chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was coming in today for their 3rd; The patient received a Hep B only immunization; The patient now missed the Hep A portion of their second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 20-JAN-2023, the patient received the 2nd dose of Twinrix. On an unknown date, the patient received the 3rd dose of Twinrix. On 20-JAN-2023, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced inappropriate preparation of medication (Verbatim: The patient received a Hep B only immunization) and inappropriate dose of vaccine administered (Verbatim: The patient now missed the Hep A portion of their second dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Patient was coming in today for their 3rd ). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and incomplete course of vaccination 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 Information: GSK Receipt Date: 26-JUN-2023 The reporter reported that the patient received a hepatitis B immunization. The reporter stated that this was discovered when the patient was coming for their third dose. The patient was missed the hepatitis A portion of their second dose. The reporter wanted to know what would be the recommendation for completing the Twinrix series. The reporter did consent to follow up. Only Hepatitis B of Twinrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Wrong vaccine administer to 6 mo old. Not approved for use under age 4 y.o.
initially she had headaches and dizziness and chills and temperature of 99.7 blushed cheeks, rash on neck  1 week later with headaches and dizziness and now accelerated heartrate that wakes her from sleep at night for 2 consecutive nights.in a row.
Tingling; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness). At the time of the report, PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
p/vax pt devel a few skin lesions & over the next three to four days pt devel more;pt devel pain over a couple of lesions @ a time that would move from spot to spot over time;pt c/o pain & cried over it;over 200 lesions;dx varicella infect;
Information has been received from a registered nurse concerning an elderly patient (gender unknown) "usually in their 70's" with an allergy to penicillin, who, on an unspecified date, was vaccinated with dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Subsequently, the patient experienced swelling, pain, and tenderness in the injected arm. It was reported that the symptoms may have spread to the underarm. The patient either called the office or was seen at the office. The patient were advised to use ice and TYLENOL if necessary. The patient recovered on an unspecified  date. No product quality complaint was involved. This is one of five reports from the same source. Additional information has been requested.
About 6hrs after injection allergic reaction that appeared were Red itchy hives in crease of both arms, slight swelling of cheeks under eyes. After about 2hrs face swelling and rash slightly dissipated. Upon waking the next morning around 9am rash and itchiness has spread up and down Arm. Took a shower around 1pm and the rashes redness on arms had disappeared by about 50%.
Thighs became numb, then stomach then weakness began 11/11/16 also with shortness of breath on 11/9/16.
Same day post vax, the pt developed a temperature of 102 and a knot on left thigh. On 7/21/00, the pt had temperature of 103 and hypertension. Given Tylenol and Motrin. On 7/22/00, the pt's temperature was 104. He was taken to ER and treated with Tylenol.
mom states pt had fever was unable to relieve-take to MD; pt came to clinic 2NOV93 for DT & OPV; dx react to HIB;
This spontaneous report was received from a physician and the patient's parents via a company representative and refers to a 10 week old female patient. Pertinent medical history or drug allergies/drug reactions were not reported. On 03-JUN-2015, the patient was vaccinated with ROTATEQ, oral (lot number, expiration date, dose, strength and frequency were not reported) (reported as "age appropriate"). Concomitant therapies included PREVNAR and PENTACEL. On that same day, after vaccination, the patient experienced diarrhoea and weight increased (units were not specified). The reporter specified that the patient did not have blood in her stool. At the reporting time, the outcome of diarrhoea and weight increased was reported as recovered on 17-JUN-2015. The patient's parents believed that diarrhoea and weight increased were associated to the dosage of oral, ROTATEQ. Additional information has been requested.
30SEP pt had mild fever;pt given APAP ater took off bandages from arms where shot given;noticed inflammed square;red;the other arm had little bumps around wound site
Case number PHEH2012US017120 is an initial spontaneous report received from a nurse on 29 Aug 2012. This report refers to three unidentified patients. They were vaccinated with MENVEO (batch number: A11052, and expiry date: Mar 2014) 0.5 ml intramuscularly on unspecified date between 20 Aug 2012 and 24 Aug 2012. On unspecified date they had injection site reaction. The injection site was raised, hard, sore, red and swollen. The outcome was not reported.
As soon as I got home I took ibuprofen right away and it alleviated the pain in my arm. In the middle of May I started having the anxiety attacks. I would wake up with this feeling of anxiousness, kind of a tingly feeling, and sometimes it would go away after I got up but then it just kept happening. I contacted my doctor and he suggested that I go to psych nurse and we tried some anti anxiety medicine and I tried Propranolol but it didn't seem to work. I was trying CBD oil but it didn't really work. I thought on my own that my thyroid has been out of balance-it has happened before- and I knew anxiety was one of the symptoms. I asked if I could get my blood tested for thyroid and sure enough I was hyperthyroid. I told the psych nurse that we found out my thyroid was hyperactive and to wait and see how the anxiety went away. After 6 weeks getting my labs, I found out I was hypothyroid because they decreased it too much. The anxiety is gone away, and the psych nurse said it was just my thyroid. She discharged me from her. Now I'm just trying to adjust my thyroid right now. I have to wait 4 weeks to be retested. I'm taking every other day dosage. They dropped me from 75  mg to 50 so it's alternated day by day and so we're waiting to see if it's taken care of. My arthritis started acting up around the same time and I know that I have arthritis in fingers but it was never much of a problem as it is now. It feels really stiff right now and I can barely make a fist. This started around same time as hyperthyroid symptoms and it's still ongoing. I added glucosamine chondroitin for joints but it seems like that with the turmeric that it's not helping much.
