chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 60 years old female patient without drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot # reported as H011426, expiration date 12-SEP-2013) on 29-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-OCT-2012 the patient experienced local injection site reaction after receiving ZOSTAVAX. The patient started having symptoms of pain, redness, swelling and warm to touch on 01-OCT-2012. No treatment for the adverse event. The outcome of event was reported as not recovered/not resolved. The patient had sought unspecified medical attention via calling pharmacist. Additional information is not expected.
Information has been received from a consumer referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with doses of GARDASIL (lot#, dose, dose# and route unknown) for prophylaxis. It was reported that the vaccine destroyed health in turn happiness, educations, athleticism, mental health, happiness, bodies and families. This vaccine was deadly and it inflicted a suffering so sever children were becoming suicidal because they could not live with the everyday pain and suffering. The outcome of the events was unknown. Upon internal review, the event becoming suicidal was considered to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected since there was no contact details provided.; Sender's Comments: US-009507513-1604USA014045:
Fever and excessive shaking, then a cardiac crisis. Heart rate exceeded 160 bpm and BP exceeding 200/118. This lasted roughly 20 minutes before wife administered a dose of her nitroglycerin. After several minutes the BP and HR began to come down and normal BP was restored within 2 hours.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 at 13:30 as dose 4 (booster), single (Lot number: GJ6738) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD s/9 6 vessel CABG" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment was Paxlovid.
Expired Vaccine given to patient- Parent notified that patient will need a additional dose due to the expired vaccine not being a valid dose.
Narrative:  Patient passed away peacefully at his home following battle with Alzheimer's Disease. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine
could hardly move; vomiting; chills; she took blood thinners; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "could hardly move"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; CHILLS (non-serious), outcome "unknown", described as "chills"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she took blood thinners".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Evening after shots were given (12-0-11) child had uncontrollable crying x 1 1/2-2 hrs with mild seizure. Parent took to ER. Pediatrician called by parents - he things reaction to pertussis. Child did not have fever.
LEFT THIGH WITH SLIGHTLY RAISED ERYTHEMATOUS PATCH APPROX. 3X4CM; NO WARMTH, NO PAIN WITH PALPATION; (+) PRURITIS.
not sure if related but interesting.  day after 1st shot i started having right side back pain. i referred to it as kidney pain to describe.  have the pain still today, 03/07/2021.  skin numb, itchy some pain.  then last night 03/06/21 i noticed a patch of bumps (?) on right side 2 inches long 1 inch wide.  i happened to look up symptoms of shingles and i think it is.  still mild at this point. had a vaccine for shingles several yrs ago.
Information has been received from a consumer concerning about her 24 weeks old son (currently 36 weeks old) who in July 2011 and November 2011, was vaccinated with 2 ml a first and a second doses respectively, of ROTATEQ (Lot # and route unknown). The consumer report that her son received his first dose at 2 months old and got the second dose at 6 months old (in November 2001). At the time of the report the baby was 9 months old and it was too old to received the third dose of ROTATEQ. There was no adverse reaction reported. Additional information has been requested.
Patient had onset of urticaria shortly after vaccine was given.  Seen in ER the following day & received Depo-Medrol 40mg IM.
Had no side effects with first two shots and first booster.. Got second booster this past Monday (6 months after first) and had extreme muscle and joint pain, fever, chills, and dizzy on day after my second booster.  Lasted about 1 1/2 days but the dizziness has remained.
Delay in menstrual cycle of 11 days; This is a spontaneous report from a contactable consumer, pfizer employee. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration in the left arm on 22Apr2021 at 15:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient's medical history reported was not applicable. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (LAMICTAL) and lurasidone hydrochloride (LATUDA); both from an unknown date and unknown if ongoing for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 31Mar2021 at 15:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient previously received cefaclor (CECLOR) and experienced drug allergy. On 03May2021 at 00:00, the patient experienced delay in menstrual cycle of 11 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event delay in menstrual cycle of 11 days was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 21-MAY-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-FEB-2016 the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Diaphoresis, Nausea, Headache, Projectile Vomiting, difficulty concentrating.    She has improved today (12/19/2019) although is not yet feeling fully recovered.
Pulmonary embolisms. Many clots in the lungs. Currently being treated with blood thinners. Developed a major cough and pain in my back, shoulder and chest. About 6 days of experiencing this I went to the ER and they found I had clotting in my lungs.
Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19,  then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose
This spontaneous report as received from nurse practitioners refers to a patient of unknown age and gender. No information provided regarding concurrent conditions, medical history and drug reactions/allergies reported. On 21-MAY-2014 the patient was vaccinated with GARDASIL dose 2 (dosage, route, lot# not reported). Prior to this the patient also was administered with first dose of GARDASIL on 31-JAN-2014. No concomitant medications reported. No adverse effects reported. Additional information has been requested.
Fever or Chills  Cough  Muscle or body aches  Headache  Sore throat  Congestion or running nose
Excessive crying- "a different cry" after vaccine 1/7/02;  Excessive sleeping 1/8/02 & went 12 hours without nursing.
Received Fluzone HD vaccine on 11/18/19. Two days later, migraine-like headache with change in eyesight, nausea, weakness, followed on 11/21/19 by chills, diarrhea (initially bloody), stomach pain, stuffy nose, bleeding/burning shoulder cyst, rectal burning requiring Anusol suppositories, achy joints, fatigue - all continuing through 11/27/19.
pt recv vax & mom states less alert & more active;could have had a staring sz;mom noticed later that day T102;took to ER;mom states was vomiting also for a long period of time approx 1mo per mom;
Asthma attack began about 20 minutes after injection, with throat tightening, slight mouth swelling sensation and immediate wheezing which grew progressively worse.  I had my inhalers (Levalbuterol and Flovent) with me, used Levalbuterol at the direction of medical people who surrounded me after I reported wheezing.  They gave me a Benadryl, then brought a wheel chair and sent me directly to the ER.  I was there about 3 hours during which I had a heart monitor,  a "breathing treatment" by a respiratory therapist, and DUONEB, famotidine (PEPCID), and (DELTASONE). I was given a 3 day Rx for 20 mg. of prednisone, and released.  My lungs felt "twitchy" the next day and my voice was muted, but was well otherwise.   The only "normal" side effect I had was some soreness at the injection site for a couple of days, with some light sensitivity there for a few weeks.
Edema and erythema of the right deltoid and tricep. PT prescribed Benadryl pt states that it reduced swelling. Pt denies any other Sx
I am 32 and am having a shingles outbreak. I have never had shingles before getting the COVID vaccine. I?m not sure if the vaccine increases the chances of getting a shingles outbreak, but thought i should report. I also expressed flue like symptoms after both vaccines. My joints where in extreme pain for 24 hours after the second vaccine. I also have not had a normal circle after and clotting after the second vaccine.  I did see my doctor about the shingles and was prescribed valacyclovir.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. A 26 year-old male subject with a past medical history of chest pain, chest pressure, shortness of breath, asthma and psychiatric illness was diagnosed with "other and unspecified acute pericarditis" on 30 April 2014, 22 days after the subject had received the following vaccine on 08April 2014: an injection of ACAM2000 (lot number and site of administration not reported. On 07 May 2014, "acute pericarditis unspecified" was diagnosed; and on 08 May 2014, "Unspecified disease of pericardium" was diagnosed. Troponin I was not performed. On 30 April 2014 an ECG was abnormal and on 08 April 2014 an echocardiogram was normal. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
swollen arm pit and its painful/swollen armpit; swollen arm pit and its painful; injection site is tender; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization, reaction(s): "my arm was heavy and painful to lift"; Bnt162b2 (Second dose), for Covid-19 Immunization, reaction(s): "my arm was heavy and painful to lift". The following information was reported: SWELLING (non-serious) with onset 10Feb2022, outcome "unknown", described as "swollen arm pit and its painful/swollen armpit"; AXILLARY PAIN (non-serious) with onset 10Feb2022, outcome "unknown", described as "swollen arm pit and its painful"; VACCINATION SITE PAIN (non-serious) with onset 10Feb2022, outcome "unknown", described as "injection site is tender ".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from a nurse on 15 October 2015. This case involves a 05-years-old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI446AA, expiry date: 30 June 2016, dose, dose in series were not reported)  intramuscularly in left deltoid on 08 October 2015. Illness at time of vaccination was reported as unknown, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as cashews and pistachios and any other vaccinations within 4 weeks of vaccinations was reported as none. Concomitant medications were not reported. On 08 October 2015, same day following the vaccination, the patient had developed blister reaction in left arm with several small blisters with warmth and induration at the injection site. It was reported that smaller blisters were clear filled. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment were not reported. The patient was not recovered from the events. Follow-up information received from a nurse on 21 December 2015. It was reported that patient was vaccinated with 0.5 ml dose of FLUZONE QIV. The patient required doctor visit. Patient was treated with Benadryl and cool compress as corrective treatment. On an unknown date patient recovered from all the events. List of documents held by sender: none.
