chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On April 12 a red burning rash appeared on face and scalp. Burning itching and peeling of face and scalp like a bad sunburn Went to dr on April 16 and was told it was psoriasis. Was given prescription cream for face and scalp. Condition resolved a few days later.
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Medium, Additional Details: Approximately 5 min after vaccine administration, patient fell over in the chair he was sitting in. He was unresponsive for approximately 10 sec. He stayed on the floor while alert until the ambulance arrived. The EMT's took over care and proceeded to check patient. The patient was removed from the pharmacy area via gurney and taken to a nearby hospital.
This spontaneous report was received from a Doctor of Pharmacy concerning a patient who on 30-AUG-2012 was inadvertently vaccinated with an expired dose of ZOSTAVAX, subcutaneous single dose (lot # 670817/0663AA, expiration date on 04-AUG-2012). No adverse effects were reported. Additional information has been requested.
Initial and follow up information has been received from a registered nurse concerning an 18 year old female with asthma, polycystic ovaries and no known allergies or adverse drug reactions reported.  On 25-SEP-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653735/0688F).  Concomitant therapy included bupropion HCL (WELLBUTRIN XL), lithium carbonate and risperidone (RISPERDAL).  That evening, on 25-SEP-2006, the patient developed left arm swelling and difficulty breathing.  It was reported that the difficulty breathing could be due to the patient having a cold and being an asthmatic.  On 26-SEP-2006 the patient developed facial swelling.  The patient sought unspecified medical attention.  It was reported that a nurse practitioner and physician were doing an assessment and consultation. On an unspecified date, the patient had the assessment and consultation and her symptoms were not considered to be serious. At the time of this report, the patient was recovering from th events. The reporter considered the events to be serious as other important medical events (date unknown).  Additional information is not expected.
Hospitalization for N/V and abdominal pain due to COVID-19 on dates 7/28/2022-8/8/2022.  Treated with dexamethasone.
Client received the 1st dose of COVID vaccine by Pfizer lot # EW0161 and expiration date: 4/17/2021 at 11:37am. At 11:50am client reported to EMT that she felt dizzy. PHN arrived and noted client had pale lips and eyes closed but able to respond to questions (alert and oriented x 4). Client reports not feeling okay and really dizzy like she is going to faint and hotness on her eyes. PHN offer client water. Client has no medical conditions and takes no medications and has never had a reaction to any vaccine before. Client reports she is not pregnant.  Other PHN arrived to assist at 11:52 am able to get oxygen: 100% and pulse: 82. Shortly after client reports she needs to throw up, provided emesis bag and client vomits X 2.  Right after client vomited color returned to her lips. At 12PM vitals are pulse: 70, blood pressure: 138/79.  At 12:05pm pulse: 64 and blood pressure 120/82, client reports no headache, no blurred vision and no nausea.  Nurse went outside to get husband and son of client and walked them over to client.  At 12:15pm pulse was 62 and blood pressure 116/78, client reports feeling tired, no pain, no nausea and no headache.  At 12:25pm client vitals were pulse: 60, blood pressure 120/80.  Client left facility with a steady gait at 12:28pm.
pt recv vax 20NOV97 & exp rxn to flu vax & or flu;pt states 1PM yesterday it hit him like a log;chills, fever, aching, so went home to bed;awoke w/bed like a lake;today aches all over & fever 107.4;ice packs on head w/cold showers;
Very sick with flu-like symptoms the day after vaccination for 2 days. Over the next 2 weeks, symptoms progressively got worse with low-grade fever, cough, difficulty breathing, and extreme fatigue. Diagnosed with double pneumonia. Prescribed cough medicine and steroids. At the same time, gastric problems were exacerbated with severe abdominal pain, distention for which I spent 2 days in the hospital. Diagnosis so far of esophagitis and gastritis but testing and the final diagnosis is still ongoing.
