chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot number 662785/1124X, route and site not reported). It was not known if this was the first dose of PNEUMOVAX for the patient. After vaccination the patient developed erythema, swelling and warmth at the site of injection adn going down the arm and fever. The outcome was unknown. Additional information was received from the medical assistant. The 85 year old male with type 2 diabetes mellitus, hypertension and hyperlipidaemia who on 13-APR-2009 was vaccinated with the second dose of PNEUMOVAX (lot number 662785/1124X) IM into his right arm. On 13-APR-2009 the patient experienced swelling and redness at the site of injection. The injection site was warm to touch. The patient has fever. The patient required doctor visit. the patient was treated with KEFLEX, 500mg three times a day for 7 to 10 days. The patient recovered. It was unknown if there was illness at the time of vaccination. This is one of several reports from the same source. Additional information is not expected.
I developed prostatitis. I went to the doctor, and I am now being treated with antibodies. I had difficulty urinating, pain, and fever.
Initial report was received on 24 October 2014 from a non healthcare professional. A patient over 65 (date of birth not reported) had received "last year" (2013) and "IM Flu vaccine" (manufacturer, lot number, site and exact date of administration not reported) and an unspecified amount of time later, experienced severe shortness of breath and chest tightness. According to the reporter, VAERS reports had already been filed on the incident, and no additional information was provided. Outcome was not reported. Documents held by sender: none.
Found out we had been exposed to a friend, felt sinus pressure. Took home COVID-19 test and it was negative. Took another home test the next day and it was positive. Wend to Urgent Care, was extremely sick with headache and sinus problems. Told to take Mucinex, Vitamin C and vitamin D,. Said she was too far into the process and decided not to prescribe Paxlovid, instead they recommended Zinc. Starting to slowly feel better.
pt recvd vax 28APR93 2 days later devel swelling & pain @ inject site rt deltoid; now erythematous, edematous & warm;
Dose #1 Moderna 01/20/2021 Lot # 041L20A Pt died  while in the hospital
a child still get IPD (Invasive pneumococcal disease) not covered by PREVNAR 13; a child still get IPD (Invasive pneumococcal disease) not covered by PREVNAR 13; This is a spontaneous report received from a contactable reporter(s) (Physician) for a sponsored program (175895).  A child patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown" and all described as "a child still get IPD (Invasive pneumococcal disease) not covered by PREVNAR 13".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The association between the event lack of effect (pneumococcal infection) with PREVENAR 13 use can not be completely excluded.
Bad headache, sudden onset 18 hours after shot.  Took two Aleve, which reduced intensity but I still have it as I complete this form at 9:30 PM.  I also had tremors in my extremities (left leg, both hands) about 4 hours after the shot, which lasted a couple of hours and haven't returned.
This spontaneous report was received from a nurse referring to a 5 weeks old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-SEP-2016, when the patient was 5 weeks and 4 days old, he/she was vaccinated with PEDVAXHIB, 0.5 ml, route: unknown, (inappropriate schedule of vaccine administration). No adverse effects and no product quality complaint (PQC) reported. No further information provided. Additional information has been requested.
PATIENT WAS IN GOOD HEALTH WHEN VACCINATED ON 2-27-21. BY 3-3-21, PATIENT REPORTED TO ER WITH SHORTNESS OF BREATH AND SEVERE FATIGUE. PATIENT WAS ADMITTED TO HOSPITAL WITH DEHYDRATION AND POSSIBLE PNEUMONIA. ONCE ADMITTED, SEVERAL BLOOD CLOTS WERE FOUND IN PATIENT'S LUNG. PATIENT SPENT 4 DAYS IN HOSPITAL AND WAS THEN DISCHARGED. SHE IS SINCE IN GOOD HEALTH.
red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red) and PRURITUS (itchy) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ERYTHEMA (red) and PRURITUS (itchy). At the time of the report, ERYTHEMA (red) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
No additional AE reported; both MMR II and VARIVAX that had undergone temperature excursion were both administered to one patient; This spontaneous report was received from a nurse referring to a 1 year old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 17-NOV-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form, both for prophylaxis. Route of administration, lot number and expiration date were not provided for either of the vaccines. No additional adverse events were reported.  The vaccines had a temperature excursion from 9 Celsius degrees (°C) to 25°C, with an average of 15°C for 6 hours. The vaccines had had previous temperature excursions. The call was due to digital data logger.
