chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced nausea; experienced tight chest; This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 2nd January 2022) for prophylaxis.   On 3rd December 2019, the patient received the 1st dose of Shingrix. On 3rd December 2019, less than a day after receiving Shingrix, the patient experienced nausea and chest tightness. On an unknown date, the outcome of the nausea and chest tightness were not recovered/not resolved.   It was unknown if the reporter considered the nausea and chest tightness to be related to Shingrix.  Additional case details were reported as follows: The batch number was update from C453 to JC453, as per sales data sheet. The patient received Shingrix and experienced nausea and a tight chest. The reporter consented to follow up. Permission was provided for follow up. The patient discussion with her physician asked her to talk to her doctor and told her the patient would hold off on the second shot until they are confident she should take it.
chills     fatigue headache   body ache nausea s/s started 1/20/21 & lasted 21/2 days
Fever 100.5, congestion, hot sweats, chills, muscle ache, headache.
Wrong vaccine was given.  Pt requested Pfizer COVID bivalent vaccine, but was given Pfizer COVID monovalent vaccine in error due to the provider moving quickly and not double-checking the label.  Pt did report mild axillary lymphadenopathy after the vaccine but otherwise no adverse effects.
Left arm went numb from site of injection down to hand. It has not improved since onset.  Tylenol and ice treatment has been tried
severe itching; dizziness; fast heart rate; low blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 15:30 as dose 1, single (Lot number: HG4628) at the age of 70 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: generally healthy. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered"; HEART RATE INCREASED (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered", described as "fast heart rate"; HYPOTENSION (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered", described as "low blood pressure"; PRURITUS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered", described as "severe itching". Therapeutic measures were not taken as a result of pruritus, dizziness, heart rate increased, hypotension.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sore aching all over body, chills, Headache, Nausea, Unable to think clearly, Fever, Diarrhea, Shortness of breath, Fatigue, No energy,
Patient called 10/10/18 at 9:15 to describe an increasingly sore rt arm. "I can now not lift my arm above my head and my hand feels like it is going to sleep". States she received her vaccine in her right arm at a flu shot clinic here on 10/4/18 and symptoms of arm discomfort started by Friday 10/5/18, but were most significant on 10/6/18 when she started not being able to move her arm fully. It has now progressed to not being able to lift her arm, feeling weak just in her right arm. Has used a heating pad with little relief with TYLENOL.
This initial spontaneous case, was received from other health professional on 17-Oct-2017, concerning a patient of unspecified age of gender. The patient's medical history and concomitant medications was not reported. On 17-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location was not reported, batch number: 185745, expiry date: Apr-2017). It was reported that, the patient received expired vaccine dose (explicitly coded as expired vaccine used). The outcome of the events was not reported. The reporter considered this case as non-serious.
Fever, Chills, Nausea, Headache, Hives (rash) on lower extremities - started at 4:30 a.m. following day (about 13 hours after injection), lasted approximately two days. Hives still present day 3.
Skin disorder; Very itchy neck only on the sides and front; Rash on the inside of my right elbow; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The medical history included type 2 diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 20, simvastatin (MANUFACTURER UNKNOWN) 20 and metformin (MANUFACTURER UNKNOWN) 1000 two times a day from unknown dates and for unspecified indications. On an unknown date in Mar2021, the patient experienced skin disorder, very itchy neck only on the sides and front, also rash on the inside of the right elbow. The patient received treatment for the reported events which included unspecified cream on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events skin disorder, very itchy neck only on the sides and front, rash on the inside of right elbow was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Patient complained of frozen limbs both legs and arms 2 to 3 hours after vaccination symptoms resolved completely after 24 hours pt has history of Sjogren's syndrome-autoimmune disease.
2 days after received injection, pt had fever of 103.8 degrees.  Began coughing, having runny nose, complaining of foot pain, leg pain, body aches, and difficulty walking.
I had a urinary tract infection after each dose.  I have never had a UTI in my life - until these two.My elderly father also received 2 doses of the Pfizer covid vaccine with me, and he had a urinar; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267 and expiration date was not reported) via an unspecified route of administration, administered in arm left on 16Feb2021 12:30 (at the age of 63 years) as a single dose for COVID-19 immunization. Medical history included blood cholesterol increased managed with atorvastatin, drug hypersensitivity from an unknown date and unknown if ongoing along with known allergies that is Penicillin, known allergies that is Soy from an unknown date and unknown if ongoing known. Concomitant medication(s) included atorvastatin (20 mg, 1x/day [daily in evening) taken for Slightly elevated cholesterol, start and stop date were not reported and calcium (ALGAE CALCIUM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 post vaccination. Historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 26Jan2021 12:30 as 1ST DOSE, SINGLE for COVID-19 immunization. On 16Feb2021, the patient experienced at 18:00 had a urinary tract infection after each dose. Patient never had a UTI in her life until these two. Cranberry juice was used to treat the adverse event. Reporter assessed the event as non-serious. The outcome of the event was recovered on unspecified date.   No follow-up attempts are possible. No further information is expected.
