chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting at 10pm I felt shaking, tremors; Headache is really bad, like a band was wrapped around my head; Chills/Starting at 10pm I felt shivering; Have fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Starting at 10pm I felt shaking, tremors), HEADACHE (Headache is really bad, like a band was wrapped around my head), CHILLS (Chills/Starting at 10pm I felt shivering) and FATIGUE (Have fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson vaccine on 16-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included GABAPENTIN, LEVOTHYROXINE SODIUM (SYNTHROID), PRAVASTATIN SODIUM (PRAVACHOL) and FAMOTIDINE for an unknown indication.    On 06-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced TREMOR (Starting at 10pm I felt shaking, tremors), HEADACHE (Headache is really bad, like a band was wrapped around my head) and FATIGUE (Have fatigue). 06-Nov-2021, the patient experienced CHILLS (Chills/Starting at 10pm I felt shivering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Starting at 10pm I felt shaking, tremors), CHILLS (Chills/Starting at 10pm I felt shivering) and FATIGUE (Have fatigue) outcome was unknown and HEADACHE (Headache is really bad, like a band was wrapped around my head) had not resolved.            Treatment information was not provided
Initial soreness in left arm deltoid muscle lasted about 2 days. Then a few days after that there was muscle weakness and soreness when I tried to use my left deltoid muscle. Pain and weakness has yet to go away and it?s been 2 months.
Patient received her first Covid vaccination not knowing that she was about one month pregnant.; congestion; upper respiratory symptoms; This is a spontaneous report from two contactable Other-HCP (patient). This is a maternal report.  A pregnant female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient received her first Covid vaccination not knowing that she was about one month pregnant. Experienced congestion and upper respiratory symptoms which she is not sure had anything to do with her exposure to the vaccine. She and her provider opted for her not to receive the second dose once she learned she was pregnant. She is doing well with her pregnancy and it is about 12 to 15 weeks along.  The mother reported she became pregnant while taking bnt162b2.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Lymph node tenderness; Swelling left armpit (same side as injection).; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Apr2021 at 08:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included hypothyroid, COPD (chronic obstructive pulmonary disease) and tachycardia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and vitamin d nos (5000) (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 22Mar2021 at 08:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Apr2021, the patient experienced injection site soreness on the day of vaccine and the day after that. On 15Apr2021 at 04:30, the patient experienced lymph node tenderness, swelling in the left armpit (same side as injection) which began on day three after the injection. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vaccination site soreness, lymph node tenderness and swelling in left armpit (same side as injection) was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 9 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received Influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine, oral antihistamines, oral steroids, bronchodilators and ice pack. The outcome was recovered and the patient was referred to a pediatrician. Reporter's comments: The attributed trigger was vaccine.
Patient is fully vaccinated.  COVID positive on 4/27/2022 at hopitalization. 36-year-old female that presented with bilateral lower extremity paresthesias and severe headaches. She also had general body aches, chest pain, fatigue.  She did not require oxygen. Lumbar puncture was done.  CSF showed mild increase in WBCs.  Cultures have been negative however and so have MRIs of brain and spine.  Discussed this at length with neurology and they recommended close follow-up as an outpatient.  Patient symptoms have resolved and she was feeling well on discharge.
12FEB99 inc temp, nasal drainage, sore throat, sudafed, APAP, fluids;flu dx;
redness, swelling and itching at injection site; redness, swelling and itching at injection site; redness, swelling and itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (redness, swelling and itching at injection site), VACCINATION SITE ERYTHEMA (redness, swelling and itching at injection site) and VACCINATION SITE SWELLING (redness, swelling and itching at injection site) in a 59-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8059068) for COVID-19 prophylaxis.     The patient had no concomitant disease or risk factor.  The patient's past medical history included COVID-19 in January 2023.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced VACCINATION SITE PRURITUS (redness, swelling and itching at injection site), VACCINATION SITE ERYTHEMA (redness, swelling and itching at injection site) and VACCINATION SITE SWELLING (redness, swelling and itching at injection site). At the time of the report, VACCINATION SITE PRURITUS (redness, swelling and itching at injection site), VACCINATION SITE ERYTHEMA (redness, swelling and itching at injection site) and VACCINATION SITE SWELLING (redness, swelling and itching at injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported.  The patient did not experience any additional symptoms/events. There were no lab data/results available. Treatment medication was not reported.
Pt developed localized cellulitis with tenderness and redness at the injection site and a fever of 102.  Physician prescribed amoxicillin.  Pt was seen again for neck pain and physician observed a sterile abscess on his left arm.  Pt. was hydrated with fluids and recovered. Follow up states patient received Motrin therapy for fever and indicated that the patient remained recovered.
