chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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 "unknown" and all described as "Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: all four of them still got Covid.  Clinical Course: The caller wanted to know if there were any differences in the Pfizer BioNTech Covid-19 vaccines monovalent and bivalent for adults in terms of ingredients. No one can tell her what is different and if the new one will cause a problem. One HCP has told her not to get the Bivalent and another one is saying to get it. The caller stated her doctor was worried about her getting the Covid vaccine because she had seizures with vaccines as a child and was hospitalized and had loss of muscle control so she never gets pneumonia vaccines and flu vaccines. They don't know what shots she was given that caused such a severe reaction but just know that it was vaccines. When this one came out she was really afraid to get it. They had a doctor and ER tech to wait with her because they knew she could have complications, but she never did. She just had a little bit of a sore arm, very slightly. She had 3 of the original Pfizer covid shots, two primary and a booster. Her last booster dose was in January.They say that the original (Covid vaccine) is just as good as the new one at fighting. She has a lot of drug allergy issues to anything. They have to be cautious with whatever they give her. There is only one antibiotic she can take. Everyone she knows that has taken the Moderna (covid vaccine) has had issues but no one with Pfizer has. Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid, but they did not have long term problems with it or didn't get that sick with it. She declined providing their information.The caller stated there are still conspiracy theories people saying "don't get the shots they are killing us" (referring to covid vaccines)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Leg pain, itching, Swelling, redness, warm to touch. No fever. Pt is able to walk normal on it. Treatment: cold pack, give ibuprofen. And BENADRYL later if still c/o itchiness. Can draw a circle around the redness to see if it gets any bigger. Monitor for any worsening of symptoms. Office visit on 1/10 for follow-up, and symptoms had improved.
no adverse event; vaccine used which were beyond the 30-Day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date).    Concomitant products were not reported.  It was reported that patient received monovalent dose that was administered beyond 30 day beyond use date. The use by date of lot  056m21a was reported as 12-May-2022.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Live Follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Covid test result=Positive; Covid test result=Positive; syncopal episodes; Heart rate began dropping into the 40-50s range; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0169) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Shellfish" (unspecified if ongoing), Known allergies: Sulfa Notes,: sulfa Codiene Percocet Compazine Reglan Shellfish. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPAMAX; LEXAPRO; ROPINIROLE; BUSPAR. Past drug history included: Codiene, reaction(s): "Known allergies"; Percocet, reaction(s): "Known allergies"; Compazine, reaction(s): "Known allergies"; Reglan, reaction(s): "Known allergies", notes: Known allergies: Sulfa Codiene Percocet Compazine Reglan Shellfish. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product=COVID 19, prev dose brand=Pfizer mRNA BNT, prev dose brand unknown=False, prev dose lot number=ER8733, prev dose lot unknown=False, prev dose administration date=05Apr2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 05Apr2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Sep2021, outcome "unknown" and all described as "Covid test result=Positive"; SYNCOPE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "syncopal episodes"; HEART RATE DECREASED (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Heart rate began dropping into the 40-50s range"; FATIGUE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "severe fatigue". The events "syncopal episodes", "heart rate began dropping into the 40-50s range" and "severe fatigue" were evaluated at the physician office visit and emergency room visit. It was unknown if patient had covid prior vaccination. The patient had covid tested post vaccination. The patient underwent the following laboratory tests and procedures: heart rate: (26Apr2021) dropping into the 40- 50s range, notes: Heart rate began dropping into the 40- 50s range; investigation: (unspecified date) unknown results; sars-cov-2 test: (27Sep2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of syncope, heart rate decreased, fatigue as multiple testing in progress.
At 8 PM the day of the shot (Thursday), my arm became extremely sore and I was very tired.  I went to bed.  By 9 PM  I had chills and could not get warm. I dozed off and on until roughly 12:20 when I got up and vomited.  I dozed from then until 5 AM continuing to have chills and vomited 3 more times. I  got up and proceeded to work.  By 10 AM (Friday) I was unable to stay at work as I continued to have chills, exhaustion,  muscle aches,  a headache, and was unable to focus on the easiest task. I had also dry heaved 2 more times. Upon arriving at home I got into bed and slept until 8:30-8:50 AM the next morning which was Saturday.  Saturday I was able to eat crackers and soda without issue.  I was just extremely tired. No more chills, mild muscle aches and a slight headache still.  Slept a full 9 hours and was fine on Sunday.
Ache joints and muscle, mood anxiety, dizzy spells, high cholesterol, cold and flu-like symptoms, concentration difficulty, cramp leg, depression, energy loss, hair falling out, pockets of infection in throat, liver failure, memory loss and trouble remembering recent information, pain lower back and knee, shortness of breath, insomnia, vision spotted, voice alteration, weakness. The study performed provides scintigraphic evidence suggesting the presence of mild diffuse parenchymal liver disease.
Received shot on 2-16-21. Noticed redness on arm and was warm to touch on 2-17-21 in the evening. Reported to us on 2-18-21.
