chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Father called to get the covid  vaccine for family. We informed him that only for children 12 years old and older are able to receive the Pfizer vaccine. Father, wife, and 2 children came to pharmacy as "walk-in" vaccines and again he was asked if the children are 12 and older.  He said they were. Father filled out paperwork writing that one child was 12 years old, vaccines were administered  and when we processed the paperwork later, it was discovered that the child was 11 years old because the father put his date of birth as Oct 8th,09.  The correlation of October 8th, 2009 and the child being 11 years old was not made pre vaccination . We called the father that evening, 5/18, to see how the child was and to let him know that he was not eligible to receive this vaccine and that we would not be able to administer the second dose. The Father said the child was fine and that he needs the second dose because they will be traveling. I asked for the child's MD name. The Father said that the MD will write a prescription so that the child can get the second dose.  I let the Father know that that would not be possible unless they change the guidelines. I called the family on 5/19/21 to check in with them and see how everyone, including the child was doing.  I was told that they were all doing well.
This spontaneous report was received from a certified medical assistant referring to a 19 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1709USA011980: US-009507513-1710USA006355: US-009507513-1710USA006363:
Received immunization on 11-21-07, fever started that p.m. & continued through 11-25-07.  Fever got as high as 101.1 & child was fussy.  Mom rotated Tylenol & Motrin for fever.  Mom also stated child was teething at the time & he runs fever this high while teething.  Notified our medical director & he gave permission to give immunizations, including future MMR which he said could have been the cause of the fever.
Patient received a booster dose of the Pfizer bivalent vaccine approved for ages 12 and older. The patient was only 11 and should not have received the vaccine. According to mom, patient did not experience any abnormal adverse events. The mom did not express concern.
both caught covid; both caught covid; he got two blood clots/one in his leg and and one in his lung; he got two blood clots/one in his leg and and one in his lung; then got pneumonia; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "both caught covid"; DEEP VEIN THROMBOSIS (hospitalization, medically significant), PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown" and all described as "he got two blood clots/one in his leg and and one in his lung"; PNEUMONIA (hospitalization, medically significant), outcome "unknown", described as "then got pneumonia". Therapeutic measures were taken as a result of drug ineffective, covid-19, deep vein thrombosis, pulmonary embolism, pneumonia. Clinical course: It was reported that mom and dad both caught covid around Christmas, and it may have started even closer to Thanksgiving. Dad got covid, and then got pneumonia after catching covid, causing hospitalization. (Individual implied that pneumonia may have been aggravated by reckless activity, like doing activity outside in the snow.) He was in the hospital 4 to 5 days on oxygen reporter believe at least, and he got two blood clots, one in his leg and and one in his lung, while in the hospital (some clotting may have been attributed to little bodily movement). Believe the situation is better now either the dad is ok or is believed will pull through. Unsure if the situation is still ongoing. And also stated do not know the vaccine status of any of these individuals whether they are vaccinated or not and with what vaccine. Dad could have received more treatments while in hospital, but unsure what.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition and medical history was reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (dosing regimen unspecified). No adverse effects reported. No further information provided. No product quality complaint reported. This is one of several reports received from the same reporter. Additional information has been requested.
loss of appetite; face red; chills; fever; headache; muscle aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue). On 11-Apr-2021, DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071421 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: event outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071421:Original Case : MOD-2021-071421
Patient reported fever of 101, rash to chest, neck, and the R arm. Recommended BENADRYL, TYLENOL, and to contact PCP. PCP felt it was due to the zoster vaccination. Patient reported no worsening of symptoms during a check-in call 4 hours after adverse event reported.
Fever and rash. Fever Tm <102 so far. Rash started on legs and went upward. Very itchy. Initially mac-pap, but now very itchy.
Arthus reaction consisting of pain, warmth, and induration developed 12 hours after administration.
Severe body pain, fever, congestion, severe fatigue starting about 10 hours after injection and lasting about 24 hours. An additional 24 hours of fatigue followed. A rash developed 72 hours later, but unclear if it is related.
