chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 7 year old male who "about 6 years ago) in approximately 2000 was vaccinated with a dose of Varivax. Subsequently "about 6 years ago" in approximately 2000 the patient experienced breakthrough chickenpox. It was not reported if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. It was reported that the patient's brother (WAES# 0607USA04565) and sister (WAES# 0605USA04471) developed similar adverse experienced after vaccination with Varivax. Additional information has been requested.
Syringe came apart; Suspension ran down arm; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a syringe issue and incomplete dose.    The patient's medical history was not reported. No Relevant concomitant medications were reported.  On 26th Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On date 26th Jan 2021, during administration one of the syringes came apart and some of the suspension ran down the patient's arm. Vaccine leaked and patient didn't receive much of the 2nd dose possibly.    No treatment information was provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the event syringe issue and incomplete dose administered was considered Recovered/Resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of syringe issue (comes apart during vaccine administration), and incomplete dose for mRNA-1273, (lot # not provided)  with no associated AEs.
Patient received Tdap (Boostrix) on 12/30/19 at pharmacy. Patient reporting numbness on tips of 2 fingers of right hand (IMZ given on left arm) - middle 2 fingers just the tip or pads of 1st digit of fingers; patient describes he doesn't seem to feel sensation when touching surfaces. Patient recalls started day after vaccine. No other symptoms. Just felt odd. He came by following week to discuss with RPh on duty who counseled patient to monitor symptoms,discussed common side effects and adverse effects -counseled patient that if gets more severe, progresses to other parts or doesn't resolve in a week then see an MD. Patient reported seeing urgent care on 1/8 because started to feel tightness on shoulder or near back of neck. Urgent Care MD could not verify if caused by vaccine. Urgent care MD did not prescribe any medical treatment. Urgent care recommended patient go to ER if continues or gets more severe or for another opinion.   At this time (1/09/2020) patient has not seeked further care. Patient reported to pharmacy manager on 1/9/20 and expressed concerns at this point that symptoms not going away. Numbness has not worsen nor spread (only in those 2 fingers) but has not gone away either. No numbness elsewhere. No symptoms on arm vaccine was administered to. Pharmacy manager counseled patient about further known side effects and adverse effects and stated will report on VAERS and internally with Pharmacy. Patient wants to go to ER but concerned about cost. Asked what can be done or if can provide any help to cover cost for patient to seek additional medical care or opinion (patient is who requested to get tetanus vaccine for personal reasons but mainly for work).
Patient reported the day after vaccination she developed an intense headache and overall fatigue/drowsiness that caused her to become hospitalized for three days before resolution of symptoms
IPV, DTAP, MMR AND VARICELLA GIVEN. 15 MINUTES LATER PT DEVELOPED GENERALIZED HIVES WITH PRURITIS. VITAL SIGNS MONITORED, BENADRYL ADMINSTERED, NO ANAPHYLAXIS.
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included lung cancer (surgery to remove lung cancer, left lower lobe was removed). Previously administered products included Flu vaccine with an associated reaction of pain in extremity (refer case US2018GSK221241). Concurrent medical conditions included emphysema and stent placement. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 1 day after receiving SHINGRIX, the patient experienced itchy rash, pain in arm and allergic reaction. On 16th August 2018, the outcome of the itchy rash was recovered/resolved. On an unknown date, the outcome of the pain in arm and allergic reaction were recovered/resolved. It was unknown if the reporter considered the itchy rash, pain in arm and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient reported that her arm was sore for about one day. A day after receiving SHINGRIX, the patient experienced an itchy rash that was almost gone on 16th August 2018 when she had to go for a preop exam. At the time of the exam, the nurse practitioner told her that she should not get the second dose of the SHINGRIX because of the rash because she thought it was an allergic reaction. Additional information was not reported. The patient consented to follow up with her physician and herself. The patient reported that her question was not resolved because her healthcare provider needs to call and more medical information needs to be given to get a correct response for the pruritis.
I had a co-worker show exactly where the vaccine was. Once we got to the freezer that it was kept in, my coworker looked at it and then I looked at it. The MMRV vaccine box was directly beside the MMR vaccinces. The boxes looked almost identical. I think that we were so busy that I only saw the MMR part of the vaccine. I realized the error when I tried to scan the vaccine into the computer and it did not scan. That is when I realized that I had given the MMRV and not the MMR. The patient was notified of the mistake and that she was still completely covered for the MMR.
I have a very swollen throat on both sides, as well as canker sores (2) which feel like tonsillitis or strep throat. When I received my first dose, I experienced these exact symptoms,  but only on one side of my throat. With the second dose, both sides of my throat are swollen, inflamed, and have canker sores (2). It hurts to swallow and talk. I also experienced extreme fatigue around this time, as well as mild body aches/chills.
Mild intermittent runny nose and cough that started evening after vaccination.  Afebrile.  Appetite, activity and sleep were normal 24 hour post vaccination.
