chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up with severe tinnitus/ringing in the ears the morning after the vaccine and it has not stopped.
More aches than usual; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (More aches than usual) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (More aches than usual). At the time of the report, PAIN (More aches than usual) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.
Information has been received from a physician concerning a female on an unspecified date who was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported).  Subsequently the patient fainted after receiving the vaccine.  The patient felt better after 20 minutes and left the office.  Subsequently, the patient recovered from fainting.  Additional information has been requested. Follow-up received 07/11/2008.  Vaccinated 30-JAN-2008 in the left deltoid, lot #659962/1740U. The patient had not eaten, but improved quickly after drinking juice. Additional information has been requested.
Says he had ADR (tremors) after he had HD flu shot. Had to go to hospital.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, no adverse event). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information received as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient received 2 doses of SHINGRIX. The patient was fine with the first shot but after the second shot the patient had flu like symptoms for a couple of days. The patient received the 1st dose at different location than the 2nd dose. The reporter gave limited information.
DTaP administered LD on 4/29/04. On 4/30 mom called exp that child's left arm swollen/red. Pt's mom gave child tylenol and applied cold compress. I had mom come in to see RN on 4/30. Area still slightly red/ swollen. Afebrile. Per MD to  continue tylenol/ benadryl PRN.
family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms). At the time of the report, VACCINATION COMPLICATION (family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided. Patient reported that her family and friends that all got Moderna vaccine, some had virus prior to or after, blood type O was significant in symptoms. Patient said that the type O blood recipients had lesser of reaction.
after vax pt was extremely sore & had extreme flu like sxs up to 10 days post vax; soreness still present, flu still present, also pneumonia
Muscle pain started with heaviness and stiffness around the injection site in left arm in the evening of being injected.  By day two muscle pain had spread to the top of the deltoid and around shoulder joint. Through the sixth day it centralized in two knots at the topmost trapezius/supraspinatus and semispinalis capitis. The worst was day seven when the pain began to extend up and down the left side of the spine. On days eight and nine, the pain left the spine and started migrating back toward the shoulder and the knots of pain diminished. By the tenth day (today) it has localized again in the deltoid/shoulder joint and injection location. Note: No fever at any time. It appears I am recovering.
36 hrs after vaccine pt had severe chest pain and SOB. Went to ER, Neg EKG and neg CXR. Symptoms resolved on their own.
Patient's guardian provided DOB for patient making the patient 8 years of age. Verified the name and DOB in the room with guardian, guardian stated this was correct. Per immunization record the patient needed Tdap vaccine for incomplete Dtap series because he was older than 7. After injections given and patient was checking out, guardian stated a different DOB, making patient 6 years of age and ineligible for Tdap that was already administered.
tired; not feeling well; nausea; dizziness/almost passed out; This is a spontaneous report from a contactable nurse and a consumer. A 46-year-old male patient received the first dose of BNT162B2 (lot number: EL3247, expiry date: 31May2021), via an unspecified route of administration in left deltoid on 15Jan2021 12:56 at single dose for COVID-19 immunization. Medical history included had allergies as a child and carried as an epi pen. Concomitant medications were not reported. Reported to the waiting area for 15 minutes observation and left then came back to facility at 14:05 was not feeling well, reported dizziness and nausea. RN assessed patient, vital signs 122/84, pulse was 78 and O2 97 on room air, respiratory rate was 20, alert and oriented, was monitored for 30 minutes, reassessed at 14:25 188/76, heart rate 76, respiratory rate 18, O2 sats 98% on room air, encouraged patient to follow up with PCP or ER. Patient walked out with companion and stated he was feeling better. On 18Jan2021, patient was called for follow p, only complained he was as still tired, all other side effects had resolved. Stated he almost passed out upon coming back to the observation unit on 15Jan2021. Reporter stated it was noted that when patient returned for 2nd dose, would monitor for 45 minutes. Outcome of the event tired was not resolved, of event not feeling well was unknown, and of other events was resolved.
