chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccination injury; Initial information was received on 15-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves Adult (unknown gender) patient who experienced flu vaccination injury (vaccination complication) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu vaccination injury (vaccination complication) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  The event outcome was unknown for the event.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an adult (unknown gender) patient who experienced vaccination complication (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Pt stated upon on that she got in shower and had passed large blood clots peri-area. She states she thinks it was from her bladder. Followed up on Sunday with urgent care told see urologist. no pain. 11/7- cramping no blood noted on tissue, but in urine sample. 11/12- no further issues currently accept back ache
pt devel fever, rash, & swollen leg for 3 days p/inject; went out of town & mom has phone consult w/MD who suggested to use ice; pt unable to bear weight on leg x 3 days;
Pt complains of chest pain that he believes to be secondary to vaccine administration. Has had chest pain before due to excess caffeine however is not currently consuming caffeine. Encouraged to follow up with his provider
Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014 at agency. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received DTaP/IPV without first reconstituting the ACTHIB component. No adverse event was reported. List of documents held by sender: none.
37 year old was given FLUZONE HIGH DOSE QUADRIVALENT in error by one of her nurses with no reported adverse event; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician via Agency number: 00784104.  This case involves a 37 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 24-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ73180 and expiry date: 30-JUN-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "that Nurse manager repeated the above question. She asks if the FLUZONE HIGH DOSE QUADRIVALENT vaccine is valid or should be repeated with a different flu vaccine and what AE's they should look out for".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I got hives all over both of my legs the day after the shot. I came back to the office to ask them why I was had all these hives and they told me that I probably is allergic to the medication and to take Benadryl.
Case number PHEH2015US021294, is an initial spontaneous report received from a nurse on 19 Oct 2015. This report refers to a 2 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 18 Oct 2015. No adverse event was reported following this maladministration.
redness and swelling @site that increased to 10cm in diameter w/ pain and hot to the touch.
Swollen upper arm. area was hard from inflammation, red, and hot. This occured for 3 days.
Information has been received from a physician concerning an 11 weeks old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 18-JUL-2011 was vaccinated with a dose of RECOMBIVAX HB (Lot #, site and route not reported). Concomitant vaccines given on the same day included a dose of PREVNAR and a dose of PENTACEL. It was reported that the site of injection was red. There were no laboratory tests performed. The patient was given TYLENOL as a treatment of the event. At the time of the report the outcome of the patient was unknown. The patient sought medical attention with a phone call and an office visit. This is one of several reports concerning the same patient (WAES # 1107USA02485). Additional information has been requested.
Tingling in the face; numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the face) and HYPOAESTHESIA (numbness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included VITAMINS NOS, ATORVASTATIN CALCIUM (LIPITOR) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PARAESTHESIA (Tingling in the face) and HYPOAESTHESIA (numbness). At the time of the report, PARAESTHESIA (Tingling in the face) and HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Chills, fatigue, nausea, diarrhea, my arms felt very, very heavy the day after my vaccine. The second day I still had some chill and fatigue with nausea but these subsided by midday of the the second day.
Fully vaccinated with Covid vaccine x 3.  Tested positive for Covid on 02/11/22. Admitted to Hospital on 02/10/2022. Expired on 02/14/2022 while still hospitalized.
Pt exp syncope p/vax w/MMR on 21AUG90;
Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves 10 weeks old male patient who received 0.5 ml first dose of vaccine PENTACEL batch number UJ104AA (expiry date 13-Oct-2020) via unknown route in the left thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ and PREVNAR 13. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that child received the PENTACEL component DTap- IPV separate from the ACTHIB powder. It was unknown if any adverse event was occurred following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Mom called 17JAN92 stating pt had inc t102-103 on 16JAN92 & 105.2 that AM (14th); t was now 100; had talked to MD x 3 & was instructed to given APAP & bathe in cool water; took pt to ER AM of 18JAN92;
Moderate and mild  site swelling X7 days, itching at site.  size of a quarter, raised- not as big as it was the day after vaccination (size of a small egg) pain only with pressure to sight, including laying on it itching around raised area started 2/23.
Painful lumbar plexopathy.   he was initially unable to walk.  after starting prednisone, he was able to walk with a cane.  He still has disabling pain, but strength returned to  normal or near normal.  he still walks slowly with a cane, and pain worsened when prednisone ended.  nerve conduction study / EMG has been requested
3 days after 2nd Pfizer COVID vaccine- developed tinnitus in left ear. Peaked 2 weeks after shot. Still present 7 weeks post vaccine. Joined a tinnitus group on social media that has been very informative and helpful. Time seems to be the most common advice.
