chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 03 October 2011 from scientific literature. Verbatim from the report: "A 68-year-old woman was referred for a 2-year history of an enlarging lesion on the right arm that developed several days after administration of the PNEUMOVAX 23 vaccine. She was healthy with no fever, malaise, or weight loss. The lesion began as a tender erythematous papule at the site of vaccination and increased in size with development of additional sites of involvement. Bacterial and fungal cultures, tuberculin skin testing, blood interferon-gamma release assay for tuberculosis, blastomycosis and coccidiomycosis serologies, cryptococcal antigen, and histoplasmosis urine antigen testing were all negative. Treatment with rifampin, azithromycin, and moxifloxican was initiated for presumed atypical mycobacterial infection without effect. Physical examination revealed a large (20 by 20 cm) erythematous plaque, with multiple hyperkeratotic papulonodules, involving the right arm (Fig 1). On the opposite arm, forearms, thighs, face and ears, there were erythematous macules coalescing into larger patches with overlying scale. Lymphadenopathy was absent. A biopsy specimen of the right arm revealed a mixed dermal infiltrate of foamy histiocytes, plasma cells, lymphocytes, neutrophils, and large pale histiocytes with feathery borders demonstrating emperipolesis (Fig 2, A). The large histiocytes were S-100 positive (Fig 2), B and CD1a negative. There was no evidence of microorganisms on acid-fast bacilli, Gram, and periodic acid Schiff stained sections. Previous biopsy specimens from multiple smaller lesions demonstrated similar findings. No lymphadenopathy was noted on a computed tomographic (CT) scan of the abdomen, chest, and pelvis. Over the course of 3 years under our care, the patient has shown partial improvement with multiple therapies, including topical, intralesional, and systemic corticosteroids; dapsone; isotretinoin; and liquid nitrogen cryotherapy." "In summary, our patient developed CRD after pneumococcal vaccination. As the eruption was temporally related and initially localized to the site of injection, we believe that an exaggerated immunological response to the vaccination is a likely cause for this case of CRD. Although, to our knowledge, RDD occurring post-vaccination has not been described previously, there has been a case of exaggerated antibody response in a child with RDD following rubella vaccination. Our experience suggests that vaccine-induced immune stimulation may provide an alternate trigger for inducing CRD." Documents held by sender: none.
I am not sure if the TDAP was Boostrix or something else. it is not noted on my online chart.  My arms had the typical soreness, nothing too bad, but the day after shots, I had severe pain in my groin area (specifically where the legs connect to torso) - had difficulty moving to put on pants and I had neck stiffness. The groin pain eventually stopped (although I feel still that my hips are not working properly when I walk) but more than a week later, I am still having difficulty with range of motion in my neck, specifically when I turn my head to the R. Some days are better than others, but yesterday I couldn't turn my head more than 1/2 inch without pain. This makes driving (and everything else) extremely difficult. I saw my dr a few days ago and she suggested I file a report. I saw my chiropractor today and he felt everything was tensed up. He and the PT I see at his office said that many of their patients had similar side effects after a tetanus shot.
diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 12Mar2021 13:00 (Lot number: EN6206) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Cholesterol" (ongoing); "Vitamin supplementation" (ongoing). Concomitant medication(s) included: ONE-A-DAY [MINERALS NOS;VITAMINS NOS] taken for vitamin supplementation (ongoing); BAYER ASPIRIN (ongoing); PRAVASTATIN taken for blood cholesterol abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose 1: Administered 19Feb2021, Time: 13:00, Lot: EN62 - caller verified this lot number documented in the CDC vaccine), administration date: 19Feb2021, when the patient was 65 years old, for covid-19 immunisation, reaction(s): "had no problems"; Flu shot (AE(s) following prior vaccinations: None), administration date: Sep2020, when the patient was 64 years old, for immunization, reaction(s): "none". The following information was reported: DIARRHOEA (non-serious) with onset 12Mar2021 15:00, outcome "recovered" (13Mar2021), described as "diarrhea". Additional information: The vaccine was administered on the left arm at the shoulder part at about 13:00-13:15. The patient's sister died of cancer about 1.5 years ago.  No follow-up attempts are possible. No further information is expected.
