chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. reports on this day that he wanted to receive a Pfizer vaccine in addition to his 03/12/2021 J&J vaccine R/T fear of Covid-19 variants and J&J effectiveness.  He did not report the 03/12/2021 J&J vaccine to SLOPHD. Reports he is well and wanted to have the extra Covid vaccine to prevent illness.  Pt. advised to not receive a 2nd dose of Pfizer. Pt. voices understanding.
Redness approx 3 inches in width and half the circumference of upper arm in Left arm near injection site. Numbness and tingling from injection site radiating down left arm to center of palm
A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B and 059H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.   On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not experiencing any symptoms.  Patient was taking different medications.  No treatment information were given.
Little bit of fever; This is a spontaneous report from a contactable consumer (patient's sister-in-law). This consumer reported similar event for herself and 3 patients. This is the fourth of four reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Not reported), via an unspecified route of administration on an unspecified date as unknown dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a little bit of fever after the vaccination, but he was fine after it. The outcome was reported as recovered on an unknown date for the reported event.  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021564473 Same reporter/drug/event, different patient;US-PFIZER INC-2021564496 Same reporter/drug/event, different patient;US-PFIZER INC-2021566846 Same reporter/drug/event, different patient
big red bruise behind legs; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 49 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big red bruise behind legs causing contusion on Sep2021 with outcome of unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Information was received on 14-APR-2017 from a pharmacist regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in April 2014 the patient was vaccinated with a properly stored dose of ZOSTAVAX (dose not specified) (lot #/exp date unknown) reconstituted with sterile diluent (DILUENT MRK) (lot #/exp date unknown). On an unspecified date in January 2017 the patient received a properly stored second dose of ZOSTAVAX (dose not specified) (lot #/exp date unknown) reconstituted with sterile diluent (DILUENT MRK) (lot #/exp date unknown). No side effects reported. No further information was reported.  The action taken is not applicable and outcome is unknown. The pharmacist did not rate the causal relationship. Additional information has been requested.
A 47 year old male was vaccinated at 10:45 on 11/6/01. On 11/13/01 recheck, noted to be c/w primary response. On 11/15/01 recheck because of "increased redness, swelling and tenderness of site that revealed 1.5cm primary response with 3" X 4" surrounding erythema and induration with sharply defined borders. Temperature noted to be 99.1F. Pt empirically begun on cephalexin 500mg BID. Recheck on 11/16/01 revealed a temperature of 97.8F and 1.5cm scab surrounded by 1.25-1.5cm of induration with faint erythematous border. Border was not sharply defined at this point. On 11/19/01 recheck, reveal "trace scattered induration at margin of primary response" with "very faint scattered erythema mostly distal to primary response site". Clinical dx: probable cellulitis, r/o vigorous primary response to vaccine.
Hardness under skin, extremely red & raised 2-3" in diameter, itching.
I told nurse my arm was tingling right through to my fingers and it really didn?t feel right. Nurse informed me to relax there are common symptoms but it will go away. After 15 minutes sitting Dow I went to nurse again and told her the tingling did not go away she restated and told me I was free to go. I returned to work. Tingling continued the entire time there was numbness as well. My chest began to tighten my head hurt and then I started sneezing and rubbing my watery eyes. I told the pharmacist where I worked and was informed these are normal symptoms and they should go away in one day. My sinus began to pain me and constant nasal drip and coughing and sneezing started. I was sent home from work because of this coughing and nasal drainage and muscle tightness and soreness. My temperature was not high. My throat was also sore and felt it was closing up and I had shortness of breath walking up stairs or from parking lot to job (short distance). Thereafter, I was so weak and fatigued and without sleep due to constant coughing nasal drainage  I took Tylenol severe sinus, occilococcinum, Sudafed, Motrin, and nothing seemed to help. I did not take meds all at once I did one drug one day another drug the following day etc. my symptoms grew increasingly worse and nothing helped.  Sunday I went to ER and explained my symptoms and the doctor there told me he Could not tell me what?s wrong or why it was happening and that what he witnessed looked like a anxiety attack. All my muscles spasm and tightened to the point they seized up completely and I was unable to move. It was uncontrollable muscle spasm and they stayed that way for over an hour. I was given versed and my muscles finally began to normalize or relax after 5-7 minutes.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of "data logger". No concomitant medications were reported. No adverse effect was reported. This is one several reports received from the same source. Additional information has been requested.
