chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 blister on the finger after receiving 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of BLISTER (3 blister on the finger after receiving 1st dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (3 blister on the finger after receiving 1st dose). At the time of the report, BLISTER (3 blister on the finger after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The first blister disappeared after 24 hours, and the rest of the 2 disappeared after 2-3 days. Concomitant medications were not provided. Treatment information was not reported
Initial unsolicited report received from a healthcare professional on 09 January 2015. A 24-month-old female patient, whose medical history and concomitant medication was not reported, had received a first dose of DTaP, (batch number, dose number, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, patient experienced redness and swelling at the injection site. Illness at the time of vaccination and pre-existing physician diagnosed allergies were reported as unknown. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the patient was reported as unknown. Documents held by sender: none. Follow up information received from a non-healthcare professional on 11 March 2015. No new information was reported. Documents held by sender: none.
had experienced long term pain; can't lift her left arm up above her head; can't move her arm to the left or to the right; arm hurts, in constant pain; stiffness up in her neck; She is not feeling too well with her left arm being like this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FC3183) at the age of 60 years as dose 2, single and administered in arm left, administration date 13Sep2021 (Lot number: FD8448) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had experienced long term pain"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can't lift her left arm up above her head; can't move her arm to the left or to the right"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts, in constant pain"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness up in her neck"; MALAISE (non-serious), outcome "unknown", described as "She is not feeling too well with her left arm being like this". The events "had experienced long term pain", "can't lift her left arm up above her head; can't move her arm to the left or to the right", "arm hurts, in constant pain", "stiffness up in her neck" and "she is not feeling too well with her left arm being like this" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller mentions she takes thyroid medicine, but she has been taking thyroid medicine for the past 5 years. The caller confirms her arm was doing fine before she took the shot. Now, she is having stiffness up in her neck. She is not feeling too well with her left arm being like this. Dose 2 time of vaccination: it was after 12 she knows, and then she had to stay in the store for like 10 minutes. Caller states she did go see the doctor and told the doctor her arm was hurting really, really bad. The caller explains she had a knot and was rubbing it and stuff, but nothing's gone away. Prior Vaccinations (within 4 weeks/within four weeks prior to the first administration date of the suspect vaccine was none. Never had adverse event prior vaccination. No illness at time of vaccination. She hasn't had x-rays or anything like that on her left arm. She didn't fall or didn't do anything to it.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 79-year-old male subject who was vaccinated with ENGERIX B. The subject's medical history included bypass surgery. Concurrent medical conditions included bladder cancer, colon cancer, hemodialysis , hypertension and pacemaker. Concurrent medication included EPOGEN, TYLENOL, COUMADIN, PRILOSEC, RENAL, XANAX and PHOSLO. On 9 February 2008 at 13:15 the subject received two doses of ENGERIX B at 20 mcg per dose for a total dose of 40 mcg. This was considered to be the 1st in a three dose series of ENGERIX B. On 12 February 2008, 3 days after vaccination with ENGERIX B, lab work for the subject was positive for hepatitis B antigen. At the time of reporting the outcome of the event was unspecified. Follow-up received on 11 March 2008 indicated that lab work from 18 February 2008 was negative for hepatitis B antigen. The events resolved by 18 February 2008 and were considered by the reporter to be related to treatment with ENGERIX B.
Area around inject site (LDT) swollen approx 2"; skin very warm & sl red; c/o difficulty lifting arm; pt states used cold compress afebriel rx Keflex;
Initial aches and chills that developed the evening of and subsided after 2 to 3 days. Then, on the 4th day, fingers on right hand started to swell. Has continued to improve but is still having some discomfort and stiffness in the right hand. Is now 2 weeks since initial injection.
Father brought in for shots - then took back to school - had seizure and was unconscious about 40 minutes later - taken to ER. Father told me this today - came in for records to start school (7-14-06 400 pm)
2 days p/inject exp nausea, abdo pain some abdo cramping; some diarrhea, urine concentrated;
Date and time of vaccination: (list both if they received both shots): #1vaccine Jan 15, 2021 #2 Feb 5, 2021 Brand and lot of vaccine: #1 lot number EL3249   #2 lot number EN5318 injection site still hurts, has a bruise now, still fatigue
pt stated that she experienced heart raising and rash and last from 10/07 to 10/08.
