chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer refers to herself as a 67 year old female patient of unknown age. The patient pertinent medical history included arthritis. On an unknown date in October 2013, the patient was vaccinated with ZOSTAVAX one single injection. Concomitant medications included AFLURIA and unspecified blood pressure drugs. On an unknown date in early November 2013, the patient experienced discomfort in her hips and was diagnosed with bursitis. On an unknown date in November 2013, the patient experienced problem with connective tissue. She also reported that her bones are fine. On an unknown date in November 2013, the patient experienced IT bands are knotted. The patient sought medical attention. The patient was treated with physical therapy and unspecified cortisone injection, which she says have not helped. On an unknown date, the patient had an X-ray. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Dizziness/Light headed; Arm pain; Body ache; Chills; headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness/Light headed), PAIN IN EXTREMITY (Arm pain), MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness/Light headed), PAIN IN EXTREMITY (Arm pain), MYALGIA (Body ache), CHILLS (Chills), HEADACHE (headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness/Light headed), PAIN IN EXTREMITY (Arm pain), MYALGIA (Body ache), CHILLS (Chills), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided
This spontaneous report as received from a medical assistant and a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 13-DEC-2016,  the patient was vaccinated with an expired dose of ROTATEQ orally (lot # L008997 expiration date: 04-DEC-2016)  for prophylaxis. The reporter stated that the vaccine was always stored properly and there were no adverse effects reported. Additional information is not expected as the reporter did not want to be contacted.
Patient had a local reaction to the vaccine that got swollen, very red, painful, and feverish (warm to touch).
Information has been received from a senior technician certified concerning a patient who on 02-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 03-OCT-2007, the patient developed a rash and swelling at the injection site. The patient may have also developed a fever. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of left sided neck pain 5/10 10 minutes after receiving the Pfizer Vaccine. The patient's mother took him to the ER but left before he was evaluated and took him home and gave him Ibuprofen.
G62.9 NEUROPATHY 4/27/2023 STRESS REACTION CAUSING MIXED DISTURBANCE
Patient received Pfizer COVID vaccine on 2/9/21 (lot # EM9810), 3/3/21 (lot # EN6198), and 10/14/21 (lot # 301358A). On 3/21/22, patient admitted to our inpatient facility s/p frequent falls, with COVID-19 infection, right pleural effusion, and ESRD on HD. Patient was admitted at outside facility from 3/13/22 to 3/28/22 and received dexamethasone during that admission for COVID-19 infection. As of today (3/24/22), patient is still admitted in our med/surg unit.
flu like synd, then pyuria p/2nd inject; the day following 2nd inject pt devel fever, chills, burning, itching area; the day p/got pyuria w/eosinophiles in the urine but no white cells; serum creatinine is nl; 16MAR92 f/u pt recovered;
COVID-19; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 62.47.  Concomitant medication of the patient was not reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. The vaccines moved to clinic on 03-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Bell's palsy; This is a spontaneous report from a contactable consumer (the patient). This 51-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm, upper arm, on 06Apr2021 14:00 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient denied being sick at the time of vaccination. The patient's medical history was not reported. No relevant family medical history was reported. There were no concomitant medications. On the night of 08Apr2021, the patient was having intense pain down her neck and behind her left ear, and it has been waking her up at night. On 09Apr2021, she went to Urgent Care and they misdiagnosed her with a possible oncoming ear infection. On Saturday morning (10Apr2021), she woke up and could not move the left side of her face so she went to the ER (emergency room) and they diagnosed her with Bell's Palsy. On 10Apr2021 at the ER, blood test for Lyme disease was negative. The ER gave the patient a steroid and antiviral pill and told her to follow up with her primary doctor in 8 days. The patient went to her physician's office on 19Apr2021 to follow-up with her Bell's Palsy. The patient stated that intense pain (down her neck and behind her left ear) was apparently a symptom of the Bell's Palsy. The only improvement with the Bell's Palsy was that she can sip out of straw a little easier but lips are still to the side. The clinical outcome of the event Bell's Palsy was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
She had a poor response to the MMR and varicella vaccines as a child; Literature Report. This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a child female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not reported.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, and route of administration were not reported) and with varicella virus vaccine (Manufacturer unknown) (strength, dose, and route of administration were not reported). Both administered for prophylaxis.   On an unknown date, it was found that the patient had a poor response to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine (Manufacturer unknown) (vaccination failure). The outcome of the poor response to the vaccines was not reported.   The authors determined the patient's poor response to be related to the vaccines: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine (Manufacturer unknown).    A copy of the published article is attached as further documentation of the patient's experience.
Moderna COVID-19 Vaccine EUA shivering chills, fever (highest was 103.6), excruciating headache, lightheadedness
Initially, numbness in middle of bottom lip.  Then a burning sensation in both lips, gums and mouth
dizziness; light headedness; couldn't hold her head up; the runs and its highlighter yellow; vertigo; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIZZINESS (light headedness), HEAD DISCOMFORT (couldn't hold her head up), CHROMATURIA (the runs and its highlighter yellow) and VERTIGO (vertigo) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), DIZZINESS (light headedness), HEAD DISCOMFORT (couldn't hold her head up), CHROMATURIA (the runs and its highlighter yellow), VERTIGO (vertigo) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), DIZZINESS (light headedness), HEAD DISCOMFORT (couldn't hold her head up), CHROMATURIA (the runs and its highlighter yellow), VERTIGO (vertigo) and NAUSEA (nausea) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant  information was  provided. Treatment include A vertigo medication Mentions she had something similar occur in 2019 after a trip she went on.
