chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a dose of PENTACEL without reconstituting with the Hib portion of the vaccine/no AE; Initial information was received on 16-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a four-month-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ336AA, expiry date not reported) via an intramuscular route in the left thigh without reconstituting with the HIB portion of the vaccine for prophylactic vaccination on 10-Mar-2021 (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of an actual medication error due to inappropriate reconstitution technique (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 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.
A male patient received Td-88 on 12/8/02 for a laceration. The patient developed flu-like symptoms that night. He developed a low grade fever, and slept for 18 hours straight. The patient was better the next day, and fully recovered.
On 10/26/2021 body aches and pain and headaches for ten days. Chest infection and Sinus infection since November 2021
Ten days later the 1st dose began to experience headaches; This case was reported by a consumer via call center representative and described the occurrence of headache in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix. On 16th May 2022, 10 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and ten days later began to experience headaches. The reporter consented to follow-up.
16 y/o patient fainted after receiving first COVID vaccine. Pt was in waiting area in front of pharmacy and all aid was managed there. Guardian helped me get pt on the ground, rolled to side w/ head supported, and tech helped provide icepack and fan to cool pt. Pt had strong pulse and breaths entire time. She came back around after about 10 min - was able to sit back in chair for another 10 min before ambulating out of store. Pt reported no hx of fainting or allergic reaction after a vaccine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and drug allergies/reactions were not reported. In August 2012, the patient was vaccinated with GARDASIL dose 1. Concomitant medication was not reported. On 01-OCT-2013, the patient went to the office to receive her second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
5 days p/inject, sore throat, fever muscle joint pain, fatigue, congestion, pain in trachea (bronchitis);
Despite exclusively breastfeeding for last 3 months, I started spotting the day after dose 2. The spotting went away after 24 hours.
Unusual and unexpected side effects of the vaccine. About 12 hours after vaccine administration: waking through the night, irritability and crying, overly frequent need to pee (within 30 seconds of fluid intake & at least once every 2 hours) ? along with the more common side effects body aching, weakness, soreness at injection site, and fever.  Within 24 hours of receiving the vaccine, also experienced parosmia & ensuing total loss of appetite, severe malaise (urge to shiver, chest discomfort resulting in urge to cough), and the more common side effects fatigue and headaches.
He wanted to know if there would be an effect to the efficacy of the vaccine if he would take Miralax; has a stomach issue; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 17Mar2021 as a single dose for covid-19 immunization; macrogol 3350 (MIRALAX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose, daily for an unspecified indication. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was asking if he can take Miralax or not. He mentioned that the vaccine and Miralax contain polyethylene glycol. He is taking Miralax almost everyday and he does not remember if he has taken a dose of Miralax after his first dose. He wanted to know if there would be an effect to the efficacy of the vaccine if he would take Miralax. He got his second dose today. He has a stomach issue on an unspecified date. Outcome of the event was unknown. Description of Product Complaint: He called earlier and someone called him back. He missed the call because he was on the other line for a business call. He got his COVID shot. He takes MiraLax everyday and that is polyethylene glycol. He has a stomach issue. Because there is polyethylene glycol in the vaccine is it ok to still take his regular MiraLax. Reference number: he doesn't have one. He was not asked for lot number when he called previous. He didn't do a report. He would not have any information such as lot numbers for MiraLax or COVID shot to provide. His question is because basically there is MiraLax in the vaccine and he takes MiraLax. He doesn't want to screw up the efficacy of the vaccine if he is taking more. Caller declined to proceed with a report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
nightmare; insomnia; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmare), INSOMNIA (insomnia) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NIGHTMARE (nightmare), INSOMNIA (insomnia) and ARTHRALGIA (joint pain). At the time of the report, NIGHTMARE (nightmare), INSOMNIA (insomnia) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-135246, MOD-2021-135246 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Action taken was updated to unknown as the events were related to the first dose of the vaccination.
Received the booster (3rd doses) on a Friday.  Had significant body aches the next day (Saturday), and felt much better Sunday.  I continued to have muscle aches, especially in the upper body with concentration in the shoulder area, since then.  The pain was more irritating than anything, and it did not stop me from doing any activities.  After about two months, I contacted my doctor's office about this.  The doctor suggested I take ibuprofen three times a day.  I believe I am feeling better; however, I will wait and see if the irritating muscle pain goes away completely.
