chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included infection (infection has not worsened or improved since she received a dose of SHINGRIX). On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, several hours after receiving SHINGRIX, the patient experienced shoulder pain, fatigue and pain. On an unknown date, the outcome of the shoulder pain, fatigue and pain were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, fatigue and pain to be related to SHINGRIX. Additional details were provided as follows: The patient noted she developed a mild infection prior to her dose of SHINGRIX. The patient noted infection had not worsened or improved since she received a dose of SHINGRIX. The patient was taking antibiotics for mild infection. At approximately 19:00, the patient was administered SHINGRIX in the right arm. The patient woke up the next morning with shoulder pain and fatigue. Shoulder pain was described as soreness. Fatigue was described as feeling like her body was hit by something.
Patient called 9/17/20, to report large warm, red band around the vaccination site and arm. She reported extreme itching in that area that started the day after receiving the High-Dose influenza vaccination. RPH recommended ice packs, antihistamine oral and topical.
Approx. 1 1/2-2 hrs. after FLUMIST, HAVRIX #2, dizzy, heart pounding, tired, weak, acted weird, moving slow, speech slow. Patient went to emergency room-no treatment.
The physician reported that on 11/07/2000 the patient presented in her office with herpes zoster following C6 and C7 dermatome from upper arm to the hand. The patient was treated with acyclovir and prednisone. Additional information has been requested.
Soreness in site of injection, left deltoid area; Next day developed headache, chills, fatigue, body ache and back pain that lasted 24 hours. Symptoms resolved in 24 hours, felt a lot better in 24 hours.
Instantly after immunization rash noted on legs. Examined by doctor Clarinex Redi Tab given. Observed for 45 minutes. SIB + strep throat. Lung clear no vomiting or diarrhea. No signs symptoms of anaphylaxis. Rash blanchable.
Pt had already received 2 doses of Pfizer, and facility was unaware upon her admission of this. Facility set up for her to get vaccinated after family consented. She received one dose of Moderna, and then her previous vaccine card was found. So she got 2 doses of Pfizer and then she got a dose of Moderna. This was prior to the mix and match became available, and prior to the booster being authorized. No adverse events.
Approx. 10 to 15 days after receiving the vaccine I began to get dizzy and began experiencing "brain fog". The symptoms were managable but progressively got worse as time went on. In January of 2010 I received the H1N1 vaccine. By Jan. 28 I was so dizzy that my employer had to drive me home on several occassions. Feburary 3, was the last day of full employment. I did try to go back to my teaching job 2 times but was unsuccessful. I have been to several doctors and eventually ended up at a clinic.  There they diagnosised me with Chronic Subjective Dizziness. I am currently on Medication and doing vestibular rehab. My insurance company has declared me disabled.
Fever at 102; Aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Feb2021 at 07:15 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior vaccination. There were no concomitant medications. No other vaccine was administered in four weeks. The patient received the first dose of BNT162B2 on 12Jan2021 at 05:00 PM for COVID-19 immunization (in left arm). On 01Feb2021 at 05:00 PM (around 10 hours after the patient received the vaccine), the patient had symptoms including fever at 102, aches, nausea, chills, and headache. The patient was unable to go to work for 2 days. No treatment was received for the adverse events. The patient underwent COVID-19 test post vaccination that was negative on 04Feb2021. The patient recovered from the events in Feb2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Patient felt stiffness and swelling in her neck in the areas of the lymph nodes beginning 2 days after receiving the vaccination, starting on the left side which was the same side the vaccine was administered in the deltoid. Neck was hot to the touch. Symptoms resolved mostly after 7 days, or 9 days after vaccination. Patient was unable to drive, sleep or move her neck during that time.
fatigue, delayed tongue/throat swelling (mild, no stridor, no resp distress)
concussion symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old female (not pregnant) patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 28Mar2021 08:00 (at the age of 62-years-old) (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included post concussion syndrome from 2020 to an unknown date, drug hypersensitivity from an unknown date and unknown if ongoing, allergy to chemicals from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol taken for an unspecified indication, start and stop date were not reported. Patient reported that, she was in a car accident on 21Jan2020 and suffered a serious concussion. The worst symptoms lessened with time but she was diagnosed with post concussive syndrome. The evening after the first shot on she was ok but definitely feeling the effects. When she woke up on Monday the 29th many of the concussion symptoms were back like speech issues, wobbly walking and brain fog on 28Mar2021 18:00. She was 2 days off work now resting to try to get back to where she was. Patient asked to take this and was wondering maybe people with concussions or post concussive syndrome should not receive this vaccine. Patient was not diagnosed with Covid-19 prior or post to the vaccination. It was unknown if patient was hospitalized due to events. No treatment was received for the adverse event. Outcome of events was reported as recovering.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Motor development slowed (called clinic 1 1/2 months after shot) - Dec 2006. Language development slowed (clinic contacted 10/2007). Autism spectrum disorder diagnosed Aug 2008. Self stimulatory behaviors emerged around age 18 mons.
Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the local Health Authority at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the local Health Authority was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the local Health Authority.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
IN FULL SEPSIS; SORENESS IN THROAT; MUSCLE PAIN; This spontaneous report received from a patient concerned a 35 year old white patient of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no medical history. The patient had no known allergies. The patient did not had any drug abuse or illicit drug use. Patient had no respiratory condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered on 02-SEP-2021 at left arm for prophylactic vaccination. Concomitant medications included probiotics, and fish oil.  On 23-SEP-2021, patient started having muscle pain and soreness in the throat. On 25-SEP-2021, saturday morning, patient woke up with fever, night sweats and also reported was losing a lot of water. By midday patient experienced nausea and vomiting. On Sep-2021, patient decided to go to urgent care as could not keep any food or water down. In the emergency room (ER), they told patient had sepsis. Patient reported resting heart rate was 119 and white blood cell count was 21,000. They had a covid test done that was negative, a streptococcus test that was negative, Epstein Barr test that was negative, urinalyses that was negative and blood culture tests were not reported. Patient reported no changes were made to diet, or exposure to anything. The discharge professional stated this was most likely related to the vaccine. In ER, patient was given broad spectrum antibiotic and IV (intravenous) fluids. Patient did not feel better at all and no symptoms had gone away or gotten any better since they started except for dehydration because patient received 4 IV bags in the ER, still had a fever and increased heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, soreness in throat, and in full sepsis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210953480-covid-19 vaccine ad26.cov2.s-in full sepsis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
could not get warm; She said that she feels like she has trouble even lifting her legs up.; blood pressure elevated; her head started hurting; weakness in her legs; leg is hurting; Chills; Tiredness; Weakness; stomach hurts; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiry Date: Unknown)), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 as dose 1, single for COVID-19 immunization (at the age of 67-year-old). Medical history included ongoing asthma and breathing problems. The patient's concomitant medications were not reported. The patient previously took singulair for asthma. On 08Apr2021, the patient experienced chills, tiredness, weakness, stomach hurts, wheezing; on an unspecified date, could not get warm, she said that she feels like she has trouble even lifting her legs up, blood pressure elevated, her head started hurting, weakness in her legs and leg was hurting. Consumer clarified that she wanted to report some side effects and said that she had chills and could not get warm, she still has tiredness and weakness. She said that she has asthma, but started wheezing after receiving the vaccine and is having more wheezing now. Caller said that she is having weakness in her legs. Stated that her stomach hurts. She said that she has a ulcer, but was not hurting like this prior to the vaccine. She said that she went to the doctor to see if it was a UTI making her stomach hurt and the doctor ruled that out and said that it was not a UTI. She stated that her legs feel like it is giving out like when someone bumps you in the back of your legs. She said that she feels like she has trouble even lifting her legs up. Consumer stated that she was due to take the second dose tomorrow and was trying to see if she should take it or what. She stated that her blood pressure elevated too. She stated that she has asthma and has breathing problems sometimes, but she was fine prior to the shot. Chills started 30 minutes after the vaccine and stated that her head started hurting. She said that she could not get warm even though it was warm outside. She said that her stomach hurting could be confused with the ulcer. She stated that her stomach hurts anyway. Stated that the first letter of the Lot number could be a P. Consumer stated that she was taking asthma medication prior to receiving the Covid vaccine and her doctor wanted to her to finish that medication before taking the vaccine. She said that she went back to taking her regular medication a couple of days after the shot. She said that she takes Singulair and things like that. The outcome of the events tiredness, weakness, stomach hurts, wheezing, could not get warm was not recovered and unknown for all other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediately after receiving vaccine, patient felt numbness and stiffness that radiated down right arm.  Patient stated this was also felt in right leg and foot.  Minimal right handed grip strength was also reported.  This lasted for around 24 hours per patient.  Fatigue was noticed immediately and lasted for 2 days.  Lastly, patient reported headache immediately that lasted for three days.    Patient was given juice and crackers.  Vital signs taken.  HR 81, BP 136/84.  Patient took Tylenol from personal medications.   Patient refused transport and EMS evaluation.  Patient was called by provider in afternoon and stated she was resting with no new/worsening symptoms.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 03-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "1", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse stated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014144.
