chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus both ears; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9263) via an unspecified route of administration in the left arm on 03Feb2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications included rosuvastatin calcium (CRESTOR), amitriptyline hydrochloride, chlordiazepoxide hydrochloride (LIMBITROL), losartan (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EI1284) via an unspecified route of administration in the left arm on 13Jan2021 at 10:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient experienced tinnitus both ears. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported event. The clinical outcome of tinnitus both ears was not recovered.   No follow-up attempts are needed. No further information is expected.
Swollen lymph nodes in armpit and side of chest, extreme pain in swollen area  Pain at injection site, but not nearly as severe as armpit pain
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A female patient of an unspecified age received a single dose of TRUMENBA; (lot M77282, Expiration Jun2017), via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced large inflammation at injection site with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Patient developed erythema, edema, fever, and induration to left upper arm 2 days after.  Diagnosed with cellulitis.
Had the vaccine but now have shingles/ SuspectedVaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the vaccine but now have shingles/ SuspectedVaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 06-JUL-2023 This case was reported by a consumer via interactive digital media.  The patient had the vaccine but now had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Vaccine was given at 0930 am. About 5 pm, patient noticed a red area at the site of injection. It was warm to the touch and sore. Area measured 3 in x 6 in. Patient did not use anything to treat the area.  She continued to watch the area and it completely resolved by 5 days after administration.
Initial and follow up information has been received from an LPN and the mother of a 12 year old female patient with aortic insufficiency and migraine headaches who on 01-FEB-2007 was vaccinated IM with her first dose of Gardasil, lot #654741/0013U. There was no concomitant medication. Subsequently, the patient experienced dizziness and developed an elevated temperature. It was also reported that the patient felt weak and had muscle aches for several days. The side effects eventually disappeared. However on 21-FEB-2007, the patient woke up with breast rashes. As of 21-FEB-2007 breast rashes persisted. Additional information has been requested.
Swelling and redness with pain at injection site on R upper thigh, which worsened over next 24 hours before improving.
Received vaccine on Saturday 1/9/21, had usual symptoms low grade fever, general malaise. On Sunday begin to experience left arm neuropathy at the media aspect of elbow, no sensation in affected area. Lateral aspect is fine, can move fingers and complete activities of daily living.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt a little sick after the first shot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced MALAISE (Felt a little sick after the first shot). On 30-Dec-2020, MALAISE (Felt a little sick after the first shot) had resolved. No concomitant and treatment and medication were use was provided. This case was linked to MOD-2022-477106 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 12:30 as dose 1, single (Lot number: EP6955), in left arm, on 07Apr2021 at 12:00 as dose 2, single (Lot number: EP6955), in left arm and on 16Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate persistent Asthma (well controlled)" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Hyperlipemia" (unspecified if ongoing); "Laryngopharyngeal reflux (LPR)" (unspecified if ongoing); "Allergic to tropical fruits -pineapple, kiwi" (unspecified if ongoing); "Allergic to pollen" (unspecified if ongoing); "season allergies" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE, start date: Mar2022; MONTELUKAST, start date: May2022; SIMVASTATIN, start date: Mar2022, stop date: 25May2022; FLUTICASONE, start date: Apr2022; DULERA, start date: Apr2022; ALBUTEROL HFA, start date: Apr2022. Past drug history included: Azithromycin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received treatment with Paxlovid (Lot number: FY8914) from 26May2022 to 27May2022 for treatment of COVID-19.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
21FEB95 3PM t102, APAP given then every 4hrs; 21FEB95 8PM t103; t0PM t105 pt taken to trauma ctr;22FEB95 3AM t107 gave tepid bath; pt shakey w/fever; pt cried for 2 days, high pitch cry; MD check 22FEB95; inj site red & warm to touch;
Allergic type reaction; Rash; Big red block on the arm; A spontaneous report was received from a physician concerning a 78-year-old, female patient who experienced a big red block on the arm/erythema, allergic type reaction/hypersensitivity, and rash.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On 10 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.  On an unspecified date, after second dose of vaccine, the patient experienced big red block on the arm, allergic type reaction, and rash. Treatment medication included Cortisone cream.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, big red block on the arm, allergic type reaction, and rash was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received 3rd dose of the COVID-19 Pfizer vaccine on 10/5/21 and then developed stroke-like symptoms of ataxia and right sided weakness on 10/7/21. She presented to the ED on 10/11/21 and MRI of the head confirmed a 7 mm acute to subacute lacunar infarct in the left posterior basal ganglia in left MCA territory. She will be treated with antiplatelet therapy and a statin. She does still have some residual speech difficulties.
