chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer and concerns a male subject of unspecified age; local case Identification number: Med-PVX-201509-065. The subject's weight, height and medical history were not reported. The subject received the first dose of typhoid vaccine oral ty21a (capsule, hard, oral) on 22-SEP-2015 and received the second and third dose on alternative days for prophylactic vaccination. Concomitant medications were not reported. It was reported that the subject would be travelling November. On 25-SEP-2015, the subject experienced urinary tract infection. On the same day, the subject started a seven day treatment with levofloxacin. Action taken with typhoid vaccine oral ty21a was unspecified. At the time of this report, the subject had not recovered from urinary tract infection. The reporter provided no causality assessment. Company causality was assessed as doubtful. This report was serious (medically significant). Sender's Comments: Urinary tract infection: Inconsistent causal association to vaccination, likely coincidental event.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, or concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, lot number, and expiration date were not reported), intramuscularly instead of subcutaneously, for prophylaxis. No adverse effects were reported. Follow up information has been received from the registered nurse via a phone call on 11-APR-2017. A request was made for additional information on the vaccines that were administered via the incorrect route, specifically the lot numbers, expiration dates, patient identifiers and dates of administration. A form which was needed to complete would be faxed to the nurse. Follow up information was received from a licensed nurse practitioner on 14-APR-2017, concerning a 66 years old male patient. It was reported that the ZOSTAVAX (Lot#: M041669) was received on 08-MAR-2017, and was stored in the refrigerator instead of the freezer and the vaccine was inactive. On 31-MAR-2017 at 12:17 pm. The patient was vaccinated with the ZOSTAVAX (Lot#: M041669) intramuscularly in the left arm.. This is one of two reports from the same reporter. Additional information is not expected as all schedule follow up information was received.; Sender's Comments: US-009507513-1704USA007589:
I started to feel really dizzy and lightheaded. I drank a water and laid down. I tried to nap, but was so nauseous I couldn?t sleep. I then got in the shower and ate a yogurt. I still felt super dizzy so I laid back down. I finally was able to nap. I napped from about 2p-7p. I woke up feeling better, but still not 100%. My head felt so heavy.
soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration in left arm on 26Jan2021 08:30 at a single dose for covid-19 immunization.  Medical history was reported as none. There was no other vaccine administered to the patient in four weeks. No known allergies. Patient was not pregnant at time of vaccination.  The patient's concomitant medications were not reported.   On 27Jan2021 at 07:00, patient experienced soreness at the injection site, headache and elevated temperature (100.2 F). Outcome of the events was unknown. Patient was given the vaccine in a workplace clinic.  The patient has not tested with Covid since vaccination.    Information about Batch/Lot number has been requested.
pt exp prolonged screaming/crying for > 3 hrs; pt was given APAP;
Patient woke up with "tingling" all over. Patient called it "like a stroke situation." Patient experienced symptoms and went to ER on Tuesday. Doctors ran test for stroke and stated patient had Bells Palsy. Patient went back in on Friday to do stroke test again to rule out stroke.
Pt. fainted during the 15 minute post-vaccination waiting period pt. was hypotensive, with blurred vision, and upon being placed in a supine position recovered within 30 seconds.
From faxed correspondence received at manufacturer on 8/12/02, it was reported that an 18 y.o. male received Menomune A/C/Y/W-135 vax, administered SC in his left deltoid on 8/8/02. 24 hrs post vax (8/9/02), PT experienced severe headache, fever of 102-103 deg F, sleepiness, nausea, diarrhea, scratchy throat and myalgia for 36 hrs.
Left leg swelling and tenderness to touch 6 days after receiving 18 mo immunizations. Located where DTaP was given. Seen by PCM 3/8/17 to monitor for infection. MOTRIN as needed.
Given vaccine in AM, had adverse reaction around 1430 when he was found unresponsive and in respiratory distress
Pt is only 4 months and was given vaccine that was for 5yrs and up.....