Initial report received from a healthcare professional on 08 September 2011. A 28-year-old pregnant female patient had received a dose of ADACEL (lot number C39385AA) on 26 August 2011. The exact date of the last menstrual period was reported as an unknown day in July 2011 with estimated date of delivery on an unknown date in April 2011. The patient had no known risk factors, and does not use alcohol or tobacco, and denied any use of recreational drugs. The patient has not experienced any adverse events since being vaccinated with ADACEL on 26 August 2011. Follow-up information was received from a health care professional on 05 March 2012. Based upon the new information provided, this case has been upgraded to serious. The patient's last menstrual period was 20 July 2011. The patient experienced a miscarriage on 08 September 2011, approximately 2 weeks after Tdap. On 08 September 2011, the patient had an ultrasound that showed thickened endometrial lining with no intrauterine pregnancy (IUP) and the patient's beta human chorionic gonadotropin (BHCG) was 84. The patient had no illness at the time of vaccination and no adverse events to prior vaccinations. The patient had no family history of congenital abnormalities. The patient's concomitant medications included prenatal vitamins. The patient's outcome was not reported. Documents held by sender: None.
slept most of the next day; Soreness at the injection site; chills and uncontrollable shivering severe afternoon; very lethargic; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 19Feb2021 11:00 (Lot Number: EL9267) (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. Medical history included chemotherapy from Apr2020 to Jun2020 for diffuse large B-cell Lymphoma, pneumonia from Apr2020 to Aug2020, hospitalized 3 nights for pneumonia (not covid-19 tested negative eight times in 2020). Concomitant medications included meloxicam taken for an unspecified indication from 3 years ago and ongoing; latanoprost taken for an unspecified indication from 1 years ago and ongoing; paracetamol (TYLENOL) taken for an unspecified indication from many years ago and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 22Jan2021 11:00 (Lot Number: EL9263) (at the age of 73-years-old) as dose 2, single for covid-19 immunisation and experienced lethargic, no appetite, no bowel movements, soreness at the injection site, chills and uncontrollable shivering, kept awake and slept most of the next day and fever. The patient was very lethargic, chills and uncontrollable shivering severe afternoon on 19Feb2021, day of and day after injection. On 20Feb2021 day after injection, patient had soreness at the injection site and slept most of the next day. The patient did not receive any treatment for the events. Patient was not admitted to hospital due to event. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Patent States: My arm was is in pain and it was a bright red where the shot was given. There was a big bruise and swelling the size of two golf balls. My arm was also numb and my fingers were also tingly. It hurts to lift my arm. My neck and shoulders are in pain and I have a severe headache. It also hurt to move my army up and down and my neck hurt to turn left to right. I still have a bruise and my arm is still hurts four days later.  On Sunday, day two of the symptoms, I called the Nurse Hotline and I was informed to go to Urgent Care.   I went to urgent care about the reaction and symptoms that I was having. They informed me that it might be Cerratis and prescribed me Docycline and informed me to go back to talk to the medical facility that prescribed the vaccination.
shingles; pain; tired; rash that went back and forth on his arm and back; This is a spontaneous report from a contactable consumer (patient wife) and a contactable consumer or other non hcp (patient) via medical information team. A 80-year-old male patient received first dose of bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 29Jan2021 at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Jan2021, the patient experienced rash that went back and forth on his arm and back. On an unspecified date,The patient experienced shingles, pain and tired. It was reported that caller's husband was 80 years old and had his first dose on 29Jan2021 and two days later came down with a rash that went back and forth on his arm and back. Once the rash got worse, he went to the ER and they said it was shingles. Caller stated they have been to 12 different doctors and on prednisone and a few other medications since then. Caller stated he was having a lot of pain and asked what could be done to alleviate all of this. Caller stated he gets tired easily and never did before, he goes outside to work in the yard and gets very tired, asked was that normal. The patient (caller's husband) received his second dose 10 weeks after his first dose. He states he gets tired real easily and his balance wasn't what it used to be. The patient stated when he worked hard with his right arm with a wheelbarrow it seems to flare up and in the 90 degree heat it did the same thing, and asked what can he done to get rid of this. Patient states he has been to 12 or 14 doctors and none of them "knew crap". The patient states it was from the base of his neck down to his right arm and thumb and forefinger and his arm was like a piece of leather. Patient asked if they can give information to his physician. Patient stated he got the covid shot and got shingles that was still there but was not contagious after a week and had all this pain and had shots and medicine. Caller asked how long will this last. Caller stated they know one fella who has pain in his right arm after the Covid shot, shingles is being affected from the shot. Caller's husband asked if he was supposed to take the booster. Responded a third dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) administered at least 28 days following the second dose of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Therapeutic measures were taken as a result of shingles, pain, rash that went back and forth on his arm and back. The outcome of the event shingles was not recovered. All other events were unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache, nausea, body aches. Lasted until 3/27/2015. Felt crummy those days. First 3 days went nowhere as felt awful.
PT STATED THAT SHE FELT THE VACCINE WAS INJECTED TOO HIGH ON HER SHOULDER. SHE HAS BEEN EXPERIENCING PAIN FROM INJECTION SITE RADIATING TO FOREARM; SHE ALSO EXPERIENCE INSOMNIA THE NIGHT AFTER VACCINE WAS ADMINISTERED.
