chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm.  On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
Headache, Myalgia, chills and fatigue Narrative:  Other Relevant History:
a 59 year old patient was administered two doses of MMRII about 4 months apart on unspecified dates/the patient did not think he was supposed to get two doses.; no adverse effects were reported; This spontaneous report was received from a pharmacist, referring to a 59-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medication and previously drug reactions or allergies was not provided.  About 4 months apart on an unspecified dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, formulation, dose, anatomical location of vaccination, dose, concentration, lot number and expiration date was not reported; indication was unknown by the reporter). For both vaccines was used a sterile diluent (MERCK STERILE DILUENT).  Furthermore, it was reported that the patient did not think he was supposed to get two doses, and thought he only needed one dose. He realized he got a second dose until he saw his medical bill (extra dose administered). No adverse effects were reported.
(R) thigh with area 4cm x 4cm redness and warmth. Non tender, no induration no drainage. Pt. examined on 11/1/10.
About 2 hours after vaccine administration, patient experienced a throbbing pain around the injection site that woke her up in the middle of the night for about 2 days. She took MOTRIN and ALEVE for pain. The throbbing subsided after 2 days but she now has pain in the shoulder joint (sharp pain when moves her arm certain ways). She has not seen her doctor yet but will make appt if pain persists after a few more days.
Pt received ZOSTAVAX on 3/4/15. Pt said that on 3/7/15 she noticed a red, itchy, rash on her hands, face and neck. Pt did not go to the doctor as of 3/16/15 when I spoke with her and she said her symptoms were better.
Bronchitis; Nasal ulcer/Sores inside nose; Itching at injection site; Injection site allergic reaction; Eye inflammation/Inflammation of eye; Fungal skin infection; Feeling hot/Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), FUNGAL SKIN INFECTION (Fungal skin infection), EYE INFLAMMATION (Eye inflammation/Inflammation of eye), FEELING HOT (Feeling hot/Feeling feverish) and NASAL ULCER (Nasal ulcer/Sores inside nose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced FEELING HOT (Feeling hot/Feeling feverish). In October 2021, the patient experienced FUNGAL SKIN INFECTION (Fungal skin infection). In November 2021, the patient experienced EYE INFLAMMATION (Eye inflammation/Inflammation of eye). On an unknown date, the patient experienced BRONCHITIS (Bronchitis), NASAL ULCER (Nasal ulcer/Sores inside nose), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE HYPERSENSITIVITY (Injection site allergic reaction). In December 2021, FUNGAL SKIN INFECTION (Fungal skin infection) had resolved. At the time of the report, BRONCHITIS (Bronchitis), EYE INFLAMMATION (Eye inflammation/Inflammation of eye), FEELING HOT (Feeling hot/Feeling feverish), NASAL ULCER (Nasal ulcer/Sores inside nose) and VACCINATION SITE HYPERSENSITIVITY (Injection site allergic reaction) outcome was unknown and VACCINATION SITE PRURITUS (Itching at injection site) had not resolved.            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.  No concomitant medication was provided.  No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2022-624170 (Patient Link).
Patient reported getting a sinus headache almost immediately after the vaccine was administered.  She said she continues to experience sinus headache and runny nose.
Post vax, pt back on 6/29/00 with right deltoid swollen, angry red, warm and painful with palpations in area. Doctor examined pt and told to take children's Motrin and apply ice packs and instructions to return the next day. This treatment continuted until 7/3 with pt returning for follow-up each day except Sunday. 7/5/00, pt returned for follow-up with no redness, swelling,or pain and noted full ROM and no evidence of original redness or swelling.