Multiple round, dime-sized rashes. Patient also reported fever of 101, fatigue and aching muscles.
fever; joint pain; bad headache; body aches; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELI283;  expiry date: unknown) via an unspecified route of administration (arm left), on 06Jan2021 at 09:00, at a single dose, for COVID -19 immunisation (front line worker, taking care of sick patients with COVID). Relevant medical history included high blood pressure. The patient has no relevant concomitant medications. Family medical history included high blood pressure. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) at a single dose, for COVID -19 immunisation. Patient's weight was between 130 lbs and 140lbs. Patient reported side effects with second COVID-19 vaccine on 06Jan2021. Yesterday (07Jan2021), patient had high fever, joint pain, and bad headache. Right now, temperature was 100.6. Yesterday temperature was 39.5. Patient felt body aches night before (06Jan2021). Patient stated that probably, it was all in her mind. Then high fever was next day around 10:00-11:00. Patient stated that the reading effects (unspecified) are probably just a few days and will be gone. She was hoping it is just the way her body was reacting. Patient was taking ibuprofen for temperature (lot number: ODE2208A; expiry date: Feb2022). The patient wanted to know if this is a common side effect and if actual people are getting the same. Outcome of the events was unknown. The reporter assessed the events related to the suspect drug.
On May 15, I experienced severe pain in my right thigh. By May 17, I was experiencing extreme shortness of breath and pain in my chest and ribs. I ended up in the emergency room on May 20th and was diagnosed with a pulmonary embolism with infarction.
Fever, body aches, fatigue, nausea, soreness at site of vaccine. It lasted approximately 24 hours.
Continuous pain/discomfort with motion at site of injection and in joint. Some numbness/tingling noted with inflammation. Times of redness, swelling, and heat noted.
Case number PHEH2013US019085, is an initial spontaneous report received from a medical assistant on 10 Sep 2013. This report refers to a 16 years old male patient. He was vaccinated with MENVEO, batch number: M12093 and expiry date: Aug 2014), at dose of 0.5 ml intramuscularly on 06 Sep 2013. MENVEO vaccine was reached 33 to 51 F overnight and vaccine did not freeze. No adverse event was reported following this administration error.
Intense chills; aches; headache; general fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 22-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 (at the age of 22-year-old)as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any other medications within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced intense chills, aches, headache and general fatigue. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events intense chills, aches, headache and general fatigue was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Staff at SNF stated, "feeling well yesterday." On 4/5 at staff initiated a call for resp. distress at 2235, he was pulseless, and CPR was started.  Fire Dept. there at 2245 to assume CPR.  EMS arrived at 2252 and found pt. in PEA with vomit in airway.  He received 2 rounds of epi with return of circulation.  He was intubated in the field.  His post-arrest rhythm appeared to be ST.  He was transferred to local ER at 2256 where a right SC line and FC placed.  He received Zosyn while in local ER.  His GCS was 3.  FiO2 = 80%, COVID-19 PCR positive.  He was transferred to another facility r/t lack of beds.  He was placed in COVID ICU on with ventilator.  He remains unresponsive during stay 4/6 - 4/7.  Pt. expired on 4/7/21
It might be a heart problem; having pain near my underarm; having pain left upper back; having pain underneath my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (It might be a heart problem), PAIN IN EXTREMITY (having pain near my underarm), BACK PAIN (having pain left upper back) and ARTHRALGIA (having pain underneath my shoulder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concurrent medical conditions included Hemochromatosis (Patient is a carrier).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (having pain near my underarm), BACK PAIN (having pain left upper back) and ARTHRALGIA (having pain underneath my shoulder). On 06-May-2021, the patient experienced CARDIAC DISORDER (It might be a heart problem). At the time of the report, CARDIAC DISORDER (It might be a heart problem), PAIN IN EXTREMITY (having pain near my underarm), BACK PAIN (having pain left upper back) and ARTHRALGIA (having pain underneath my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-109939 (Patient Link).
l got the vaccine, l just keep getting; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included neuropathy.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got the vaccine, but neuropathy had already done damage. So the patient just keep getting the shingles. The patient stated that 13 years now it was just a way of his/her life. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Approximately 24 hrs post IPV in R arm, had red lacy rash (flat) approximately 1cm below injection site over 2-3  days rash became circumferential and approx. 2cm in width, resolved over 1 month period.
BECAME SYMPTOMATIC. EXPERIENCED RESPIRATORY FAILURE AND COVID19 PNEUMONIA. DIED 9/17
Patient came in for the Back to School Vaccination Clinic. On File it showed she was due for Tdap, but in Records it showed she was current. I was given the vaccination form from the front office who checked the vaccines prior to giving then to the nurse for administration. Patient was given Tdap too early due to her age.
