chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AKI; AIN; This is a literature report.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; pembrolizumab (PEMBROLIZUMAB), (Batch/Lot number: unknown) for bladder cancer. The patient's relevant medical history included: "Bladder cancer" (ongoing), notes: was on Pembrolizumab. The patient's 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: ACUTE KIDNEY INJURY (medically significant), outcome "recovering", described as "AKI"; TUBULOINTERSTITIAL NEPHRITIS (medically significant), outcome "recovering", described as "AIN". The patient underwent the following laboratory tests and procedures: Blood creatinine: 2.18 mg/dl, notes: (b/1 0.8 mg/dL); C-reactive protein: 40 mg/dl; less than 3, notes: prior; Renal function test: Returned to baseline; SARS-CoV-2 test: Negative; Urine protein/creatinine ratio: 3797, notes: Units: mcg/g Cr (Normal less than 190) Elevated. The action taken for pembrolizumab was dosage permanently withdrawn.  Clinical course: The patient with h/o bladder cancer on pembrolizumab developed AKI. 3 weeks prior she got a booster dose of Pfizer SARS-CoV-2 vaccine. ICPi was discontinued. The patient declined kidney biopsy. Kidney function returned to baseline in 6 weeks without steroids. The cause of AKI was presumed to be AIN based on the elevated uRBP/Cr ratio.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, the causal association between the events Acute kidney injury, Tubulointerstitial nephritis and suspect drug BNT162b2 cannot be cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201326258 Same article/drug/event different patient;US-PFIZER INC-PV202200110499 Same article/drug/event different patient;
Sore; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore; pain at the injection site) in a male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore; pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore; pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment, medical history, lab data and concomitant medications were not reported.
Administered vaccine to patient . A few moments after patient reached the observation area they signaled they wanted some help. Once I arrived the patient stated they felt like fainting. Patient fainted for 3-5 seconds before regaining consciousness. Patient refused going with first responders.
I had a Covid arm a few days after the first vaccine.  After that I have had shooting pain in my arm for the last  year, cannot move arm as before, cannot reach up or back.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Medical history, concurrent conditions and concomitant therapies were not reported. On 07-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L022795, expiration date 05-NOV-2016, intramuscularly for prophylaxis (strength, dose and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Temp 101. Left arm shoulder, front and back especially chest, red and swollen. 12/15/03 Called and client doing well today.
As stated before, pt. was forced by his employer, to get the vaccine to continue his employment. He received his first vaccine in August 21 and second one in September 21. He was a healthy guy no issues prior to this. In July 22, he suffered a brain aneurysm and stroke. Since this time, he has been incapacitated. We believe this vaccine had something to do with leading to both of these things.
Fevers up to 101.8 degrees F, headache, myalgias, right upper arm pain and local erythema. Treatment: TYLENOL, ADVIL.
Developed hydrops of gallbaldder and acute cholecystitis 12 hours after vaccination with no history of gallbladder disease prior to this. I was 26 weeks 5 days pregnant with EDD 04/15/2021
suspected vaccination failure/Had vaccine 5 years ago and got shingles; shingles on my back; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had vaccine 5 years ago and got the shingles last year on his/her back. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
mom states pt ran fever between 103 & 105;states didn't have any APAP;taken to ER & given APAP;test revealed no other problems;
FEVER AND; fever and patient was complaining of a sore throat; PATIENT WAS COMPLAINING OF A SORE THROAT; fever and patient was complaining of a sore throat; COVID WERE NEGATIVE; FLU A POSITIVE; FLU B POSITIVE; ALLERGIC RHINITIS; A spontaneous report has been received from a health professional. The report concerns a male patient of Unknown ethnic origin (age 4 years).    The patient's past and current medical history included allergic rhinitis . The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PJ3267) once/single administration, via nasal route, on 07-NOV-2022. The patient received 1 dose(s).     A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On 07-NOV-2022, the patient experienced allergic rhinitis (preferred term: Rhinitis allergic). On 10-NOV-2022, the patient experienced fever and (preferred term: Pyrexia), patient was complaining of a sore throat (preferred term: Oropharyngeal pain), covid were negative (preferred term: SARS-CoV-2 test negative), flu a positive (preferred term: Influenza A virus test positive) and flu b positive (preferred term: Influenza B virus test positive).     The outcome of the event(s) of fever and, patient was complaining of a sore throat, covid were negative, flu a positive, flu b positive and allergic rhinitis was unknown.     The events were considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Mild dizziness after shot.  But I passed out the next day after feeling extremely dizzy & nauseous.  Then my husband also got dizzy & nauseous the following day.  I thought it might be my meds but the only thing we both take is Levothyroxine.  We were dehydrated??