Patient developed a rash to arms and chest after receiving vaccination.  Patient declined Benadryl and any other medical treatment.  He stated that he spoke with his father who is a doctor and that he will take Benadryl when he gets home.  No other distress noted by observer.
No PQC or additional AEs reported.; PROQUAD administered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 29-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T028296 has been verified to be valid, expiration date reported and validated as 16-FEB-2022, 0.5 milliliter for prophylaxis (anatomical location and route of administration were not reported). Digital Data logger was involved. The vaccine was stored at the temperature that was reported as -10.6 degrees of Celsius for 3 hours. There was no previous temperature excursion reported. No product quality complaint (PQC) or additional adverse events reported.
This spontaneous report was received from a pharmacist refers to a 63 year old female patient. Medical history was not reported. On 05-JUN-2014 the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, subcutaneous, lot number and strength were not reported. Concomitant therapy was not reported. The pharmacist informed that on 07-JUN-2014, the patient experienced a lump at the injection site, after receiving ZOSTAVAX. The pharmacist described the injection site reaction as a lump that was rashy and bumpy, also stated that it felt like she bumped herself at the injection site. The patient did not receive treatment for the adverse events and she saw the pharmacist as a sought medical attention. The outcome of the events was unknown. Additional information has been requested.
Mom brought patient in 48 hours after vaccination complaining of swelling and redness in the childs right leg. Swelling was around the site as well as redness surround about 10 inches away from vaccine site. Child state the area had been itchy and it hurt.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. During 2016, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician for the onset of a vesicular rash which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 19-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J011339 with expiration date 13-DEC-2014, single dose, subcutaneously). There were no concomitant medications. On 21-NOV-2014 the patient developed two "quarter sized" red spots at the injection site. No treatment was given for the event. No lab diagnostics studies were performed. The patient had sought medical attention via calling pharmacy. The outcome of the event was reported as not recovered. Additional information is not expected as there was no consent to contact the physician.
This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions drug reactions, allergies and concomitant medications were not reported. On 07-AUG-2012, the patient received a dose of PNEUMOVAX 23 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 17-JUL-2018, the patient inadvertently received a dose of PNEUMOVAX 23 for prophylaxis, intramuscularly on the left deltoid, lot #N024717 and expiration date 06-APR-2019. No adverse effects were reported.
Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting & Palpitations Narrative:  Couldn't report to work for 2 days
Patient stated she became fevered and had a headache and felt hot later in the evening and overnight after receiving the vaccine.
Patient had extreme pain, fatigue, chills, fever. Patient developed lump in arm pit, approx 1 cm that is still there currently. Patient could not get out of bed for over 24hrs post 2nd dose. Reporting kidney pain and full body pain.
Patient received first dose of Pfizer COVID-19 vaccine (lot EW0168, esp 08/31/21) on 5/13/2021 at approximately 2:15 PM. Patient waited (with her 3 year old daughter) seated in the waiting area, but got my attention about 3 minutes after receiving the vaccine to let me know she didn't feel well. I asked her if she just received the vaccine (I was not the vaccinator) and she indicated she did and that she felt unwell and lightheaded. I asked if she felt comfortable with laying on the floor so that I could elevate her legs, and she stated she did but would like it to be in the consultation room (it seemed she was really embarrassed and didn't want to be so exposed where other people could see her). I asked if she felt sure she felt well enough to walk to the room (probably 6-8 small steps away) and she said yes so I physically assisted her in walking to the room. When we were approximately 2 steps from the room, she lost consciousness. She was very small (I'd say right under 100 pounds; which is something I considered originally in my decision to allow her to try to walk to the room), so I was able to easily catch and guide her body the last step or two to the consultation room without risking injury. I immediately elevated her feet and instructed my technician to page help (approx 2:20PM); she regained consciousness within one minute or so. We provided her with a cold bottle of water and a cold paper towel to apply to her face. She kept apologizing and was clearly embarrassed, but I assured her it was completely fine. I also made sure her young daughter stayed with me and tried to make her feel as comfortable as possible and provided her with stickers and a marker/paper and tried to keep her calm (she was noticeably worried). After coming to around 2:22PM, she continued to lay on the floor with her feet elevated around 2:35 when she stated she felt well enough to sit up. HCP's had arrived approx 2:25PM and she declined to have an ambulance dispatched as she was feeling better. She explained that she hadn't been to the doctor in over 10 years because she is worried/nervous about any type of medical intervention, including shots. This is the first shot she had received in the past 10 years per patient. By 2:40PM she expressed she was ready to stand up and I stood by her in case she needed assistance or in case she became lightheaded again. She waited around for a few minutes after that stating she felt back to normal.
