chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death Received Pfizer Vaccine 2/06/21 and 02/27/21. Presented to ED 04/06/22 via EMS after cardiac arrest 15 min prior. According to the patient's family he has been feeling week for several days, today he seemed more SOB. Upon EMS arrival the patient was in PEA, placed on Lucas device, administered 1 round epinephrine and intubated. ROSC was achieved after total of 5 min. down time estimated by EMS. Intubated and sedated upon arrival to ED. Workup in ED showed AKI, lactic acid 8.3, Trop I HS 90, BNP 618, WBC 19.4 and is Covid-19 positive. Family decided on comfort measure only. Pt expired on 4/7/22.
This spontaneous report as received from a registered pharmacist refers to a currently 55 year old female patient. The patient's medical history included shingles. The patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, after receiving the vaccine, the patient did not have a titer. The patient stated that any vaccine she had gotten she did not get a titer. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Superficial thrombosis in left calf muscle Eliquis prescribed Follow up with vascular MD Compression stockings prescribed.
Day 1 of shot- soreness after a couple of hours at injection site Day 2- extreme fatigue (slept most of day), severe pain in left shoulder (couldn't move arm forward), chills, widespread muscle and joint aching Day 3- improved widespread S/S but still with pain specifically with left shoulder flexion and internal and external rotation Day 4- felt significantly better and able to raise arm overhead without pain, able to go about daily tasks Day 5- 5:45 am in morning- woke up with injection arm in severe spasm- painful to lift forward and rotate again, noticed decrease in sensation in anterolateral left shoulder to touch Day 6- 4:45 am- woke up with left arm in spasm again, pain with movement or weight bearing up to 8/10, feels swollen in chest and anterolateral left shoulder, referred pain in front of arm into biceps insertion, pain in injection site in anterolateral aspect of left shoulder
body pain; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, after first dose, the patient experienced fever and body pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after receiving the vaccine I went almost completely blind,  my eyes were very painful. I developed bumps on my skin that turned into open lesions. I feel like I have Bells Palsy on one side of my face. I have been on antibiotics since September and birth control because they thought it could also be hormonal. I have been fighting to get a diagnosis, I finally found that part of the problem with my skin condition is bacterial. I have never had skin issues until after the second vaccine.
polyarteritis nodosa; This literature-non-study case was reported in a literature article and describes the occurrence of POLYARTERITIS NODOSA (polyarteritis nodosa) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced POLYARTERITIS NODOSA (polyarteritis nodosa) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (intravenous) at a dose of 500 milligram once a day and METHOTREXATE (oral) for Immunosuppressant drug therapy, at a dose of 12.5 milligram once a day. At the time of the report, POLYARTERITIS NODOSA (polyarteritis nodosa) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: Revealed the presence of numerous vascular irregularities in the celiac axis, bilateral renal arteries, and inferior mesenteric artery consistent with polyarteritis nodosa (PAN), a medium vessel vasculitis..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient developed diffuse abdominal pain two days after receiving the mRNA-1273 COVID-19 vaccine (Moderna). The patient was placed on oral methotrexate for immunosuppressive maintenance treatment.  The author explained that until now, a limited number of cases of polyarteritis nodosa secondary to the COVID-19 vaccine was reported. Major mechanisms of postvaccine autoimmunity were molecular mimicry and autoantibody production. Rare adverse events from COVID-19 vaccination were possible, however there remained an immense benefit to vaccination in preventing COVID-19-related morbidity and mortality.  Company Comment: This is a literature non-study case concerning a 59-year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of polyarteritis nodosa. The event occurred approximately 2 days after receiving the second dose of mRNA-1273 vaccine. A computed tomography (CT) angiogram of the abdomen and pelvis revealed the presence of numerous vascular irregularities in the celiac axis, bilateral renal arteries, and inferior mesenteric artery consistent with polyarteritis nodosa (PAN). Treatment received included intravenous methylprednisolone 500 mg daily for three days followed by oral methotrexate (MTX) 12.5 mg daily for immunosuppressive maintenance. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Case number PHEH2013US023416 is an initial spontaneous report received from a health care professional on 04 Nov 2013. This report refers to a 12-year-old female patient. She was vaccinated with MENVEO, (batch number: M11081) intramuscularly on an unspecified date. On 08 Oct 2013, she experienced redness, swelling and pain at injection site. She also had big red welts on arm, hot to touch with golf ball to orange size. Outcome of the events was unknown. No seriousness and causality was reported.
chest tightness and SOB lasting seconds; acute elevation of blood pressure that trended to normal over 20 minutes
Injection Site pain; Tiredness; Headache; Muscle Pain; Feeling Unwell; Feeling Feverish (but no fever); This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Mar2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included ards (acute respiratory distress syndrome) survivor and reactive airways disease. The patient had known allergies to mild latex allergy ((rash/hives). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 21Mar2021 at 01:00, the patient experienced injection site pain, tiredness, headache, muscle pain, feeling unwell and feeling feverish (but no fever). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of events of injection site pain tiredness, headache, muscle pain, feeling unwell and feeling feverish (but no fever) were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
It was reported that a 73 year old male patient received a Fluzone SV 2001/2002 vaccination, administered on 10/8/01. On 10/24/01 the patient was seen in physician's office with a cystic like area at the injection site 1.3"x2" area. This reaction is currently unresolved.