10 hours after vaccines, I had not only a high fever with chills and excessive sweating, but such severe lightheadedness and weakness that I almost passed out. To avoid falling from fainting, I just laid down on the floor. Additionally, my arm was bright red, warm to touch and painful several inches below the injection site; this subsided 4 days after the vaccine.  A low grade fever, chills, sweating and weakness lasted for 3 days; treated with Tylenol and Advil. Please notes the that my husband had the same vaccines the day after me and he had almost all the same symptoms with dizziness, but not faintness. I wonder if this was related to the batch of vaccines we were given.
Headache, Myalgia, Arthralgia, Fever, Rash, NauseaVomiting, chills Narrative:
Allergies; Itching on both legs, from calves downwards; Redness on both legs, from calves downwards; Rash on both legs, from calves downwards; Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), HYPERSENSITIVITY (Allergies), PRURITUS (Itching on both legs, from calves downwards), ERYTHEMA (Redness on both legs, from calves downwards) and RASH (Rash on both legs, from calves downwards) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 014C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Feeling unwell). On 22-May-2021, the patient experienced HYPERSENSITIVITY (Allergies). 22-May-2021, the patient experienced PRURITUS (Itching on both legs, from calves downwards), ERYTHEMA (Redness on both legs, from calves downwards) and RASH (Rash on both legs, from calves downwards). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling unwell), HYPERSENSITIVITY (Allergies), PRURITUS (Itching on both legs, from calves downwards), ERYTHEMA (Redness on both legs, from calves downwards) and RASH (Rash on both legs, from calves downwards) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Patient had redness and swelling in a ring around injection site the evening after administration. These symptoms improved on 12/16/18 however they reappeared on 12/17/18 lower on the same arm closer to the elbow. Patient will ice the area and take acetaminophen is necessary. Will call PCP to see if they advise further action.
Left health department at 5:15pm. By 6:00pm complained of sudden, severe headache. Took Ibuprofen. By 6:30pm began vomiting. Vomited 10 times from 6:30pm to midnight. Headache continued until around midnight. Slept through night and felt fine at 7:00am when awakened by parent.
Right arm at injection site red, slight rash, very itchy and slightly swollen Occurred 9 days after shot given on 1/31/21
1. Severe headache - treated with ibuprofen - did not go away with treatment. Severe headache has persisted on-and-off (between 1-5x per day) since first dose. 2. Dizziness - no treatment. Dizziness has persisted on-and-off (between 1-5x per day) since first dose.
Dose was administered past the beyond use date.  Gray cap vial was punctured 28 hours prior to dose being given.  Contacted CDC and Pfizer for more information on stability of vaccine.  Since Pfizer didn't have any data on the stability of the vaccine for this length of time, we deferred to CDC guidelines to repeat dose.
J96.00 ACUTE RESPIRATORY FAILURE 4/7/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/7/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 4/7/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/7/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
On 6/21/2022: Initial complaint of Fever 103F with chills. resolved 6/25/22. Then, on 6/30/22, he began having  pinprick sensations in toes. Progressed to numbness in legs (had to hold handrails to walk). Progressed to numbness in hands and arms (had trouble playing piano).  Medical record notes weakness in all extremities. Onset was reported to be about a week before he went to the ER on 7/10/22.    He flew to Private on 7/6/22 and returned home at advice of physician, who told him of Private. He presented to the ER on 7/10/22.  He was also complaining of Epididymitis, which his  primary care provider had given him antibiotics for, some time before he went to the ER. In ER, he was started on IGIV. Case remains inpatient at local Hospital at this writing.  Notes indicate his numbness progressed up his chest and chin.  He received IVIG and symptoms are improving. Information regarding his health and medications prior to current incident would be known by his provider.        Case received vaccines at  two different pharmacies on two different days.  Vaccine information was reported local authority. Time of immunization is  not found. Hospital information was obtained from Infection Prevention at the facility.       Information submitted by Public Health Nurse.
No additional AE; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a Healthcare Business Professional and refers to a patient of an unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-SEP-2022, thepatient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023) (strength, and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was above 46 (62.8) degrees Fahrenheit for a time frame of 8 hours on 05-SEP-2022, without any previous temperature excursion.; Sender's Comments:  US-009507513-2209USA002722:02242096 US-009507513-2209USA002532:02242096 US-009507513-2209USA002779:
Patient reported anaphylaxis episode with Shingles vaccine.  Patient monitored secondary to history of reactions.  Vital signs 132/70-71-13-98% O2Sat.  Skin warm and dry.  Breath sounds clear.  1300  Vital signs 126/74-71-13-97%O2 Sat.  Skin warm and dry.  Breath sounds clear bilaterally.  Patient continued to be monitored for 30 min.  Discharged with no reported side effect at 1318.