Severe nausea, vertigo, chills, vomiting soreness at injection site.
patient accidentally received a second dose of Shingrix at less than the recommended interval.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 33a2z, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 02-AUG-2023, the patient received the 2nd dose of Shingrix. On 02-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient accidentally received a second dose of Shingrix at less than the recommended interval.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: Receipt date: 07-AUG-2023 The reporter called in to report that a patient accidentally received a second dose of Shingrix at less than the recommended interval. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received 2nd dose of Shingrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
I experienced intense chest pain and shortness of breath and had to go to the ER. The doctors checked to see if there were any issues with my heart and lungs (tests came back negative). I was given an Albuterol inhaler for the shortness of breath for a few days and to follow up with my PCP. I have an appointment with my PCP scheduled for. 10/18/2021 as a follow up for the shortness of breath.
Mom called reported red bump on left thigh low-grade temps present. Patient developed reactions 9 day later after receiving MMRV and PCV13 on (L) thigh.
Patient received less than full dose of booster vaccine on 09/12/2022, was not discovered until 09/13/2022. Contacted manufacturer and then CDC for further guidance on 09/14/2022 and again on 09/15/2022.
Numbness in lower jaw, started 6am on 4/4/21, lasted over 48?hours; muscle aches, tiredness, all started a couple hours after shot. Nausea came and went day of shot. Headache came and went, day of shot.
Lightheaded, dizziness and disconnected feeling about 2-5 minutes after injection.  Pulled over to AMR technician and was reviewed for blood pressure and pulse. Stayed for review for about 30 minutes.  On 3/15/21 had another episode very similar to the original one. Went to ER that same day about 30 minutes later. Was reviewed and examined them released about 1 hour later. Have had a few small episodes since that time.
Since around september I have been having severe headaches/migranes which I have never in my life has before
Narrative: Timing error only. No ADR. Vet received 2nd  dose days after 1st dose due to scheduling error.
Received vaccines on 2/1/00 and on 2/3/00 became congested, 2/5/00 became clingy, 2/6/00 began vomiting. 2/8/00 developed a rash on trunk. 2/11/00 the rash spread to the rest of the body. The pt experienced a fever of 102 to 104 which was controlled with Tylenol.
I experienced moderate chest pain that developed after about two weeks from the first Pfizer vaccine dose; then, about 20 hours after the second dose, I experienced fairly severe chest pain and fatigue that caused me to stay in bed all day. The chest pain was was isolated to the full chest area and was intense and lasted throughout the day. The pain felt muscular and was aggravated by movement. The following day, the chest pain had mostly subsided and was only faint at times. I've never experienced chest pain like this before.
Hospitalization COVID-19 + (admitted 2/17 and still hospitalized on 2/19)
Initial report received on 27Jul06 from an investigator participating in the above mentioned trial. A 67 yr old female subject developed Bells palsy 17 days after she had received an injection of Adacel, lot C2341AA. The pt had relevant medical history of CVA in 1995, hypertension and hyperlipidemia. Prior to the onset of the event, the subject had a two to three day history of left sided headache. On 23Mar06, 17 days after receiving the vaccine, the subject noticed left sided facial droop and weakness. She was unable to fully close her left eye or raise her forehead musculature. She was seen in an ER, where a CT of the head showed no acute bleed or mass. A chest x-ray and EKG were normal. The pt's blood work showed an elevated BUN of 18mg/dl, elevated hemoglobin of 15.4 g/dl, elevated hematocrit of 46.3% and decrease neutrophils of 48%. She was diagnosed with Bells palsy and was treated with prednisone, acyclovir, artificial tears, and Vicodin. She was seen on 17Apr06 and at that time continued to have facial paralysis. On 31May06 she began a course of acupuncture. By her tenth acupuncture session on 26Jul06 she was showing improvement and felt that her appearance was becoming more normal. She was no longer holding her mouth to speak and her left eye was blinking more normally. The event is considered as ongoing at the time of this report. According to the investigator, the event was possibly related to the study vaccine and resulted in a persistent or significant disability or incapacity. Documents held by sender: ER record and acupuncture visit notes.
Patient was admitted with neurologic complaints (arm numbness and tingling) and chest pain/tightness.  Was found to be hypertensive, thrombocytopenic and in AKI.  Was evaluated for mutltiple problems but found to have aTTP.  Patient received plasma exchange, high-dose steroids, rituximab and caplacizumab.    AKI resolved, neurologic complication resolved and thrombocytopenia resolved.    Patient was discharge 6.21.21 with prescription for caplacizumab.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 102.5 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.