chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; swollen glands; burning/aching lungs; burning/aching lungs; headache; nausea; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: IRON; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 (COVID vaccine details: (Product= COVID 19), brand=Pfizer, Lot number= EW0151, Lot unknown= False, Administration date= 10Apr2021,, administration time=10:30AM, dose number= 1), administration date: 10Apr2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen glands"; PULMONARY PAIN (non-serious), outcome "not recovered", BURNING SENSATION (non-serious), outcome "unknown" and all described as "burning/aching lungs"; FATIGUE (non-serious) with onset 11Apr2021, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; NAUSEA (non-serious), outcome "not recovered", described as "nausea"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness". The events "sore throat", "swollen glands", "burning/aching lungs", "burning/aching lungs", "extreme fatigue", "headache", "nausea" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oropharyngeal pain, lymphadenopathy, pulmonary pain, fatigue, headache, nausea, dizziness.  Additional information: No other vaccine in four weeks. Other medications in two weeks was multi vitamin, iron, Zyrtec. Covid prior vaccination was yes. Covid tested post vaccination was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx. 24 hrs. after BOOSTRIX and MENACTRA vaccinations (same arm), pt developed warm, red indurated left upper arm at BOOSTRIX site.
Trouble breathing, restlessness (slept 1 or 2 hours), mild persistent headache, nausea (no vomiting), no appetite, skin sensitive to touch, tired
I still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest.; I was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest; I was not feeling well.; My left arm went numb; my fingers were tingling, my left leg also had the same reaction.; I was still having chest pain and it''s like my body just did not feel normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE 50 mg, Frequency, every day in the morning taken for hypothyroidism. The following information was reported: CHEST PAIN (hospitalization), outcome "unknown", described as "I still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest."; CHEST DISCOMFORT (hospitalization), outcome "unknown", described as "I was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest"; MALAISE (non-serious), outcome "unknown", described as "I was not feeling well."; HYPOAESTHESIA (non-serious), outcome "unknown", described as "My left arm went numb"; PARAESTHESIA (non-serious), outcome "unknown", described as "my fingers were tingling, my left leg also had the same reaction."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I was still having chest pain and it''s like my body just did not feel normal". The events "i still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest.", "i was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest", "i was not feeling well.", "my left arm went numb", "my fingers were tingling, my left leg also had the same reaction." and "i was still having chest pain and it''s like my body just did not feel normal" were evaluated at the emergency room visit. Therapeutic measures baby aspirin, Sulpha Codeine were taken as a result of chest pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recv vax;extreme lethargy, sleepiness & staring at noc when pt awakened fr sleep, occurred noc of vax & next day;probably related to sleep pattern rather than vax;
Multiple bruises formed across body without physical injury.  Both eyes, chest, left wrist, right knee and both thighs affected. Most formed within 24 hours, a few more by 48 hours and they started disappearing around 60 hours after the shot.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the first of four patients. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
Pt walked into HD 11/27/2001 with complaint of rash. Upon assessment, found to have reddened oval areas with defined borders to face, neck, chest, abdomen and back. Reddened areas slightly raised with scaling/peeling centers. Treatment: Allegra PO and clicon cream. Pt reported symptoms began 48-72 hours after vaccine administration. No local reaction at injection sites.
Approximately 30 minutes after receiving the Tdap injection, the donor was sitting outside the facility. The donor states that she began to feel nauseated and felt paralyzed. She also stated that she was having trouble breathing and having chest pain. She alerted her husband and he alerted the RN staff. When the first RN arrived, the donor had already vomited a copious amount of emesis and was complaining of difficulty breathing and chest pain. Donor also stated that when she vomited it was a strange taste that tasted like "poison". The donor was given 3 liters of O2 via nasal cannula. The donor began to have rapid breathing and appeared to have trouble keeping her eyes open. Donor was laid flat on a bench and ice packs were applied to the nape of her neck and chest. The donor begain to slowly recover and was sat upright. At 10:44 am an apical pulse of 80 bpm was obtained via stethoscope. At 10:46 am a manual b/p of 92/62 was obtained. The donor stated that she no longer felt nauseated and was given 8 oz of water. At that time, 10:55 am through 11:00 am) multiple attempts were made to obtain the donor's b/p, which was unattainable. Donor was transported into the building and we made an additional attempt to get the donor's b/p. At 11:05 am, the donor's b/p was 82/56 and pulse was 72 bpm. Donor was given another 8 oz of water. Donor's b/p was retaken at 11:12 and b/p was 76/51 and pulse was 75 bpm. Donor was then transferred to an exam table and at 11:20 am, given a bolus of 500 ml of NS. Donor's b/p was 110/72 and pulse was 68 bpm at 11:49 am and donor stated no complaints and was released to her husband in satisfactory condition.
