chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few days later I began to feel muscle aches and chills, I thought it would pass but it was increasing Until the 23rd I went to the emergency room and they determined that I could have a pseudo pneumonia but it continued to advance or we had to return to the emergency room on the 26th and they told me it was pneumonia but with many symptoms of covid, although they did not give the tests  Never in my life did I get pneumonia  Now they suspended my second dose for April 7
Approximately 5 minutes after getting the HPV shot, the patient passed out.  She passed out from a standing position and hit her head on the tile floor.  She was examined by a doctor in the clinic and released home in stable condition.  Dad was given instructions to seek medical help if she showed signs of a concussion.  She returned to the clinic on 5/15/19 for a doctor's visit due to headache, dizzy, light-headedness, nausea and abdominal pain.  She was diagnosed with a concussion.
No additional adverse event; Custumer reporting AE administration of improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    On 03-SEP-2020, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 1 injection (route of administration was not provided) lot # reported as T012422 expiration date 19-SEP-2022, for prophylaxis.   The improperly stored dose experienced temperature excursion of 14.4 Fahrenheit (F) degrees for 30 min. There was no previous temperature excursions. The call was because a digital data logger. No additional adverse event was reported.; Sender's Comments:  US-009507513-2009USA002498:
3/26/2021: 7:30 pm low grade fever, pain in arm, tiredness  10:30pm through the night shaking, chills, fever, flu like symptoms, cold sweats, could not sleep  12:00 pm on 3/27/2021 fever of 101.3F , body aches, tiredness,
Arm had immense itching, swole area 3 times size, area moving towards shoulder.
arm begin to ache; Headache; radiated down into her neck; placement was too high on her deltoid / didn't pinch her arm during administration; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension.   On 9th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 9th August 2021, 2 hrs after receiving Shingrix, the patient experienced pain in arm, headache, neck pain and vaccine administered at inappropriate site. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, headache and neck pain were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain in arm, headache and neck pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received Shingrix in the left deltoid. Two hours after the vaccination, the patient's arm began to ache and also stated that later in the evening developed a headache that started at the top of her head and then radiated down into her neck.  The patient stated that she felt as if the placement was too high on her deltoid and noted that he didn't pinch her arm during administration, which led to vaccine administered at inappropriate site. The patient took Tylenol and had some moderate relief. The patient was referred to health care professional. The reporter consented to follow up.
COVID Vaccine Breakthrough Case. Pfizer Dose 1- 3/5/21 (EN6206). Pfizer Dose 2- 3/25/21 (ER8732). COVID Positive 10/31/21. 10/31/21: This is a 78 years old gentleman with a history of coronary artery disease status post stents, ischemic cardiomyopathy with ejection fraction in the 20s%, presents to the emergency department at County Hospital due to difficulty breathing and cough. The patient states that the symptoms started about 4 days ago and are getting worse. There is no associated exacerbating or relieving factors. Denies recent travel or sick contact that he can recall. Denies recent weight gain, lower extremity swelling. The patient currently denies shortness of breath and chest pain. On lab work he was found to have acute kidney injury as well as elevated D-dimer and a positive COVID test. Patient is reportedly vaccinated against COVID with Moderna vaccines last year.  Due to the abnormalities in the lab work patient was recommended to transfer to our facility to undergo V/Q scan to evaluate for PE given the elevated D-dimer. He was started empirically on IV heparin in the ED. EKG shows a right bundle branch block, patient without complaint of chest pain however does have an elevated troponin level at 0.04 in the setting of acute kidney injury. 11/4/21: Patient was admitted to this hospital to undergo V/Q scan which the County hospital did not have the capacity to perform, this resulted low probability for PE. Patient was initially on heparin prior to transfer to our campus, this was discontinued after V/Q scan result. Patient was on Lovenox sub-Q for VTE prophylaxis while undergoing treatment for COVID-19 pneumonia with antiviral and antibiotic therapy as well as steroids due to transient need for O2 supplementation via nasal cannula. Home medications were resumed.  He was given gentle IV fluids with subsequent improvement in renal function. He was advised strongly to follow up with his PCP and repeat blood work to monitor renal function. Plan of care was discussed in detail with patient and he expressed understanding and agreement. He was seen and examined on the day of discharge, states he is doing very well and is very eager to be discharged home. Total time spent on discharge 45 minutes. Patient discharged in stable conditions.
Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting commencing the following day and continuing for 24 hours; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  on 27Jan2021 at 16:30 at single dose in Right arm for covid-19 immunisation. Patient was not pregnant.Medical history included allergies to cefalexin (KEFLEX), codeine and sulfa.Concomitant medication included escitalopram oxalate and omeprazole (PRILOSEC) . Patient experienced naseau and vomiting commencing on 28Jan2021 at 10:00 and continuing for 24 hours. On 28Jan2021 at 10:00 patient also had redness and swelling and acute pain at site of injection, aches and pains in arm radiating in back and shoulder.No treatment given. Final outcome of the events was recovering. Information on the lot/batch number has been requested.
