chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/21/2021 presented to ED for SOB and cough.  Patient stated that she developed cough, congestion and body aches 7/14/2021.  Patient son tested positive for COVID and she subsequently went to Urgent care to be tested positive for COVID 7/18/2021. Patient stated that she received the Johnson and Johnson vaccine in April 2021.  diagnosed with COVID-19 pneumonia and viral sepsis, acute hypoxic resp failure. Remdesivir through 7/26.  7/26: patient still admitted as of the time of this report submission.
This is a 71y.o. female hx of HTN, HLD, and breast cancer dx in 2018 with lumpectomy/radiation in 2018 taking Arimidex since presenting secondary to DIB.  The patient states she had her covid vaccine Pfizer completed in March. She then decided to go to her timeshare and had flown there last week. She states that they had done multiple driving trips and had only gone to one casino that was low crowds.  She states starting on Tuesday prior to flying home she developed shortness of breath with exertion to where she needed a wheelchair for transport. She denies any syncope or chest pain. She denies any history of blood clots. She denies any fever or COVID exposure.   In emergency department patient is found to be Covid positive as well as have acute PE.  ID consulted and pt on Heparin.      seen this morning. No tobacco history, resides with her husband. To check lower extremity venous Doppler studies for completeness. Plan of care discussed with patient. To coordinate outpatient follow-up with her primary care physician, Doctor. Anticipate 6mos of anticoag ID following, on decadron and Remdesivir
Presented to hospital 11/29/07 with severe low back pain, tingling, numbness and burning sensation in BLE. Dizziness, unsteadiness & weakness. Developed severe paraesthesias follwoing the flu shot. Diagnosed Guillian Barre Syndrome 2nd to flu shot. Demyelinating Polyneuritis. Pain under control by discharge to home 12/21/07 2/6/08-records received for DOS-11/28-12/21/07-DC summary not available. C/O severe low back pain, tingling, numbness and burning sensation in both lower extremities. Unsteadiness and weakness. After flu shot developed diarrhea and nauseous feeling. PE: positive Romberg phenomena, areflexia in both lower extremities without affecting the bulbar muscles or cranial nerves. Severe stabbing pain low back area radiating to thoracic region. Developed severe pain in epigastric area with bloating. DX: acute pancreatitis. 4/3/08-DC Summary received for DOS 11/28-12/21/07-DC DX: Acute inflammatory demyelinating polyneuropathy or Guillain-Barre syndrome following vaccineation. Acute or subacute onset of pancreatitis, probably related to IVIG immunoglobulin-G treatment. Severe neuropathy in both lower extremities. Pneumonia. Severe ataxic gait. Abdominal pain from pancreatitis. Chronic pain as result of demyelination of dorsal ganglion resulting in acute Guillain-Barre syndrome. Ptient recovered enough to go home but had residual neurological findings for which she was to recieve home rehab.
Within approximately four (4) hours of the vaccine shot, my shoulder started feeling tender and painful. By the evening, pain intensified and my shoulder was getting stiff and throbbing. Overnight I was woken up several times due to sharp pain. By the following morning (11-16-18) my shoulder was frozen, extremely tender to the touch and painful. Over the next several days I used a homemade sling, took 2,200 mg  of Ibuprofen daily and applied heat. I remained bedridden for three (3) days. I was unable to move my arm. On 11-21-18, I was still in extreme pain with limited motion at which time I obtained an Ultrasound and X-ray from the clinic. The Ultrasound revealed a small pocket of fluid as well as bone erosion at the injection sight. On 11-23-18, I went to the Medical Center ER and was diagnosed (without any tests) with Tendonitis. On 11-26-18, I received another Toradol shot for the pain and stiffness. Still in pain. Still tender and limited range of motion without shooting pain
Vaccine given on 5-2-12, started with rash on 5-13-12. Generalized - fine - raised - red, diagnosed with Measles rash S/P vaccination - viral exanthem.
Arm pain; This is a spontaneous report from a contactable Pharmacist reported in response to HCP letter sent in cross reference case. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 intramuscular, administered in Deltoid Left on 09Jan2021 16:45 (Batch/Lot Number: EL3249; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation and Prevention of SARS-COV-2 at Hospital. patient medical history and concomitant medications were not reported. The patient experienced arm pain on 09Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.
