chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling very crummy; dizzy; weak, very miserable; bit constipated; broken up aches and pains; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated) and PAIN (broken up aches and pains) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer double vaccine from 01-Apr-2021 to 26-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer double vaccine.    On 02-Dec-2021 at 1:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated), PAIN (broken up aches and pains) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 03-Dec-2021 at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 03-Dec-2021 at an unspecified dose and frequency. At the time of the report, MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated) and PAIN (broken up aches and pains) outcome was unknown and HEADACHE (very bad headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient reported a very rough night. The headache had subsided a bit, but he was up most of the night.
This spontaneous report as received from a pharmacist refers to a 62 years old female patient, with drug reaction/allergy to sulfa and who is prone to skin cancer, and sees a dermatologist every 6 moths. The patient was vaccinated with lot # 0366AE (exp date 23-MAR-2013), 0.65 ml ZOSTAVAX on 14-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. ON 24-AUG-2012 (approximately 10 days post vaccination) the patient developed itchy blisters on the right arm. The patient was treated with Calamine Lotion and Cortisone. Three weeks after getting vaccinated with ZOSTAVAX the patient got vaccinated with an unspecified flu vaccine, it was unknown in which arm. The outcome of itchy blisters on the right arm was reported as not recovered/not resolved. The relatedness for itchy blisters on the right arm was not reported for ZOSTAVAX. Additional information is not expected.
itchy throat after 10 minutes of injection.  Patient was given 2 tablets of 25 mg Benadryl. After 30 minutes after administration, symptoms resolved.
LIKE A FLU; This spontaneous report received from a patient via a company representative 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: unknown) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced like a flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of like a flu was not reported. This report was non-serious.
After more than two weeks, I still have a large, swollen red arm at the site of the injection, which has been painful and now itches terribly. I also have swollen glands in my neck, on the left side.  Reading on the internet indicates This is a rare reaction, ?covid arm? and that a doctor?s intervention with antibodies or steroids are not especially helpful and that the issue is eventually resolved.
Severe upper arm pain, felt like hit funny bone after reaching around and hugging another individual. Severe pain upper arm with decreased ability to move freely, pain, weakness left arm.
"Whooshing"/rushing sound in my left ear for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 12:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included oxybutynin hydrochloride (OXYBUTININ ACCORD) from an unknown date for unknown indication and unknown if its ongoing. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 08:00, the patient experienced "whooshing"/rushing sound in her left ear for 2 days. No therapeutic measures were taken as a result of the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event "whooshing"/rushing sound in her left ear for 2 days was recovered on 17Apr2021.   No follow-up attempts are needed. No further information is expected.
Nausea, abdominal pain, vomiting for several weeks.  Patient has missed 6 weeks of normal activity d/t this illness.  Patient was hospitalized for 7 days.  Patient is now diagnosed with Gastroparesis.  Thought patient caught a virus but realized after several days that something else was wrong.  Realized after a couple of weeks of patient being ill that the symptoms started the day after the vaccine.
This case was reported by a physician via other manufacturer and described the occurrence of fatigue in a female patient who received BEXSERO. In June 2016, the patient received BEXSERO. In June 2016, less than a month after receiving BEXSERO, the patient experienced fatigue and heaviness of head. On an unknown date, the outcome of the fatigue and heaviness of head were recovered/resolved. It was unknown if the reporter considered the fatigue and heaviness of head to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that her daughter received and injection of BEXSERO about a month ago and she experienced fatigue and heaviness of head that lasted a few days before resolving. The physician wanted to know if the patient could complete the series of BEXSERO using TRUMENBA. The reporter hung up the phone before she could ask for her address.
tested positive (chills, headache, body ache), paxlovid for 5 days, persistent coughing and brain fog even after 10 days
Pain in arm around 15-20 minutes after first shot, nausea and vomiting setting in within 4 hours of first shot
Only had this vaccine as a second dose. Previous vaccine was at the same time as a DTP (different arms). First vaccine woke up the next morning with a low grade fever and rash. After 2-3 days rash spread to about 5 inches across and very painful to touch and hot. Second dose had a small rash and low grade fever the next morning as well. After less than 48 hours the rash is about 6 inches long and 3 inches wide. Very tender, painful and hot.
Left arm had a big knot. I was weak the entire weekend had no self control. Bad headaches couldn't drive home from work a co worker had to take me home. I also had bad diarrhea and vomiting.
