chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of swelling injection site in a 77-year-old female subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). Concurrent medications included (ZOCOR), (COUMADIN), (DIGITEK), (ACTONEL), (CLARITIN), (PRILOSEC) and Potassium salt (Potassium). On 23 June 2009, the subject received a dose of FLULAVAL (.1 cc, unknown, left arm). On 23 June 2008, less than one day after vaccination after vaccination with FLULAVAL, the subject experienced swelling injection site, arm pain, headache, dizziness, injection site redness, swelling arm and wrong vaccine administered. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLULAVAL. The subject was administered the FLULAVAL vaccine in error and the home health nurse administered the vaccine in the subject's arm. The subject returned to the physician's office today complaining of headache and dizziness as well as a swollen, sore arm and the arm is red at the injection site. Physician had no detailed information regarding lot number or expiration date information. Physician does not believe that the subject has had a similar reaction to previous flu shots in the past. 10/07/2009 Follow up received from the reporting physician 27 July 2009: The subject received FLULAVAL intradermally instead of intramuscularly (intramuscular formulation administered by other route). She was supposed to get PPD TB test. The events improved on 30 June 2009. The physician considered the events could have been associated with erroneous administration.
medication error; Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 16 years old male patient who experienced medication error, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Nov-2018, the patient received a dose  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U51808A via unknown route in unknown administration site.  The patient developed a non-serious medication error <<Unknown latency>> following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Final diagnosis was medication error.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for medication error.       Additional information was received on 14-Jan-2019 by << "the same reporter" or "reporter type if other reporter">>.
Mild uncontrollable tremors to (L) hand noted in fingers. No other problems about 2 hrs after receiving flu vaccine.
FATIGUE; This spontaneous report received from a patient via social media (Facebook) via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fatigue. "Didn't get the fatigue like I did with the first one".(Dose number in series 1) The patient received additional covid-19 vaccine ad26. cov2. s unspecified manufacturer (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination (Dose number in series 2). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious.
Information has been received from a 23 year old female pharmacy student, with no pertinent medical history, no drug reactions or allergies, who in August 2010, was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The pharmacy student mentioned that after receiving her second dose of GARDASIL, she experienced minor injection site reaction, the site was red and tender. The pharmacy student mentioned that she received the second dose of GARDASIL only 3 weeks after receiving the first dose. No treatment was given. No lab diagnostics studies were performed. The pharmacy student did not seek medical attention. One or two days after the vaccination, the pharmacy student recovered from minor injection site reaction, site redness and site tenderness. Additional information has been requested.
Since this patient had a 2nd "HB" shot, she can't use her left arm at times, where shot was administered. There was a sharp pain to the point of yelling and then she couldn't hardly use her left arm for almost 2 weeks and it still gives her trouble. The 1st shot she had no problem.
Narrative: 63yo male in home community GEC care with PMH: Osteoarthritis Schizoaffective disorder, bipolar type Murmur Substance Abuse Negative PPD Tobacco user Essential hypertension Legal blindness died on 12/24/2021. Pt had received covid vaccines from Health dept on 1/16/21 & 2/6/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
2/14/23 that night I felt a little tired, more than usual. As the evening progressed, I got a little achy. The next day I did an at home COVID test which was positive. I called my doctor on 2/15/23. She told me if I got worse to go to urgent care.  I had congestion, stuffy nose, sneezing, cough, tired, headache and achy. This continued for two weeks. It gradually got better. I have Atrial Fibrillation and it was exacerbated when I got COVID. I continue to have issues with the Atrial Fibrillation.
chills; fever of 99.6F; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever of 99.6F) and VACCINATION SITE PAIN (arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension, MAGNESIUM, VITAMIN C [ASCORBIC ACID], ZINC and AMYLASE, ASCORBIC ACID, CELLULASE, FOLIC ACID, LIPASE, PROTEASE NOS (JUICE PLUS) for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 99.6F) and VACCINATION SITE PAIN (arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, CHILLS (chills), PYREXIA (fever of 99.6F) and VACCINATION SITE PAIN (arm soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Pyrexia: 99.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-029583 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever of 99.6F) and VACCINATION SITE PAIN (arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension, MAGNESIUM, VITAMIN C [ASCORBIC ACID], ZINC and AMYLASE, ASCORBIC ACID, CELLULASE, FOLIC ACID, LIPASE, PROTEASE NOS (JUICE PLUS) for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 99.6F) and VACCINATION SITE PAIN (arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, CHILLS (chills), PYREXIA (fever of 99.6F) and VACCINATION SITE PAIN (arm soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Pyrexia: 99.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-029583 (Patient Link).
