chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; chills; muscle ache; Fatigue; pain at injection site; This is a spontaneous report from a contactable consumer.   A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration left arm single dose on 21Jan2021 10:00 for covid-19 immunisation. No other vaccine was received in four weeks.  Medical history included renal cancer (currently no evidence of disease), migraine with aura, irritable bowel syndrome, attention deficit hyperactivity disorder, cyclothymic disorder. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), Hemp-derived CBD/CBG, magnesium, polycarbophil calcium (FIBER). The patient had allergy to clindamycin and azithromycin. The patient experienced headache on 21Jan2021 13:00, chills on 21Jan2021 13:00, muscle ache on 21Jan2021 13:00, fatigue on 21Jan2021 13:00, pain at injection site on 21Jan2021 13:00.  No treatment administered. The events outcome was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Case previously recorded as MA2009-4372. Initial case report received from a medical assistant via agency, on 12 NOV 2009. A patient 6-month-old female was vaccinated with 0.5 S-OIV FLUVIRIN (batch no. 102041P) once i.m. on 09 NOV 2009. No adverse event was reported. Agency reference no.: NA09-008119.
Patient went to ER who reported that they had a Arthus reaction. Was told by ER to take ibuprofen especially but also acetaminophen as needed for discomfort. Apply cool compresses over next 1 to 2 days. Was told this might continue to worsen over the first day but then should start to improve. They do not expect to have fever or increasing redness after 48 hr. If she does return to ER.
Starting the morning after 1st dose, burning skin reaction, all over body, bright red skin - no rash, no fever. Following days painful sores on left ear &  neck painful head area. Burning sensation comes and goes, still experiencing problem, every 3-4 days it re-occurs starting the whole inflammatory response over again.  Asthma is exacerbated.
This spontaneous report was received from Pfizer and was assigned manufacturer report number 2015130234 concerning a female patient of unknown age who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). It was reported that the patient received PNEUMOVAX 23 2 or 3 times. On an unknown date, the patient underwent a surgically removed spleen and experienced disseminated intravascular coagulation (DIC) and lost both legs-bka (below knee amputation) and six fingers. At the time of the report, the patient's outcome was unknown. Upon internal review DIC and surgically removed spleen were considered to be medically significant. This was originally reported by a physician. Additional information has been requested.
Information has been received on 10-SEP-2001 from a RN concerning an adult female who approximately one year ago was vaccinated with a dose of Meruvax II. Subsequently the pt failed to seroconvert. The pt sought unspecified medical attention. Additional information has been requested.
Patient asked for 1st COVID-19 vaccination on 07/31/2021. Vaccination administered with Pfizer. This patient already received 2 doses of the Moderna vaccine on 01/20/2021 and 02/15/2021. No adverse events reported at this time.
swollen throat that hurts when she swallows; having normal seasonal allergy symptoms; feels like symptoms are getting worse everyday; swollen lymph nodes in both sides of nec; lowgrade fever; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swollen throat that hurts when she swallows), SEASONAL ALLERGY (having normal seasonal allergy symptoms), CONDITION AGGRAVATED (feels like symptoms are getting worse everyday), LYMPHADENOPATHY (swollen lymph nodes in both sides of nec) and PYREXIA (lowgrade fever) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL, VALACICLOVIR HYDROCHLORIDE (VALTREX), VITAMIN B12 [VITAMIN B12 NOS] and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PHARYNGEAL SWELLING (swollen throat that hurts when she swallows), SEASONAL ALLERGY (having normal seasonal allergy symptoms), CONDITION AGGRAVATED (feels like symptoms are getting worse everyday), LYMPHADENOPATHY (swollen lymph nodes in both sides of nec) and PYREXIA (lowgrade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swollen throat that hurts when she swallows), SEASONAL ALLERGY (having normal seasonal allergy symptoms), CONDITION AGGRAVATED (feels like symptoms are getting worse everyday), LYMPHADENOPATHY (swollen lymph nodes in both sides of nec) and PYREXIA (lowgrade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No known adverse effects; patient received an expired dose of PNEUMOVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 22-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # R024025 was confirmed to be valid, expiration date was 02-SEP-2020 (dose, route of administration, anatomical location were not reported) for prophylaxis.  No known adverse effects were reported. No product quality complaint (PQC) was involved.
Dizziness.  100/50, 111/58, HR 58 Blood Sugar 81.  C/O dizziness after COVID vaccine.  Pt. will be monitored at home.
mild soreness around injection site for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness around injection site for a day) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 026A21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (mild soreness around injection site for a day). At the time of the report, VACCINATION SITE PAIN (mild soreness around injection site for a day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, C-reactive protein: 0.6 (normal) 0.6mg. On 31-Aug-2021, C-reactive protein: 60.5 (High) 60.5mg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that on 31-Aug-2021, he received a lab test which showed 100-fold increase in his C-reactive protein compared to last year's test. It went from 0.6mg to 60.5mg.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 101 and for 2 days, very achy, sore throat. No hospital trip.
feeling very sick; watery diarrhea; throwing up; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got first dose yesterday evening, then on 01Mar2021 the patient was feeling very sick, has been having watery diarrhea and is throwing up. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered to left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Extreme Pain in the arm where the COVID vaccine  was inyected . I gave tylenol, but the pain  never left. The left arm still hurt the poor girl a lot. However, the pain  go to all the arm, and the neck.
