chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: Five minutes after the 1st shot, patient passed out. we laid him down on floor, he came back but very tired, pale, sweating and shortness of breath. we gave him water to drink, one dose of Epipen Jr and called 911. The Epidemics arrived, he did feel better then, can sit on chair for them to check up. His vital signs came up normal, he was observed for 15 more minutes before allow to go home
Minor headache; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot no. and expiration date were unknown), via an unspecified route of administration on 18Dec2020 23:45 on the left arm at single dose for COVID-19 immunization. Medical history included heart stent. The patient had no known drug allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Dec2020 01:00 AM, the patient experienced minor headache and chills. No treatment received for the events. The events recovered on unspecified date in Dec2020.  Information on the lot/batch number has been requested.
Patient developed minor rash 24 hours after first dose; This is a spontaneous report from a contactable consumer (pharmacy intern). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient developed minor rash 24 hours after first dose. The pharmacy intern stated that he has a question about the COVID vaccine, stated that it was reported to him vaguely that a patient received the vaccine and developed a mild rash about 24 hours after the first dose of vaccine and wanted to know if it is okay for the patient to proceed with getting the second dose. He looked online for the information and could not find anything. The event was assessed as non-serious. Outcome of the event was unknown.  Information about Lot/batch no has been requested.
No additional adverse events reported; was administered improperly stored during a temperature excursion; This spontaneous report was 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, allergies, drug reactions, concomitant therapies or medical history provided. On 29-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115 was verified as valid, expiration date: 17-FEB-2022, albumin status: rHa), in dose 0 .5 ml for prophylaxis (dose number, route of administration and anatomical location were not reported). The temperature to which the vaccine was exposed was: 6 degrees of Fahrenheit (F) to 14 F (8.5F) and the time frame was reported as 18 minutes and additionally 6F to 14F (11.9F) for 1 hour. Cumulative Timeframe was 1 hour and 18 minutes. No previous temperature excursion was reported.  It was unknown if digital data logger was involved. No adverse symptoms were reported.
Information has been received from a physician concerning a female who was vaccinated with a series of three doses of GARDASIL. The patient developed cramps after her first two doses of GARDASIL. Subsequently, the patient recovered from cramps. She did not have cramps (type unknown) after the third dose of GARDASIL. Medical attention was sought in the physician's office.
Upon standing up to leave the booth, she turned around to me and was shaking/trembling. She sat back down in the chair. Removed her mask so she could take some deep breaths, was nauseated. At 4:45 began applying ice paks to back of neck,  and wrists.  BP reading at 4:48pm was 175/112 pulse 82. Called 911, took another BP at 4:52pm 185/114. She had dry heaves a few times during this period. The EMTs arrived quickly within about 2 minutes. They took over checking her out. She opted to call someone to take her home to rest. I followed up 4/16/22 6:50pm. She stated she was still shaky and nauseated but a little better. She was sipping chicken broth. I advised she reach out to her PCP and to get attention if symptoms got worse and to let us know at a later time as well.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 23-JUN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 02-JAN-2000 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 464 hours, with the highest recorded temperature of 1 degrees Fahrenheit (1degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT STATED THAT HE BEGAN TO HAVE A LOT OF ITCHING BEHIND HIS KNEES AND ON HIS UPPER ARMS. HE BROKE OUT IN WELTS ON THE BACKS OF HIS ARMS BILATERALLY. THIS OCCURRED ONE WEEK AFTER RECEIVING THE FLU VACCINE. HE SAID THAT THE ITCHING A WELTS WERE BEGINNING TO SUBSIDE.
Patient stated the morning after vaccination he was feeding his cat and just felt faint and "off", he called 911 and the came and brought him to the hospital up where he stayed 5 days and was treated for sepsis.
Extreme pain in her arm from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extreme pain in her arm from shoulder to elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002Az1A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Extreme pain in her arm from shoulder to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Extreme pain in her arm from shoulder to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
On the 13th had red spot. Got smaller on Saturday, the 20th.  On the 21st it came back larger. Went to ER on the 22nd. Was told to take Benadryl and extra strength Tylenol.
sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications was provided by the reporter.
Had redness and swelling in Rt upper arm with aches and fever.  Rt arm measures 1.5 inches larger that LT arm.
Sudden hearing decrease with loud ringing in left ear.  Continued for several hours.  Gone within 24 hours.