Attendee received first dose Pfizer vaccine at 16:44 in the left arm.  Lot# EW0182. Attendee was directed to observation area.   At 16:49 attendee passed out in her chair and her mother called for a nurse.  Attendee's skin was Diaphoretic. Attendee's respirations were not tachypneic or dyspneic.  Attendee assisted to the cot to lie down, legs elevated. Icepack applied to face and neck.  16:50  EMS called. Unconscious x 1 minute. Aroused to alert and oriented. HR:  62   BP:  188/88   RR:   16   O2Sat%:  98   Temp:  97.3 Oxygen Sat probe left on attendee HR 60-62 and O2 Saturation 98  100.  16:57  EMS arrived and took over care of the attendee.   17:02 -  EMS transported attendee to Hospital per mom's request.
FLU LIKE SYMPTONS FOR 2 DAYS, THEN MIGRAINES, BACK OF HEAD PAIN, SWOLLEN FACE, FOR 4 DAYS. WENT BACK TO PHARMACIST AFTER FLU SYMPTONS WHO TOLD ME TO TAKE 2 BENEDRYL AND IBPROFEN EVERY 4-6 HOURS. ARM AT INJECTIION SITE TURNED VERY RED AND ITCHY. WITHIN 10 DAYS OF RECEIVING THE INJECTION I HAD A SHINGLES OUTBREAK AND IMMEDIATELY STARTED VALTREX.  iT WAS GONE IN 5 DAYS. THE FIRST INJECTION OF THE SERIES BASICALLY HAD NO SIDE EFFECTS OTHER THAN A SORE ARM.  IF I HAD ANY CLUE I WAS GOING TO BE THIS SICK WITH THE 2ND INJECTIION I WOULD NOT HAVE TAKEN IT AND I HAVE TOLD EVERYONE NOT TO DO IT. I WAS SO VERY SICK.
No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine; A VFC contacted them and let them know what happened and that the product was actually received 2 days late/No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 03-NOV-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T014309 and expiration date 24-APR-2022 administered as prophylaxis.  The improperly stored doses of the suspect vaccine experienced a temperature excursion on 27-OCT-2020, the reporter stated that the VFC contacted them and let them know what happened and that the product was actually received 2 days late. The temperature excursion was at an unknown temperature for an unknown timeframe; no previous temperature excursion were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several reports received from the same reporter.
Copious mucus in back of throat. Headache. Nausea. Stomach ache. Weakness in arms and legs. Numbness in fingers and face. Severe pain in calf muscles, both legs, resulting in difficulty walking and using stairs both up and down. Most symptoms subsided after 2-3 days. Leg pain continued for one week.
I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking straight, can?t think in depth (it?s challenging to write graduate level papers); have to absolutely sleep 8-12 hours a night otherwise, I cannot function well with multi tasking as I did before the vaccine;   Thirsty a lot more than usual, coughing sore throat  (maybe this is normal w/the vaccine, I?m not sure). Today at 9:00pm,  I realized that I lost my sense of taste. I ate a pizza and could not taste it. I am able to taste really sweet juice with my taste buds near the back of my tongue.  This was something different today which is why I wanted to report. It does not feel like it is life threatening. Just uncomfortable to deal with.  I?m so glad that I received the vaccine. If this is all that happens to me then , I am thankful for being alive and just having to deal with these discomforts while the vaccine is working through my system.  Just note the symptoms maybe this is something in common with other people too.
Bilateral tinnitus began 5-6 weeks after the Moderna COVID-19 booster; continues to persist.
Paresthesia and prolonged pain in the Lt arm. Left carpal tunnel and swelling of the left lateral wrist.
Pharmacist administered Engerix-B 10mcg/0.5ml child/adolescent dose instead of Engerix-B 20mcg/1ml adult dose to the left deltoid. Patient will come in 5/22/2023 evening to receive an adult dose Engerix-B 20mcg/1ml.
