chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRONCHITIS; SHORTNESS OF BREATH; BODY ACHES; COUGHING; HEADACHE; FEVER; This spontaneous report received from a patient by a Business partner on 24-JUN-2021 was received on 24-JUN-2021 and concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included incision and drainage, covid-19, covid-19 pneumonia, cyst on middle of breast, slurred speech, difficulty in walking, and several ear infection, and concurrent conditions included penicillin allergy, moderate to severe rheumatoid arthritis, heart murmur, no tobacco use, abstains from alcohol, high blood pressure, back pain, and diabetes, and other pre-existing medical conditions included the patient had sulpha drugs allergy manifested by difficulty of breathing. The patient experienced drug allergy (cannot breathe/chest pain, bronchitis) when treated with infliximab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tramadol for back pain, glimepiride for diabetes, metformin for diabetes, lisinopril for high blood pressure, and adalimumab for moderate to severe rheumatoid arthritis.  On 22-JUL-2020, Laboratory data included: Body temperature (NR: not provided) 104 F, Chest X-ray (NR: not provided) Pneumonia, and Culture nose (NR: not provided) Positive for covid-19. On JUN-2021, the subject experienced bronchitis. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced coughing. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, bronchitis, headache, coughing, fever and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Pt developed muscle/back ache, nausea and redness at LT deltoid (injection site) this AM. Injection given 7/1/15.
Redness, Swelling of bottom portion of upper arm, Hot to touch, Headache, Fever.
She got her vaccine, and unlike the first 4 she had very little discomfort, the shot did not hurt and had minimal discomfort.  She was a little tired.  6 days later it aches, it was stabbing pains alternating with aching, felt like she needed her arm in a sling, could not sit or do anything.  She took Advil or Tylenol and iced it.  It was bad the next day, talked to her PCP and he informed her to go to an UC and then it went away.  Then last night in the middle of the night the sensation came back again, uncomfortable most of the night, woke up with a lot of pain in that arm, specifically in the muscle itself.  It's better than it was this morning, and felt like she was having some symptoms of a strange muscular symptoms, it's just her arm in the muscle where the shot was.   Her PCP had no idea what to do for her symptoms.   It is easy up, the severe sharp have gotten better as the day goes on, had serious discomfort for 7 hours.   She wonders if this is going to continue to happen.  She can feel it lurking, but not severe.  She is clutching her arm and rubbing her muscle.    She reacted badly to the Shingles vaccine a few years ago.  Was in bed for 2 days and an infected arm from that and had to take antibiotics.   She did not have this type of reaction with the COVID vaccines, just tired, but able to get up and go about her daily activities.
No adverse effects reported.; one patient received one dose of MMR II intramuscular instead of subcutaneous; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, concurrent conditions, and concomitant medications were not provided.     On 31-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscular instead of subcutaneous (incorrect route of product administration) (strength and anatomical location were not reported; lot number R019391 and expiration date 05-JUL-2020) for prophylaxis. No adverse effects reported.          Lot number and expiration date were reported in the source document. But, when entering the lot number in the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced inadvertently gave FLUMIST to a patient with asthma. The outcome of the event of inadvertently gave FLUMIST to a patient with asthma is unknown. The report was considered to be non-serious.
Information has been received from a physician concerning a 24 month old female who in 2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In 2007 the patient developed rash and fever. The physician stated that the rash was not varicella-like. The patient also had elevated IgG level. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 17-MAR-2016, the patient was vaccinated with a dose of M-M-R II (lot # L032181, expiration date: 25-AUG-2017, dose and route were not reported), that was improperly stored (temperature and time frame were unknown at the time of reporting). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient indicated that about 3-4 hours after she was given the Zostavax immunization, she noticed swelling of her lip/face. Patient called the next morning to let the pharmacy know of the reaction. No medical treatment necessary as issue had resolved.
PATIENT WAS INADVERTANTLY GIVEN MENVEO WHEN IT WAS NOT ORDERED
Headache, chills, fatigue, sore arm, joint and muscle pain (slept almost all day 5/1)
headache; injection area itch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection area itch) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy and Drug allergy (Anti-Itch cream allergy.).    On 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection area itch). On 28-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (injection area itch) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Patient did not seek medical attention but treated events with Advil, dose not provided.
I received Flu vaccine 2 hrs after my throat started to close up. I develop Hives over Body. Headache & Joint Pains & Vomiting.