Breakthrough COVID-19 case.  8/20/21: admitted for syncope, recurrent falls, generalize pain secondary to falls. tested positive for covid on 8/20/21. Previously vaccinated with J&J Covid-19 vaccine on 5/26/21. Asymptomatic for COVID symptoms. Discharged 8/30/21.  tested positive for covid on 8/20/21. Asymptomatic. Discharged 8/30/21.
Fever of 102.6; Nausea; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Patient had no allergies. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired). In March 2021, PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: Fever of 102.6.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  On 05-Mar-2021 night, the patient had fever of 102.6, nausea and was tired. The symptoms lasted for 36 to 48 hours.  Treatment information was not provided.   This case was linked to MOD-2022-648152, MOD-2022-648153, MOD-2022-648157, MOD-2022-648275 (Patient Link).
Pt was seen i ER 3 times for a large localized reaction. ER initially diagnoses as cellulitis and started treatment with abx. It did not get better after 48 hrs so abx were stopped and it was decided that pt was having a large vaccine reaction versus a local infection.
Patient received second dose of Moderna COVID-19 vaccine at 21 days rather than the recommended 28 days.
Patient got burning painful rash, went to ER and was told she was having an anaphylaxis reaction.
Patient reported back to the pharmacy nearly 5 hours later stating that her arm had inflammation. Upon examining the arm, it was not warm to the touch and did not seem to have significant inflammation like the patient had stated. She also stated it was slightly painful. The pharmacist gave a cold compress and suggest that they take an antihistamine and wait to see if there was improvement but patient said someone was waiting on her and she left the building.
Patient came into the store on 9/5/20 stating that on 9/3/20 she stated to have a rash below the site of the injection (mid arm above the elbow but below injection site)  Patient stated that is was warm to the touch but no hives or itching.  Since it was a Saturday, recommended that patient go to Express Care to be evaluated since she expressed concerns
I had a congestion that became pneumonia, I cracked my rib because I was cough so hard. I don't remember being this sick in my whole life, I still have a lot of congestion that its not going away. I very troubled by it, I wouldn't think it had to do with the vaccine but I am not sure.
STIFF KNEES; DIFFICULTY IN STANDING; SICK TO HER STOMACH; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered to left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced sick to her stomach. On 27-MAR-2021, the subject experienced stiff knees. On 27-MAR-2021, the subject experienced difficulty in standing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to her stomach on 25-MAR-2021, and had not recovered from stiff knees, and difficulty in standing. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Headache, Sedation, NauseaVomiting CHILLS Narrative:
Swelling and red rash at injection site of left arm (deltoid region) that was warm to the touch, starting 7/22/18 and reported to pharmacy on 7/24/18; recommended patient to take BENADRYL for rash.  Patient stated that swelling and red rash had completely resolved on 7/26/18 10:55 a.m., when she was in pharmacy to pick up other medications.
Fever, red papular rash, coalescing lesion head to toe. Was currently on amoxicillin.
This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face is swollen today) and SWELLING (happen on legs, belly area and back but as of recent, it happens everywhere) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced SWELLING FACE (face is swollen today) and SWELLING (happen on legs, belly area and back but as of recent, it happens everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face is swollen today) and SWELLING (happen on legs, belly area and back but as of recent, it happens everywhere) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment included Benadryl. The patient stated that she took allergy medicine as her face was swollen. Action taken with mRNA-1273 in response to events was not applicable. This case was linked to MOD-2021-072640.
5cm indurated area @ inj site;tender, warm & red 2wk p/vax;also <20modified varicella lesions on trunk;
severe headache and fatigue began about 3 p.m. on 1/21/21 (the day after vaccine administered).  I went to bed early and slept later than usual and after about 9 1/2 hours of sleep, the headache and fatigue were only very minimal.  On 1/22/21 when I woke up I had an enlarged lymph node under my arm about 2 inches in diameter.  The lymph node was enlarged until 1/27/21
Raised hives covering limbs.  Every section of skin was covered from knees to feet, elbows to hands, bottom.
pt recvd vax several yrs ago; exp a high fever, irritability & febrile szs; pt now 4 yrs old; cont to exp febrile szs & other neurologic sx; 2nd neuro consult being pursued; family h/o sibling who had abn cry p/Tetramune/OPV/ENgerix
light spotting; Slight headache; sore right arm; Had no had menstrual cycle since receiving 1st and 2nd doses.; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Had no had menstrual cycle since receiving 1st and 2nd doses.), PAIN IN EXTREMITY (sore right arm), INTERMENSTRUAL BLEEDING (light spotting) and HEADACHE (Slight headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced AMENORRHOEA (Had no had menstrual cycle since receiving 1st and 2nd doses.). On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore right arm) and HEADACHE (Slight headache). On 08-May-2021, the patient experienced INTERMENSTRUAL BLEEDING (light spotting). On 11-Apr-2021, PAIN IN EXTREMITY (sore right arm) and HEADACHE (Slight headache) had resolved. On 09-May-2021, INTERMENSTRUAL BLEEDING (light spotting) had resolved. At the time of the report, AMENORRHOEA (Had no had menstrual cycle since receiving 1st and 2nd doses.) had not resolved. Not Provided          No Concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2021-116659 (Patient Link).
