chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), intramuscular on 11Jan2021 at a single dose for COVID-19 immunization.  Medical history included obesity from an unknown date and unknown if ongoing and ongoing stress.  There were no concomitant medications. It was reported that the patient developed Shingles on 16Jan2021, which was 5 days after receiving the first dose of the COVID-19 vaccine, on 11Jan2021. The patient received Valtrex as treatment for the event. The physician stated that she wants to say that it was not serious but she is not sure but reported that the patient is ok. This was the first time the patient was diagnosed with shingles. The physician added that the patient's lesions are getting better but she still has nerve pain and was prescribed gabapentin. It was also reported that the patient stated that there are other reasons such as stress as to why she developed shingles, like loss of a family member and loss of her client. It was clarified that the patient is stressed since she works for a senior care facility and co-workers and clients have lost their lives. She lost her mom last year and stated that she basically has stress in her life.  The patient is scheduled for her second dose on 01Feb2020 and asked the physician if she could get the second dose. The physician doesn't see any reason why the patient wouldn't be able to receive it. The physician did not think it was a problem but she called Pfizer to ask if the patient should get the second dose and asked for recommendations on administering the second dose to her patient. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
received vaccines on 5/12/20 5/20/20 @ 3am started with fever around 11pm child started "convulsing" and vomited x 1 also had red bumpy rash around mouth, seemed tired and less responsive parents called EMS who advised Tylenol, parents declined to be taken to ER Parents ended up taking him to ER --was examined and told it was a febrile seizure
Broke out with chicken pox on body and face. Blisters, rash, afebrile. 06/05/05
On 8/30/2011 subject reported by phone that she had started on 6/5/2011 with diffuse abdominal pain of moderate-to-severe intensity, nausea, vomits, generalized pruritus, and jaundice. Abdominal sonogram on 7/22/2011 showed a mass in the liver. Local hospital admission (7/23/2011) and testing led to referral to national hospital and exploratory laparotomy (8/8/2011), and discovery of liver tumor (5 cm diameter) in the portal vein bifurcation with infiltration of the extrahepatic bile duct. Tumor was unremovable. She was discharged 8/11/2011 with treatment against pruritus and referral to Oncology (appt 9/7/2011). On 12/22/2011 subject was in terminal phase, receiving palliative care at home; diagnosis was liver cancer.
Fever, severe headache, body aches. Administered IV fluids. No redness at injection site.
ITCHINESS AT INJECTION SITE; INJECTION SITE ARM FEELS PAIN/SORE/HURTS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with nortriptyline for antidepressant, duloxetine for antidepressant, progesterone, and estradiol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 27-APR-2021, the subject experienced itchiness at injection site. On 27-APR-2021, the subject experienced injection site arm feels pain/sore/hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site arm feels pain/sore/hurts, and itchiness at injection site. This report was non-serious.
UNSPECIFIED LOCALIZED DISCOMFORT; DIFFICULTY IN WALKING; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoarthritis on her right leg. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown) dose was not reported, 1 total administered on 29-APR-2021 to left arm for prophylactic vaccination.  On an unspecified date, the patient experienced some unspecified localized discomfort/felt the muscular discomfort on her left leg and spread all over her body when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient recovered from some unspecified localized discomfort/muscular discomfort on left leg and spread all over body, and had not recovered from muscular burning sensation (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 221D21A, and expiry: Unknown) dose was not reported, 1 total administered on 21-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient stated after booster shot discomfort came back again (dose number in series 2). It had not subsided since and she had to take 2 extra strength Tylenol and Aleve to be able to walk. Patient stated, that while walking, she had to stop due to the discomfort (dose number in series 2). The patient was concerned regarding polyethylene glycol but was informed that Janssen vaccine did not contain polyethylene glycol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified localized discomfort, and difficulty in walking (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220253476 (series 1).
Got vaccine on left side, same side of mastectomy. Sore arm, turned black and blue, lympatic fluid under arm, swelled to size of baseball. Continued to get red and itchy. Swelling did not go down. As of 11/07/21 swelling has gone a little. Under arm and area of mastectomy of left side is bruised black and blue.
The patient complains of major swelling in the arm where the vaccine was administered. Swelling to the point where he could not lift his arm.  He complained of a lot of pain. The patient also complained of a high fever and chills. The fever began 12 hours after the vaccine was administered.  The fever was as high as 103 degrees.
administered  past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.  The vial expired on 13 October 2021 and was administered to the patient on 20 October 2021.   This case was linked to MOD-2021-359945, MOD-2021-360524, MOD-2021-359936 (Patient Link).