2nd dose not administered on day 58 after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not administered on day 58 after the first dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not administered on day 58 after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not administered on day 58 after the first dose) outcome was unknown.        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 concomitant medications are reported.
The ink used to print the lot# and expiration date smears/smudges if the product gets wet. The product can frequently arrive wet from the wholesaler due to ice packs included in the packaging. The quality of the ink used needs to be improved. Otherwise it renders the product unusable.
5 months old female excessive irritability and unconsolable crying more than 5 hours after DTaP was given. Pt. developed fever 102 x 24 hours; mother described high pitched cry; Irritability persisted x 48-72 hrs.
The client came into the clinic with her parental consent to get the Pfizer vaccine.  She recieved the vaccine.  When staff was entering it into database, they noticed that the client had already recieved the COVID-19 vaccine 3 days prior (11/12/2021).  The consent had the parent's signature and the question of whether or not the child had the vaccine before was answered "no". The supervisor called the parent to notify him that the patient recieved the dose of Pfizer 3 days after the initial dose.  No adverse effects have been noted thus far.  The patient weighs 130 lbs.
On 2/23/2021 was very weak and very tired.  She has been this way for weeks.  By March 3/11/21 she was hurting so bad in her back, to her spine that she had to go to ER. they gave her shot for her pain and a prednisone shot.  She was released and given a prescription for 4 days of prednisone 50mg.  She was some better while taking this medication.  She called and made an appt w/ her a Neuro Surgeon.  to get an MRI.   She had an already scheduled appt w/ PCP on 3/24/21 w/ her PCP.  She was given another prednisone shot and prescribed another Medrol pack.  She has completed that medicine and is starting to get pain in spine, the right leg and buttock.  She had an MRI on 3/26 and the results have been sent to her Neuro doctor that she will not see until 5/21/2021 so she called and asked them to be sent to her PCP.  She is waiting to hear back from her PCP.
This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-DEC-2018, the patient who was 2-month-old infant (less than the recommended age) was vaccinated with PNEUMOVAX 23 for prophylaxis (lot # R012360, expiration date: 15-JAN-2020; dose, and route of administration were not reported). No adverse effects were reported.
Fluvirin w/ Thimerosal given to OB pt. LMP = 2/20/2009. EDC = 12/3/2009. Pt does NOT have an OBGYN. Pt NOT hospitalized after receiving H1N1 vaccine. 11/18/09 Medical records received from date 10/26/09 and 11/9/09 DX: IUP. Assessment: WNL, normal pregnancy.
FEVER STARTED AS LOW GRADE 1 HOUR AFTER INJECTION.  ELEVATED TO A HIGH OF 103.7f AT 3 HOURS AFTER.  TREATED WITH ADVIL AND ASPRIN.  LEFT AND RIGHT HAND JOINT PAIN INTERMITTENT, AND PERSISTS TO CURRENT.  TREATMENT HAS NOT BEEN SOUGHT AS IT HAS NOT BEEN NEEDED.
Chills, fever over the course of  20 hours. Tylenol taken every 4-6 hours. Resolved after 20 hours.
Nausea vomitting and fever up to 102 degrees. Had muscle aches, body pain, fatigue.
I noticed that my first adverse event a few days after the vaccine. If I had wine/alcohol the night before, the next day I would have facial numbness, visual disturbance and knife like jabbing pains throughout my body.
Severe Headache. Nausea. Swelling at injection site. Took 2 Benadryl in case it was an allergic reaction.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age. On an unknown date in 2013(reported as unspecified dates), the patients were vaccinated with a dose of VAQTA (lot # H012669, expiry date 17-APR-2015) which was exposed to 30F for 12 hours in 05-AUG-2013. No adverse effects reported. Additional information has been requested.
