chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 71-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case (201804098) was cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Crawling, cramps, numbness, chills, lots of sweaty cold, pain in he hips and body, strong pain in the chest, pangs in the chest.
I have a warm lump on my left arm about 1.5 inches from the injection site. It has been slightly itchy in this area since a few days after the shit but now it is more itchy and inflamed.
Bad headache, shortness of breath, sweaty clammy , non stop violence vomiting , blood coming through nose while vomiting nausea and stomach , dizzy , vision . Weak . Felt like I was dying
Left arm with 3 x 3 cm area of erythema and swelling. No induration, minimally tender, persisting for > 72 hours. Left anterior thigh with 5 x 5 cm area of swelling. No induration mildly tender, persisting for > 72 hours.
rash on her arm; itches; Knot on the injection site; Itchiness in knot; rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Knot on the injection site), INJECTION SITE PRURITUS (Itchiness in knot) and INJECTION SITE RASH (rash on the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE MASS (Knot on the injection site), INJECTION SITE PRURITUS (Itchiness in knot) and INJECTION SITE RASH (rash on the injection site). At the time of the report, INJECTION SITE MASS (Knot on the injection site), INJECTION SITE PRURITUS (Itchiness in knot) and INJECTION SITE RASH (rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2021: No specific follow-up information recorded.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reactions/allergies. Pharmacist reported that the patient came into the pharmacy today, 25-SEP-2013, and stated after receiving ZOSTAVAX (vial, lot #, dose/frequency were unspecified), on an unspecified date at another unspecified pharmacy, she experienced redness at the injection site that subsided within a few hours. The patient showed the pharmacist where the ZOSTAVAX was administered and the pharmacist believed the ZOSTAVAX was given via the intramuscular route instead of the subcutaneous route. The pharmacist stated this was the first time the unspecified patient was seen at the pharmacy therefore she had minimal information. The outcome was reported as recovered. Additional information is not expected.
Pt received 2 doses of varicella, 9/8/08 & 1/29/10. Pt is in office now with chicken pox.  Provider concerned vaccines were not strong enough.
Patient reported itching at injection site, within 24 hours after receiving the vaccine. It lasted about a month.
Patient was told to wait in the waiting area for 15 minutes before leaving. He tried to stand 5 minutes after vaccination & he fell to his knees upon standing.  I asked the patient what symptoms was he feeling & he said he felt dizzy. He also started to sweat. Patient was told to remain seated. I asked the patient if the wanted me to call 9-1-1 or an ambulance & he said no. I asked if he wanted he to call someone & he said his friend was in the work truck. I asked if he wanted me to have someone to get him, he said no. A few minutes later he called his friend to come in the pharmacy & I asked his friend to sit with him.   Patient drank some water while remaining seated & used paper towels to wipe his forehead. After 20 minutes from the adverse event the patient said he was ok to walk & got up by himself. His friend & I walked him out the store & his friend walked him to the truck. His friend said he will be driving the patient home & the patient said he would not be going back to work that day.
crying, broke out in rash until 17th on 25th running fever & sz again- partial 10min;25 min full body sz;stopped breathing almost died in ER: taken to hosp-on phenobarb meningitis, encephalitis
Pt developed fever 10 days after immunization, then had fever for 21 days, hospitalized 10-4-00 then transferred to another hospital on 10-8-00 due to seizures and encephalopathy. MRI showed white matter changes consistent with acute disseminated encephalomyelitis (ADEM).  Pt treated with Solumedrol (20 mg/kg x 5 day) then prednisone taper.  Improved markedly on steroids.  Returned to baseline.  Developed complex partial seizures in April 2004, is now on Lamictal and seizure-free but school performance has declined. Discharge Summary received on 3/11/2005 states nystagmus, vomiting, autoimmune disorder, and unresponsive.
The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 21-SEP-2021. Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment information was provided.