The following morning I had:  Heart palpitations Shortness of breath  Dizziness  Weakness
p/vax pt exp temp inc; nausea; rash on arms; pustules present; 2+ cervical adenopathy; strep pharyngitis;maculopapular rashes
A week after being vaccinated, I had pain in my right shoulder where vaccine was administered. Pain for like 3 days. It kept getting stronger and stronger, it traveled into my muscle through my shoulder area. My muscle is in spasms. Also, this pain does not leave. It traveled inside my arm, down my arm, into my forearm. My whole complete arm is in non stop pain. I dont take pain meds, I have tried icing, mild stretching, yoga, even mild kayaking like I use to. It hurts so bad inside my arm. I cant even do the funky chicken. If I dont put my arm above my head and stretch it, thats the only way I can have my arm function for today. This is my right arm. If I grab and squeeze it, it relieves, but then goes right back.
Tongue swelling, angioedema. EpiPen, Benadryl, Prednisone, Solumedrol, Pepcid.
Patient experienced nose bleeding starting about 4 hours after getting second shot and continued for 24 hours straight. Patient denied experiencing this after the first shot.
Information has been received from a pharmacist referring to a currently 66 year old female patient. There was no information about concurrent condition, concomitant medication and medical history.   On an unknown date, the patient was vaccinated with a partial dose of  PNEUMOVAX23 (strength and dose unknown) (lot # M040004, expiration date 20-MAY-2018) intramuscularly for prophylaxis due to a defect with PNEUMOVAX23 pre-filled syringe (product quality issue). Because the patient didn't receive a full dose of PNEUMOVAX23, she administered a second dose of PNEUMOVAX23 (strength and dose unknown) (lot # M040004, expiration date 20-MAY-2018, intramuscular) during the same vaccination session.  The patient had not experienced an adverse effect. Additional information has been requested.
Chills and fever at the same time, extreme fatigue, restlessness, insomnia, muscle aches.
After 10 days, the injection site became hot, red, swollen, and itchy. It was also painful. These symptoms increased and remained for 6 days. By the second day, the redness had formed into a circular rash about 2 inches in diameter and there was noticeable heat coming off of my arm. I had a slight fever of 100.9 on the second and third night. By the third night when the fever broke, the pain and heat began to subside. By the end of day 6, it had cleared.
Uncontrolled screaming for hours (5+) for days on end. Resolved after a few weeks, recurred at every vaccination date subsequently. Eye turned in, fever, irritability.
on May 13, 2022 had fever, headache, nausea, sore throat.
1 inch bruise with skin tone center with a pink (light red) oval rash descending below the bruised are approx 3 inches log by 2 inches across
Information has been received from a consumer concerning her 9 year old daughter with low blood pressure, low heart rate and environmental allergies to rag weed and mildew, who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL, (lot #660553/0070X), 0.5 ml, intramuscularly (IM).  There was no concomitant medication.  It was reported that following the vaccination the daughter fainted.  She was taken to the emergency room and all tests (types not specified) were negative.  She was discharged home after four hours.  No treatment or outcome information was provided.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008.
Tinnitus. Persistent loud ringing in both ears. Present when I awake in the morning. Very unusual.
7/16/22 pt to ED from a rehabilitation facility with acute respiratory failure; O2 saturations in 40s on RA; NRB; admitted for severe sepsis, left femoral DVT; 7/19/22 developed respiratory failure again due to PNA vs COPD exacerbation; intubated; 7/23/22 able to be extubated; found to be positive for COVID; steroids; pt's condition worsened (respiratory and renal); placed on NIPPV; was later able to wean to nasal canula; renal function worsened; A Fib with RVR; PEA arrest twice with ROSC; pt was transitioned to comfort care, extubated and passed away in the hospital
had a headache since then.; This is a spontaneous report from a contactable consumer. Follow-up (PRD 08Apr2021) received from a contactable consumer was processed together with initial information.   A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6205; Expiration Date: 31Mar2021), via an unspecified route of administration, administered in Right arm on 30Mar2021 09:00 as SINGLE DOSE for covid-19 immunization. Dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:30 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included Kidney transplant from 2012 and ongoing, hyperglycaemia on an unspecified date, she started out with hypoglycemia then after her kidney transplant had hyperglycemia so maybe it was before her kidney transplant, ongoing hypertension diagnosed when she was 19 years old, on an unspecified date back pain, back injury, ongoing diabetes mellitus, ongoing high blood pressure. On an unspecified date the patient concomitant medication(s) included loratadine taken for back pain LOT: P121557; EXP: Aug2022; acetylsalicylic acid taken for back injury. The patient previously received bnt162b2, dose 1 for COVID-19 immunization and experienced mild headache on 02Mar2021 with recovering. First shot, she had a mild headache for three or four days, that was the only side effect. second shot, she still has a headache, but more intense and for longer. She takes Aspirin and it doesn't seem to go away. Second Dose: Headache, but more intense and for longer: the intense headache started that evening of her second shot, 30Mar2021. She's been taking Aspirin and taking, she has back injuries, so she has some pain medicine and has been taking that. Caller states it will go away and then the pain medications will wear off and it's back. She has had a kidney transplant. Because of a back injury, she takes pain medicine. She hates taking pain meds but sometimes takes it three times a week due to her back pain. The headache will go away. when she takes the pain medicine, as soon as it wears off, the headaches back again. Its nagging, not intense, she just knows it's there. She can function and everything. The patient experienced had a headache since then (headache) on 30Mar2021. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Soreness at injection site, fatigue, swelling of face, nausea, vomiting, diarrhea
patient's mother reported 8 hours after vaccination, patient was reported pain between her shoulder blades radiating up to her neck (patient is in remote learning during covid), patient denied swelling, redness, or soreness at injection site.    12 hours after vaccination, patient's mother reported over night patient had a 101 degree fever, treated with tylenol, body ache, vomitted twice, and headache.  patient still denies redness, soreness, and swelling at injection site
Awoke at 11pm w/fear/tingling in hands and feet/upset stomach. By 7am, temperature was 103 degrees-> given ibuprofen. All symptoms resolved by 10am. Physical exam normal no treatment needed.
