chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed shipment of Fluzone HD shipped on 06Nov2019 and not received until 11Nov2019 at 13:08; delayed shipment of Fluzone HD shipped on 06Nov2019 and not received until 11Nov2019 at 13:08; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (lab technician).  This case is linked to case 2019SA316735 (same reporter).  This case involves 5 patients who inadvertently received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] after shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and product shipment delay.  Lab technician reported delayed shipment of Fluzone HD which was shipped on 06-Nov-2019 and not received until 11-Nov-2019 at 13:08. Caller reported that Fluzone HD was inadvertently administered to 5 patients.  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.  Information on the batch number was requested.
Headache, swollen red (R) upper arm "hard and red" per mother, MENVEO was on right. Left arm was BOOSTRIX and smaller red area not as swollen.
Delayed adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed adverse reaction) in a female patient of an unknown age 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 VACCINATION COMPLICATION (Delayed adverse reaction). At the time of the report, VACCINATION COMPLICATION (Delayed adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Delayed severe hypersensitivity. Large red/purple rash on arm around injection site. Warm and raised. Around 4in X 3in in size.
after the first dose, the patient had herpes outbreak,she had herpes before and after the vaccine; after the first dose, the patient had herpes outbreak,she had herpes before and after the vaccine; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 20Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Feb2021 as a single dose for covid-19 immunisation. Medical history included herpes. Concomitant medications were not reported. On an unspecified date in 2021, after the first dose, the patient had herpes outbreak. Patient enquired whether she could take medication (Valaciclovir) because she had herpes before and after the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Few days ago, in approximately October-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the arm. Concomitant therapies included influenza virus vaccine (manufacturer unknown) in a different arm on the same day as ZOSTAVAX. The arm that ZOSTAVAX was administered, the injection site was pretty swollen and itchy in approximately October 2013. The patient had sought medical attention via a visit to pharmacy. The outcome was unknown. This is one of several reports from same source. Additional information has been requested.
Significant swelling at the site of injection. 5"x4" local reaction with lot of pain Fever up to 101.6 degree Fahrenheit. Treated with Tylenol and Benadryl and Ice pack.
Initial report received from a health care professional (medical technician) on 13 Oct 2010: This patient with an unknown medical history was vaccinated MENVEO (batch number unknown) intramuscularly on 15 Sep 2010. It was reported that, MENVEO vaccine was not reconstituted and the patient only received the MenCYW-135 component and not the Men A lyophilized powder on 15 Sep 2010. No adverse events were reported. The outcome of the event was not reported. Follow up report received from a health care professional on 26 Oct 2010. It was reported that the patient was inadvertently administered only the Men CYW-135 liquid conjugate component of MENVEO. The patient did not receive the MenA lyophilized conjugate of MENVEO. The patient received a complete dose of MENVEO on next day. Follow up report received from a nurse on 16 Nov 2010. Patient demographics added. The batch no: of MENVEO was reported as 090701. The patient took FLUZONE concomitantly.
Patient stated that he received both shots in the 2 shot Moderna series in 2021 - unable to provide exact dates nor location vaccine was administered.   Hospital stay extended due to contraction of Covid illness.
lost taste of coffee - rash on left side of neck - cold sore on left side of lip - chills - Dizzy - Left shoulder blade area on back very sore; Rash on left side of neck; Chills; lost taste of coffee; cold sore on left side of lip; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261 nd Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 15:30 at the age of 65-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Medical history included dust allergy , seasonal allergy from an unknown date and unknown if ongoing. On 14Feb2021 07:00 the patient experienced lost taste of coffee - rash on left side of neck - cold sore on left side of lip - chills - dizzy - left shoulder blade area on back very sore , rash on left side of neck, chills, lost taste of coffee, cold sore on left side of lip. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
CLOT ON THE LEFT SIDE OF NECK; STROKE; DEPRESSED; ANXIOUS; This spontaneous report received from a patient concerned a 52 year old  female. 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: 041A21A, expiry: 19-SEP-2021) dose was not reported,1 total, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, 20 days after the vaccination, the patient started experiencing a terrible headache. The patient took tylenol for headache but it did not work. The patient went to the doctor of medicine (MD) and the doctor gave her a shot for the headache. On an unspecified date, the patient had a negative Covid-19 test. The patient was hospitalized for 7 days. When the patient woke up, she was not able to speak and was told that she had a stroke and a clot on the left side of her neck. The patient was transferred to another hospital and was there for 3 weeks and 4 days. The patient was not taking any medication after she was discharged from the hospital. The patient was still taking tylenol and could walk, talk and move now. The stroke affected the right side of the patient. The patient was going to speech therapy and physical therapy. She was still going for follow-up appointments, this month so far she had been for an appointment twice. The patient was very anxious following the events of stroke and this was a current situation and not the one that occurred during the stroke. On an unspecified date, the patient was depressed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of depressed, clot on the left side of neck and anxious was not reported. This report was serious (Hospitalization Caused / Prolonged).     .; Sender's Comments: V0: 20210921019-Covid-19 vaccine ad26.cov2.s-Stroke, Clot on the left side of neck. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On  8th day after after the Moderna COVIDvaccine, I awoke and noted that site of inoculation on left upper arm was very itchy with a 2x3 inch raised, red hive.   I  felt woozy, unsteady, a bit short of breath, a small headache, a bit of nausea,&  fatigued.  These symptoms  subsided gradually over the next 4 days.