1st dose: on the second day 7/10, patient has a fever, headache, then he complains about chest pain and difficulty breathing. He describes the chest pain as the two bullets shooting through the two sides of the chest. He takes rest for more than a week.  2nd dose: on the second day 7/31/21, patient has a fever, neck pain, and headache. He slept for more than 24 hours. After he wakes up, he complains he has chest pain and difficulty breathing. Since then he has had chest pain and difficulty breathing till now.  About 6 pm on Oct. 27, 2021, patient faints during the swimming practice. At about 11:30 am on 10/28/21, he experiences severe abdominal pain at school and is sent back home earlier. Since then he is very ill and has not been able to return to school. On the night of 11/5/2021, he runs less than 1/2 miles and he experiences faints again.
Wed had shaking, fever. Thursday, not feeling great started to get a rash around the injection site with itching. Friday still running a fever, rash was raised with itching, like hives. It continued on Friday. The rash spread down almost to the elbow. Spoke with pharmacist, suggested she take Benadryl. Hot to the touch with itching. Yesterday, still  had rash. Today, still hot to the touch, itching or fever.
Information has been received regarding a case in litigation. A consumer with hypothyroidism reported that she in September 2007, was vaccinated with a first dose of GARDASIL vaccine (lot number, injection site and route not reported). In December 2007, the patient was vaccinated with a second dose of GARDASIL vaccine (lot number, injection site and route not reported). In March 2008, the patient was vaccinated with a third dose of GARDASIL vaccine 0.5 mL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included NUVARING and levothyroxine. The patient reported she had a normal PAP smear prior to the vaccination. In the beginning of June 2008, the patient had a positive HPV test with squamous dysplasia. The test included HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. The patient sought unspecified medical attention. The patient's events persisted. This is case 1 of 2. Additional information has been requested.
varicella outbreak after immunization given. Pt admitted for IV acyclovir x 4 days.  Continued out pt acyclovir x 3 more days.   See pt summary.  Pt starting school in Aug 2004  Nurse follow up on 06/18/04 states: "Add: headache, pain."
Benign paroxysmal positional vertigo; Slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG207) via an unspecified route of administration in the left arm on 19Mar2021 at 08:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 11:00, the patient experienced benign paroxysmal positional vertigo, including slight nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of benign paroxysmal positional vertigo, including slight nausea included treatment with exercise similar to epley manoeuvre. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events benign paroxysmal positional vertigo and slight nausea was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recv vax 23OCT96 & approx15min p/vax began to devel sx & was seen in ER;4hr p/vax face, tongue, lips & throat were swollen;30JAN97 has outbreaks of hives w/swelling of throat unless on med;recurrent allerg sx
received 2nd dose almost 4 months later; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient have not experienced any known symptoms and not received any treatments. no concomitant medications are provided, treatment to the events not reported.
After the first dose, I had headaches that did not respond to medication (excedirin, Motrin or norco) that lasted for about 2 1/2 weeks. I also had deep fatigue that lasted for about the same amount of time. After the second dose, I had fever, chills, rigors & body aches That started around 9 PM same day and ended at 5 AM the next day. With a second dose I also had persistent headaches and deep fatigue for about three weeks. I started developing heart palpitations in June 2021. It started with multiple palpitations per hour for a couple of months and then they started to decrease.  They finally stopped in May 2022.
Our facility only has the capability to store COVID19 vaccines in the refrigerator. Patient was given a vaccine that was outside of the 10 week expiration window. The 10 week expiration date was 6/10/22, patient was given vaccine on 6/22/22. Patient has not reported any adverse events or symptoms to our facility.
