chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. received the Dtap on 5/10/22 and developed a nodule on the right thigh Pt. received the Hep A on 10/14/22 and developed a nodule on the left thigh From that point forward the area where the injections were given became pruritic granulomas with periods of exacerbation continuing now for over a year with areas of blue to brown discoloration (varies), hyperpigmentation and hypertrichosis, sleep disturbances and skin break down from scratching. Treated topically with hydrocortisone ointment and hydrocolliod dressings when flare ups occur. Condition continues to persist daily.
p/vax pt exp erythema & inflam @ inj site;given DPH;next 4-5 days site indurated & oozed pus w/inc erythema extending 4-5cm in either direction;plastic surgeon excised area & sent specimens for path & micro analysis;necrotizing fasciitis;
Patient's death was reported to our facility by a file. Any other information is unknown at this time.
Extreme muscle soreness (14 days) Blurred vision, rapid heartbeat, brain fog, migranes, increased light/sound sensitivity, nausea, trouble eating (over 70 days) Patient was experiencing mild symptoms however post vaccine, all of the above symptoms magnified, and most continue to persist today.
30 min after injection, started feeling dizzy, lightheaded, sweating, N+V multiple times. Felt S/S all day long and next day only has lightheadedness and dizzy. "Off Balance".
Redness, swelling (baseball size redness on right arm, with nodule of swelling on underarm as well; smaller swelling and redness on left arm). Patient went to emergency room on the evening of 9/9, approximately 48 hours after the injections. Emergency room physician prescribed cephalexin and pain medication and patient reported that the doctor told her it was a cellulitis.
Initial report received from a consumer on 22 February 2013. An 85-year-old female patient had received an intramuscular dose of FLUZONE HD (batch number and number in series were not reported) in the left deltoid on an unspecified date in December 2012. The patient had no illness at the time of vaccination and medical history included hypertension. Concomitant medications were not reported. On 11 February 2013, the patient presented symptoms of cough, sore throat, nasal congestion and "just feeling sick" for the last 11 days. No laboratory tests were performed and corrective treatment details were not reported. At the time of this report, the patient had no recovered from the events and on 22 February 2013, it was the first day that the patient was feeling better. Documents held by sender: None. Follow up information received from a healthcare professional on 08 May 2013. The vaccination date was updated to 15 January 2013, lot number: V4491AA and expiry date: 03/27/13. The patient had not reported this adverse event previously.
Under arm swelled from injection site to elbow, turned red, and warm. Hurt to move arm and elbow. Applied ice, kept raised as much as possible and three days later redness and swelling down to elbow area only and still warm.  School nurse advised me to make notification to you. VIS IIV08/14/2014  Location RA Lot#UI/73AB Exp 6/30/15
23OCT92 PM rt arm @ site hurt terrible x 4 days; 6NOV92 loss of appetite, malaise, fever of 101.2, muscle aching, chills w/h/a, nausea;
Patient presented to pharmacy today (6/18/18) with a reddened, inflamed, itchy and painful left arm at site of injection. She had already taken Benadryl for several nights. I recommended her to go to her doctor right away and faxed injection information to their office. She was seen immediately and given a course of antibiotics (zpack) which was filled and patient started taking today.
54 YO NY F 11D POST-VAX PURITIC RASH BILATERAL ARMS, LEGS; UPPER L ARM ERYTHEMATOUS, MACULAR RASH; LOWER ARMS AND R LEG SCATTERED PAPULES AND SMALLER VESICLES; PATIENT HISTORY SEVER POISON IVY REACTIONS; DERMATOLOGIST DX POISON IVY DERMATITIS, TX 40MG/D PREDNISONE WITH 1 MONTH TAPER, OBSERVE FOR EVOLUTION OF LESIONS; WORKING DX: CONTACT DERMATITIS FROM POISON IVY, UNRELATED TO VACCINE
Patient states she took a hot shower the day after vaccine administration and developed a rash - associated symptoms including itching, facial flushing and rash all over body except hands and feet.
Hives developed the next morning after DTAP, IPV, PCV7, Rotateq administered. Also had pears for 1st time
reported getting HPV despite receiving GARDASIL 9; reported getting HPV despite receiving GARDASIL 9; This spontaneous report has been received from a consumer via Company representative concerning a currently 26-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date (also reported as receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at the age of 19-years), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, administered as prophylaxis (frequency, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient reported experiencing Human papillomavirus (HPV) (Papilloma viral infection) despite vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Vaccination failure). Outcome of the events papilloma viral infection and vaccination failure was not provided. No additional information was provided.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event papilloma viral infection was not provided. Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event vaccination failure was related.   This was one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA006375:
Tenderness in lymph gland area under left arm along with pain and tenderness in left breast.
Information has been received from a physician, consumer and nurse concerning a 12 month old white female with no allergies or medical history who on 22APR2003 at 2:45PM was vaccinated IM in the left thigh with a dose of varicella virus vaccine live (lot 643532/0601M). There was no illness at the time of vaccination. The reporter indicated that the patient developed cellulitis at the site of injection. In the AM of 6MAY2003, two weeks after injection, the patient developed a poc at the site which became infected. It was indicated that the patient was also on ibuprofen. It was noted that the patient was well at the time of the visit to the office and had developed a hot and swollen area at the injection site that was treated with ibuprofen and amoxicillin. It was noted that the patient recovered. A product quality complaint was not involved.