On April 1st lost all eye sight in right eye for a few minutes and  wet feeling in right quad all day (thought my leg was wet all day but wasn't).  On April 2 woke up to stabbing pains in eye and couldn't see in right eye.  Went to (Regular doc) that afternoon (Vision in left eye 20/25, right eye 20/70)she referred me to Opthamologist right then. Opthamologist diagnosed me with Optic Neuritis in right eye (50% loss of brightness and color). Referred to Neurologist, hands and legs going numb, bad vertigo.  Neurologist ordered 3 MRIs with and without contrast (Brain, Thoracic spine and cervical spine).  All clear.  Numbness, vertigo continues.  On April 18th woke up with swollen/red cheeks and fluid build up under both eyes.. same place a where filler was injected into face.  On April 19, did a wide range of blood work...all normal except CRP was 25.1.  Gave me penicillian and steroid shot, and 7 day steroid pack.  Vertigo and numbness continued.  On April 27th symptoms seem to be a better but everyday this moves around my body with different symptoms like one day my left hand is numb and the next it's my right hand.  Eyesight still not normal.  Vision in right eye is blurry, compared to left.
My tinnitus went from mild to near maddening. It is consistent and I am afraid a second dose will drive me over the edge.
No adverse event; accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date).    No concomitant drug was reported. Pharmacist reported that they just found out last 18-Mar-2023 that they accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date. They were from 2 different vials but the same lot number.  HCP worried of providing patient's details because of HIPAA. This case contains information for the 1st of 2 patients. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716519 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716519:Patient 2
Swelling and redness with warmth to areas of right upper arm and left upper arm at injection site. BENADRYL Allergy 12.5mg/5ml 1/2 tsp po Q 6 hr prn, ORAPRED 15mg/5ml 3ml bid x 3 day, KEFLEX 250mg/5ml 1 tsp po tid x 7 to 10 day.
received flu shot in left arm at 11:00am area became hot and swollen to touch, itchy  and swollen about 10 minutes after
Same day of administration of flu shot went to Urgent Care due to swollen yes, feeling like "throat was closing up" - given steroid injection.
Pt developed symptoms of varicella with approximately 50 lesions (face and truncal) after vaccine.
Patient given Tdap, should have been DTap. None known adverse events  none known not noticed of any adverse events. (patient was scheduled for 5th dose of DTap) not notified of any adverse events.
Pt called at 1502 4/21/2021 regarding of left eye got red after covid vaccination. Pt denies emergency s/sx. Noted no health issue currently. Pt describes his left sclera part of eye got red this morning after covid vaccine without swelling.
hives on my arms, forhead and chest; fatigue; chills; headache; dizziness; nausea; This is a spontaneous report received from a consumer, the patient. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: not known) via unspecified route of administration in Left arm on 13Mar2021 at 12:45 (at the age of 41-years-old at vaccination) for COVID-19 immunisation. The patient's medical history included asthma, obesity and mitral valve prolapse w/ regurgitation. Concomitant medications included lorazepam (MANUFACTURE UNKNOWN), sertraline(MANUFACTURE UNKNOWN), lamictil (MANUFACTURE UNKNOWN), benedryl (MANUFACTURE UNKNOWN) and Motrin (MANUFACTURE UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient didn't not receive any vaccines within four weeks prior to the vaccination. The patient had no history of allergies. The patient experienced headache, nausea, chills, fatigue and dizziness within 24 hours of the vaccination. The patient broken out in hives on her arms, forehead and chest after 48 hours of vaccination.  Today is day 3 (72 hours) however, she still experiencing mild nausea. The patient received the treatment for the adverse events telehealth, benedryl for rash and nausea medications. At the time of report, the outcome of the events was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
(Vaccine was not injected in the correct area of the deltoid of left arm)Shoulder pain and limited range of motion within one hour of vaccine and continues today.  I have been to the doctor three times and was told bursitis and tendinitis. I have been prescribed Celebrex, Voltaren Gel,  received a steroid injection, and physical therapy at home. It has been 20 days since vaccine and have had very little improvement in shoulder pain and range of motion.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not reported. Treatment medication was not reported.
Information received from a nurse on 29AUG2013 regarding a 33 year old female who was administered expired vaccine without adverse event. On 28AUG2013 the female received dose 3 of BioThrax (Lot FAV308; exp. 14AUG2013) and a primary dose of Typhoid vaccine both intramuscularly in an unspecified arm. It was later noted, that the BioThrax had exceeded its expiry date at the time of administration. There were no reported adverse events.
FIVE SEPARATE INCIDENTS OF LIP & EYELID SWELLING STARTING 36 HRS AFTER SHOT. LAST INCIDENT 9/17/2009. TODAY IS 9/29/09.
VIAL WAS DILUTED WITH ONLY .8 OF THE DILUENT AND NOT 1.8
Hives over body within 2 hours of vaccine. Next morning eyes and face puffy, vomited once. F/U phone call day #4 lips and eyes swollen. Refer to allergist. 12/1/17 Sore throat x 3 weeks, seen by Dr. 3 weeks ago. TC neg at that time. Rx OMNICEF. Without fever, without improvement. PE: exudate on cryptic tonsils, erythematous, TM's clear. Lungs clear. T 98.6.