might have received only adjuvant portion; might have received only adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. when the reporter was checking the box containing Shingrix noticed there were 1 powder vial missing so she assumed a patient only received adjuvant vial and no entire dose of Shingrix. The reporter was not sure if there was a patient actually vaccinated with only the adjuvant vial of Shingrix instead of the full dose of Shingrix. The reporter did not consent to follow up.
5 cm injection site reaction. Swelling, redness, warm to the touch. Client reports pain and itching.
Information was received from a medical assistant regarding a 15-month-old female who was administered a dose of PROQUAD on 28-JUN-2017 (lot #M031942, exp 27-DEC-2017) instead of  MMRII. Medical history and concomitant medication was not reported. No adverse event was reported.  Additional information has been requested.
Within 5 minutes of injection, my blood pressure got high (in the 150's/110's), heart rate was high (100+), I got nauseous and I got a headache.  I was observed for approximately 1 hour after injection, when my heart rate finally went down to 80 and they let me leave.  I did not have high blood pressure or a high heart rate prior to the 1st injection.  When I went to the see my Dentist on 2/02/21 my by was 153/104, 156/113 and 153/114.  They would not see me and sent me to my Primary Care Physician's Office.  Since that time, my BP has stayed high, my heart rate is typically between 80 and 100, and I have had nearly a constant headache; becoming so severe it models a migraine with pain in the left temple, nausea and light sensitivity.  My primary care physician's office has me record my BP at least two times daily until I see them again on 02/15/21.  When I was at my rheumatologists office today, my BP was 150/100.  I continue to have headaches daily and high BP and at times chest tightness.
Pt developed 2 episodes of cold sores after being vaccinated. No history of cold sores prior to vaccines.
Patient came in on 10/31 to ask about side effects on arm. Pt said arm was swollen, very tender to touch & painful. I recommended BENADRYL, ice pack & ibuprofen. When I called patient on 11/4 to check up on her, she said she broke her fever (low grade) the evening she spoke to me & started to feel better. Redness & swelling are almost gone. Minor tenderness. No MD visit required. Patient says she is feeling better.
Information has been received from a physician concerning a male in his 70's who was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included methotrexate.  Subsequently the patient experienced a minimal localized shingles rash.  As of 17-SEP-2007 the patient had recovered.  Additional information has been requested.
15 YO had adverse reaction to HPV. Patient fainted immediately after given the shot. Inhaled ammonia and returned to consciousness. Vitals checked BP 97/67 RR 18 temp 97.6 no complaints of pain. Pulse 68. Patient was observed by the nurse for 15 minutes and discharged. VIS given to the family.
Soreness in left upper arm never went away feels like I got the immunization today. A lump formed at the site, became bigger more painful over time. Unable to dress. Pain arm - saw chiropractor. "Pushed on lump", it dissipated, now a depression exists in its spot. 1" diameter and 1/2 " deep depression located 6" below acromium (L) upper arm.
The day after I had a dull headache and pain at the injection site. I also had a slight body ache. This progressed as the day went on. The headache became a severe migraine and extreme body aches. Symptoms are somewhat relieved today, but are still bothersome to the point of having to miss a day of work.
7 days after injection, I developed a large red, warm, raised area area around the injection site (Hive like).  It was approximately 2-3 inches in diameter. It did slightly itch.  It resolved in 2 days, but now appears more bruise-like.  Also significant fatigue around that time with a headache.
Headache, Fever, CHILLS, NECK PAIN Narrative: STAYED HOME FROM WORK
This spontaneous report as received from a pharmacist refers to a 43 years old female patient with pertinent medical history of rheumatoid arthritis. The patient had unspecified drug reactions or allergies. The patient was vaccinated with dose the first dose of PNEUMOVAX 23 (lot number reported as H009826; expired date 11-FEB-2014) intramuscularly for the patient was immunosuppressed on 06-NOV-2012 on unknown injection site. No other co-suspects were reported. Concomitant medications included methotrexate, hydroxychloroquine sulfate and HUMIRA. On 07-NOV-2012 the patient developed cellulitis at the injection site after receiving a first dose of PNEUMOVAX 23. The reporter mentioned the patient came into the pharmacy the day after receiving PNEUMOVAX 23 and had a rash at the injection site and was later admitted to the hospital for worsening symptoms. Treatment information BENADRYL, ice and unspecified antibiotics were given for adverse events. Unspecified blood work performed, and the result was not reported. The patient was not recovered at the time of report. The patient had sought unspecified medical attention. Pharmacist requested a lot check for PNEUMOVAX 23 (lot number H009826; expired date 11-FEB-2014). Additional information has been requested.
