ lot number has been requested.  Follow-up attempts are completed; information about batch/lot cannot be obtained.
Initial report was received from a health care professional on 22 December 2011. A 20-year-old pregnant female patient had received an intramuscular (IM) injection of ADACEL (sanofi pasteur Ltd. lot number C3984AA) on 22 December 2011. The date of the patient Last Menstrual Period was not reported. Estimated Date of Delivery was reported as 19 August 2012. The patient did not experience an adverse event. The patient's obstetrical history, current medical history, and concomitant medication were not provided. The outcome was reported as unknown. Follow-up information was received from a health care professional on 16 April 2012. Based upon this new information, the event has been upgraded to serious and a separate case has been created to capture the fetal death in case number 2012-04016. The patient received the dose two of ADACEL in the left deltoid. The patient had one previous dose of ADACEL. The patient had an incompetent cervix and had a cervical cerclage on 25 March 2012. The patient got an infection, was in the hospital and on intravenous (IV) antibiotics (dates not reported). The patient had a miscarriage on 08 April 2012. Prior to the miscarriage, the patient's health status was good and had no family history of congenital abnormalities. The patient had no previous pregnancies and received no treatment for infertility. The patient has no adverse events following prior vaccinations. The patient's concomitant medications included prenatal vitamins. The patient's outcome remained unknown. Documents held by sender: None.
she experiencing side effects (fatigue, a little bit nausea and achiness); she experiencing side effects (fatigue, a little bit nausea and achiness); she experiencing side effects (fatigue, a little bit nausea and achiness); This is a spontaneous report from a Pfizer sponsored program. The contactable female consumer reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and expiration date unknown) via unspecified route on 30Apr2021, at 2:00 pm as 2nd dose single for COVID-19 immunisation. The patient received first dose of BNT162b2 on PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and expiration date unknown) via unspecified route on 07Apr2021, as 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01May2021, the patient experienced side effects (fatigue, a little bit nausea and achiness). The patient wanted to know and asked for over the counter medications for side effects. Cold transfer due to longer than normal wait time. Unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
DRY MOUTH; CHILLS; HEADACHES; BODY ACHES; FEVER 103.1; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included patient have no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced headaches. On 12-MAR-2021, the subject experienced body aches. On 12-MAR-2021, the subject experienced dry mouth. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from headaches, body aches, dry mouth, and fever. This report was non-serious.
Information has been received from a Registered Nurse referring to a 3 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5(unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Anaphylactic  type reactions such as dizziness,  cough and throat swelling, BP drop - happened slowly within 1 hour with antihistamines taken 1 hour prior to injection ( Chlorphenerimine 4 mg, Pepcid 20 mg  tabs) Swelling of feet, hands, face in 1.5 hours. Used Flucatisone nasal spray x2 , albuterol puffs x 2 and pseudophed 15 mg tablet Continued to use Antihistamines for 3 - 4 days post injection for rash and swelling. VERY FATIGUED for 3 days.  Rash over trunk of body for 7- 10 days post injection
Patient presented to the ED with status epilepticus. The initial seizure lasted 15-20 minutes prior to arrival in ED. In ED, he was given Ativan, Phenobarbital, and fosphenytoin which were successful in stopping the seizure. Patient was intubated and placed on ventilator. He was admitted to the PICU and stayed for 3 days prior to transfering to the hospitalist floor. He remained seizure free after his initial insult.
30 weeks pregnant and experienced heart palpitations on and off for about half an hour about 7 hours after vaccination during both first and second doses of the Pfizer Covid vaccine. I haven?t experienced palpitations again since then but any long term effects are unknown.
Pt is a 12 y/o female, a&o x4, accompanied by mother. Within 5 minutes of vaccination the patient complained of stomach cramping and nausea. On further assessment both of the patient's arms appeared red and she developed a rash on the neck and right side of cheek. Pt spit clear fluid x2. Pt vital signs were within normal limits. Lung sounds were clear. The patient was administered 25 mg of diphenhydramine hydrochloride IM. Last vital recording was at 1:50 pm 111/77, HR 88, Spo2 98%, when EMS arrived.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 18-NOV-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). This specified lot number vaccine was exposed to temperature excursion eleven times. The total cumulative excursion time (hour) and lowest recorded temperature (Fahrenheit degree) for each time were as below: (216, 29.3); (24, 33.6); (52, 33.1); (72, 32.9); (100, 34.5); (28, 30); (104, 29.1); (36, 31.1); (24, 34.8); (24, 32.4); (120, 34.2). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 05-APR-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R022879, expiration date 02-AUG-2020) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008542: US-009507513-1904USA008551: US-009507513-1904USA008552:
Generalized tonic clonic seizure. It lasted about 1-2 minutes. The patient was evaluated in the ED and discharged. She has been acting normally since then.