Pfizer-BioNTech COVID-19 Vaccine EUA. Injection site pain, headache, tiredness, muscle pain, chills and fever. Took acetaminophen, no longer have fever after 12 hrs.
Chicken Pox Vaccine. Site of injection became hot to the touch, swelled to the size of a golf ball and became black and blue.
Patient states that they are experiencing pain and soreness in the upper arm. Have been experiencing pain since the vaccine was administered 1 month ago. Patient does have a condition called Bell's Palsy and the vaccine may have aggravated their condition.
Per Doctor report. Pt started with general weakness about 2 days ago (10/5/11) and was still present on 10/7/11. Pt had difficulty walking. Weakness in both legs. Pt also has dizziness and had one fall on 10/7/11. Pt denied any numnbness, tingling impared speech, vision problems or swallowing difficulties. Maximum deficit was described as severe. Pt had difficulties with breathing, a headache, chest pain, and nausea. Left sided Bell's palsy.
Information has been received from a physician concerning a 75 year old female patient who on 20-JAN-2010 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (Lot # 663305/1781x) inadvertently instead of ZOSTAVAX (Merck) (MSD) due to a human error. No adverse effect was reported. The patient did not seek medical attention. This is one of two reports received from the same source. Additional information has been requested.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: The reporter read online about 2 different formulations of the Pfizer covid vaccine gray cap formulation, said the article came from an official site which she couldn't remember, says it might have been from the CDC but since she got the gray cap with lot# of FK9895 and says she did not have any side effect with the vaccine. The reporter wanted to know the inactive ingredients of the vaccine if there would be differences for each formulations. The reporter said the shot from gray cap vaccine went well as compared to her purple cap dose which she had some minor reaction which is headache. The reporter said the event was nothing serious and fairly mild.   Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE details or PQC; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 11-APR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot # U022819, expiration date 14-JAN-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided). Vaccine was improperly stored for 96 hours in temperature of 70 F (Product storage error). Data logger was not used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event or product quality complaint was provided (No adverse event).
fever, purpuric/petecchial rash on LE, migratory arthralgias, crampy abd pain, diarrhea (some bloody) about 3 weeks after vaccination, suspect HSP
No major side effects day of or day after Moderna 2nd booster shot (like other three, coincidentally: Pfizer). Just a little tender at inj site. The weird effect I just wanted to share: Day three there is a little swelling/redness/warmth (?) / itching (?) at inject. site ? form of a large reddish circle apx 2-2.5" diameter, with what looks like a thin 'white' perimeter 'line' (color is slightly lighter than my skin color). And the area itches, too. Just sharing as it's a side effect I hadn't had before: itching, slight swelling 2" reddish circle/welt.
10 days after vaccine, had vertigo for 10 days; Sore arm, pain on arm lead to unable to sleep; Sore arm, pain on arm lead to unable to sleep; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 15:15 (Lot number: EP7533) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), INSOMNIA (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Sore arm, pain on arm lead to unable to sleep"; VERTIGO (non-serious) with onset 14Apr2021 12:00, outcome "recovered" (Apr2021), described as "10 days after vaccine, had vertigo for 10 days". The events "sore arm, pain on arm lead to unable to sleep" and "10 days after vaccine, had vertigo for 10 days" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, insomnia, vertigo. Additional information: event treatment included nausea medication (as reported). No covid prior vaccination; no covid tested post vaccination and no known allergies. No follow-up attempts are possible. No further information is expected.
Narrative: Covid infection following COVID vaccine series 02/03, Pfizer, dose #1 02/23, Pfizer, dose #2 09/13 COVID swab, result: detected 09/10 pt cc: cough, diarrhea, fatigue, loss of taste or smell, myalgias, nausea, rhinorrhea, vomiting exposure: unknown 09/13 SARS-COV-2 Variant Sequencing result: pending 09/21 clinically resolved
Day after injection (L) arm was swollen, tender and red, T. 103. Loose stool and vomiting also.
4/16/19 about 2hrs after vaccine noted pain and redness on left deltoid; progressed today. Seen in clinic 48 hrs after reaction. Erythematous warm, no significant edema no fluctuance 2x10cm area of redness dermal edema.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 18-DEC-2012, the patient was vaccinated with a first dose of GARDASIL and on 08-JUN-2013 the patient was vaccinated with a second dose of GARDASIL (Lot number, expiry date, route and dose were not reported) and no adverse event reported. Additional information is not expected.