chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator on 27 August 2012. A 23-year-old male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 23 November 2009 (also with a reported date of 19 October 2009) an elevated central laboratory Troponin level of 0.46 ng/ml and on 03 December 2009 (also with a reported date of 04 December 2009) a central laboratory Troponin level of 0.46 ng/ml. It was reported that treatment (other than medication) was given. The subject had a rapid Troponin I level on 23 November 2009 that was within normal limits (negative). The subject had an ECG performed on 03 December 2009 with normal results. There was no other reported visit. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was ongoing. According to the Investigator, the event of elevated central lab Troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Lightheadedness,  profuse sweating.  Patient was transported to hospital for evaluation.
Highest/lowest temperature reached: 8.5°C, Duration of excursion: 6 minutes with no reported adverse event; products been administered post excursion with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of unknown demographics who was administered IPV (VERO) [IPOL] post excursion and highest/lowest temperature reached: 8.5°c, duration of excursion: 6 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose 0.5 ml of suspect IPV (VERO) Suspension for injection strength: not reported lot V1B901M expiry date: 02-jun-2024 via unknown route in unknown administration site for immunization and highest/lowest temperature reached: 8.5°c, duration of excursion: 6 minutes with no reported adverse event (product storage error).  On an unknown date product been administered post excursion with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event highest/lowest temperature reached: 8.5°c, duration of excursion: 6 minutes with no reported adverse event and was Unknown for the event products been administered post excursion with no reported adverse event.   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.
sore arm / Just being sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm / Just being sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included HYDROCORTISONE for Fibromyalgia.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced MYALGIA (sore arm / Just being sore). At the time of the report, MYALGIA (sore arm / Just being sore) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L026602. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Does the vaccine cause infertility; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFERTILITY (Does the vaccine cause infertility) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFERTILITY (Does the vaccine cause infertility). At the time of the report, INFERTILITY (Does the vaccine cause infertility) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. No treatment medications provided by the reporter.   Reporter did not allow further contact
Pt became irritable and restless following second dose of Prevnar. Pt's mother had a history of latex allergy. No further info was available at the time of this report. Follow-up stattes a nurse reported via a company representative that her daughter became irritable and restless following her second dose of Prevnar. The child's mother had a history of latex allergy. Info from the child's physician revealed the child also received DTaP, HIB, and IPV vaccines that same day. The child has since recovered.
Information regarding PREVNAR 13 was received from a healthcare professional regarding an 8-month-old female patient who experienced generalized papular erythema described as "scant" on the posterior trunk, on her head and 4 extremities, hive-like in appearance and generalized papular erythema. At 8 months of age, the patient received a dose in Jun-2010, along with a dose of ROTARIX (GlaxoSmithKline) and a dose of PENTACEL (Aventis-Pasteur) in Jun-2010. In Jun-2010, the patient experienced generalized papular erythema described as "scant" on the posterior trunk, on her head and 4 extremities, hive-like in appearance. Treatment was not reported. The outcome was unknown. No additional information was available at the time of this report.
Severe upper back pain started 1/23, lessened in severity by 1/29 then became very severe again on 1/30, decreased in severity again on 2/2. Still have some pain today (2/4) but is no longer constant. There was no precipitating injury or strenuous activity.
Pfizer / BioNTech: dose#4, Moderna: dose#1-4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 40 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 041L20A), on 27Mar2021 as dose 2, single (Lot number: 020B21A) and on 16Nov2021 as dose 3 (booster), single (Lot number: 039fzia), in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: Vicks Dayquil/Nyquil; Gabapentin; Lamotrigine; Pristiq; Spironolactone; Zyrtec [Cetirizine Hydrochloride]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Oct2022, outcome "unknown", described as "Pfizer / BioNTech: dose#4, Moderna: dose#1-4". Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Redness, warmth at injection site approximately 2x2 inches. Soft, blanchable. No other symptoms, occurred today 1-13-21.
This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot numbers K014833, expiration date: 14-SEP-2016 and K024036, expiration date 26-NOV-2016, (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
The next day I started to get the chills,fatigue,headache,muscle pain, nausea, fever. I came home and took 2 acetaminophen and went to bed. After I woke up the fever broke and I felt better.
whole body was sore; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient got a shot of Shingles vaccines so far and it was not painful but his/her whole body was sore for nearly 2 days. The patient stated Covid vaccine only made him/her tired and also stated that they were just different. The follow-up could not be possible as no contact details were available.