This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient had no pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose #, route of administration, lot # and expiration date were unknown). Concomitant therapies included unspecified blood pressure and thyroid medications. On an unknown date, the patient developed extreme swelling of the arm where the vaccine was administered, and the injection site was red, hot to the touch and hard. The symptoms spread to the patient's collarbone on the morning after receiving the vaccine. The patient had not sought any treatment, and no laboratory diagnostics were performed. At the time of reporting, the outcome of the adverse events was unknown. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1712USA000628:
Within the hour redness and swelling at site of injection. By next morning swelling had travelled down to elbow and was also hot to the touch. By the second day side effects had not worsened and then became less as the day progressed.
Pt stated that arm is swollen and red, there is also a round puffy circle around the area of injection.
I had virtually no effects other than minimal injection site soreness.  Approximately 72 hours after the dose I developed moderate, persistent, generalized itching.  I also had a few skin papules -- neck, hands.  I am a retired physician (internist) and I'd be happy to talk with anyone.
Information has been received from a pharmacist concerning her currently 15 year old daughter who in approximately 1995 (about 14 years ago) was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). There was no concomitant medication. In approximately 1995 (about 14 years ago) the patient developed shingles. The lesions were around her ribs. Unspecified medical attention was sought. No lab diagnostics studies was performed. No treatment was given. On an unspecified date about 14 years ago the patient was completely recovered. Additional information has been requested.
positive for COVID; patient experienced COVID on 20FEB2021 after the first dose of vaccination; This is a spontaneous report received from a contactable consumer. A Female patient of unspecified age received first dose bnt162b2 (COMIRNATY, Solution for injection Lot No. Unknown, Expiration date-unknown) via unspecified route of administration on unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were unknown. Family History was unknown. The patient experienced COVID on 20FEB2021 after the first dose of vaccination, now she feels well and asked her doctor what she needs to do because her second dose is scheduled by 13Mar and her doctor replied as don't know.   No follow-up attempts are possible; No information about lot/batch cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event COVID-19, Drug ineffective and the suspect drug BNT162B2.
severe hypersensitivity; swelling of tongue; dyspnea; skin rash; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient administered vaccine and developed swelling of tongue, dyspnea, skin rash on an unspecified date. There is a report of severe hypersensitivity for his awareness. The patient was treated with dexamethasone, Benadryl, IM epinephrine in ER. Outcome of events were unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
This spontaneous report as received from a nurse refers to 20 patients of unknown age and gender. On an unspecified dates from 23-DEC-2013 until 17-JAN-2014 the patients were vaccinated intramuscular with LIQUID PEDVAXHIB with reported lot number J011121 (exp. date 04-JUN-2016), intramuscular. On 18-DEC-2013, a shipment of PEDVAX was shipped to the nurse's office. However, the LIQUID PEDVAXHIB remained in transit in the sealed shipper until 23-DEC-2013. When it arrived at the nurse's office the LIQUID PEDVAXHIB was placed into refrigeration. The refrigerator had no temperature excursions. On unspecified dates from 23-DEC-2013 until 17-JAN-2014, 20 patients received these LIQUID PEDVAXHIB doses (incorrect storage of vaccine). No known adverse effects. Additional information has been requested.
she felt pain in the arm and body; she felt pain in the arm and body; inflammation in the injections site; fever; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Jan2021, she felt pain in the arm and body, inflammation in the injections site and fever and had taken 6 Tylenol tablets as treatment, but the fever has not been fully controlled. The outcome of event fever was not recovered; for other events was unknown.  Information about lot/batch number has been requested.
