chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Vaccine brand: Pfizer/BioNTech; Vaccien administraton date: 15Sep2022; vaccine brand other=Moderna; vaccine administration date: 01Apr2022; This is a spontaneous report received from contactable reporter (Consumer) from product quality group. The reporter is the patient. A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: FW1331) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 033K21-2A), in right arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FAMOTIDINE, start date: 14Jun2022, stop date: 13Dec2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech; Vaccien administraton date: 15Sep2022; vaccine brand other=Moderna; vaccine administration date: 01Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive, notes: with only symptom being runny nose; (14Dec2022) Positive, notes: but still testing positive through 14Dec2022 with no symptoms after 10Dec2022; (25Dec2022) Positive, notes: Retested (before gathering with family large group) and tested positive with no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 with isolation and Paxlovid. Additional information: The patient has no known allergies.
second dose / 2 months following the first / I've had Shingles 5 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (5 months ago from the date of reorting). Previously administered products included Ganciclovir.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had shingles. For the tolerance of 2nd dose, refer linked case US2021AMR000330.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000330:same patient (2nd dose)
My son received his vaccines around 9 in the morning, by about 3 in the afternoon he had a fever of about 102, and was very uncomfortable, at which point, I gave him infant tylenol in hopes to relieve his discomfort. By 5 in the afternoon he was completely inconsolable, he was screaming at the top of his lungs and this continued for another 3+ hours. By 10 pm, after doing everything I could think of to calm him, he finally fell asleep. The next morning I noticed a large swell at the injection sight (looked much like a welt) about the diameter of a nickel. The swelling was only at the injection sight, and lasted for about a week.
Acute hypoxemic respiratory failure due to COVID-19; Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type
Information has been received from a physician concerning a 23 year old female patient with depression, who on an unspecified date, was vaccinated with the first dose of GARDASIL and on approximately 29-NOV-2008 was vaccinated with GARDASIL.  Concomitant therapy included TRAZODONE HC1, CLONAZEPAM, METHYLPHENIDATE and YASMIN.  The physician reported that the patient reported feeling weak, dizzy, tremulous over her entire body and her subclavian lymph node was enlarged on the same side where the vaccine was received.  The physician reported that the patient experienced the same reaction after both doses of the GARDASIL vaccine.  The symptoms were more severe after her 2nd dose.  Exact dates of vaccinations were not available.  It was 4 four weeks post dose 2 and patient still did not "feel herself".  The patient reported she still felt weak and is unable to concentrate.  At the time of the report, the patient had not recovered.  The patient sought medical attention and was seen at the physician's office.  Additional information has been requested.
- Severe, entire body itching 10 days after 3rd dose. In many cases no visible rash. - Hives and rashes 10 days after 3rd dose - Sudden onset dermatographia 10 days after 3rd dose
I was fine for a week and a half and then I began to have pain in my leg, I also got bit by a dog. I went to emergency room hospital and they did ultra sound of my leg found four DVT and kept me over night.
pt recv vax & laid head on table stated had h/a, everything blacked out & knees buckled;pt head rolled back, was sweating profusely & very pale;pt stated felt sleepy;dx acute vasovagal syncope;
I submitted.  received error.  Submitting this again.  Previously I reported stiffness in the hands and developed a trigger finger.  These occurred began on Feb 19th.  See report 330994.  I have had a cortisone shot in both hands.  This has relieved the stiffness somewhat, but not entirely.  No relief for the trigger finger.  The new adverse event is a ear ache and tinnitus.  These started about a week ago.  They are continuous.  I have tried sudafed and zyrtec to no avail.  I will be seeing doctor shortly.
Fever after 1 hour of receiving shots of 102.8. Fever went to 103.1 degrees with TYLENOL. Slept after leaving office for about 1 hr, but did not sleep after that for about 8 hrs. Fever & irritability for about 3 days following shots. MOTRIN did help. No rashes or redness at injection site.
