chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, after receiving PNEUMOVAX 23, the patient developed swelling in the arm. It was unknown if any treatment for adverse event was given or if the patient had any lab diagnostic studies performed. The outcome of the adverse event was unknown. The patient sought an unspecified medical attention. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
From initial information received on 06/03/03 from a RN, regarding an adverse event occurring in the US, it was reported that a 42 year old male pt received a dose of TD ADS ADULT, Lot # U0838AA, given IM in the right deltoid on 05/29/03.  The following day, the pt developed a large local reaction of redness, covering his upper arm, soreness and mild itching. The pt also experienced chills, did not have a temperature was afebrile at the time of exam. On an unspecified date, the pt was seen by a physician, in a doctor's office and was prescribed Zyrtec and Zithromax. At the time of vaccination, the pt was taking Keflex. The recovery status was not reported.
Patient fainted after getting up to walk out (possible shock and seizing), patient reported he passed out before due to a vaccination. He woke up after a couple minutes and BP was checked out at 119/80. Paramedics were called and patient refused to be taken to hospital.
has a lump under his left arm in the arm pit area; he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (has a lump under his left arm in the arm pit area) and OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 011J20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised). On an unknown date, the patient experienced AXILLARY MASS (has a lump under his left arm in the arm pit area). On 29-Sep-2021, OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised) had resolved. At the time of the report, AXILLARY MASS (has a lump under his left arm in the arm pit area) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.
The patient developed aseptic meningoencephalitis with symptoms starting 10 days after the Flu Mist vaccination.  Had headache and cognition deficits.  Lumbar Puncture consistent with aseptic meningitis with a lymphocytic pleocytosis, MRI with meningeal inflammation, non specific EEG.  Was treated with empiric antibiotics and has made a gradual full recovery.
C/o aches & difficulty moving around-no other problems, ran blood tests; pain in joints; Inflammation in joints & rash;
Pt had a seizure within a few days (before 08/01/01) of receiving her 4 month old shots on 07/27/01. This has turned into epilepsy that is treated with Depakote. The 60 day follow-up states epilepsy (seizures) which requires blood work and twice daily doses of Depakote (1.5ml each) and Canitor 1/2 t. twice daily and frequent doctor visits to pediatric neurology.
Resting heart rate rose to 135 to 150 beginning an hour after injection and lasting for about 15 hours.; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received bnt162b2 (Pfizer; formulation: solution for injection; lot number: EN6203), dose 2 via an unspecified route of administration, administered in right arm on 01Mar2021 at 11:30 as dose 2, single (at the age of 77 years) for covid-19 immunisation. Medical history included pericarditis and atrial fibrillation from Jul2020 and unknown if ongoing. Patient had no known allergies. Concomitant medications included hyoscyamine and atorvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no covid prior to vaccination and patient did not test for covid post vaccination. The patient historical vaccine includes BNT162B2 (Pfizer; lot number: EM9809) dose 1, single (at the age of 77 years) on 08Feb2021 at 11:30 for covid-19 immunisation. The patient reported that the resting heart rate rose to 135 to 150 beginning an hour after injection and lasting for about 15 hours on 01Mar2021 at 12:30. Patient did not receive any treatment for the event. The outcome of the event was recovered in Mar2021.  No follow-up attempts are possible. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted about 2 minutes after administration. EMS was contacted and vitals were normal when checked by EMS personnel.
Slight rash and itching at injection site a week after shot, like a large flea bite
Flu-like symptoms 6/22/2022. Tested positive for COVID-19.
3/14/23 mild fever.  3/15/23 Rash on face, torso and back and top of legs.  Diagnosis from PCP and topical Calamine lotion.
Persisting diarrhea; nausea; tiredness; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Persisting diarrhea), NAUSEA (nausea), FATIGUE (tiredness), VOMITING (vomiting) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIARRHOEA (Persisting diarrhea), NAUSEA (nausea), FATIGUE (tiredness), VOMITING (vomiting) and CHILLS (chills). At the time of the report, DIARRHOEA (Persisting diarrhea), NAUSEA (nausea), FATIGUE (tiredness), VOMITING (vomiting) and CHILLS (chills) 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.
