chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/4/21 pt noticed a red, raised rash on her right forearm that later spread to her left arm, then to her shoulders and torso. The rash does itch some. Pt saw her PCP on 2/26/21 and was given hydroxyzine and permethrin cream to treat for possible scabies. Pt returned to clinic on 3/1/21 and was told it was not scabies because the rash did not respond to the permethrin. PT saw her dermatologist on 3/2/21 and 3 biopsies were taken. Pt was told not to take the second vaccine before she returns to his office for results on 3/16/21.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with oral, ROTATEQ (dose, strength, frequency and lot number were not reported), that were improperly stored. No adverse experienced reported. This is one of two reports received from the same source. Additional information has been requested.
Vaccination site became swollen, warm, sensitive to touch, now itchy. Size of half dollar. Just happened today. 8 days after vaccine. Feels like a very large bug bite.
On Friday July 16,Patient was administered 0.5ml of Pfizer vaccine instead of 0.3ml by . An Incident report has been filed, management was informed. Patient will be notified by medical staff.
Chills, weakness, increased mucous, coughing, nausea, muscular aches.
A non-serious spontaneous report of FLUMIST given to patients greater than 49-years-old was received from a physician concerning a 50-year-old female. As per the reporter, there was inadvertent administration of FLUMIST to two patients who were more than 49-years-old. On 05-Nov-2010, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
w/in 3 days of vax pt devel an inj site rxn characterized by swelling, warmth & an area of redness measuring 3 to 4 inches in diameter;pt tx w/APAP;the redness persisted 3 days;
Patient received Pfizer first dose on 3/22. Over the course of the next few days, patient experienced hives and throat closure. She had to be hospitalized in ED on Friday 3/26
PT arrived escorted by parent at 4:00pm. 4 year old received Dtap as well as the Flu vaccine. Mother was inform and instructed to wait 15 minutes in waiting room. Parent was informed she will receive a call from the supervisor within 24- 48 hours. No adverse reaction at the time of administration.
The patient's arm swelled up a few hours later. It wasn't discolored, but she stated it was painful. She took some acetaminophen and diphenhydramine and it had improved when we spoke this morning (3/27/2019).
About 15 minutes post vaccine, experience overall numbness of the left cheek from lower jaw and to the eye.  No other sypmtoms.
Total body joint pain, low grade fever, headache x 16hrs Injection site pain, axillary pain/tenderness x 1 week
10/23 PM Pain on the shot site (left shoulder), pain in shoulder, swelling, 10/24 pockets of fluid under the tissue, warm to the touch, pain radiating upwards and downwards, 10/25 decreased range of motion of that shoulder, headache, neck pain.
Rash- Started day after vaccination resolved within three days Headache- Started day after and continues one week after Lower left calf pain continues one week after Patient has had a blood draw today, April 13th. waiting for results
3/20/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  rapid heart rate, reported feeling flush, and was visibly shaking.   Assessment : Time of assessment- 1845. Alert and oriented.   Actions taken:  Vitals sign taken at 1845 BP 139/84, P 74, T-98.2,R 16, O2- `100%, JUICE OFFERED AND ACCEPTED, RECHECK AT 1858, BP-156/75, P-116, DRINKING JUICE, AT 1918 BP- 131/82, P- 105, VS AT 1933 BP-113/59, P- 98, AT 1951- BP- 114/80, P-95, PATIENT FEELING BETTER AND LEFT WITH FAMILY.       Medications administered: No medication administered.   Disposition: PATIENT GIVEN INFORMATION OF ALLERGIC REACTION, AND ADVISED TO FOLLOW UP WITH PCP. Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/19/2021  6:36 PM 0.3 mL 12/11/2020 Intramuscular
This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number T2F4Z, expiry date 20th November 2022) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Engerix B adult with an associated reaction of product administered to patient of inappropriate age (received 1st dose on an unknown date, refer case US2022AMR003832). On 16th September 2021, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 16th September 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Manager informed that the patient received two first doses of Engerix B adult instead of pediatric, which led to overdose and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR003832:Same patient. 1st dose.
aches, chills, headache began 12 hours after vaccination, treated with Advil and Tylenol at the 24 hour mark i began to have a 102 fever all continuing to treat with Advil and Tylenol. I am now roughly over the 36 hour mark and starting to feel better despite the exhaustion.
Patient fainted 10 minutes after receiving his first dose of the Covid vaccine. He was sweating profusely and very clammy. We gave him an ice pack and monitored him for 30 minutes after. His blood pressure was 90/60 a few minutes after the episode but then it came up to 124/84 a few minutes later. His eyes were dilated and we were concerned about a possible concussion from the fall so EMS came and evaluated him. They cleared him to go home.
Information has been received from a consumer concerning a pt who was vaccinated with MMRII and subsequently the pt was dx'd with Autism. Three other pts (WAES 01081467; 01082119; 01082832) had similar experiences, post vax, with MMRII. It was reported that there may be other cases as well. Upon internal review, Autism was considered an "Other Important Medical Event". Addition information has been requested.