Fever spike to 103F, left deltoid arm red and swollen. Vancomycin iv started empirically for left arm cellulitis. After 2 days of iv vancomycin, redness and swelling diminished and patient was stable for discharge.
during pt's observation period reported signs of tunnel vision, pale and clammy skin, and chills. Pt vitals were taken and Dr. called for pt vasovagal. Pt was given snacks and water then observed for an hour with vitals taken every 15 min. released after an hour after Dr. final evaluation.
By 11:30 pm (3 hours after shot), throbbing in shoulder, arm and across back. Took Tylenol., which allowed sleep eventually. By next morning: sore wrists, hands, and shoulders. By afternoon: same soreness, but from elbow to elbow, across shoulders, felt like a bad sunburn of skin. Ankles and knee swollen. 2nd night: intermittant, surprising shooting pain in shin bones, general myalgia, plus upset stomach. 3rd day: more of same, relieved somewhat by Tylenol, but not at all by 1 Aleve (my ususal anti-inflamatory pain med of choice). Thursday, day 4: lessening of inflamed joints, but still soreness across shoulders, neck and back. Day 5: improved.
Product Complaint; leaky vial, content got over pharmacist's hands; leaky vial, content got over pharmacist's hands; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P4, expiry date 25th January 2024) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not receive Shingrix. On 15th November 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product and exposure via skin contact. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the occupational exposure while administering product, exposure via skin contact and product complaint were unknown.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comments: Pharmacist reported a leaky vial during reconstitution. Pharmacist stated she added the adjuvant into vial 2 and the liquid came out from the needle puncture in the stopper, having the impression that too much pressure was inside vial 2.  Suspect product was not administered, part of the content got over the hands of the pharmacist.  Both components were impacted, a single dose of Shingrix would be replaced. Prepaid and preaddressed label would be sent to pharmacy to return vials.  Questions were asked to reporter that, did the he/she inject air from the syringe into the vial during preparation, at what step of reconstitution was the air injected and how much air was injected. The reporter replied that yes, 0.5 ml air was injected during reconstitution of vial 2  Reporter was asked if the leak coming from the stopper at the neck of the vial or from a needle puncture in the stopper and did the vial rubber stopper or metallic skirt detach or become loose during handling or without any manipulation, did customer remove only the plastic flip-off or also the metallic skirt or ring of the vial before handling. The reporter replied that leak was from the needle puncture in the stopper and only the plastic flip-off of the vial before handling. there was no evidence of leakage in package or carton (e.g. wet PIL or faded label) Additional Supportive Information: while administering Shingrix, part of the content got over the hands of the pharmacist, which led to Occupational exposure while administering product and exposure via skin contact.
Pt received immunization around 1630. He was monitored after immunization for 15min with no side effects. Pt woke up at 7AM on 1/721 with sweats, chills, shaking, bodyaches and fatigue. Reports increased back pain and dizziness on Friday. Did take Acetaminophen with some pain relief. Felt better Sunday. Complains of some fatigue.
Thrombosis after both doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.  Company comment -This case concerns a 65 year old male patient with medical history of Hypertension and Hyperlipidemia, who experienced the unexpected serious event of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine), within unknown days after the dose of mRNA-1273 vaccine.  Limited information regarding the event have been provided at this time.  Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-334636 (Patient Link).; Sender's Comments: This case concerns a 65 year old male patient with medical history of Hypertension and Hyperlipidemia, who experienced the unexpected serious event of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine), within unknown days after the dose of mRNA-1273 vaccine.  Limited information regarding the event have been provided at this time.  Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.
Administration Error: Patient completed a series of Pfizer and did not disclose at time of visit. He received a dose of Janssen on 6/22. data was collected by paper and later entered.
Fever, chills for 3 to 4 days. After 4 days developed vaginal yeast infection and hemorrhoid's with severe pain and itching. and also developed hives and rashes all over the body, head and face. the hives and rashes are growing day by day. Its also effecting the menstrual period cycle.
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N028258, expiration date on 30-MAY-2019, oral for prophylaxis (dosage schedule was not reported) and with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccines experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Felt "like sand in my eyes", soreness under tongue, cough, chills, sweats, tired, heavy breathing.
Pain at injection site that did not go away.  Still having pain in shoulder area with pain upon trying to raise arm above head.
- Muscle soreness within 4 hours that lasted  for over 4 days - Swelling, circle size of 5 inch diameter with redness and warmth - Fever slightly over 100 F next day - Urinary tract infection occurring 36 hours after shot
Pt mother called 05/27/05 stating pt's left arm swollen above the elbow. Pt denies pain. Advised to apply ice to area and give Tylenol or Motrin for discomfort. Spoke with mom on 05/31/05- states reaction gone. No other symptoms.
recent mild COVID infection (4/8/2022), monoclonal gammopathy,  retest 4/30/2022
1. Soreness almost immediately at injection site day #1 1/13/21 2. Dizziness, nausea and vomiting day #3 1/15/21 for 2.5 hours on/off beginning at 7:45 am.  My stomach was empty as it was first thing in the morning. I vomited bile. After 3 hours, I was able to drink a cup of tea and a few crackers.
