chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient broke out in hives between legs, on back of upper thighs, back, shoulders, neck and behind ears starting 5/24/01 at 11 PM. It got worse, and she went to the ED at 1:45 AM when lips began to swell. She complained of increased blood pressure. She was given mild IV steroid and IV Benadryl.
A company representative reported that a 2-month old male received Acel-Imune (diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed), Hib-Titer (haemophilus b conjugate vaccine), Prevnar (pneumococcal 7-valent conjugate vaccine), and Polio "Pasteur" (poliomyelitis vaccine inactivated) vaccines on 2-JAN-2001 On 10-JAN-2001, the infants sputum was positive for DFA fluroescent antigen test for pertussis).  Additional information received 110-APR-2001 from the infant's physician, confirmed the positive result for DFA. The physician also noted that after speaking with a clinical advisor and sales representative, he was informed the vaccine was an unlikely cause of the positive DFA, since it does  not excrete in the saliva. Follow up information also stated the infant recovered.
COVID Vaccine Breakthrough Case  Moderna Dose 1 3/5/21 (023M20A) Moderna Dose 2 4/7/21 (019B21A) COVID Positive 9/29/21  10/8/21: The patient had fever and chills with shortness of breath and cough with exertion and nausea without vomiting or diarrhea or abdominal pain for about 2 weeks became progressively worsen last 3 days specially shortness of breath while he was walking within the room distance.  No chest pain or palpitation or orthopnea or lower limb swelling or pain.  No known history of venous thromboembolism.   At emergency, his oxygen saturation normal room air but dropped to 84% while he was walking with a in the hallway, his labs show stable CKD and anemia.  CT chest angiogram negative for PE and show bilateral consolidation.  COVID-19 test is positive  10/9/21: Patient is a 88-year-old male admitted to the hospital for dyspnea associated with COVID-19 pneumonia, during the course of his hospital stay patient did not have any fevers or chills, did not require any supplemental oxygen, patient was treated with remdesivir and Decadron. On the day of discharge patient is hemodynamically stable comfortable on room air without any respiratory distress, patient was evaluated by respiratory therapy did not qualify for any home oxygen.  Patient will be discharged to home with oral antibiotic for completion.  Per patient's request VNA and COVID safe at home has been ordered for patient.  Patient recommended follow-up with his PCP within 1 week.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAR-2016 (also reported as 23-MAR-2017), the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L041204, expiry date 20-OCT-2017 (dose, route and site of administration were not reported). No adverse events were reported. Temperature excursion was reported as -13.7 Celsius for 20 minutes, it was not out of range before. Additional information has been requested.
According to Registry, pt received JNJ vaccine 3/17/21.  She came to covid clinic and proceeded to get 1st pfizer dose 6/1/21. received second dose 6/25/21. Pt scheduled appt for 1st vaccine dose online (for 8/15/21) and upon checking Registry, noticed patient had received these prior vaccines.  Pt was informed that she will not be receiving the third dose as that was what she was seeking due to her already having had 2 different vaccines.
Approximately 2 weeks after patient received his MMR booster to comply with workplace regulations, he started to develop small bumps on his scalp. They then started to grow in size and become painful. Hair would not grow on these sites. He sought the help of at least 2 Dermatologists. He first went to see Dr. who diagnosed him with Hidradentis and prescribed him Doxycycline Hyclate, Prednisone & medicated ointments on and off for about 1 year without relief. He then became a patient of Dr., who diagnosed him with Hidradentis & Dissecting Scalp Cellulitis. He was prescribed (Clindamycin 300mg 4 x a day), Rifampin (300mg daily) & unknown medicated ointments without any relief. Symptoms remain to this day.
Patient received Prevnar 13 on 11/11/15.  24 hours later, she called & reported being spacey in the head and having a headache.  She said she was also running fever and had chills.  I told her to take Tylenol and if the fever did not start coming down, to go to the E.R.  The next morning, she reported that she felt normal 2 hours later, after taking the Tylenol and everything was well.
Nausea; Vomiting; Headache; Joint pain; Muscle cramping; The patient received a third/booster dose; This is a spontaneous report from a contactable health care professional, the patient. A 50-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 18Nov2021 at 07:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history includes thyroid condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in left arm on 25Jan2021 at 12:00 (at the age of 49-years-old) as a single dose and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 15Feb2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  On 18Nov2021 at 22:00, the patient experienced nausea, vomiting, headache, joint pain and muscle cramping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, headache, joint pain and muscle cramping were resolving at the time of this report.
Chills; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "recovering", described as "Fever".  Additional information: Temperature was going down already and she was much better.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
his left arm pit was swollen as well as his left chest; his left arm pit was swollen as well as his left chest; side of his chest became very swollen. It was numb.; This is a spontaneous report from contactable consumer (patient). A 16-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 12May2021 at 15:45 (at the age of 16-years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received his first dose of the Pfizer COVID-19 vaccine on 12May2021 and the next day on Saturday 13May2021 noticed his left arm pit was swollen as well as his left chest, he states that was the side he received the dose. Yesterday he started noticing improvement. It was after his first dose that he developed a very swollen arm pit, and the side of his chest became very swollen. It was numb. The afternoon the next day he noticed the swelling for the first time, but he thinks he had it that morning. He was playing basketball, and he remembers his armpit was swollen, and it was fat and jiggly. It started to improve some as of yesterday. He had not gone to the physician or ER. The outcome of the events was recovering.  Information on lot/batch number was available. Additional information has been requested,  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
runny nose; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced RHINORRHOEA (runny nose) and HEADACHE (headache). On 28-Feb-2021, RHINORRHOEA (runny nose) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Narrative:  Fully COVID vaccinated, admitted for shortness of breath and sepsis due to leg celluliits
Redness and swelling down the arm from injection site for 3 or more inches. White spot at injection site.
