chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported feeling dizzy, shivering, and a large red, painful spot at injection site. In addition, she has a similar red, painful rash on her right hand (on top and wrapping around the thumb). She has a smaller reaction on the left hand wrapping around her hand as well, but not painful.
Caller stated she received the first Pfizer covid vaccine and had a "bad reaction" and blocked memory; This is a spontaneous report from a non-contactable consumer (Patient).  A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date unknown), via an unknown route of administration on unknown date, 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she received the first Pfizer COVID vaccine and had a bad reaction and blocked memory. Patient did not further elaborate and unable to clarify and was abruptly disconnected due to telephone issue. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing), notes: The caller also has a heart condition. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2021, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jul2021) positive. Therapeutic measures were taken as a result of covid-19. Then on 23Jul2021, she received the monoclonal infusion. The patient wanted to know when she should get the booster dose since she already had 2 doses of the vaccines and an infusion. The patient clarified that because of her heart condition she had the monoclonal infusion treatment done after she tested positive for Covid. Because the patient has had the Covid shots and the monoclonal infusion she did not know how much time she should wait until she could get the booster dose. The patient tested positive for Covid on 20Jul2021 and received the monoclonal infusion on 23Jul2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Hospitalized 5/30-6/10 for altered mental status following recent bacterial sepsis and atrial flutter, discharged to hospice, died 6/16. Primary cause of death acute respiratory failure, underlying cause COVID-19 pneumonia
Information has been received from a legal firm concerning a minor male child who on 6/9/98 at 12 month of age was vaccinated with MMR (second generation) (batch not reported). It was reported that before the patient was a month old, he was given his first vaccination (therapy unspecified). Concomitant therapy included globulin, immune and Rho (D) immune globulin (BAYRHO-D). By 13 months old, the patient was given sixteen vaccinations, sometimes four at a time and that through these vaccinations he was subjected to very high doses of the mercury contained in thimerosal, a highly toxic preservative intentionally added to the vaccines he received. Additionally, while she was pregnant with the patient, his mother received three injectable globulin products containing thimerosal. It has been alleged that as a result of the mercury in the thimerosal-containing vaccinations and the MMR (second generation) vaccine that the patient received as an infant, he now suffers and in the future will continue to suffer neurological damage, including but not limited to developmental and speech delays. Upon internal review, mercury poisoning, neurological damage, developmental delays and speech delays were considered other important medical events (OMIC). No further information is available. Follow up information received on 04Aug04 reported the following adverse experiences: food sensitivities and food intolerances (onset unknown), treated with a gluten free/casein free diet. No furthere information is available. All available medical records will be provided upon request.
Skin localized pain, tenderness with erythema, induration, and warmth to vaccination area. Treatment : Start Cephalexin Suspension Reconstituted
Pt states the day after the vaccinations she started with fever and bodyaches and flu symptoms. She also had redness and swelling at the site of the Pneumovax on the right deltoid area.
mom states pt noted some redness near inject site on 6MAY92 @ 6PM; states removed the bandaid & noted the reddness; taken to MD 7MAY92 PM for physical;
Reason for PCP office visit on 6/7/16:  The symptoms began 1 day ago and generally lasts 1 day as being moderate occur randomly are acute and have worsened.  Pt received vaccines on 6/6/16, that night started having a fever 101, and pain in left thigh with a small area of redness where she received shots, mom thought it was normal side effects from shots but pain has become worse and redness has increased along with swelling.  Has been giving her Tylenol for fever.  Eating and drinking normally.  Assessment:  Cellulitis.  Plan:  Warm compresses to left upper thigh three times a day for 20 min, Ibuprofen for pain or fever.  Take medication as directed, start tonight (cephalexin 250/5, 10 ml BID x 10 days).  Return Thursday to have checked, if redness spreads past red (body maker) line, high fever, increased pain, need to go to ER or return to office sooner. I talked w/ mom after office visit, she noticed fever (not measured/per touch (99.2 at this OV)) and L thigh swelling at 8 pm yesterday (6th).  I measured the red area laterally 11 cm X 12.3 cm longitudinally. I called mom to see how pt's L thigh is doing (13th).  She said it is completely normal today.  Still taking ABX.  Did go to ER the night of 6/7 because the redness extended beyond the drawn outline at the OV; but ER said it looks good.  No concerns at this time.
a 6 years old patient received a dose of Flublok with no adverse event; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA304264.  This case involved a 6-years-old male patient received a 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2055, Expiration date- 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age) on 20-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  It was a case of an actual medication error due to inappropriate age at vaccine administration (Latency: Same day).  No relevant laboratory data 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.