Took second dose on day 2; Spontaneous report received on 27FEB2020.   A pharmacist reported that a consumer "took second dose on day 2" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer took the first and second dose of Vivotif on 26FEB2020 and 27FEB2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif on day 2 (Inappropriate schedule of product administration). Vivotif should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif on day 2 (Inappropriate schedule of product administration). Vivotif should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
MMR and VARIVAX given 3/11/13 when well. 12 days later seen on 3/23/13 very fussy with fever. Fading rash with extreme irritability and fussiness evaluated by Neurology and Peds ID. Work up most consistent with viral encephalopathy.
On March 20th, 2021 I began having sharp pains radiating from the left side of my neck, down into my left shoulder blade.  On March 25th, I had my first visit to the Doctor for this condition.  I saw a nurse practitioner who's notes say "1) Acute pain of left shoulder.  2) Neck pain.   Pain persisted became extremely bad from April 1st through 15th.   I began with neck and back stretches at this time.   May 4th I saw the doctor her notes say 1) Thoracic myofascial strain.  She prescribed physical therapy.  I began physical therapy on May 15th.  Just before that, say around May 10th, my neck began to get better.  but at that same time, I began to feel pain in my left ass.  I did physical therapy for 7 weeks.  During that period, the neck became a lot better, now there is just a knot on the left side under my ear and it is stiff.  But the pain in my left ass went to the whole left side sciatic nerve, down through my knee and around the front of my shin.  Then the right side started.  Except the right side now goes from the hip down through my knee and into my big toe.  I sleep with a pillow under my knees at night and usually wake up 2 or 3 time due to pain.  Right now, my left hip is radiating pain at a 3 to 5 level.  Pain is much worse in the AM, I have difficulty walking at first.  Things loosen up and within a few hours, all is pretty good.  Getting in and out of cars is tough.  After I drive somewhere for say 20 minutes, it is difficult to walk when I get out of the car.
Initially, had no strength to get out of bed (1 - 2 minutes)  Long lasting / Persistent: Phlegm cough Loss of appetite Runny nose Fatigue / low energy Indigestion Feeling of weight / pressure around eyelids and head Low alcohol tolerance
9 DAYS AFTER ANTHRAX VACCINATION ON 10JAN2003 HE DEVELOPED EYELID SWELLING, FACIAL ERYTHEMATOUS PRURITIC RASH,MALAISE, ARTHRALGIAS. RECEIVED SHOT #2 TWO WEEKS LATER ON 25JAN2003 AND DEVELOPED SAME REACTION. EACH REACTION TOOK ABOUT 4-5 DAYS TO RESOLVE. BOTH WERE LOT FAV065.
Patient had redness of the arm around the injection site, traveling down the left arm. The area of redness felt hot and patient also reported flushing of the face that evening. The redness in the arm lasted approximately 4 days. Patient took BENADRYL OTC to help with the redness along with applying ice to the injection site.
Dizziness severe, headache, aches and pains all over, feeling "sick", taken to bed for 16 hrs.
After getting my booster in August, I came down with Covid symptoms on 12/8. I had fevers, shortness of breath, cough, anosmia, weakness. On 12/10 I received  monoclonal antibodies due to being immunosuppressed on cimzia for Crohn?s disease. I have been on cimzia since 2019. After recovering from Covid, I got sick again with the same symptoms on 12/25/21. On 12/27 I sought medical care with my PCP. Went to get a chest X-ray and labs which were normal. I started wixela inhaler and albuterol as needed. I was told by agency I needed to report this. Currently still coughing but doing better.
No adverse event; 2 vials of VAQTA taken from a damaged carton were administered to 2 patients; Medical assistant reports 7 of 15 boxes received were partially opened on the sides of the carton. The opened boxes looks like the cartons had moisture on them; Medical assistant reports 7 of 15 boxes received were partially opened on the sides of the carton. The opened boxes looks like the cartons had moisture on them; This spontaneous report as received from a medical assistant and a physician concerning to 2 patients of unknown age ang gender.  No information regarding the patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies was reported.  It was reported that on 31-MAR-2021 the product of hepatitis A vaccine, inactivated (VAQTA) were received. Then, as reported by the medical assistant, on 08-APR-2021, 7 of 15 boxes (multi-unit packaging, 10 vials per box) of hepatitis A vaccine, inactivated (VAQTA) strength: 25U/0.5 mL (lot number reported as # T036813 with expiration confirmed as 11-DEC-2021) received were partially opened on the sides of the cartons, nonetheless, the safety seals were not affected (product quality issue, product packaging issue). The opened boxes looked like the cartons had moisture on them. It was also reported that the cartons looked like the shipping freezer bags moistened the cartons and the 7 cartons affected were partially opened.   Additionally, two vials of hepatitis A vaccine, inactivated (VAQTA) strength: 25U/0.5 mL (lot number reported as # T036813 with expiration confirmed as 11-DEC-2021) were administered at a dose of 0.5 mL (route of administration, and dosage regimen was not reported) as prophylaxis to 2 patients (poor quality vaccine administered). The two (2) vials of hepatitis A vaccine, inactivated (VAQTA) were taken from a damaged carton. No additional adverse events (AEs) were reported (no adverse event).  No further information was provided.