I got Covid Vaccine on January 7th. I was fine. Day 2 or so very tired muscle soreness. On Day 8 I had the chills which I took my temperature 100.5 temporal and 1 hour later I took it, it was 98.5 orally. I happened to notice my injection site was a thumb sized reddened area. Throughout the day I put ice on it because it was a hot red area. It increased in size throughout the day I took Benadryl 25mg at bedtime. Woke to it hurting and burning. Hot to the touch and its like the size of a softball now. Hot hard mass/ lump.
PAIN IN LIFTING MY LEFT ARM, PAIN IN MOVEMENT OF MY LEFT ARM. DIFFCULTY IN WRITING, AND DOING EVERYDAY THINGS, (BATHING, DRIVING, EATING, ETC.) IN NOVEMBER SEVER FLU LIKE SYMPTOMS WHERE THERE I TOOK TIME OFF AND HAVING TO DEAL WITH THE ABOVE ISSUES. MEDICATING FOR PAIN AND FLU LIKE SYMPTOMS WERE TAKING TO HELP COMFORT AND TAKE AWAY THE PAIN AND TO BE AT EASE.
Shoulder had a small healing bruise in the center of a large (3-5 inches in diameter) reddened area. Warm to the touch, even at day 4 post vaccine, when I saw her. Recommended topical diphenhydramine.
Same day as vaccine I began to have an itchy rash develop. The next day I was feeling sluggish and not like myself, comparable to being inebriated. By 07:00PM day after vaccination, I was bedridden and pretty much slept for 3 days straight. Appetite was gone and if I did eat anything the food would come back out. Coughing and vomiting caused pain as well as headaches that came on.  Fever of 101, body ache, chills, fatigue, muscle stiffness. Codeine cough syrup was prescribed to help with pain however cough is starting to improve however phlegm is still coming up. Achiness, fatigue, and loss of appetite comes and goes in comparison to when this all began.  Headaches and fever have gone away.
Patient reports feeling "like a cold is coming on, a little odd in my throat, a little odd in my head"
Low-grade fever 24 hours after injection. 36 hours after injection, diarrhea set in. Approximately 54 hours later, uncontrollable shaking which progressed to high fever. Went to ER for IV fluids and anti-diarrhea meds. Diagnosed with dehydration, fever and adverse affects to Hepatitis A vaccine.
Dermatographia, I've been getting welts where I scratch, depending on body temperature.  Happens more when I'm hot or take a bath/shower.  Sometimes they appear even where I dont think I've scratched.  Has been going on for 3 weeks now.
a few hours after injection developed headache, felt ill, dizzy, feverish--eventually subsided the following day. I skipped my next period (2 weeks later) and i was constantly regular--this was unusual. My period changed was super thin and intense bleeding with heavy blood clots w/ heavy cramping. I bled through my tampon and through my pants the bleeding was so heavy and intense. My period also lasted longer than it would have normally and, again, it threw off the timing of my period, I missed my normal date and the date of my period changed. It was very abnormal. No other events or things or meds or anything I was doing at that time to explain these symptoms I had shortly after getting the vaccine.  My vertigo has gotten worse, more frequent since getting this vaccine too.
8 days after vaccination developed redness at site and 6 maculo-papular lesions, slightly pruritic.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sept-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Chills; Headache; Sleepy; Tired; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), SOMNOLENCE (Sleepy), FATIGUE (Tired) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache), SOMNOLENCE (Sleepy), FATIGUE (Tired) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, CHILLS (Chills), HEADACHE (Headache), SOMNOLENCE (Sleepy), FATIGUE (Tired) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication were provided. Patient had Multiple Sclerosis. She was experiencing chills, headache, sleepy and tired,like having the flu. She wanted to know how long these side effects will last and can she travel after receiving the first dose.
Second Dose was not administered; Developed lymphedema; Immediate swelling at injection site; Immediate pain at the injection site; Vasculitis-type rash on lower extremities; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second Dose was not administered), VASCULITIS (Vasculitis-type rash on lower extremities), LYMPHOEDEMA (Developed lymphedema), VACCINATION SITE SWELLING (Immediate swelling at injection site) and VACCINATION SITE PAIN (Immediate pain at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced VASCULITIS (Vasculitis-type rash on lower extremities). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second Dose was not administered), LYMPHOEDEMA (Developed lymphedema), VACCINATION SITE SWELLING (Immediate swelling at injection site) and VACCINATION SITE PAIN (Immediate pain at the injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second Dose was not administered), VASCULITIS (Vasculitis-type rash on lower extremities), LYMPHOEDEMA (Developed lymphedema) and VACCINATION SITE PAIN (Immediate pain at the injection site) outcome was unknown and VACCINATION SITE SWELLING (Immediate swelling at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.
herpes labialis; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 24-JUL-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered from multiple outbreaks of herpes zoster and herpes labialis. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and herpes labialis were considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events herpes zoster and herpes labialis to be disability.