Last evening cranky, warm T 101.5 rectally. Noted to have redness and swelling on right thigh where varicella 11 days earlier. This was not there before. Today (9/21/10) still sl. fever area sl. less red & swollen. She is scratching it, too.
Early cellulitis - warmth, swelling in the arm, mild redness. pain in the arm up to the neck started 2 days after injection. Treated 3rd day with OTC antihistamine and analgesic. Treated 4th day with ZPAK - pt reports she tolerated the abx since she had other abx med allergies.
No observed problems at the time of the booster shot (just like with shot 1 and 2)
Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational study under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3952AA received on 09 December 2011, lot number C4130AA received on 01 February 2012 and lot number C4081AA received on 24 April 2012 (routes and sites of administration not reported). The subject developed a cough on 03 May 2012, approximately 9 days after the last dose and a paroxysmal cough on an unspecified date with a whoop. The subject also experienced posttussive vomiting. Laboratory testing included negative PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
2 months old baby received Engerix-B adult formulation by error; 2 months old baby received Engerix-B adult formulation by error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: 2 months old baby received Engerix-B adult formulation by error) and accidental overdose (Verbatim: 2 months old baby received Engerix-B adult formulation by error). The outcome of the adult product administered to child and accidental overdose were unknown.   Additional Information: GSK Receipt date: 02-AUG-2023 A pharmacist tec reported that he/she noticed that 7 months ago from reporting, probably back on December or November, a 2-month-old baby received Engerix-B adult formulation by error, which led to overdose and adult product administered to child. The patient was okay.  The reporter consented to follow up by email.
pt rcvd vax; pt devel abdominal pain & mild fever; joint pain; muscle aches & fatigue; pt was treated w/ methylprednisolone;
Cellulitis of the left arm, encompassing the entire upper arm. Flu like symptoms such as fever, chills, body aches, malaise, headache and nausea. Given clyndamycin 300mg four times a day for 10 days and bactrim twice a day for 15 days, also vicodin for pain.
Patient was leaving the store 10-15 minutes after his vaccine when he had to sit in the aisle. He was unable to get back up and emergency services were contacted. He was transported to Hospital and released three days later. He had low blood pressure but no other pertinent findings according to his wife.
Information has been received from a nurse concerning a 30 or 31 year old female with a history of pneumonia and "MA" who on 12-OCT-2010 was vaccinated with PNEUMOVAX 23 syringe for prevent pneumonia, and other flu vaccine in the other arm (manufacturer unknown). The patient felt that the injection really hurt. On 14-OCT-2010 the patient developed a high fever of 103 degrees. Patient went to her doctor on the 14-OCT-2010. The nurse reported the doctor stated this might be an infection; it was red and swollen with indurations at the injection site (onset date 12-OCT-2010). Follow up information on 18-OCT-2010 the nurse reported that patient did require hospitalization. Her white blood cell count was extremely elevated. The nurse reported that the infectious disease doctor said it was the vaccine. Nurse also reported she thought it was the PNEUMOVAX 23 because that was the arm that was swollen. Patient had received the Flu vaccine in the other arm at the same time. Additional information has been requested.
Complained of pain in Right leg, could not stand correctly while keeping her balance. She "limped" for 3 weeks. She could not run at all. She also had some sort of "virus" I was told that caused bleeding from her gums.
Sedation, Myalgia, Arthralgia, NauseaVomiting, Chills, nasal congestion Narrative:
Information has been received from a consumer concerning his daughter who in October 2009, was vaccinated with the first dose of GARDASIL (dose not reported).  On unknown dates, the patient received the 2nd and 3rd dose of GARDASIL (doses not reported) (lot #s 661841/0653X, 661846/1312X and 663452/0671Y;  unspecified the schedule in which each lot # was administered).  On an unknown date, the patient experienced a seizure after receiving GARDASIL.  The patient's outcome at the time of the report was unknown.  It was unknown if the patient sought medical attention.  In follow-up the patient's father did not provide any further details or contact information.  This is one of two reports from the same source.  A lot check has been initiated.  Additional information is not expected.
Was 32+2 weeks pregnant at first dose. Developed preeclampsia after vaccination and 2 weeks later delivered baby at 34+4 due to severe preeclampsia. Due date was July 5th. First vaccine was May 12th. Preeclampsia diagnosis on May 21st. Delivered baby on May 28th due to severe features of preeclampsia.