6 x 4cm tender patch of erythema Lt buttock w/ induration (Flu shot) without heat. 3 cm tender patch of erythema Rt buttock w/ induration (ADACEL) without heat. No fever, no chills no SOB no cough.
I received an injection of the vaccine.  The needle and the syringe were not properly connected.  The sera squirted out of the syringe and most of the vaccine ran down my arm and formed a puddle on the floor.  The person administering the vaccine said "enough of the vaccine had gotten into my arm, not to worry."  It is doubtful, since there was a puddle on the floor.  I need this vaccine!  I am very frightened of getting Covid-19.  Please help.
Body Aches, headache, cough, tiredness, low grade fever (101), stuffy nose, eyes sensitive.
COVID-19 Vaccine 3rd dose administered. Resident at psychiatric residential treatment facility. Per immunization record in chart resident had not received second dose of COVID-19 Vaccine. Resident reported already receiving second dose prior to appointment. Reported she took herself to the appointment for the second dose. Resident transported to appointment to receive what we thought was second dose of COVID-19 Vaccine 8/19/2021. Vaccine administered at location. Resident notified biological Father that they received a 3rd dose of the COVID-19 Vaccine. Resident then reported godparents took them to get second vaccine. Father contacted godparents and they reported they did take the resident to get both COVID-19 vaccine doses 1 & 2 confirming that dose administered 8/19/21 would be the 3rd dose. Documentation of this not included in chart and not provided on admission. Current immunization record documented dose one. Dose 1 administered 5/28/21 pfizer EW0178 IM injection to left arm Dose 2 administered: 6/18/21 pfizer EW0181 IM injection to left arm both vaccines received. Father provided copy of vaccine administration record to RN staff. Resident return to residential treatment center after 3rd vaccine dose administered.
Immunization-induced bilateral optic neuropathy treated with IV steroid (Prednisone) for 4 days then oral for approx 2 weeks. Treated by ophthalmology. 9/4/07-records received. DC DX: Optic neuritis. Progressive vision loss over past 3 weeks.  During hospitalization progressive improvement in visual fields. 9/18/07 Received neuro-ophthal medical record which reveals patient seen on 7/5/07 in follow up for rapidly progressive bilateral optic neuropathy.  Had previously been evaluated in hospital on 6/25/07 & dx w/postviral bilateral optic neuropathy.  In hospital, ICP elevated & patient tx w/Diamox & steroid taper.  On 7/5 patient vision had improved & was to continue same meds & return for further f/u.  No other medical records provided. 1/4/10 Reduced vision./11/2010 He first got optic neuritis whcih was followed by aprox. 30% permanent damange to his optic nerves.
23 YOM 9 days s/p primary SPV pt started to feel substernal CP. He presented to a local ER 36 hrs later and was d/w myopericarditis. He was admitted to CCU for observation and was treated with prednisone. The sxs quickly resolved. 60-day follow up on 02/11/04: "It is unknown if the pt recovered from adverse events.  We cannot state whether he has recovered until after his 2 year follow up."
Expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 26-Oct-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  The reporter also said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
pt presented to clinic w/ c/o lt upper arm redness & discomfort radiating up into neck redness/raised area approx 4cm x 2cm indurated urticaria;
Heart pap. body aches . headaches and joint pain. chill and fever also could not eat or drink. brain fog chest tightness.
several hours, 8, after getting the COVIDvaccine, my throat began to feel tight and my chest began to feel tight as well.  I began to wheeze and notice that my breathing had changed and it was not normal.  symptoms similar to anaphylaxis of when I was given Rocephin in my teen years and had anaphylaxis within a minute of receiving that medication.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VOMITING (vomit) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. Concomitant products included METFORMIN, GLYBURIDE, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL, INSULIN, INSULIN ASPART (NOVOLOG) and INSULIN DETEMIR (LEVEMIR) for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (dizzy). On 30-Mar-2021, the patient experienced VOMITING (vomit) and PYREXIA (fever). At the time of the report, DIZZINESS (dizzy), VOMITING (vomit) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 102 (Inconclusive) 102 degree Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non significant FU:TCR attached.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 2), Moderna COVID-19 Vaccine (Dose 1) and Moderna COVID-19 Vaccine (Dose 3). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 31-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. On 16-DEC-22, patient did not had any COVID symptoms. She was advised by her doctor to wait for 2 weeks after COVID to receive a bivalent booster. She was asking whether she can go ahead and had a Moderna COVID-19 bivalent booster on that day.   Reporter did not allow further contact
Instead of using sodium chloride to mix the vaccine, it was mixed with sterile water and administered to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00688236) and transmitted to Sanofi on 19-Jul-2021.  This case is linked to case 2021SA241742 (same reporter).  This case involves a patient (demographics unknown) who received YELLOW FEVER VACCINE - US [YF-VAX] which was mixed with sterile water instead of using sodium chloride (Product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE -lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Wrong diluent used (latency same day).  No adverse event was reported.  It was reported "Caller stated read instruction instead of using sodium chloride to mix YF VACCINE with they mixed the vaccine with sterile water. She wanted to the implications as it has already been administered. Caller transferred to Management Information Systems (MIS). Medical Information Anywhere (MIA) transferred caller. Caller asking how to proceed if Yellow Fever Vaccine was given to 2 patient mixed with the diluent that is used for measles, mumps, and rubella (MMR) and Varicella vaccines, it is sterile water. Caller asking why do they need to revaccinate? Do you have any specific data showing that the sterile water that they used makes the vaccine not work or stable? She asked if this is a general Centers for Disease Control and Prevention (CDC) statement or specific to YF vaccine? Does Sanofi Pasteur have actual data showing why the specific diluent is the only one that can be used? Caller said she was doing inventory and came across 2 extra vials of YF vaccine diluents and she back tracked it to a medical assistant (MA) who gave the YF vaccine with sterile water instead of the supplied diluent to patient. Caller came back on the phone after a long hold and said she would like to wait for the medical director to make the report after they have fully investigated what happened. Medical director will be back in the office next week"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
This spontaneous report as received from a other health professional refers to a 13 month old patient. On 07-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Drop attack. No loss of consciousness, dizzyness,  or loss of balance. No associated symptoms except abrupt fall to the ground, falling to the left on two separate occasions.
patient called 11/11 and told me she was fine the day after her vaccine but yesterday 11/10 experienced a sharp pain into her back and vomiting. she vomited three times that night. she said the pain was a dull achey pain. has not experienced any vomiting or sharp pain since
Myalgia, Arthralgia & Fever Narrative: dose 3 day 1-3- fever;chills;myalgia; ache; fatigue
right sided numbness; tingling to face,lips and arm to fingertips; slight headache within 15 minutes of vaccination; This is a spontaneous report from a contactable nurse. A 55-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: elo140), intramuscularly on 19Dec2020 13:15 at single dose for immunization. Vaccine location provided as Right arm. Medical history included asthma.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight headache within 15 minutes of vaccination on 19Dec2020. On 19Dec2020 13:45, 35 minutes after vaccination reported right sided numbness, tingling to face, lips and arm to fingertips. No treatment was received for all the events. The outcome of the events was recovered in Dec2020. The events were assessed as non-serious.
Hives all over her body; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives all over her body) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced URTICARIA (Hives all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, qhs. At the time of the report, URTICARIA (Hives all over her body) had resolved. Not Provided      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.   No concomitants products were reported.
My son was administered 8 shots at once (4 sticks) on 6-16-08 and within two hours, began screaming, sweating, and crying uncontrollably for over an hour.  He also complained that his arms hurt bad at the site of injection and there are red rashed on both arms.  I gave him a dose of motrin and he took a nap.  He was irritable and and had no appetite all night.  In the a.m. 6-17-08 at 8:00am, he lost consciousness and had a seizure which lasted almost 15 minutes of jerking and staring blankly, eyes rolling back in his head, heavy drooling and then complete unresponsiveness.  He was terrified and so was I. He was then transported by ambulance to hospital and the whole time he was yawning (which the paramedics told me was neurological) and staring blankly. He was monitored and then administered childrens tylenol.  They released us at 11:00 am.