anxiety; Acoustic Neuritis; didn't hear/TV sounded awful like "blur blur", no recognition off any words, just garbled mess, it lasted the whole night; Acute Eustachian Salpingitis/ears started to feel funny going to my throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (didn't hear/TV sounded awful like "blur blur", no recognition off any words, just garbled mess, it lasted the whole night), OTOSALPINGITIS (Acute Eustachian Salpingitis/ears started to feel funny going to my throat), ACOUSTIC NEURITIS (Acoustic Neuritis) and ANXIETY (anxiety) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Product used for unknown indication, BIMATOPROST (LUMIGAN PF), LANSOPRAZOLE, COLECALCIFEROL (VIT D3), CYANOCOBALAMIN (VIT B12), IBUPROFEN, GABAPENTIN, FAMOTIDINE, HYDROCHLOROTHIAZIDE, POTASSIUM CHLORIDE (KLOR CON), DICLOFENAC SODIUM, DOCUSATE SODIUM (STOOL SOFTENER), MILK OF MAGNESIA and VALSARTAN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOACUSIS (didn't hear/TV sounded awful like "blur blur", no recognition off any words, just garbled mess, it lasted the whole night) and OTOSALPINGITIS (Acute Eustachian Salpingitis/ears started to feel funny going to my throat). On 20-Feb-2021, the patient experienced ACOUSTIC NEURITIS (Acoustic Neuritis). On an unknown date, the patient experienced ANXIETY (anxiety). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; GABAPENTIN at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOACUSIS (didn't hear/TV sounded awful like "blur blur", no recognition off any words, just garbled mess, it lasted the whole night), OTOSALPINGITIS (Acute Eustachian Salpingitis/ears started to feel funny going to my throat), ACOUSTIC NEURITIS (Acoustic Neuritis) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a consumer refers to her granddaughter, a 26 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown dates, when the patient 11 or 12 years old, she was vaccinated with  3 doses of GARDASIL 9 (lot # and expiry date were not reported). On an unknown date, patient was still tested positive for HPV (papilloma viral infection) other day after baby was born. The outcome of the events were reported as not recovered. Causality assessment was not provided. No PQC has been filed. Upon internal review, the event vaccination failure was determined to be medically significant.      Additional information is not expected as there is no consent to contact reporter.
EXPIRED VACCINE USED; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No signs and symptoms of any distress was present and offender also denied signs and symptoms any at that time.It was unknown whether patient had any medical history or had any chronic conditions. It was unknown whether the patient had any allergic reactions to any medications, foods or other products. Concomitant product use was not provided by reporter. Treatment information was not provided. Patient's race was reported as B. This case was linked to MOD-2021-391981 (Patient Link). Most recent FOLLOW-UP information incorporated above includes:On 23-Nov-2021: Follow up received contains significant information: Patient initials updated and DOB added. Dose number updated.
Patient complains of arm soreness that continues to worsen, making it difficult to move her arm.
Fluvirin w/ Thimerosal (seasonal flu vaccine) given to OB pt. LMP = unsure. EDC = 01/08/2010. Pt does NOT have an OBGYN. Pt is being followed by Dr. at Medical Center for OB care. Pt notified on 11/5/09.  Denies any adverse effects. Pt NOT hospitalized after receiving seasonal and H1N1 flu vaccines. 11/24/09 and 12/1/09 Medical records received for dates 11/5/09 to 11/13/09. DX: Normal IUP Pt. is pregnant and received H1N1 vax on 10/26/09. Medical office states vax. contained preservatives. OV 11/13 Normal IUP. No c/o.
At approximately 9:45pm, c/o a headache while providing patient care, she then had an emesis that was greenish in color and went unresponsive.  Emergency services was contacted,   arrived approximately 5 minutes later to transport her to the local  ER via stretcher.    Facility received an update from patient's daughter later that night,  informing staff that she had experienced a brain aneurysm and was being transferred to Hospital.
After the flu shot a large black spot the size of a quarter formed. I went back to pharmacy and the pharmacist said it was a bruise. A week later bruise was still there. I showed it to another pharmacist and he said to go see a doctor. I did and was told the shot hit a blood vessel and I had a hematoma. I told doctor about other pains and was told it appears that a nerve was nicked.
deep eye bleed; Headache; Dizziness; This is a spontaneous report from a contactable consumer (patient husband). An 82-year-old female patient (reporter's wife) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8730) at single dose in right arm on 29Mar2021 at the age of 81-year-old for COVID-19 immunisation. The first dose was on 27Feb2021 (Lot number: EN6202) at the age of 81-year-old administered in right arm. Medical history and concomitant medication were none. Patient had experienced headaches, dizziness, and had a specialist evaluation of her eyes. She had a deep eye bleed which occurred around 01Sep2021. She had had EEG, MRI, and MRA testing done in 2021, all unknown results. Her headaches and dizziness started the last of Jul2021 to the first of Aug2021. It was ongoing, and had stayed the same. It was unpredictable. She had her last EEG today. The outcome of event deep eye bleed was unknown. The outcome of rest events was not recovered.  Follow-up attempts are completed. No further information is expected.
