chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site atrophy in a 57-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included unknown medications. On 15 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 16 December 2011, 31 days after vaccination with FLULAVAL, the subject experienced injection site atrophy. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved.
Pain in left arm pit beginning the night of the vaccine. The following day, red streaks noted from left shoulder to the center of chest. Streaks lasted 2-2 1/2 weeks.
This case was reported by a pharmacist and described the occurrence of decreased oxygen saturation in a neonate male subject who was inadvertently vaccinated with FLUARIX (GlaxoSmithKline). There were no concomitant medications or relevant medical history. On 6 April 2009 the subject accidentally received a dose of FLUARIX (0.5 ml, unknown site) instead of ENGERIX B; wrong vaccine administered and maladministration (asymptomatic/child too young). On 7 April 2009, 1 day after vaccination with FLUARIX, the subject experienced decreased oxygen saturation. The subject was transferred to the Neonatal Intensive Care Unit, prolonging hospitalization. He was discharged on an unspecified date. On 8 April 2009, the events were resolved. The reporting pharmacist considered the maladministration occurred due to the ENGERIX B and FLUARIX syringes resemblance and small print. The pharmacist also stated that FLUARIX had been stocked in the ENGERIX B holder in the refrigerator in labor and delivery. The pharmacist intended to complete a "report".
had dose two in the morning - felt fine all day - went to sleep that night - woke up with headache, got up, took Advil, which promptly made me nauseous - went into bathroom, fainted, collapsed on floor - my husband came in and took care of me, then diarrhea, then back to sleep and I was pretty much fine the next day, although I rested all day
Diarrhea, chills, severe fatigue, head to toe rash with welts, bumps, large raised areas, itching
Patient was given a monovalent pfizer vaccine as a booster. Patient should have been given the bivalent pfizer vaccine as a booster. No adverse outcomes.
This spontaneous report as received from a physician refers to physician's daughter, a currently 47 year old female patient of unknown age with lupus. Drug reactions or allergies were not reported. On 22-MAY-1995 the patient was vaccinated with VARIVAX (Merck) dose 1, 0.5 ml, subcutaneous (anatomical location, lot number and expiration date were unspecified) and, on 30-JUN-1995, VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous. On an unknown date (also reported as later), her antibody titers were checked and they were negative. On 01 September (year was not reported), the patient was vaccinated with VARIVAX (Merck) dose 3, 0.5 ml, subcutaneous (anatomical location, lot number and expiration date were unspecified). On an unknown date, after receiving dose 3, the antibody titers were still negative. On 21-JUL-2001 the patient was vaccinated with VARIVAX (Merck) dose 4, 0.5 ml, subcutaneous (anatomical location, lot number and expiration date were unspecified). No treatment was given to the patient for the adverse event. On an unknown date in 2006, her titers were checked again and they were positive. The physician's daughter did not get further doses of VARIVAX (Merck). The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Patient had vaccine administered yesterday 3/10/04. When she woke today 3/11/04 left thigh had positive erythema and induration measuring 7 cm lat. 4.5 cm long. No shortness of breath. No wheezing.