Pruritic rash on right half of body, similar to allergic contact dermatitis on right ankle up front and back of shin. on right hip up right flank to axilla, right forearm, right dorsum of hand, right shoulder, scalp and chest.  Has been using mometasome 0.1% ointment BID, CeraVe lotion multiple times a day, Bendaryl 50 mg nightly, levocetirizine BID . No relief after 1.5 weeks treatment.
This spontaneous report was received from a physician referring to an 85 year old female patient with hypertension, mitral valve prolapse, osteoarthritis, chronic colitis ulcerative and sulfonamide allergy. The patient's medical history included cerebrovascular accident. On 25-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX administered subcutaneously (strength, dose, lot number and expiration date were not provided) for prophylaxis, at unspecified local facility. Concomitant therapies included naproxen sodium (ALEVE), alprazolam, aspirin (manufacturer unknown), losartan potassium (manufacturer unknown), metoprolol, sertraline hydrochloride, spironolactone and colostrum. On approximately 27-OCT-2016, 3 days after vaccine administration, the patient experienced diffuse umbilicated rash at the injection site (injection site rash) and it spread to both arms and legs, which looks like chicken pox (rash vesicular). At the time of reporting, the outcome of injection site rash and rash vesicular was reported as not recovered. The causal relationship between the events and the ZOSTAVAX was unknown. Additional information has been requested.
A person took the first dose of Pfizer and has some fast heartbeat; This is a spontaneous report from consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number, expiration date was unknown) via unspecified route of administration on unspecified date. The patient's medical history and concomitant medications were not reported. The patient experienced some fast heartbeat on unspecified date. Additional information: Reporter wonders if a person took the first dose of Pfizer and has some fast heartbeat, can that person take the second dose. Reporter seriousness for A person took the first dose of Pfizer and has some fast heartbeat was unspecified. The outcome of the event was unknown.  No follow-up attempts are possible, Information about lot/batch number cannot be obtained.
Mild headache; Mild nausea; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal hay fever. The patient was allergic to tree nuts. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the right arm on 02Mar2021 at 11:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 06:00, approximately 24 hours after second shot, the patient woke up with mild headache, mild nausea and sore arm at injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, nausea and sore arm at injection site was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
About 12 hours after the injection, I experienced a severe headache, dizziness, sore muscles, fever of 103, nausea, and tiredness.  I went to a physician who said "if it's an adverse reaction to tetanus vaccine, there is nothing I can do about it."  He prescribed promethegan 25 mg suppositories and tylenol.  Symptoms disappeared in approximately 12 hours.
Chills, body aches, T 103 deg. No treatment needed, monitor symptoms.
Body felt like on fire, no fever,,every joint had extreme pain and movement. Deep throbbing in tibia, fibula, and thigh first night, felt like wanted to tear the skin of leg bones for relief. Severity lasted 24 hours.. Severe right sided neck pain in occipital region on day 3. In bed 2 full days, difficulty walking for 2 days, then residual joint discomfort in all joints which still experience but to a lesser degree. Did experiences chills throughout first week, never a fever.
Developed a rash on the trunk of his body today, 10/21/19. Denies itching or burning.  Advised to see PCP for treatment.
