chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received expired Fluzone HD with no adverse event; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 50 months old patient of unknwon gender who received expired Fluzone HD with no adverse event (Expired product administered) vaccine of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AA via intramuscular route in the left deltoid.  It was a case of expired product administered.  At the time of this 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.
he has a lousy memory; Used a shampoo that's orange and it has a weird smell like garlic or onion; Tasted smell of shampoo in mouth; Felt like saliva was orange; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot Number/Expiry Date: Unknown/Unknown , Route: Injection , Anatomical Location: Right arm), administration date: 30Jan2021, when the patient was 76 years old, for Covid-19 immunization.  The following information was reported: PAROSMIA (non-serious) with onset 23Feb2021, outcome "recovered" (23Feb2021), described as "Used a shampoo that's orange and it has a weird smell like garlic or onion"; TASTE DISORDER (non-serious) with onset 23Feb2021, outcome "recovered" (23Feb2021), described as "Tasted smell of shampoo in mouth"; SALIVA DISCOLOURATION (non-serious) with onset 23Feb2021, outcome "recovered" (23Feb2021), described as "Felt like saliva was orange"; PAIN IN EXTREMITY (non-serious) with onset 22Feb2021, outcome "recovered" (22Feb2021), described as "Sore arm"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "he has a lousy memory".  Additional information: Vaccination time for second dose between 13:00 and 14:00. The patient had received Shingles vaccine within 4 weeks administered in arm via injection route for flu on 12Jan2021 had experienced immediately got the flu. Description of complaint: Immediately got the flu after receiving the flu shot. Caller reported that the event occurred 3 decades or longer ago. Caller unable to provide product details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt's 12mo immunizations were not loaded in the state immunization registry which resulted in pt receiving her 12 mo immunizations on 11/08/2018. She received a 2nd set of her 12 mo immunizations(Hep A, MMR, Varicella). Mother was notified as well as employee with the State. ****Child did not have an adverse reaction to any of the immunizations given.
Fainting; Dizziness; Body ache; Joint pain; A spontaneous report was received from a 22-year-old female consumer, who received Moderna's COVID-19 vaccine and experienced dizziness, fainting, joint pain, and body aches.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020 at 13:30, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 31 Dec 2020, after vaccine administration, the patient experienced dizziness, fainting, joint pain, and body aches. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events, dizziness, fainting, joint pain, and body aches, was not reported.; Reporter's Comments: This case concerns a 22 year-old, female patient, who experienced events of dizziness, fainting, joint pain, and body aches. The events occurred on the same day after the first dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
slight cough high on her chest over the right breast; shortness of breath; hurt torso/hurt arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (hurt torso/hurt arm), COUGH (slight cough high on her chest over the right breast) and DYSPNOEA (shortness of breath) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL, ATENOLOL, LOSARTAN, SIMVASTATIN, LEVOTHYROXINE, ALLOPURINOL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced MYALGIA (hurt torso/hurt arm). On an unknown date, the patient experienced COUGH (slight cough high on her chest over the right breast) and DYSPNOEA (shortness of breath). On 12-Jun-2021, MYALGIA (hurt torso/hurt arm) had resolved. At the time of the report, COUGH (slight cough high on her chest over the right breast) and DYSPNOEA (shortness of breath) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No treatment information was reported.
This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from an office manager concerning a 70 year old female with no medical conditions who was vaccinated (SC) in the right arm with a first dose of ZOSTAVAX (Merck) (lot # 656861/0329U). There was no illness at the time of vaccination. Subsequently, "the patient developed redness and swelling around the injection almost immediately following vaccination". Unspecified medical attention was sought. No product quality complaint was involved. No further information is expected.
Patient received Moderna then rescheduled multiple times for second dose and 47 days later came in for appt and was given Pfizer  No adverse effects.  wanted combo noted
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mg. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On 16th February 2018, the patient experienced headache. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, headache and rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, headache and rash to be related to SHINGRIX. Additional details were provided as follows: At 14:00 hours, the patient received SHINGRIX in right arm. After vaccination the patient had pain at the site for 6 days and redness for 7 days. She also had swelling in about a 3 inch circle around the injection site. On 16th February 2018, she woke up with headache that lasted for 24 hours. A few days after the injection she had a rash on her right arm where she got the injection, about 10 small red dots down her arm to her wrist. This lasted for about 5 days. About a week later her left arm developed the same rash. The patient has denied permission to contact their physician. This case has been linked US2018GSK135577, reported for further dose of SHINGRIX. This is 1 of the 5 cases reported by the same reporter.
chills/shivering; NO ENERGY; NO APPETITE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, 8 hrs after receiving Shingrix, the patient experienced chills, loss of energy and appetite absent. On an unknown date, the outcome of the chills, loss of energy and appetite absent were unknown.   It was unknown if the reporter considered the chills, loss of energy and appetite absent to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that the patient developed chills, shivering, no energy, and no appetite after vaccination. The reporter asked how long does it take for the symptoms to go away.
