chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost immediately after injection client developed a rash about 2 1/2 - 3 inches in circumference around area where vaccine injected.  Area became itchy.  About 10 minutes later 2 hives appeared on left side of face
Patient with pain in arm night of vaccination, red was and pain at 24 hours.  Cellulitis changes below area of vaccine at 48 hours.  Both shots + b12 gone in sauce left deltoid region.  Prescription with Cefobid 300 three times per day.
Information has been received from a Certified Medical Assistant (CMA) concerning unknown number of patients of unknown demographics. There were no medical history or drug reactions/allergies reported. It was reported that since 04-MAY-2015, the patients had been administered improperly stored GARDASIL (dose, frequency, route, lot number and expiration were unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Other medication in 2weeks: No. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, covid-19 was Paxlovid from 05Dec2022 to 10Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose 1 on 2018, and never received dose 2.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
COVID-19/Headache/ Fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/Headache/ Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 012M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (2 weeks ago (from 01Nov2022)). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension, Diabetes, Asthma and Drug allergy (Levaquin).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced COVID-19 (COVID-19/Headache/ Fever). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of took Paxlovid 4 days. At the time of the report, COVID-19 (COVID-19/Headache/ Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: Positive.         No concomitant medication information was provided.  Patient did not experience a similar event in the past.  Patient took Paxlovid 4 days and not feel so good after taking it so she did not complete the 5 days.   This case was linked to MOD-2022-667343 (Patient Link).
Pain of the arm; Redness of the arm; Toenail pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles. Concomitant products included acetylsalicylic acid (Aspirin).   On 14th June 2022, the patient received the 1st dose of Shingrix. On 14th June 2022, less than a day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, nail pain and headache. On an unknown date, the outcome of the pain in arm, erythema of extremities, nail pain and headache were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities, nail pain and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter called and stated that she had her first dose of Shingrix and then experienced pain and redness of the arm, toenail pain and headache. The patient was referred to health care professional.  The reporter consented to follow up.
Patient received Pfizer vaccine dose 1 IM in L deltoid per portcol. During 15 min post vaccine monitoring, patient developed a cough, SOB, diff swallowing and hive like rash within 10 minutes of vaccine administration
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 18:37, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I received a mandatory flu vaccination through the hospital I work for. % hours later my hands and feet felt like they were vibrating for 15 minutes. About 10 hours later I woke up with my arms and legs feeling very heavy and weak. I have had symptoms ever since receiving the vaccination which include limb heaviness and weakness, difficulty walking, fogginess and dizziness, difficulty concentrating, speaking, and swallowing. I have been to the ER and Neurologist 2 times. I had 2 MRI's and an EEG. The Neurologist believes it is a mild case of Guillain-Barre Syndrome from the flu vaccination.
Redness at injection site, which spread.  Hard and warm to touch after injection.  Progressively got worse.  On 3/31/16, patient called pharmacy to report reaction.  Patient was told to come in to be examined by nurse practitioner on site.  Diagnosis:  probably infection at injection site.  Treated with Cephalexin 500mg qid for 10 days.
Swollen and painful area around injection site.  Warm, red, tender and itchy,  with a 5 inch circumference, raised about 3 cm. .  Periodically applied  an ice pack with some relief.  Swelling and redness subsided after 3 days,   Tenderness and itch subsided on the 5th day.
PM of 10OCT96 rt arm (mid upper arm to elbow) became red & puffy & itchy-rt shoulder sore;tx w/cold compress;12OCT96 all subsided;
Starting on 2/6/21, I felt fatigued, and had soreness at injection site, along with hot flashes. Fatigue, sluggish and joint pain 2/7/21. Continued fatigue, hot flashes and joint pain since. On 2/11/21 at 10am, felt stiffness on back of my neck that travelled to the front of my neck. By noon, it felt like the muscles in the front of my neck were tightening. By 1pm my head was tilting to the left. I went to Hospital,  ER where I was given a muscle relaxer, lidocaine patch, and Tylenol. Symptoms were improved and was discharged home with medication. ER staff stated neck stiffness d/t working with telephone at work. Continued to have some neck stiffness through the weekend. On the evening on 2/14/21, left side of face and jaw swollen, hard to touch, painful. Have been taking muscle relaxer prescribed by ER Physician, and have appointment with PCP on 2/17/21.
Post 2nd dose of vax, the pt's mother stated her daughter's adenoids became constantly swollen, and she has not able to hear for the past 3 months.
1 week after vaccine I developed a small circular red rash at my injection site. In 24 hours it grew to a red circular rash approximately 5x6 inches. The rash is warm to the touch and itchy. I also developed a severe headache and chills with the rash. I was seen at the urgent care clinic for it and they suspect it might be cellulitis and prescribed me keflex. After being on keflex for one day, the rash is still growing in size. 3 other people at my workplace who received the vaccine have reported similar rashes 1 week after receiving the vaccine.
Full body itching and pain at injection site.  Itching and hives occurred 6 hours after injection of Pneumovax 23. Humira injection was completed Thursday 9-25. Treatment with Benadryl 25mg and Tylenol 1000mg interrupted itching and pain response was diminished.  Doing much better after 20 minutes.