Case number PHEH2014US005188, is an initial spontaneous report received from a nurse on 12 Mar 2014. This report refers to a 10 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13011), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine  component on 10 Mar 2014. No adverse event was reported following this administration error.
Took unrefrigerated doses of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a consumer "took unrefrigerated doses of Vivotif" (PT: Product storage error) while being on Vivotif for immunisation. On 02FEB2020, the consumer took the first refrigerated dose of Vivotif. The consumer took the remaining three doses of Vivotif which were unrefrigerated. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
onset 09/24/08 - swollen injection site, warm to touch, HA, dizzy, feeling bad x 1 week, severe HA's x 3 days.  Hydrocortizone 1% cream to site for itching.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates between 01-SEP-2015 and 09-SEP-2015, the patients were vaccinated with GARDASIL 9 (lot # L004104 and expiration date 04-MAR-2017, lot# L011846 and expiration date 16-JUN-2017, lot# K026246 and expiration date 28-JAN-2017) (dose and route were not reported) that were improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
This child has a rash, pruritis of both arms, hands, and face; one hour after vaccination. No history of allergies. No respiratory distress, temperature of 99. Home with dad.
Arm was red at the injection site and below. Arm was swollen and hot to the touch and painful to the patient. Area that was red and swollen was about 3 inches in diameter. Patient states it did that with the first injection and stayed like that for a week. I advised ice, an antihistamine such as CLARITIN and ADVIL.
Diarrhea and lower abdominal cramps started 10/20. No nausea, vomiting, fever, HA or rash. 10/21: started Levaque 500 po qd for 5 days. 10/22: blood in stool. 10/24: getting better.
This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with the first dose of MMRII (lot not reported). In approximately April 2008, when the patient was 26 months old, the patient was diagnosed with autism. The reporter added that in January 2009, the patient was diagnosed with seizures, and he has been having diarrhea issues and acid reflux too. The patient underwent a 2 day electroencephalography EEG (results not reported). Upon internal review autism and seizures were considered as Other Important Medical event. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II, subcutaneous for prophylaxis. On an unknown date the patient experienced underdose, no adverse event and needle issue. The outcome of underdose, no adverse event and needle issue is unknown. The reporter considered underdose, no adverse event and needle issue to be not related to M-M-R II.
Malaise, weakness, diarrhea at 2-3 days post vaccination, acute renal failure at 9 days post-vaccination.
itching, redness, swelling more than 1 week. Used antihistamines.
Fever,; Pain in injection arm; Headache; Tiredness; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01May2021 at 15:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 10Apr2021 at 18:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 02May2021 at 07:00, the patient experienced fever, pain in injection arm, headache, tiredness, chills and body aches Therapeutic measures were taken as a result of body aches, fever, pain in injection arm, headache, tiredness and chills and included treatment with acetaminophen (TYLENOL) from unknown date. The clinical outcome of the event body aches, fever, pain in arm, headache, tiredness and chills was recovered on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right bicep swollen to double the normal size. Red striations appear on her skin. Area under the right armpit is sore. Pt went to see PCP, he prescribed AUGMENTIN 875MG #14, 1 PO BID.
ARM became sore around 5 pm.  Pain continued down my arm. Then I began to itch on left arm then scalp, then neck & face real bad.  Left Ear became real hot and last til bout 8 am.   Body felt like i had a sunburn. I applied 2 ice packs from 9 to 10 pm on arm . Red around injection site and felt hot to the touch since 5pm yesterday.   when I woke up I tried to call clinic, they were closed. I took  generic benadryl and it has helped but started itching again around 7pm 4/2/21.  So I am going to take another beadryl.
Started with small quarter sized hive on injection site. Next morning 6/13/2021, hive had grown to size of grapefruit. Hard, red, swollen, itchy and hot to touch. Started feeling dizzy, fatigued. 6/14/2021 swelling went down on arm but redness spread further down and began with diarrhea.
Woke up about 12 hours after receiving vaccination with hives covering the trunk of the body. Took BENADRYL to help with the hives.
Numbness on complete R arm and R lower extremity especially the calf, foot. Ambulation was possible but slower than usual. Walking and continuing activity as usual appeared to help. The numbness did not start improving until the 5th day, first resolved in the arm.  The numbness continued in the lower extremity, there was slight improvement progressing from the 5h day and resolving by the end of the 9th day. This adverse reaction was not reported to my Nurse Practitioner until the next visit possibly in January 2020. I do not recollect that we went into any of the details mentioned here. Only my concern that I would not be able to receive the flu vaccine again. I do not recollect that there were notes taken to include in my chart.
Lymphadenopathy. Twelve hours after injection, noticed soreness in left armpit. Now, 47 hours later , slight swelling and still discomfort. Twenty minutes after first notice of pain, I started getting chills. I took Tylenol and the chills subsided. Temperature was 99.7 degrees. No chills or fever after 24 hours from injection time.