administered only the diluent portion; administered only the diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number CT44F, expiry date 10th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st April 2022, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 1st April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   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: 01-APR-2022 Reporter's comments: Registered nurse reported that a medical assistant of her office administered only the diluent portion of Rotarix to a patient without reconstituting it. Lot number and expiration date was regarding the administered diluent portion. The consent to follow-up was not asked to the health care professional(HCP) Additional Supportive Information: The patient received only diluent portion of Rotarix vaccine, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Increased heart rate immediately following the injection along with ringing in the ears for about 3 hours
Shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 22-OCT-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered varicella-like rash, redness, blisters, bumps and ongoing pain in her legs and buttocks and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event shingles to be disability.
itch at the inj site began 3 days post inj.   several days later rash began and eventually spread from top of arm to elbow.  itch very strong.  used OTC   anti itch cream w short term relief.   mixed baking soda w a bit of water to make a paste which was applied and provided 4-5 hrs relief.      today, the 23/21,   the rash remains but itching has diminished.      probably WILL NOT  get the  2nd  dose.
Information has been received from a medical assistant concerning a female patient who in approximately February 2009 finished the series of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient experienced "foot drop". It is unknown if the patient sought medical attention. As of 06-FEB-2009 the patient had not recovered. Additional information has been requested.
Approximately 48 hrs. after 1st dose on 1/22/21, body aches, especially the back muscles and nausea. Also headache.
Not feeling good today; Is uncomfortable; Arm was really sore at the injection site; Did not sleep well; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Did not sleep well), FEELING ABNORMAL (Not feeling good today), DISCOMFORT (Is uncomfortable) and VACCINATION SITE PAIN (Arm was really sore at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (3 stems after heart surgery.) in 2017. Concurrent medical conditions included Diabetic (Diabetic from 37 years now.). Concomitant products included METFORMIN, INSULIN, INSULIN DEGLUDEC (TRESIBA), INSULIN ASPART (NOVOLOG) and LIRAGLUTIDE (VICTOZA) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced POOR QUALITY SLEEP (Did not sleep well) and VACCINATION SITE PAIN (Arm was really sore at the injection site). On 16-Jul-2021, the patient experienced FEELING ABNORMAL (Not feeling good today) and DISCOMFORT (Is uncomfortable). At the time of the report, POOR QUALITY SLEEP (Did not sleep well), FEELING ABNORMAL (Not feeling good today), DISCOMFORT (Is uncomfortable) and VACCINATION SITE PAIN (Arm was really sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood thinners.  Treatment information was not provided.
I experienced the most severe menstural cramps that I have ever had since I started my period as a teenager. Normal pain relief medication did not reduce the pain at all. I was in extreme pain for approximately 6 hours before the cramps stopped on their own. Pain was in my uterus, radiating to my lower back, down the front of my legs, and I had nausea which has never happened to me on my cycle before.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 09Mar2021 at 14:00 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. It was unknown if the patient had any allergies to medications, food, or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), morphine (MANUFACTURER UNKNOWN), temazepam (MANUFACTURER UNKNOWN), atorvastatin calcium(LIPITOR) and acetaminophen-oxycodone hydrochloride(PERCOCET) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 11Mar2021, the patient experienced sore arm. The patient had not received any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm was resolved on an unknown date in Mar2021.   Information on lot/batch number has been requested.
mistakenly given a 3rd round of shingrix /received 2 dose series /around 2-3 years ago; She is having reactions/ fever; She is having reactions /chills; She is having reactions/nausea; She is having reactions/vomiting; She is having reactions/muscle / aches; She is having reactions/stomach aches; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose around 2-3 years ago) and Shingrix (received 2nd dose around 2-3 years ago).   On 13th July 2021 12:00, the patient received the 3rd dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered, fever, chills, nausea, vomiting, muscle pain and stomach pain. On an unknown date, the outcome of the extra dose administered, fever, chills, nausea, vomiting, muscle pain and stomach pain were unknown.   It was unknown if the reporter considered the fever, chills, nausea, vomiting, muscle pain and stomach pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter was the husband of the patient. The reporter reported that the patient went to HCP yesterday (day of reporting) and was received 3rd dose of Shingrix (around 12 noon), which led to extra dose administered. Later that evening (around 10 pm) the patient experienced fever, chills,nausea, vomiting, muscle and stomach aches. The reporter asked would the reactions be more severe with a 3rd shot. No further information reported. The reporter did not consent to follow-up.