Redness at site; 7cm circular of erythema, palpable axillary lymph node  Doubt infection Instructed to monitor, hot compresses
Immunizations 3/17/04 at 2:15pm. Awoke with maculopapular rash, angioneurotic edema of hands, feet, ears, lips the next morning. Resolved within 4 hrs after Benadryl. No new foods, soaps, etc to account for reaction.   Nurse follow up on 07/21/04 states: "ears red, ears swollen, irritable
Severe lower back pain; sleepy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain) and SOMNOLENCE (sleepy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (sleepy). On 17-Apr-2021, the patient experienced BACK PAIN (Severe lower back pain). At the time of the report, BACK PAIN (Severe lower back pain) had not resolved and SOMNOLENCE (sleepy) outcome was unknown. Not Provided          Treatment details included ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080129, MOD21-078128 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080129:1st Dose Case MOD21-078128:Husband report
Salmon colored rash that began on head and worked down entire body. Rash began 11 days after vaccine was given
Pt recvd vax in 1989.On 18OCT90 pt recvd 2nd dose & subsequently devel a local reaction w/ induration & erythma @ inject site.
Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then elbow to shoulder. Attributed it to tennis elbow from strenuous hitting, then got raised welts like hives following evening on right shoulder. Rash  appeared and I started to suspect shingles. ( have never had before) saw doctor on 3/30/2021 and got shingles diagnosis.  I believe it is due to the vaccine and have spoken to multiple medical professionals that believe there is a connection. I have had racing heartbeat, numbness on right side of face, severe pain in right ear.
Redness, quarter size swelling (lil bigger) to (L) arm. TYLENOL for pain & cool compresses.
Patient received first dose of Moderna 19 vaccination on 1/25/2021.  Patient states the vendor ran out of vaccinations when her second appointment was due.  Since then, patient has moved and made an appointment for her second dose of Moderna at 1338 4/12/2021.  This is eleven weeks after first dose was given.
Started with chills, fever, headache, followed by arm pain and swelling from shoulder to just above elbow. Got medical treatment on 11/2/17 and dr prescribed doxycycline and tylenol with codeine for cellulitis.
After giving vaccine patient stated he felt lightheaded and then slumped over and fainted for about 30 seconds in chair. MA stayed with patient until he came to, called in another MA who got a provider. Provider came in room and observed patient. Patient threw up once, was given water and ice pack and laid down for about five minutes. Patient then had appointment with provider and felt dizzy once during appointment. Was given a chewy bar and stayed in room until he no longer felt dizzy and left. Patient in clinic about 35 minutes after receiving vaccine.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 020A21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Chest discomfort, Hearing loss, Cataracts, Inguinal pain, Neck pain, Obstructive sleep apnea syndrome, Glucose tolerance impaired, Dizziness, Lung cancer, Renal insufficiency, Dyspnea, Fatigue, Skin cancer, Gastroenteritis, Vitamin D deficiency, Bronchitis, Osteoarthritis, Uric acid, Colon cancer, Prostate cancer, Lumbar disc disease, Epicondylitis, Coronary artery disease, Hypercholesterolemia, Colon diverticulitis, Hypogonadism and Shoulder pain. Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse reaction with Influenza vaccine. Concomitant products included TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE) for Hypogonadism, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, GLUCOSAMINE SULFATE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), SERENOA REPENS FRUIT (SAW PALMETTO [SERENOA REPENS FRUIT]), ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]), VITAMIN D3, GLYCERYL TRINITRATE (NITROSTAT), EZETIMIBE, ISOSORBIDE MONONITRATE, ROSUVASTATIN CALCIUM, CLOPIDOGREL BISULFATE (PLAVIX) and PANTOPRAZOLE SODIUM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had to take FLUVAX,PNEUMOVAX,TD BOOSTER vaccines patient has to check for hemoccult or sigmoid   This case was linked to MOD-2021-424036 (Patient Link).
runny nose; sneezing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient got the first dose of the covid-19 vaccine yesterday on 12Jan2021 and she was currently experiencing runny nose and she continuously sneezing in Jan2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
BODY ACHES; NIGHT SWEATS; SORE ARM; This spontaneous report received from a patient 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: Unknown) dose, start therapy date were not reported for drug used for unknown indication. 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 subject experienced body aches, night sweats, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, night sweats, and sore arm. This report was non-serious.
20MAR91 began stinging, itching, & hurting; Pt rubbed arm down w/alcohol-continued this tx until 22MAR91; Began warm compresses; 22MAR91 warm towel; 27MAR91 contacted clinic by phone told to seek med advice @ that time;
Fever. Redness below the site of injection. Instructed to take TYLENOL/MOTRIN for pain or fever. Take BENADRYL for itching.