Received Moderna vaccine at 8:30 PM on 1/6/21.  Experienced expected arm muscle soreness starting in the morning of 1/7/21 lasting until 1/9/21 without treatment.  Experienced sharp chest pains on exhalations only, starting around 10:30 AM on 1/7/21.  Chest pains faded throughout day and relieved by 5:00 PM on 1/7/21 without treatment.  Experienced fatigue, body aches, chills, and skin sensitivity around 7:30 PM on 1/7/21, treated with OTC ibuprofen with symptoms continuing going to sleep but resolved by waking up in morning on 1/8/21.  Experienced nasal congestion on the morning of 1/8/21 and lasting until evening of 1/10/21 without treatment.  Experienced headache, nausea, and brain fog 1/11/21, treated with OTC ibuprofen with no success in relieving symptoms.  Nausea and brain fog continued until resolving in afternoon of 1/13/21 (1 week following vaccine).  No other symptoms since.
Finger tips on left hand were numb/my fingers were numb; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female consumer received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot: EL0140 or EL, don't know if that's an O or 0, 14, O or 0), via an unspecified route of administration on an unspecified date about 10 o' clock at single dose on left arm for COVID-19 immunization. Medical history included type 2 diabetes, stent in right coronary artery and cardiac issues. Concomitant medication included metformin for diabetes mellitus and rosuvastatin calcium as cardiac medication. The consumer realized that the finger tips on her left hand were numb. By 2 pm her fingers were numb. The consumer 'can drive a needle across her palm' (not clear over the call and not clarified) and can't feel it. The outcome of the event was unknown. No treatment was received for the event.  Information about lot/batch number has been requested.
Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient was inoculated with a dose of ZOSTAVAX, on or about 09-JUL-2014 at a pharmacy, as recommended for routine  adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-MAY-2016, the patient was treated at the emergency room for dermatitis secondary to Shingles. On or about 12-MAY-2016, the patient was treated at the emergency room for a painful rash that was diagnosed as shingles. On or about 17-MAY-2016, the patient was treated at the same emergency room for a worsening condition of post herpetic neuralgia. On or about 24-MAY-2016, the patient was treated at the emergency room for worsening symptoms that were diagnosed as post herpetic neuralgia. On or about 18-AUG-2016, the patient  was treated at the emergency room for residual symptoms, diagnosed as chronic pain syndrome. The patient was prescribed acyclovir, gabapentin, hydroxyzine HCl, and oxycodone to manage her symptoms. 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 expense, and pain and suffering, and other damages. Additional information has been requested.
Patient stated that she lost vision in her right eye approximately 36 hours after receiving Dose 1 Moderna information.  Adverse reaction was reported on 3/31.
PATIENT STATES THAT HER ARM HURT FOR 3 WEEKS AFTER RECEIVING THE VACCINATION AND WHEN SHE SAW A DOCTOR, DOCTOR STATED SHE HAD FROZEN SHOULDER AND IS IN NEED OF THERAPY TREATMENT
Mild fever, fatigue,headache, muscle aches (legs), vomiting (sputum/phlegm for 2 days)...symptoms started 3 days after immunization, and have lessened although not completely resolved as of 7/18/17.
light headed, diaphoretic, felt faint, nausea, tinnitus. pt drank water and ate oreos
This spontaneous report was received from a registered nurse refers to a 4 year old patient of unknown gender. The reporter stated that the patient was supposed to receive (Oka/Merck) VARIVAX, but inadvertently received ZOSTAVAX 0.5 ml, subcutaneous on 21-NOV-2014. No dose of (Oka/Merck) VARIVAX was administered. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a physician's assistant refers to an 80 year old female patient. On 26-DEC-2012, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported). The physician reported that on 15-FEB-2013, the patient appeared at her office with a rash and a pain consistent with shingles. The patient was treated with acyclovir. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
09/30/2022 I woke up with a sore arm and feeling not quite my usual self. This lasted for about 5 days. I then began having a sinus headache, achy, fever up to 100 degrees, stuffy with a lot of drainage and tired. I did not feel like doing my usual activities. I felt it was a sinus infection. 10/11/22 I had my regular appointment with my PCP.  She prescribed Augmentin, told me to drink a lot of fluids and stay in bed. I have not recovered yet.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). On an approximately 12-SEP-2013 (about a week ago), the patient was vaccinated with an expired dose of PNEUMOVAX23, 0.5 ml (route, lot number not reported, exp. Date 10-MAY-2013). No adverse effect reported. The patient's outcome was unknown. Additional information has been requested.
This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 05-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
The patient was admitted on 6-30-22 to our Medical/Surgical unit at 1724 from the ER department with hypoglycemia and atrial fibrillation.  Patient was tested for covid-19 on arrival and was confirmed positive for covid-19 at 2353 the same day.
