chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neck (both sides) was swollen; Right side of the neck hurts; Throat is painful when she swallows; Pain inside ear; Bloody nose (both nostrils); Arm swelled up really bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up really bad), EPISTAXIS (Bloody nose (both nostrils)), SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts) and OROPHARYNGEAL PAIN (Throat is painful when she swallows) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02PR21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up really bad). On 10-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EPISTAXIS (Bloody nose (both nostrils)). On 31-Jul-2021, the patient experienced SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts), OROPHARYNGEAL PAIN (Throat is painful when she swallows) and EAR PAIN (Pain inside ear). In 2021, PERIPHERAL SWELLING (Arm swelled up really bad) outcome was unknown. At the time of the report, EPISTAXIS (Bloody nose (both nostrils)), SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts), OROPHARYNGEAL PAIN (Throat is painful when she swallows) and EAR PAIN (Pain inside ear) outcome was unknown.            No concomitant product use was provided by the reporter.  Patient placed a warm wash cloth on her neck to alleviate the pain as a treatment.   This case was linked to MOD-2021-275070 (E2B Linked Report).; Sender's Comments:  MOD-2021-275070:dose 1
I received my Pfizer booster shot on 4 Dec 21 and a short time later started to experience, what I call... a metallic sounding, persistent ringing that reminds me of Morse code.  I only have it in my right ear (thank goodness).  The condition really bothers me at night when I try to sleep as it wakes me up.
Case number PHEH2014US021530 is an initial spontaneous report received from a pharmacist on 22 Oct 2014. This case refers to a 17 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 161207), intramuscularly on 22 Oct 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Missed Dose; fatigue; pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Dose), PAIN IN EXTREMITY (pain in my arm) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Dose) and FATIGUE (fatigue). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Dose), PAIN IN EXTREMITY (pain in my arm) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received- Event outcome update received, Missed second Dose
Complaint of elevated temperature, Headache, runny nose and/or congestion, loss of tastes and/or smell, myalgia and malaise.
bad anxiety which hinders her ability to function around people/ hindered her ability to finish school; experience aches/pain over her back and legs; experience aches/pain over her back and legs; headaches; fatigue; This spontaneous report has been received from a consumer referring to his daughter, a currently 19-year-old, non-pregnant female patient. The patient had no medical history, concomitant medications nor previous drug reactions/allergies.   On an unspecified date, 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) (dose, lot number and expiration date were not reported). On an unspecified date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration reported as "shot her arm" (dose, anatomical site of vaccination, lot number and expiration date were not reported). Both doses were administered to prevent human papillomavirus (HPV).   On an unspecified date, the patient began to experience aches or pains over her back and legs (back pain, pain in extremity), headaches, fatigue, and "bad" anxiety (severe) which hindered her ability to function around people. Moreover, the patient's anxiety hindered her ability to finish school and the reporter was worried that in the future the patient's anxiety would affect her ability to work, and he thought she may be affected for life. Due to the events, the patient did not receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   It was reported that the patient did not seek medical attention, no treatment was given for the events and no lab diagnostics or studies were performed.   The reporter stated that he reached out to an attorney's office to see if he would have a case.    At the time of reporting, the patient had not recovered from the events. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was withdrawn. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2112USA003013:
The following symptoms occurred appr. 6 hours after vaccination and lasted appr. 8-10 hours: - Convulsing - Muscle Spasms - Severe Back Pain - Severe Leg Pain - Leg Stiffness - High Fever (102/103+) - Severe Migraine
3 hours after injection onset of wheeze, tachycardia 130 dyspnea 911 called, ER eval sx improved without treatment. Waxing waning course. PCP eval next day, EKG, LE Duplex neg. Persistent SX day x 2-3 led to repeat ER eval. Positive D Dimer led to spinal CT. Persistent tachycardia x 3-4 days with exertional dyspnea. Gradual resolution over 12-13 days.  MR received revealing a patient who developed wheezing and the sensation of palpitations and difficulty in breathing, the evening of her flu vax. Pt was brought via ambulance to ER where she began to have chest pressure and nausea. Evaluation was GERD and she was released.  Chest pain occured again the following day and she was evaluated in the office and then sent to another ER where she was admitted. PE: WNL except for a 1-2/6 short systolic ejection murmur along the left sternal border.  Symptoms of chest pressure and tachycardia seem to be related to activity and eating. Improvement noted when leaning forward or lying on left side. Assessment: Chest tightness-unclear etiology (?reactive airway spasm or pericarditis).  Tachycardia of unknown etiology.  PCP MR received with ER notes from first ER visit included. ER visit as noted above. Labs and Diagnostics: all negative. DX:? mild allergic reaction to flu vaccine, ? GERD. F/U visit to PCP on 11/14/2006 where pt. states resolution to chest pain except for occasional transient discomfort with exertion.