Narrative: COVID infection following COVID vaccine series 02/16, Pfizer, dose #1 03/09, Pfizer, dose #2 08/03 pt cc: cough, fatigue, dyspnea, exposure: unknown 08/09 COVID swab, result: detected 08/09 EKG: 93005: NSR 88, N-axis, no stemi 08/09 pt admit ED dx: ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/2 COVID-19 PNEUMONIA loc: 10 days 08/09 FIBRINOGEN 440 mg/dL 214 - 489 [67] 08/09 DDIMER 0.43 mcg/mL 0.27 - 0.49 [67] 08/09 TROPONIN I <0.016 ng/,mL Ref: <=0.031 [67] 08/09 CXR: impression: No acute cardiopulmonary abnormality or significant change since August 2020. 08/09 CT chest w/o: impression: 1. Bilateral patchy foci of groundglass opacity is pronounced in the lower lobes, consistent with COVID-19 pneumonia. 2. Hepatic steatosis with probable hepatomegaly. 3. Small hiatal hernia.
Received Moderna Booster on 12-7-21. Symptoms of hives began to appear on 12-14-21. The hives started on my scalp and neck. The past week the hives have worsened. I have developed dermatographia (skin writing) and will get hives for 10-40 minutes on any location that is scratched. Seams of clothing will also trigger hive development.
PATIENT DESCRIBES AS HOT, FEVERISH, ACHING PAIN, FEVER, PAN.
One week post vax, the child had definite lethargy and high fever. Additionally, the child had heat and a 2cm induration at the injection site. The pt was seen by a physician and treated at the office. The most recent information received on 4/12/00 reported the condition as completely resolved.
The information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gende. The patients' concurrent condition, medical history and concomitant therapy were reported. On an unspecified date, an unspecified number of patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#N009802, expiration date 19-DEC-2019) (dosage, frequency and route were not reported) for prophylaxis(incorrect product storage). The vaccine was stored at a temperature from 32F to 35 F for 6 days. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. No adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006766: US-009507513-1708USA004001: US-009507513-1708USA004000:
Arm & hand of injected limb was red & swollen for 2 days. Arm also stiff with some numbness. Today (day 5) no swelling seen. Redness at site. Some stiffness & numbness still present.
his arm was sore; This is a spontaneous report received from a non-contactable consumer identified during social media monitoring.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patients arm was sore after receiving the vaccine but was otherwise felt fine. Patient took covid-19 vaccine after it was approved for children ages 12-15. Outcome of the events was reported as unknown.  No follow-up attempts are possible,information about lot/batch number cannot be obtained
I was in hospital for hernia repair.  An un-named nurse "PUSHED" pneumoccal vaccines on me and my roommate when I was recovering from my surgery.  She was very pushy.  Seven days later, I fell victim to the sudden onslaught of Guillian Barre' Syndrome.  6/02/2008 MR received for DOS 7/27-8/21/2007 with D/C DX: Guillain-Barre Syndrome.  Respiratory Failure 2' to GBS. Pneumonia. Hypertension, Hyperglycemia, Chronic Pain.  Pt presented with worsening progressive ascending weakness. Sx began with leg weakness and hip pain and progressed to arm weakness, numbness of the lower extremities with walking difficulty and subsequent fall. PE (+) for weakness and decreased muscle strength of the legs and stocking-glove sensory loss. Absent reflexes in lower extremities and depressed in upper. L toe upgoing. Pt progressed to respiratory failure and was intubated, complicated by Serratia and Pseudomonas pneumonia. Tx with IVIG with minimal improvement. PEG tube placed for nutrition on 8/14/08. Tracheostomy done. By transfer date pt was breathing on own and taking po, but still weak. D/C to rehab.
This spontaneous report was received from a medical assistant via office manager and refers to patient of unknown age and gender. On 26-AUG-2014 the patient was vaccinated with LIQUID PEDVAXHIB, (lot # K000331, expiry 23-OCT-2015, dose # and route unspecified), that were exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness in face. Swelling and redness in the peri-orbital areas. Redness around each fingernail. Red, scaly rash over the chest, upper back and lower back. Still recovering.