Received at 11:20 a.m. on March 8,  Woke at 2:30 a.m. March 9 with slight fever, muscular aches, headache, chills and nausea.  This went on until around 9:00 p.m. that same day, March 9.  I then took 2 Advil and went to sleep.  When I woke up this morning, March 10, I was perfectly fine.  My temp was back to normal..  I had heard you could have a slight reaction and I am usually pretty tough about being sick of which I am rarely.  But this one hit pretty hard.  I did not even get out of bed the entire time except to use the restroom.  I am not complaining, I just thought I would report my reaction if it would help.  I am absolutely thrilled that I received the vaccine and also the place that I received it was wonderful.   Everyone was very kind and efficient!  I was truly impressed and I will continue to encourage everyone I can to receive the vaccine.  Thank you.
pt was given 0.2ml of the pediatric pfizer vaccine but the original vial was not diluted as required. pt has no adverse reaction we are following this person and mother was informed
urticaria lesion @ site, 5x7 cm, tx DPh po, lesion on lt anterior thigh;
This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-SEP-2017, the patient received an adult dose of ENGERIX-B. On 19-OCT-2017, the patient received a pediatric dose of RECOMBIVAX HB 2.5/0.5 (units not provided) (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No product quality complaint has been filled.
Headache, nausea, extreme chills, muscle soreness at injection site and all over body, fatigue. Treated with ibuprofen.
6/28/03 headache, nausea, dizziness, chills, cold sweats, temp 100 deg F. Seen by PMD 7/1/03 sxs resolved. Pt also had appetite decrease, fatigue. Groin tenderness.
Moderate hives head to toe x 7 days; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3248) via an unspecified route of administration administered in left arm on 21Jan2021 at 18:00 (at 59 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included multivitamin, calcium, magnesium, zinc, and vitamin D3, all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER5730) via an unspecified route of administration administered in left arm on 31Dec2020 at 15:45 (at 59 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient experienced moderate hives head to toe x 7 days on 23Jan2021 at 18:00. The event resulted in physician office and emergency room visit. The event was considered medically significant. Treatment for the event included methylprednisolone sodium succinate (SOLU MEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) via intravenous twice. Outcome of the event was recovered on unspecified date.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported event cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dizziness, Headache, numbness in the head, hands; feeling cold, sensitive to temperature, tired. Narrative:  The employee stated that he will not need to see ED provider at this time. He will, if sx get worse. Was advised to seek care from PCP, and alert Occupational Health if any changes. The employee in agreement.
Initial solicited report received on 01 June 2018 from an investigator participating in the below mentioned study. This non-serious case involves a 19-year-old female subject who had palpitations, sation of lump in throat- panic attack during the study participation. The subject had medical history of palpitation, anxiety and panic attacks. The subject received concomitant medications of MIRENA IUD inserted previously in uterus IUD in place for birth control (ongoing), alpha-amylase swine pancreas, cellulase, lipase, protease (Digestive enzyme) 01 cap QD orally for digestive health (ongoing). On 01 June 2018, same day after receiving 0.5 ml single subcutaneous dose of STAMARIL (batch number: N3H32) on 01 June 2018, 0.5 ml single intramuscular dose of Td Vaccine (batch number: U5883AA) on 01 June 2018, 0.5 ml single intramuscular dose of HPV vaccine (batch number:N019104) on 01 June 2018, 1.0 ml single intramuscular dose of Hepatitis A vaccine (batch number:4h374) on 01 June 2018, the subject had palpitations, sation of lump in throat- panic attack. Subject received four vaccine as above at 01:20 pm on that day. At 01.50pm, after coming cilic she developed acute onset of palpitations, fig of perpending dorm, sensation of lump in throat, felt like could not swallow/breath. Subject rened to clinic. Examined at 02 pm/ exam of- rrnl, hrnl,bp nl, heart/lungs clear, nish/urticarial/no swelling of throat/face. Observed in clinic for 45 mins. Symptoms resolved after 15 to 20 min. no evidence of reaction. Subject stated that to vaccines- she felt it was a panic attack. The corrective treatment was not reported. The event of palpitations, sation of lump in throat- panic attack was resolved on unknown date of June 2018. The causal relationship of the concomitant medication with the event was not reported. Relationship to investigational product according to company: not related. Relationship to investigational product according to company: not reportable. List of documents held by sender: none. Sender's Comments: A 19-year-old female subject who had palpitations, and sensation of lump in throat- panic attack, on same day after receiving STAMARIL Vaccine. She also received MMR vaccine, Td Vaccine and Hepatitis A vaccine concomitantly to study vaccine. She had significant history of palpitation, anxiety and panic attacks. Based on the available information, the sponsor assesses the event to be not related to the study vaccine, in agreement with the investigator.