Extreme fatigue, muscle aches, joint pain, trouble sleeping as I have gotten older the symptoms have gotten worse. Also, anger issues also.
The area on the left arm where the vaccine was taken was swollen, red, warm and painful (about 2.5 inches in diameter). Seemed like there was a lump underneath the skin at that spot. This lasted for over a week, after which I visited an urgent care. The Doctor there prescribed oral steroids (6 days course - 6, 5, 4, 3, 2, 1 pills/day). The medicine really helped - the swelling, redness and pain completely reduced and returned to normal by day 3 of the medication.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 (US) hours post puncture) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 (US) hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 (US) hours post puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided. Moderna COVID-19 Vaccine was administrated on 22 APR 2022 from 10:30 AM to 12:00 PM. It was reported that vial was initially stored in the refrigerator on 20 APR 2022 and was first punctured on 21 APR 2022 at 8: 45 AM. Vial was stored at room Temperature post puncture and did not undergo temperature excursions. Vial was exposed to room temperature for more than 24 hours within the range 8 degree to 25 degree C which was equal to 46 degree to 77 degree F for 27 and half hours. No treatment medications were provided.
Headache; Really really tired; Really really cold; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient herself).  This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685, Expiration Date Mar2021), via intramuscular, on 28Dec2020 at 13:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. Age at vaccination was 57-year-old. Relevant medical history included anxiety and fibromyalgia. The patient was receiving concomitantly a drug (unspecified) at dose of 60 mg daily from  Sep2020. This patient stated that she is not a healthcare professional but works in the diet area/kitchen of which is a hospital.  On 29Dec2020 she felt really really tired, got really really cold, had chills, nausea. On 30Dec2020, in the morning, she had onset of headache.  She still had a slight headache and a little nausea, but did not have the chills. She did not knowif this has anything to do with the vaccine but wanted to report the information. She did not plan to change her dose; she was scheduled to get the second dose on 15Jan2021 at 1:00pm which she still plans to get. The outcome of 'really really fatigue' and 'really really cold' was unknown; the event 'chills' recovered in Dec2020; the outcome of 'nausea' and 'headache' was recovering.
Full-body hives/itching began about 9 days after receiving my COVID 19 booster. Hives were all over body: chest, legs, waist line, groin, hands, feet, face, neck, scalp, arms. They move around from place-to-place. Some red flushing as well, where hands, face, ears feel red hot.   After 2 weeks, went to urgent care. Took predisone 6-day dose pack. Didn't seem to help much. Also started taking OTC Claritin antihistamine, which seemed to give some relief from the itching, but hives still present. Did a bunch of labs, and no indicators of anything else going on (see labs below).  After 3 weeks, went to Allergy specialist who indicated he'd seen ~5 patients this week who started getting hives about 1 week after their booster. Hives looked very similar. Given no medical history and all labs looking ok, seemed most likely to be related to C19 Moderna booster. Prescribed Allegra to take in the AM and Xyzal to take in the PM. Have been taking for ~3 days now. Helps with itching, but hives still very present and face flushing pretty common and uncomfortable.
Approximately 8 hours after the shot, my joint pain was severe - mostly in joints that I am aware of pretty regularly but the pain was much more intense.  This continued and then at 3:30am I began a fever, headache and the joint pain intensified.  I was barely able to leave bed, and couldn't eat at all, for the next 15 hours - and only then because I took some Tylenol.  Highest temp recorded was only 101.1 but symptoms were horrible.  I had covid in late October, even though two tests were negative Red Cross verified antibodies before my vaccine, and this felt the same but actually intensified even worse.  The fever broke the next night and I woke in a pool of sweat and felt normal for the most part but weak from not eating the entire day before.  So, in total, 36 hours from the time of the shot until the fever "broke" and the joint pain started to subside.
This spontaneous report as received from a vaccine coordinator refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB with either lot number M022077 and expiration date of 10-MAR-2019 or L048849 with expiration date of 04-FEB-2018 (strength, route of administration and dose were not reported), which was stored at 47.5 Fahrenheit degrees for 1 hour and 32.9 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. There were no concomitant therapies reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
he had a lump in his armpit; nose bleeds; had a hard time sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team,).  A 33-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: AXILLARY MASS (non-serious), outcome "unknown", described as "he had a lump in his armpit"; EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeds"; INSOMNIA (non-serious), outcome "unknown", described as "had a hard time sleeping".  Additional information: A 33 years old male who experienced some side effects after his second dose of the Pfizer COVID-19 Vaccine Apr2021. As per agent, he experienced a hard time sleeping, which was later denied by caller. But confirmed he had a lump in his armpit and nose bleeds. Caller wanted to know if he should get the booster dose. After the second dose, he had a hard time sleeping and a lump in his armpit. Its been over a year and are asking if its okay for him to get the booster dose. Verified above information with caller. The boyfriends arm pit lump went away in a day. He had 5 or so nose bleeds then they went away. Declines to complete report at this time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itchy rash; blistered rash; Rash in multiple forms--red, raised,very itchy,; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 30Jan2021 at 17:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Patient had no allergy to food, medication or other products. Concomitant medications included ibuprofen sodium (IBUPROFEN), vitamin d (VIT D), tocopherols mixed, tocotrienols nos (VITAMIN E), melatonin (MELATONINE) and magnesium (MANUFACTURER UNKNOWN); all for unspecified indication and from unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Jan2021 at 13:00, the patient experienced rash in multiple forms, red, raised, very itchy, 1/4 to 1/2 inch in diameter, some were blistered, some turned purple and some that were pink, some red. The rash was appeared over forearms and legs and additionally there was a different kind presentation with an abdominal rash that was very concentrated with tiny dots. It lasted 3 weeks with new itchy spots were showing up over about 2 weeks. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with antihistamines(unspecified) and cortisone cream from an unknown start date to an unknown stop date. The clinical outcomes of the event itchy rash, red rash and blistery rash were recovered on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient (age was not reported) who was sick and her HIB titter was drawn and it was low, while she received vaccine HIB VACCINE. The patient's past medical history included anaphylactic reaction to Latex (Rubber sensitivity). The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced sickness. It was reported that she kept getting sick. It was also reported that her HIB titer was drawn and it was low. Relevant tests were not reported. Final diagnosis was sick. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender: none.