Sustained tachycardia. Heart rate was consistently over 110 for two days. On Saturday 10/28/2023 heart rate climbed to 189 while cleaning and stayed between 120-150 while resting for a 3 hour period. I have had mild tachycardia with the previous COVID 19 vaccines and while having COVID 19 but not to this degree or for this sustained period of time.
Saturday 5/29/21 I experienced extreme fatigue, which kept me in bed all day.  Sunday 5/30/21 I experienced nausea, vomiting and diarrhea beginning around 7:30 AM.  Those symptoms had dissipated by around 8 PM Sunday 5/30/21.
This spontaneous report as received from a 67 year old female (also reported as male) patient refers to herself. On 07-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified), injection, single dose vaccine (dose, route and location unspecified). Concomitant hormone therapy included with Provera. A few days later on 11-NOV-2013 the patient broke out with shingles pain and rash in the vicinity of her right arm and shoulder. Over the counter unspecified hydrocortisone cream was given for the adverse event. No medical attention had been sought by the patient. The patient had not yet contacted physician. At the time of report, the outcome of the event was not recovered. Additional information has been requested.
About 3-4 minutes after getting vaccine, patient started feeling light headed and that he was going to vomit. He laid on his back for a couple minutes then felt well enough to sit in a chair. He then proceeded to vomit. He said that he felt very hot and was sweating. He stayed seated for 15-20 minutes then felt well enough to go home.
being tested positive; being tested positive; felt very sick; congestion; This is a spontaneous report from a contactable other healthcare professional (patient herself). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt very sick and that's not her normal. The patient felt great after getting the vaccine she hadn't felt that in a while. Today (23Dec2020) the patient had this congestion and 4 -5 people came back positive post covid-19 vaccination on unknown date. All of them sent home after being tested positive. The patient just someone to keep track, she just wanted Pfizer to know. She didn't have any problems, she was working COVID patients. They had a lot new cases. She just didn't feel 100%. The patient wanted to know if it's safe for her to get the second dose after being tested COVID positive post vaccination. The outcome of events was unknown.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the reported events and vaccination with BNT162B2. Additional information regarding therapy vaccination date, lot number and investigation results will aid in comprehensive assessment of the case.
Developed cough and shortness of breath. Admitted to hospital and found to have Strep pnuemo sepsis.
Extreme fatigue for 48 hours, low-grade fever for 8 hours (99.9°), profuse sweating for 6 hours beginning 55 hours after the shot. Reduced endurance after 72 hours, shot site felt warm and was slightly red for a week.
Patient reported waking up the day after both vaccinations with hives and itchy hands. Later that day patient passed out and was taken to hospital. Later that evening, patient had a seizure. Pt has past history of hives, but this was first seizure.
Patient came to clinic for MENACTRA vaccine for college and his mother also wanted him to have his first GARDASIL 9 shot. Patient was informed the purpose of both vaccines and possible side effects. Patient was given 0.5 ml of GARDASIL 9 in his right deltoid muscle and then MENACTRA 0.5 ml into his left deltoid muscle. After removing the MENACTRA needle from the patient's left arm, patient fainted into my arms and I called mother into the exam room to call 911. Patient was brought down to the floor and was noted to have tremors in his upper extremities and then pinched my upper arms; patient was noted to have loss of conscious and delirious behavior for about 1 minute. Patient woke up and requested water to drink. Patient also stated he did not eat anything prior to coming to the clinic, and stated he not does have a history of seizures or never had a reaction to getting a vaccine. A mini physical exam was conducted on the patient, which was within normal limits. EMS arrived at the clinic, and patient was safely escorted to the hospital with his mother.
Malignant neoplasm of ascending colon. The patient was admitted, brought to the operating room and underwent laparoscopic right hemicolectomy. Postoperatively, he went to the standard surgical floor and his diet was advanced as tolerated. He did have some rectal bleeding of bloody stools, so his subcu heparin was stopped. He was transfused 2 units. His hemoglobin remained stable. He was otherwise doing well with, and incision was clean, so he was discharged home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Narrative: COVID infection following COVID vaccine series 01/23, Moderna, dose#1 02/20, MODERNA, dose #2 08/21 COVID swab result: detected 08/21 pt cc: No symptoms exposure: unknown
On March 1, 2006, patient presented to ER with complaints of redness and swelling to Left upper leg.  ER physician noted on 'left lateral thigh, there is an area of cellulitis appearing patch roughly 12-cm in diameter with spreading erythematous margin.  Slightly raised and textured.  Hot to touch.  No fluctuance or pointing is noted.'  Treatment:  Augmentin 400 mg per 5 ml one teaspoonful PO b.i.d. for ten days.