Mother called to report child had a painful, swollen L arm that was red, hot to touch and itch on the site of injection.
swollen arm; dizziness; body aches; major headaches; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), PAIN (body aches), HEADACHE (major headaches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), PAIN (body aches), HEADACHE (major headaches) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), PAIN (body aches), HEADACHE (major headaches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The injection was very painful. About 4 hrs later, I had intense pain in my back that spread all over my body. I had pain in my joints and muscles with a fever. I felt very cold though. My symptoms felt like the flu. These symptoms continues about 48 hours.
A nurse described the inability of a 37 y.o. female to respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject's medical history included no known diagnosed allergies. No concurrent medications were reported. She received no concurrent vaccines. The subject experienced no adverse events following previous immunizations. On 3/27/97, 4/29/97, and 10/1/97,the subject received injections of Engerix-B. Each injection consisted of 2 pediatric doses of 10 mcg to provide the recommended adult dose of 20 mcg. An unspecified titer was performed on an unspecified date after the 3rd Engerix-B injection and the result was "negative." On 10/23/02, the subject received her 4th injection of Engerix-B (lot ENG5156A2; expiry, May 02) approximately 5 months past the expiry date. On 11/14/02, the subject's Hep B surface antibodies tested positive.
Rash all over her body, rash not really itchy which spread to the legs; Rash on the upper part of abdomen; Face swelled up again; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelled up again), RASH (Rash all over her body, rash not really itchy which spread to the legs) and RASH (Rash on the upper part of abdomen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067E21(LI)A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Botox and Juvederm Treatment since 4 years) since an unknown date. Concomitant products included ABATACEPT (ORENCIA), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), THYROID (ARMOUR THYROID), DULOXETINE HYDROCHLORIDE (CYMBALTA) and VITAMINS NOS for an unknown indication.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced SWELLING FACE (Face swelled up again). On 24-Sep-2021, the patient experienced RASH (Rash on the upper part of abdomen). On 26-Sep-2021, the patient experienced RASH (Rash all over her body, rash not really itchy which spread to the legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face swelled up again), RASH (Rash all over her body, rash not really itchy which spread to the legs) and RASH (Rash on the upper part of abdomen) outcome was unknown.            This case was linked to MOD-2021-333742 (Patient Link).
Pneumonia, fever, chills, pain in back of neck, cough, and heavy chest.
mom called 25APR94 stating that pt had woke up 22APR93 broke ot w/ a rash & taken to MD; dx w/measles, related to the MMR;
Reported joint pain in right arm, tenderness, in right arm, redness and hot to touch at approximately 3 weeks after injection.
Myocarditis; This is a spontaneous report from a contactable consumer reported for a patient that a patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced myocarditis after mRNA vaccine. The reporter stated that they know of this one additional report of a single cardiac biopsy, but nothing particularly informative beyond the absence of cellular infiltrates. This paper mentions the recommendation to avoid excessive physical activity for several months after an episode of myocarditis. I think it was clear that we are vigorously seeking info to inform about rare risk of cardiac findings after mRNA vaccines. I will be eager to learn about any outcomes from further discussion with Doctor. Please find attached a report in follow up to our discussion about any biopsies obtained in setting of suspected myocarditis after mRNA vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Rec'd first round of SHINGRIX vaccine yesterday. Injection site very sore today. Flu-like symptoms today (aches, headache, weakness). Was warned by pharmacist that I would experience sore arm, but was surprised to feel so lousy today. Will get the second round of the vaccine in 2-6 months, but will plan to do so before a weekend so as not to be sick during week.
Redness, swelling and warmth at the injection site within 4 hours, post vax. Entire arm was swollen within 8 hours, post vax. Pt stated increased use of Albuterol Inhaler throughout the night. She had joint pain and redness at injection site still present. She went to MD and he prescribed no treatment. Last TD greater than 10 years ago.
Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (lot # M007964, expiration date: 15-AUG-2017; lot # L046508, expiration date: 17-MAY-2017; dose and route were unknown) for prophylaxis. The nurse reported no adverse effects noted. The temperature for the vaccine stored was 12.9 Fahrenheit degree with 2 hours 10 minutes time frame. Previous temperature excursion was reported as exposure to 13.8 Fahrenheit for 3 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008934: US-009507513-1701USA001204.
Strong pain in the whole arm up to the fingertips Cold hand Strong pain in the armpit radiating to the breast. Headache.
This spontaneous report was received from a pharmacy technician and refers to 60 patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L040458, expiration date: 04-FEB-2018; dose and route were not provided). No adverse symptoms were reported. Additional information has been requested.