chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe ringing in both ears (tinnutis)within 1 hour of vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 13May2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. 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 patient did not receive any other medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 22Apr2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 17:30, one hour after the vaccination the patient experienced severe ringing in both ears (tinnitus). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe ringing in both ears (tinnitus) was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Chills, body aches, nausea, & extreme fatigue. Lasted from 10:00am-4:00pm. Took Tylenol at 1:00pm.
under left arm, area is extremely swollen, sore=possibly lymph node///right calf muscle extremely sore.
Hot red hives on upper left arm below shot injection site. Today is the 3rd day. Feeling much better than yesterday.
Same day post vax, the pt developed urticaria and heavy feeling across chest. Took Benadryl tablets which alleviated symptoms. No reoccurrence.
Dizziness, Headache, NauseaVomiting, tired, throbbing left arm, hot sweats, Narrative:
pt recvd vax & had dizziness, faintness & flushing; sx resolved; 30 mins p/2nd inject had hot & cold sweat, heart racing, weakness, SOB & fever;
I started having right hip/groin pain about since one month post vaccine.  Today, I started to have left hip groin pain.
muscular pain; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "muscular pain"; CHILLS (non-serious), outcome "recovered", described as "chills". Patient had a lot of chills for more than a week, which was a normal stuff.    No follow-up attempts are possible. Information on lot/ batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse, concerning an unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of VAQTA (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unspecified number of improperly stored VAQTA doses were administered to patients. No adverse effects reported. This is one (1) of three (3) reports from the same source. Additional information has been requested.
extreme catarrh and extreme runny nose the day after the vaccine, fatigue, achiness, general malaise the day of
Information has been received from a healthcare worker in a physician's office concerning a 27 year old white female with an allergy to morphine who on 12/01/03 at 4:45pm was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #647635/0864N)(also reported as Lot # U1291AA).  There was no illness at the time of vaccination. The pt experienced fever and cellulitis at the injection site. Unspecified medical attention was sought.  It was noted that the physician was concerned about the vaccine because the injections were from the same lot. Follow up was received from the healthcare worker in the physician's office who indicated that on 12/01/03 the pt developed a severe local reaction with pain, erythema, warmth, swelling and fever. No diagnostic lab tests were performed. Subsequently, the pt recovered. It was noted that the pt and her sibling had no adverse events following prior vaccination.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  No further information is expected.  The reporter also indicated that a female pt had a similar reaction after therapy with pneumococcal 23v polysaccharide vaccine (Lot # 647635/0864N)(WAES#0312USA00798).
Arm became very sore during the night 11-20-03 noticed hives down arm from shot area, next afternoon face flushed, no fever, no problems breathing.
06/15/22 Had a temp of a 100.xx that evening.  On 06/16/2022 left deltoid arm area was swollen and hot to touch.  The area affected was approximately 4 inches in an oval shape. There were pin point blisters.  The child c/o it itching a bit. 06/17/22 the swelling continued to reduce.  06/20/2022 went to see doctor for poison ivy on face and received a steroid.  Mom showed the doctor pt.'s arm and the doctor was not concerned about the vaccination or arm area at that time.  06/21/22 mom said pt. is doing pretty good, no swelling at this time, still a little hard but no redness.
Information has been received from a 38 year old male patient who on 20-FEB-2009 was vaccinated with a 0.5 mL first dose of VARIVAX(Merck) and on 22-MAY-2009 received a second dose of VARIVAX (Merck). The patient stated that he received the second dose of VARIVAX (Merck) 50 minutes after reconstitution rather than within the recommended 30 minutes. In approximately August 2009, about 3 months after getting the VARIVAX (Merck), the patient experienced stiffness and swelling in hands and fingers. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered from stiffness and swelling in hands and fingers. No further information is available.