large lump or phlegm in throat; Trouble swallowing at about 2 hours after vaccination; Hoarse voice within the hour after vaccination; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. A 85-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Left arm on 04Feb2021 at 02:00 am (85-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included hbp (high blood pressure) from an unknown date and unknown if ongoing. The patient had allergies to various medications and products. The patient's concomitant medications were none. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 04Feb2021, the patient experienced hoarse voice within the hour after vaccination, trouble swallowing at about 2 hours after vaccination, at 16:00 pm, 14 hrs after vaccination, the patient experienced large lump or phlegm in throat. No treatment was received for the events. The outcome of the events were recovered on Feb2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Initial reaction was pain and immobile arm at injection site. Following day (8/22) had fever, chills, body aches head ache and unclear thinking. 8/23 brought severe swelling and redness from shoulder to elbow, previous symptoms subsided.
1 day p/vax pt devel fatigue, malaise & achiness which lasted for about 1 wk, followed by several days of diarrhea then genl rash; which lasted for about 5 days;
Seventeen year old received vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received vaccine) had resolved. Not Provided      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.   No concomitant product use was provided. Treatment information was not available.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 016B21A , with no associated AEs. US-MODERNATX, INC.-MOD-2021-067250:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067510:Cross link, same reporter US-MODERNATX, INC.-MOD-2021-067198:Crosslinked cases
Swollen lymph node under arm where shot was administered.   This was painful.  I used heat and pressure so I could sleep.  Pain lasted approximately two days.  Guess that means the vaccine is working?!?   I did report this to my Dr. and she said I should report it to you.
patient received expired Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other healthcare professional via Global Medical Information via call-center (reference number- 00378864) and transmitted to Sanofi on 02-Dec-2020.  This case is linked to case 2020SA347741 (same reporter).  This case involves a four-month-old male patient who was administered with 0.5 mL dose of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ021AAA and expiry date: 31-Oct-2020 (also reported as 21-Oct-20)) once via an unknown route in the left thigh for prophylactic vaccination in error (expired product administered) on 27-Nov-2020.  Medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency: same day).  The reporter would like to know if the patient must be revaccinated.  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 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.
This spontaneous report was received from a licensed practical nurse and refers to a pediatric patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions or allergies. The nurse reported that her facility received a shipment of PROQUAD which was mistaken for M-M-R II, and additionally, it was improperly stored on 10-NOV-2016. The temperature was maintained between -9 and 8 Celsius degrees (with a maximum of 6 Celsius degrees) for 143 days. There was no previous temperature excursion. Subsequently on 06-FEB-2017, the patient was vaccinated with a dose of PROQUAD lot number: M033612, expiration date: 14-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a properly stored sterile diluent, instead of a dose of M-M-R II. Additionally, on the same date and as a concomitant therapy, the patient was vaccinated with a dose of VARIVAX (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) which was reconstituted with a properly stored sterile diluent, also for prophylaxis. No adverse effect reported. The call was not because of a "data logger". There was no product quality complaint involved. This is one of four reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002246: US-009507513-1704USA014147: US-009507513-1704USA014146.
Within 2 days of DPT vaccination, 3 grand mal (tonic clonic) seizures. Patient was resuscitated by paramedics after third grand mal seizure.  Cyanosis. 6-7 minutes, lifeless. Transported to hospital.
Cellulitis in L arm (deltoid area). Seen in Emergency Department, treated with Amoxicillin for 7 days.
During injection - site pain. Immediately after injection - metallic taste/hands shaking (visually observed)/heart racing.
Patient came to the ED with shortness of breath and congestion.  Patient admitted to the hospital with Covid and treated with remdesivir.
Acute onset paresthesia, pain, weakness 1/1 of lower extremities. MRI - acute disseminated encephalomyelitis assoc. w/transverse myelitis. Corticosteroids and IVIG.