This spontaneous report as received from a registered nurse refers to a 67 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23, dose regiment unspecified (lot # L029306, expiry date 23-JUN-2016). On an unknown date the patient experienced redness and swelling localized at the injection site. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering/resolving. The causality assessment was not provided. This is one of the several reports from the same reporter. Additional information has been requested.
Afib symptoms within an 1.5 hours after vaccine injection.   I haven't had afib symtpoms in a very long time and experienced them after the vaccination.  Symptoms lasted 7 hours and went away on their own.
Extreme arm soreness and redness extending through the entire arm up to the shoulder beginning the day after immunizations. . Treated with ibuprofen and ice. Consulted primary physician.  Improvement noted on day 3.
Fever, chills, and fatigue starting around 7PM the following day (4/2/2021). Rash was noticed later in the evening along upper chest and lowe neck, also along upper left portion of chest. Rash is relatively minor, but red and irritated and itchy.
Developed body aches, headaches which worsened over the course of a week or more progressing to arthralgia and severe fatigue.  Treated with prednisone.  Symptoms have currently resolved after treatment.  Follow up testing planned for July 2021.
In early June it started with sniffles and a cough. I thought it was allergies at first. I took FLONASE but that didn't help much. After my daughter tested positive, I took a home test and negative. Second home test was positive for COVID-19. I was very fatigued and coughed so much my chest was sore. I reached out to my doctor by phone and was prescribed PAXLOVID. After the second day I began to feel better except for the bad taste in my mouth.
Case previously recorded as MA2009-5709. We received the following information from a physician via agency, on 24 NOV 2009. This 6-month-old patient (unknown gender), was vaccinated with S-OIV FLUVIRIN (batch number unknown) intramuscularly on an unknown date. The vaccine was inadvertently administered. Patient information was refused to the reporter. Patient outcome was not applicable, as there was no event. Reference no: NA09-008755.
temperature excursion due to leaving the refrigerator door ajar with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown gender who had temperature excursion due to leaving the refrigerator door ajar with no reported adverse event while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7117BA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7207AA via unknown route in unknown administration site.  On an unknown date the patient had temperature excursion due to leaving the refrigerator door ajar with no reported adverse event (intercepted medication error) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion due to leaving the refrigerator door ajar with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion due to leaving the refrigerator door ajar with no reported 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 the 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.
Developed a blister on upper left inner forearm after about 10 hours. It resolved over night. After 24 hours, developed several  small blisters (some that ran into each other) on inside of lower left forearm. They itch and hurt a little. Also have a few blisters on inside of lower right forearm, back of left leg, a couple on chest and trunk.
no adverse event; A child received a dose of VARIVAX and PROQUAD concomitantly; A child received a dose of VARIVAX and PROQUAD concomitantly; A child received a dose of VARIVAX and PROQUAD concomitantly/The child was supposed to only receive PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 06-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T028298, expiration date 16-FEB-2022, 0.5 milliliter once; concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317, expiration date 22-SEP-2022, 0.5 milliliter once, (administration routes were not reported) for prophylaxis; and the patient was supposed to received only measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No adverse events were reported.
muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barely stand; could not eat; fever; lots of sweating; muscle fatigue; hard to breath; body aches all over; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. Medical history included asthma and samters syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and aspirin and experienced allergies. On 12May2021 12:30, the patient experienced muscle soreness which is much less and is gone at the time of the report, patient came down with the flu which began around 11:30 am to 12 pm, 20 hours after receiving the second shot. It began with headache, muscle aches, chills, weakness and fatigue. The patient also began having difficulty thinking straight. The patient is a truck driver and was on the road trying to finish up so he just could go home and call in sick. When the patient got out of the truck, he could barely stand as he was so weak. It was both fatigue but also his body had no energy to give. The patient had a hard time getting energy to finish and get ho//2021nt then got home and felt worse, like a full blown flu, could not eat, fever and lots of sweating yet lots of chills all over, weak, headache was worse, body aches all over, hard to breath from muscle fatigue, woke up soaked in sweat. The patient added that he has not felt this bad in years. The patient did not receive treatment for the events. Event muscle soreness was recovered on unspecified date; all other events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On day 10 post vaccination, patient started to develop hives on hands, elbows, knees and feet.  They have recurred each day since (total of 4 days so far).  Patient has been taking loratadine each day since appearance and using hydrocortisone cream but has not yet sought any medical visit.
