chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a 68 y.o. female patient with history of nonalcoholic liver cirrhosis, history of gastric bypass 1998, peptic ulcer disease presented with confusion COVID-positive   Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 9/2/2022 Symptoms present on admission: Yes Date of covid positive test: 9/4/2022 Vaccination status: vaccinated Imaging: Chest x-ray Oxygen requirements on admission: Yes Current oxygen requirements: She was weaned off to room air before discharge Medical therapy: steroids and remdesivir Consultants following: ID Anticipated special isolation end date: 9/13/2022   Acute encephalopathy, likely hepatic in the setting of lactulose noncompliance and viral infection, resolved Nonalcoholic liver cirrhosis Ongoing diarrhea Lactulose 30 mg 3 times daily, she did not have a bowel movement yesterday, up titrate to 3 bowel movements a day Supportive care Pain management   History of gastric bypass   History of peptic ulcer disease Protonix IV   Urinary tract infection, ceftriaxone   Weakness and frequent falls She was provided with home health
This spontaneous report as received from other source via pharmacist refers to 3 unspecified patients. On an unknown date, the patients were vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date, the patients developed shingles. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information is not expected, there was no consent for contact.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 05-NOV-2013 the patient was inadvertently vaccinated intramuscularly with a 0.5 ml expired dose of PNEUMOVAX23 (lot # 672781/1706AA, expiration date: 03-OCT-2013). No adverse effects were reported. Additional information has been requested.
Pt recvd vax & had extreme tiredness that lasted approx 10 days; pt indicated @ the time of vax was on ANafranil & thought this was the cause of the tiredness so was switched to Zoloft;
NauseaVomiting fatigue Narrative:  nausea, fatigue within 45 minutes of vaccine; follow up 1/21/21, emp is at work but states he is "still having joint pain and feeling weak."
chills, muscle pain, pounding headache, light-headed, fatigue lasted for approximately 24 hours.  Muscle aches and pounding headache w fatigue for an additional 24 hours.  Fatigue for an additional 12 hours.  Resolution by 4th day.  Took 650 mg aspirin every 3-4 hours for first 48 hours.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (COVID-19). In January 2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided. Reporter did not allow further contact.
Hives under left arm by arm pit, down left side, on stomach. Hives appeared 1 hour after vaccination injection and became itchy by hour 2. Benadryl was taken.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II lot#L024268 with expiry date: 01-JUL-2017,lot#M002418 with expiry date: 12-JAN-2018, lot#M015930 with expiry date:29-MAR-2018 lot#L030162 with expiry date: 01-AUG-2017 (reported as 11-AUG-2017) or lot#M010426 with expiry date:01-MAR-2018 (dosing details, anatomical location, route were unknown) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored diluent (lot#, expiry unknown). All doses of M-M-R II lot# L024268 and lot# L030162 were administered prior to expiration dates. It was reported that all lots of M-M-R II were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot#L024268 and lot#M002418; 1 hour 43 minutes for lot#M015930 and lot#L030162; and 70 minutes for lot#M010426. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
I am currently on DAY 4 with  High fever Terrible chills Muscle ache Headache  Nausea Exhaustion   Symptoms getting worse
8/26/10 call patient's injection site, on her thigh where she received 2 immunizations. The area has been swelling, reddened & painful. Per PA she should put ice on it & give her Ibuprofen.
On 11 Dec 07, pt noted onset of lightheadedness and feeling of being mildly 'off-balance' while walking.  No flu-like or viral-type symptoms.  No pain.  Over the next few days, pt developed blurry vision most pronounced with reading and far-->near vision.  He numerous discrete episodes of vertigo.  Symptoms progressed to 'wobbly' walking where he could not walk independently.  At that time, he also noted decreased appetite, softening of his voice, slowing of speech, diplopia and incoordination with involuntary movements.  Admitted to medical center for 1 1/2 weeks with some symptom improvement after IV steroids, PT, OT and speech therapy.  Transferred to medical center on 1 Jan and given presumptive diagnosis of brainstem encephalitis.  (Discharged on 24 Jan after continued improvement of symptoms.  (Could walk with 4-point cane, no diplopia up to 100 m, but still images at long distances continued to demonstrate horizontal diplopia.  Having facial contractions.)  Re-admitted to medical center on 2/15/08 for IVIG x5 days after noted MRI changes (presumed ADEM).  Discharged on 2/19/08 with follow up in OT, PT, speech therapy and Neurology.  04/01/08 Reviewed Clinical summary of 2/22/08 & medical records. Admitted 12/20/2007-1/24/08.  Readmitted 2/15-2/19/08.  FINAL DX: cerebellitis; acute disseminated encephalomyelitis Records reveal patient had received vax in past w/o problems.  Patient experienced lightheadedness, feeling off balance, unable to walk, blurry vision, diplopia, vertigo, dysarthria, ataxia, involuntary movements, weakness, decreased appetite beginning approx 28days s/p vax.  Initially seen in clinic & dx w/viral illness.  Continued to worsen & was admitted overseas & transferred to US.  Tx w/IV steroids, PT/OT/ST.  Neuro consult done.  LP done.  D/C to home, wheelchair bound.  Outpt MRI revealed ADEM changes & was readmitted.  On second admission, tx w/IVIG. Vision & balance improved dramatically.  Using only cane since 2/29/08.  To continue outpatient PT/OT & neuro clinic f/u. Annual Follow-up Information 27-FEB-2009: Continue OT and vocational therapy. 2/09 Neuropathy testing - Generally normal. Did not meet criteria for cognitive disorder. 9/08 MRI (results enclosed). Has had L ankle surgery to correct gait. Was diagnosed with mild sleep apnea. Medical disability board pending (submitted in Dec 2008). Follow-up Information 02-MAY-2008: Continues PT and OT. See Neuro note dated 4/16/08.