March 10 developed large lymphnode with pain under injected arm. Next day or so noted increased tinnitus. I had tinnitus before but not like this. Very intense and doesn?t stop
anemic; lost 20 pounds; low grade fever 99.5 to 100 highest; fatigue; delayed reaction; This spontaneous case was reported by a patient and describes the occurrence of ANAEMIA (anemic), WEIGHT DECREASED (lost 20 pounds), IMMUNISATION REACTION (delayed reaction), PYREXIA (low grade fever 99.5 to 100 highest) and FATIGUE (fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced IMMUNISATION REACTION (delayed reaction). On an unknown date, the patient experienced ANAEMIA (anemic), WEIGHT DECREASED (lost 20 pounds), PYREXIA (low grade fever 99.5 to 100 highest) and FATIGUE (fatigue). At the time of the report, ANAEMIA (anemic), PYREXIA (low grade fever 99.5 to 100 highest) and FATIGUE (fatigue) had resolved and WEIGHT DECREASED (lost 20 pounds) and IMMUNISATION REACTION (delayed reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, Blood test: narrowed down their anemia to low ferritin. On 21-Feb-2022, Serum ferritin: back in normal range at 88, Next reading was 120 in Jun2022. On 18-Oct-2022, Serum ferritin: came back into full normal range for 204. On an unknown date, Mean cell haemoglobin: size of red blood size typical run high end of normal but came down to the mid range of normal. On an unknown date, Mean cell volume: size of red blood size typical run high end of normal but came down to the mid range of normal. On an unknown date, Serum ferritin: ferritin which should have been in 200 range was 11 and completely eliminated. On an unknown date, Weight: lost 20 pounds.         No concomitant medication was received.  The patient also lost 20 pounds with no lifestyle changes whatsoever but had not gained weight back.  The patient recommended they took an iron supplement and the ferritin went from 14 to 11 so they stopped taking it and let it resolve on its own.
Upon return home after vaccination, patient experienced pain and heaviness of (L) arm. Arm was difficult to move. Following day, unable to move arm. Pt instructed to seek medical care. Seen at urgent care. Given sling and pain medication.
Chest Pain and Fatigue Low intensity continued pain on left side of chest after 2nd day of 3rd booster dose. Uncomfortable feeling Headach sometimes  NO FEVER Earlier Vaccines 1st and 2nd dose were Moderna and 3rd dose is Pfizer
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of unknown demography who experienced received only the Dtap-IPV portion from vaccine PENTACEL lot number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Migraine, shore arm, chills, muscle pains at 4/12/2021 from 12.00pm till 10.00pm.
Information has been received from a consumer concerning a 13 month old son with no pertinent medical history, who on 05-APR-2010 was vaccinated with a dose of 0.5ml MMR II. "The patient had reactions to every vaccine he had gotten". There was no concomitant medication. On 10-APR-2010 the patient had a fever of 104.5 degrees that lasted 5 days. On 11-APR-2010 the patient developed a rash. The patient recovered from fever but his rash persisted. The mother brought the patient to ER. He was not admitted. The patient's physician did not think this was a reaction to the vaccination. Follow up information received from a physician concerning a 13 month old male patient with no illness at time of vaccination, who on 05-APR-2010 was vaccinated with a first dose of MMR II (lot # 665596/1272Y, IM) in the left thigh. On 10-APR-2010 at 9:00 pm the patient had high fever and significant local reaction 10 days after immunization. There were no labs or diagnostic tests performed. The patient did not require emergency room or doctor visit. At time of reporting, the patient recovered. No further information is available.
Patient received her first dose of Moderna on 03/06/2021 @1102. At 1110 she started to have numbness and tingling down right arm and difficulty swallowing but was able to maintain her airway. Was seen in ED and given 25mg Benadryl, was feeling better and symptoms went away, was discharged home the same day.