Information has been received from a physician concerning a 22 year old female patient, who on unknown date, received the 1st and 2nd doses of GARDASIL (routes and lot numbers not provided), with no reactions reported. On 16-FEB-2010, the patient was vaccinated with the third dose of GARDASIL (lot number 662304/1013Y) (route not provided). A TB skin test was performed on the same day but different site, and the results were not provided. On 23-FEB-2010, "1 week after the third dose was given", the patient had an injection site reaction. The physician stated that the patient started with a "sore arm". The patient was treated with KEFLEX but still had an arm that was "swollen, warm and had a rash". On 17-MAR-2010, the patient was seen by the physician, and the patient was still presenting with "shoulder pain, redness and swelling". A TB skin test was performed on the same day but different site, and the results were not provided. At the time of reporting, the patient had not recovered. Follow-up information has been received from a physician concerning a 22 year old female with hypersensitivity to morphine and codeine, that produce vomiting and nausea, and, no illness at time of vaccination, was vaccinated with the third dose of GARDASIL on 16-FEB-2010. After vaccination, the patient experienced cellulitis of the left upper arm. The patient also experienced pain with movement and palpating. One month post immunization, the patient had a red circle of 4 inches. Physician reported that the patient recovered on an unspecified date. On an unknown date, an ultrasound of lower extremity/non vascular was performed, however the result was not provided. No additional information is expected.
a patient who thinks he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine/ Tested positive for Covid after second dose; a patient who thinks he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine/ Tested positive for Covid after second dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2020 (Batch/Lot number: unknown) as dose 2, single and administration date 2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "a patient who thinks he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine/ Tested positive for Covid after second dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The reporter reported about a patient who thought he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine. He was asking about the recommendations of giving the booster dose to the patient. The reporter stated the patient lived in a nursing home and the 2 vaccines would have been given around this time last year because they live at a long term care facility, so they were the first ones to get shots. The reporter stated exact dates are unknown of first and second vaccines, but he knew they were Pfizer. The reporter stated that the patient tested positive about 3 weeks ago. Reportedly, this report was related to a study or programme.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
While starting to have more severe migraines the doctor found a very large nodule on my right side of thyroid that was not there before. I also have no history of thyroid problems.  After testing I know need to have the right side of my thyroid removed.
tendonitis is flaring up; pain was so excruciating that the patient couldn't even walk; both knees are flaring up; excruciating pain in the right wrist; low grade fever; both ankles have had a tendonitis flare up; pain was so excruciating that the patient couldn't even walk; both knees are swallen; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (tendonitis is flaring up), GAIT DISTURBANCE (pain was so excruciating that the patient couldn't even walk), ARTHRITIS (both knees are flaring up), ARTHRALGIA (excruciating pain in the right wrist) and PYREXIA (low grade fever) in a 69-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 No adverse event (No medical history reported.).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDONITIS (tendonitis is flaring up), GAIT DISTURBANCE (pain was so excruciating that the patient couldn't even walk), ARTHRITIS (both knees are flaring up), ARTHRALGIA (excruciating pain in the right wrist), PYREXIA (low grade fever), TENDONITIS (both ankles have had a tendonitis flare up), PAIN (pain was so excruciating that the patient couldn't even walk) and JOINT SWELLING (both knees are swallen). At the time of the report, TENDONITIS (tendonitis is flaring up), GAIT DISTURBANCE (pain was so excruciating that the patient couldn't even walk), ARTHRITIS (both knees are flaring up), ARTHRALGIA (excruciating pain in the right wrist), PYREXIA (low grade fever), TENDONITIS (both ankles have had a tendonitis flare up), PAIN (pain was so excruciating that the patient couldn't even walk) and JOINT SWELLING (both knees are swallen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment details were reported.
Patient received 1 dose of moderna covid vaccine on 02/27/21 then the patient visited the pharmacy and requested 1 dose of pfizer covid vaccine and it was administered as if it were her first dose of covid 19 vaccine which this was on 05/08/21. Then patient went to the pharmacy for her second covid pfizer dose and it was administered on 05/29/21. patient received a total of 3 doses of covid 19 vaccine, she was instructed not to request the booster.
sweating to death; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating to death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 HYPERHIDROSIS (sweating to death). At the time of the report, HYPERHIDROSIS (sweating to death) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Information has been received from a consumer concerning her 11 year old daughter with no medical history or drugs allergies, who in January 2008, was vaccinated with a first dose of GARDASIL. The patient received the second dose of GARDASIL six months after the first one, and the third dose of GARDASIL six months after the second one. Concomitant therapy included montelukast sodium (MSD), 5 mg, once at bed time. The mother stated that her daughter has experienced bruising everywhere on her body. She was unaware of when the bruising started but when she wakes up in the morning she had bruising. The patient had a blood work done. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
pneumonia; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the pneumonia was recovering/resolving.   It was unknown if the reporter considered the pneumonia to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's wife. The patient was hospitalized due to surgery and pneumonia. The patient was being seen by a home healthcare nurse.  Due to the unforeseen medical issues, the patient was unable to get the 2nd dose before the recommended 2 to 6 month period.  This case has been linked with case US2020018207 (wife's case), reported by same reporter.