9/25/21-Episode onset: 5 days ago. The problem occurs hourly. The problem has not changed since onset.The cough is productive of sputum. There has been no fever. Associated symptoms include chills, headaches, rhinorrhea, myalgias, shortness of breath (increased from baseline) and pleuritic pain (left). Pertinent negatives include no chest pain, no sweats, no ear pain, no sore throat and no wheezing Exposure to covid through a child at her grandsons sporting event Positive for chills and malaise/fatigue. Negative for fever.  HENT: Positive for congestion and rhinorrhea. Negative for ear pain and sore throat.   Respiratory: Positive for cough, sputum production and shortness of breath (increased from baseline). Negative for wheezing.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Positive for diarrhea. Negative for abdominal pain, nausea and vomiting.  Musculoskeletal: Positive for myalgias.  Neurological: Positive for headaches. Negative for sensory change.  Covid positive today. No evidence of pneumonia on chest x-ray per my review however patient with increased shortness of breath, pleuritic pain, productive cough so will treat from a preventive standpoint as patient is very high risk for developing pneumonia. Patient does meet criteria for Regeneron infusion. Discussed with patient who is agreeable to have infusion. Discussed CDC isolation guidelines and advised to follow. Encouraged to continue supportive care. Patient advised to go to the emergency room for any worsening symptoms which were discussed in detail. Patient verbalizes understanding and agrees with treatment plan.   9/26/21-Regeneron infusion
1 day post vax developed generalized rash & rt flank pain; Resolved in two day & the flank pain resolved in five days; Pt subsequently recovered;
3-4 hours after second dose, started having facial drooping, facial paralysis and watery eyes on right-side of face. The next day she came to clinic for treatment (antivirals and steroids).
Loss of function of both hands, weakness, numbness. Loss of fine motor control in both hands. Tremors.
Nausea, headache, achiness all over, redness and pain at site of Pneumonia vaccine.
lt leg swollen red & hard lump;pt cried very frequently for 3 days;sl relief w/APAP;
stated she gave an expired Tenivac vaccine to a patient today with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse on 27-Oct-2020.  This case involves an 87 years old male patient who received an expired dose of vaccine (expired product administered) DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6091AA, Exp date:12-Oct-2020 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, 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 holder's 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.
Symptoms included fever, nausea, fatigue, headache, chills - confusion, uncontrollable body shaking in legs and arms -
Flushing, itching, chest tightness, and dyspnea immediately after flu vaccine administration.  Received single adult epinephrine autoinjector.  Oxygen 15-10 LPM via nonrebreather mask.  Patient was transported to Medical Center via ambulance. 10/21/08 Reviewed hospital medical records of 10/9-10/2008. FINAL DX: acute allergic reaction to flu shot Records reveal patient experienced hives, itching, SOB, wheezing, throat tightness & chest pain.  Tx w/epi, nebs, Benadryl & steroids.  29 weeks pregnant.  No reaction on prior flu shots.  Admitted for fetal monitoring overnight. D/C to home on continued antihistamines.
ARMS ACHE; HIP ACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced arms ache. On 09-JUN-2021, the subject experienced hip ache. On 09-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, arms ache and hip ache was not reported. This report was non-serious.
blood clots; covid 19; Initial information received on 20-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional via social media.  This case involves an adult patient of an unknown gender who experienced blood clots and covid 19 ,while receiving vaccine Influenza Vaccine.  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 of suspect Influenza vaccine produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient  reported  they had their shots then got 2 blood clots 4 months later(thrombosis)(latency:4 months) then 2 months after that covid-19 (latency: 6 months) then a month later another clot. Now the patient is on warfarin for life. The patient was healthy before then. The patient had 3 hospital stays totaling 7 days. Doctor said no booster for the patient.   Action taken: not applicable for both events   corrective treatment: warfarin for thrombosis.  At time of reporting, the outcome was Unknown for the event blood clots and was Unknown for the event covid 19.  Seriousness criteria: medically significant and hospitalization for thrombosis and hospitalization for covid -19; Sender's Comments: Sanofi company comment dated 30-Jan-2022: This case concerns an adult patient of unknown gender who had thrombosis and hospitalization , after vaccination Influenza vaccine (manufacturer unknown). The time to onset is compatible with the role of the vaccine. However the lack of information regarding past drugs, relevant medical history, concurrent conditions, psychiatric history, personal history, therapy details, latency and concomitant medications preclude a comprehensive assessment of this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.