deafness in one ear/ hearing loss; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. Other Case identifier(s): 2022SA142853 (Sanofi).  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; insulin glargine, lixisenatide (SOLIQUA), since 2020 (Lot number: 1F467A, Expiration Date: 30Jun2023) at 15 iU 1x/day for type 2 diabetes mellitus; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Elasomeran (Moderna covid-19 vaccine) and Tozinameran (Pfizer BioNTech Covid-19 Vaccine). The patient's concomitant medications were not reported.  The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "deafness in one ear/ hearing loss"; TINNITUS (non-serious), outcome "unknown". The action taken for insulin glargine, lixisenatide was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/2/2008-Received anthrax shot, On 8/3/2008, not able to sleep on right arm, On 8/4/2008, felt nausous and on 8/5/2008, area around shot red and warm to the touch.  Also, the shot area was hard.
Ran a fever for about 1 week. Had extreme pain in left leg beginning the day after vaccine. Visited emergency room 1 week later based on guidance from physician but little was done- they seemed unsure of what to do. They ran blood tests but since I had no swelling, they assumed no blood clots and did no more testing.  Released after about 3 to 4 hours. Pain continued so contacted my doctor a 2nd time. She indicated other patients were reporting the same and suggested continuing aspirin or tylenol.  After about 4 weeks pain resolved.
3-4 days later pt had loss of head control, unable to sit w/o propping, arms limp, weak cry, labored breathing; listless called MD x 5 days p/vax; returned to hosp 11MAR92 for further eval;
A report was received from a health professional, concerning a 3 year old female patient. The patient's medical history, concurrent diseases and concomitant medications were not provided. On 07-Feb-2013, the patient was received nasal FLUMIST, but the vaccine was expired on 04-Feb-2013. At the time of reporting, the outcome of the event of gave expired FLUMIST was unknown. The report was considered to be non-serious by the reporter.
started 24 hours after vaccine -- from 2/9/21 into 2/13/21 and continuing now persistent disequilibrium slight dizziness slight queasiness slight headache
T. C. from MD stating client had nausea/vomiting starting @ 9 pm and continuing through the night. Fever in am - no thermometer available. Con't to feel peeky through following day - then resolved.
pt recvd vax 2AUG95 & in mid OCT95 pt was exposed to chicken pox;30OCT95 2wks p/vax pt devel fever & vomiting next day presented to MD office w/30 small sores that looked like chicken pox;
Left shin and back of right lower calf. Started itching and developed bumps which blistered. Serious itching.
ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE DVT OF RIGHT ILIOFEMORAL VEIN
Fever, nausea vomiting, anorexia, myalgia, sore throat, malaise
6 to 7 days of continuous colic-like symptoms; vomiting, crying, fever.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 66-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced dizziness, with outcome of unknown. Additional information: Patient had no symptoms after first dose except a short period of dizziness (less than 30 seconds). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021401211 same reporter/drug/patient, different dose/event.
lower half of face including under chin and some of neck was red and swollen; some of neck was red and swollen; lower half of face including under chin and some of neck was red and swollen; unusual taste on tongue; roof of mouth bumpy; lower half of face including under chin and some of neck was red and swollen; This is a spontaneous report from a contactable consumer. A 69-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN531005121), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 13:00 as 1st dose, single for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. Medical history included TIA from May2020 and high blood pressure. Patient was allergic to penicillin, omeprazole, bactram, adhesives, gold, and other metals. Concomitant medication in two weeks of vaccination included 40 mg VALSARTAN and 81 mg ASPIRIN. On 20Feb2021 13:00, the patient experienced lower half of face including under chin and some of neck was red and swollen, unusual taste on tongue, roof of mouth bumpy. The patient underwent lab tests and procedures which included body mass index: 30. Patient went to Emergency room/department or urgent care as result of events. No covid tested post vaccination. Therapeutic measures were taken with BENADRYL 25 mg. Patient was recovered from events in 2021.  No follow-up attempts are possible. No further information is expected.
been vaccinated for shingles, and got it last week/suspected vaccination failure; got it last week; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles 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 had been vaccinated with Shingles vaccine and got shingles last week. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.