very itchy; Have some bumps on my skin; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (very itchy) and SKIN MASS (Have some bumps on my skin) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy) and SKIN MASS (Have some bumps on my skin). At the time of the report, PRURITUS (very itchy) and SKIN MASS (Have some bumps on my skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported . The patient was very itchy and had some bumps on my skin.
Patient passed out, resulting in her to fall and hit her head on the stove on her way down. She was pale and came back to within less than a minute. She stated she felt dizzy before she passed out. Once she was able to sit up we applied ice to her head due to a lump from hitting her head and only two minor scratches on her scalp that we cleaned well. We gave her something to eat and drink when she was able to sit up and we knew she was alert  enough to eat. She began to feel better after this.
I had a massive stroke at work a few weeks after the 1st vaccine shot. Rushed to hospital for emergency surgery to remove blood clot in right side of brain. My paralysis was reversed after surgery but lingering headaches exist.
Three hours after immunization, right leg was swollen and hot and cried continuously and color "wasn't right" for several hours. Slept well. the next day seemed ok, but was not his usual self". Mom was very concerned (Probable local reaction). After receiving Dtap, Hib, and IPV pt became ill. He had less PO, appeared pale, threw up once and was "not himself". Mom reported it at the next visit- 7/10/02. It lasted only 24 hrs.
Case number PHEH2013US023423 is an initial spontaneous report received from a pharmacist on 06 NOV 2013. The report refers to a 24-year-old male patient. He received FLUZONE (other manufacturer and batch  number unknown) in SEP 2013. He was further vaccinated with FLUVIRIN 2013/2014 (batch number: 13372P) intramuscularly on 06 NOV 2013. No adverse event was reported following medication error (inappropriate schedule of vaccine administered).
A 59 years old patient was administered Fluzone High Dose Quadrivalent, No AE; A 59 years old patient was administered Fluzone High Dose Quadrivalent, No AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.   This case involves a 59 years old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other medications or vaccines had been administered to the patient.   On 01-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AA, expiry date: 30-Jun-2021) once via unknown route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration. It was also a case of an overdose (latency same day).  The reporter wanted to know the recommendations for a patient that was younger than 65 receiving Fluzone high dose Quadrivalent.  At the time of reporting, no adverse event 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.
5ml syringes that had been provided by local Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/23/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
I did not feel particularly lightheaded or dizzy, but I passed out in my kitchen while preparing breakfast at approximately 7:30 AM on the morning following my vaccination
got sick with a flu shot; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (patient) via Social media on 20-Nov-2020.  This case involved a patient of an unknown patient who got sick with a flu shot (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got sick with a flu shot (Illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
8/16/07 Hib #1 (VF086AA0, inconsolable within 30 minutes, lasted 14 hours, gave Tylenol at 11;30pm (at 12 1/2 hr) with resolution sx; no Tylenol prior. No prior or other vaccines given.
Following the flu shot, in the left arm, for the next 48 hours, the upper left quarter was so painful that I could not move my arm or even breath without pain. There were no other symptoms - no temp, no nausea, etc.
extreme lethargy for 3 days-pt only woke once for feedings on 3 days subsequent to vax-mom did not seek medical call-brought to my attention today @ subsequent well pt visit; pt recovered uneventfully;
patient developed COVID 2.5 weeks after the J&J vaccine. I was told by the ID team to report this. We are obtaining a genotype
Fever 102 with congestion and cough followed by seizure for 5-15 minutes, taken to ER.  Intubated for 2 days, given clindamycin, keppra, amoxicillin, ibuprofen and acetaminophen.  Discharged on 11/6/09  12/01/09 Medical records and discharge summary received for DOS 11/3-11/06.  Final DX: New onset seizure. Fever 102,  L eye blinking,  R eye open, shoulder shrugging. Unresponsive. x5-15 min.  Flu vaccine day before. Tachycardia, tachypnea. Intubated. Temp dropped to 95, increased w/ warm blankets.  Max temp 105.  Additional 5-10 sec seizure overnight. Back to baseline after.  D/C to home.