chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a full-body rash around 10-11 days after my Moderna booster. The rash progressively got worse over 4 days and has remained. The rash presents as hives. It is itchy, with red splotches. Pressure and scratching make the rash worse. Antihistamines help the rash. On a scale of 1-10 (1 Not Painful; 10 Very Painful), the rash is between a 2-4.   I take cetirizine HCL10mg every AM, and Fexofenadine HCL 60mg additionally if there is a breakthrough rash.
T104, lethargic, rapid heavy breathing, vomiting 24hrs p/receiving immun; Treated @ ER;
Information has been received from Merck Pregnancy Registry for GARDASIL from a physician's office worker concerning a 14 year old female with no pertinent medical history reported and no drug reactions or allergies reported who on 19-APR-2010 was vaccinated with a first dose of GARDASIL (lot # 659180/1758U) 0.5mL. There was no concomitant medication. Later was found out that she was pregnant at the time she was given the vaccine. She had "9 weeks and 4 days" of pregnant gestation. Her last menstrual period was on approximately on 02-APR-2010 and estimate delivery date is on approximately on 07-JAN-2011. No adverse event was reported. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. Follow up information has been received from a licensed practical nurse via a complete pregnancy questionnaire and telephone call, concerning the 14 year old female patient with asthma, allergic rhinitis, and causalgia of upper limbs and a history of having had a spontaneous abortion or miscarriage (date unspecified) and one previous pregnancy resulting in a full term delivery without birth defects and no complications during pregnancy (date unspecified). Concomitant medications used in this pregnancy included cetirizine hydrochloride, KEFLEX and prenatal vitamins (unspecified). It was confirm that date of last menstrual period was on 02-APR-2011 and estimate delivery date was on 07-JAN-2011. The nurse reported that the estimated conception date was on 15-APR-2010. On approximately in June 2010, the patient experienced vomiting and nausea and was treated with 12.5mg twice a day with promethazine. Prenatal laboratory tests included two ultrasound performed on 08-JUN-2010 and on 26-AUG-2010 for evaluating the fetus size and position. Other diagnostic laboratory tests performed included a Gestational Blood Sugar (GBS) performed on 30-NOV-2010 (Also reported as 30-NOV-2011). On 29-DEC-2010, the patient delivered a normal, healthy male baby at 39 weeks from LMP without congenital anomalies or other complications, who weighted 6lb 11 oz, 19 cm length, APGAR score 7/9 and a head circumference 33 (units not provided). It was reported that the patient did not have complications during pregnancy or during labor/delivery, and no illnesses during pregnancy. At the time of the report the outcome for nausea and vomiting was not reported. Additional information is not expected.
COVID19 Infection (Omicron most likely) - mild infection, did not require medical intervention
mom phoned stating pt recvd vax yesterday & has cried since then very irritable has not slept; will not take formula but is eating baby foods;
p/vax pt devel rash & severe pruritus;pt was seen by MD who did not thing the rash was vaccine related;rash began on back, ears, arms, neck, eyes;
Patient developed cellulitis at site of injection. Next day, spiked a fever with elevated white blood cell count.
expired dose of Kinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 30-MAY-2023, the patient received Kinrix. On 30-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix administered). 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: 31-MAY-2023 A nurse reported that a patient was given an expired dose of Kinrix, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal mail.
Patient came  into pharmacy to receive the Pfizer Bivalent vaccine. It was discovered at end of shift to record unused doses that the vial was the original Pfizer vaccine not the bivalent. The patient was called on 12-7-22 and explained that he was given the original Pfizer vaccine . Patient was understanding.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 2:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 2:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 58.83 years.  Concomitant products were not provided.  Number of vials sent to clinic were 3. Vial moved to fridge on 08-Jan-2021 and beyond use date for these vials was reported as 07-Feb-2021. Vial was moved to clinic on 12-Jan-2021. Batch number 041L20A administered on 12-Jan-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 08: 00 am and at 09:00 am.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976 (E2B Linked Report).; Sender's Comments:  MOD-2022-566976:Master Case(Same Reporter)
I have had a severe banging sinus headache, very clogged up, it is hard to breathe. I had coughing alot, and was dehydrated and ended up in the ER and they gave me bags of saline. They took 4 vials of blood work, they did an EKG, chest x-ray and treated me with IV fluids. I am still testing positive for COVID. It started on 03/29/2023 and it continues to this day.