Started 6 days after vaccination and lasted 7 days. Skin rash and hives, rash, swelling, large vesicles on hands, forearms, neck. DIPHENHYDRAMINE, METHYLPREDNISONE.
Within 15-minutes of vaccination, the patient reported an "odd" metallic taste in their mouth. EMS monitored the patient's condition on-site.
67y.o. female presenting with acute nausea and vomiting for about a week. Upon presentation, she was found to be COVID-positive. She did have 3 doses of Pfizer COVID-vaccine and has never had COVID before. She is initially placed on dexamethasone. She was seen by ID as well as endocrinology. She had very labile blood glucose requiring titration of her insulin regimen. Without verified hypoxia, there is no indication for remdesivir or other COVID directed therapies. Steroids were discontinued as she did not require supplemental oxygen. Her symptoms improved and she was able to tolerate oral hydration.Patient was discharged home in stable condition.
Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulder blades Nausea Fatigue All symptoms began roughly 12 hours after administration. Today is the fourth day, and symptoms are persisting.
Pt presented with redness, swelling and induration at injection site. Antibiotics prescribed and instructions given to parents to follow-up if symptoms do not clear up in 1-2 days.
8-12 hours post vaccination, patient had seizure, apnea, required CPR, ended up recovering.
36 Hours after - started with fever and chills, body aches, cough, headache Also, lymph nodes in underarm area and along collar bone became swollen and sore and this lasted until the present time. Did do a televisit with family doctor on Tuesday 3/23/2021.
Shot was administered at 10:40 am. I felt fine all after noon, the arm was getting sore. By 9pm I started getting achy all over. My hands were like ice and I tried to sleep but could not. Got up at 12:30am shivering so put on a sweater. Then I got really hot. Took my temp and it was normal. Could not sleep. my mind was racing, my facial cheek bones hurt, every muscle ached and could not find a comfortable position. Got up at 7am and went to couch to try to sleep there. The cat started kneading my hip and it hurt so much. I must have drifted off for a few minutes as when I woke up at 9 I was feeling a tiny bit better. I feel like I had a bad case of the flu where you need to be careful of everything you do because it hurts and aches. I know I will feel better after a good nights rest. wonder if the vaccine and amitriptyline counter each other.
Burning and itching feeling; Couldn't sleep because of the itching; Burning and itching feeling; The redness on my arm, going down my arm; Fever (99.9F); Headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm) and PYREXIA (Fever (99.9F)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm), PYREXIA (Fever (99.9F)) and HEADACHE (Headache). At the time of the report, BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm), PYREXIA (Fever (99.9F)) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.9 (Inconclusive) 99.9 F.         No concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vaccine given 4/29/21  at 11 am, by 2200 had  h/a, nausea, brain fog, fatigue.  hives and chest pain. Took increased antihistamines at that point, this continued until 5/5 when she began having tongue swelling and went to the ED. Was given steroids, observed for 2 hours, and sent home with prednisone 20 mg BID 4 day burst. On final day of steroids developed hyperglycemia
Infant became very "fussy", developed a fever and diarrhea.  Resolved itself with administration of Tylenol for fever reduction.
Patient had Rota vaccine on Thursday. 2 days later her stools turned a greenish color. The next day she started with green diarrhea. She has had about 1 stool per hour. She is having frequent crying spells lasting anywhere from 5-20 minutes, inconsolable during this time. Crying spells are happening about 1-2 hours. She is pulling her knees to her chest. She is making a squeak/grunting noise intermittently, does not seem to be related to stools.
local erythema 12cm x 9cm @ deltoid;tx w/DPH, Atarax & cool compresses