No additional AE/PQC reported; temperature excursion on PROQUAD which was administered to one patient today; This spontaneous report was received from a medical assistant (also reported as nurse) referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not reported.     On 13-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) (lot # S035109, expiration date 03-MAY-2021, 0.5 milliliter, route was not reported) which undergone a temperature excursion for prophylaxis (product storage error). Temperature excursion was 10.5 Fahrenheit degree for 1 hour 20 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse event (AE) and product quality compliant (PQC) was reported.
This spontaneous report was received from a pharmacy technician referring to a 30 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date "during childhood", the patient was vaccinated with a dose of VARIVAX (strength, dose number, rote, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that on an unknown date, recent antibody titers drawn were negative for immunity to varicella (viral titre decreased). No treatment was given. The case did not involve cancer or overdose. At the time of the report, the outcome of viral titre decreased was not provided. Additionally it was reported that the patient had not developed any symptoms of varicella disease. The reporter did not assess the relatedness between viral titre decreased and VARIVAX. Additional information has been requested.
2/24/08 Patient presented in clinic with 10X10 centimeter erythema, warm without tenderness, rt upper arm x24 hrs.  Treated with Benadryl QID until inflammation gone.
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties.  States that with 1st vaccine had hives inside rt elbow and wrist,
Nurse had just finished administering Tdap vaccine and was going to administer MCV4 when noted pt had slumped and was unresponsive (less than 1 minute since vaccine adminitered).  Arms and upper body were rigid and nurse was unable to place pts head between his knees.  He quickly became alert and recovered well/completely from the incident.  Head was placed between his knees and cool cloths applied to back of neck and forehead.  He stated prior to fainting he remembers feeling some numbness on the left side of the body and then remembers nothing after that. Kept pt. for approx 15 minutes after incident.  Did well.  Advised he avoid any strenuous activity for at least the next 24 hrs or until completely recovered. Sister was present and would be driving him home.
On April 24, 2021, I went to ER with first episode of AFib.  Followed by Cardiologist,  On July 19, 2021, I went to ER with second episode of AFib.  I was hospitalized because AFib did not convert to normal sinus rhythm.  Released on July 20, 2021 after heart finally returned to normal sinus rhythm.  Being followed by Cardiologist.
redness on arm next day growing to the next day. painful and warm to the touch. no itchiness. beginning first day, flashes of burning in my arm, fatigued, and headache.
dose_received: 3; injection site soreness; joint pains; minor swollen axillary lymph node (unilateral to injection site side); lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 10:15 (Lot number: FF 8841) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma & severe allergies" (unspecified if ongoing); "severe allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: 27Jan2021, when the patient was 32 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 18:00, outcome "unknown", described as "dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "injection site soreness"; ARTHRALGIA (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "joint pains"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "minor swollen axillary lymph node (unilateral to injection site side)"; LETHARGY (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "lethargy". Therapeutic measures were not taken as a result of vaccination site pain, arthralgia, lymphadenopathy, lethargy.    Additional Information: Facility type vaccine was workplace clinic. No other vaccines were given within 4 weeks. Other medications were given within 2 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Swelling, redness, tenderness within 26 hours past dose.  5-6 inch induration.  Treatment with Tylenol 1.5 teaspoon every 4-6 hours, cold compresses.
After 2nd Covid vaccine experienced pain in right ear. Applied warm compresses and ibuprofen for relief.  Aug 12 2021  urgent care visit for RIGHT OTITIS MEDIA  (primary encounter diagnosis)  RIGHT CERUMEN IMPACTION  RIGHT OTITIS EXTERNA  Oct 14 2021 Otolaryngology Comprehensive Visit right Ear Acute Otitis externa and Tinnitus  Left ear pulsating Tinnitus after booster.  Feb 4 2022  another Otolaryngology Comprehensive Visit for fungal otitis externa in the right ear   Apr 19 2022 Audiology visit for Bilateral Tinnitus (worse on the left and different tones R vs L)   Aug 26, 2022  doctor visit for cerumen impaction right ear , Tinnitus in both ears  Tinnitus has not resolved. Never had tinnitus until Covid vaccine.
Vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021 at 11:51 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021) to be not related.    No adverse reaction reported.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.