Rash started at 8 pm, spreading all over trunk, sparingly axilla, flank. Urticaria.
pt recvd vaax 1MAR93; 2MAR92 recvd call that pt was in ER in asystole; found not breathing;
I began to experience wheezing in my chest about 12 hours after vaccine . After 14 hours, I took claritin-d and singulair to help my breathing.  Within 15 hours, my eyes were red and began to ache and swell. After 22 hours, my eyeslids (upper and bottom) were swollen , teary, and had crust around the eyelids. I also experienced a headache so I took some tylenol. Headache has mostly subsided but my eyes are still achy and swollen.
On the afternoon following the vaccine, patient noted swelling and itching of upper arm originating at site of influenza injection. Parent gave him Benadryl, swelling continued to grow; at peak arm swollen shoulder to elbow. Parent took child to Urgent Care clinic.
Fever, vomiting, headache, cough, husband wasn't to take pt to ER if possible.
Itchy; metal taste reduced smell.reactions; metal taste reduced smell.reactions; very hard reaction to the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), DYSGEUSIA (metal taste reduced smell.reactions), HYPOSMIA (metal taste reduced smell.reactions) and VACCINATION COMPLICATION (very hard reaction to the shot) in a patient of an unknown age and gender 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, the patient experienced PRURITUS (Itchy), DYSGEUSIA (metal taste reduced smell.reactions), HYPOSMIA (metal taste reduced smell.reactions) and VACCINATION COMPLICATION (very hard reaction to the shot). At the time of the report, PRURITUS (Itchy), DYSGEUSIA (metal taste reduced smell.reactions), HYPOSMIA (metal taste reduced smell.reactions) and VACCINATION COMPLICATION (very hard reaction to the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information were provided.
prior to vax pt c/o feeling warm, cheeks flushed, t99.7;p/vax cheeks remained flushed but pt was crying & shaking;pt hadn't eaten so given H20 & a cookie;c/o feeling faint, mom lowered pt to floor;
After the initial soreness and mild itching at the injection site, the symptoms subsided for two weeks. Two days ago (2/17/2021) the symptoms returned along with redness at the injection site. The area is also warm to the touch.
unable to blink left eye and move left side of mouth. Right side face looks dissformed.; Stiffness; swelling of face; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162b2 (BNT162B2), via an unspecified route of administration administered in right arm on 29Jan2021 at 14:00 (Batch/Lot Number: EN5318) (at the age of 68-years-old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included previous cancers, and known allergies: shrimp. The patient has no COVID prior to vaccination and unknown if patient was tested for COVID post vaccination. Concomitant medications included lisinopril, levothyroxine sodium, atorvastatin calcium and acetylsalicylic acid (ASPRIN), all taken as of two weeks for an unspecified indications, start and stop dates were not reported. The patient previously took olmesartan medoxomil (BENICAR) and ciprofloxacin (CIPRO) and experienced allergy. The patient did not receive any other vaccine in four weeks. On 27Feb2021, the patient experienced stiffness, swelling, of face, unable to blink left eye and move left side of mouth. Right side face looks diss-formed. Treatment for the events included Prednisone and Valacyclovir. Relevant tests and procedures included X-Rays and Computerized tomography (CT) Scan on an unspecified date in 2021. The events resulted in a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Severe Hair Loss (May be due to COVID Positive); Difficulty getting up and going to the bathroom; Low stamina, her Body was weak; Headache; Severe chills; Fever 100F to 101F; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Severe Hair Loss (May be due to COVID Positive)), HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache) and CHILLS (Severe chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache), CHILLS (Severe chills) and PYREXIA (Fever 100F to 101F). On 04-Apr-2021, the patient experienced ALOPECIA (Severe Hair Loss (May be due to COVID Positive)). On 28-Mar-2021, HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache), CHILLS (Severe chills) and PYREXIA (Fever 100F to 101F) outcome was unknown. At the time of the report, ALOPECIA (Severe Hair Loss (May be due to COVID Positive)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positve (Positive) she had Patient had COVID Pneumonia towards end of JAN2021, a positive PCR test, and  was Hospitalized.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she had COVID Pneumonia towards end of JAN2021, a positive PCR test, and was Hospitalized.   No relevant concomitant medication information was provided by the reporter.  No relevant treatment medication information was provided by the reporter.  Patient wanted to know whether the second dose will have more side effects.   Reporter did not allow further contact