chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 61-year-old female patient who received Shingrix for prophylaxis. Concomitant products included Tylenol. On 28th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th August 2018, immediately after receiving Shingrix, the patient experienced injection site muscle pain, sleeplessness, muscle pain, headache, pain in arm and skin warm. On 29th August 2018, the patient experienced red blotches, back pain, sniffles and injected limb mobility decreased. The patient was treated with Advil and Lidocaine Patch. On 29th August 2018, the outcome of the back pain was recovered/resolved. On an unknown date, the outcome of the injection site muscle pain, sleeplessness, headache and skin warm were recovered/resolved and the outcome of the red blotches was not recovered/not resolved and the outcome of the muscle pain, sniffles and pain in arm were unknown and the outcome of the injected limb mobility decreased was recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, red blotches, sleeplessness, muscle pain, headache, back pain, sniffles, pain in arm, injected limb mobility decreased and skin warm to be related to Shingrix. Additional details were reported as follows: At 1:00 pm, the patient received Shingrix in left deltoid. The nurse reported that the patient experienced severe deltoid pain and red splotches on her deltoid. The splotches were not raised but it was big and red. The patient also experienced bad pain the night after the vaccination and couldn't sleep and her whole muscle was sore. The patient also experienced headache and severe back pain next day and sniffles. The day before the reporting date, her arm was so sore that she couldn't raise her arm but by noon it was better with Tylenol. The patient's arm was warm and ached with soreness on the deltoid after injection with Shingrix vaccine. The patient developed 3 separate red spots on her arm. The patient did not believe they were hives, were more pronounced at the time of reporting rather than before. Till the time of reporting, the patient's arm was still little sore. The patient used a lidocaine patch on her back for her back pain. The patient took Advil for back pain and arm pain. The patient also stated that, when the medicine was injected into the muscle in her arm it burned going in and her arm got more sore as the day went on. Further details shared upon transfer to MACC.
BOTH VACCINATION SITES SWELLED UP TO THE SIZE OF A GOLFBALL, WERE VERY ITCHY
erythematous maculopapular rash on trunk/neck non pruritic. Blanches. Received MMR 7 days prior,
no adverse effect; one pediatric dose inadverently administered; This spontaneous report was received from a health care professional regarding a 62-year-old non-pregnant female patient. The patient's relevant medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 11-OCT-2019, the patient was inadvertently vaccinated with one pediatric dose of VAQTA (strength, frequency and route not reported) lot # S005723 and expiry date :10-JUL-2020 for prophylaxis instead of an adult dose (product administered to patient of inappropriate age). No adverse effects were reported.
(L) pain, hot to the touch with redness that radiates through upper (L)arm. Given abx to tx cellulitis. Pt presents for a Tdap reaction. Pt was here on Monday and received a Tdap vaccination, Tuesday is when pt started complaining of pain in (L) arm. Pt states this morning is when she noticed heat and redness radiating from arm. Pt denies n/v, diarrhea, and any other symptoms.
Information has been received from a physician concerning a 16 weeks old (also reported as 14 month old by the physician) female patient with no drug reactions or allergies and no pertinent medical history who on unspecified dates were vaccinated with the first dose and second dose "on time" of ROTATEQ, 2 ml orally "twice" (lot number not reported). On unspecified date, the patient was given a dose of ROTARIX in place of the third dose of ROTATEQ. Concomitant therapy included unspecified "oral antibiotics". "Within 10-15 days after getting ROTARIX, the patient was vomiting had diarrhea and watery stools. On unspecified date, the patient was brought to the emergency room of an unspecified hospital where she was given IV fluids (unspecified) and released". At the time of the report, the patient recovered (on unspecified date). The physician reported that the patient had a breakthrough with Rotavirus despite receiving two doses of ROTATEQ and one dose of ROTARIX. Follow up information has been received from a medical assistant concerning 14 month old female patient who on 23-APR-2010 was vaccinated with the first dose of ROTATEQ (lot number: 664076/0768Y) (dose and site of administration not reported), PEDIARIX (lot number: AC21B024AA), ACTHIB (lot number: UH01944) and PREVNAR (lot number: D88184). On 25-JUN-2011, the patient was vaccinated with the second dose of ROTATEQ, 2 mL orally (lot number: 664945/0147Z), PEDIARIX (lot number: AC21B248CA), ACTHIB (lot number: UH091AA) and PREVNAR (lot number: E60221). On 27-AUG-2010, the patient was vaccinated with a dose of ROTARIX (AU1FB058A) in place of third dose of ROTATEQ. On the same day, the patient was also vaccinated with the third dose of PEDIARIX (lot number: AC2B248CA), ACTHIB (lot number: UH093AA) and PREVNAR (lot number: 914265). On 15-MAY-2011, the patient had vomiting and watery stool. On 18-MAY-2011, the patient was seen by the physician. The patient's stools test positive for rotavirus. The patient was taken to hospital and not admitted. The patient was observed in the hospital and was given IV fluid for hydratation. At the time of the report, the patient had recovered from rotavirus. Additional information has been requested.