Difficulty breathing; Legs have also itched; Hives painful to touch; Hives; Little nausea; A spontaneous report was received from a consumer, who was a 81-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch.   The patient's medical history included afib (atrial fibrillation). Products known to have been used by the patient, within two weeks prior to the event, included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that he felt a little nausea for the first few days after vaccine administration.  On 25 Jan 2021, the patient woke up at 1:00 AM with hives on his right arm from the elbow to the shoulder. He stated the hives were painful to touch. The patient took diphenhydramine and the hives disappeared that morning. Later that day, the patient developed difficulty breathing and the hives appeared on his left arm from the elbow to shoulder.  The patient went to the emergency room and was hospitalized overnight due to breathing issues. He was given diphenhydramine and steroids and was released from the hospital on 26 Jan 2021.    On 27 Jan 2021, the hives reappeared from the patient's hands, spreading to the arms, shoulders, head, neck, and face. He described some of the hives as being nearly a quarter-inch high and he stated they looked like water blisters.  On 28 Jan 2021, the patient went to the emergency room again because he was having a lot of trouble breathing.   On an unknown date, the patient's legs had also itched but there were no spots.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch, was unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, with medical history of atrial fibrillation, who experienced serious unexpected event of dyspnoea, and non-serious unexpected events of urticaria, pruritus, pain, and non-serious expected event of nausea. The event of nausea occurred on day 1 after mRNA-1273 (Lot# Unknown). The event of dyspnoea, urticaria, and pain occurred 14 days after mRNA-1273 and the event of pruritus occurred on an unspecified date after mRNA-1273. Treatment included diphenhydramine and steroids. Concomitant medications included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
3"x2" erythema on left arm at site of immunization (VARICELLA #2).
Fever, Chills, Sore Arm, Tinnitus - Started around 8 PM on the day of the vaccine and then throughout the night. Was gone when she woke up in the AM.
patient received a half dose, but she should have received a full dose because she is immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a half dose, but she should have received a full dose because she is immunocompromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (patient received a half dose, but she should have received a full dose because she is immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a half dose, but she should have received a full dose because she is immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
1251 Dizziness BP 144/88, HR 88, poc glucose 79, resp 17 sats 98% 1300 expressed Dizziness improved states she is ok to go home. She is accompanied. S/S to call 911 and seek immediate care discussed. They verbalized understanding.
pt brought to ED with hypoxia; pt tested positive for COVID at facility 1 day earlier; pt on 3 L O2 every day for chronic respiratory failure; O2 sats with EMS 60%; placed on 15L NRB with O2 sats 98%; tachycardic; limited code, BiPAP and CPAP only; DNR/DNI; given steroids, ABX; transferred to ICU; on BiPAP; pt did not improve; care turned over to Hospice; pt died in the hospital under hospice care
Tightening of chest after activity. Feels like I have a 25lb weight on my chest(in the middle).  It goes away and then comes back.
8 hours post vax, the pt developed febrile seizures. Evaluated and released from the emergency room.
Headache; woke up at 2am with headache due to muscle spasm in left neck and shoulder; woke up at 2 am; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraines and allergy to latex, PCN, neomyocin. Concomitant medications included gabapentin, omeprazole, melatonin and cetirizine hydrochloride (ZYRTEC ALLERGY), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included 1st dose of BNT162B2 (Lot/Batch No: EL3247) on 12Mar2021 in arm left for COVID-19 immunisation. Patient woke up at 2 am with headache due to muscle spasm in left neck and shoulder on 03Apr2021. Patient received 2 DF paracetamol (TYLENOL), 2 DF ibuprofen (ADVIL) (4am) and icyhot for headache, muscle spasm in left neck and shoulder. Outcome of the events was resolved.   No follow-up attempts are needed. No further information is expected.
Bruising and swelling at injection site.  No other Sx. NSaids for 2 days
Vaccinated on Feb 2, slight pain in the side of injection for two days, Then on Feb 9 (5 days after injection) strong gradually  increasing pain in R leg at hip and knee (medial side) - these parts were painful previously but not as strong pain as it is now. Using ibuprofen  200mg two tablets (400mg) twice a day with 80 % relief, strong pain during walk, but still worse during the night -  difficult to find  right position to reduce pain.