Four hours after the vaccine, I started to experience a metal taste in my mouth. This lasted for about 2 days.  The day after the vaccine I started smelling a burning smell. However, nothing was burning. It is 4 weeks later and I still experience this. Today, I am in day 2 of smelling something like burnt toast. It drives me a little crazy and it is disorientating.
Sore on underside of tongue. Swelling, hardness, redness radiating out from injection site, fatigue.
43 y/o female received her influenza vaccine injection on 10/6/2010. 5 days post vaccination developed myalgia, extreme exhaustion, double vision and eyelid droop. Patient cannot recall the exact time of onset of the visual symptoms. It is possible that the visual symptoms started even before day five, because in the early stages patient believed the vision problems were related to a new prescription for bi-focals. Patient sought care with her ophthalmologist and was sent directly to a neurologist to rule out myasthenia gravis. Patient was tested on 11/17/2010, the diagnostic results returned the first week in December and were positive for myasthenia gravis. Patient was started on MESTINON the first week of December. On 2/1/2011 patient reports the medications are helping, but she still experiences fatigue in the mornings and later in the evening when the medications are wearing off. Patient is working and going to school full time and has been able to fulfill all of her requirements.
Patient was administered lot 5D4H4 exp 6/30/21 and experienced lightheadedness right after the vaccine was given.  This resolved in approximately 5 minutes.  Prior to receiving this, it was attempted to administer her vaccination with same vaccine lot 373H3 exp 6/30/21; however, there was an issue with the needle/syringe and the plunger would not depress.
PFizer 6/8/21, 7/1/21, 10/26/21  CHIEF COMPLAINT Hyperglycemia   HISTORY OF PRESENT ILLNESS Patient is a 21 y.o. female with medical comorbidities including  type 1 diabetes, transaminitis likely due to NASH, and macrocytic anemia who presents with hyperglycemia.   She had an outpatient video visit on 11/17 for evaluation of lower extremity edema, abdominal swelling, and worsening type 1 diabetes.  See the note of Dr. on 11/17 for a very detailed recent patient history.  Essentially, she has had a couple of admissions for DKA along with some issues with severe transaminitis thought to be due to NASH.  She has some labs obtained 11/18 following this visit and they showed a glucose over 900 and a sodium of 118.  She was then told to come into the emergency department.   In the emergency department, vital signs were largely unremarkable.  Labs showed a normal hemoglobin, WBC, and platelet count.  Sodium was 125, bicarbonate 20, anion gap 22, potassium 4.5.  Creatinine was normal.  She had a undetectable beta hydroxybutyrate.  Initial lactate was quite elevated at 9.1.  She was given 2 L of IV fluids in the subsequently improved to 4.4.  VBG showed a normal pH of 7.37.  CT abdomen and pelvis showed no acute findings.  ECG was unremarkable.  She incidentally tested positive for COVID with no symptoms.  She is vaccinated.  She was not given any insulin, but she was admitted to the floor.   On arrival to the floor she was lying in bed.  She appeared sleepy but would answer questions.  She states that she normally takes 33 units of Lantus in the morning and 1:10 carb correction.  She denies any cough, chest pain, shortness of breath, or abdominal pain.
Infection on injection site; Large dark red on the injection site; Injection site was swollen; Injection site was warm; injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE INFECTION (Infection on injection site), VACCINATION SITE ERYTHEMA (Large dark red on the injection site), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PAIN (injection site was sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was sore). On 16-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm). On 17-Jan-2021, the patient experienced VACCINATION SITE INFECTION (Infection on injection site), VACCINATION SITE ERYTHEMA (Large dark red on the injection site) and VACCINATION SITE SWELLING (Injection site was swollen). On 11-Jan-2021, VACCINATION SITE PAIN (injection site was sore) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE INFECTION (Infection on injection site), VACCINATION SITE ERYTHEMA (Large dark red on the injection site) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment included advil and amoxicillin.
Myalgia, Arthralgia. injection site pain, fatigue, malaise Narrative:
12/17/2020 at 1530  Patient states she has a little anxiety from just having received the COVID-19 vaccine. Per patient, she already spoke with her PCP who recommended she get the COVID vaccine. Patient offered ER evaluation for severe or worsening symptoms. Provided patient with phone number to Occupational Health dept to schedule appointment. States she will give them a call before going home.    1545  Patient observed for 30 minutes after vaccination. States she feels fine at this time and does not feel dizzy. No further needs
Headache, Arthralgia, Fever, Chills/ Fatigue Narrative:  Other Relevant History:
Febrile seizure; parents took child to ER at Medical Center and followed up with Dr. on 3-9-06; labs done, treat fever.