SHORTNESS OF BREATH, IRREGULAR MENSTRUAL CYCLE, LEFT AXILLARY LYMPH NODE SWELLING, HEADACHE, ARM PAIN AND SWELLING.
felt little pain/pain aching on the whole body; headache; injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt little pain/pain aching on the whole body), HEADACHE (headache) and INJECTION SITE SWELLING (injection site was swollen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (felt little pain/pain aching on the whole body), HEADACHE (headache) and INJECTION SITE SWELLING (injection site was swollen). At the time of the report, PAIN (felt little pain/pain aching on the whole body), HEADACHE (headache) and INJECTION SITE SWELLING (injection site was swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Evaluated patient had cellulitis on right thigh 6 cms oval had induration (L) thigh 1 cm oval induration warm compress / IM & PO antibiotics, mom stated the cellulitis is subsided & is feeling well.
The morning after receiving my second Pfizer vaccination I awoke with a mild head ache which I have had ever since.  The intensity sometimes fluctuates from mild to medium at different times of day.  I have looked for patterns regarding the affects of sleep, stress, eating habits but have not found anything definitive.  It does seem to worsen when I have facial tension.
4 hrs p/administration pt became restless, cyanotic, gasping ?apnea; had large constipated BM then became pale w/nl breathing & had small diarrhea stool; pt given APAP 1 hr p/vax t101;
Lymphadenopathy (L) axilla (vaccine site (L) deltoid) pain awakened pt from sleep. No loss of use of arm, no loss of work.
Patient developed painful induration at site of BEXSERO injection about 2 cm in diameter. Induration lasted > 8 days.
his wife ended up in a hospital for 9 days, she had her gallbladder removed; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER DISORDER (his wife ended up in a hospital for 9 days, she had her gallbladder removed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gallbladder removal on 15-May-2021.   On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GALLBLADDER DISORDER (his wife ended up in a hospital for 9 days, she had her gallbladder removed) (seriousness criterion hospitalization). The patient was hospitalized for 9 days due to GALLBLADDER DISORDER. The patient was treated with Surgery for Gallbladder disorder. On 24-May-2021, GALLBLADDER DISORDER (his wife ended up in a hospital for 9 days, she had her gallbladder removed) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient received the Moderna vaccine, the 2nd dose on 09 May 2021, 6 days later she ended up in a hospital for 9 days, she had her gallbladder removed.  Although a temporal association exist, there s still limited information to assess the causal association between the reported event and the administration of mRNA-1273.  Critical details such as the patient's medical history. concomitant medication, clinical presentation and hospitalization details including investigations is lacking.  Additional information has been requested.; Sender's Comments: Although a temporal association exist, there s still limited information to assess the causal association between the reported event and the administration of mRNA-1273.  Critical details such as the patient's medical history. concomitant medication, clinical presentation and hospitalization details including investigations is lacking.  Additional information has been requested.
This is a spontaneous report from a contactable physician via Pfizer sales representative. An infant patient of unspecified age ethnicity and gender received at the age of 4 months the 2nd dose of PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  The patient previously took at the age of 2 months the 1st dose of Prevnar 13 for immunisation. The patient experienced vocal cord paralysis on an unspecified date with outcome of unknown.
I had a headache come on that continued to get worse, had continuous extreme neck pain that goes to the skull (occipital area) and joint pain. Went to see a chiro and got adjusted hoping it would get better, but the pain got worse and continued. Then about 4 days later it got better but now comes and goes. I had soreness at the injection site and surrounding muscle. I  have continued to have soreness in the left arm. Right arm has continued to become inflamed at random periods since. Have tinnitus now in mainly left ear but it is in both.
Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; This spontaneous case was received on 17-Sep-2021 from other health professional (pharmacist) via Agency (reference number: SEQW21-02439) and concerned a 61-years-old female patient.   The patient's medical history was not reported. The patient's concomitant medication included Plavix (clopidogrel bisulfate), Hydrocodone (hydrocodone bitartrate), Lipitor (atorvastatin calcium), Protonix (pantoprazole sodium sesquihydrate), Losartan (losartan potassium), Amlodipine (amlodipine besilate), chlorthalidone (reported as Chlortalidone), Cymbalta (duloxetine hydrochloride) all used for an unreported indication.   On 10-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was P100360857 and expiry date was reported as 30-Jun-2022.  On the same date after receiving Afluria Quadrivalent, the patient had severe nausea, vomiting and diarrhea.  On 12-Sep-2021, the patient recovered from the events of 'nausea', 'vomiting' and 'diarrhoea'.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company Comment: Events 'nausea', 'vomiting' and 'diarrhoea' are considered as related to Afluria Quadrivalent.; Sender's Comments: Events 'nausea', 'vomiting' and 'diarrhoea' are considered as related to Afluria Quadrivalent.