shingles/herpes zoster along dermatone, mild case, no post-herpetic neuralgia.
Soreness unable to raise arm, slightly warm to the touch, slightly swollen, very tender to the touch.
Joint pain and swelling 2 wks following MMR vaccine. Some mild tingling sensation.
Muscle pain; Chills; Not feeling good; I had some 100.4 to 100.6, I still have a temperature; fever most of the day; dull headache; Feeling very tired; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Mar2021 08:30 (Batch/Lot Number: EN6199) at the age of 75 years, as single dose for covid-19 immunisation.  Medical history included thyroid disorder. Concomitant medication included levothyroxine taken for thyroid disorder, start and stop date were not reported.   The patient experienced feeling very tired (non-serious) on 07Mar2021 20:00 with outcome of unknown, I had some 100.4 to 100.6, I still have a temperature; fever most of the day (non-serious) on 08Mar2021 with outcome of not recovered , dull headache (non-serious) on 08Mar2021 with outcome of unknown, muscle pain (non-serious) on an unspecified date with outcome of unknown , chills (non-serious) on an unspecified date with outcome of unknown , not feeling good (non-serious) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included antibody test: unknown results on unknown date; body temperature: 100.4 to 100.6 on 08Mar2021.   No follow-up attempts are needed; No further information is expected.
Friday at 1:30 (3/5 my husband received the first shot. That evening he wasn't feeling well at all. Went to sleep in the morning on 3/6 he still was feeling horrible. Looked gray in color- thought he was getting the flu. At 2AM I woke to him having a seizure. Followed by another seizure at 10AM ( 3/7) followed by another seizure at 3PM (3/7) followed by another seizure at 3AM  (3/8) and another seizure at 6:30 AM on (3/8).
Information has been received from a Bachelor of Science in Nursing concerning a 12 year old male patient who on 27-MAR-2010 was vaccinated subcutaneously in the left arm with the second dose of VARIVAX (Merck) (lot number 665411/1158Y). The same day the patient was administered in the left arm with a dose of TDap (lot number G3246BA) and MENACTRA (lot number 230158A). It was reported that one day after the patient received VARIVAX (Merck) had fever of 101 degrees for 8 hours and halo effect that was 2 circles, 3 quarter of an inch wide with no open wounds, pink on the inner circle and white on the outer layer. The nurse stated that the swelling was going down and the patient was doing better. The nurse reported that she felt as though the fever was due to the other vaccines the patient received that day because none of the other vaccines were given in the same arm. It was unknown if the patient sought medical attention. Additional information has been requested.
Patient diagnosed + Covid 1/17/2022, Patient lived in a long term care nursing facility.
Felt malaise after vaccine 6 weeks later June 9, 2021 on Routine Labs found AST, ALT significantly elevate at 392/158. Symptoms Improved by 7/1/21 and AST/ALT then normalized. Suspect vaccine
Rash; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: :decreasing chemotherapy for breast cancer patients after pre-surgery chemo and targeted therapy. Concomitant medication(s) included: ARIMIDEX; CYTOXAN; TAXOTERE. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "recovered" (2022), described as "Rash".  Additional information: Patent's past medical history included:; decreasing chemotherapy for breast cancer patients after pre-surgery chemo and targeted therapy. On Mar2021, patient started therapy with Adriamycin for Breast cancer Her2+, We have no further information  regarding the reported  event(s) described above Any additional material information  received will be forwarded to you in accordance with policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient did not actually have an adverse event, patient just received the booster dose (0.25mL of moderna covid vaccine) 3.5 months after their 2nd dose, instead of the 5 months after their 2nd dose.  Patient did not exhibit any side effects in the 15minutes after receiving their booster.
Hospitalization for altered mental status and generalized weakness due to COVID-19 on dates 7/20/2022-8/13/2022.  Treated with dexamethasone and vitamin D 25 mcg PO daily.