Patient presented to emergency department on 11/5/2021 with altered mental status. She was diagnosed with COVID-19 infection on 10/28/2021. She was admitted to the intensive care unit. for management COVID-19 infection and acute toxic metabolic encephalopathy.  She was transferred out of the ICU on 11/15/2021. Patient's symptoms continued to worsen during hospital stay and she was changed to comfort measures only on 11/20/2021. Patient expired on 11/20/2021.
Tested positive for Covid 19; Tested positive for Covid 19; breakthrough infection; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208; Expiration Date: Jun2021), dose 2 intramuscular, administered in Arm Left on 17Mar2021 16:00 (at the age of 71-years-old) as a single dose for covid-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198; Expiration Date: Jun2021), dose 1 intramuscular, administered in Arm Left on 24Feb2021 16:00 (at the age of 71-years-old) as a single dose for covid-19 immunization. Medical history included hypertension: Blood pressure high. Concomitant medication(s) included lisinopril taken for hypertension. Since the vaccination, the patient been tested for COVID-19. 5 months later she has a breakthrough infection and has tested positive for Covid 19. The patient tested positive for covid 19 on 18Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Aug2021. No more information available. The adverse event doesn't require to visit emergency room and required to visit physician office for covid-19. Outcome of the event was unknown.   Description of Product Complaint: Calling about the Pfizer BioNTech Covid Vaccine. States that she received her 1st dose on 24Feb2021 and her 2nd dose on 17Mar2021. Now, 5 months later she has a breakthrough infection and has tested positive for Covid 19.   Follow-up attempts are completed. No further information is expected.
5/28/09: Client received MMR and Varicella vaccines. Mom was instructed to observe carefully for fever 5-12 days after vaccine administration and to consider giving TYLENOL prophylactically during this time; due to client's history of febrile seizure disorder. 6/4/09: Mom reports that client developed a low fever of <101 degrees Fahrenheit on 6/3/09. He experienced "3 small seizures" on this date that mom related to the fever. He also vomited a couple of times. She did not administer any DIASTAT to manage his seizures. Mom states that he is better today (6/4/09)--eating and drinking normally, and playing. She is giving him TYLENOL and/or ibuprofen every 4-6 hours around the clock to manage his fever. PMD and client's pediatric neurologist notified. 6/5/09: Mom reports that client still appears ill and vomited this morning. He is eating and drinking normally. His energy level is variable. Mom took client in to see MD this afternoon. No change in plan of care was created during MD visit on 6-5-09. Mom continued to give TYLENOL every four hours to manage client's fever. 6/11/09: Mom reports that the episodes of vomiting continued, and that on the evening of 6-5-09, client also developed diarrhea, which continued for the next two days. During this time, mom reports that client was very fatigued and was either sleeping or "staring off into space...he just seemed ill." She denies any observable seizure activity during this time period. She states that he was "back to normal" by 6-8-09 and is not currently experiencing fever or the gastrointestinal symptoms. He has not seen his MD since the 6-5-09 visit. 6/12/09: MD and client's pediatric neurologist notified by public health nurse of subsequent symptoms during this time period after vaccine administration.
Chronic full intense back and knee pain with radiating stomach bloat and pain with intermittent diarrhea and constipation. Nauseous on and off. Extreme fatigue with off and on chills. All Started about 7 days after shot.
hives; itchy scalp; burning tongue; itchy/swelling throat; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue), THROAT IRRITATION (itchy/swelling throat) and URTICARIA (hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue) and THROAT IRRITATION (itchy/swelling throat). On 05-Feb-2021, the patient experienced URTICARIA (hives). At the time of the report, PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue), THROAT IRRITATION (itchy/swelling throat) and URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, chills, rash 12 hours after vaccination and again the 2nd night after vaccination
Initial unsolicited report received from a consumer on 10-Oct-2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOTS) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was reported that, the patient received pneumonia vaccination in the past. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced near lethal flu. It was a case of potential vaccination failure. It was reported that, the patient received flu shots in the past and experinced near lethal flu as an event after the vaccination. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: near lethal flu and potential vaccination failure. Documents held by sender: none.; Sender's Comments: This social media case reported by consumer on facebook patient had two flu shot and both times he got lethal flu. Time to onset is unknown, additional information regarding patient medical history , lab investigation regarding the type of virus, culture report are needed to further assess the case. Based on available information the role of vaccine cannot be assess.
