chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hours, I developed intense, severe pain in my lower back. It was localized, but almost crippling. I was not able to get out of bed for the first day without great pain. As a result, I missed a day of work and had to take it as sick leave. It took a week for the pain to subside.
Severe pain while shot being given. I noticed that the injection was given very high on my left arm, seemed higher than the deltoid muscle. It was almost at the top of my shoulder. I expected my arm to be somewhat sore that day, and it was. That evening when I went to bed, pain in my same arm awakened me. Thought that was a little odd. Since then, Dec. 10th, 2018, my arm has not been the same. I have given it some time, thinking maybe I was just very sensitive, but at this point, I am having trouble moving my arm. There is pain from shoulder down and quivering at times. It has awakened me every night. I called out of work today. I have not contacted a physician yet, because I thought it would resolve and it was Christmas - very busy time. I called insurance provider today, my insurance provider and they advised me to contact Rx company- since that is who contracted with the Pharmacy where I received the vaccine. Was having a hard time getting through to them. I read my paper work from pharmacy and found this contact.
Child received 0.2mL dosage for 2nd dose of primary series (orange cap Pfizer formulation), but should have received (purple cap Pfizer formulation) of 0.3mL.  First dose was 0.3mL, 2nd dose was 0.2mL.
30 MINUTES AFTER IMMUNIZATION WHEN PATIENT GOT HOME..A WELT ABOUT THE SIZE OF A BASEBALL APPEARED ON HER UPPER CHEST AND MOVED UP TO MOUTH AREA. WENT TO MD OFFICE WHO GAVE HER A EPIPEN SHOT...THE EPIPEN RAISED HER BP TO HIGH AND SHE WENT TO THE HOSPITAL WHERE THEY OBSERVED HER FOR 2 HOURS, THEN SENT HER HOME.
Day after:  nausea, sore arm, joint pain, tired, HEART STRAIN  Days later:  hot flashes day and night, heart palpitations, anxiety, diarrhea, stomach aches   No  period since first shot.
Pain In arm after shot for 4 days. Extreme sickness after 2nd shot. Throwing up and chills. Irregular periods. Heavy bleeding. Miscarriage in December, trouble conceiving due to irregular periods
Patient came over and said she didn't feel well. Said she was feeling warm and light headed. Had her sit and observed and spoke to her asking questions about her symptoms. She started to feel well. Kept observing in store over 20 min. She felt better by that time.
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS SITTING DOWN WHEN SHE FAINTED. SHE HIT HER HEAD LIGHTLY. SHE WAS UP IN A COUPLE OF SECONDS. WE CALLED 911 BUT AFTER CHECKING HER THEY LET HER STAY FOR A FEW MORE MINUTES AT THE STORE, SITTING DOWN. WE GAVE HER WATER AND AN ICE PACK FOR HER HEAD, AND WHEN SHE SAID SHE WAS FINE, WE LET HER GO HOME.
swelling rt arm measuring 16" in relation to lt arm of 14" w/hard, red indurated area the evening p/4th dose in series;
SHINGLES STARTED AROUND 4/10/21, DX 4/12/21. PRESCRIBED VALACYCLOVIR. CURRENTLY RECOVERING.
Pain at injection site, headache, fever, nasal/sinus congestion and cold sweats.
Pt. was given her Pfizer COVID vaccine 2 months too early. As of 9/9/21 Pt. has not experienced any adverse effects.
enlarged heart; booster; his oxygen level this morning was in the 80's and is on oxygen now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1,Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for covid-19 immunization. The following information was reported: CARDIOMEGALY (hospitalization), outcome "unknown", described as "enlarged heart"; IMMUNISATION (hospitalization) with onset 27Sep2021, outcome "unknown", described as "booster"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "his oxygen level this morning was in the 80's and is on oxygen now". The event "enlarged heart" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: 80. Therapeutic measures were taken as a result of oxygen saturation decreased.  Additional Information: Caller reported her husband started to have issues at 12:01 AM this morning. Caller reported she took her husband to the clinic and he was taken to the hospital from the clinic by ambulance. Caller reported her husband is in the hospital now. Caller reported he was tested and found he has an enlarged heart. Caller reported his oxygen level this morning was in the 80's and is on oxygen now. Caller stated she first did not think it was related to the vaccine but found out her sister that got her booster around the same time had  similar issues and also had an enlarged heart after the vaccine so she thought it might be related to the vaccine. Caller asked are there reports of occurrences 3 months after the booster. Caller asked is this a common occurrence for anyone else.  The lot number for bnt162b2 was not provided and will be requested during follow up.