pt recv vax 16APR97 230PM & 430PM pt became very limp & pale-pupils very constricted would not react to light;sl fever would not respond to parent;called MD told to watched closely;remained listless & slept more next 2 or 3 days;
History of adverse reaction:  The day after the patient received her second Covid vaccination, she states she had ?Covid Arm? - her L. Deltoid had a red inflamed patch the size of an orange, the arm was very sore and hot to the touch.  The inflammation resolved in 3-4 days. One week later an itchiness began on her low back and small red papules began appearing on her arms.  She saw her PCP,  at the beginning of April  was uncertain of the cause but prescribed her triamcinolone 0.1% cream.   The patient was concerned she could have had contracted scabies and began permethrin cream without relief.  She was first seen by another doctor on 7/7/21 after many months of suffering from a sporadic rash. At that visit her arms and legs were scattered with minute vesicular lesions.  An immunofluorescence biopsy was performed where 2 4mm punch biopsies were performed to assess for an underlying autoimmune blistering disease.  At that time the patient was prescribed a Medrol dose pack and Triamcinolone 0.1%.  The biopsy was returned one week later and was negative for bullous pemphigoid or other autoimmune blistering disease.   It resulted in focal eosinophilic spongiosis and subepideral vesiculation associated with superficial perivascular mixed infiltrate with eosinophils and dermal edema. Patient returned on 7/15/21 for removal of sutures, at this patient complained of being extremely pruritic. She did not tolerate medal dose pack well, c/o insomnia and jitteriness.  She denies any dietary changes, new detergents, medications, GI upset, HA, exposure to chemicals. Patient had new blisters on her abdomen, back and right ear.  She was given a stronger cortisone cream, Clobetasol, and prescribed a bottle fo 5mg prednisone tablets, she was instructed to take 2-3 prednisone pills per day and to call every few days to give updates.  She returned to the office on 7/22//21 with painful blisters on chest and abdomen, resolving lesions on her back. She had been taking 12.5mg of Prednisone daily. She called on 7/28/21 she tried to stop Prednisone but within 2 days she developed new blisters on arms and legs.  Blisters on abdomen ruptured and are raw and are painful.  Patient returned on 8/13/21, she has become very frustrated with duration and discomfort of rash.  She continues to get new blisters and reports the existing blisters are not healing.  Blisters are currently on back, abdomen, chest, legs and arms.  She continues to take prednisone daily.  She denies blood in her stool, fever, or other illness, she has no environmental allergies that she is aware of.  Decision to send blood work for Lipids, CMP and CBC with diff.   Active blisters were injected with Kenalog 10mg/ml.
Information has been received from a mother concerning her approximately 15 month old daughter who was vaccinated with VARIVAX (Merck) (lot # not reported) about 3 months ago (in approximately December 2008).  About 2 days after vaccination, the patient developed a swollen injection site, fever, flu-like symptoms and malaise.  They were treated with cold compresses to the injection site and TYLENOL.  The symptoms lasted 3 weeks.  Subsequently, the patient recovered from swollen injection site, fever, flu-like symptoms and malaise.  Unspecified medical attention was sought.  It was reported that the patient had had similar reactions to other unspecified vaccinations.  Follow-up information from the physician revealed that the patient was a 13 month old female with benign left breast buds and food intolerance who on 27-OCT-2008 was vaccinated SC with the first dose of VARIVAX (Merck) (lot # 661868/1009X) into the right side.  Concomitant therapy included the first dose of HAVRIX (lot # 18243M).  The physician reported that she was unaware of any adverse advent.  Subsequently, the patient recovered.  The physician considered the events to be non-serious.  Additional information is not expected.
Nausea, chills, fatigue, body aches with unusual and extreme upper back pain. Took Aleve. Too tired and hurting too much to move.
Patient received Moderna booster dose at 2:18pm.  After 30 minutes of Moderna booster, patient c/o "something get stuck on my throat". No Rashes, no swelling on lips or face.  BP 155/80 Pulse 86 RR 18 O2 Sat 98% RA Informed Dr. via phone.  Benadryl 50 mg, IM given at 1504 as ordered by Dr.  1514, Dr. evaluated patient  1520, bp 152/72, P 80,  O2 sat 99% on room air, R 20.  Patient verbalized no more sensation of "something get stuck on my throat" Per Dr. to observe patient 30 minutes after Benadryl injection & discharge home.  1542pm bp 153/82, Temp. 97.9, P 81, bp 153/82, R20, O2sat 100% on room air. No resp. Distress.  Patient felt fine.  Informed Dr. via phone, ok to discharge home.  Advised patient to call 911 for any severe reactions such as  difficulty breathing, throat closing up, hives, rapid heart rate.  Patient made aware to schedule bp check in 2 weeks as per Dr..  Discharged patient home  with daughter.
pain on her arm; itching; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Mar2021 as dose number unknown, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On Mar2021, the patient experienced pain on her arm, and itching. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives, generalized over body esp trunk and face 5 days after vaccines. Prednisone taper, KENALOG injection and ZANTAC given to patient.
After the vaccination at around 6 PM the injection site (arm) started to feel sore and warm.  The day after the vaccine in the early morning hours I started to feel a headache and I took Aleve and also nausea where I then took Zofran. Once I took medication  hours later I started to feel a bit of  relief but then the symptoms came back again.  On  02/16/2021  my arm didn't feel sore but I still feel the headache.
Shivers/Shaking with 100.5 F Fever starting 6 hours after injection. Body aches (back, knees, hips, neck) and headache starting 8 hours after injection. Head fog/congestion starting 12 hours after injection.