IMMEDIATELY STARTED SHAKING VIOLENTLY, THROWING UP, STIFFNESS OF JOINTS AND MUSCLES, BLEEDING (MORE THAN A NORMAL SHOT).  THIS HAPPENED 1-2 MINUTES AFTER RECEIVING SHOT.  THIS IS THE FIRST TIME SHE'S HAD THE FLU SHOT.  THIS WAS EARLIER THIS MORNING AROUND 9 AM.  SHE IS CURRENTLY AT THE DOCTOR BEING SEEN.
Upset; Patient received Fluad Quadrivalent instead of 'high dose' influenza vaccine; This spontaneous case was received on 06-Oct-2020 from other non-health professional via agency (reference number: SEQW20-03031) and concerned an elderly male patient of an unknown age.   The patient's medical history and concomitant medications were not reported.  On an unknown date in 2020, nurse practitioner recommended to the patient to make sure that he got a high-dose influenza vaccine. The patient called several pharmacies in the area to see if they had a 'high-dose' influenza vaccine and was told that they did.  On 06-Oct-2020 before administration, the patient confirmed that he was receiving a 'high dose' influenza vaccine with pharmacist.  On the same day, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration, anatomical location and indication: not reported) instead of a 'high dose' influenza vaccine (explicitly coded as 'Wrong vaccine administered'). The batch number was not reported.  On the same day, when the patient got home and looked at the paperwork, however, patient saw that he received Fluad Quadrivalent. He did not experience any issues post vaccination, but he was very upset that he did not receive the vaccine that his healthcare provider had recommend he receive, despite he verified with pharmacist that this was what he received.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The reported assessed the case as non-serious.  Company comment: Anxiety was associated with the use of the suspect product - Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. According to the narrative wrong product was more likely a result of upset state than received vaccine therefore causality is assessed as unrelated to the product but more likely related to medication error. Wrong product administered is assessed as unrelated per company conventions.; Sender's Comments: Anxiety was associated with the use of the suspect product - Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. According to the narrative wrong product was more likely a result of upset state than received vaccine therefore causality is assessed as unrelated to the product but more likely related to medication error. Wrong product administered is assessed as unrelated per company conventions.
Syncopal episode at home, occurred after standing up quickly, no loss of consciousness, no head trauma, no chest pain, no shortness of breath.  CT head shows chronic subdural hematoma. Reported dizziness, likely orthostatic hypotension  Patient incidentally noted to be COVID positive, asymptomatic received vaccine and booster.
Her throat was scratchy and tight; swelling and redness at the injection site which was the left deltoid; swelling and redness at the injection site which was the left deltoid; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 49 years old female patient whose throat was scratchy and tight (Throat tightness), swelling and redness at the injection site which was the left deltoid (Injection site swelling) and (Injection site erythema), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included sodium (NA).  On 22-Oct-2020, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2049, expiration date: 30-Jun-2021, via intramuscular route in the left deltoid for immunization.  On same day, 15 mins, after the administration, the patient's throat was scratchy and tight (throat tightness), swelling and redness at the injection site which was the left deltoid (injection site swelling) and (injection site erythema).  Final diagnosis was swelling and redness at the injection site which was the left deltoid, swelling and redness at the injection site which was the left deltoid and her throat was scratchy and tight.   No laboratory data was reported.  Her friend gave her an antihistamine and a steroid, and she did not need any intervention after that.  The event outcome were reported as resolved on an unknown date for all.  No further relevant information was reported.
no adverse side effects have been reported from the patient; improperly stored dose of PROQUAD was administered to a patient on 8/16/2022; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-AUG-2022, the patient was vaccinated with improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), recombinant human albumin (rHA), subcutaneous injection, 0.5 milliliter, lot #U019287, expiration date: 15-DEC-2022, administered subcutaneously for prophylaxis (strength was not provided) (Product storage error).  Administered doses of vaccines experienced the temperature excursion of -12.3 degrees Celsius for 1 hour. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm  ( not sure due to mask or injection) started with soreness/heat to site,  joint pain,  flu-like symptoms- body aches, tired and headaches. - January 9th.   most joint pain gone except to fingers gone. soreness and heat to site of injection.  - January 10th finger joints hurt still hurts,  site of injection - redness  swollen/ heat still - around site a "pinching"  pain, which is a new today - Jan11th
Patient was given the FLUAURIX QUAD 2017/2018 vaccine (0.5ml) around 10am and patient waited in store as advise to monitor if any reactions occurred. I suggested that she sit down (she is allowed to sit in our vaccine area for privacy if she wishes). Patient said she needed to shop so she went to shop and after 20 minutes of getting the vaccine she said that she was feeling a little dizzy. I tried to speak to patient as much as possible and stay with patient as she expressed her dizziness. She was sitting at the pharmacy benches after she shopped around the store and when someone started to cough in back of her she stood up and moved to another area away from the coughing patient to speak to me. I asked her about her dizziness and if she wanted me to call an ambulance for her but she said, no it wasn't that bad. Patient waited a little longer and said she felt okay to go home. She called the pharmacy 4 hours later to say that she has bled more than usual from the injection site and was wondering why. She did mention that the bleeding stopped. I informed her that there were patients that have bled more from this type of vaccine so I didn't think it was that uncommon. She wanted to know if it was the vaccine formulation or the exact reason but she was feeling okay overall just not very pleased with her flu shot experience.