Pfizer Dose 1 2/17/21 (EN9581) Pfizer Dose 2 3/10/21 (EN6204) Pfizer Dose 3 10/26/21 (FF2588) COVID Positive 1/26/22 COVID Positive 2/18/22  2/18/22: This is a 77-year-old female with history of hypertension, rheumatoid arthritis, deconditioning, chronic dementia and multiple recent fractures, recent C diff colitis and sepsis who presented to the emergency department with right shoulder pain and swelling. Patient is demented and cannot provide history. History was obtained from patient's daughter in-law. She states that patient has been complaining of pain and swelling in right shoulder. Her pain is moderate to severe in intensity and worse with movement. Patient is from a nursing facility. Patient had a recent humeral neck fracture on the right side which was deemed nonsurgical.   In the emergency department, patient was noted to be in sinus tachycardia. Labs showed a proBNP level of 941, WBC count of 1.2, hemoglobin of 7.5. Patient had a positive COVID-19 PCR test. Patient was given a dose of IV Zofran.  3/1/22: The patient presented to the hospital with generalized weakness and decreased p.o. intake, severe right shoulder pain and lower abdominal discomfort with diarrhea, she had dry oral mucosa and initially she was lethargic due to hypovolemia and sepsis, the patient she was diagnosed with C diff colitis and COVID-19 infection on January 26, later she developed bloody diarrhea due to severe C diff colitis, she require p.o. vancomycin and IV antibiotic and IV hydration, hemoglobin dropped and require total of 3 units of blood to be transfused, the patient was on Eliquis due to bilateral lower limbs DVT, the gastroenterologist consulted and recommend conservative management and no intervention due to high risk of perforation and general deconditioning, the patient had IVC filter placed. Her diarrhea improved while she is on vancomycin. The patient had chest CT show bilateral pleural effusion, CT abdomen show colitis. Blood cultures are negative. The patient does have severe difficult to control arthritis pain, she does have severe deconditioning and severe protein calories malnutrition, discussed with the patient and her family and decided to pursue with comfort measures and hospice care.
Upper arm with erythema, length of deltoid positive warmth, positive swelling given 10 days KEFLEX 250 mg every 12.
Treatment of COVID-19; Treatment of COVID-19; 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 (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0162), in left arm, on 09May2021 as dose 2, single (Lot number: EW0183), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: Z-PAK, start date: 27Jul2022, stop date: 31Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Adverse event: After testing negative and feeling fine on last day of taking Paxlovid, I've had a return of COVID symptoms and am testing positive again. Have a sore throat, nasal drip, and a headache. Brand-Paxlovid (start date-01Aug2022, stop date-05Aug2022), indication=Treatment of COVID-19. Known allergies: None, Other medical history: None. Other medication in 2 weeks product=Z-pack (azithromycin) start date=27Jul2022, stop date=31Jul2022.  No follow-up attempts are possible. No further information is expected.
Ringing in left ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in left ear) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 015A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (ANA abnormal no reason found) since 30-Sep-2019 and Acid reflux (oesophageal) since 2020. Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), ALPHA LIPOIC ACID, VITAMIN B COMPLEX, MAGNESIUM and L-ASCORBIC ACID for an unknown indication.    On 26-Feb-2021 at 12:40 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced TINNITUS (Ringing in left ear). The patient was treated with CURCUMIN for Tinnitus, at a dose of 750 mg; ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, PECTIN, RUTOSIDE (SOLARAY SUPA BIO C) for Tinnitus, at a dose of 250 mg; LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for Tinnitus, at an unspecified dose and frequency; FLUTICASONE for Tinnitus, at an unspecified dose and frequency and AZELASTINE for Tinnitus, at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in left ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Acoustic stimulation tests: abnormal (abnormal) lost hearing (mainly high pitched tones). On 25-Jun-2021, Antibody test: 2.7 (Low) 2.7. On an unknown date, Antinuclear antibody: positive (Positive) Positive.     The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.