Injection site pain; Muscle pain; Nausea; Vomiting; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 26Feb2021 at 10:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control medications for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Feb2021, the patient experienced injection site pain, muscle pain, nausea, vomiting and headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, muscle pain. nausea, vomiting and headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient had SHINGRIX on 6/24/18,  and started to have stomach discomfort, injection site swelling/ redness, felt like having fever (did not take temperature), very fatigue since 6/25/18.  Patient took Ibuprofen yesterday, fever subsided.
For two days after receiving the first vaccination for Covid-19 I ran a temperature of 101.9 and was not able to go to work. When I returned to work on Friday February 12, 2021 at approximately 8:40am I had a stroke and was rushed by ambulance to the hospital.
Patient had swelling like a softball in her left arm injection area and a fever. We were told to put ice on it and give her motrin and/or tylenol for pain and swelling.  I thought it  was common so at the time I was not too worried.  A few days later it went away.  She then had reoccuring swelling with pain and fever and brusing that sent us to the doctor again.  We came home and were told that it was alright. Once again she got better.  One evening about a week later the softball swelling and pain reappeared with the fever, and the bruising also. I took her back to the doctor and they gave her an xray.  It came back alright and at that time they told me that she probably had two injections given too close together and it formed a blood pocket.  It went down and now 3 months later a fever has reappeared and she has pain and swelling as well as itching and the two injections sights are red and blistery looking. I am very concerned and need to report this so I can find out what is going on with my daughter.
Received the Pfizer vaccines on 2/12/2021 and 3/5/2021 COVID 19 positive on 12/04/2021 Hospitalized with COVID 19 pneumonia and hypoxia on 12/4/2021
inadvertently administered DTap-IPV component of Pentacel without reconstituting it with Hib vial to a patient; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from other health care professional (Office staff manager).  This case involves a 18 months female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included MMR VACCINE and VARICELLA VACCINE on unknown date.   On 30-Apr-2019, the patient received a fourth dose in series, 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ084AA, expiry date 24-Jul-2020 via intramuscular route in the left thigh.  It is an actual medication error due to inappropriate reconstitution technique.  It was reported that patient who was inadvertently administered DTap-IPV component of Pentacel without reconstituting it with Hib vial.  It was not reported if the patient experienced any adverse event following 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.  List of documents held by sender: none.
Initial information received on 30-Jul-2018 regarding an unsolicited valid serious case received from a nurse. This case involves (65-70 year) male patient who experienced Guillain Barré syndrome and could not walk, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE HIGH DOSE lot number not reported via unknown route. The patient developed a serious Guillain-Barre syndrome following the administration of FLUZONE HIGH DOSE. This event was leading to disability. The patient developed a serious could not walk (walking disability) following the administration of FLUZONE HIGH DOSE. This event was leading to disability. It was reported that patient used cane to walk. The patient had to have extensive rehab and used cane. Other relevant tests included No lab data. Final diagnosis was could not walk and Guillain Barre syndrome. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for Guillain Barré syndrome and as Unknown for could not walk. Sender's Comments: This case involves an elderly patient who presented with Guillain Barré syndrome (GBS) and could not walk post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Guillain-Barré Syndrome is a listed event for FLUZONE HIGH DOSE. However, further information including patient's medical history, medical condition at the time of vaccination, clinical description of GBS, CSF, EGM, viral and bacterial serology result would be relevant for accurate assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
A non-serious spontaneous report of wheezing has been received from a non-health professional concerning a child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST last flu season in 2010-2011. The patient developed wheezing after receiving FLUMIST. The patient went to hospital but not admitted. The outcome of the event was unknown.
Rather sudden onset of sneezing, runny nose, and coughing.  Temperature was 99.9 degrees.  Pulse was 111.  Oxygen level fluctuated between 84% and 94%.  I took Tylenol.