a little bit of redness; painful to touch; superficial skin ulcer; A spontaneous report was received on 28 Dec 2020, from a 47 year old male patient who is also a radiologist. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced a superficial skin ulcer, a little bit of redness, and painful to touch with the use of mRNA-1273.    There was no medical history provided. Concomitant medication included olmesartan.  On 22 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # 039K20A) intramuscularly, in the left deltoid, for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient experienced the non-serious event of painful to touch, on 24 Dec 2020 the patient experienced a little bit of redness, and on 25 Dec 2020, the patient noticed a superficial skin ulcer. It was noted that all reported events were at the injection site and the patient felt the administration was intramuscularly but may not have been deep enough into the muscle. Additionally, he described the area as a superficial ulcer, with no drainage, which initially had been painful and nownot painful at all. He also notes the ulcer had not been there on the 24th when he removed his band-aid. At the time of this report, the ulcer was no longer painful to touch, but ulceration has stayed the same size. He noted it looked like it was trying to heal for the last two days. There were no other symptoms associated with the events. The patient spoke with other physicians, but the event has not been reported to his physician. The patient did not take anything to treat the reported events.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the events of superficial skin ulcer, a little bit of redness, and painful to touch was not reported.   The events of superficial skin ulcer and a little bit of redness were recovering at the time of this report. The event of painful to touch was reported as resolved.   Causality was not provided for the events of superficial skin ulcer, a little bit of redness, and painful to touch.; Reporter's Comments: This case concerns a 47-year-old male patient, who experienced non-serious expected events of Injection site pain and Injection site erythema, and no-serious unexpected event of Injection site ulcer. The event of Injection site pain occurred on the same date after first dose of mRNA-1273, lot # 039K20A. The Injection site erythema  and Injection site ulcer occurred approximately 2 days and 3 days respectively after first dose of mRNA-1273, lot # 039K20A. No treatment  was taken for the events.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
2 year old was given expired Pentacel with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from nurse via Medical Information (Reference number- 00309771) and transmitted to Sanofi on 09-Oct-2020.  This case involved a 2 years old male received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number- UJ060AA, expiration date- 04-Oct-2020) (Expired product administered) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, family history were not provided.   Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) and MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (MMRV) for prophylactic vaccination.  It was actual medication error as expired vaccine was administered to a patient (Latency: Same day).  At the time of reporting it was not reported that the patient had experienced any adverse event.  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.
hive like reaction; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 14Jun2023 as dose 1, 0.5 ml single (Lot number: GF4142, Expiration Date: 30Aug2025) at the age of 18 years intramuscular, in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (medically significant) with onset 15Jun2023, outcome "unknown", described as "hive like reaction". The event "hive like reaction" required physician office visit. Therapeutic measures were taken as a result of urticaria. Clinical course: The patient got a hive like reaction on her chest, abdomen and back on 15Jun2023. Seriousness criteria was medically significant from a medical standpoint. Causality: directly related to the vaccine because after they did a whole health history there was not anything new except that regarding this first dose of the patient's Trumenba vaccine. Treatment: They recommended she take two different types of antihistamines and it was Benadryl as needed and Zyrtec every night at bedtime. For the time of administration of the Trumenba, caller states they put her vital signs in at 2:58pm so the vaccine would have been administered probably around 3:15pm and 3:30pm roughly. The patient has no drug allergies or food allergies or environmental allergies and has no history of any allergies.; Sender's Comments: Based on the close temporal relationship, the association between the event urticaria with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
14FEB92 started having fever (unk how much); Cont to 20FEB92 @103;