The day after the vaccine, participant felt very tired and slept most of the day. Participant complained of headaches and took Tylenol 500mg -1000mg three times a day and would add Ibuprofen 400mg if needed. Headaches can range from mild to severe and cause her to wake up in the middle of the night. Participant continued to have daily headaches and hesitant to get the 2nd dose. However, she went ahead and got the 2nd dose of the vaccine. The headaches intensity and severity remained the same. After about 1 week after the 2nd dose, participant had an online consult with the doctor. Doctor did not prescribe anything and participant continued to take Tylenol and ibuprofen.
24MAY93 pt came to MD office w/report of initial burning on evening w/inc discomfort; muscle soreness, worsening w/activity; PE: mild swelling in lt shoulder area, inc sensitivity to muscle lt upper thoracic area & trapezis muscle;
This spontaneous report as received from a nurse refers to a patient of unknown age. On 21-AUG-2014 the patient was vaccinated with expired dose of M-M-R II (HSA, lot # H014647, expiration date 03-AUG-2014) (dose, route unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
woke up extremely achy in shoulder and neck; all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck; everything ached; feeling kind of beat up after; Consumer states he was knocked out; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (woke up extremely achy in shoulder and neck), ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck), MYALGIA (everything ached), FEELING ABNORMAL (feeling kind of beat up after) and FALL (Consumer states he was knocked out) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (he previously has pneumonia and was intubated). Concomitant products included APIXABAN (ELIQUIS), ROSUVASTATIN CALCIUM (CRESTOR), DOFETILIDE, COLCHICINE, PREDNISONE and LOSARTAN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (woke up extremely achy in shoulder and neck), ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck), MYALGIA (everything ached), FEELING ABNORMAL (feeling kind of beat up after) and FALL (Consumer states he was knocked out). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (woke up extremely achy in shoulder and neck), ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck), MYALGIA (everything ached), FEELING ABNORMAL (feeling kind of beat up after) and FALL (Consumer states he was knocked out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-300373 (Patient Link).
Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 3-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Allergy to Penicillin. Baby was conceived through IVF, Low AMH is the culprit for infertilitiy.  The mother's past medical history included Alcohol use (Mother was taking 1-2 drinks, 3 times per week) on 22-Jun-2020 and Subfertility (Baby was conceived through IVF, Low AMH is culprit of infertility).    No Medical History information was reported.    On 03-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The mother's last menstrual period was in June 2020 and the estimated date of delivery was 12-Apr-2021. On 03-Mar-2021, the infant was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 02-Apr-2021, which was reported as Premature. For neonate 1, the birth weight was 2551 grams (5lbs 10oz) with an APGAR score of 1 and 5 at (1, 5 minutes). The outcome was reported as Pre-Term Birth NOS. Baby was measuring small- labeled as IUGR.  Water broke and chose to do a C-section. Live Preterm birth =37 weeks gestation. No other fetal/infant abnormalities identified on delivery or one month post-partum. On 03-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramammary) was unknown.       No concomitant and  treatment medications  were reported. Weekly NST's test was normal.  Weekly ultrasounds with MFM was normal.  No Perinatal complications for the infant. No identified infant abnormalities at 1-month post-partum.   This case was linked to MOD-2021-051792 (Patient Link).
This is a spontaneous report from a contactable father. A female patient (age unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient experienced bruising, bleeding, fever, slept more, high pitched crying and voice changes (hoarse). The father noted that they were trying to find a cause for the bleeding and bruising because they were being accused of causing th events. The outcome of the events were unknown.
Patient's daughter called me this morning saying her mother was complaining of pain that radiated from the arm to her waist and that she felt very cold. I asked her if she had a fever and she said no. I suggested she go to the ER and that for her to follow up with the results. I also told her we will call her dr tomorrow (Mon) that she had a bad reaction.
very superficial reddish  erythema like patches of one inch or more around ankle joint both sides medial & lateral   no other complaint at locally or other
the vaccine has been administered to a patient after it was out of range with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a consumer (Office Staff) on 13-Nov-2019.  This case involves a 5 years old female patient for whom it was reported that the vaccine has been administered to a patient after it was out of range with no adverse event (Preferred Term: Product storage error), while she received vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 16-Sep-2019, the patient received a dose of suspect IPV (VERO) (lot number: P1A242M, expiration date: 26-APR-2020) via intramuscular route in the left arm.  This is a case of actual medication error due to Product storage. It was reported that the vaccine has been administered to a patient after it was out of range with no adverse event (Preferred Term: Product storage error), while she received vaccine ipv (vero).  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.
palpitations; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing). At the time of the report, PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing) had not resolved. Not Provided          no concomitant mediations are provided. treatment to the events not reported. patient experienced having a hard time breathing and palpitation for 2 days, until now.