Left thigh cellulitis treated with Keflex 250mg X 10 days; ice prn; Tylenol/Advil prn. Shot given on 4/13/01 and seen for cellulitis on 4/14/01. Quarter-sized red and warm area at injection site.
Extreme dizziness; vertigo. Worse in the early part of day, lessens as day goes on.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 35-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 at 20:30 as dose 3 (booster), single (Lot number: FH8027) at the age of 35 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 11Feb2021 at 19:00 as dose 1, single (Lot number: 015M20A) and on 11Mar2021 at 15:00 as dose 2, single (Lot number: 036A21A) for Covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: Dextroamphetamine [Dexamphetamine]; Mesalamine Delayed Release; Mometasone Furoate; Fexofenadine HCL; Vitamin D [Vitamin D Nos]; Deplin [Calcium Levomefolate]; Dextroamphetamine [Dexamphetamine], stop date: 19May2022. Past drug history included: Ritalin, reaction(s): "Known allergies: Ritalin"; Zyrtec, reaction(s): "Known allergies: Zyrtec"; Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive; (26May2022) Negative; (27May2022) Negative; (28May2022) positive. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, Covid-19. Clinical information: Patient received Other medication in 2 weeks included Multivitamin 2/D. Patient developed COVID-19 symptoms on 19May2022, tested positive on 20May2022, and started treatment with Paxlovid. Patient symptoms stopped and tested negative on 26May2022 and 27May2022. Patient symptoms returned and tested positive on 28May2022. Patient received Covid-19 treatment from 20May2022 to 22May2022. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.
Adverse reaction to shot was swelling in face, rash on face, neck, & arms and severe itching and redness. Later, rash also developed on body.
severe swelling & reddness-outbursts of screaming & crying & t101 only temp for 1 day;
extreme fatigue, chills down back, arms and legs, but head on fire started on 1/13/2021 and continued until 4/7 ...it still may return...it has stopped for 5 days before  and then returnedi .    in the beginning it was daily & increased when 2nd dose was given 2/3..... fatigue always started in the afternoon & chills a couple eof hrs later    both would continue for hours.....after a shower i had to sit ion the toilet seat to dry myself......it was awful ....deepressed by it all.....only anble to fix a bowl of cereal
Co-worker reported she brought her "epi pen" with her to receive vaccine as she has allergies. Pt was given vaccine and waited 30 minutes and did not report any symptoms. Co-worker returned the next day to the vaccine clinic at approximately 11Am and reported that she was having symptoms of a reaction "(unable to walk), ". She was taken to the emergency room. Co-worker had already taken Benadryl prior to coming to report the adverse reaction. Co-worker was called the next day by co-worker health 12/23/2020 and she reported that she had symptoms the evening of the day she received the vaccine that consisted of hives on her arms, shortness of breath and felt like "something was coming on" and she was disoriented.  Co-worker was treated and released from the ED the same day.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 1:54 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 1:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient allergic to medications, food and other product was unknown at the time of reporting. It was unknown that the patient had ever been diagnosed or tested positive for COVID-19. The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight. Excursion duration was reported as 1 month and on 19-Nov-2021 vials went from the super cold freezer to the refrigerator. At the time of reporting, 70 vials were still in ultra cold freezer and 8 vials were stored in refrigerator. No vaccine state changes were noticed and the vaccine was never refrozen. Number of vials/doses 78 vials were impacted. No previous temperature excursions were noticed.  No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report was received from a pharmacist who referred to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 19-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number R006754, expiration date: 06-MAR-2020, strength, dose site and route of administration were not reported) for prophylaxis. It was reported that sterile diluent (STERILE DILUENT) (lot number M037018, expiration date: 01-MAY-2019) used for reconstitution of the vaccine was properly stored. It was reported that the vaccine was stored in temperature range of 15 to 46 Fahrenheit degrees for 3 days (date unspecified). There were no previous temperature excursions. A Digital Data Logger was not involved. No adverse effects were reported.
Pt developed left should pain shortly after injection. She tried physical therapy without benefit and consulted with orthopedic surgeon. On MRI 3/25/10 found to have supraspinatus tendon tear.
Two day after his 1st covid-19 vaccine, he experienced CP  and fever and was taken to ER where a bedside US showed possible pericardial effusion. He was hospitalized overnight and an ECHO showed mild pericardial effusion. He was otherwise well, sent home on 10 day course of scheduled ibuprofen with f/u with cardiology in 2 weeks. When I saw him 9 days later he was asymptomatic.
3 x 3 1/2 cm slightly raised, reddened, warm area on upper (R) arm. Seen in office 8-14-15 for reaction.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 15-JAN-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not provided) and the first dose of VAQTA, injection, 50/1.0 U/ml (route of administration, lot # and expiration date were not provided). On 16-FEB-2016, the patient was supposed to receive the second dose of RECOMBIVAX HB but instead received the second dose of VAQTA (reason was not provided). No symptoms were reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple dates, the patients received improperly stored VAQTA (lot # M012261, expiry date: 01-MAR-2018; lot # M031806, expiry date: 30-MAR-2018; lot # M011116, expiry date: 17-JUN-2017; lot # M002268, expiry date: 20-SEP-2017 and lot # M022924, expiry date: 24-JUN-2018). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same reporter. Additional information has been requested.