chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm to the touch; Itching; Swollen like a knot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Swollen like a knot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Swollen like a knot). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Swollen like a knot) outcome was unknown.            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.  Concomitant product use was not provided by the reporter.
Pt developed pneumococcal pneumonia post receiving 4 doses of Prevnar. Was in ICU, on ventilator. The hospital discharge summary received on 3/23/04 states failure to thrive, influenza, oculogyric crisis, RAD.
After FLUAD vaccine on the left arm at the pharmacy, patient had another pneumonia shot at doctor office on the same day on the right arm. Around 5:00pm. Patient experience adverse events of inflamed/swelling at the site of immunization on the left arm and the right arm. Inflamed areas feel hot and painful on scale of 5 out of 10 per patient report. She felt achy and tired for the rest of the day. She checked her temperature reported 98 to 99 and did not have any fever. The patient reported to pharmacy of her adverse events on 9-12-2020 at 12:30pm. The symptoms was less severe, but the pain and inflammation on both arms remain around the injection sites. Patient was advised to discuss with the primary doctor if follow up is necessary.
Narrative:  Patient tested positive for Covid-19 and was hospitalized despite full vaccination of Pfizer 1&2, 2nd dose on 0/23/2021. No booster was received. Admitted 11/23/21.
Moderna COVID- 19 Vaccine EUA  Vaccination was on 01/26/2021.  Client noticed itching at injection site on 02/03/2021.  Redness was observed, although small in size. The swelling and redness increased in the following days.  Client called public health on 02/08/2021 to report symptoms.  She stated that the swelling had decreased and itching is controlled by topical Benadryl cream.  The area of redness and swelling is about 5 inches x 4 inches at the injection site.  This client does not have a cell phone so is not enrolled in V-Safe.   She plans to receive her second dose as scheduled.
1/31/11 Baby was given immunizations. 2/2/11 Mom called clinic stating baby was throwing up with no appetite. 2/13/11 Baby was still throwing up. 2/4/11 Baby was screaming most of nite as if in pain - still throwing up also loose stools. 2/4/11 Baby was evaluated by his pediatrician. Diagnosis was possible adverse reaction to ROTATEQ vaccine. No fever but vomiting and diarrhea and belly cramping, gas and very irritable. Parents were told to continue to push fluids, slowly restart solids. Also try 3/4 tsp BENADRYL to help with histamine response and quiet his tummy. Also given an Rx for ZOFRAN prn for vomiting and nausea. Monitor for signs of dehydration.
Bilateral upper arm redness, warmth and itching at site of Varicella and MMR vaccine. Treated with warm compresses, TYLENOL and BENADRYL.
Stiffness, edema of hands with paresthesia and radiation to elbow primarily on right side. Symptoms occurred approximately 20 minutes follow anthrax immunization. Previous symptoms occurring for same immunization April 14-15 2007 the day after immunization. Manager reported this and recommended Ibuprofen resolved in 3-4 days.
Severe arm pain, nausea, malaise. Went to CNP and was diagnosed with acute shingles. Patient presented 7/2/18 with prescriptions for. Valacyclovir, Norco, and Lidocaine-HC 3-0.5 kit.
This study case was received from the investigator in a trial on 28 October 2011. A 23 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 12 days after he had received on 22 July 2011 an injection of ACAM2000 (lot number, route and site of administration not reported). The subject also received on 20 July 2011 an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.28 and an abnormal ECG on 03 August 2011. The subject's Echocardiogram was not available. A Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Started feeling throat tighten and lips go numb.  She was given Benadryl 25 mg orally at 2:36.  This did not start releaving the symptoms and epi 0.3mg was given IM at 2:45pm.  This began to work and her upper lip numbness begin releaving at 2:53PM.   She told us that she used epi and benadryl after her 1st dose but did not tell anyone.