Fever of 101.6 starting at 8pm and lasting until around 12pm.  The next morning I was feeling fine.
Minutes after the first dose my body started itching in different areas. I took Cetirizine when I got home and it went away. However, a week later started itching just on the injection area and it lasted for three days. With the second dose, the itching manifested right away but does not go away. It has been three days and I still have itching in my body with headaches and body aches. My doctor prescribed me Benadryl but it's not working, still itches.
Patient is a 66 y.o. female who presents with chest pain.  Patient was transferred from emergency department for further evaluation and management of unstable angina.  The patient initially presented there with sudden, onset severe intermittent dull pressure-like left sided chest pain with radiation to her left arm that started 2 days prior to admission.  She reported that the chest pain was intermittent in nature, noting that the episodes of chest pain would last about an hour at a time.  She further explained that she would have these intermittent episodes of chest pain roughly 3 to 4 times a day, with her last episode occurring while she was present in the ED prior to transfer.  When EMS arrived, the patient was diaphoretic and experiencing severe chest pain.  EMS administered 324 mg Aspirin at this time, of which provided the patient little relief.  She initially rated her chest pain a 8-10/10 at its onset, but rated the pain a 7/10 upon arrival to the hospital.  She was placed on 3L NC O2 while in the ED, of which was weaned down to 2L upon transfer to Facility.  She received several doses of sublingual nitroglycerin that provided some relief.  Upon my evaluation here, the patient denied any shortness of breath and mentioned that her chest pain has improved.  She reported that laying down flat and resting helped relieve her symptoms.  She denied experiencing anything like this before.  Denied any nausea, vomiting, or abdominal pain.  Patient denied any history of cardiac stents, heart failure, heart attacks, ulcers, bloody stools, or a significant family history of cardiac issues.  She also noted that she does wear 3.5L NC O2 at baseline.   During the hospital stay, chest pain resolved, ACS was ruled out.  Serial troponins were negative and Lexiscan stress test was negative.  After a 3 days hospital stay, patient was discharged to a swing bed unit for ongoing PT/OT.
mom phoned clinic day following vax & stated pt did not act right on way home; stiffened out x 2 as if having a sz;
nausea; vomiting; cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweat), NAUSEA (nausea) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0071321A) for COVID-19 vaccination.     The patient's past medical history not  included .  relevant concomitant products usage were not reported by the reporter.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COLD SWEAT (cold sweat). On 24-Mar-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomiting).  At the time of the report, COLD SWEAT (cold sweat), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
red rash on her left arm; knot like bump at injection site; very sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on her left arm), VACCINATION SITE MASS (knot like bump at injection site), PAIN IN EXTREMITY (very sore arm) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC (TRESIBA), PANTOPRAZOLE, TIZANIDINE, TAPENTADOL HYDROCHLORIDE (NUCYNTA) and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on her left arm), VACCINATION SITE MASS (knot like bump at injection site), PAIN IN EXTREMITY (very sore arm) and HEADACHE (headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash on her left arm), VACCINATION SITE MASS (knot like bump at injection site), PAIN IN EXTREMITY (very sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No additional AE reported; received her 1st dose of GARDASIL 9 in Aug2018, 2nd dose in Nov2019; This spontaneous report was received from a consumer and refers to a 15-year-old female patient.  The patient's medical history, historical drugs, concurrent conditions and concomitant therapies were not reported.   On an unknown date in August 2018, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in November 2019 the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration) and at the time of reporting she has not received her 3rd dose (no adverse event).
High blood pressure, light headed, dizzy, minor chest pain, hematoma and pain to injection site. No medications taken. Side effects have resolved except for hematoma/pain at injection site.
Severe body aches & pains.  Chills & sweats. Headache. Extreme fatigue. Slight sore throat. Suspect slight fever, but did not measure. Onset = 18hr after vaccine duration = 3 days.