Sore left injection site arm; Was very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very sick) and VACCINATION SITE PAIN (Sore left injection site arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis since 01-Mar-2014. Concomitant products included CELECOXIB (CELEBREX) from March 2020 to an unknown date and GABAPENTIN from March 2020 to an unknown date for Arthritis, ALENDRONATE SODIUM (ALENDRONATE) from March 2020 to an unknown date for Brittle bone disease and Osteoporosis, METHOCARBAMOL from March 2020 to an unknown date for Muscle relaxation.    On 05-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ILLNESS (Was very sick). On 05-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 06-Aug-2021, VACCINATION SITE PAIN (Sore left injection site arm) had resolved. At the time of the report, ILLNESS (Was very sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  The patient's left arm was sore for a day.   This case was linked to MOD-2021-335248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow-up received: Patient's demography, relevant medical history, batch/lot number and concomitant medication was updated.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 31-JUL-2017 the patient was vaccinated with incorrectly stored PNEUMOVAX 23 lot # M042324 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 to 77 degrees Fahrenheit for 19 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
The nurse administered a pediatric dose of HAVRIX to an adult patient. The syringes were taken out of their box and stocked in the clinic refrigerator. The pediatric syringe does not have "adult" or "pediatric" labeled on them like the box does.
Information has been received from a physician concerning a 6 year old male with unspecified eye problem who was scheduled to receive PROQUAD (Merck upgrade process) on 05-NOV-2010, was accidentally vaccinated with a dose of ZOSTAVAX (Merck) 0.5 ml. There was no concomitant medication. It was unknown if there was any relevant laboratory data. As of 05-NOV-2010, it was unknown if the patient has experienced any adverse event from the inadvertent administration of ZOSTAVAX (Merck). Follow up information from the physician concerning the six year old patient who received ZOSTAVAX (Merck) instead of the scheduled PROQUAD (Merck upgrade process). The physician stated that it was a case of the wrong product was grabbed by mistake. It was not a case of product confusion. The physician explained that there was an internal medicine group next door that was sharing their pediatrics freezer, so ZOSTAVAX (Merck) was in the freezer when it would not normally be in the pediatrics office. The internal medicine group was getting their own freezer so this will not occur again in the future. Additional information is not expected.
Right foot numbness followed three days later by left foot numbness. Progressed up her left thigh. Followed by upper extremity weakness with bulbar involvement (left facial nerve).
This case was reported by a consumer (the patient's mother) on 02 August 2007. A 10-year-old male patient with no reported medical history received IMOVAX (lot number A0017-2) after being exposed to a bat in his house. According to the reporter, after the second dose of IMOVAX the patient began experiencing mild headaches and nausea. After the fourth dose of IMOVAX, the patient experienced left sided chest pain, described as "sharp" and lasting 10 to 15 minutes. All events were reported as persisting "occasionally". The patient's mother reported that he "may have received at least one dose of RABAVERT" but was unsure as to which dose it may have been. Additionally, upon presenting for his second dose of IMOVAX, the patient was inadvertently given INTERFERON. Per the patient's mother, the patient was "late getting a few of those doses" and "still needs one additional dose"; he had received a total of four doses (dates not provided). No additional information was provided. Follow-up information received on 19 September 2007 from a health care professional. Although the patient was a patient in the reporter's practice, his vaccination and follow-up care for the adverse event were provided by another facility. Per the reporter, "I had nothing to do with this incident."
There's no adverse events. The error is that the patient is almost 18 years old (not 18 yet) and received the Moderna Vaccine. As the recommendation, Moderna should be given to patients of 18 years old or older.
Dizziness, Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:  flu like symptoms following 2nd dose, missed one day of work  Other Relevant History:
Chills started about 1 hour after the injection and happened on and off for about 3 hours. A headached developed over about 3 hours and has lasted about 20 hours so far. Fatigue was almost immediate but joint pain and slight swelling occurred after about 10 hours and has been intermittent.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Right arm tricep area with warmth, erythema, induration - started 48 hours after varicella. Advised TYLENOL/MOTRIN/heat QID x 20 min.