2-3 DAYS POST VACCINE DEVELOPED SEVERE MUSCLE ACHES, FATIGUE, FLANK PAIN.  WAS IN ER ON 4/5/2021
approximately 5:05pm started to become itchy, hives on face, neck, chest, breast and arms. lips felt tingly and started to swell, became pale and found a nurse in the waiting area. I was taken to the ER and seen by ER Doctor, IV solumedrol and IV famotidine were administered. Placed on heart monitor and blood pressure. Was monitored in ER for 5 hours before being released with rx for Prednisone and advised to continue my current course of allergy mediations - famotodine, singulair. hyrdoxozine and zyrtec, epipen if needed. Friday morning I had a secondary reaction, became itchy all over, hives returned on face, neck, arms, chest and lip swelling. I took benadryl and was seen by doctor at the clinic, as my normal allergist was out of the office. I was given a half dose of epinephrine and was okayed to return to my desk in the Surgery Center with instructions to contact office if symptoms did not improve or if they started to worsen. I spoke with nurse around 1pm, symptoms had not improved and I was asked to come back to the allergy department. I was given an additional half dose of epi in the office. I was sent home with a half dose of epi in case needed. Was advised that if did not improve would need to return to the ER.
FEMORAL DEEP VEIN THROMBOSIS; This spontaneous report received from a physician concerned a 30-40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions were unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On 14-APR-2021, approximately 20 days after the patient received vaccination, he experienced femoral deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from femoral deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 30-40 year-old man experienced femoral deep vein thrombosis approximately 20 days after vaccination. No past medical history or concomitant medications were reported. There were no details provided, including diagnostic workup. There is insufficient information to make a meaningful medical assessment.
She got tested positive for COVID-19; still have effects that are happening now; She got tested positive for COVID-19; still have effects that are happening now; Having issues breathing; short of breath and couldn't breathe; Not a lot of strength; is in physical therapy; was freezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She got tested positive for COVID-19; still have effects that are happening now"; DYSPNOEA (non-serious), outcome "unknown", described as "Having issues breathing; short of breath and couldn't breathe"; ASTHENIA (non-serious), outcome "unknown", described as "Not a lot of strength; is in physical therapy"; FEELING COLD (non-serious), outcome "unknown", described as "was freezing". The events "she got tested positive for covid-19; still have effects that are happening now", "having issues breathing; short of breath and couldn't breathe", "not a lot of strength; is in physical therapy" and "was freezing" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of asthenia. Clinical course: She did get COVID, she's had some effects, where she is still having issues breathing, not a lot of strength and is in physical therapy. After she's already had the COVID- 19 vaccine, actually came, she was diagnosed, she got tested positive for COVID-19 and that she still have effects that are happening now. The patient thought that's not because of the vaccine, it's because she had COVID.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of VARIVAX (dose not reported). The consumer stated she experienced "itchiness" at the site of VARIVAX. It was unspecified if the patient sought medical attention. At the time of reporting the patient outcome was unspecified. No further information is available.
The patient had chronic fatigue; This spontaneous report was received from a pharmacist via company representative and refers to a patient of unknown gender, around 40 years of age. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On an unknown date, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (product quantity, lot #, expiration date and route were not reported) for prophylaxis.   On an unknown date, the patient experienced chronic fatigue.    At the time of the report, the outcome of chronic fatigue and the relationship between chronic fatigue and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and hepatitis b vaccine (recombinant)(manufacturer unknown)  were not reported.    This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA008265:
I had a bad cough and a headache. My ribs hurt from coughing, and I felt like I couldn't get enough oxygen. I went to urgent care on April 24, 2023. They did a Strep test. It was negative. They prescribed Prednisone, an Albuterol Inhaler, and Robitussin with Codeine. On April 26, 2023, I took an at home COVID-19 test. It was negative. I had COVID-19 previously in February of 2023. I went to my regular doctor on May 03, 2023, because I wasn't getting better. I had a Chest X-Ray. It was negative for Pneumonia. She prescribed medications, but I did not get them filled. By May 05, 2023, I felt better. The symptoms lasted 14 days.
Pt vaccinated with HIB/OPV/DTP/MMR  developed chills, shiver, lips turned blue, eyes rolled to back, jerk & shake, convuls, rash, diarrhea.
