chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary Sarcoidosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: Apr2021, for Covid-19 immunisation. The following information was reported: PULMONARY SARCOIDOSIS (medically significant) with onset Sep2021, outcome "unknown", described as "Pulmonary Sarcoidosis". Patient had the Pfizer 2 dose Covid-19 vaccine in Apr/May2021. By Sep Patient noticed trouble swallowing, talking, and breathing. After several CT scans, doctors have determined that Patient have Pulmonary Sarcoidosis. It's Patient's belief that this diagnosis is directly related to the vaccine. The event "pulmonary sarcoidosis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (Sep2021) pulmonary sarcoidosis, notes: After several CT scans, doctors have determined that I have Pulmonary Sarcoidosis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
102 fever, extreme fatigue, diarrhea, stomach pains, body ache & sever h/a, loss of appetite lasted 2 1/2wks p/vax;no sickness prior to inj
Saturday morning - woke up with severe headache, fever, whole body ached, sore throat.  Took 2 Tylenol - Extra Strength - Rested and drank plenty of fluids.  5:00 pm - all symptoms gone Sunday morning - no symptoms
In post-vaccination waiting area 10 minutes after receiving vaccine, patient began scratching arm and started getting red appearance.  Patient complained not feeling well and began turning redder 10 minutes later and began to complain of swelling tongue. Was given a 0.3 mg injection of epinephrine in right leg. Ambulance was called and patient was taken to Medical Center approximately 15 minutes later.
Eyelids swelling 9/286/08 pm. Top lip swole 9/27/08 am. Palms of hands started swelling and red discoloration  9/26/08 pm
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 25-NOV-2013, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused a persistent strain of herpes zoster. On or about 10-OCT-2014, the patient was treated for an ongoing painful rash and persistent nerve pain which was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested
Eyelashes are almost gone; Hair thinning; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: MADAROSIS (non-serious), outcome "unknown", described as "Eyelashes are almost gone"; ALOPECIA (non-serious), outcome "unknown", described as "Hair thinning".  Additional information: Patient just do not want to have the side effects she had with the other one. Eyelashes are almost gone and hair thinning. Reporter (patient) considered event caused by vaccine.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix 1440) (expiry date 30-JAN-2023) for prophylaxis.   On 12-JUL-2023, the patient received Havrix 1440. On 12-JUL-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter wanted to know if the vaccine dose was still viable. The reporter asked what steps need to be taken after the fact. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used. The reporter did not consent to follow up.
Rash 2 weeks after Varicella vaccine (1/27/11); seen on 2/24/11; 2 pinpoint scabs on lower abdomen; 1 pinpoint scabs on buttocks; 1:3mm vesicle on left middle finger; 2:3mm vesicles on rt palm (1 vesicle) rt thumb (1 vesicle)
Lightheadedness about 1 1/2 hour after injection, BP increased, HR irregular, felt faint, dry mouth, overall achiness. PCP diagnosed allergic reaction.
fever to 105 w/in 24 hrs of DTP vax; no other sxs x/sl runny nose; pt non toxic on exam & no localizing signs;
Localized vesicular rash, itchy at injection site. BENADRYL & ZOVIRAX cream.
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild
1st injection: after 15 minute monitor neck started to itch, hives on L arm and all over my neck and chest. About an half hour after that when I received Benadryl and shot of Solumedrol I started to get a rash around my lips and my lips swelled. I took another dose of benadryl. I went home and by the end of the day had 125mg of Benadryl.  2nd injection: PCP advised me to pre medicate and I took Benadryl and Clariton. I was fine thru my shift with taking 50mg of benadryl. When I got home around 9pm I laid in my chair and fell asleep. I woke up around 3am and was freezing and aching. I went to bed and when I woke up my eyes, jaw, lips and L arm were swollen. I could barely walk. I took a benadryl  throughout the day. I had a severe headache. The Left lymph node was very sore and hard in the side of my neck. My facial swelling finally went down Sunday into Monday.  I will not be receiving the booster. I was made to take the vaccine in the first place. I did not want to take but was afraid it was going to come down to me getting fired.
This spontaneous report as received from a licensed practical nurse refers to an 11-month-old male patient. Current conditions and other relevant history were not reported. On 21-OCT-2014 the patient was vaccinated with the first dose of M-M-R II (subcutaneous injection, dose 1, 0.5 ml, subcutaneous; batch/lot # and expiration date not reported). Concomitant therapies were not reported. The reporter informed that he patient received the first dose of M-M-R II on 21-OCT-2014, 8 days before the patients 12 month birthday. No adverse effects were reported. No further information was provided. Additional information is not expected because the reporter did not consent to be contacted for further follow-up.