Could not sleep; Tremendous amount of shaking; Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), TREMOR (Tremendous amount of shaking) and ARTHRALGIA (Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 013L20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previous experience with COVID-19 1.5 years ago, before receiving the vaccine) in 2020.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced INSOMNIA (Could not sleep), TREMOR (Tremendous amount of shaking) and ARTHRALGIA (Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK, qd. At the time of the report, INSOMNIA (Could not sleep), TREMOR (Tremendous amount of shaking) and ARTHRALGIA (Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk) was resolving.            The patient had received two primary series doses and two booster doses of the Moderna COVID-19 vaccine by intramuscular injection. No concomitant medications were reported. It was reported that following the most recent dose, the patient came home and could not slept. The patient had a tremendous amount of shaking and could not got up and walk the day after getting the vaccine. The patient felt this like previous experience with COVID-19. The patient symptoms were still ongoing today although 99.9 percent resolved.  Treatment medication information included the patient had been taking Advil daily for her symptoms.   This case was linked to MOD-2022-542606 (Patient Link).
Severe leg cramps for first 2 nights;  extreme fatigue on and off for over 1 week
Left foot got infected; Difficulty to walk due to pain in left foot; Swelling left foot; Itching; Weakness; Swelling at injection arm; Red streaks at injection site; Headache; Fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot), PERIPHERAL SWELLING (Swelling left foot), LOCALISED INFECTION (Left foot got infected), PRURITUS (Itching) and ASTHENIA (Weakness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included PROPRANOLOL for Blood pressure high, ESOMEPRAZOLE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Itching), ASTHENIA (Weakness), VACCINATION SITE SWELLING (Swelling at injection arm), VACCINATION SITE ERYTHEMA (Red streaks at injection site), HEADACHE (Headache) and FATIGUE (Fatigue/tiredness). On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot) and PERIPHERAL SWELLING (Swelling left foot). On 28-Jan-2021, the patient experienced LOCALISED INFECTION (Left foot got infected). At the time of the report, PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot), PERIPHERAL SWELLING (Swelling left foot), LOCALISED INFECTION (Left foot got infected), PRURITUS (Itching), ASTHENIA (Weakness), VACCINATION SITE SWELLING (Swelling at injection arm), VACCINATION SITE ERYTHEMA (Red streaks at injection site), HEADACHE (Headache) and FATIGUE (Fatigue/tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 13 Jan 2021, the patient had an x-ray of the left foot (results not provided).  On 25 Jan 2021, the patient visited an oncologist who advised an ultrasound of the left foot to rule out a clot (not specified whether the ultrasound was done and/or what results were).  Treatment for the events included cefaclor, probiotics, and fexofenadine hydrochloride.  She was also fitted for ankle braces for the left foot.
Rash all over body and eyes are swollen. Dr prescribed Benadryl 2 tsp Q 4-6 hours.
2 hours later, developed severe itching and broke out in rash and hives also developed a sore throat.  Went to ER and was given fluids through IV as well as Benadryl, also was prescribed steroids.
The very next day after the vaccine, in the evening I started feeling feverish and the next day I got chills, fever and that is pretty much it. I was ok the next morning, I thought I was going to be alright, then Saturday my temperature went up to 104.6 and I could not get it to go down. was taking Tylenol every 4 hours and it would not go down.  I was shaking so bad. I was trying to do my chores and I could not physically do anything. I could hardly walk, I could not even go get some water. I felt disoriented. It was my own house that I lived for 24 years and I felt disoriented. I could not remember where the kitchen was. It lasted until about 8PM Sunday evening. Then I started feeling like a human again. I was able to walk to the bathroom by myself. My husband made me a bowl of soup that was the first time I ate since Friday. By that time I was coherent, was able to take a shower and around 10PM I went to bed and slept until 8AM Monday morning, I woke up like nothing had happened.
Information has been received through the Merck pregnancy registry from a physician (MD) concerning a 2 month pregnant hospitalized 35-year-old-female who approximately 2 months ago, about the time she became pregnant, had her 17-month-old child vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, on an unspecified date, the patient experienced an atypical rash on her abdomen that was atypical for varicella and was hospitalized. It is reported that the patient has no known history of chicken pox and is considered not immune for varicella. Diagnostic laboratory tests included titers to be drawn on an unspecified date. The patient was also seen by a dermatologist and said if the patient were felt to have varicella, they would call the MNSC to obtain information regarding testing to determine the type of varicella. The M.D. placed a call to infectious disease for consultation. The M.D. was not aware of the child who was vaccinated having a rash. It is unspecified if a product quality complaint was involved. Additional information has been requested.