This spontaneous report as received from a registered nurse refers to a unspecified number of patients. Reporter stated she had no patient data available. On an unknown date the patients were vaccinated with GARDASIL, 0.5 ml, (dose unspecified in series) once, intramuscularly. Lot number or expiry data were not available (no dates were expired). On unknown dates the patients received doses of GARDASIL which were exposed to 9C degree for 360 hours. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headaches, chills, fever, body aches, swelling around area, treated with MOTRIN until able to get to a doctor.
pt recv vax 08MAY94 & 12MAY94 devel alopecia & was taken to MD 13MAY94 who described the alopecia as abn in a child because the hair loss was coming off in big blocks;
Patient states that right after receiving the vaccinations she felt burning, and pain, as she's had vaccinations previously, she assumed the pain would go away after a day or two. When the patient woke up the next morning, she had pain, burning, and swelling that ran down her arm. After a few weeks, that patient's pain was so severe she went to her MD, and was prescribed Gabapentin and PERCOCET. She states that after a week of Gabapentin and PERCOCET, her pain continues and she has numbness in her index finger.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L009544, expiration date: 19-MAR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
In November 2021, I saw  an allergist regarding my allergies. He suggested I get a sleep study done because I was sleeping a lot with the allergy meds, but wouldn?t prescribe it. I had an appointment with my neurologist shortly after, and she prescribed the sleep study. I did the sleep study in January, and my next appointment with the doctor was the last week of March, at which point she told me the results. The sleep study came back normal, except it showed I have a tachycardia, and my heart rate ranges from 80-180 while I?m asleep. My neurologist referred me to get a heart monitor to see what kind of tachycardia it is. I am waiting on the results of that now.
awakened by h/a @ 2Am or 3AM;cold sweats, dizziness, chills, vomited off & on until 7Am;felt weak, tired & disoriented & a sore arm;also admits to diarrhea;returned to work next day;
Local response within 1 hr site swollen and very painful x 48 hrs. Red rash - red/inflamed upper arm, torso(back, chest and stomach) and neck, rash feel like fire and itchy x 24 and continues tx with BENADRYL and generic antihistamine (Lantidine).. Controlled = BENADRYL
Right after the vaccination I experienced neck pain.  on Monday 2/15/2021  I felt rash around the area by the shot , neck and shoulder. Tuesday 2/16/2021 in the morning , I noticed in the mirror a lot of rash all over the same area. I went to work but I had to leave early  because I felt very weak and fatigue, pain in the neck and shoulder and also bad headache.  next day on Wednesday 2/17 I could not make it to work from the rash, pain and fatigue. I went to the dermatologist whom he diagnosed as Herps Zoster (Shingles) that it  is related to the vaccine.  The doctor prescribed  Valacyclovir HCL 1 Gram to be taken one table3 times a day for 1 week.
Adverse events started/were noticed approximately 1-1/2 to 2 months after injection:  1.  Previously undiagnosed Alpha Thalessemia (genetic) began to produce noticeable severe symptoms - shortness of breath when walking and extreme fatigue.  Diagnosed with blood tests.  2.  Pain and weakness in area of injection, including upper left arm and shoulder.  (Immediately after injection, the pain was no worse than with any other injection - this started about 2 months later.)
Intermittent chest discomfort/pain; Irregular heartbeat/palpitations; Diaphoresis lasting minutes to hours; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Intermittent chest discomfort/pain), PALPITATIONS (Irregular heartbeat/palpitations) and HYPERHIDROSIS (Diaphoresis lasting minutes to hours) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced CHEST DISCOMFORT (Intermittent chest discomfort/pain), PALPITATIONS (Irregular heartbeat/palpitations) and HYPERHIDROSIS (Diaphoresis lasting minutes to hours). At the time of the report, CHEST DISCOMFORT (Intermittent chest discomfort/pain), PALPITATIONS (Irregular heartbeat/palpitations) and HYPERHIDROSIS (Diaphoresis lasting minutes to hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient was seen by insurance companies urgent care, a cardiologist for the events reported and it was noted that patient had a right axis deviation in heart. This was confirmed at a follow up visit to a cardiologist. A few months later, patient had a clinic visit for evaluation of vascular system to determine if he had Vascular Ehlers Danlos, which was negative. At that time he no longer had a right axis deviation. Since then, patient moved to state and continued to experience intermittent chest discomfort/pain. Patient would provide EKG, echo cardio and other test/lab results from his clinic visits. Treatment information was not reported.
right away I felt light headed and started feeling like I could pass out. I sat there for about 30 minutes and then my granddaughter drove me home where I took a nap. The next morning I awoke very dizzy with a swollen eye, tremendous pressure in my head, and very tired and achy. Dizziness and swollen eye lasted 2 days. Pressure n my head and tiredness lasted 2 weeks. The doctor had me take Benadryl and Tylenol as needed. I never went to the office because I started feeling better after a couple days, but I felt off balance and had the pressure in my head as well as the tiredness for longer.
EMPLOYEE IMMEDIATELY TASTED METAL IN HER MOUTH AT TIME OF INJECTION, INJECTION SITE BECAME RED, SWOLLEN, WARM AND PAINFUL 7/10 IN MINUTES AFTER THE INJECTION. HAS HAD FLU SHOT BEFORE WITHOUT INCIDENT. SITE CONTINUES TO BE PAINFUL 5/10 TWO HOURS LATER, WITH THROBBING PAIN. LEFT CHEEK BECAME SWOLLEN AND FLUSHED AT JAW LEVEL.
0705: 3rd dose of Moderna given 0717: Employee reported tingling to lips, teeth, tongue, and right eye heaviness. 25 mg po Benadryl administered per protocol. O2 98 RA, HR 99.  0734: Employee reports that tingling decreased and only present in lips and teeth.  0745: Employee reports symptoms resolved.
11-21-02 right arm above elbow red, warm swollen and tender to touch. Doctor notified, order for warms packs, lab works. Started on Devaquin 500mg qd for 10 days. Seen in office 11-25, vaccine given. 11-20-02 Improving.
Extreme chills, shaking(shivering), elevated temperature, elevated heart rate, body aches
I woke up with a head cold and did not think a thing about it because I have sinus issues. The next day I woke up feeling better but over the next few days sinus and congestion issues continued so on Tuesday November 22 2022 I tested for COVID-19 the result was positive.
How I can report side effects after 1st shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 02-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (How I can report side effects after 1st shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How I can report side effects after 1st shot). At the time of the report, VACCINATION COMPLICATION (How I can report side effects after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       AE submitted via text - "How I can report side effects after 1st shot" Consumer answered "Yes" when the chatbot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 15 year old female student who on 09-MAY-2007 was vaccinated IM in left deltoid with a first dose of Gardasil (lot #654272/0319U).  Concomitant therapy included ADACEL.  On 09-MAY-2007 the patient experienced dizziness and became diaphoretic after getting the injection.  The dizziness last 5-10 minutes and the blood pressure measurement was 80/48.  During the examination time the blood pressure measurement was 110/70.  She was given juice and crackers and 10 minutes later she reported feeling better.  She was released in mother's care and her blood pressure measurement was 80/52.  Additional information is not expected.
Improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # W006595 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish 10-OCT-2024) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 57.49° Fahrenheit (F) for 1 hour and 45 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Chills and fever 8:30 pm chills  9:30 pm fever 101 10:30 pm fever 102 11:30 pm fever 103 12:30 am fever 102.5 2:30 am fever 101 7 am headache, took aspirin.  Temperature normal. Note that I usually have a low normal temperature, so this fever  was very high for me.
pt recvd vax 18APR94 w/no react; 21JUN recvd 2nd series of vax (same lots given); remained clinic 20 mins w/no problems noted; following day 22JUn had a feb seizure & another 23JUN & 24JUn; ER visit fever 103-104 x 2 days; unk if tx given;
Breakthrough case. Received dose 4 in 04/2022 and had starting having a fever so took a home test which came up positive. Sent message through Dr's portal and was prescribed Paxlovid. Recovered after 3 days.
Moderna covid vaccine was given 1/31/22 at 1:42 PM. Within minutes patient stated she wasn't feeling well. Said she had tingling sensation in her left arm. I then asked about throat, tongue swelling, and breathing. She said her tongue felt thick and was tingling. Instructed technician to call 911. I administered 50 mg oral diphenhydramine solution. Patient said she was still feeling strange. Prepared epipen for administration. Started to monitor blood pressure and pulse, unable to get reading because Patient began to seize. We administered epipen. Patient continued to go in and out of seizures. She was able to communicate between seizures. EMT arrived and transported to a local Emergency room. Spoke to patient 2/1/22. She was kept at ER for approximately 8 hours to be monitored. She knew they gave her famotidine and a steroid. Followed up with patient 2/9/22. She stated she had to go back to ER 2/2/22 at approximately 11pm because she was feeling short of breath and tingly again. Said they gave her famotidine, steroid, and antihistamine again and monitored her. She was released and has had no symptoms since.
A few hours post vax the pt got hot and cold and then became light headed. The symptoms have stopped. The site of injection is soft, no redness. Denies fever.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on his arm, legs and other parts of body since taking shot) and ERYTHEMA (Redness on his arm, legs and other parts of body since taking shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00011A) for COVID-19 vaccination. It was reported as patient did not have any pre-existing condition and allergy. On 22-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness on his arm, legs, and other parts of body since taking shot) and ERYTHEMA (Redness on his arm, legs, and other parts of body since taking shot). At the time of the report, PRURITUS (itchiness on his arm, legs and other parts of body since taking shot) and ERYTHEMA (Redness on his arm, legs, and other parts of body since taking shot) outcome was unknown. No concomitant medications were reported by the reporter. Patient said he seen this reactions for the first time. Antihistamine medication was taken per HCP advise meanwhile.