Adverse effect of other vaccines and biological substances, initial encounter on 2022-10-19, COVID-19 on 2022-10-20.
Tested positive for COVID in August, Sore Arm for a couple, I was released from the ER with Oxygen.
Metallic Taste in Mouth - Similar to when I had COVID-19, except I still can taste things - but all dairy products now taste intensely like metal & I have a constant metallic taste in my mouth (for 3 weeks now). No physical harm, but I just can't really enjoy food or eat foods I used to like.
The mother of a 4 month old female reported that her daughter received Rota Shield, DTAP, HIB and IPV in June, 1999. The day of IZ's, the infant developed uncontrollable screaming, which persisted for 24 to 48 hours. She was then "just uncomfortable" with grunting, groaning, and arching of her back. The physician could "not find anything wrong" and attributed the event to the infant's pre-existing gastroesophageal reflux. The infant recovered.
went on to develop a learning disablity; seizure; This spontaneous report as received from a mother concerning her 1-year-old son, during an interview. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  In 2007, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.       On an unknown date in 2007, the patient ended up having a seizure, and had to go to the ER two separate times, on an unspecified date. After the first visit he was sent home, and then they had to go back to the ER. Eventually the son recovered (date unspecified) but went on to develop a learn (learning disability), on an unknown date.  The outcome of seizure was reported as recovered, on an unknown date and the outcome of develop a learn (learning disability) was unknown.   The reporter considered seizure and learning disability to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).  Causality of the event of develop a learn (learning disability) with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  was unspecified.  Upon internal review, the event of syncope was considered to be medically significant.
pt recvd vax & 10 mins p/vax exp muscle pain in back & neck, intense pain in legs for 4-5 days & joint & muscle pain for 4 months;
got the flu shot and within days had a very nasty prolong flu; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-health care professional.  This case involves a patient of unknown demographics who got the flu shot and within days had a very nasty prolong flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported that patient can name six people off the top of head who got the flu shot and within days had a very nasty prolong flu (Influenza, non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for flu, at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported.
On 6/26/2022, the patient was given a full vial of the COVID 19 Pfizer vaccine which equals 2.0ml's IM to right deltoid. Patient was admitted cautiously for observation at the Hospital over night. Reported symptom was low grade temperature. no other symptoms at this time.
Developed numbness in 3rd and 4th finger after AVA #1 and large local rx. Pain in left arm with certain range of motion. On 28Jan04 he received AVA #1 at an unknown site in left arm. Reports no systemic effects but developed very sore left arm for about 1 month. Because of this soreness he avoided use of the arm whenever possible. After one month, the continuous pain subsided but he had sharp discreet pain when raising the arm over his head as well as reaching around to the back or holding the arm straight out in front of him. This pain has continued to the present. He also states that the strength in the left arm is considerably weaker than in the right and that he has intermittent numbness in the superior aspects of the left 3rd and 4th fingers. Referral to neurology showed an EMG consistent with left cervical radiculopathy at approximately c6-c7. Neurological exam was normal.  The lack of neck pain or true radicular components to the pain suggested that the symptoms are not related to the electrodiagnostic abnormalities. MRI of the cervical spine showed "a minimal 1mm retrolistheses with small disk/ osteophyte complex at c5-c6 with degenerative changes and mild left foraminal narrowing with no nerve impingement. Consequently he was referred to orthopedics for further evaluation.  Orthopedics diagnosed left shoulder impingement. His shoulder impingement radiologic series was WNL. On physical exam he demonstrated a positive Hawkins and O'Brien's sign and decreased ROM due to pain. He received an intrarticular steroid/lidocaine injection to the shoulder and was placed on a COX-2 inhibitor. During the evaluation period pt was referred to nephrology for evaluation of microscopic hematuria and to pulmonary for intermittent cough and previous pulmonary nodule. Nephrology diagnosed a benign asymptomatic urinary abnormality vs early stage of chronic kidney disease after obtaining a normal renal ultrasound. Pulmonology discontinued his ace inhibitor and initiated irbesartin after the CAT scan of the lungs and PFTs proved normal.