Patient was here for 2 nd Covid Vaccine. She did not bring her vaccine card with her but she  stated she got Pfizer vaccine. She also completed Consent Form and marked "Pfizer" vaccine to be administrated. Therefore, she received a Pfizer vaccine today. However, we found out that she received Moderna as a 1st dose 4 weeks ago. I reported  and spoke with State Covid hot line and CDC hot line representative. I was told she is considered as fully vaccinated and no further vaccine needed at this time. Patient was informed about this event and verbalized understating.   Patient was monitored  for another 20 mins at clinic and there was no adverse reaction.
Pt. had swelling erythema from her elbow all the way up to her shoulder.
breathing diff,tightness in chest w/wheezing w/in 4hrs of vax;tx w/breathing treatment & IV DPH & Pred;
Patient reported neck muscle spasms approximately 30 minutes after vaccination, followed by foot/leg muscle discomfort later that evening. By Friday (12/24/21) morning, she felt she could barely walk, with the right side worse than left side. She also reported that the outline of her tattoo had raised up. She reported this to pharmacist 12/27/21 around 2:00pm, and reported that she had not seen any improvement over the weekend, and her left side was starting to get worse. Pharmacist recommended patient call her primary care physician.
Very very ill with the last shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very very ill with the last shot) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very very ill with the last shot). At the time of the report, ILLNESS (Very very ill with the last shot) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2022: No new information received.
VACCINE ADMINISTERED TO PATIENT FROM A VAIL OPENED FOR MORE THEN 6 HOURS; VACCINE VIAL OPENED FOR MORE THAN 6 HOURS STORED IN REFRIGERATOR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-JAN-2022 14:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine administered to patient from a vail opened for more then 6 hours, and vaccine vial opened for more than 6 hours stored in refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient from a vail opened for more then 6 hours and vaccine vial opened for more than 6 hours stored in refrigerator was not reported. This report was non-serious.
Never again shoulder pain for over two months; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who experienced shoulder pain (Arthralgia), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  In first week of October (year unspecified), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site.   The reporter stated that he/she got the flu shot in the first week of October. It was the concentrated version for people over 65. Never again shoulder pain for over two months (Arthralgia).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information about the batch number in this case.
7 month old patient was returning to get their 6 month shots. Patient was suppose to get the 3rd dose of Vaxelis (contains DTaP, inactivated poliovirus, Haemophilus influenzae type b, and hepatitis B vaccine). Due to stock issues, MA   administered two doses of Pentacel (contains DTaP, inactivated poliovirus, and Haemophilus influenzae type B vaccine), one dose of hep B, and one dose of Prevnar instead.
This is a 70y.o.female with a history of hypertension, hyperlipidemia, diabetes, previous stroke, atrial fibrillation who presents secondary to weakness, abdominal pain, nausea, and vomiting. Her symptoms have been progressively worsening over the past couple of days. She also reports a dry cough. She is unable to tolerate oral intake secondary to vomiting. States she is vaccinated for COVID 19 Found to have fever of 100.2  Tachycardic with heart rates in the 100s.  COVID 19 positive. Abdominal x-ray, chest x-ray, UA, blood cultures are all pending Started on IV fluids.
Information has been received from a 60 year old female patient who was not pregnant with allergy to loratadine (CLARITIN) concerning herself. The patient's concurrent conditions included diabetes, high blood pressure, high cholesterol and bronchitis. Concomitant therapies included metoprolol, vitamin D, sacubitril, valsartan (ENTRESTO) and atorvastatin. On 11-JUL-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were unknown), for prophylaxis. On approximately 10-AUG-2017 (reported as two weeks ago), the patient experienced symptoms of diarrhea. On approximately 13-AUG-2017 (reported as a week and a half ago), the patient experienced a mild skin rash. On an unknown date, the patient performed unspecified lab diagnostics. The patient did not seek medical attention and did not receive any treatment. The outcome of the events was unknown. The reporter did not assess the causality.
Chicken pox vaccine adm on 7/29/08 and pt dev fine red spots on abd, chest, back & face on 8/3/08 - seemed to spread on 8/4/08 - to date none have crusted over.
had fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (had fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0326210A, 037U21A and 021F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), MAGNESIUM, LISINOPRIL and MELOXICAM for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-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 FATIGUE (had fatigue). At the time of the report, FATIGUE (had fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: 756 (High) Showed 756 level of antibodies on SARS-COV-2 S protein quantitative test.. On 08-Dec-2021, SARS-CoV-2 antibody test: 246 (Low) Showed a level of 246 on SARS-COV-2 S protein quantitative test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Symptoms: It was reported that the patient experienced event where her antibody levels were dropped to low level than they were prior receiving booster dose of Moderna COVID-19 vaccine, she wanted to know if she had to revaccinated.   No treatment medications were reported