Male 53 got Shingles vaccine 02/15.  Herpes-like lesion appeared on genitals 02/26. Partner, female 58, developed painful rash around midsection & genitals about 03/04.  Female initial diagnosis HSV2 via swab.  Female blood test negative for HSV1 & HSV2; diagnosis shingles.  Initial male blood test positive for HSV1.  Later blood test positive for HSV1 & HSV2. No prior history of HSV in either male or female. Possibilities: 1) coincidence, 2) shingles vaccine stimulated latent HSV1/2 in male, but no explanation for female reaction, 3) shingles vaccine caused this.
joint pain and stiffness in hands, knees, after 2nd shot, starting 3 days after the vaccine
unbearable itch, three times; unbearable pain, three times; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus and pain. On an unknown date, the outcome of the pruritus and pain were unknown.   The reporter considered the pruritus and pain to be possibly related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the Shingle vaccine and it was an unbearable itch and an unbearable pain. The patient yet managed to survive it three times after his/her wonderful vaccination. The patient believed that the vaccination triggered it. The follow-up would not possible as no contact details were available.
I suffer from exhaustion; can barely hold my head up on both shots; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots). At the time of the report, FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots) outcome was unknown.            No concomitant and treatment medication was provide by patient.     Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Reporter is discussing about her husband's AE and medical condition. On 18-Aug-2021: Reporter is discussing about her husband's AE and medical condition.
See attached; "Patient" received the shingles vaccination on January 7, 2008. Sometime, the following week, she began to experience a tingling sensation beginning with the upper right portion of her face. Over the next week, the tingling and slight lack of feeling to the entire right half of her face, the right side of her tongue and the right side of her bottom lip. The feeling was similar to a novacaine shot which has almost worn off. She also had a mild headache which lasted about three days. Her face hot to her but it wasn't hot to the touch. The only visible symptom was a slight redness which appeared on her right cheek. A week to 10 days later, she called the Hospital.  After describing her symptoms, she was told that the symptoms couldn't be caused by or related to the vaccination. The Center called Dr.'s internist. He gave her the name of a neurologist that he strongly suggested she see for a neurological exam as soon. After a series neurological tests and brain and neck MRI's and MRA's, Dr. concluded that "patient" has a mild case of shingles. Dr. prescribed Neutrontin. As of this date most of the symptoms remain.
fever 105 on 7JUL92 seen @ hosp given fever med; 9JUL92 seen @ clinic temp running 101-103 x 2 days; given Pediaporfen & APAP; t99.4 w/meds;
Expired doses were administered on 20Oct2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  3 doses were administered after manufacturer date of expiry. On 19-Oct-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. HCP declined to report AE.   Reporter did not allow further contact
This spontaneous report was received on 10-JUL-2017 from a licensed practical nurse (LPN) and refers to an unspecified patient of unknown age and gender. The nurse reported that an unspecified patient may have received an improperly stored dose of one of the following vaccines, but she is not sure which of the vaccines the unspecified patient received. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The names of the vaccines involved were GARDASIL [Lot number L036301, expiration date reported as 31-DEC-2017 (The expiration date of 10-DEC-2017 is the date that automatically showed in the product screen.) Lot number M034437, expiration date reported as 02/2019.]; RECOMBIVAX HB (Lot number M035487, expiration date 02/2018); VAQTA (Lot number M018644, expiration date 09/2017 (Expiration date shows as 20-SEP-2017 in the product screen); and ROTATEQ (Lot number M044395, 01-MAY-2018 (The expiration date of 31-MAY-2018 is the date that automatically showed in the product screen.) The temperature was reported as -0.5 degrees Celsius (C) for the time frame of 14 hours. There was no previous temperature excursion. The call was because of a "data logger". Product quality complaint was not involved. No adverse effect reported. No additional information was provided. A Lot verification request has been sent for GARDASIL Lot number M034437, expiration date reported as 02/2019. Additional information has been requested.