Arm with the shingles shot got red; Arm with the shingles shot got swollen; Swollen arm hurt less then the shingles patient had years ago; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles (patient had shingles years ago) and shingles.   In September 2020, the patient received Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 6 months after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient got shingles shot and flu shot in September 2020. The arm with the shingles shot got red and swollen, but eventually it left once the doctor gave oral medication. The patient said that swollen arm hurt less than the shingles that they had years ago.
Bruning sensation while administering vaccine.; Joint pain; Aching in bones; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Aug2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to Penicillin. Concomitant medication received within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On 30Aug2021, the patient experienced bruning sensation while administering vaccine. On an unknown date in Aug2021, the patient experienced joint pain, aching in bones. The clinical outcome of the events bruning sensation while administering vaccine, joint pain, aching in bones was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
pt recv vax & approx 30min post vax pt collapsed @ home brought to hosp & pronounced DOA;
Patient c/0 fever of 101.8 approximately 12 hours after injection and body aches.  Had cough, no sob.  Symptoms resolved on their own.
The patient received 4 doses of MMR II; No additional AE; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient.  The patient's concurrent conditions, medical history or concomitant medications were not provided.   On 19-JUN-2018, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose regimen details, lot # and expiration date were not provided). On 25-APR-2021, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose regimen details, lot # and expiration date were not provided). On 05-AUG-2021, the patient received a third dose and on 12-AUG-2022, the patien received a fourth dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml dose (lot # U006485 with expiration date 26-FEB-2023). All the doses of the vaccine were administrated as prophylaxis.   The reporter confirmed that the fisrt two doses of 19-JUN-2018 and 25-APR-2021 were not indicated on the records received from the other pediatrician. No adverse events were reported.
ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way through the fingers lasting for 2 hours.
Hypersensitive skin and burning sensation starting in torso and spreads to the legs and arms. No unusual physical appearance, markings, or temperature change can be seen. Second COVID vaccine dose (also PFizer) caused similar reaction, but symptom developed 24-36 hours later and then symptom dissipated within 48 hours, versus the current symptoms developed less than 18 hours later. Anticipating the symptoms to resolve within the next 48 hours.
This case was reported by a consumer via call center representative and described the occurrence of thirst in a 69-year-old female patient who received FLUARIX TETRA (batch number HX3XT, expiry date 29th June 2017). The patient's past medical history included hypothyroidism, diabetes and thyroidectomy. Concurrent medical conditions included reaction to drug preservatives (allergy to various preservatives). Concomitant products included glimepiride and Thyroid Medication. On 24th August 2016, the patient received FLUARIX TETRA (intramuscular). On 24th August 2016, 10 min after receiving FLUARIX TETRA, the patient experienced thirst (serious criteria other: serious as per reporter), injection site hives (serious criteria other: serious as per reporter), rash (serious criteria other: serious as per reporter), local swelling (serious criteria other: serious as per reporter), pain in extremity (serious criteria other: serious as per reporter), fatigue (serious criteria other: serious as per reporter) and increased blood pressure (serious criteria other: serious as per reporter). The patient was treated with BENADRYL. On 25th August 2016, the outcome of the thirst, injection site hives, local swelling, pain in extremity, fatigue and increased blood pressure were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved. The reporter considered the thirst, injection site hives, rash, local swelling, pain in extremity, fatigue and increased blood pressure to be almost certainly related to FLUARIX TETRA. Additional details were provided as follows: This case was previously reported to a doctor. The patient received a FLUARIX vaccine 2016-2017 strain on her left arm at her private physician's office. The patient began to feel parched. She went home and was feeling fatigue. The patient also noted red bumps on her arm, but nothing around the injection site. The patient felt pain in her arms and legs. The patient's blood pressure went from 126 per 78 to 154 per 92. The patient went to urgent care and was observed for two hours and given an injection of BENADRYL. On the next day, the symptoms were resolved except some rash on her left forearm.
Urticaria, started after 3rd dose of oral Typhoid, No resp distress, on face and neck. Tx- Clarinex. Started oral pill 9/9/04.
Patient presented to Emergency Department approximately 5 hours post vaccination with rash. Prescribed BENADRYL 12.5 mg/5m administer 1.5 mL oral/TID x 7 days prn.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 04-MAY-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plaque forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016; dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months. There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced swelling and venous congestion after I received my 1st covid vaccine in the arm in which I received it.   28 days later and my arm is still swollen with venous congestion.  Although it's not acutely painful, it does feel heavier with some aching that I'm not experiencing in the other arm.  I have scheduled an appt with my PCP to have this evaluated but cannot be seen until 09/24/21
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid as treatment. Treatment start date: 22Jan2023, Treatment stop date: 27Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.