came down with COVID; came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: Drug ineffective (medically significant), COVID-19 (medically significant) all with onset 01Sep2022, outcome "recovered" (Sep2022) and all described as "came down with COVID". Patient's husband reported that his wife (patient) came down with COVID on 01Sep2022 and was for two weeks; by the end of Sep, she was over it. They had an appointment for the new Bivalent booster on 27Oct2022. Patient's husband wanted to know if they should wait longer before they get their second booster. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256055 same reporter/products/AEs, different patient;
nausea, dizziness & itching all over body w/in 10 minutes of dose; observed for 15 mins; no progression of sx; itch is still present;
Pt received 0.3 ml of the Pediatric formulation, and therefore was under-dosed.
At 9:30pm I experienced an immune response consisting of chills fever vomiting body aches migraine and extreme fatigue lasting about 36 hours. The injection site contained a ping pong ball size knot that was warm to the touch and painful. These symptoms prohibited me from performing my job duties for 36 hours. On the morning of April 16,2021, I had a 2nd wave of massive blood clots, heavy bleeding, debilitating migraine, body tremors, blurred vision, numbness and extreme cold sensation in my extremities. Hands and feet swollen and stiff, face was puffy under eyes bruised due to swelling. Brain fog and confusion. Severe tinnitus and vertigo referred to as abnormal gape. At  4:00PM on 04-16-2021 the confusion was so bad that I did not know who she was. I was unable to speak and we went to the emergency room. I was unable to remember my name or date of birth nor was I able to understand what they were relaying. Upon triage my blood was 198/134. Heart rate was 91. A physician came to triage and completed initial stroke evaluation. Stated mild neurological damage. He was concerned regarding cognitive and motor skills. A stroke and heart attack crash cart was administered and everything came back normal. ER physician attempted multiple emergency medications to stabilize blood pressure. Due to uncontrollable hypertension and other issues, I was admitted to ICU for a 12 hours period. I was sent home after my bp stabilized for 2 hours. After 24 hours, my blood pressure spiked again and I experienced a TIA-Transient Ischemic Attack. I called my primary care provider who instructed amlodipine, meclizine, & clonidine. I have had recovered, I am scheduled to see a rheumatologist on Monday for a systemic medically induced Lupus. 8 blood pressure medications were administered that did not work during this time frame. After BP medication was overly administered, I experienced a seizure. I am still experiencing all the issues along with confusional migraines.
Patient received a 4th dose; 3rd dose outside recommended schedule; 2nd dose outside recommended schedule; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-week-old female patient who received HBV (Engerix B) (batch number 39A3L, expiry date 23rd February 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 18th May 2022, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 13th April 2022, the patient received the 3rd dose of Engerix B. On 31st August 2021, the patient received the 2nd dose of Engerix B. On 31st August 2021, not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device and Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On 13th April 2022, the patient experienced drug dose administration interval too long. On 18th May 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, drug dose administration interval too long and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: Clinical coordinator stated that a patient received a 4th dose of Engerix-B on the day pf reporting. The patient received 1st dose on 22th July 2021.  No lot number available for 1st 3 doses that were not administered per recommended schedule as not asked prior to disconnecting the call. The reporter consented to follow-up via postal. Additional supportive information: The patient received a 4th dose of Engerix-B today (day of reporting), which led to extra dose administered.  The patient received 2nd and 3rd doses of Engerix B later than the recommended interval, which led to lengthening of vaccination schedule.
Same day and following day weakness and pain in my legs.  Continuing for weeks additional weakness in my legs.  This caused a fall and swollen painful right foot/ankle.
Day after injection noticed swelling & warmth at injection site.  Came into office 3 days later still with pain, swelling & redness at injection site.  1 1/4" x 3" edematous area.
side effects began with severe chills/shivering, followed by nausea (I could not eat anything for 40 hours), pounding headache, soreness in all major muscle groups (esp. legs), weakness in right leg (which is already weakened by MS, but seemed to be enhanced), a "full stomach" feeling near the top of my stomach that borderlined painful, extreme fatigue, bizarre racing thoughts when I tried to sleep.