low grade temp, pain, swelling w/lump no abscess; lt anterior thigh;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Lot number: GJ5342) for covid-19 immunisation; BNT162b2 (BNT162B2), in Jul2022 as dose 1, single (Batch/Lot number: unknown) and in Aug2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she came down with COVID 19. The clinical course was reported as follows: the patient mentioned she got a dose of the Pfizer BioNTech COVID-19 in Jul2022 and then in Aug2022 she came down with Covid. She then checks her vaccination card and confirms she had her last Pfizer Booster was in Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
allergic reaction; swelling of the injection arm (left); heaviness; change in her skin color (reddish color); numbness in her hand; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: not reported), via an unspecified route of administration administered in Arm Left on 27May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27May2021 after 4 hours, the patient experienced allergic reaction, swelling of the injection arm (left), heaviness, change in her skin colour (reddish color), numbness in her hand. The patient reported that she received the first dose of the Pfizer Covid-19 vaccine on 27May2021 and experienced reactions afterwards. She was receiving the second dose yesterday (28Jun2021) but nurse referred her to Primacy Care Physician (PCP). Where she explained she had symptoms after 4 hours, she is not sure if it was an allergic reaction. She experienced swelling of the injection arm (left), heaviness, change in her skin color (reddish color) and experienced numbness in her hand. She wanted guidance on how to proceed. The patient is asking that If she received the Pfizer Covid-19 vaccine on 27May2021 how much time do she have left to get the second dose. She also asked can she get the Moderna Covid-19 vaccine as a second dose instead of Pfizer's Covid-19 vaccine or not. There is no product complaint to report, no medical information request and no other report. The outcome of all events were unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained
pt recv vax 2230AM mom called 340PM stating pt has egg sized knot on lt leg;mom states pt would not stop crying (pt could be heard in background crying) & that pt would not take bottle or pacifier;referred to ER:MD state virus or vax rxn
Local Redness, swelling a injection site, about 7cm x 10cm induration, warm to touch, soreness.
Slurred speech started morning of 1/8 and patient went to ED after dialysis appointment. Admitted for TIA (transient ischemic attack). Discharged home on 1/10 with follow up appts with Neurology.
pt was overcoming cold when recvd vax; pt fainted outside clinic; pt was drowsy & asked to sit inside car; at time R-10, P-68; BP 90/40; pt into clinic & rested for 10 min; R-14; P-72; BP 110/78; pt dismissed; instruction given to mom;
Sudden trachycardia  with patient unable to breathe (resolved before emergency intervention).  The incident repeated itself. Sore throat.
sore arm; The patient was inadvertently administered with an undiluted Pfizer-BioNTech COVID-19 Vaccine (orange cap).; The patient was inadvertently administered with an undiluted Pfizer-BioNTech COVID-19 Vaccine (orange cap).; This is a spontaneous report received from a contactable pharmacist and a contactable consumer. This pharmacist and consumer also received report in response to HCP letter sent in a cross-referenced case. A 6-year-old patient received BNT162b2 (BNT162B2), on 09Mar2022 at 16:00 as dose 1, single (Lot number: FL0007), in right deltoid and on 30Mar2022 at 14:00 as dose 2, single (Lot number: FL0007) at the age of 6 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset Mar2022, outcome "unknown" and all described as "The patient was inadvertently administered with an undiluted Pfizer-BioNTech COVID-19 Vaccine (orange cap)."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient did not provided information to you regarding the adverse event(s) with the use of the product. Patient age at time of vaccination: 6 (years). Pfizer/BioNtech COVID-19 Vaccine Details: Dose: 1st, Date: 09Mar2022, Time (24hr): Approx. 16:00. Dose: 2nd, Date: 30Mar2022, Time (24hr): Approx. 14:00. Vaccination Facility Type: Doctors office/ Urgent care. Vaccine Administered at Military Facility: No. Prior vaccination (within 4 weeks): None. Patient Medical History (including any illness at time of vaccination): None. Relevant Tests: None. Relevant Test for thromboembolic events with thrombocytopenia: None. Comments/Narrative: Vaccine was received from pharmacy repackaged in plastic bag with 'Do Not Dilute' sticker affixed. Dose was administered to patient undiluted. With the exception of a sore arm, parent reported no adverse effects.  Follow-up attempts are completed. No further information is expected.