5 months later I developed left big toe pain. It was red with swelling and tenderness. My doctor diagnosed me with Gout after doing a physical exam and lab test. My uric acid was elevated. I was prescribed a 7-day dose of prednisone. It took about 2 weeks for the symptoms to go away but then I had a recurrence about a week ago, but it was on the right side. This time they prescribed indomethacin to treat my symptoms for 7 days. I have been taking the medication for about 4 days and the symptoms have improved. I am about 90% better so by the time I take the 7-day dosage. I have a follow up visit with my doctor to be placed on chronic medication. They stopped the hydrochlorothiazide and checked my blood pressure to see if was normal and it was.
Temporary loss of consciousness occurred immediately after receiving Tdap MCV4 and HPV. Slight body twitching, jerking and pale coloring. Pt was sitting, no harm or injury occurred. Incident lasted 30 sec and consciousness was regained. Recovery occurred in a few minutes following. No medical intervention other than observation was needed. Child left the building ambulatory.
shot #1 on 05-Nov-2021, yet to receive second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot on 5th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The patient had not yet to receive the second dose and was beyond the 6 month window. The patient did not had the lot number of the vaccine which was administered. No further questions asked (due to difficulty understanding each other).  The reporter was failed to asked for his date of birth. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a physician concerning a 15 year old female who was vaccinated IM, first dose, with Gardasil vaccine (yeast). Subsequently the patient experienced itching both arms after receiving the vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Immediately after flu shot was administered, patient felt pain from right deltoid down to her fingertips. Pain then settled into (R) upper arm. Developed limited range of motion of (R) shoulder. ROM is improving.
Hepatitis B # 2 injections of 3 step series. Both eyes swelled shut for 6 hours about 6 hours post injection.
Information has been received from a consumer who is a health care worker concerning her son who "sometime in the past" was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication. Subsequently, shortly after being vaccinated, the patient experienced a fever. It was reported that he was fully recovered within 10 days post vaccination. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Was GIVEN KINRIX AND PROQUAD. PATIENT HAD EMESIS 2 MINUTES AFTER THE SHOTS.
Baby was taken to the Emergency Department due to vomiting and bloody diarrhea.  He was found to have an intussusception, which was reduced with an air contrast enema.  3/15/07 Medical records reviewed which reveal patient admitted 9/25/06 after 1 day history of multiple episodes of vomiting w/1 episode of currant jelly diarrhea.  IS reduced w/air contrast enema.  Held overnight for observation.  Did well & was d/c to home on 9/26/06. FINAL DX: Intussusception.
Experienced expected fever at ~ 24 hours post vaccine #2, then next day exquisite pain in lower back radiating down left leg. 4 days after vaccine experienced exquisite pain in left shoulder radiating from axilla to hand, followed by muscle weakness and neuropathy to pinky and ring finger (ulnar nerve). Saw chiropractor same day with little relief, then PT on day 11 post shot. Used acupuncture treatments until 4/19/21 before finger function was back, but still weak.  Had planned rotator cuff surgery on 5/6/21. 2-3 weeks post-op experienced horrific nerve pain from top of hand extending to 2nd knuckle of all fingers and up to top of forearm almost to elbow. Used acupuncture again for pain until 6/28/21 and returned to work on 7/1/21 Decreased sensation to top of hand and some weakness in right hand remain.
Patient was administered bivalent vaccine beyond the 30 day use; No adverse event; Patient was administered bivalent vaccine beyond the 30 day use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine beyond the 30 day use), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine beyond the 30 day use), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine beyond the 30 day use) and PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use).    No concomitant medications were reported. Vial size was reported as 2.5 ml. The vial was initially stored in the refrigerator on 13-Sep-2022 at 2:20pm. Use by date was reported as 13-Oct-2022. The vial did not undergo any temperature excursions. The patient was administered the vaccine before noon time. No treatment medications were reported. This case contains information for the 1st of 2 patients described by the reporter.
Pt. was supposed to get an MMR vaccine. A previous T-Dap given 4/19/2023
Symptoms began the following day: Body aches/ myalgia, fatigue, dizziness. Occurred daily for the next 4 weeks before self-resolving.