Two days after the vaccination I started feeling pain under arm, followed by two lumps in throat and arm went to the ER at a clinic was told it was side effect of vaccine 3 weeks before effects subsided. Lumps recurring in my throat.
Sweats; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats) and CHILLS (Chills) outcome was unknown.            No concomitant medication was reported.    No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647578, US-MODERNATX, INC.-MOD-2022-647571 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647578:Case for patient-2 US-MODERNATX, INC.-MOD-2022-647571:Reporter's case
Both arms and legs were in a lot of pain/Still head and arm hurt; Felt like someone was constantly pulling hair; Throat was dry; Kept urinating all night; Stayed mostly in bed the night of the shot then for the next two days; First night have shivers; Hot; Cold; Chest pains that night; Still head and arm hurt; This is a spontaneous report from a contactable consumer (Patient). A 84-year-old non pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262), Solution for injection, Dose 2 via an unspecified route of administration, administered in Arm Right on 08Feb2021 15:00 and dose 1 via an unspecified route of administration, administered in Arm Right on 18Jan2021 15:00 (Batch/Lot Number: EL8982) both as single dose (at the age of 84-year-old) for covid-19 immunisation. Medical history included (Long-term Previous) Neuropathy, Epstein-Bar Virus. Concomitant medications included meloxicam (MELOXICAM) and amlodipine (AMLODIPINE). The patient previously took statin [atorvastatin calcium] and experienced statin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 08Feb2021 20:00, the patient experienced both arms and legs were in a lot of pain/still head and arm hurt, felt like someone was constantly pulling hair, throat was dry, kept urinating all night, stayed mostly in bed the night of the shot then for the next two days, first night have shivers, hot, cold, chest pains that night, still head and arm hurt. It was reported that, Monday night after shot Both arms and legs were in a lot of pain, felt like someone was constantly pulling hair, throat was dry, kept urinating all night. Stayed mostly in bed the night of the shot then for the next two days. First night have shivers, hot and cold (and had to take an acetaminophen to help relieve). Felt well by Wednesday afternoon, then chest pains that night. Still head and arm hurt on Thursday. Friday feeling better.Therapeutic measures were taken as a result of first night have shivers, hot and cold. No treatment was received for other events. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
her smell is off; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (her smell is off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (her smell is off). At the time of the report, ANOSMIA (her smell is off) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected non serious AESI of Anosmia , 3 weeks after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date of vaccination, details of the first dose and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected non serious AESI of Anosmia , 3 weeks after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date of vaccination, details of the first dose and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
She got her vaccine, and within the first 15 minutes felt like her tongue was fat.  The reaction started at 1:15 and her headache was getting bad and turning into a migraine, and took her migraine medicine.  She was getting a stretching and painful sensation in her skin over her head.  She lost her ability to swallow, and everything around her face and neck were numb.  She called the hotline and called her doctor, and was able to focus very hard and able to swallow but felt very narrow passageway.  She then felt like she had a bubble in her throat, and then decided to call 9-1-1.  The first responders came to her house and said that they could not see anything in her throat, they gave her Benadryl and within the hour everything seemed to dissipate and they stayed with her until she stabilized.  Her BP was high and her heart rate was high as well, 98-100.  Her temperature was 98.5.  She felt really awful and nothing was going on with her throat or breathing after the Benadryl and felt foggy and tired and by the third day she was completely fine.
I had hives on my chest and arm. I also had a rash under by breasts and between my breasts with blisters. I have taken pictures if you would like if they are needed.
Patient came in to receive her COVID vaccination and received the Janssen (J&J) vaccination this morning.  Patient confirmed that she had not received a vaccination previously but after administering the J&J vaccination, pulled out a completed vaccination card for both doses of Moderna completed in February 2021.