Resident complained about back pain in the middle of the night and when they went to do a blood pressure examination, she passed away at 2:40 am.
Massive Nose bleed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP7533) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaphylactic shock" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "reaction to a bee or wasp" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine.; "Hospitalization" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine.; "Swelling" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine.; "not breathing" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine. Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder (ongoing). The following information was reported: EPISTAXIS (non-serious) with onset 28Mar2021, outcome "recovered" (Mar2021), described as "Massive Nose bleed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of epistaxis.  Additional information: Time of vaccination was reported as was early, around 08:30 or 09:00. Consumer reported that patient had been taking concomitant products Armour thyroid for many years, since she was 25. It was a low dose and need a prescription for it. It was a very little table, its like almost taking a drug, that could get at the drug store. No vaccination was reported prior to Pfizer vaccine. She had not had any since childhood. She did not take any vaccines at all. She just remembered in school rolling up and getting it, but that was it. She was sitting down in her car, driving. It just seemed odd to her and has not had nosebleeds in the past 20 to 30 years and it was always at night. She was used to standing up and would have to sit down. It was just weird. She leaned back and her sister was there as well. It was scary, like it just flew out of her nose. She leaned back, it was really creepy, like a faucet. She was just sitting there. It was like, if somebody just hit here in the nose, she would understand. She was driving, so she pulled over and leaned back.  No follow-up attempts are possible. No further information is expected.
Stroke; Headache; This is a spontaneous report from a contactable healthcare professional through a Pfizer sales representative. A 7-decade-old (60 to 61 years old) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 28Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included migraine; was COVID-19 positive from 06Dec2020 to an unspecified date; and was sick from Dec2020 to an unknown to an unspecified date. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) for COVID-19 immunization. On 16Mar2021, the patient had stroke; assessed as serious (medically significant). On an unspecified date in 2021, the patient had headache. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event stroke most likely represents an intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
the patient refused more doses of Imovax and thought it was not needed; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that the patient refused more doses of Imovax and thought it was not needed.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received 1st dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incomplete course of vaccination  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  List of documents held by sender: none.
It was reported that a pt received Fluzone SV '99-'00 and Pnu-Imune 23 vaccines mixed in 1 syringe, on 11/4/99. Reportedly, on 11/7/99, at 04:00, the pt's temperature was 98.8F, the pt complained of generalized pain. At 12:00 noon, the pt's temperature was 101.6F and took 2 Tylenol. On 11/8/99, at 12:24, the pt's temperature was 99.4F. At 15:30, the pt complained of severe headache and body ache, temperature was 99.3F and was given DCN twice a day per oral. At 16:25, the pt complained of headache being worse and body ache and was given DCN 100, 2 X a day. No additional information was received from follow-up correspondence returned on 12/6/99.  Follow up on 10/28/2002: "During internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added medication error).  Case was upgraded to a 15-Day-Alert Report.  This case is closed."