This spontaneous report was received from a pharmacist refers to a 62 year old female patient. The patient had no drug allergies, no known health conditions. On 18-OCT-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot number J004268, expiry date 12-JUL-2014), subcutaneous. No concomitant medications were reported. On an unknown date in OCT-2013, the patient developed rash at the injection site and a rash on one thigh. The patient visited her physician who thought that the rashes were staph infections. The patient was prescribed an unspecified antibiotic as a treatment. The physician told the patient that the rash on thigh (which looked like 4 to 5 pimples) was shingles and was a residual effect from ZOSTAVAX. The physician decided not to treat the shingles on the thigh. The outcome of the events were unknown. The patient sought medical attention. The pharmacist mentioned that approximately 50 percent of her patients who receive ZOSTAVAX develops rash at the injection site. Additional information has been requested.
Generalized rash starting on chest then spreading to back, arms, legs, hands, and feet. fever of 101 degrees that lasted three days
Parents report "shivering" spells daily that last approximately 5 seconds each. These spells started the day after receiving last set of vaccines. She is otherwise well. This history is not consistent with seizures.
Accidentally injected her with the Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Accidentally injected her with the Pfizer vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Accidentally injected her with the Pfizer vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Accidentally injected her with the Pfizer vaccine) had resolved. Not Provided          No concomitant medication details was provided.  Patient reported that their niece was vaccinated a little over a month ago for first vaccine and later went for her second vaccine.  No treatment medication details was provided.
Myocardial infarction; cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 at 13:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 61 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "GI reflux" (unspecified if ongoing), notes: Other medical history: GI reflux.; "Normal cholesterol, LDL, triglycerides" (unspecified if ongoing), notes: Other medical history: Normal cholesterol, LDL, triglycerides; "Normal cholesterol, LDL, triglycerides" (unspecified if ongoing), notes: Other medical history: Normal cholesterol, LDL, triglycerides; "Normal cholesterol, LDL, triglycerides" (unspecified if ongoing), notes: Other medical history: Normal cholesterol, LDL, triglycerides. Concomitant medication(s) included: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]. Vaccination history included: Covid-19 vaccine (Primary immunization complete; Manufacturer unknown, Dose: 1), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization complete; Manufacturer unknown, Dose: 2), for Covid-19 Immunization; Covid-19 vaccine (Booster dose, Manufacturer unknown, Dose: 3), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant, life threatening) with onset 26Dec2022 at 09:30, outcome "recovering"; CARDIAC ARREST (medically significant, life threatening) with onset 26Dec2022 at 09:30, outcome "recovering". Therapeutic measures were taken as a result of myocardial infarction, cardiac arrest includes  cpr, coronary artery stent.  Clinical course: No Known allergies. covid prior vaccination Yes. covid tested post vaccination No Other vaccine in four weeks: No. Other medications in two weeks: protonix prn. Ae treatment: cpr, coronary artery stent.; Sender's Comments: Based on the available information in the case, the causal association between the events MYOCARDIAL INFARCTION, CARDIAC ARREST and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
her lymph nodes swelled in her arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "her lymph nodes swelled in her arm pit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient wants to report about her son's Pfizer Covid-19 Vaccine second dose. She wanted to report what happened to her son. Her son received a heart transplant after his second dose. He was healthy 24-year-old. It happened on 16May2022. While reporting on her son, the caller mentioned that she has cancer. She stated that she also had the same Pfizer Covid-19 Vaccine. Her cancer was diagnosed after her Pfizer doses, and she believes that the vaccine showed them that she had cancer. She thinks the vaccine sped up her cancer. After her first vaccination, her lymph nodes swelled in her arm pit. She did not want to get a second dose but was getting a new job and did not want to lie on the application, so she got fully vaccinated. She was diagnosed with a very aggressive breast cancer in Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372253 Same product, patient, different AEs, different dose;
10/30/2020 Hard lump, swelling, and aches/pain at the injection site (right shoulder).  Also, experienced unusual weakness, loss of control, and numbness of right arm, hand and wrist, causing me to think I was having a stroke.  Currently, 11/02/2020, side effects are improving (at about 80% of normalcy).  However, my normal writing strokes (penmanship) and right hand and wrist strength have not improved.  Currently, I am wearing a "Drop sky" support to help restore hand and wrist control.  I am making appointment with my doctor.
Body aches, Headache, runny nose, dizziness, Loss of apatite,
The day after the second shot April 6, 2021, I had a swollen lymph node and a very swollen and painful right armpit.  On approximately April 30 2021, I had a large swollen lymph node above my right collar bone, and a series of smaller swollen lymph nodes along my neck to the an area near the mastoid sinus behind my right ear.  On approximately July 10, 2021 I had a swollen lymph node and  moderate pain in right armpit.  On July 19, 2021 the swollen lymph node and enlarged  right armpit returned.  PLEASE NOTE that the incidents of lymph node and armpit swelling that occurred in July were smaller and less painful than the initial event that occurred the day after my second injection.