This morning I woke up swollen under my eyes right where I had filler done; The swelling and tenderness is the exact same swelling and tenderness experienced right after the filler was done; achy and tired; achy and tired; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization.  Medical history included Celiac disease, allergy to gluten, filler under eyes in Jul2020, and the patient is prone to inflammation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included GUARANA [PAULLINIA CUPANA] and a multivitamin, both from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date for COVID-19 immunization and experienced fatigue and feeling achy. The patient stated she did not have any kind of reaction to her first dose other than fatigue and feeling achy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 the patient experienced feeling achy and tired, the patient had no other initial reactions after the injection. On 07Feb2021 at 06:30, the second day after the second immunization, the patient woke up swollen under her eyes right where she previously had filler done (last Jul2020, so per the patient, it wasn't recent). The patient stated the swelling and tenderness was the exact same swelling and tenderness that the patient experienced right after she had the filler done. The patient stated she should also note that she does have Celiac disease, which is an autoimmune disease and she is prone to inflammation, however the patient was not on immunosuppressant drugs and was otherwise very healthy. The patient did not receive any treatment for the events feeling achy and tired, swelling and tenderness under her eyes. The clinical outcome of the feeling achy and tired, swelling and tenderness was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: A Week Have Completing The Taking Of Paxlovid. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 23Oct2023 to 27Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300365985 same patient, different drug/event;
Twenty minutes after administration, patient experienced itching all over. Patient took 50 mg BENADRYL and within 60 minutes itching subsided and no further itchiness occurred. Two hours after administration, patient started having redness at the site, swelling, pain, high fever and fatigue. Today raised, warm, red erythematous areas are noted at right deltoid one is 4 inches by 3 inches with a second medial to the first that just started this morning, measuring 1 1/2 " x 1 ".  Patient states this second one is getting bigger.
Patient started with eye blinking, sniffing, and breath holding tics. This has resolved overtime.  Recently, another illness brought back out, but this has also subsided. Patient had also started Montelukast the same day tics started which has been discontinued.
In calling patient to schedule her second dose of the shingles vaccine, patient expressed some concerns and hesitations in getting the second dose.  Patient reports she had a reaction with first dose of Shingrix-- states she had flu like symptoms following the first dose for the next 1-2 days, and then significant pain and soreness in her left arm where it was administered leading her to favor that arm and subsequent muscle weakness for the next couple months.  She was seen by her physician about 3 months later and discussed her arm pain and weakness at that time and was prescribed physical therapy to help strengthen those muscles in her arm again.   She is still undergoing physical therapy to strengthen the muscles in her left arm and would like the second dose, but requesting an alternative injection site such as in the gluteal muscle.
About 24 hours after the second dose, I experienced tenderness in an area about  1.5" in diameter around the  injection site.  Around 6 PM that day, I started feeling fatigued and my body felt achy.  I felt like my breath and body were warm, as though I had a fever, but my temperature was normal.  Drinking a lot of water did not help the feeling go away.  On the second morning following the vaccination (about 42 hours after the injection), I felt fine, but around 6 PM (52 hours after the injection), I felt tired again but not achy.  On the third morning, the only symptom that I felt was very mild tenderness near the injection site.
minor aches; LOW FEVER; This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced minor aches and low fever. No further information reported. The reporter did not consent to follow-up.
SKIN TAG / SPOT ON SITE OF INJECTION APPEARS RAISED AND BLACK; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient has no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 260A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced skin tag / spot on site of injection appears raised and black. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and the outcome of skin tag / spot on site of injection appears raised and black was not reported. This report was non-serious.
Approximately 6 hours post-injection I began running a low fever (99-101F) and had body chills. This progressed and turned into body chills and extreme body aches for the next 18 hours. Fever topped out at 102F. Those were the only adverse reactions from the vaccine. 2 days after, I am feeling back to normal and ready to resume my normal activities.
No adverse effects other than soreness from the shot.   Patient contracted Covid within 25 days of shot Significant other also believe she contracted covid from patient after shot was given as she was not around anyone with covid before she came down with covid April 8 and tested positive April 13
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 12:00 as dose 1, single (Lot number: EP7554), in right arm, on 12Apr2021 at 12:00 as dose 2, single (Lot number: EW0153), in right arm, on 09Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH8027), in right arm and on 12Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing); "seasonal allergies in spring" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jul2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Negative, notes: Tested negative on Sat 16Jul; (23Jul2022) Positive, notes: took another test on 23Jul - positive again. Therapeutic measures were taken as a result of covid-19 included Anti-viral medication Paxlovid. The patient did not have any known allergies.  .
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 54-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 19th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced fatigue, fever, chills, headache and general body pain. On an unknown date, the outcome of the fatigue, fever, chills, headache and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, fever, chills, headache and general body pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The day after receiving FLUARIX, the patient experienced extreme fatigue, occasional fever, chills, headaches and body aches which lasted for 4 to 5 days.
Initial information received on 10-Aug-2022 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-hcp via MERK. This case involves a male patient  (unknown age) who experienced severe headaches and experienced severe headaches with episodes of vomiting while receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination. On an unknown date, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (strength, dose, formulation, route, lot number not reported) for prophylactic vaccination. On an unknown date the patient developed a non-serious event  severe headaches (headache) and experienced severe headaches with episodes of vomiting (vomiting) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events (vomiting, headache). At time of reporting, the outcome was Unknown for the event vomiting, headache.