Medical Assistant administered Pfizer-BioTech Bivalent, instead of the primary series (non-bivalent); there was no adverse reaction, no treatment was required
Shortly after getting the vaccine, I came down with low grade flu symptoms (dizziness, fever, and extreme aching in the bones, particularly lower back). After a week, that subsided. However, the lower back pain has continued and I now suffer from shooting pains and temporary paralysis (loss of control) of my legs, often short enough to just invoke jerking movements while walking, running and bicycling (no falls yet). It hurts to sit, it hurts to stand, it hurts to move. Basically, I fidget to find a comfortable position all the time, then a few minutes later it hurts in my spine again and I have to move.  [[Vaccine Lot # UH745AB ]]
Vaccinated with the expired vaccine for their 2nd doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 10:16 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.
MILD HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the patient experienced mild headache. On 11-MAR-2021, the patient experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild headache, and tiredness. This report was non-serious.
Information has been received from a healthcare worker concerning multiple unknown patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unknown dates, the multiple unknown patients received improperly stored M-M-R II (lot #, expiration date, dose and route were not reported) for prophylaxis. Previous temperature excursion was reported as greater than 10 excursions. No details were provided regarding temperature or time frame for the excursions. No adverse effects was noted. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014513: US-009507513-1612USA014298: US-009507513-1612USA014512:
Pt with diagnosed heart failure. S/S:  Lethargy/Fatigue,  Fever/Chills, Onset 02/15/2021 Patient does not have myocarditis or pericarditis.  No new cardiac diagnosis given.   Patient has post vaccine dehydration and syncope.  Was not felt to have a stroke/thrombosis (brain MRI normal). Do not count in case load.  Patient also with hx of hypertension, past hx of breast cancer and adrenal adenomaq
immediately following injection pt states "i fell dizzy and funny in the head". she also reports "itchy throat".
clarification if one experiences a severe allergic reaction with 1st dose as one of their family members has experienced a severe reaction; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced a severe allergic to the 1st dose. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
9AM 7/19/02 woke up with a very sharp pain that radiated from the back of the neck down the spinal cord. During the day until she went to bed that night, raising her right arm caused her great pain in the mid spine region. Her neck also hurt. The pain took her breath away. She took Advil twice during the day with only moderate relief. When she awoke the next morning her symptoms had completely gone.
This 80 year old   white  male received the Covid shot on  4/8/21 and died on  4/18/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Varicella rash (about 20 lesions) on scalp, trunk, diaper area. 1st noted 17 days after vaccine. Treatment - symptomatic.
Fever; Tiredness; Weight gain; Vitamin D deficiency; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency), SINUSITIS (Sinus infection), FATIGUE (Tiredness) and PYREXIA (Fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-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) 1 dosage form. In December 2021, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency), FATIGUE (Tiredness) and PYREXIA (Fever). At the time of the report, WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency) and FATIGUE (Tiredness) outcome was unknown and SINUSITIS (Sinus infection) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 Degree. On an unknown date, Vitamin D: Lacked.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  On an unknown date BODY TEMPERATURE: 99-100 Degree On an unknown date VITAMIN D: Lacked  Treatment Drugs Not Reported  The reporter's causality for the event(s) of FELT TIRED, WEIGHT GAINED, LACKED VITAMIN D, SINUS INFECTION and FEVER with Humira was not provided.  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   Reporter did not allow further contact
day of vax pt exp 3-4cm wheal & flare react localized to rt thigh. observed for half hr & ice pack applied to wheal, lesion decreased
This spontaneous report as received from a physician refers to a 15 month old male patient. On an unknown date, the patient was vaccinated with a 0.5 ml "twice" dose of M-M-R II (dose and lot # not reported) subcutaneously. On an unknown date, the patient experienced a subcutaneous nodule at the injection site. At the time of the report, the patient's ouctome was unknown.
Fever to 102, lasting 48 plus hours, 4cm local Reaction with pain, redness, swelling. Treated with Motrin and Vicodin.
Period started 7 days early, 7 days after vaccination. Period lasted 9 days instead of 7.  Also had a random hot spot (splotchy & red, warm, did not respond to benadryl) on my right knee that would come and go for 2-3 days post vaccination.
Client presented to Health Department for a Pfizer COVID-19 vaccine - client documented he had not received a prior COVID-19 vaccine on the consent form.  Pfizer vaccine was provided. While documenting the vaccination into the writer found documentation that client had received a Janssen COVID-19 vaccine (Lot 0434A21A) on 4/7/21 at the Pharmacy.  Pharmacy contacted and verified client had received the Janssen vaccine 4/7/21.  Client did not respond to voice messages left.  Letter sent to his address.+  No negative outcome reported by client.