7am  May 1, woke up with the expected sore arm and headache.  Arm pain radiated up into jaw and down to fingers. By noon fever (102) started accompanied by chills, pain in most joints and increasing head and neck pain.  This continued until around 3am when the fever subsided and took the chills with it.  Headache and neck pain continued with lethargy and breathlessness when walking or talking, slowly decreasing through to Monday morning. At the time of this note headache nearly gone but still tired and having chest heaviness, especially when walking around.
Information has been received from a bachelor of science in nursing concerning a female who on 03-APR-2009 was vaccinated with the second dose of GARDASIL, IM, 0.5ml.  On 03-APR-2009 the patient developed hives.  The hives were on her left arm from the injection site down to her hand.  She took BENADRYL Saturday (04-APR-2009) morning and evening and the hives were gone by Sunday (05-APR-2009).  No problems reported with her initial dose on unspecified date.  The patient was recovered on 05-APR-2009.  The patient sought medical attention to the office.  No further information is available.
Migraine, Diarrhea, Cramping legs and arms, Menstrual bleeding very heavy at times and I was told I was through  menopause - had not had a period in months.  Now I am bleeding like crazy. Feel gross and sick.  Debating skipping second shot.
01/17/2021 I woke up around 5 and I have cold and chills, it took about 3 days to go away then I woke up with a large lump in my arm pit and breast- left side. It was very painful, I went to ER.
A few days after the shot, my arm was still in extreme pain.   I was noticing that my arm wasn't able to extend how it normally does .  I called my PCP and let them know about the pain, and mobility issues., I called a week after, and then two weeks later because I was getting concerned.    My PCP referred me to get an EMG.  After that, he referred me to someone else,   He evaluated my shoulder and gave me the diagnosis of  Adhesive capsulitis.  doctor  sent me for physical therapy  for 1 month 2x a week.  I had that appointment with  Dr on June 4th.   I return to see him Monday June 21st for a follow up to see if I have had any improvement .   I am in excruciating pain.  I have never had any issues with my arm/shoulder.  It was a nurse that gave me the injection, at the health department.  I did go to a CVS and got my 2nd dose of pfizer on 6/8/21 with no additional side effects.  I have been to a lot of doctors for this.  My pain doctor was in shock.  And no one seems to have ever heard of this being a lasting side effect.   I struggle dressing, putting my seatbelt on, I can extend or reach in certain directions.   Its not just because of the pain? I physically can extend after a certain angle.  I am very concerned about the next steps on seeing how my doctors can help me through this bizarre diagnosis.    Like I said, I've never had any issues with my shoulder
got the first dose lower that the deltoid muscle,; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the first dose lower that the deltoid muscle,) 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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the first dose lower that the deltoid muscle,). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the first dose lower that the deltoid muscle,) had resolved.            Concomitant and treatment medication was not provided. Patient had no adverse events.   Reporter did not allow further contact
Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient experienced vaccination failure and shingles after receiving both the doses of Shingrix in last year. This case was considered as suspected vaccination failure as the details regarding laboratory confirmation were unknown at the time of reporting. The patient was asking, why did he experience shingles even after taking the shingrix shots. Consent to follow up has been requested.
swollen tongue; loss of taste; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program..  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that, patient complaining of side effects after getting covid vaccine. Patient said they had loss of taste and swollen tongue. Wondering if that's a possible side effect and should patient get 2nd dose of vaccine. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
PERIPHERAL NEUROPATHY ACUTE NON ST ELEVATION MI 2/3/2023 &  2/7/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Received anthrax shot in left arm. Arm started hurting and swollen about 2 hrs after shot. 24 hrs later arm starting to turn red and hurts. Swollen more than yesterday.
She is having to use a walker due to the pain; pain on her left leg from hip to foot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 86 year-old female (not pregnant) patient received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 09Mar2021 10:00 (Lot number: EJ1686) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bypass AAA surgery for the abdominal aorta", start date: 2017 (unspecified if ongoing), notes: Relates patient in 2017 had bypass AAA surgery for the abdominal aorta and had 3 stents applied.; "3 stents applied", start date: 2017 (unspecified if ongoing); "Clogged arteries" (unspecified if ongoing); "Sciatic pain" (unspecified if ongoing), notes: she developed a sciatic pain to her right leg and chronic right foot pain. The patient's concomitant medications were not reported. Past drug history included: Cannabis for leg for pain, reaction(s): "it didn't help"; Tylenol, reaction(s): "didn't help". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "pain on her left leg from hip to foot"; WALKING AID USER (non-serious), outcome "unknown", described as "She is having to use a walker due to the pain". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient on 09Mar2021 at 10:00AM in the left arm, got the first injection. on evening of 12Mar2021 she started to get a pain on her left leg from hip to foot. her husband gave her a massage and it didn't help. He has a jar of body balm with cannabis drug in it and he has used it in the past on her right leg for pain related to past Triple A surgery on right leg. He tried the body balm on the left leg and it didn't help at all. The pain is very severe now. She is having to use a walker due to the pain. They also tried Tylenol and it didn't help. Adds now she can't put any weight on her left leg. The patient had no AE prior to vaccination(within 4 weeks). The patient did not required any physician or ER.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with a dose of VARIVAX (Merck) (lot numb, expiration date, dose, route were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information was received from a registered nurse refers to a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that the patient received her first dose of GARDASIL 9 intramuscularly on an unknown date in 2014 (lot number and expiration date not provided). The patient presented on 01-MAY-2017 to receive her second dose of GARDASIL 9 intramuscularly. No adverse effect reported. No additional information provided. Additional information has been requested.