2-8-10 soreness in vaccinated arm. 2-9-10 (am) soreness in arm, (pm) heartburn, no relief with TUMS, pain with deep breath that extends to back. 2-10 and 2-11 pain on L side that wakes her up, sharp pain, better with position change. 2-11-10 (pm) soreness on L side, tired, dizziness. Denies fever, headache or allergies.
Soreness in upper arm around area receiving vaccine. Following day redness around area and following down inner part of arm almost to elbow. Area was hot to touch. Two days following vaccine reported to Pharmacy where vaccine given. Note made to my record. Soreness started to subside. By day four, all soreness and redness gone.
Patient received DTaP, MMR on 1/22/04. Developed erythema multiforme rash beginning at site of DTaP injection, on 1/23/04 developed fever/swollen joints/ serum sickness like reaction.
Swelling and redness around the vaccination site. Fever 104 degrees F orally for 2 days. Painful left arm.
the vaccine is active against the cancer he currently have; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "the vaccine is active against the cancer he currently have".  Additional Information: The reporter (Patient) said he would like to inform Pfizer that he didn't had any problem with the Pfizer Covid 19 vaccine. He received letters from Pfizer asking if he had problems with the vaccine. He said he previously work on a cancer research institution and now he was suffering from Kaposi sarcoma cancer. He said he would like to inform Pfizer the vaccine is active against the cancer he currently have and would like to talk to a scientist. He was requesting to receive an email stating that we understand him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331476, 2018SA331477 and 2018SA331478 (same reporter). This case involves 38 year- years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) (lot number, was reported as unknown, dose, dose in series, route and site of administration was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported if the patient experienced any adverse events following the vaccination. 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. Documents held by sender: none.
Patient was afraid of getting immunization so after the injection he waited in our imz room for approximately 5 minutes and was feeling okay. I asked him to wait on our benches in front of the pharmacy for a little longer period. He waited approximately 10 minutes there and appeared to be okay. He stood and walked about 30 yards and started to fall to the floor and was caught by his mother. He had fainted. He was immediately responsive so we raised his legs to help with blood flow while he laid on the floor. After approximately 10 more minutes he felt well enough to try and stand again. He was fine and proceeded to shop in our store.
RIGHT ARM RED FROM DELTOID TO ELBOW, SLIGHT SWELLING WITH SORENESS, NECK PAIN AND HEADACHE.
This spontaneous report was received from a certified pharmacy technician, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-JUN-2016, the patient was vaccinated with expired M-M-R II, lot # K005175, expiration date 30-APR-2016 (dose, dose number, route, and anatomical location were unknown by the reporter). No adverse effects reported. Additional information has been requested.
Expired vaccine. The expiration in system (States vaccine tracking system) was 5/31/22. We were unaware the use by dat was 3/17/22.
to get my flu shot/accidentally gave me a COVID19 Pfizer vaccine; lack of energy; body aches; Nausea; Tired; Loss of appetite; This is a spontaneous report received from a contactable consumer (patient) reported for self. A 39-year-old patient of an unspecified gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: FC3184) via an intramuscular route of administration, in left arm in 08Sep2021 (at the age of 39-year-old) as dose 3 (booster), single for COVID-19 immunization at Pharmacy or drug store; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration in right arm on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. The patient's medical history included PTSD from 2008 / Anxiety, Onset: 10 + Years and it was ongoing. Pertinent details: On medications to manage PTSD. Vaccine was not administered at military facility. Relevant test and Specific relevant test for thromboembolic events with thrombocytopenia were none. The patient's concomitant medications were included DIAZEPAM for PTSD by orally and GABAPENTIN for PTSD and anxiety by orally. Patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0161) via an intramuscular route of administration, in left arm on 25Apr2021 at time of AM (at the age of 39-year-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8732) via an intramuscular route of administration, in left arm on 04Apr2021 at 09:50 (at the age of 39-year-old) dose 1, single for COVID-19 immunization. The patient had a similar immune Response to the Covid Shot as second shot. Nausea, lack of energy, body aches which lasted about 2-3 days. The patient experienced tired and loss of appetite. It was reported that the Patient went in 2 weeks ago to get the flu shot. The local store accidentally gave me a COVID19 Pfizer vaccine in 08Sep2021. That was patient's 3rd dose about 5 months from when patient got they second. The patient was given the flu shot on Right arm following the Covid shot. They told it was Safe to have both. They gave me a new card indicating she now have 3 shots in patient body. She was reaching out to see if she could be of any medical use to Pfizer because of this. Patient wants to know if there's anything that can learn from patient. She was otherwise a healthy individual 39-years-old.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected  Follow-up (08Nov2021, 15Nov2021, 23Nov2021 and 29Nov2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: lot number, age at vaccination, first and second dose information, relevant medical history, concomitant drugs, route of administration, events added  Follow-up attempts are completed. No further information is expected.