all of a sudden it's 200 something 300 something and then the last couple days I'm battling 500 and something/the ingredients in the shot and it has sucrose; all of a sudden it's 200 something 300 something and then the last couple days I'm battling 500 and something/the ingredients in the shot and it has sucrose; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received her first dose of bnt162b2 (BNT162B2; lot number: EL3248; expiration date: unknown) at 67-year-old vaccination age at a single dose in the left arm for covid-19 immunization and sucrose at unknown dosing regimen for an unspecified indication, both via an unspecified route of administration on 30Jan2021. Medical history included diabetes. Concomitant medication included levothyroxine sodium (SYNTHROID) and insulin for diabetes. The patient reported that she received her first dose on 30Jan2021 with no problem at all but this past week her blood sugar levels have been climbing. She normally was 120-150 [unknown unit] then all of a sudden, it's 200 [unknown unit] something or 300 [unknown unit] something and then the last couple days (2021), she was battling 500 [unknown unit] and something. She was just wondered because she looked at the ingredients in the shot and it has sucrose, so she just wondered if that is why her sugar levels are rising. The patient has tried getting hold of her doctor to ask the same question, but her office is closed since last three days, so they didn't have their phones connected. She reported that she did not have issues with the shot, its fine didn't get sick or anything. She's just worrying if that's the reason her blood sugar levels are rising. The outcome of the events unknown.
Client started feeling feverish and week the am after receiving vaccine. Had a severe headache. Went to ER in the evening and was admitted for observation.
Vaccines (L) arm Hep A and HPV9 (R) arm administered to each deltoid. Moments after injections patient slumping in chair, verbally non responsive with (B) arms rigid/flexed responsive after moving patient to table (approximately 1 min ?)-O2 Sat 100%, orthostatic B/P's within normal limits. Awake, alert as leaving office with mother. Patient to follow up with Neurology. Per pt, remembers event except for time at which non responsive (approximately 1 min). AAO x 3. No loss bowel/bladder fxn. Positive fatigue post episode.
My menstrual cycle started 10 days earlier than usual. I experienced heavy bleeding unexpectedly for over 2 weeks. My regular cycle started, and the heavy bleeding continued. And my cycle continued to be irregular the next couple of months. I had heavy bleeding for extra days whenever my period did start up again. It was very painful and quite abnormal for me.
realized that the vaccines were not viable; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a unknown.  This case is linked to case 2019SA290919.  This case involves a 6 years old patient of unknown demographics who experienced realized that the vaccines were not viable(Wrong product administered), while the patient received vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2019, the patient received a one dose of suspect influenza quadrival a-b vaccine pre filled syring lot UT6686LA via Intramuscular route in the right thigh.  The patient developed a non-serious realized that the vaccines were not viable (wrong product administered) following the administration of influenza quadrival a-b vaccine. Final diagnosis was not applicable realized that the vaccines were not viable.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as not applicable for realized that the vaccines were not viable.  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.
After reviewing vaccine ingredient lists on CDC website, parent requested to stay in office for observation post vaccine administration as DTaP listed bovine casein (a milk protein) in ingredients. Immediate hives at injection site, progressed to wide spread hives within minutes and total body redness, frequent coughing, complaint of itchy throat, eyes/facial swelling (still in pediatricians office for observation after vaccine).  Administered Benadryl and epinephrine with physician present and went to nearest emergency room for anaphylaxis.
fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 5th of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown. The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020096703 same reporter/ drug/ event for different patients.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. The reporter stated that doses of GARDASIL 9 (dosing details were not reported) lot # L019297 with an expiry date 18-AUG-2017 which were exposed to temperature 31.1 degree F for a time frame of 2 hours on 29-JAN-2016, were administered to unspecified patients on 18-FEB-2016. No concomitant medications were reported. No adverse effects were reported. This is one of the reports received from the same reporter (case # 1602USA011510). Additional information has been requested.
I stayed for 15 minutes and when I was driving home my face started to swell.  I had tingling in  my teeth and lips.  My throat felt full and I was coughing slightly.  Within an hour and 10 minutes after the injection, I started to feel back to normal.
Information has been received from a RN concerning a female pt who was vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation), when in school. It was reported that the pt was trying to get pregnant and is going through infertility treatments. The pt sought  unspecified medical treatment and was found to have a negative rubella titer. Additional info has been requested.
Information has been received via a physician's assistant concerning a 32 year old female with asthma who on 16-DEC-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23. On 17-DEC-2006 the patient developed cellulitis to her arm and presented to the emergency department. At the time of this report, the experience was still being treated and the outcome was unknown. Additional information has been requested.
Vaccines given 9/7/04. Patient presented for care 9/10/04. Left thigh warm to touch, slightly swollen. Afebrile.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, unspecified number of patients were vaccinated with PEDVAXHIB (dose, route and frequency were not reported) which was exposed to 34 F for four months (worst case). No adverse effects were reported. No further information was provided. This case was linked to the case 1404USA006470 and 1404USA007006 (same reporter link). Additional information has been requested.