Fever, swelling of arm in area of injection, pain, itchiness. Blew up to the size of a baseball flattened out. Redness as well. KEFLEX and steroids
Fever up to 103, severe chills, body aches, headache for 3 days. swollen and red at site of inject (3x4 inches) (still there after 6 days).  heart racing, heart pounding, chest tightness, difficulty taking deep breath times 3 days heart skipping beats often, still occurring after 6 days
Information has been received from a healthcare worker concerning a 21 year old female with no allergies who on 12-AUG-2008 was vaccinated with a first 0.5 ml dose of GARDASIL intramuscularly in the deltoid (lot number not reported). On 12-AUG-2008 the patient developed itching to her left foot then redness and swelling to both hands. Unspecified medical attention was sought. The patient's events persisted. Additional information has been requested.
Pt given varivax on 09/05/02 Pt developed break through varicella on 11/16/05
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date lot #GL0447. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into Epic prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and reconciliation o Training on how to enter information into Epic when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Information has been received from a health professional concerning a patient (34 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Bleeding at injection site followed by muscle pain for 2 days. Then severe pain and inability to move right arm in an upward motion, with muscle failure began on Tuesday morning 10/17/2017. It has not improved. I have limited mobility in my right arm and constant pain. I have placed a call in to my doctor today and await a response.
I was fine the first day, but had pain in my right leg on the second day. It radiated down the entire leg, with the greatest pain in the hip. In bed, I would wake up when I turned over and put my weight on the right leg. Then, when I walked, I could not keep my right foot going straight, i.e., the foot would turn out at a 45 degree angle away from my left leg when I would step down. It was as if I had a "club foot." Dr. gave me some prescription strength Tylenol for the pain. I took those pills twice a day for two days and the pain was gone. However, it took at least two weeks before I could control my right foot when walking. (I have a dog and walk several miles per day.) FYI: I had a herniated disk in my back several years ago and pain radiating down my right leg. This pain was different -- not the sharp pain of a pinched nerve, but more of a muscular pain.  Also: During the several weeks my foot turned out when I walked, if I stood still and gently lifted my right leg and put my foot down in front of me, I could prevent it from turning. But the minute I walked, it just turned out. Very strange. I do not know if this was a result of the Covid vaccine, or just some strange muscular problem that basically cured itself.
chills; funny taste in mouth; body aches; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), TASTE DISORDER (funny taste in mouth), MYALGIA (body aches) and INFLUENZA LIKE ILLNESS (flu-like symptoms) 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 CHILLS (chills), TASTE DISORDER (funny taste in mouth), MYALGIA (body aches) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, CHILLS (chills), TASTE DISORDER (funny taste in mouth), MYALGIA (body aches) and INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
no adverse event; Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021) and NO ADVERSE EVENT (no adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-651138 (Patient Link).
Patient was flushed, warm to touch, shivering, redness and urticaria to his face, trunk, arms and inner thighs. BENADRYL 12.5 ml given PO. Symptoms resolved and discharged at 11:39.
Fever; Was Tired; 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 PYREXIA (Fever) and FATIGUE (Was Tired) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Was Tired). At the time of the report, PYREXIA (Fever) and FATIGUE (Was Tired) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
devel fever 103 1 hr p/vax; later began vomiting which has cont'd to present; MD has called in rx for Phenergan supp;
Throat swelling, hard to breathe.  Took 2 Benadryl immediately.
pt was given flublok  0.5 ml instead of  flu 0.5ml
About 20 minutes after shot face was feeling very flush and left cheek was tingling. I was driving home and noticed the red flush and extreme warmth on cheeks spreading down toward neck. 15 minutes later at home noticed the red had covered my neck, chest, and injection site as well, had also moved up face toward forehead. At which time I went to the ER and the injection site has closed right after my shot and my primary care office was unable to assist.
WEIRD DREAMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On 20-MAR-2021, the subject experienced weird dreams. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weird dreams was not reported. This report was non-serious.
16OCT95 pt recvd vax & exp inner arm pain-no moving arm;19OCT95 swelling over area diff raising arm;pain radiates down arm; tingles in ringing in little finger lt hand;
tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The patient reported that the patient had taken the first doses of the vaccine and asked for how long do the patient have to wait to get the booster dose of the vaccine.  Company comment: This case concerns a female patient with no reported medical history who experienced non-serious unexpected  of SARS-CoV-2 test positive, that occurred unspecified time after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history who experienced non-serious unexpectedof SARS-CoV-2 test positive, that occurred unspecified time after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.