Client was here on 3/285/2023 requesting  Moderna Bivalent booster. She described reaction following last two vaccines including; numbness, tingling in hands, clenching of fists, unable to move arms. States she was concerned it may be stroke but symptoms improved and have occurred twice now. First reaction seemed to be worse than second, but both followed same pattern with side effects occurring in the morning following both booster vaccines.  bed bound for several minutes feels nauseous and dizzy and breaks out in cold sweat, does not feel well for several days following last two (booster) COVID vaccine. Client is being seen for Complex Regional Pain and is receiving work up for MS. Client informed of side effects prior to Bivalent vaccine, this has been held pending further recommendation from her specialist
Information has been received from the authors in a literature article, concerning a 14 year old male patient. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL as prevention of human papilloma virus (HPV) infection (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported).  On an unknown date, two weeks after third dose of the vaccine was administered, the patient presented with left retro-orbital pain and blurry vision in the left eye, diagnosed with left optic neuritis. He had a second attack of left optic neuritis two months after initial presentation, it was reported that the patient experienced multiple sclerosis (MS). On unknown dates, a cerebrospinal fluid (CSF) showed presence of oligoclonal bands, magnetic resonance imaging (MRI) of the brain showed presence of white matter lesions with periventricular and corpus collosal involvement, and the rest of the work-up was unremarkable including neuromyelitis optica (NMO) antibody. The patient was treated with intravenous (IV) steroids for relapses, and started on disease modifying therapy with interferon beta-1a for relapsing remitting MS after second event. The patient was followed for two years. The authors indicated that this case and the others that had been previously reported, suggested a temporal association between HPV vaccination and onset of MS. Although live, attenuated vaccines had generally not recommended in MS patients, GARDASIL is an inactivated and recombinant vaccine, and does not contain any viral DNA. Whether the vaccine increases the risk of the initial demyelinating event in an already predisposed population or triggers the onset of MS, by way of an immune response, remains to be studied. Upon internal review, the multiple sclerosis was considered medically significant event. This is one of two cases from the same literature article (MARRS# 1804USA010662). US-009507513-1804USA010662:
This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 10-JUL-2015, the pharmacist gave VAQTA (dose, lot# and route unknown), Tdap (dose, lot# and route unknown) and MENACTRA (dose, lot# and route unknown) all three vaccines to the patient. On an unspecified date in 2015, the patient complained of elbow pain. The patient sought medical attention by speaking with the pharmacist. The outcome of the event was unknown. Additional information has been requested.
sz (convuls) onset w/in few mins;unresponsive;no apnea or hypoxia, emesis or incontinence;VS stable throughout;convuls occurring initially every 3-5min-lasting 10-60sec-recurring x 4-5hr-IV Diazepam, Dilantin prior to EMS transfer to hosp
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient was feeling cold, hot, shaky, weak, a heavy chest feeling, numbness in extremities a few minutes after her vaccine.  Her pulse went from 80, 99, to 110 after 3 readings.  Her BP was normal.  Her brother said she just had a unspecified chest procedure.  It wans't noted on her intake.  She wasn't feeling after lying down for 30 minutes with legs propped up and wanted to paramedics to come. They sent her home after another 30 min. She doing well before she left.She went to school day after.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 25-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M014544, expiration date on 27-NOV-2017), orally, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
When I received my first shot, I passed out. This could have been from extreme anxiety. A month after receiving my second dose, I woke up in the middle of the night (2am) not feeling particularly well. I thought I was having an anxiety attack and sat down to meditate.  I felt a little lightheaded and looked at my fitbit and saw my heart rate was extremely high. I didn't have my glasses on but I am fairly certain it was 220 bpm. At that time I also had an unusual feeling in the lower area of my sternum. I decided to call an ambulance and was taken to the hospital.
Chest pain- Squeezing/tightness feeling in left side of chest. Mild to moderate pain, occurring with activity and rest
Information has been received from a certified medical assistant concerning a 71 year old retired caucasian female with medication allergies to atorvastatin calcium (Lipitor), pentazocine lactate (Talwin), and butorphanol tartrate (Stadol) who on 11/09/2004 at 10:45am was vaccinated intramuscularly in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P) (first dose given in November 1999).  Concomitant medications included alendronate sodium (MSD) and calicum carbonate cholecalciferol (Caltrate D).  There was no illness at the time of vaccination.  Subsequently, at 15:30 on the same day as the vaccination the patient developed a local site reaction of slightly raised area, painful, red, hot.  The patient sought unspecified medical attention and no laboratory or diagnostic studies were performed.  The patient recovered from the swelling, redness, and fever in the arm.  It was also reported that 4 other female patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine within the last 2 months.  No product quality complaint was involved.  Additional information is not expected.