This spontaneous report as received from a healthcare worker refers to a 16-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 12-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date was reported as 16-JUN-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
State a few minutes after got MMR and Flu states burning sensation at shoulder and neck and back of neck felt stiff. After 15 minutes pt states burning is now just in shoulder of arm. Neck still a little stiff.
Arm pain, headache, body aches, chills, fever 101 degrees, fatigue.  This lasted all day from 8am to 8pm when I went to bed.  I woke up the next morning feeling fine again.  I have never had this adverse effect with any of the other Pfizer Covid vaccines.  I literally had to take a "sick day" because I did not get anything done this day.
Extensive redness, tightness but no tenderness at left anterior arm and out and top of shoulder. Extends to just above antecubital fossa. Swelling, redness 16cm (top to bottom) circumference 20cm on right.
Large swelling and hardness at injection site developed after one week.   First swelling then hardness two days later.  Approximately 3 inches in diameter
A 55-year-old patient was inadvertently given his second booster prior to the recommended interval of 4 months.  Dates of doses:  1/22/21, 2/26/21, 12/10/21.  The fourth dose was given 1 week early.
PERSISTENT FATIGUE SINCE GETTING THE SHOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced persistent fatigue since getting the shot. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from persistent fatigue since getting the shot. This report was non-serious.
Fever, chills, body aches, cough. Gone after 10 days. Shortness of breath and chest tightness. Gone after 14 days post vaccine. Returned more severely after I caught a flu 1 month post vaccine. Symptoms have not resolved. Have improved. Treated with nebulizer, albuterol inhaler and fluticasone inhaler.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unspecified dates starting on or after 23-MAR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of PROQUAD (Merck), lot # K025766, expiration date 08-JUN-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Rash appeared below injection site 10 days after first dose. Rash was warm, slightly itchy, and grew larger over 48 hours. Treated with Benadryl and hydrocortisone. Rash is getting smaller after 72 hours
Rash all over arm like hives  Fever Chills Body aches  Swelling of arm
Initial unsolicited report received from nurse on 08-Dec-2017. This case involves an 83-year-old female patient who was vaccinated with 0.5 ml dose once of FLUZONE HD (Batch number: UI892AA, expiration date: 06 Jun 2018, dose, route was not reported) in left deltoid on 13 Nov 2017. The patient's medical history was not reported. Patient did not receive any other vaccines at the time. It was reported that patient has no known drug allergy (NKDA). On an unspecified date, few days following the vaccination, the patient flare up of her arthritis, especially in her Left shoulder, had limited range of motion, and generalized joint pain. Lab data was not reported. The patient received corrective treatment with Prednisone. On an unspecified date, after 2 week, the patient recovered from events. List of documents held by sender: none.
This case was reported by a health professional and described the occurrence of a seizure in her 6 month old daughter who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The patient had no concurrent conditions or medical history. On 5/14/03 the patient received the 3rd dose of Infanrix. On the same date, the patient also received an injection of inactivated poliomyelitis virus vaccine. Approximately 2 weeks post immunization, the patient experienced a seizure and was hospitalized. The event resolved.
inj site red & swollen-size of silver dollar p/24hr; no change p/48 hr x/hot to touch;72hr later came in to have it checked;t101 w/some vesiculation near inj site;Augmentin;
sore muscles; sleepiness; This is a spontaneous report from a contactable consumer (patient). This 67-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 21Feb2021 at 09:00 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included COVID-19 prior to vaccination on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were none. The patient did not have any allergies to medications, food, or other products. On 21Feb2021 at 21:30 the patient experienced sore muscles and sleepiness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of sore muscles and sleepiness were not recovered. It was also reported that since the vaccine it was unknown if the patient had been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
From e-mail correspondence received at manufacturer on 9/1/02, it was reported by a physician that a 6 month old female was vaccinated with Hib. No date of vaccination provided. Two weeks after vaccination, pt developed febrile seizures and also found to have urosepsis after sepsis work up. pt's cerebrospinal fluid immunology and serology studies were positive for Haemophilus Influenza B, with weak agglutination. Cerebrospinal fluid cultures, however, were negative.