Patient stated shortly after vaccination she became dizzy and nauseated. She was in a different area of the store at that time and an associate notice and asked if she needed help. She was seated and a member of management contacted. Patient told manager she was also diabetic at which time the patient was given a piece of chocolate. After a while the patient felt better and was able to drive home. She stated today that she still felt weak.
Showed signs of illness approx. 6 hours after shot was administered on Thursday morning. She complained of pain at the site of the shot. Her mood became elevated and she was very argumentative. She later described it as being outside of herself. After very little sleep, she woke up on Friday morning with a scratchy throat and a mild headache. Feeling exhausted she slept most of the day. Saturday she woke up with no voice. She was flushed and achy. She has constant chills. Her muscles from the shot site on her right arm up through her neck were extremely tight and sore. Sunday she still had no voice. The aches and chills continued. She started feeling dizzy. Monday her voice returned although it was extremely hoarse. The dizziness worsened and she went to a doctor.
INCORRECT STORAGE OF DRUG; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. On an unspecified date, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine  was not applicable. The outcome of the incorrect storage of drug and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210531096.
Area around injection site was initially red, raised and sore but went away after 2 days. Today is day 8 post-vaccine, and the area around the injection site is red, raised, and very itchy. Lymph node under arm  feel swollen.
muscle ache; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-MAY-2022 Reporter's comment: The case was self reported by the patient via interactive digital media. The patient asked could he/she take Tylenol for muscle ache experienced after the Shingrix injection.  Additional Supportive Information: The follow-up would not possible, as no contact details were available.
Left arm at the injection site has a large round red circle. It is red, firm to the touch, hot and a little itchy.
Report #200002456-1 describes numbness in a pt who rec'd Engerix-B for the prophylaxis of hepatitis B. No known allergies, or medical history, reportedly. The pt rec'd tetanus vaccine on 8/14/00. On 5/14/00 the pt rec'd her first IM-L deltoid dose of Engerix-B. On 8/15/00, the pt experienced numbness and tingling in the left ring finger and left pinky. a doctor visit was required. Symptoms resolved  in 2 weeks. As of 9/5/00, the outcome of the event is resolved.
Dizziness, Headache, Fever, Diarrhea & NauseaVomiting Narrative:
woke up on the 13th with 102.2 degree fever and flu-like symptoms which lasted for about a day and a half.  She complained of nausea and diarrhea later in the day. The diarrhea has continued for the last 7 days.  She has had a lower fever of 99 or so off and on for the last 7 days also.
Initial report received from a physician on 21 December 2006.  A 1 year old, male patient (with no medical history) was difficult to console, had difficulty getting to sleep, had increasing tantrums and irritability, in the evening after he received his second dose of Fluzone (lot number UT2191KA) intramuscularly in the left thigh in the morning on 18 December 2006.  He received his first dose of Fluzone (lot number U2220BB) intramuscularly in the left thigh on 18 November 2006.  On 08 December 2006, he received Hep A (Merck, lot number 1209F) intramuscularly in the right thigh and ProQuad (Merck, lot number 0970F) intramuscularly in the right arm.  He was not on any medications and did not have any illness at the time of vaccination.  At the time of the report, the patient had not recovered.  Follow-up information received on 02 April 2007 from a health care professional.  No treatment was provided or needed.  The duration of the events was four to five days.  The patient recovered from the event.
TRANSIENT CEREBRAL ISCHEMIA 4/6/2023 TRANSIENT CEREBRAL ISCHEMIA
Patients husband states at 7am on 9/12/22 the patient was in her normal state of health. By 8:15am, the patient called her husband and sounded confused. He noted that patient was repeating her self and asking the same questions over and over again. Patient taken to the hospital to rule out stroke. Imaging negative for acute stroke. Possibly has transient global amnesia
side effect after being vaccinated; Sleep all day; NAUSEA; got sick; sweating profusely; Hot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect after being vaccinated ), HYPERHIDROSIS (sweating profusely), FEELING HOT (hot), SOMNOLENCE (Sleep all day) and ILLNESS (got sick) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018BZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS) and METFORMIN for Diabetes, ATORVASTATIN, OMEPRAZOLE and VITAMIN D3 for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HYPERHIDROSIS (sweating profusely), FEELING HOT (hot) and FATIGUE (Tired). On 30-Mar-2021, the patient experienced ILLNESS (got sick). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect after being vaccinated ), SOMNOLENCE (Sleep all day) and NAUSEA (NAUSEA). On 01-Mar-2021, HYPERHIDROSIS (sweating profusely), FEELING HOT (hot) and FATIGUE (Tired) outcome was unknown. On 30-Mar-2021, ILLNESS (got sick) outcome was unknown. At the time of the report, VACCINATION COMPLICATION (side effect after being vaccinated ), SOMNOLENCE (Sleep all day) and NAUSEA (NAUSEA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Glycosylated haemoglobin: increased to 8.5% from being in the 7's (Inconclusive) increased to 8.5% from being in the 7's.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up :- additional information( adverse events, suspect drug details, concomitant medications) added On 28-Jun-2021: Non-significant follow up appended
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-OCT-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 56, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.