01/17/2003: Father called to report that the childs Left arm was swollen, warm and reddened from elbow to shoulder.  Denies any difficulty moving the arm.  Advised symptomatic Treatment, Tylenol or Advil and cold compresses.  Advised to notify Family Doctor if not resolved in 2-3 days.   01/17/2003 @ 10:45: Contacted family Dr. Spoke with vaccinee and reported above symptoms, shots received, advised treatment and follow up if necessary. 01/22/2003: Follow up care
Possible Guillain-Barre; Weakness in his legs up through his abdomen and lower back; Numbness in his legs up through his abdomen and lower back; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure abnormal and Blood cholesterol abnormal.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre) (seriousness criterion medically significant), ASTHENIA (Weakness in his legs up through his abdomen and lower back) and HYPOAESTHESIA (Numbness in his legs up through his abdomen and lower back). At the time of the report, GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre), ASTHENIA (Weakness in his legs up through his abdomen and lower back) and HYPOAESTHESIA (Numbness in his legs up through his abdomen and lower back) outcome was unknown.            Concomitant medications included blood pressure medicine and cholesterol medicine.  Treatment information was not provided.  The caller stated that although they are still running some tests, his doctors believe that he developed Guillain-Barre after receiving the vaccine  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Temperature 99.6 F by ear thermometer; experienced mild fatigue, red rash on left arm; arm still sore to touch. Took 500mg acetaminophen, temp dropped to 98.4F, still some fatigue, rash still present.
Chills; Headache; Fever; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe) and Crohn's disease (Moderate to severe).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Pre-filled pen. On 17-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) had not 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 medications reported.  No treatment information provided.
This was my second PFIZER vaccine, but I received the Johnson and Johnson vaccine first. On 11/3/2021 I had a thunderclap of a headache that would not go away. It seemed to get a little better with ALEVE. IT was waking me up at night for a few nights in a row. 11/7/2021 I went to the ER and had a CT scan done. It was normal. The doctors believed it was a vaccine response. They referred me to a neurologist. I talked to my internist who told me to take ALEVE around the clock. It felt better but did not go away. On 11/17/2021 I saw the neurologist and he suggested I add a muscle relaxant to my routine. The headache did not completely go away until end of November or early December.
Headache like I experienced with Covid, painful hips/back like I experienced with Covid - both only on 12/20/2020.  I took Ibuprofen.  My arm was sore at the injection site and it still is sore 12/22/2020. A small area around the site of the injection became red on 12/20/2020 and the red area continues to grow on 12/22/2020.  What was the size of a thumb nail on 12/21 has grown to about 2" long by 1" wide.
Patient was given an expired vaccine. Vaccine expired 10/28/2023. No known adverse effects.
10 mins after the vaccines given to the baby, the mother called us to the room because she had noticed red rash on periorbital areas and left temporal areas. On exam baby was alert, active pulse ox 100% RA, HR 137/min, skin and papules on upper eyelid checked, left temporal and upper back and diaper area. Lungs clear. Abd soft. Oral cavity intact. Continuous pulse ox decreased, heart monitoring were applied, 1 ml of BENADRYL given orally, in next 20 mins the rash faded, pt was D/C'd home stable with appointment to return in 24h and ER precaution.
Lightheadedness reported .  Apple juice given. BP 112/81.  BP at 1726: 96/63 HR 62.  Reports feeling stable and left clinic.
Information has been received from a physician's assistant concerning a female in her 40's who on 05/26/2002 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently, "several days later" in approximately May 2002, the pt experienced arthralgias, and minor paresthesias of the left hand. The pt also developed a golf ball sized lymphadenopathy in her neck. The pt did seek medical attention. Additional info has been requested.
Mother reports child developed fever and rash on bilateral feet and hands after immunization. Rash is improving - but today developed bright red area on (R) ant thigh at injection site. Has cellulitis of (R) thigh. Rx - antibiotics and follow up in 2 days.
Patient received  first dose of vaccine, and faint within 3 minutes.  Did not receive epinephrine dose at the pharmacy because the paramedic  arrived within 3 minutes.  They took the patient to the hospital, and release him at 5:00PM.  He is resting and doing great at home according to patient's dad.
pt recv vax 19FEB97  215PM & 320PM c/o dizziness & lightheaded feeling;p/resting 15min pt felt better & returned to work;no rash or dyspnea;f/u 20DEC reveals well
FIVE MINUTES AFTER TAKING THE VACCINE, PT EXPERIENCED BLURRY VISION WHICH PROGRESSED TO LOSS OF VISION AFTER FEW MINUTES. PT APPEARED PALE, SKIN HOT TO TOUCH THEN HAD A LOT OF SWEATING, THEN HEADACHE. BUT VISION CAME BACK AFTER 30 MINUTES.