I received my first dose of the pfizer vaccine at 11am at the safeway pharmacy. I had consumed several glasses of water in the morning before the event, a cup of yerba mate tea, and a piece of toast. I smoke, and had smoked one cigarette in the morning before my appointment. Just after receiving the vaccine I ate a few pieces of jerky and maybe 15 Jojo potatoes from the safeway deli.  I was advised to wait 15 minutes before leaving. I set an alarm. I bought some food to eat (jojo potatoes and jerky) and waited to leave the site until 11:22am. I felt strange/weird, but this isn't an unusual feeling after receiving any kind of shot/vaccine for me.   I was driving to work and I started to feel just a little bit strange after smoking another cigarette. I got a little nauseous but nothing too bad. Thirty seconds later I started to get dizzy, my ears rang, I felt my blood pressure drop, and I passed out on the interstate going freeway speeds. I woke up around a minute and half later according to my brother who was on the phone. I was treated for injuries at emergency room.
Arm hurt and was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm hurt and was sore) in a 68-year-old female patient 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 MYALGIA (Arm hurt and was sore). At the time of the report, MYALGIA (Arm hurt and was sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.  Reporter stated that Dring market research, the respondent mentioned that she had both shots of the Moderna Covid-10 vaccine and her arm hurt and was sore after both doses.  This was a minor issue and resolved within a couple of days each time   This case was linked to MOD-2021-372569 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: follow up received on 03 nov 2021, reporter details updated
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-MAY-2016, the patient was treated at a clinic for a persistent and severe vesicular rash, which was then diagnosed as varicella zoster. The patient has been prescribed valacyclovir and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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 and pain and suffering and other damages. Additional information has been requested.
Ran fever all night, body aches, vomit, diarrhea, swollen throat.
Vomiting repeatedly for about 4-5 hours. Couldn?t keep anything down. Had no other symptoms but this.
A nurse reported that a pt received Prevnar and 2 days later, the pt developed an injection site reaction characterized by an area measuring "about 22mm" of redness and warmth. The pt was treated with Tylenol and an antihistamine (unspecified) and recovered the next day. This is 1 of 10 pts from this facility who experienced an injection site reaction following receipt of Prevnar lot 471215 and 471202. The reporter indicated that 10 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Patient became light headed and fainted from a seated position and fell on floor within one minute of receiving vaccination. Patient checked by pharmacist on site as well as Nurse practitioner and paramedics and was deemed well and fit to go home. There was a facial injury from the fall.
4/7/21 I recieved the Johnson & Johnson vaccine in my left arm. Within 45 minutes of the vaccine I ran a fever that reached 104.2.  I felt weak with chills.  This began the consecutive 7 day cycle of fever, chills, and sweats.  During this time, my fever would range from 101.1 to 103.  After taking two extra strength tylenol it would come down but then go back up before the 6 hour mark to take the next dose.   The chills were the worst of the symptoms as they were full body spasms curling me into the fetal position.   As the Tylenol would kick in, the chills and fever would subside and I would begin to sweat. This was a full body sweat that soaked my clothing and bedding.
A report was received from a health professional on 17Oct02, concerning a 72 year old male vaccinee who inadvertently received the Fluvirin vaccine on 17Oct02. The vaccinee inadvertently received 0.1ml of Fluvirin ID instead of Tuberculin PPD. The vaccinee has not developed or reported any untoward or adverse reactions. There was insufficient information to determine the reporters causality assessment.
Pt died 1/7/22. Pt was critically ill, maxed out on pressor support for sepsis, renal failure and multi system organ failure. She was made a DNR.
On May 15, 2021, I developed an extremely itchy rash at the site of vaccine injection. The rash moved down my arm and then on my other arm (on both arms all the way to the wrist) and also on both legs, and groin area.
Neuropathic pain through the shoulders. Intense #10 level pain. Pain radiated through  C7 pathway down the shoulder and arm. Mainly right arm. Similar to pain I had from a slipped disc and subsequent spinal fusion done in 1979.
Went to doctor because rash appeared at the injection site from when he received his ZOSTAVAX injection on 11-9-15.
Patient was on nurse visit schedule. Medical assistant read providers note in chart as order to give vaccine today which was actually note from previous visit. Nurse inadvertently gave same vaccines as previous visit. On July 27, 2023 patient received MMRV and Tdap. Patient returned on 8/7 and received another dose of MMRV andTdap. No adverse effects have resulted.
Patient reports upon evaluation of reaction in clinic on 3/24/2011 at 1600 that it was red only the evening of the injection on 3/22/2011 and then became hard and heat noted with increased edema on 3/23/2011.
Rash on (L) thigh that started on 4/8/15 and resolved by 4/10/15. Fever (temp 102.4) started on 4/9/15.
This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by other health professional, concerning a female patient of unspecified age. The patient's historical drug included: Pneumococcal vaccine. On 03-Feb-2018, the patient was administered with AFLURIA (TIV) after first excursion (dose: 0.5 ml, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018, route of administration: not reported). On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
1 hour after shot:  low grade fever, chills, fatigue, headache, nausea, sore at injection point, ALL still happening 1 week later (10/06/2015).
Sore bone in m neck - the big bone that separates the neck from spine - felt bruised.  Constant ringing in my left ear.  Neck pain comes and goes, ringing in left ear continues.