Extreme dizziness, ears ringing at first which then developed into static sound, wheezing, hyperventilating, loss of vision when attempted to walk, almost passed out.  Lasted about 15 minutes in total.
This spontaneous report was received from a nurse via company representative refers to unknown number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with GARDASIL (dose, route of administration, lot# and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date, 15 min after vaccination, unspecified number of patients fell and fainted. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The causal relationship between the events and GARDASIL vaccine was not reported. Additional information has been requested.
Patient was given .25ml of The booster 50mcg 0.5ml instead of the Moderna 6m-<5 dose 25mcg .25ml
1 DAY AFTER VAX EXPER FEVER,NAUSEA,TINGLING. TINGLING LASTED 1 DAY. NAUSEA LASTED 2 WEEKS. "TYLENOL DID HELP WITH SYMPTOMS". TO DATE ALL SYMPS HAVE RESOLVED COMPLETELY
16OCT97 pt called & reported flu inj site from yesterday was swollen, red, & itching;pt called PMD who said could take flu vax again in future if sx did not worsen & they did not;
mild blistering rash on the hands, starting on the index finger of the injected arm, and over a period of days beginning on the other hand as well. caused little change in daily routine, possibly helped by skin care regimen necessitated by eczema. cleared up by current date
Vein is protruding, enlarged and purple; allergic reaction; her vein was popping out felt a little hard; tingling, numbness and achiness down to her toes; Felt tingling in her legs right behind her knee; tingling, numbness and achiness down to her toes; Vein is protruding, enlarged and purple; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2021, outcome "unknown", described as "allergic reaction"; VEIN DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "her vein was popping out felt a little hard"; PAIN (non-serious), HYPOAESTHESIA (non-serious) all with onset Sep2021, outcome "unknown" and all described as "tingling, numbness and achiness down to her toes"; PARAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "Felt tingling in her legs right behind her knee"; VASODILATATION (non-serious) with onset Sep2021, outcome "unknown", VEIN DISCOLOURATION (non-serious) with onset 29Sep2021, outcome "unknown" and all described as "Vein is protruding, enlarged and purple".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen arm at injection site  hot to touch sore shoulder arms knees hips backs stiff
17JUL91 pt recvd Engerix-B; 3rd day p/vax pt exp h/a & fever; tx Advil; events abated approx 4 days p/inject;
All her joints started aching really bad; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (All her joints started aching really bad) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Asthma (The past medical history includes asthma.). Concurrent medical conditions included Allergy to vaccine (The patient is reported as possibly allergic to tetanus injection.). Concomitant products included MONTELUKAST, DESLORATADINE (CLARINEX [DESLORATADINE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 07-Jan-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced ARTHRALGIA (All her joints started aching really bad). At the time of the report, ARTHRALGIA (All her joints started aching really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details include ibuprofen and aspirin; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
following vax w/flu pt devel a local reaction, a circular red welt the size of a one half dollar which eventually faded;
pt is uncomfortable and experiencing local pruritis, pain and swelling after a week. pt will wait a few more days to see if adverse events subside but will go to see physician if not
Case number PHEH2016US032425, is an initial spontaneous report received from a physician on 08 Dec 2016. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of influenza virus vaccine INN (unknown whether seasonal or pandemic) intramuscularly on an unspecified date. On an unspecified date after vaccination, the patient experienced a metallic taste in her mouth. The patient was unsure which flu product it was. The outcome of the event was unknown. The seriousness and causality were not reported.
severe swelling and paint at injection site the size of a tennis ball, numbness on right side of scalp-pins and needles feeling, had trouble moving left hand and could not grip with left hand on 7/19/21 pt started having numbness in right side of head went to urgent care had ct scan and was diagnosed with bells palsy and pt will see a neurologist
swelling and lump near elbow and some redness. lump lasted for about 6 days
Fever of 101 plus Fatigue, muscle and body aches.  Stomach upset.  Urgency to urinate. for first 24 hours. low grade fever on and off for next 11 days.  Day 12, woke up with low fever and rash on chest and back. Day 13, woke up with low fever and rash spreading to neck, face, ears, underarms and all of torso.
Pt with early pregnancy. Reports hx anaphyllaxis with flu shot in past. Pfizer covid lot #FE3592 given at 2:24pm. At 2:45 c/0 lightheadedness and feeling "weird". vs 121/72 hr 92 and reg o2 sat 100%. Rapid resonse team attended and pt taken to ER via stretcher. No difficulty breathing.