About 7:30 through 10:00 p.m. on 04/01/2021 my hands were mildly itchy - I didn't think anything about it and chalked it up to dry skin. But then, about 4 a.m. 04/02/21 I woke up with EXTREMELY itchy and burning hands. It was excruciating for about 45 minutes. The only thing that would help it was to hold ice packs to freeze my hands. It was so horrible I was in tears; the worst itching and burning I have ever experienced. I was able to get back to sleep after about an hour. Upon waking up for the day, around 8 a.m.), I had about a half dozen hives on my face and upper torso. Those eventually went away by mid-afternoon.
This spontaneous report as received from a physician refers to 9 months (at the time of third vaccination) and currently 18 years old male patient. On 06-APR-1995 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 08-MAY-1995 and the third dose was administered on 22-JAN-1996. The reported stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. No treatment was given for adverse events. This is one of 10 reports from the same source. Additional information has been requested.
Initial report received from the consumers' parents on 28 June 2011. An 11-year-old male patient with a history of seasonal allergies, received an intramuscular injection site (site not reported) of MENACTRA, sanofi pasteur lot number U3839AA, and an injection (route and site not reported) of TUBERSOL 5 TU, sanofi pasteur lot number not reported. The patient had a reaction to ADACEL at age 10 on 10 June 2010. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the MENACTRA and TUBERSOL. The patient took no concomitant medications. On 24 June 2011, the patient developed a fever of 102 (oral), sore throat and a runny nose with clear drainage. The patient was seen by a physician and tested negative for strep. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 02 August 2011. The patient had received MENACTRA in the left deltoid and TUBERSOL 5 TU, lot number C3373AA in the left forearm. The patient's parent called on 24 June 2011 to report the patient had a fever, sore arm and body aches. It was recommended that the patient taken MOTRIN and limit activity. On 27 June 2011, the patient was evaluated and he continued to have a fever, body aches, runny nose and diarrhea. No treatments were prescribed at that time. The patient has not been seen and no calls have been received since 27 June 2011. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
pt recv vax 26JAN96&12FEB96 pt began to exp h/a which have not been relieved by an medications;@ the time of the report,pt cont to exp h/a&was being treated by an internist&a neurologist
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # M007762, unknown for prophylaxis. On 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to LIQUID PEDVAXHIB. This is one of several reports received from the same reporter. {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-1707USA001815: US-009507513-1708USA008731: US-009507513-1708USA008730:
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied.  called the morning of 08/03/21 and spoke to the medical team at Pfizer who gave the same information. was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 06-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-SEP-2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-JAN-2013, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This is a spontaneous report from a contactable healthcare professional received from Pfizer Sponsored Program. A currently 49-year-old male patient of an unspecified ethnicity started to receive ZITHROMAX, allopurinol, codeine, colchicine, TRESIBA, HUMALOG, and MOBIC, all via unspecified routes of administration on unspecified dates at unknown doses for unspecified indications and TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced drug allergies to azithromycin, allopurinol, codeine, colchicine, insulin degludec, insulin lispro, meloxicam and TRUMENBA. The action taken in response to the event for azithromycin was unknown, allopurinol was unknown, codeine was unknown, colchicine was unknown, insulin degludec was unknown, insulin lispro was unknown, and meloxicam was unknown. The clinical outcome of the event, drug allergies, was unknown. The reporting health professional clarified that "drug allergies to azithromycin, allopurinol, codeine, colchicine, insulin degludec, insulin lispro, and meloxicam" were the patient's past adverse drug experience but the health professional is not aware of recent "drug allergies to azithromycin, allopurinol, codeine, colchicine, insulin degludec, insulin lispro, and meloxicam" experienced by the patient. Follow-up (03Aug2017): New information from the same contactable health professional includes: patient information (name). Follow-up (22Aug2017): New information received from the same contactable health professional includes: the physician was not aware of recent allergy experienced by the patient. Follow-up attempts are completed. No further information is expected. Follow-up (31Jan2019): This is a follow-up report combining information from duplicate reports 2017360611 and 2017336335. The current and all subsequent information will be reported under manufacturer report number 2017336335. New information includes: suspect drug (TRUMENBA was added).
Patient had redness at injection site two days after.  Her arm was red and she used Hydrocortisone cream. The next day it became warm to the touch and redness became worse. Patient called MD and went to Urgent care, The Dr. said it was cellulitis and prescribed Hydrocortisone Cream and an antibiotic for 1 week and to follow up with a dermatologist, if needed.
On the next evening following the injection 10/8/04, I noticed a rash and itching of legs. After that I noticed a rash and itching that developed first on the area on the inner aspects of the arms above the wrists and gradually spread to the legs, back, chest, upper arms. The only place I didn't have a rash was my face. This has been happening for one month. The Allegra keeps the rash and itching down.
Pt had vaccine and went to lobby and fainted 10 mins later. VS stable after.