Pt arrived to health center Wed 8/24/22, reporting he had dose #2 MonkeyPox vaccine on Mon 8/22/22; Tues 8/23 reports redness, had photo: small lemon size area of pink/red around posterior rt bicep. 8/24 on inspection, noted large, very red area , from lower deltoid to just above elbow, hot to touch. Pt temp 97.8F, no axillary or cervical lymphadenopathy noted; Sent to urgent care. Pt reported back to this RN he was placed on 7 day course of Cephaxalin PO .
Patient developed facial swelling on 8-23-18 and a shingles-like rash on the right ear and extending down the neck and upper arms. Patient describes rash as pink, painful, itchy, and blister-like. No fever or chills reported.
Mother reports "golf ball size" lump in left deltoid area where Hep A #1 was given on 3/11/08-Area is hard and sore to touch, warm and red; swelling began on 3/13/08. No other problems reported.
Information has been received from a health professional concerning a 28 year old black female with polycystic ovarian syndrome who on 07-JUL-2005 was vaccinated SC with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck) (lot # 648297/02178R). Concomitant therapy included a first (lot ABBVB074AA) and second (lot AHBVB074BA) dos IM of hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B) on 09-JUN-2005 and 07-JUL-2005 respectively. There was no illness at the time of vaccination. "Two weeks later", on approximately 21-JUL-2005, the patient developed a varicella like rash. All symptoms have since resolved and the patient is recovered. Unspecified medical attention was sought. Follow-up information indicated that on 23-JUL-2005 the patient had a headache. On 24-JUL-2005 the patient had watery pustules on the back, abdomen and chest that were itching constantly. The patient had a doctor visit and recovered on 01-AUG-2005. Additional information is not expected.
got up of my bed and experienced dizziness; dizziness; fatigue / tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue / tired"; DIZZINESS POSTURAL (non-serious) with onset 21Mar2021, outcome "not recovered", described as "got up of my bed and experienced dizziness"; DIZZINESS (non-serious) with onset 21Mar2021, outcome "not recovered", described as "dizziness".  Additional information: The patient experienced fatigue and it was not a big deal since it went away. This past Sunday (2 weeks later), the patient got up of his bed and experienced dizziness. It was reported that the events (got up of my bed and experienced dizziness; and dizziness) was continuing until today (day of report) though it was not debilitating but it comes and it goes. The patient was wondering it was just a side effects or something else was going on because the patient was tired again. The patient read on the internet that other people experienced dizziness and was concern regarding the second shot that was supposed to get next week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon arrival for second dose, pt stated that he's noticed some changes in his ears and hearing.  He stated that a "high pitched hissing sound" comes and goes.  It is predominately in his left ear, his first injection was given in his left arm, but occasionally will get the sensation in his right ear too.  The frequency that he experiences it hasn't changed in the 4 weeks since the first dose.  He's concerned that the second will make it worse.
Pain, inflammation and redness beneath injection site beginning 1 1/2 inches beneath injection site. Each day lowering to elbow. Pain (severe) (and extreme chills first night and 5 days after). (Pain and inflammation).
Developed hives on arms, legs, and feet within 24 hours. Was able to suppress hives for the first week and a half with Benadryl. Switched to Zyrtec and Pepcid with some break through hives. It has been 7 weeks since the vaccine and hives continue. Sometimes they will be mild or completely suppressed by the medicine. Other weeks there will be bad outbreaks despite continued medication (40 mg Zyrtec, 40 mg Pepcid as prescribed by the doctor and occasionally an additional Benadryl). This includes hives covering feet, legs, butt, back, chest, arms, and hands. Sometimes the hives are small and distinct and other times they merge together to large red swollen areas. Hives are red and swollen often surrounded by a thin white area. Sometimes they are not at all itchy and other times they are highly itchy.
Dizziness at night.  When getting out of bed felt like I was drunk.  Lasted one day and then 4 days later the same thing. Then on the 5th day the same thing.  Seems better the next day.
tested positive for Covid-19; Lack of drug effect; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021. The most recent information was received on 16-Apr-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by an occupational therapist and describes the occurrence of COVID-19 (tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced COVID-19 (tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). On 04-Apr-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 04-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not provided by the reporter.  Treatment information was unknown.  This is a lack of efficacy of the vaccine. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Upon internal review on 22-Jul-2021, an event (lack of drug effect) was added, event was recoded and onset date corrected. MAH causality for COVID-19 made not applicable after event recoding.; Sender's Comments: This is a lack of efficacy of the vaccine. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable.