chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for covid-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after vaccination) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Moderna on 4/9 and 5/6. Positive on 9/5 admitted 9/6 to current
On 10/17/22, I was going through my normal spotting during my cycle. Later that evening into 10/18/22 spotting picked up to heavy bleeding that continued until 10/26/22 until I received medication to get it to stop. I consulted with my physician's office and an appointment was made for me to have, a pelvic and cross vaginal ultrasound, nothing out of the ordinary was found. I am now taking hormones to keep the heavy bleeding from coming back and I was referred to a gynecologist.
I received my first vaccine on the 17th of December, I was exposed to COVID. I got COVID and was treated in the hospital for covid 19. Two weeks after the vaccine.
No adverse event.  Shot given 7 days earlier at day 14 rather than day 21.
General arm soreness at injection site within 12 hours. Approximately 30 hours after injection, chest pain and tightness developed, including shortness of breath. Chest pain and tightness lasted approximately 30 hours. Labored breathing lasted approximately 24 hours from onset.
swelling with readness and slight induration at the injection site. cold compresses to be applied.analgesics if necessary
31 weeks pregnant with 3rd baby. Baby is female & due in March.  No complications of pregnancy.  Had this whooping cough vaccine at 12 and by 1pm I started to feel unwell... a little achy, lack of energy. By approx 2pm I had a headache and my right arm was very tender and felt bruised. Also slightly red at injection site. By 3.30pm I felt extremely unwell... high temp of 39.4 (after paracetamol), I felt shivery and cold, both hands were icy cold and I had pins and needles in both hands and fingers. I had an awful headache which was central on my forehead. I vegan to vomit and was very dizzy & weak. This was very frightening. I was caring for my 2 younger children and had to ring for help to come and unlock the front door so this person could enter my property incase I was collapsed on the floor. I slept from about 4.30pm untill 1.30pm the next day (on & off), just waking to take pain relief. I was extremely stiff and sore.   Now, the next day @ 3pm I still have a slight temperature, and the headache. I also still feel achy.   I have too 3 covid tests to ensure I do not have coronavirus, all negative.
My stomach hurts badly. If I am walking or exerting myself, I will sometimes get light headed. I have tried drinking more water, then ibuprofen, then peptobismol. Nothing has helped so far. It does feel better if I lay down flat though. Also, it may be from all of the fluid consumption, but I have  had to urinate more often than usual.
Patient stated she felt dizzy and then fell over and had a seizure. Seizure lasted 3-4 minutes. Vitals were monitored and EMS was called to take the patient to the ER.
Local reaction and cellulitis right thigh over 48 hours. Treated with Keflex with resolution of symptoms.
Every night for 5 weeks I have broken out with VERY VERY VERY small itchy bumps all over my body. It starts between 4 and 7 pm, and it gets to it's worse between 9pm and 2am. It's gone by morning.  Sometimes it starts at the dining table, sometimes the couch, sometimes the bedroom. And it is not bugs. This is not environmental. I have switched homes, switched, beds, switched mattresses, tried several different aloe/oils to help, nothing works.  This is miserable!!!!
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=MODERNA, vaccine dose number=1, 2, 3, 4/vaccine brand=Pfizer; BioNTech, vaccine dose number=5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Lot number: 025A21A), in left arm, on 30Mar2021 as dose 2, single (Lot number: 044A21A), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm and on 05Jun2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Grains" (unspecified if ongoing); "Known allergies: Nightshades" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Vaccine brand other=MODERNA, vaccine dose number=1, 2, 3, 4/vaccine brand=Pfizer; BioNTech, vaccine dose number=5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid.
01/14/2023 took Quidel home test, 01/15/2023 diagnosed with covid from rapid test with employer.
Lymphadenitis - swollen lymph nodes under arm area of right arm, shoulder & lower arm off work 3 days prescribed hydrocodone unable to drive for 24 - 48 hrs
No Adverse Event; A consumer is calling in to report an AE on behalf of herself. The consumer reports that she received her first dose of GARDASIL 9 at the age of 65. No additional clarifying statements or AE details were provided and no additional AE's were reported; This spontaneous report was received from a consumer refers to a 65-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Denies developed rheumatoid arthritis, TIA, and breast cancer folowing vaccine adminstration
Vaccine administered in the afternoon. That night, pt started with headache, vomiting, body aches, malaise, nightmares, hallucinating and uncontrollable sobbing. No fever. Husband reports symptoms have lessened since the night time.
Arm swollen; Arm hard; Arm redness; A spontaneous report was received from a consumer concerning his wife , female patient (age not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm swollen/peripheral swelling, arm hard/induration and arm redness/erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: N/A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced swollen arm, arm hard and arm redness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events arm swollen, arm hard and  arm redness were unknown.
Pain at injection site X 1 week with difficulty abducting + adducting, and rotation of shoulder joint pain started 3 hours post injection.
On 3/2 patient received vaccine without incident. However, on 3/4 patient called the pharmacy complaining of severe soreness near the site of the injection and the upper part of her arm had felt hot. The patient state that it had improved from the day earlier with use of ibuprofen and a cold pack. Patient stated it only really hurt when she moved it and that it did not require medical attention. The patient stated it would probably be better in "a couple of day".
localized swelling-20cm diameter w/heat, mild cellulitis x 72hr, fever to 103 x 72hr;rx APAP, pediprofen;
Sick as a dog; flu-like symptoms; This case was reported by a consumer interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and influenza-like symptoms. On an unknown date, the outcome of the sickness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and was sick as dog with flu-like symptoms. The patient was going to take her second dose on 29th November 2021 and he/she was scared to death due to symptoms from first dose. The patient hope that she did not go through the same symptoms after second dose.
Moderna COVID?19 Vaccine EUA  Premedicated with benadryl and phenergan prior to injection.  No pain at time of injection. 2.5 hours later, arm started to be sore at site, fever of 101.4, diarrhea x 1 episode. Went outside and fresh air helped, felt much better.  Fatigue and very mild body aches, arm soreness (no more than flu shot, less than tetanus) .  630pm: Acid reflux was the worst side effect I experienced. I asked a co-worker who received the same vaccine the day prior to me. She also had bad reflux. Even with a history of GERD, I do not need to take PPI's any longer and I needed to take an omeprazole the night of my vaccine, which helped some. Took tylenol 500mg and went to bed. Woke up today (the following day after vaccine feeling normal with arm soreness which got better throughout the day.  I would describe my symptoms as mild. The MD I work with said I should report these to Moderna just so they can track all symptoms that people are experiencing post vaccine.
fever of 103; chills; headache; fatigue/extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 103), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue/extremely tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever of 103), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue/extremely tired). At the time of the report, PYREXIA (fever of 103), CHILLS (chills) and HEADACHE (headache) outcome was unknown and FATIGUE (fatigue/extremely tired) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was taken.No concomitant medication was taken.
Sleep on Friday evening.  Fatigue on Saturday.  Racing heartbeat of 138 on Sunday evening.  My rpm is 65.  I walk 3x/week minimum.  I can't get it that high if I jog.   All I did was go downstairs and clean the kitchen.
small lump approx 1cm in size noted in lt anterior thigh & another lump in same area approx 1/2cm in size;
Approx. 7-8 hours after recieving the vacination, I developed the following symptoms:  Local reactions:swelling, approx. 4 inches x 5 inches, redness, soreness, and severe itching around injection site. These reactions still exist, after 3 days.  General reactions: mild muscle and joint pain occured the first two days after vaccination.  Mild, sparatic dizziness is still prominent.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
urinary tract infection; This is a spontaneous report from a contactable consumer reported for a patient (mother). This is a report received from Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for Covid 19 immunisation. The patient medical history and concomitant medications were not reported. The patient had experienced urinary tract infection on an unspecified date. The patient underwent lab tests which included investigation: tested positive for urinary tract infections. The caller is asking for his mother who is due to get the second dose of the Covid19 vaccine because his mother tested positive for urinary tract infections. The caller is asking how long her mother can take the second dose since her mother still has urinary tract infections. The outcome for event urinary tract infection was not recovered.  Information about lot /batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Started itching all over body with no rash. Went on for 10 days. Didn't think much about it at first until I talked to another Pfizer person and they had the same thing happened about 5 weeks after second shot like I did. Don't know if it was the shot but never had that happened before. It burned and itched but couldn't see a rash.
No additional AE reported; expired dose of MMR II was administered; This spontaneous report was received from a registered nurse concerning a patient of unknown gender and age. The patient's medical history, concurrent condition, concomitant therapy and drug reactions or allergies were not provided.  On 06-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) 0.5ml (strength, route of administered not provided) lot # T013724, expiry date: 21-APR-2022 for prophylaxis (Expired product administered). No temperature excursion on the product. No additional adverse event reported (No adverse event).
Since receiving the vaccine I have developed a autoimmune disease called Polymyalgia Rheumatica- PMR. I was unable to walk or lift my arms for sever al weeks. I couldn't get out of bed, comb my hair, brush my teeth, get dressed, etc. This is a nerve/joint disease that comes on suddenly. After going to several doctors and being in excruciating pain PMR was diagnosed through blood work and symptoms. I am currently unable to work and carry on with normal day to day activities due to pain. I am currently on prednisone. I need to now see a rheumatologist for life long treatment. The prednisone is very dangerous to take with multiple side effects, I will on that for a minimum of a year.
Vertigo (first week, only when laying down)  Fatigue (slept 36 hours) Fever 10 days after shot arm swelled, got feverish, turned bright red (upper arm area near injection) large blotch not a small dot Still very red and blotchy
Hot/heat at the touch (temperature raise); Stiffness; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot/heat at the touch (temperature raise)), MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Injection site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot/heat at the touch (temperature raise)), MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE WARMTH (Hot/heat at the touch (temperature raise)), MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-022834 (Patient Link).; Sender's Comments: This case concerns a male of unknown age with nonserious events of unexpected musculoskeletal stiffness and injection site warmth and expected injection site pain.  Event onset with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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.
Edema, Tenderness (L) Deltoid, warm + Red + Tender, firmness also noted.  (L) arm circumference 31.5 cm (R) arm circumference 31 cm.  Given Hydroxyzine HCL 25mg Tab omnicef 300mg caps.  Cool compresses to area 3x day.
Began by sneezing - swallowing frequently and got very quiet when spoken to, he answered appropriately. Then he said "I feel like I'm going to throw up". He did a few minutes later. Then his face and ears became flushed, sclera red. No noted breathing probably approx 20 minutes after injection. He said his feet were itching. Had mother to take him to hospital ER. He and mom later returned all back to normal. Mom said Dr. at ER gave some type med.
Tiredness; headaches; chills; nausea; loss of appetite; arm pain; not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 5 (booster), single (Lot number: G10446) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer in remission" (unspecified if ongoing); "IBS" (unspecified if ongoing); "several surgeries" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; LOSARTAN; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (booster), unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (booster), unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "arm pain"; CHILLS (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering"; HEADACHE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "headaches"; DECREASED APPETITE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "loss of appetite"; NAUSEA (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering"; MALAISE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "not feeling well". Therapeutic measures were not taken as a result of fatigue, headache, chills, nausea, decreased appetite, pain in extremity, malaise.  Additional information: Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient has an unspecified vitamin as a concomitant medication.
Information has been received from a health professional concerning a 49 year old female, who denied having any allergies or medical history, who on 30-OCT-2006 was vaccinated once with a first 0.5 ml subcutaneous dose in the left upper arm of MMR (Lot# 654687/1025F). There was no concomitant medication. Illness at the time of vaccination was denied. Immediately after vaccination, on 30-OCT-2006 the patient experienced redness, swelling, bruising, warmth, and discomfort at the injection site on the left upper arm. The patient had not experienced systemic symptoms. An ice compress was applied to the site but the patient had not noticed improvement at the time of the report. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient recovered on 31-OCT-2006. Additional information is not expected.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 2-year-old female patient had been fully vaccinated with PREVNAR 13 via an unspecified route of administration at 0.5 ml, single 3 doses on unknown dates and the 4th dose on 17Jun2016 (Lot # M79320), all for immunisation. The child received 3 doses in another pediatric clinic and received the 4th and final dose in reporting physician office. The patient medical history was and concomitant medications were not reported. On 08Mar2017 the patient was diagnosed with pneumococcal meningitis, invasive pneumonia presenting with vomiting when she was admitted to the hospital on 08Mar2017. The outcome pneumococcal meningitis and invasive pneumonia was not recovered, the outcome of vomiting was unknown. The patient went into the physician office on 08Mar2017 and was immediately sent to the hospital and was currently under the care of another physician at the hospital. The patient's hospitalization was prolonged as a result of this event. The reporting physician said that there was no medical conditions to report and he/she was not given any information about any tests the patient has had since she has been in the hospital. A product complaint was filed. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.