Patient reports a mild zoster outbreak on her face about one week after receiving the vaccine. Patient states she has some shooting pain as a result.
Pt states had 1" X 1" local, reddened and warm to touch area a few hours post revaccination of the Pneumovax. Today, arm is not sore, but continues with the red local reaction. Pt advised to call back if area.
Development vesicular rash to scalp and body and mouth.  15-17 days after varicella vaccine.
some spit/RotaTeq got into the healthcare professional's left eye. She immediately felt burning; The HCP's eye is a little pink; the patient spit and some spit/RotaTeq got into the healthcare professional's left eye; the patient spit and some spit/RotaTeq got into the healthcare professional's left eye; This spontaneous report was received from a Registered Nurse referring herself, a 42 year old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 24-MAY-2019, the nurse was administering rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R021650 with an expiration date on 27-MAY-2020, to a baby; however, the baby spat up (captured in MARRS: 1906USA001158) and some rotavirus vaccine, live, oral, pentavalent (ROTATEQ) got into the nurse left eye (accidental exposure to product and occupational exposure to product ). The nurse stated that she immediately felt burning (eye irritation), she flushed her eye with the wash system (total time flushing was unknown); however, the burning continued. It was additionally reported that on the same date, the nurse's eye was a little pink (ocular hyperaemia). It was specified that the nurse did not have vision changes.  At the reporting time, the nurse had not recovered from eye irritation and ocular hyperaemia.  The causality assessment between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the events was unknown.; Sender's Comments:  US-009507513-1906USA001158:
Vaccine administered at 20 days after 1st dose.  No ill effects at this time.
more arthralgias than usual/ developed arthralgias in his DIP joints of his left hand/ pain was about 3-4/10. Mostly 3rd and 4th digit/ persisted for more than a day or two; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 31Dec2020 15:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included hand arthralgias from an unknown date and unknown if ongoing. The patient's known allergies indicated codeine. There were no concomitant medications. The patient did not receive any other medication within two weeks and did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after vaccination, almost three weeks ago, on 01Jan2021, the patient felt more arthralgias than usual. He developed arthralgias in his DIP joints of his left hand (vaccine was in left arm), pain was about 3-4/10. Mostly 3rd and 4th digit. No warmth or swelling that he can discern. It was odd to him because he has had hand arthralgias, but nothing that has persisted for more than a day or two. It seems to be a bit better now. Therapeutic measures which includes administration of Ibuprofen was done in response to the event. The outcome of the event was not recovered  Information on the lot/batch number has been requested.
This spontaneous report was received from a medical assistant referring to a 9 month old patient of unknown gender, whom concurrent condition and medical history were not provided. On 24-NOV-2015, the patient was vaccinated with a dose of M-M-R II (concentration, route of administration, dose number, site of administration and duration were not provided). On 28-NOV-2015, the patient was inadvertently vaccinated with a second dose of M-M-R II (concentration, route of administration, dose number, site of administration and duration were not provided). At the time of the report, no adverse effect was reported. Additional information has been requested.
The following day after getting the 2nd dose I couldn't get up to work, I was feeling fatigue, so weak I couldn't get up from bed,  The palms of my hands and feet, were feeling so cold, I pass the thermometer and shows low in both feet and hands, while my forehead showed normal 36.4. I had nauseas and strong stomach ache. I continued fatigue until Monday .. but strong enough to drive and walk.  Another reaction on Tuesday was itching  on my lips and face, even on my scalp.  This week of April 19-23 I found some hives on my throat. ( I never had any type of allergies in my life). And the itching comes and goes occasionally since the 2nd dose vaccine.
One day post vax, this pt developed a red, blotchy rash with minor soreness on  her arms and legs. The rash on her arms resolved by the end of that same day and the rash on her legs abated on the following day. She then developed swollen, sore knees.
vaccination site pain, fever, chills, body aches, nausea, joint pain, swollen glands in neck, under armpit on the same body side as vaccination,
patient was administered an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Havrix. On 01-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Havrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient was administered an expired dose of Havrix, which led to expired vaccine used. The case had been linked to US2023078480, reported by the same reporter, for a different patient.