Nine days after 2nd shot, sudden, nearly complete hearing loss occurred in right ear, which previously was within normal hearing ranges.
bells palsey - severe issue in left eye and left side; minor chest cough I didn't have before
facial tingling and numbness; facial tingling and numbness; This is a spontaneous report received from contactable consumer (patient) reported for herself. A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 05Apr2021 (age at vaccination was unknown) at a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. Caller reported that she received her first vaccine dose 1 week ago on April 5th, and afterwards she experienced facial tingling and numbness which went away but then came back on Wednesday. She reported that she had no other symptoms but went to see her Primary doctor who considered this to be a reaction to the vaccine and advised her to call Pfizer for guidance on getting the second vaccine dose given her symptoms. The patient stated that she had a side effect after the first dose of the vaccine. She asked whether she should get the second dose. She asked if there was any guidance available for delaying the second vaccine dose after having a reaction to the first vaccine dose. Caller reports that she already spoke with safety, no reference number was provided. They informed her that as noted in the Fact Sheet for Recipients, she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knew her health situation and had access to information that can better help inform this decision. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
for first two days- headaches, body aches, pains, sweats, unsettled stomach and general malaise; on 3rd day after- had increased heart rate, rapid breathing palpatations; now- 2 weeks later body aches stopped but still have malaise, fatigue, fogginess, dizziness, very sensitive to sound and light, headache, stomach and poops are off; can't focus; brain fog; heaviness in limbs; fluttering sensation throughout body
Flu shot 10-23-08 0800. By noon wheezing, anxious SOB, heart racing. 3PM Flu-like achy & burning at inject. site - Reports no redness, swelling or heat at site. 1st Flu shot ever. Full recovery by Mon.
Experienced feeling weak the night following vaccine administration (10-21-16) Saturday 10-22 - experienced nausea/ H/A, chills Sunday-10-23 experienced chills-temp 100.0 dry heaves, nausea.
Numbness and tingling head, foot, arm, fingers and face; fatigue; lightheaded ness; foggy brain; Numbness and tingling head, foot, arm, fingers; This is a spontaneous report from a contactable consumer(patient). A 40-year old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8732), via an unspecified route of administration at Arm Left in MAR2021 at 40 years old at single dose for COVID-19 immunization.  The medical history was Hypothyroidism and diagnosed with COVID-19. The concomitant medications were liothyronine sodium(CYTOMEL) for Thyroid and Synthesis. The patient was not pregnant. There was no other vaccine in four weeks. On 22Mar2021 the patient experienced Numbness and tingling head, foot, arm, fingers and face, Foggy brain, fatigue and lightheaded ness 6 periods in 3 months (beginning the day after my first vaccine). Two ER visits to rule out serious medical conditions, two MRIs, blood work, and 2 day hospital stay. All of the events resulted in Emergency Room Visit and Physician Office Visit. All of the events resulted in hospitalized from 2021 to 2021(duration of 2 days). The patient received the treatment Gabapentin for Numbness and tingling head, foot, arm, fingers and face. The patient received the second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0170822021), via an unspecified route of administration at Arm Left 18-APR-2021 11:15 at single dose for COVID-19 immunization. There was covid prior vaccination. The patient underwent lab tests and procedures, which included blood work Unknown result; MRI Unknown Result; MRI Unknown Result; PCR on 07Jun2021: Negative. The outcome of the events was not recovered.
mild vesicular rash consistent w/varicella;MD said it was chickenpox/varicella;
1OCT91 pt seen by MD: afebrile, appetite good, not irritable, has generalized rash; pt recd DPT #2, OPV #2 & HIB #2 on 30SEP @ clinic; MD reporting DPT related & give DT next visit;
Rash under the armpits & body; Itching a little; Tightness in the chest; A little tightness in the throat; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under the armpits & body), PRURITUS (Itching a little), CHEST DISCOMFORT (Tightness in the chest), THROAT TIGHTNESS (A little tightness in the throat) and PAIN IN EXTREMITY (Sore left arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 31-Dec-2020, the patient experienced RASH (Rash under the armpits & body), PRURITUS (Itching a little), CHEST DISCOMFORT (Tightness in the chest) and THROAT TIGHTNESS (A little tightness in the throat). On 31-Dec-2020, PAIN IN EXTREMITY (Sore left arm) had resolved. At the time of the report, RASH (Rash under the armpits & body) had resolved and PRURITUS (Itching a little), CHEST DISCOMFORT (Tightness in the chest) and THROAT TIGHTNESS (A little tightness in the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included hydrocortisone.  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.; Reporter'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.
I was called at approximately 11:40. I went to evaluate the patient who was c/o feeling itchy, having bumps come up on her forearms, and feeling short of breath. Pt denied feeling pressure on chest of having trouble getting air in, but did describe it like she had just gotten done climbing a flight of stairs. Denies any trouble swallowing. Discussed with patient that the safest option would be for her to be transported to Emergency Department via EMS for further evaluation and possible treatment. Patient preferred not to go if she did not need to and was also informed of OTC treatment options for possible allergic reactions. Discussed OTC Benadryl and Pepcid to be taken when she gets home if she is declining transportation to ED. Again informed the patient that safest option would be for her to be in ED but with normal SpO2, good breath sounds, no trouble swallowing, and rather benign exam that she could go home if she wanted to and take OTC Benadryl and Pepcid as directed on packaging. I did recommend that patient monitor for additional symptoms, that she have an extended wait in observation area, and that she be monitored. Pt instructed to present to ED should she have any issues after leaving the facility.
ISSUES ON ANKLE; TERRIBLE SWELLING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of ankle issues in the entire life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced terrible swelling. On an unspecified date, the patient experienced issues on ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible swelling and issues on ankle was not reported. This report was non-serious.
Sudden hearing loss in right side ear,  prednisolone 60mg pre day Nothing got better still cant hear
Arm was sore about 5 mins after injection. Around 8 pm I began to feel chills and very sleepy, when I woke up at 10 pm I felt very cold, nauseous and feverish. At 6:30 am I woke up feeling warm, very painful at injection site, I took Tylenol. At 9 am I began to feel very warm, nauseous and headache this continued on. I took Tylenol every 6 hours until 12 am, fever would rise to 101 and go down to 99 when Tylenol was taken. Had chills, headache and nausea within those 16 hours. 4/2/2021- no more symptoms, slight pain at injection site
Moderna COVID-19 EUA    4 hours after receiving the vaccine,  I experienced bilat ear popping.  Approx 12 hours after receiving the vaccine, I experienced a headace, joint pain, severe dizziness and fatigue, and R ear pain.  After about 8 hours, symptoms resolved.
An hour after my vaccine I noticed that my arm was red where I got the shot. It got bigger and bigger. The biggest is what it is currently at 8pm on the 22 of Feb 2020.
Cough This is a new problem. The current episode started in the past 7 days (x3 days. Possible covid exposure to covid 2 weeks ago. Had had both covid vaccines. Seen at clinic this week and started on antibiotics for bronchitis. Did not get tested for covid and wants covid test.). The cough is productive of sputum. Associated symptoms include headaches, myalgias, shortness of breath and wheezing. Pertinent negatives include no chest pain, chills, fever or sore throat. Associated symptoms comments: Decrease in taste. N,V,D.. She has tried a beta-agonist inhaler (antibiotics, phenergan) for the symptoms. Her past medical history is significant for COPD.  Vomiting  This is a new problem. The current episode started in the past 7 days (x3 days). There has been no fever. Associated symptoms include abdominal pain, coughing, diarrhea, headaches and myalgias. Pertinent negatives include no chest pain, chills or fever. Risk factors include ill contacts (No traveling.). Treatments tried: phenergan. The treatment provided mild relief.
Ear pain, sore throat, congestion, cough, sneezing, headache, back pain and pneumonia.
Sm had PPD placed on 7/8/07 lt forearm. He now presents with a 20 mm blister in the center of a 45 mm erythema area.