Patient received first dose of COVID-19 vaccine on Friday, January 15th. When the patient returned for her second dose on February 12th, she was given P instead of M.
Treatment of COVID-19; Treatment of COVID-19; a recurrence and tested positive on 03Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 at 12:30 as dose 1, single (Lot number: EN6095), in right arm, on 21Feb2022 at 14:30 as dose 2, single (Lot number: EN6198), in right arm and on 15Apr2022 at 12:30 as dose 3 (booster), single (Lot number: EN6204) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 04Jan2010, stop date: 07Aug2022; VALSARTAN, start date: 05Dec2011, stop date: 07Aug2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 03Jul2022 at 10:30, outcome "recovered" (09Jul2022), described as "a recurrence and tested positive on 03Jul2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Neagtive, notes: Tested negative on 01July2022; (03Jul2022) Positive, notes: tested positive on 03July2022; (09Jul2022) Neagtive, notes: 09July2022 to get a negative result again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: Tested negative on 01Jul2022, then had a recurrence and tested positive on 03Jul2022 and tested myself every day and it took till 09Jul2022 to get a negative result again. No Known allergies were reported.
Donor stated having a head to toe rash a few days after the injection, donor took a z-pack.
Received Vaccine on 3/19/2021, spent the weekend with a COVID  person  (unknown at that time)on 3/26 to 3/28,/2021 developed a fever, chills, headache, phlegm on  3/31/2021, tested negative at Urgent Care on 4/2/2021. Given Mucinex, Guaifen with Codeine. Symptoms not better, returned to Urgent Care in the beginning of May, given zpack,Benzonatate. and prednisone. Referred to Asthma and allergy dr along with pulmonologist. Tested for allergies, confirmed allergies of dust, cats, dogs and a type of grass. (I've had cats my entire life) currently have 2 cats and a dog. Pulmonologist said that I have asthma. Asthma dr said I dont have asthma. Latest diagnosis from allergist is Vocal Cord Dysfuntion. I have been on the following meds since May of 2021- Mucinex, Hydroxyzine, Guaifen, Z pack, Doxycyline, 5 rounds of steriods, Amocicillin, Albuteral, redihaler, Benzonatate, Breo inhaler and Montelukast. I have phlegm, cough  non stop, have trouble breathing, rattle in chest especially when I lie down. shortness of breath, fatigue, headaches, sore throat and hoarseness.
L/D became red & swollen 7 days after vaccine. Pt went to Urgent Care and saw Pt 3/6/11 - Dx rash.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Aug-2022 at 4:42 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine)       Vaccination site was deltoid muscle.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions reported for the patient.  No treatment medications were reported.
I got dermal filler on April 8 2021 and my throat swelled tongue swelled. Eyes itchy, lips itchy, Ears itchy and high pitch ringing. Also face numbness off and on. I was treated in the ER 3 times. Saw a Dermatologist and a Ears Nose Throat Doctor and A allergy Docter. I had hydralauise shot in my face to  dissolve some of the filler. Symtoms improved . BUT still have  problems with itch face numbness face ears ring and hurt. I am currenty  seeing a cosmetic surgeoun. I am getting test done to see if filler is still in my face and if nerves in my face are cut .
Within seconds of injection, cod burning sensation to armpit and down armpit to little finger. 2.5 hours after injection fatigue, nausea and arm burn increased. That night arm tender to any touch to armpit and to elbow. Still an issue day3. Sweating for no reason the first day, then dizziness, intense weakness, heart palpitations starting the day after the injection through day 3. Could barely walk into work on day 3 with shaky weakness and shortness of breath, when normally can work hard all day every day without a problem.
pt hospitalized at another hosp approx 1 wk ago, tested positive for COVID, dc'd to home on steroids and home O2 @ 3 LPM via NC; called EMS with c/o dyspnea, fever, and chest pain; presented to ED with worsening SOB, hypoxic; COVID test was positive; DNI; on NRB mask; admitted to ICU; pt's condition worsened and she was moved to comfort care measures; BiPAP mask removed and she passed away in the hospital
Herniated disks; Ortho joint related side effects; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "Herniated disks"; ARTHROPATHY (non-serious), outcome "unknown", described as "Ortho joint related side effects".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
w/in 2 days pt developed small, red, itchy, raised rash to both arms.
After the two vaccinations, patient got home and she fainted and hit her head and that there was blood bleeding  from her head. She said there seems to be a lump on her head.  Patient had no previous history of dizziness or fainting.  Patient was recommended to go to the ER.
This spontaneous report was received from a pharmacist referring to a 60 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
hiving COVID in Jan2022; hiving COVID in Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "hiving COVID in Jan2022".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.