Information has been received from a respiratory therapist concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009. On an unspecified date after received the vaccine she developed low grade of fever and pain at the injection site. The symptoms had been lasting about 24-48 hours. The patient sought medical attention by telephone. At the time of the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow up information has been received from a respiratory therapist concerning an 85 years old patient with a allergic to codeine and derivates, mercury and DETOX caps, localized osteoarthritis of the vertebral column (01-APR-2009), headache and joint pain, localized in the shoulder (29-APR-2009) and hypothyroidism, hypertension, peptic ulcer diseases, gastrooesophageal reflux disease at the time of vaccination and medical history of motor vehicle collision with another motor vehicle on a road, who on 01-JUL-2009 in the afternoon was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659922/1667U) intramuscular into right deltoid. Concomitant therapy include acetaminophen (+) codeine phosphate, amlodipine besylate, cephalexin, diazepam, flaxseed oil, LEVOXYL, omeprazole, PRESERVISION AREDS, temazepam, hydrochlorothiazide (+) triamterene. On 01-JUL-2009 in the afternoon the patient experienced redness and warm to touch at injection site and fever treat each lasted a few days. On 02-JUL-2009 therapy with methylprednisolone 4mg oral tablet was started. On 02-JUL-2009 following of vaccination the patient experienced cellulitis of the right arm, insomnia, neck sprain, osteoporosis senile, right trapezoid muscle strain. On 02-JUL-2009 the patient was started on therapy with CALTRATE D, alendronato (MSD), lisinopril and vitamin D. On 04-JUL-2009 the patient recovered from redness and warm to touch at injection site and fever. A standard lot check investigation was performed. All in-process quality checks for the lot number 659922/1667U were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received via telephone call from a respiratory therapist who verified cellulites of the right arm start on 02-JUL-2009, insomnia, neck sprain start on 02-JUL-2009 and right trapezoid muscle strain start on 02-JUL-2009. This is one of four reports from the same source. Additional information is not expected.
Injection site redness; Raised injection Site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The pharmacist reports the patient's injection site was red and raised. The health care professional describes injection site redness as being approximately 3 inches by 2 inches in size.
Pt recv vax 8JUN95 & 11JUN95 devel a gen rash throughout body w/blisters that did not itch, head congestion, was very tired; approx 10 blisters; pat exposed to chickenpox coincid w vax, vax not impl.
Right deltoid- 2 days sfter vaccine administration, the injection site is hard, red, warm to touch and tender upon palpation.
Patient  woke up at 4 am with chills, fever, nausea.   Patient recovered by that Saturday.
extreme itching rash with hives.  both arms and chest /neck.  after 8 days of itch its starting to feel better
day p/vax pt found having seizure lasted 2-3 min& febrile. postictal period about 4-6 min then listless.
Had vaccine, noted regular arm soreness. 5 months later developed lump at site, arm pain awakening her at night.
I had swelling under my left arm in my lymph node and the tissue around it the lymph node just got huge it went from a robin egg size to the size of a extra large chicken egg.  It still has not gone away.
C/o upset stomach, fatigue and red arm at site of injection.  Wife is a doctor and talked to on-call provider at her place of employment, rx for abx given.
Break through heavy menstrual bleeding while on the oral contraceptive bleeding was heavy and prolonged-length of duration was 11 days.
patient received expired Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via phone at call center as a medication inquiry on 23-Nov-2020.  This case involved a four-month-old female patient who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant vaccines included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX).  There was an actual medication error due to expired vaccine used.  On 21-Nov-2020, the patient received an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Expired product administered) 0.5 mL (lot number: UJ053AA, expiry date: 27-Dec-2020) via intramuscular route in an unknown administration site for prophylactic vaccination.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient stated she felt nauseous at the end of her 15 minute monitoring period. She was asked to stay for another 15 minutes while having a seat. At the end of the second 15 min monitoring period, she stated nausea had subsided and she felt okay to go home.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure"; "Known allergies: sulfa based antibiotics". Concomitant medication(s) included: LISINOPRIL, start date: 01Feb2019. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient experienced sore arm or hurting after SHINGRIX. The healthcare professional did not have the details about the patient (site of vaccination, severity, etc) because different person reported this adverse event to the pharmacist. The reported batch number (BSEK2) for SHINGRIX did not exist and was updated to B5EK2 as per sales database. This case has been linked with case US2018055975, reported by the same reporter.
Patient felt tired, body aches and feverish. Since that time she has noticed severe fatigue, sleeping several hours without feeling refreshed. Loss of interest in activities. Irritability with coworkers. Mental fog. Lack of concentration.
Case number PHEH2014US003838, is an initial spontaneous report from a medical assistant received on 24 Feb 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medications were not reported. He was administered only MenCYW-135 liquid component of MENVEO (batch number: A13013) without being reconstituted with MenA, intramuscularly on 11 Feb 2014. No adverse event was reported following the administration error (inappropriate preparation of medication).