Rabies vaccine (Imovax) and Rabies Immune Globulin were given in same extremity (right arm).
Erythema, swelling, warm to touch. Advice to apply cool compress - can give BENADRYL return to clinic if no improvement, 1 to 2 days.
no adverse event; The 16 year old patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 16 year old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 16-JUL-2020, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # S021729 (expiration date: 20-AUG-2020) for prophylaxis (additional dosage regimen information was not reported). No adverse effects were reported.
This report was received from manufacturer for Infanrix and was assigned manufacturer report number A0390426A. This was originally reported by a consumer concerning a 59 day old male pt with no allergies and no medical conditions who on 12/20/02 was vaccinated with a dose of Comvax. Concomitant vaccination in the thigh included an IM dose of Infanrix. It was not known if the pt had received previous doses of Infanrix. There was no concomitant medication. At an unspecified time post vaccination on 12/20/02, the reporter stated, "My child had a severe reaction, uncontrollable crying for three hours." The pt's pediatrician recommended Children's Tylenol, which "significantly" helped treat the event. The reporter stated that the event was probably related to Infanrix administration. As of 12/30/02, the event had resolved. Additional info is not expected.
ED to Hosp-Admission Discharged  5/9/2021 - 5/11/2021 (2 days)  Principal problem Discharge Summary            Discharge Summary   Hospitalist Medicine       Date: 5/11/2021  Admission Date: 5/9/2021  Length of Stay: 2 Days  Discharge Date: 5/11/2021     Admission Diagnosis     Medical Problems     Hospital Problems        POA   * (Principal) Sepsis  Yes       Type 2 diabetes mellitus, with long-term current use of insulin  Not Applicable       Benign essential hypertension Yes       CKD (chronic kidney disease), stage IV  Yes       Gastroparesis Yes       Granulomatosis with polyangiitis  Yes       Hypothyroidism Yes       COVID-19 virus infection Yes       DVT, lower extremity, proximal, acute, right  Yes       Acute on chronic respiratory failure with hypoxia  Yes       Monilial vulvitis No        Hospital Course:        Patient recently was admitted for possible sepsis picture.  He was treated according to sepsis protocol including antibiotics for bacterial infection for pulmonary infiltrates however it was felt the pulmonary infiltrates are more related with COVID-19 pulmonary findings. Eliquis was started for DVT. Medical Center had been contacted Dr was the pulmonary attending and discussion is documented below- Attending hospitalist spoke to Dr from Medical Center.  At this point they know that she has Wegener's granulomatosis involving her kidneys and causing her renal failure but they do not think that is what is going on in her lungs.  They have still trying to work-up her infiltrates.  She has it we obtain a nocturnal oximetry study.  She was reassured that the patient is on her normal oxygen rate despite the DVT in her leg.  She feels this should rule out a pulmonary embolism.  If the patient is doing well from cardiopulmonary standpoint tomorrow she should be able to go home on Eliquis and follow-up with the specialist.   She was continued on Monistat cream for 3 nights total.   At this point patient will not require antibiotics will continue on Decadron and may be discharged to follow-up with her specialist.
Smallpox (vaccine) provided on 2 Dec 2009 for military deployment. On 15 December 2009, she developed a macular-papular eruption on both arms and legs. Dermatolgy consultant-diagnosed as smallpox vaccination generalized (self-limiting).