Have several reaction; got severely sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Mar2021 (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: ILLNESS (non-serious), outcome "unknown", described as "Have several reaction; got severely sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gastroenteritis & fever 12 days post inject; Rx w/antibiotics; Had episode of flu-like sz; including fever, malaise, nausea & some headache;
My reaction occurred approximately 12 hrs. following the injection.  I awoke on the night of Jan. 8 after rolling over on my right arm where the injection site was.   I immediately awakened with sharp burning pain and as I became more awake, I realized that I was confused, slightly disoriented and very diapheretic.  I alternated between having a chill to sweating profusely.  My head was throbbing as in a migraine and the orbits around my eyes hurt as well.  I was extremely nausea to the point of gagging but I had not eaten anything so I did not throw up.  Later that night I also at watery diarrhea.  All of my joints ached and my pelvic region seemed to hurt more than the rest of my body and joints.  When I got up, I found that my equilibrium was off and that I was dizzy. My temperature 100.2 but over the next 2 days it went as high as 102, but continued around 100.8 for several hours.  Early in the a.m. I called my PCP service and later spoke with the physician on call.  We discussed in depth.  At that point, my panic had subsided somewhat and he told me to take Tylenol for my fever and I also had Benadryl available and I took 50 mg.  I hydrated myself (I did not have an appetite) but forced my to drink fluids and eat a serving of fresh fruit.  By mid-day on 1/9 I was feeling less anxious and was able to sit and watch t.v.  I continued to take Tylenol and Benadryl and slept for almost 16 hours.  On Sunday I was more improved.  Since then, I have continued to feel dizziness and tire very easily.  Today, my equilibrium is still off and I have difficulty focusing.  I have spoken with my PCP twice this week and I will be going into the Covid research clinic next week as they want to examine me and draw blood samples close to the two week period after the first injection.
In November, I started having coughing symptoms three or four days after my grandson was diagnosed with RSV. My coughing symptoms persisted for the next month; I didn't take any real medication other than MUCINEX. I wouldn't describe it as severe, but it was annoying. I later developed COVID-19. My symptoms were extremely mild. I noticed some nasal congestion and a very short interval of soreness in my throat. I tested for COVID-19 and was positive. My temperature only got up to 99 degrees and that only lasted one day. I called my physician and was prescribed PAXLOVID and a steroid. I isolated for five days and tested negative after the five days. I spent one night out of isolation and then felt congested again, so I tested again the next morning and was positive. I isolated another five days but was only mildly symptomatic again and did not take any additional medication.
body aches - day one after vaccine headache - day one and continuing to present after vaccine  sore arm at injection site - evening of vaccine through day three after vaccine extreme back/hip pain - day two through day five after vaccine hives around injection site - day seven and continuing to present after vaccine
RT-PCR positive for covid; Tiredness; drowsiness; congestion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), SOMNOLENCE (drowsiness), NASAL CONGESTION (congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (RT-PCR positive for covid) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (Tiredness), SOMNOLENCE (drowsiness) and NASAL CONGESTION (congestion). On 24-Apr-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (RT-PCR positive for covid). At the time of the report, FATIGUE (Tiredness), SOMNOLENCE (drowsiness), NASAL CONGESTION (congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (RT-PCR positive for covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a consumer refers to a 48 year old female patient with compromised immune system, drug reaction/allergies to penicillin and sulfa. Approximately in November 2007, 6 years ago, the patient received a pneumonia vaccine (assumed PNEUMOVAX23) and had no adverse reaction. On 04-NOV-2013, the patient was vaccinated with an other dose of PNEUMOVAX23 (Dose, route and lot number were not reported). No co-suspect drug was reported. Concomitant medication was reported but unspecified by the patient. On 04-NOV-2013, the patient reported that the injection site became painful probably within 1 hour. Several hours later the reaction had worsened. The injection site was painful, red, very hard, hot and the size of a baseball. The patient also felt flushed. The patient called physician's office and talked to anonymous nurse. At the time of this report the outcome was unknown. The patient was treated with TYLENOL and ZYRTEC. On 04-NOV-2013, 10-15 minutes after injection, a routine blood work was performed (result not provided). The causality was not reported. This is one of two reports from the same source (other case MARRS # 1311USA011367). Additional information has been requested.
Pre-scheduled surgery; Missed second dose time window due to surgery; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SURGERY (Pre-scheduled surgery) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (Pre-scheduled surgery) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose time window due to surgery). At the time of the report, SURGERY (Pre-scheduled surgery) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose time window due to surgery) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.   No treatment information was provided. Patient received the first dose of the Moderna COVID-19 vaccine on 06Mar2021. The patient was then hospitalized for a surgery that was believe to be pre-scheduled. Due to this surgery, the patient did not receive their second dose of the vaccine and is now outside of the allowed time window. The patient is looking to receive this second dose of the vaccine on 11May2021. No other side effects were reported from the first dose of the vaccine.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 027A21A  and an AE of Surgery. Based on the current available information and temporal association between the use of the product and the start date of the event of Surgery, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 027A21A  and an AE of Surgery. Based on the current available information and temporal association between the use of the product and the start date of the event of Surgery, a causal relationship cannot be excluded.