pt recv vax; fever 100-101 & crankiness for 3 days; fever goes down w/ apap;
had one shot in 2018, and another today; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose was received in October 2018).   On 17th October 2022, the patient received the 2nd dose of Shingles vaccine. On 17th October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first shot and another was received on the day of reporting.  The patient was asking do he/she need another one. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Heart palpitations for over a month now; 31Mar2021 08:30 (Batch/Lot Number: ER8734) as DOSE 1, SINGLE/ on 31Mar2021 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (50-year-old age during vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:30 (Batch/Lot Number: ER8734) as DOSE 1, SINGLE; and via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included obesity, sleep apnea treated with cpap, hypertension treated with medication all from an unknown date and unknown if ongoing. Concomitant medications included losartan/hctz, venlafaxine hydrochloride (EFFEXOR) and montelukast sodium (SINGULAIR) all taken for an unspecified indication, start and stop date were not reported. The patient previously took macrodantin and experienced allergies (known allergies). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. The patient is not pregnant at the time of vaccination. Since the vaccination, has the patient been tested for COVID-19 (Nasal Swab) on 04May2021 and was negative. The most recent COVID-19 vaccine was administered in a public Health Clinic/Veterans Administration facility. It was reported that on 23Apr2021 08:30 the patient experienced heart palpitations for over a month now. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department orurgent care]. No treatment was required. The outcome of the event was not recovered.
rash all over; red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over) and RASH ERYTHEMATOUS (red rash) 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 21-Jun-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 21-Jun-2021, the patient experienced RASH (rash all over) and RASH ERYTHEMATOUS (red rash). At the time of the report, RASH (rash all over) and RASH ERYTHEMATOUS (red rash) outcome was unknown.            No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Lower arms (elbow to fingers) and lower legs (knees to top of feet) had severe shooting pains and aches, even without movement. General tiredness and stiffness, especially in the morning. This lasted two months (while we were on a vacation) before I saw a doctor. I  took aspirin and Tylenol. After about two months the discomfort subsided slowly over the third month.
Right leg pain. Swelling and redness where immunization was given. Fever. Seen in ER and admitted antibiotic treatment on 2/19/12.
out of 35 vaccines, this is one 1 of 3 pt from this site to exp lightheadedness, dizziness & weakness w/in minutes of vax;
tremor 2 days after vaccine, dx of graves disease with undetectable TSH 12/27/21
I am experiencing significant swelling in the lymph node of my right armpit. The swelling extends the side of my breast to my right should blade. Most other symptoms (e.g. body aches, headache) from booster vaccine have subsided; however, the lymph swelling still persists. Note: all COVID vaccines I have received were administered in my right arm.
This case was reported by a consumer and described the occurrence of nocturnal cough in a 48-year-old female subject who was vaccinated with Tdap (manufacturer unspecified), Flu vaccine and pneumonia vaccine (non-gsk). A physician or other health care professional has not verified this report. Concurrent medical conditions included gastroesophageal reflux disease and human immunodeficiency virus. Concurrent medications included TRUVADA, "Entellence", and Dexlansoprazole. Following vaccination on an unspecified date with unspecified dose of Flu vaccine (unknown manufacturer) and unspecified dose of Pneumonia vaccine (Non-GSK) (unknown) the subject reported that she experienced a cold. On 16 September 2010 the subject received unspecified dose of Tdap (unknown, right arm). On an unspecified date in 2010, after 16 September 2010 and before 05 November 2010, less than one year after vaccination with Tdap, the subject experienced nocturnal cough, migraine headache, and unable to sleep. The consumer reported that since she was vaccinated with Tdap vaccine on 16 September 2010, she has been experiencing headaches, coughing at night and has been unable to sleep. She went to the emergency room (ER) regarding her headache and the physician requested a CAT scan that came back fine and she was released from the ER. She has had one doctor's appointment since that time and stated that the physician who is treating her for HIV did not believe that her symptoms were coming from the vaccination and suggested she see a primary physician which she has not seen. She was unable to specify the date(s) when she started experiencing the side effects but insisted they started sometime after she received the vaccination on 16 September 2010. At the time of reporting the outcome of the events was unspecified.
Patient was found unresponsive by mother on 12/23/14 about 2:30 AM - paramedics took him to ER - transferred to another hosp. Pronounced dead.