She went shopping with an unvaccinated friend who also got sick around the same time as her, but otherwise has no clear exposure history.  Since her illness started she reports labile blood sugars, generalized weakness, orthostasis and very poor appetite in addition to above symptoms.  She's felt too unwell to take her medications for about two days last week but has otherwise taking her tacrolimus, mycophenolic acid, and prednisone 5mg daily as prescribed.  She's on chronic suppressive cephalexin for recurrent UTIs.  She actually called EMS last Saturday due to not feeling well and low blood sugar, but opted not to be brought in at that time.  Admitted 06/18/2022 and currently hospitalized.MPRESSION AND PLAN: 1. Acute kidney injury on chronic kidney disease.  Currently, the patient with     renal function, which is worse than previous baseline with a creatinine of     2.3, her baseline is usually 1.8-1.9.  The patient may have hyperabsorbed the     Prograf and may have a high tacrolimus level, although she does not     demonstrate symptoms of toxicity.  We will check levels obviously.  The     patient may also have some soft hemodynamics, acute tubular necrosis.  We have     seen COVID related renal impairment many times.  Once again, I think this is     volume contraction in the setting of a complex drug regimen.  We will hydrate     and monitor. 2. COVID-19 infection.  Main manifestations at this time would include cough,     fever, and diarrhea.  We will continue to monitor intake and output, hydrate     as described.  The patient has about 10 days out, so not really a candidate     for Paxlovid or monoclonal antibody therapy. 3. Diabetes mellitus.  Continues on a sliding scale insulin regimen. 4. Hypertension, well controlled on current medical regimen. 5. Distant seizure disorder, stable on current medical regimen.  Other problems     not as active.
Dose 1 - Fever 104.1 degrees, severe chills, dizziness, temporary loss of bladder control (12 hrs. duration), weakness, muscular body aches all over.  Symptoms commencing eleven (11) hours after dose 1.   Ended in about 24 hours. Dose 2 - Myocardial infarction,  Acute Congestive Heart Failure commencing eleven (11) hours after dose 2.   Hospitalized 3 days.  Symptoms of m/i:  couldn't breathe, dizziness.  911 summoned.
Reportedly, 30 minutes post third injection of vax, this pt experienced severe fatigue, arthralgias, and myalgias. Treatment and outcome of events are unknown.
1/10/2022 covid +, admitted to Medical center for 7 days with dyspnea.  Readmitted 2/21 with AHRF and PNA. transferred to Hospital on 3/2/22.  Patient experienced spontaneous pneumothorax and  code blue event.
Pt. left exam room, checked out at front desk. Became pale & light headed in hallway after leaving clinic. No LOC.
Patient was 4 years old at the time of administration. Patient was given Pfizer Covid vaccine for ages 5-11. Parents were notified. No side effects anticipated.
after a month about 15 days I was feeling intermitten shock like pain in the region near my right air; I am experiencing dull pain in my head region also near my ear; I feel like my head is being heavy sometime.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "after a month about 15 days I was feeling intermitten shock like pain in the region near my right air"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "I am experiencing dull pain in my head region also near my ear"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "I feel like my head is being heavy sometime.".  Additional Information: The patient reported for self that doubly vaccinated by pfizer vaccine couple of month ago in withheld. I didn't have any immediate side effect. However, after a month about 15 days I was feeling intermittent shock like pain in the region near my right air. Now the shock like pain is gone. However I am experiencing dull pain in my head region also near my ear. I feel like my head is being heavy sometime. And questioned is this the side effect of vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Gastrointestinal - immediate onset of watery diarrhea multiple times  on the first day 4/26/2021 ;  multiple watery stool events each day 5- 6 times; after 3-4 weeks, mild improvement,  During July 2021 more improvement but still loose stool,  3  times per day; continued improvement to soft bowel movement 2 times per day, but not watery. August 10, 2021 - first normal bowel movement that has continued to date of this submission.
9   6:30 Pm 01/07/2021   broke out into a rash on arm and leg , side headache and  front headache, Waive of extreme  tiredness . Arm  at the site started to itch and swell huge , very hot and sensitive to the touch
About 3 days after my first shot the arm I received it is started going numb. It would happen about every 5 minutes for a few days. It's worse when I am sitting down. That lasted about 4 days. It now happens every now and then and my other arm is starting to go numb as well. I have opted to not get the 2nd one because I am afraid of what will happen to my arms and nerves.
Pt exp stinging @ inject site following vax w/MMR; no further details were provided;