Experienced fever/chills and extreme fatigue within 48 hours after injection. Then,  day 3 after vaccine woke up with full body hives and swollen joints. Went on 3 days of steroids with Zyrtec 2x a day. On day 6 after vaccine ended steroids and continued Zyrtec 2x a day, Pepcid 2x a day, extra strength Tylenol every 6 hours and benedryl  at night.
At the time of vaccine I was 25 weeks. I experienced a lot of fetal movement, that evening 3-4 times a lot of fetal movement throughout the night. EDD: 08-02-2021.  I called the help line and I was told to wait it out and by the next day everything was back to normal.
I had painful, red, and swollen arm at the injections site. These lasted for about a week.
One large red itchy area below injection site; One large red itchy area below injection site; This case was reported by a consumer and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were unknown.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had one large red itchy area below injection site after Shingrix dose.
Kinrix (age 4-6 years)  given to a 4 month old, instead of recommended Pediarix.  No harm came to patient and no reaction noted.  After checking with our district rep, the dose is counted - (Dtap #2, and IPV #2) and we will proceed with next dose of Pediarix at 6 months as recommended.
However, they tested positive for COVID-19/Tested Positive for Covid after first dose Vaccine; Fever; sick; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. A 60-years-old female patient reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6205) via an unspecified route of administration in upper left arm on 20Mar2021 at 14:00 (at the age of 60-year-old)  as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and Concomitant medications were not reported. The reporter stated that she had gained a little weight since last weigh in at the doctor, confirms this weight gain happened prior to receiving first dose Pfizer COVID Vaccine.   On 31Mar2021, the patient tested Positive for COVID after first dose Vaccine and had been sick. The patient second dose was scheduled on Saturday 10Apr2021. After testing positive for COVID the patient received treatment with Tylenol and Ibuprofen pills. The Tylenol was extra strength 250 or 200 each pill, the patient took Ibuprofen 200 sometimes 2 pills, sometimes 3 pills, sometimes 4 pills, depending on the level of the fever. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021, the patient had a nasal swab test (SARS-CoV-2 test) left and right at two diff pharmacies. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021389801 same reporter/drug/event, different patients
shoulder killing me; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of arthralgia (1st dose received on an unknown date, refer case US2021AMR264980).   On 10th January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a day after receiving Shingles vaccine, the patient experienced shoulder pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2021AMR264980  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced his shoulder was killing him/her. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR264980:Same patient/reporter
Arm swollen, red and painful. Fever / chills / general malaise as well as pain in arm spreading to chest and back over 24 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 17:30 as dose 1, single (Lot number: EM9810), in right arm, on 03Mar2021 at 15:00 as dose 2, single (Lot number: EN6202), in right arm and on 17Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FD7218) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Yes" (unspecified if ongoing), notes: known allergies Yes. Concomitant medication(s) included: AMLODIPINE BESYLATE; ARMOUR THYROID; VITAMIN C [ASCORBIC ACID]; METHENAMINE HIPPURATE; GLYCOPYRROLATE; VENLAFAXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid Treatment start date=25Jul2022,Lot number= 1917017A.  No follow-up attempts are needed. No further information is expected.
Pfizer Dose 1 3/6/21 (EN6205); Pfizer Dose 2 3/31/21 (EN6207); Pfizer Dose 3 10/1/21 (FF2588); COVID Positive 3/3/22. 3/3/22: 71-year-old gentleman presented to the emergency room with complaint of mid section abdominal pain that started earlier yesterday.  Patient reports that the pain is constant with no obvious radiation.  The pain is almost generalized.  However, it is at its peak on the right upper quadrant.  Reports episode of nausea with no vomiting.  He has had normal bowel movement. 3/7/22: Patient is a 71-year-old male with history of anxiety disorder, BPH, and recently diagnosed hemophilia a, who was admitted on 3/3/2022 with acute gangrenous cholecystitis, severe sepsis, and bilateral COVID pneumonia.  He was admitted to the medical floor and was started on IV antibiotics.  The general surgeon was consulted.  The patient was taken to the operating room that afternoon for a laparoscopic cholecystectomy.  During the procedure, the surgeon noted that the patient's gallbladder was gangrenous and had ruptured, spilling bile contents into the abdomen.  He placed a JP drain.  The patient developed some postoperative diarrhea and was placed on cholestyramine, which helped.  After having his gallbladder removed, the patient's symptoms have improved greatly.  His sepsis has completely resolved.  His vitals have been stable and the patient has not required any supplemental oxygen.  The patient was evaluated by Physical therapy and they felt that he would need skilled nursing placement at discharge.  The patient today reports that he is feeling well.  He has been getting up and moving around the room with physical therapy and the nursing staff.  He denies any shortness of breath at rest, dyspnea on exertion, chest pain, palpitations.  He does report some mild to moderate abdominal pain, but reports that it is overall better, and improving daily.  Dr. has cleared the patient for discharge and would like him to follow-up with him in the office on 3/11/2022 at 09:00 for drain removal.