Pt returned to clinic 15-20 minutes after vaccine was given with wheezing throughout lungs, extreme pruritus to eyes/nose/ears/neck, copious rhinnorrhea, and sneezing. 2.5 mg albuterol nebulizer was given with resolution of wheezing and 25 mg of benadryl was given with improvement in pruritus and rhinnitis. No vomiting, no lip swelling.
arm hurt; Infection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurt) and infection (Verbatim: Infection). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the pain in arm and infection were not reported.   It was unknown if the reporter considered the pain in arm and infection to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm and infection to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot and arm hurt and had to go to doctor to get antibiotics for the infection. The reporter did not think he/she would get the second one now.
pt recv vax 10MAR97 & was found to be pregnant (LMP 11FEB97);estimated date of delivery 18NOV97;APR97 a sonogram revealed fetal demise @ 10.5wk gestation;12MAY97, @ 14wk pt had a spontaneous abortion;
Raised red bumps on elbows, back of hands, knees, feet. Itchy and painful.
pt recv vax 5SEP95&a titer was drawn which was negative;in f/u the MD reported that the pt did not exp any adverse effects from the vax;
This spontaneous report as received from a certified medical assistant refers to a 13 year old female patient with no medical history or drug reactions/allergies reported. On 17-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (lot # 668819/0477AA, exp 29-JUN-2013), intramuscularly. After receiving the first dose of GARDASIL, on 17-JUN-2011, the patient fainted and developed a seizure. Oxygen was given to the patient. No lab diagnostics studies were performed. Patient's outcome was reported as recovered on 17-JUN-2011. The patient sought medical attention, the physician saw the patient. Upon internal review, seizure was considered as other medically important event. This is 2 of 4 cases reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-APR-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Injection received on a Wednesday 1/13 afternoon. By Friday, noticed slight sore throat, slightly swollen axillary lymph nodes on that side only and some slight shortness of breath on exertion, fatigue. By Monday, unable to place right arm by side or sleep on right side.  Lymph nodes were significantly swollen golf ball size, slightly feverish and continued shortness of breath increasing. Unable to sleep Monday and Tuesday nights, restless increasing discomfort. Awoke Wednesday 1/20 increased shortness of breath, increased axillary swelling, warm to touch. Called clinic and was told to come right in. Saw FNP and she sent me for ultrasound scan at Radiology,  reported back to clinic and was told to have someone drive me to ER due to increase shortness of breath. I was unable to speak more than 2 words without difficulty breathing. Saw MD at clinic, he ordered oxygen and a chest x-ray, conducted an exam and gave a dose of Tylenol and Prednisone. My breathing improved and I was placed on oral steroids and followed up via phone with initial provider Dr. .
Total body numbness; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Severe left sided head pain; Low oxygen; This is a spontaneous report from a contactable other hcp (patient). A 47-years-old female non-pregnant patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 23Aug2021 10:30 (at the age of 48 years), (Batch/Lot Number: Fc3183) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took sulfonamides and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Aug2021 10:45, the patient experienced total body numbness, fave and tongue numb and tingly, severe left sided head pain, low oxygen. The events resulted in visit to Emergency room/department or urgent care. The treatment received for the events was unknown. Device Date was 24Aug2021. The clinical outcome of the events was not recovered at the time of report.
Pt received Proquad in left leg. T97.4 2 days later pt had 4cm diameter area of warmth and induration. Pt seen by physician, given Zyrtec liquid one tsp q day x 10d, recheck in 3 days. Per administrator, Pt fully recovered.
Roughly 15-20 mins after shots were administered as patient was walking out he told his wife that he was feeling weak and his lower back was in excruciating pain. Stated he was having difficulty breathing due to pain, 911 was called and taken to hospital. Wife then reported pt. broke out in hives at hospital.
My heart heart was elevated to twice my normal rate for 8 hours.  I had body aches, headache and fever.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot#, dose and frequency were unknown). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Urinary Tract Infection / Enlarged testicles / Frequent Urination / lasted 1 Month.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022 at 3:28 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jan-2022 at 3:28 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. No treatment medications were provided.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The unspecified patients were administered MMRII (lot# L012479, expiration date 10-APR-2017; lot# L005291, expiration date 17-FEB-2017) (dose, route and frequency not reported), which were exposed to temperatures outside of the recommended range since 05-NOV-2015. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse in the physician's office who stated that PNEUMOVAX 23 (dose, route and lot # not provided) and other unspecified immunizations, caused sore arms and allergy immunizations did not. Dates were not provided. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Induration at the site on March 7th 2020, hot to the touch that spread to hives that began this morning, March 9th 2020, on the right thigh.  Given Prednisolone 10ml and Benadryl 5 ml at 10 am this morning MArch 9th 2020. No wheezing noted by provider.