Information has been received from a consumer regarding a3 year old (also reported as a 5 year old)  male with a history of craniosynostosis (also reported as having no medical history ) who on 29OCT1998 was vaccinated in the arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved. follow up information was received from a physician which indicated that on 12MAY2003 the patient had "typical case varicella although mild after vaccination on 29OCT1998." The physician also reported a "varicella type rash on skin difficulty." The patient recovered on 19MAY2003. The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live. He also indicated that the cases were mild, however he did know that two of the cases were not mild. No further information is expected.
inadvertently administered Flublok Quadrivalent vaccine to 6 month old patient/ no AE; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA301262, 2020SA301293, 2020SA301312, 2020SA301272, 2020SA301284, 2020SA301290 and 2020SA301276 (same reporter).  This case involves a six-months-old female patient who was inadvertently administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot QFAA2051, expiry date- 30-Jun-2021) via intramuscular route in the left vastus lateralis for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency-on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
About 6 hrs. after vaccine I developed mild flu like symptoms:  fatigued, body aches, headache, flushed, temperature was one degree above normal for me, but technically not a fever. I had symptoms people get after the second vaccine, after this, my first vaccine.  If I was still working I would have needed to take two sick days. Theses symptoms lasted only a little over two days, but the the body aches continued for weeks. My legs felt sore, tight and sometimes crampy, and both of my upper arm pit areas were sore. Areas of my back were also sore off and on. I otherwise felt okay. Leg pain has gradually gotten better, with little to no leg pain today. I feel these symptoms are a reaction of my immune system to the vaccine. Is it safe to get the second vaccine if  I?ve had this prolonged reaction to the first? I don?t want to do anything to jeopardize my health.
After the initial vaccination I began to randomly experience hives and swelling in my hands, fingers, elbows, and knees. The event was cleared up with allergy medicine but lasted the entire day. The itching of the hives and swelling of my joints were uncomfortable and my fingers tingled from the event. For 2 1/2 years after the initial shot and the 2nd round of the HPV vaccination I experienced these events. They would be random and always around the same body parts from my fingers, hands, elbows, knees, and face. They would only subside with an antihistamine.
Patient felt numbness in tongue 10 minutes after injection - resolved after 1 hour - has returned intermittently over past 2 days - no other signs/symptoms.
died after receiving a booster, died the next day; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after receiving a booster, died the next day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant and treatment details were provided.  The reporter stated that,  'a relative of his died after receiving a booster, died the next day.'  Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of death. The event occurred 1 day after the third dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. As reported, patient died after receiving a booster, died the next day. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-445190, US-MODERNATX, INC.-MOD-2022-445179, US-MODERNATX, INC.-MOD-2021-127441, US-MODERNATX, INC.-MOD-2022-445363, US-MODERNATX, INC.-MOD-2021-420943, US-MODERNATX, INC.-MOD-2021-385861 (E2B Linked Report).; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of death. The event occurred 1 day after the third dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. As reported, patient died after receiving a booster, died the next day. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-445190:Mothers case US-MODERNATX, INC.-MOD-2022-445179: US-MODERNATX, INC.-MOD-2021-127441: US-MODERNATX, INC.-MOD-2022-445363: US-MODERNATX, INC.-MOD-2021-420943: US-MODERNATX, INC.-MOD-2021-385861:; Reported Cause(s) of Death: died after receiving a booster, died the next day
Bleeding gums (x3 days). Fever, muscle spasms, body aches (all resolved within 24 hours). Severe weakness (weakness is persistent to this day).
Patient returned to pharmacy due to a small wound on his arm he got vaccinated on.  He states the day of the vaccine it bled off and on and he left the bandaid on for 2 days.  When he took it off, there was a "wound" that was oozing liquid and somewhat scabby/red.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. The patient's past medical history included fibromyalgia.  On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site lump and injection site induration. On 17th October 2018, the patient experienced injection site pain, injection site warmth, fever, general body pain, headache, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site warmth, injection site lump, general body pain, injection site erythema, injection site swelling and injection site induration were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, fever, injection site lump, general body pain, headache, injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination not reported, but it could be 50 or 51 years. The healthcare professional (HCP) reported that the patient developed pain, redness, hotness to touch, swelling, and a hard lump at the injection site, body aches and pains, headache and a low grade temperature after her a dose of SHINGRIX. Injection site reaction was about 8 cm across. The HCP did not want to provide exact date of birth or initials of patient.