Fever, chills, extreme muscle pain beginning 12 hours after second dose and lasting 24 hours.  Extreme nerve pain in face and head and metallic taste beginning on 3/6 overnight and continuing to worsen over the next 72 hours. Within 48 hours of onset of symptoms, facial paralysis and loss of taste (suspected Bell?s palsy, awaiting confirmation) began in addition to worsening pain and extreme discomfort. Still ongoing.
7JAN92 began w/t102 p/inject @ 10AM 3" diameter red, swollen hot to touch found 3" below inject site; lethargic, cranky moving head; appeared neck hurt; intermittent crying unconsolable; arm stiff; poor sleeping pattern;
12 hours after the vaccine my right hand was really cold.  There was a significant difference in the temperature of the left hand.
Patient received booster dose instead of first dose (0.25mL vs 0.5mL).
Myalgia, Arthralgia, Fever, Chills, fatigue Narrative:
Patient received two doses of Spikevax.  No signs of adverse reaction.  Pt was monitored for 30 mintues and continues be monitored by facility.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ACUTE HYPERCAPNIC RESPIRATORY FAILURE J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 3/29/2023 ACUTE HYPERCAPNIC RESPIRATORY FAILURE
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 62-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "hysterectomy" (unspecified if ongoing), "menopause" (unspecified if ongoing), notes: Caller states she is 62 yrs old, 15 years into menopause, and all of a sudden, I am having constant bleeding. The patient's concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "15 years into menopause, and all of a sudden I am having constant bleeding"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "the bleeding is worse than ever"; POLYPECTOMY (medically significant), outcome "unknown", described as "I had one polyp removed". The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results; invasive procedures: Unknown results. Therapeutic measures were taken as a result of postmenopausal haemorrhage, condition aggravated, polypectomy. Clinical course: It was regarding the PBCV and booster dose. Received her 1st vaccine dose Feb2021, her 2nd dose Mar2021 and her booster dose Nov2021. she will not be having anymore". Patient stated she was 62 yrs old, 15 years into menopause, and all of a sudden, she was having constant bleeding. She stated she had already had a D and C and 3 invasive procedures to make sure patient did not have cancer or something else and had nothing else. She had a Hysteroscopy and a biopsy because menopausal women shouldn't be bleeding. She did not have cancer. she had one polyp removed and the bleeding was worse than ever. Constant bleeding like a constant period. This was not normal, she knew the Covid Vaccine has caused some reactions with women's cycles and post-menopausal bleeding. She had done research on her own, but she wanted to have access to the studies that Pfizer has done. She had hysterectomy and she really did not want to have her uterus removed. The case was reported as non-serious. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse referring to a 13 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 12-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Client received TWINRIX on 12-1-15 the same evening she reports breaking out with rash to same arm but 2 inches below site of vaccine injection. No pain, itching or other s/s. Client reports to clinic next day with wheal to that area only. Still no other complaints. Somewhat irregular superficial localized to (L) arm.
This spontaneous report was received from a 71 years old female consumer reporting on herself with no pertinent Medical History or drug reactions/Allergies who on 17-OCT-2012 was vaccinated once subcutaneously with a dose of ZOSTAVAX (Lot # and dose not reported). No other co-suspects were reported. There were concurrent concomitant medications, but they were not supplied. Consumer said that on 18-OCT-2012, there was bright red spot at injection site, on her left arm. She stated that she later, as the week progressed saw welts on the 3 inch spot on her arm. She believed it to be shingles, but that was not confirmed by a physician, she stated. She advised it seems to be going away, and the itching that was first associated with it, has gone away. She stated it was like a rash around the site. The patient did not seek medical attention. No treatment was given to patient. Patient outcome was recovering/resolving. Additional information has been requested.
After the visit as pt. Was checking out she became dizzy and pale in color.  I had mom bring pt. Back to a room and we layed her flat on her back with knees bent and gave OJ.  Pt. Refused to drink the OJ, so I gave her a bottle of water.   She sipped that.  Within a few minutes the color came back into her lips and she was feeling better, playing on mom's phone.  Dr. assessed her and d/c her.
Patient contracted COVID after being fully vaccinated.   Loss of taste, sort throat, runny nose, cough, shortness of breath, fever
No adverse event; Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patients post temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion).    This case contains information for the 26th of 104 patients described by the reporter.  Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
pt recv vax & devel h/a & an inj site rxn characterized by redness, warmth & swelling;pt recovered the following day;this is 1 of 2 pt from facility to have an adverse exp p/vax;
Day after vaccine, noticed multiple blood vessels, which were not visible before, on upper thighs and lower abdomen.