red arm/injection site red; abdominal cramps; diarrhea; fever; nausea; fatigue; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm/injection site red), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), PYREXIA (fever) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, SERTRALINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), METFORMIN HYDROCHLORIDE (METFORMIN ER), ATORVASTATIN, MULTIVITAMIN & MINERAL and MAGNESIUM for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm/injection site red), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), PYREXIA (fever), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, VACCINATION SITE ERYTHEMA (red arm/injection site red), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), PYREXIA (fever), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-Apr-2021 included no new information. Consent to FU removed
2/10/21: Mouth, lips, tongue, throat, and neck swelling. Blistering on tongue. Dysphagia. Racing heart. Weak feeling. Swollen neck lymph nodes.  Took Benadryl which helped some with the swelling and swallowing. Still experiencing swollen lymph nodes, tongue swelling, and weakness.   In addition: 1/21/21 - 8:30 am: Experienced face swelling and red rash on face. 1st Covid Moderna Vaccine dos 1/8/21 Lot # 026L20A. Also took Benadryl for relief. Rash lasted 2 days.
2 days after the shot, developed a bad headache and blurred vision in my right eye. Also felt achy all over. Instructed to go to ER for treatment.
no adverse event; vaccine improperly stored and administered/ Temperature: 27-OCT-2020 BELOW 36 degrees F (35.70F)/ 14-OCT-2020 ABOVE 47 degrees F (64.36 F); This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 18-NOV-2020, the patient was vaccinated with incorrectly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T011167 with expiration date on 27-MAY-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent a temperature excursions of 35.7 degrees Fahrenheit for 1 hour and 30 minutes on 27-OCT-2020, 30.2 degrees Fahrenheit for 1 hour and 30 minutes on 28-OCT-2020 and 64.36 degrees Fahrenheit for 3 hours on 14-NOV-2020. Digital data logger was involved. No adverse events were reported.
On February 14, I had used the handlebar rotation exercise of a stationery bike for 5 minutes.  The next day I noticed a large swelling about the size of half a pear on the muscle where my Moderna injection was done.  It was as hard as a nut, red, and warm and itchy with a red rash around it.  I saw an urgent care medical person and was told it was probably a reaction to the exercise and that sometimes that happens after an injection.  I was told to use cold compresses, hydrocortison cream, and rest it.  I did this, for 5 days, but  though the swelling subsided, the rash continued to move around and down my arm.  I went back to urgent care on February 19 and was told that it looked better.  I was offered prednazone for it, but declined since I was still on Budesonide .  I was told it would probably clear up over the weekend.  On February 22  it hadn't cleared up so I saw  a PC.  She  noted the rash  had spread, but swelling had gone down.  She checked my lymph node under my left arm and noticed it was swollen.  She said it was most likely due to a mild infection in the arm where I had  received the vaccination.  She  prescribed  a Zpack and after 2 days, all symptoms were gone and I felt so much better.  This event happened 10 days after my vaccination.
Loss of equilibrium,ringing in the ears, pain in right eye and in right side of brain, sensation of bubbles in my right ankle,, mild chest, heart papitation, gritty grinding noise like sand in my neck joint when I turn my head
Patient says she had a small cold sore in the corner of her mouth. It does not cause any pain but appeared a few days after getting the vaccine.
2 hours after shot became dizzy when moving and standing. At worst point also became nauseous. These symptoms lasted about 5 hours. The injection site was also painful to touch during this time.
Information has been received from a consumer concerning his daughter (a year old female) with no medical history or drug allergies who on 3-MAR-2006 was vaccinated with a dose of MMR II (lot # 649748/0301R). Secondary suspect vaccinations included: the third dose of hepatitis B virus (lot # 651854/0306R) and the first dose of VARIVAX (Merck) (lot # 64668/0625R). Concomitant therapy included the third dose of HIB. The patient had been formally diagnosed as Autistic shortly after receiving the vaccines. The patient sought medical attention by visiting the physician's office. Multiple tests had been performed. At the time of reporting the patient was not recovered. Upon internal review it was determined that "diagnosed as Autistic" was an other important medical event. There is no additional information.
Pt was mistakenly given high dose flu vaccine at age 64 and 10 months. No adverse reaction noted.