Within a couple hours of the shot, I developed arm pain at the site of injection. Headache onset was around 7-9pm and initially mild. Pain grew through the night. Headache became a migraine sometime between 4-6am. By 10am the pain was among the worst I?ve felt. Developed low grade fever around this time (about 100.8 F). I took 2 regular strength OTC tablets of Tylenol sometime between 10am and 12pm.  The head pain only lessened a little in severity. Sometime around 3pm the migraine dissipated rapidly. For the following 24 hours, I had no pain but felt lethargic.
first dose 12Jan2021 has not gotten second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose 12Jan2021 has not gotten second dose yet) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CITALOPRAM for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose 12Jan2021 has not gotten second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose 12Jan2021 has not gotten second dose yet) had resolved.
elevation of some labs, including ASTs.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ASPARTATE AMINOTRANSFERASE INCREASED (non-serious), outcome "unknown", described as "elevation of some labs, including ASTs.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a physician/HCP. Pfizer covid 19 vaccine/Comirnaty confirmed. Caller is asking for any information available on the effects of the vaccine and liver enzymes, including what labs were monitored or tested during the clinical trials of the vaccine or available toxicity information. Caller reported his patient had a moderate, symptomatic reaction following her booster dose administration of the vaccine. Caller "Ran her annual labs about five days after that" and observed elevation of some labs, including ASTs. Response provided caller with information from the Landmark trial protocol: LFTs are not required as a routine safety monitoring procedure for all participants in this study.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Almost instantly after getting her 4th Shot, her mouth filled with a pronounced metallic taste.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 16May2022 at 18:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP7534), administration date: 16Mar2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8734), administration date: 06Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (DOSE 3, SINGLE, Lot number: FF8839), administration date: 11Oct2021, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: DYSGEUSIA (non-serious) with onset 16May2022, outcome "recovered" (17May2022), described as "Almost instantly after getting her 4th Shot, her mouth filled with a pronounced metallic taste.". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Almost instantly after getting her 4th Shot, the patient experienced mouth filled with a pronounced metallic taste. Patient stated that it was like her sense of smell from taste smelled like burning rot like something rotten was on fire. It started when she had just sat down to wait 15 minutes. The event tapered off over the course of that day evening. She woke up the next morning it was recovered. She didn't experience palpitations or anything. Metallic taste lasted for 12 hours or less. Patient did not required emergency Room or physician Office visit.
On 8/2/21, client had a reported sudden death in the morning after complaining of "being unable to hear" and dizziness.  EMS was called to the site and CPR was attempted by employees until EMS arrived.  Resuscitation attempts were unsuccessful. Pt had tested positive for Covid 19 approximately one week after the first vaccine was given. She had not been hospitalized.  An autopsy was conducted with reported preliminary report of citing cardiac arrhythmia. PCP name is Dr. was notified.  Medical Director Dr. and she was notified.  Both the Covid 19 and autopsy reports should be available through Hospital.
she lost her balance and fell down; Fell down; More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021); This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (she lost her balance and fell down), FALL (Fell down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BALANCE DISORDER (she lost her balance and fell down), FALL (Fell down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)). On 07-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)) had resolved. At the time of the report, BALANCE DISORDER (she lost her balance and fell down) and FALL (Fell down) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
10/14/21 SEEN IN THE ER AND THEN ADMITTED TO HOSPITAL WITH COMPLAINTS OF SOB, COUGH, BROWNISH SPUTUM. SOME FEVERS REPORTED, DECREASE APPETITIE AND PO INTAKE . ROOM SAT. = 84%. DX WITH COVID PNEUMONIA, ACUTE RESP FAILURE. 10/18/21 DISCHARGED HOME AND WILL FOLLOW UP WITH PCP.  NOTE: NO OTHER VACCINES NOTED WITH IN ONE MONTH. ON NEXT PAGE JANSEEN INADVERTANTLY CLICKED ON AND NOW UNABLE TO REMOVE.
My first injection in 2021 was Jansen; first booster was Pfizer in Oct 2021, and second booster was Pfizer Bivalent in Oct 2022. Started with a cold in the holiday week; tested negative twice. Cold lagged on; woke up on December 9 with a severe headache, sore throat, increased cough and chills.  Fever of 101. Tested positive for covid. Sent Dr. a portal message and she contacted me right away and did a telehealth visit. Prescribed pavlovax. I only took it for two days because it made me feel worse and the taste it gave me in my mouth was horrid.  Headache, fever, chills and sore throat did not last but a few days, but cough is still lingering. Tested negative on December 17.
One week after injection my arm became red and hot and had a rash. The area was the size of a hamburgers bun. I applied cortisone cream and it was gone in three days.
Patient called stating she was having trouble breathing and both arms are sore and she does not feel well. I asked if she had an inhaler and she said yes so I advised her to use it and get to an emergency room.  I called back after a couple of minutes and she was breathing better but not normal. I advised her to get to an er to be seen. She said she would go.