BREAK THROUGH COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (BREAK THROUGH COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In January 2022, the patient experienced COVID-19 (BREAK THROUGH COVID-19). At the time of the report, COVID-19 (BREAK THROUGH COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Initial unsolicited report received from an office staff on 05 Oct 2016. This case involves an 8-yeras-old female patient who was vaccinated with Second dose of FLUZONE (manufacturer: Sanofi Pasteur INC.)(Batch number, expiry date, site of administration and Route: unknown) on 05 Oct 2016. Medical history and concomitant medications were not reported. On 05 Oct 2016, the reporter reported that the patient developed rash over fore arm and lower back of body. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Menstrual Cycle began on 4/22/2021, the same day I received my second dose of Pfizer-BioNTech Vaccine. The next day I had extreme cramping that lasted longer than usual. My periods are consistent with pain + the general time frame for cramps is usually a few hours on the first day of bleeding. However, I experienced intense cramping and pain in my ovaries, and lower back for three full days. While there was not heavier bleeding, there was more pain in the ovaries and uterus.
ANXIOUS, TINGLING IN LIPS, HX OF SAME SYMPTOMS FROM UNKNOWN RECENT ALLERGY AND RECD EPINEPHRINE. VSS, PROVIDED WATER, REFUSED TRANSPORT, AMA SIGNED.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # L001626, expiration date 06-OCT-2016; lot number L016427, expiration date 13-APR-2017) (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
headache; fever; myalgia; arthralgia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative.  A 29-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received their first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced headache, fever, myalgia and arthralgia on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
questioning lack of efficacy; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 70 year-old patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 22Dec2021 10:45 (Lot number: FH8030, Expiration Date: 28Feb2022) 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: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome "unknown", described as "questioning lack of efficacy"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 22Dec2021 10:45, outcome "unknown" and all described as "administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days".  Additional information: Caller stated that she reported that it was in the freezer too long. Stated that it was stored within normal temperature in the fridge. Stated that it was in the refrigerator for seven days before it was administered during a vaccination clinic to eight separate patients as a booster dose. Provided a case number of 524685. Stated that she did not know a lot of fine details but through root cause analysis that she has come up with a lot more information. Stated that she did not complete reports on the patients. Stated that she has not gotten an email yet. Clarified that the vaccine came from district health, and they put it in their freezer, and it is kept between 25 degrees below Celsius and -15 degrees Celsius. Stated that it was at the normal temperature up to two weeks and was extended to 17 days per Pfizer from the other phone call. Count for which of the 8 patients received the Pfizer purple top vial pediatric dose not provided. Later clarified that they were not all booster doses. Patient stated that she is not aware of any antipyretic use around the date of vaccination. There were no predisposing factors. No culture performed. Relevant Tests was none. Questioned lack of efficacy on 28Dec when they discovered the mistake. Stated that they stopped questioning efficacy after they called Pfizer. Later clarified that she is still questioning the efficacy.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010841 as same reporter/drug/event, different patient.
Started with a mild fever and crankiness. Later during the day fever increased, and she slept all day. Awake for maybe an hour the whole day. By Wednesday the fever had increased to 104. Not taking food or liquid. Slept all day, not speaking or signing, not very responsive. Diarrhea on Wednesday, throwing up Tuesday and Wednesday, fever not breaking with Tylenol. Contacted nurse on Tuesday and advised that symptoms still seemed mild. Wednesday took her back to the doctor.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Pateint had taken Claritin 10mg prior to appointment under MD directions*
pt recvd vax & had 4" area of redness & warmth; had a local itching x 24 hrs;
Headache, Myalgia, Arthralgia, NauseaVomiting, PAIN Narrative:
stroke; can't remember things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "can't remember things".  Clinical course: Reporter stated that he has a friend, who did not want to take the shot. They made him take the shot in order to get any of his pensions. He had a stroke and was a concert. He now can't remember things and cannot play the violin. Bivalent means 2 times the original dosage and over Labor Day they doubled the dosage of the shot. That is why they are having more problems with the shot then they did with the first shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 3/15/2021 pt was trying to use her computer when she started having problems with her vision.  She noticed her left hand was clumsy and awkward.  Her left leg would not operate properly.  She could not swallow pills with water and her speech was slowed and slurred.  She went to the Hospital ER.  They did MRI, CT, blood test that showed she had a small stroke.  She was released to go home to do physical therapy and speech therapies.  She has both of these scheduled and will follow up w/ PCP on 4/23/2021.
10/26/19 :Redness, warmth, and pruritis surrounding  injection site on RT developed 2 days after administration of  vaccine.  Mom administered benadryl with improvement.  Seen in office on 10/26/19.  Symptomatic treatment, mom given s/s to monitor for infection/cellulitis.  12/22/18:  Treated in office for LT cellulitis with benadryl and keflex.
Pre-existing diagnosis fibromyalgia, chronic pain.  Increased body-wide pain of a different character after first shot, much more marked after COVID booster