Itch back, hip and arm (both); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch back, hip and arm (both)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itch back, hip and arm (both)). At the time of the report, PRURITUS (Itch back, hip and arm (both)) outcome was unknown.            Treatment medications was not provided by the reporter
Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted Covid". Clinical course: patient had the first PFizer COVID 19 booster in Nov2021 and contracted COVID about 4 months ago.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pyrexia (achiness, along with her feet feeling hot after 1st dose received in May 2018, refer case US2018147867). On 13th August 2018, the patient received the 2nd dose of Shingrix. On 13th August 2018, less than a day after receiving Shingrix, the patient experienced general body pain, fever, hot feeling in feet and feeling cold. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fever, hot feeling in feet and feeling cold were unknown. It was unknown if the reporter considered the general body pain, fever, hot feeling in feet and feeling cold to be related to Shingrix. Additional details reported as follows: The evening of vaccination, the patient began to experience feeling hot and cold, with fever and aching all over. This case has been linked with US2018147868, reported by same reporter and linked with case US2018147867 for same patient.
Patient received Pneumonia Vaccine on I/2/04 at 4:20 PM. It was given in her right lateral thigh. At the same time she rec'd a flu injection in her  R arm.  Her other arm was not available for an injection due to previous surgery.   She called on 1/5 stating "At 8 PM on 1/2/04, Friday night, my right knee and lower leg started to hurt.  It was red and started to swell.  I kept hoping it would go away." Patient was seen on 1/5/04 by a doctor and a registered nurse. On 1/5 redness and warmth were noted about an inch above the kneecap and around the back of the knee and down the lower leg a few inches in front. There was no redness at the injection site at midthigh. Cellulitis was diagnosed.
pt recvd vax & bled when the needle came out following vax; a couple of days later exp itching, local irritation, pain lateral to inject site, bumpy @ inject site; devel flu-like synd; treated w/APAP;
PATIENT CALLED AT 4:20 PM ON 11/18/2021 REPORTING DIZZINESS, DIFFICULTY SLEEPING, AND SEEING SMOKE STREAKS.
Acute suicidal ideation with strong intent to hang herself; Severe body aches; Severe chills; Had cognitive side effects where she was forgetting basic facts including her date of birth; This is a spontaneous report from a contactable physician. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8729), intramuscularly in left arm on 13Apr2021 at 09:00 (at the age of 38-years-old) at single dose for COVID-19 immunization. Medical history included post-traumatic stress disorder (PSTD), obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), premature ventricular tachycardia, hashimoto's disease, migraine, celiac disease, hysterectomy and was diagnosed with COVID-19 prior vaccination. Concomitant medications included trazodone, lisdexamfetamine mesilate (VYVANSE), venlafaxine hydrochloride (EFEXOR XR), and metoprolol (METOPROLOL XR). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER2613) intramuscularly in left arm on 23Mar2021 at 09:00 (at the age of 38-years-old) at single dose for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19, did not receive any other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 13Apr2021 at 17:00, the patient experienced acute suicidal ideation with strong intent to hang herself and at the same time she developed severe body aches and chills. The patient also had cognitive side effects where she was forgetting basic facts including her date of birth. It was reported that, all the side effects resolved after 1.5 days. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered on 15Apr2021.; Sender's Comments: Based on the information currently available, the event Suicidal ideation is considered most likely associated with intercurrent or underlying medical conditions, appear unrelated to the suspect drug.
This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medication was reported.    It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein age group added and I narrative updated.
8/24/21: Presents to the ED with epigastric pain for 2 days. Tested positive for COVID on admission via pre-procedure test. Diagnosed with: Abdominal pain, dehydration, gastritis, diffuse abdominal pain, appendicitis 8/26/21: Patient discharged.
chills; Body ache; Fever of 102; Severe headache; Joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no  relevant medical history andknown allergies. 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. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LUPIN) and birth control medication; all from unknown dates for unknown indications and unknown if ongoing. On 21Apr2021 at 03:00, the patient experienced chills, body ache, fever of 102, severe headache, joint pain and loss of appetite.  On 21Apr2021,  the patient underwent body temperature test and the result was 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, chills, body ache, fever of 102, severe headache, joint pain and loss of appetite was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local inflammatory reaction for approx 2-weeks, improving, suspect sensitivity to component of immunization.
Patient received a dose of Pfizer COVID-19 Vaccine  formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.