Deltoid muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Deltoid muscle pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Deltoid muscle pain). At the time of the report, MYALGIA (Deltoid muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Tinnitus-Mild
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD, either lot number L050910 with expiration date of 14-JUN-2017, lot number L030591 with expiration date of 10-FEB-2017 or lot number L041628 with expiration date of 20-APR-2017 (strength, route of administration and dose were not reported). No concomitant therapies nor adverse effect were reported. This is one of two cases from the same reporter. Additional information has been requested.
my chest feels a little tight; with a light pulsating pain in my right shoulder blade down to elbow; with a light pulsating pain in my right shoulder blade down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (my chest feels a little tight), PAIN (with a light pulsating pain in my right shoulder blade down to elbow) and ARTHRALGIA (with a light pulsating pain in my right shoulder blade down to elbow) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced CHEST DISCOMFORT (my chest feels a little tight), PAIN (with a light pulsating pain in my right shoulder blade down to elbow) and ARTHRALGIA (with a light pulsating pain in my right shoulder blade down to elbow). At the time of the report, CHEST DISCOMFORT (my chest feels a little tight), PAIN (with a light pulsating pain in my right shoulder blade down to elbow) and ARTHRALGIA (with a light pulsating pain in my right shoulder blade down to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The events started after an hour of vaccine administration.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.
redness of skin at injection site itched and felt warm. Size 5 inch circle.  6-12-21 to 6-14-21. Applied ice pack until   redness disappeared.
Had MMR #2 4/6/10; on 4/19 (approx) she developed fine, red rash on chest and face, also runny nose and sneezing. Unsure if running temp; No problems with Respir. Rash remains, not worse.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, in left arm, as dose 2, single (Batch/Lot number: unknown) for 1 day, in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Adhd" (unspecified if ongoing); "reactive airways" (unspecified if ongoing); "non-allergic rhinitis" (unspecified if ongoing); "Known-allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) medication taken in 2weeks of product included: ADDERALL taken for 7 years, MUCINEX, other medication in 2weeks brand= Have taken 1-2x daily to treat nonallergic rhinitis for 9 months.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative for covid on day 7 (antigen) since initial diagnosis; tested. negatively repeatedly in subsequent days, with improvement of symptoms; Positive, notes: tested positive again (antigen) on day 12 and day 14 (today is day 14). Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product COVID 19 Treatment, bran: Paxlovid, treatment start date:27Apr2022, treatment stop date:02May2022, indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received 2nd Dose of COVID-Vaccine. Approximately 7-8 minutes later she became light headed, ten minutes after that she her face and neck became very red , hives began to appear on arms, throat very scratchy, voice altered.  Patient transferred to the ER where she was treated for Anaphylaxis. Drugs given included IV fluids, Benedryl (PO and IV), Epinepherine, Solumedrol, and Pepcid. Patient was observed for several hours but was discharged the same day.
Hoarseness, sore throat, watering eyes, blurry vision, mucus in eyes, vomiting, nausea, fever of 100.4, muscle ache, headache, achy joints, tiredness.
Pt called and stated she has 4" x 2" red welt on arm at the injection site. Redness and welting started almost a week after vaccine received.
She came down with shingles the other day; blisters all over her neck are nasty; Very painful; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient reported on unspecified date on 2021, she came down with shingles the other day and her daughter in law, who was a nurse, said there had been studies of people getting shingles after getting the vaccine. She didn't think of any relation of that to the vaccine. Patient reports on unspecified date on 2021, that the blisters all over her neck were nasty. Very painful. Patient stated that people should get their shingles shot, that they should get the Covid vaccine, definitely, but also get that if you're older. She reported she went to a dermatologist initially and was mis-diagnosed it before, but today got a definitive diagnosis and started the medication, which was not as effective as it would have been if she would have started it in the first few days. The reporter was not related to a study or programme. The patient received treatment for the events. The outcome of the event was unknown.   Follow up attempts are needed. Information on the lot/batch number has been requested.
FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HANDS AND LIPS WITH LIKE PADDING AND TINGLING. PAIN IN THE INJECTION SITE.
8 pts recv vax 13JUN95 & 4 of the pts devel gen morbilliform rash & fever greater than 102 24 to 48 hrs p/vax; a child who was not vax devel chicken pox w/in 24 hrs of contact w/one of the vax children;
This non-serious spontaneous case, initially received from other health professional (nurse) on 08-Nov-2018, concerning a 3-year-old, child patient of unspecified gender. On an unspecified date, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). At the time of this report, no adverse event was reported.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 THROMBOSIS OF LEFT INTERNAL CAROTID ARTERY  HYPOXIA 7/9/2021 THROMBOSIS OF LEFT INTERNAL CAROTID ARTERY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CHEST PAIN  HYPOXIA 7/9/2021 CHEST PAIN  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOXIA 7/9/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 HEART FAILURE W NORMAL LVEF >=50%, UNSPECIFIED ACUITY  HYPOXIA 7/9/2021 HEART FAILURE W NORMAL LVEF >=50%, UNSPECIFIED ACUITY