This spontaneous report was received from a physician assistant refers toa 12 month old patient. On 13-SEP-2013, the patient was vaccinated with first dose of 0.5 ml PROQUAD (Merck) (lot number J000137, expiry date 04-JUL-2013, subcutaneous) and first dose of 0.5 ml VARIVAX (Merck) (lot number H010958, expiry date 31-MAY-2014, subcutaneous) at the same visit. No adverse effects were reported. Additional information has been requested.
Couldn't Move Arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Couldn't Move Arm) 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 No adverse event.    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, the patient experienced LIMB DISCOMFORT (Couldn't Move Arm). At the time of the report, LIMB DISCOMFORT (Couldn't Move Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   This case was linked (E2B Linked Report).; Sender's Comments:  Patient case
8/22/98- anthrax #1- < 5mins after the shot- felt clammy, lightheaded, dizzy- lasted 24 hours- denies urticaria, angioedema, pruritus- nl local rxn. 9/5/98- anthrax #2- moderate redness and edema around injection site- lasted 3-4ds- no systemic sxs. 9/19/98- anthrax #3- increased redness and edema around the site- involved most of her upper arm- worse than #2- tenderness around the site- EXTREME pruritus- given atarax- lasted 3-4 ds- no f/c, malaise, rashes, or sxs of anaphylaxis. 2/16/99- anthrax #4- mentioned about rxn to a practitioner- was given motrin/steroid cream/atarax days prior to vaccine- despite pretreatment, experienced same rxn as #3- except less pruritus d/t atarax- no systemic sxs 8/16/99- anthrax #5- pretreated- same rxn as #4- no systemic sxs 2/14/00- anthrax #6- pretreated- same rxn as #4- no systemic sxs
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-DEC-2015 at 09:51, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.6 and 1.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Developed hand & feet shinles the day after the shot, got chills only the first night. Visited Dr on 11/26/2019. Prescribed Valtrex for 7 days & betamethasone dipropionate cream for external use. returned 12/4/2019 to Doctor's prescribed no further treatment.
Shingles outbreak on left arm; lymphadenopathy; Dose received: 3; This is a spontaneous report received from contactable reporter (Physician). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:30 (Lot number: FS1620) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression; "Influenza" (unspecified if ongoing), notes: other vaccine 4weeks product=Influenza. Concomitant medication(s) included: SERTRALINE HCL. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number=EK9231, vaccine location=Left arm), administration date: 08Jan2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, lot number=EH9899, vaccine location=Left arm), administration date: 19Dec2020, when the patient was 35 years old, for COVID-19 immunization; Influenza vaccine, administration date: Oct2021, for Influenza. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 12:30, outcome "unknown", described as "Dose received: 3"; HERPES ZOSTER (non-serious), outcome "not recovered", described as "Shingles outbreak on left arm"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "lymphadenopathy". Therapeutic measures were taken as a result of herpes zoster, lymphadenopathy  Additional information: Shingles outbreak on left arm with associated lymphadenopathy of left axilla (approximately golf ball size). Therefore, the patient received treated with Valacyclovir. The patient was neither diagnosed with Covid prior vaccination not tested post vaccination for Covid. The patient did not had any allergies.  No follow-up attempts are possible. No further information is expected.
3/1/2021  Caller with hx of Afib corrected by surgery woke up at 06:00 this morning with a racing heart like she feels used to feel with her afib. She is also dizzy and having a hard time breathing (observed from exertion of talking while on the call).  No hospital care yet, but a nurse friend said her HR seems irregular to her.   3/2/2021 Follow up call:   Still has difficulty breathing  Patient can't really explain. Felt like she did  when had A-fib.  Palpitations largely Tired This AM, but did not sleep well tonight. Call into Cardiologist for possible appt and further care.   3/7/2021 Follow up call:  Caller is feeling a lot better this week. She is still mildly SOB but her Afib episode seems to have resolved. She has been in continuous contact with her Cardiologist and has an appt. this upcoming Tuesday. They did say on the phone she is not the first person to report this event to them after receiving the COVID vaccine. Caller provides DOB so that this AE can be adequately reported.
Rash appeared approximately 7 days after vaccines were administered. Rash consisted of multiple circular raised erythematous papules over entire body.
I received the vaccine on 2/5/2021 at 0840.  I woke up this morning at 2/9/2021 at  0800 and brushed my teeth.  My tongue has all these white dots on it.
Not feeling well; Arm sore; Fever 103-101.5; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever 103-101.5) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-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 10-Feb-2021, the patient experienced FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever 103-101.5). At the time of the report, FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever 103-101.5) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator No treatment medications provided by the reporter.
1/6 vaccination 1/7  I started feeling light headed and dizzy. Chest pressure. Went to ER. Hypertensive.  Put on medication. Kept as inpatient; observation.
102 fever lasted 4 days, could not lift arm, vomiting, redness, and swelling that was moving down to her arms. Went to doctor 2 times was given antibiotic. She reported to us on 9/25 after her Dr visit and by then fever was down and redness was outside a line where her Dr. made a line around the area. 9/28 no fever, swelling is down and still some redness. Dr added more days to be on antibiotic.
flushing reaction and difficulty breathing. able to speak and was conscious. reaction started about 5-10 minutes post vaccination as patient returned to pharmacy. patient sat while paramedics arrived no treatment administered. no reaction at site of vaccination. patient continued to shop after about 15 minutes
Expired dose given to patient.  Expiration date of vaccine not printed on vial during manufacturing.  After dose was given, lot number was checked against the Janssen website to which it was determined expired on 05/26/21.  The patient has not experienced any adverse clinical effects at this time, two hours after vaccination.
I went to the pharmacy had my covid shot. I waited my 15 minutes and went home. I was feeling well covid arm but it went away. Months later I got Covid. I was out of work for about 2 weeks. I notice it at worked I left home early. I was feeling bad at work. I had a fever for the first couple of days, I was very tired and lethargic. I did have after effect. I had Osteopenia in my neck.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-078782, US-MODERNATX, INC.-MOD-2021-078032 (E2B Linked Report). This case was linked to MOD-2021-081263 (Patient Link).
Significant foggy brain the next day. Struggled greatly at work. I didn't see this listed as a side effect anywhere. I also had fatigue and generally feeling unwell 2 days after the shot
Low grade fever, redness, soreness, and swelling at injeciton site. (3x4cm LD).
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 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid administered from 06Oct2023 to 11Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a licensed practical nurse (L.P.N.) concerning a female who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. After receiving a dose of GARDASIL, the patient fainted and seized. The patient was taken to the emergency room as the result of fainting episode. It was reported that vaccination with GARDASIL was discontinued and then the adverse events improved. The outcome of the events was unspecified by the reporter. The reporter considered syncope and seizure to be other important medical events. Additional information has been requested.
The patient was scheduled to receive the Bivalent booster, however received the Monovalent booster in error.
Patient is a 15 year old female with a history of asymptomatic acute cystitis and restrictive eating behaviors with concern for possible eating disorder. Pt received flu vaccine and lab work and had syncopal event for less than 5 sec. while in office. Then pt transferred to ER via EMS (concern vasovagal vs adverse reaction to vaccine).
p/recv vax pt exp wheaL 6'' long; inj site not affected, but medial; area swollen/red/sore; could not move arm; seen by acupuncturist & treated w/local acupuncture & bleeding methods to release heat; relieve pain/reduce swelling(disappeared
Daily urticaria and dermatographic hives, itchy nose and throat. Treated with antihistamines. Ongoing?
Leaky needle, have patient remaining dose with what he thinks is the full dose; A spontaneous report was received from a pharmacist concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported during vaccination, needle was not fully attached to barrel, competed the dose on the other arm with 0.2mL because pharmacist thought needle was leaked out.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 Jan 2021, the patient received their dose of mRNA-1273 (Batch Number: 038K20A), intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, during vaccination of patient, needle was not fully attached to barrel. The Pharmacist completed the remining dose on the patient's other arm with 0.2mL because Pharmacist thought needle was leaked out.  Laboratory details not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, during vaccination, needle was not fully attached to barrel, competed the dose on the other arm with 0.2mL because pharmacist thought needle was leaked out was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of device connection issue for mRNA-1273, Batch Number: 038K20A with no associated AEs. Causality for the device connection issue is not applicable
MUSCLE ACHES; INJECTION SITE SORENESS; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced injection site soreness. On 11-APR-2021, the subject experienced injection site redness. On an unspecified date, the subject experienced muscle aches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, and was recovering from injection site soreness, and injection site redness. This report was non-serious.
My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep.  Day two the chills were gone but still very achey, weak, tired and headache.  Day three she is still tired and weak with headache.
During monitoring period post Pfizer COVID-19 vaccine, pt experienced Flushing, sweating, chills, dizzy, lightheaded headache. VS: 145/93, P 55, R 25, O2 97%. oMedications Ordered/Given Per Protocol: Benadryl 25mg IM x 1 per patient request, declined Epi-Pen. Patient remained in extended Observation with family member present. VS reassessed: 153/98, P 55, R 22, O2 99%. Patient elected to get lunch after 2 hours in observation. Reported still dizzy and lightheaded. Declined additional treatment. In a wheelchair, patient left the clinic in care of family. Emergency symptoms discussed with patient and family both verbalized understanding.
Patient states she has a slight headache, nausea, dizzy and had an episode of vomiting. She is eating lightly and resting. I advised to call her primary care provider as well to find out if he would like her to try any other treatment, etc.
ON 8/11/21 HAD AN EPISODE OF DIZZINESS LASTING 10 MINUTES, FOLLOWED BY BREAKING OUT IN A COLD SWEAT. A RASH THEN DEVELOPED ON LEFT UPPER ARM, 9 X 5 CM AREA OF ERYTHEMA WITH PROMINENT BORDER, HOT TO TOUCH,NOT TENDER TO LIGHT TOUCH.
Family member called to report that the patient fell extremely ill, less than 24 hours after receiving the 2nd dose in his Shingrix series. He experienced loss of bladder and bowel function, and was cognitively impaired, requiring medical attention.
Chest pains, chest exray, Pulminary Embolism, admitted to hospital early morning of 4-30-21, put on blood thinners, released 5-2-21 afternoon
Patient complained of nausea, shakes, aches, pain and dizziness. Fever unknown. Recommended: fluids, rest, OTC APAP or ibuprofen for fever.
Patient had experienced progressing weakness and tingling in limbs and finally fell at home on 12/12/14 when she went to the emergency room and was admitted to the hospital. She was diagnosed with Guillain-Barre either during her stay or shortly after and has been receiving physical therapy, occupational therapy, has had IVIG infusions, and is currently using a wheelchair as she is unable to walk or stand on her own.  She is in an assisted living facility currently.  Disability level is unknown at this time.
Pfizer BioNTech COVID-19 Vaccine EUA Patient received Pfizer Vaccines on 3/5/2021 and 3/23/2021. Presented to urgent care on 7/24 and had a positive COVID test, started on azithromycin and benzonatate. Patient presented to ED on 7/30 with fever, dyspnea, myalgia, loss of taste, muscle weakness. Patient was initially admitted to the medical floor, on 4 L nasal cannula, but quickly escalated to high-flow nasal cannula and was then transferred to the ICU.  The patient required high levels of oxygen and also developed delirium, as well as had acute kidney injury.  Patient was treated with dexamethasone, terbutaline, remdesivir. In discussion with the patient's primary medical decision makers, including the patient's husband and son, the patient/s status was made a do not attempt resuscitation, but may continue the treatments.  The patient was transferred to the medical wards on high levels of oxygen 60 L and 90% FiO2.  Unfortunately, the patient continued to decompensate and passed away the evening of 8/3/2021. Additional information for Item 9: Atorvastatin 10 mg QD, Azithromycin 250 mg QD, Benzonatate 100 mg TID prn, Cholecalciferol 1000 units QD, Furosemide 40 mg QD,  MagOx QD, Metoprolol 25 mg QD, Mycolog cream BID.