Felt strong pain in chest through that woke me up, hurt more when laying down and when breathing. Persisted until the morning. Took Covid test and was negative. Went to urgent care, received EKG and doctor said I had pericarditis. Treatment with naproxen and methylprednisolone has eased pain.
Pt. rec'd flu and pneumonia shots in (L) arm on 10/23. Pt. presented to pharmacy on 10/26 with redness/swelling in (L) arm at lower elbow to wrist region. RPh recommended BENADRYL. Pt. had existing appt with MD and consulted. MD called 10/29 and said pt. to continue ZYRTEC. Redness and swelling had decreased.
I received my second vacation on Friday morning, February 19th, 2021 at 8:30.  By 6:30 that night I became feverish with painful body aches.  These symptoms lasted until Sunday when the body aches subsided.  My fever continued through Monday.  Monday through Sunday, February 28th I was so fatigued that I missed five days of work and could barely move.  I was dehydrated with intermittent headaches and deep joint pain.
On 12/18/20, I woke up with a fever of 103.6, so I took Tylenol and applied wet wash cloths to my face and body to cool down. I initially was successful, and passed the temperature screening gates at work. But later that day at work I needed to take Tylenol every 8 hours because my fever returned, and I spent the whole day working while febrile. I am a respiratory therapist, so I knew that my fever was Covid vaccine related, and not because I was infectious.  I also experienced base of the skull headache, bilateral eye orbital pain, and tachycardia on my pulse ox about 130 HR, probably due to fever.  I also had joint pain, mostly of hip girdle.
Tachycardia, Dyspnea, Dysarthria, wtihin seconds after receiving the vaccine injection. injection site showed no erythema, edema or tenderness. patient could not verbally describe what he was feeling. patient was given Epinephrine. After epinephrine patient stated improvement, but as patient was being moved the observation room symptoms returned mainly the dysarthria which was accompanied by cogwheel rigidity, petechias and global muscle contraction. EMS was called, benadryl injection was given as EMS arrived. Patient was then taken to ED.
Narrative:  1/20/21- pfizer dose 1 2/10/21- pfizer dose 2 7/16/21- sx first started with a sore throat, cough, congestion, body aches which lasted until 7/20 7/27/21- covid positive, reports wife is also covid positive and is in the hospital 7/25/21- reports cough, headache, muscle pain, sore throat; given tessalon pearls, prednisone, and mucinex
This spontaneous report was received from a consumer refers to herself as a 64 year old female patient. Current condition included drug allergy DEMEROL. The patient's medical history included, chicken pox as a child, developed shingles on an unknown date approximately in 2010 (four years ago), thyroid storm, appendix removal on an unspecified date approximately in 1979 (35 years ago) and unspecified knee surgery on an unknown date approximately in January 2014 (9 months ago). On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX, (dose unknown) (lot number not specified), subcutaneously. Concomitant therapies included ATIVAN. On 30-SEP-2014 (also reported as this morning) the patient wasn't feeling well at all, upon speaking with her doctor was informed that she developed shingles again (vaccination failure). No treatment was given. Patient sought medical attention by visiting the doctor this morning. The outcome was reported as not recovered. The causality was unknown. No product quality complaint was reported. This is one of several reports from the same source (1410USA000805-same patient). Additional information has been requested.
ADACEL 8-17-07. Symptoms started on 8-21-07, pain left arm, no redness, swelling noted entire arm. Pain in arm with movement.
No additional AE; expired PNEUMOVAX 23 to a patient; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 24-OCT-2023, the patient was administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported), lot# W007035 has been verified to be valid, expiration date reported and established as 20-OCT-2023 (expired product administered). No additional adverse event was reported.
About 30 minutes after injection, patient got pale, faint, and nausea which lasted the rest of the day.
Patient was given the Monovalent vaccine as a booster instead of the bivalent booster.
Body aches, fatigue, vomiting x 3, pain in right arm from shoulder to elbow x 3 days, skin was painful to the touch.