Adverse reaction; This case was reported by a other health professional and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than 2 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The message received from the commercial team that an adverse event following administration of Flulaval MDV had been reported a subsidiary of reported hospitalizations (including ICU) following the administration of Flulaval MDV to their employees. The reporter did not know how many employees received the vaccine. They have pulled all other MDVs from use. The reporter wanted to make you aware of this situation in case this is not an isolated event. The reporter asked is there a way to monitor this internally. This is 1 of 3 case having same reporter.
I was pregnant in 2019 with my first child, had a healthy pregnancy and a healthy delivery. I am currently pregnant, and at the time of the adverse event I was 27 weeks pregnant. So far my pregnancy has been normal like my first one.   The day after getting the vaccine, I began having intense Braxton Hicks contractions at 5:30. I had been drinking plenty of water that day and was not more active than I normally am.  The pain was in my sides and my lower back; it gradually got worse and felt more intense than the labor pains I had with my first child. The pain stayed with me and did not come and go like it does with normal contractions. The pain was so intense that I did not fall asleep that night until about 2am. I was still experiencing a little bit of pain the next day. On April 3rd, I experienced pain in my side, it was like a bad cramp, for several hours in the afternoon. Today, April 4th, is the first day I feel normal again.
Patient "getting her periods every 8 days" after getting COVID 19 vaccine Patient with 'bloating' with PMS / periods and then 'resurgence of eating disorder' thoughts Prior periods were "kind of irregular."
Three days after the shots were given, patient and I started noticing small bumps appearing on her arms.  A few days later, her entire body was covered, from her neck down to her feet.  Patient complains a lot about the burning, itching and discoloration of her skin.
Patient only received the diluent portion of the Rotarix. They did not have any signs or symptoms due to this.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with first dose of GARDASIL (dosing details not reported), for prophylaxis. Subsequently, on 14-AUG-2017, received a second dose of GARDASIL 9 (interchange of vaccine products, wrong drug administered and inappropriate schedule of drug administration). No adverse symptoms reported and no further information provided
Patient developed sores in his mouth one day after receiving the vaccination and then 2 weeks later he developed more sores in his mouth. He developed hives that cleared overnight after taking BENADRYL 1 week after vaccination. He developed hives over body that cleared again overnight after taking BENADRYL 2 weeks after the vaccination. He developed hives even worse over entire upper body/torso/face on 04/20/2018 and 04/21/2018 to the point he had to be treated in the ER with (DECADRON and ZYRTEC).
Had similar rash and discolored lip problem 8/04. Increased temp for 4 days; irritability for 4 days. Rash on arms, face, trunk, legs and lips with discoloration. Decreased appetite and decreased sleep for 4 days. All problems spontaneously resolved by 5/19/05.
Initial and follow-up information has been received from a physician, concerning his 61 year old, female retired wife with gastrooesophageal reflux disease, hiatal hernia, glycerin allergy, cholesterol high and osteoporosis who on 26-JUN-2008 (also reported as 24-JUN-2008) was vaccinated with the first dose of PNEUMOVAX 23 (lot # 659487/1960U), intramuscularly to the arm. Concomitant vaccinations on 26-JUN-2008 (also reported as 24-JUN-2008) included ZOSTAVAX (lot # reported as 566601). Other concomitant therapy included NEXIUM, ACTONEL, hormone replacement therapy (unspecified), ZETIA and FOSAMAX. Within 8-9 hours of receiving PNEUMOVAX 23 and ZOSTAVAX, the patient developed a high fever ranging from 101-102.2 with rigors, nausea, myalgia, arthralgia (especially back), and profound weakness. She developed an injection reaction in the left arm with pain, swelling, and a raised welt area of 6-7 cm surrounding the injection site. She also complained of left axilla pain. On 26-JUN-2008 the patient became dehydrated and was seen in the emergency room. Her temperature was 96.4, pulse rate was 108, respiratory rate was 16, oxygen saturation was 98% on room air, and blood pressure was 107/57. Laboratory work was obtained and a chest x-ray was performed. The patient had elevated lab studies: white blood cell count: 13.1 x 10^3/uL, c-reactive protein (CRP) was 20, her aspartate aminotransferase (AST) was reported as high at 70 U/L and her amino alanine transferase (ALT) was high at 63 U/L. General chemistry showed a low sodium of 133mmol/L, a low potassium of 3.3 mmol/L, and a high glucose of 224 mg/dl. Her chest x-ray showed no evidence of acute cardiopulmonary abnormality and her urinalysis was reported as normal, with trace occult blood. She was given intravenous (IV) fluids. Normal Saline .9% in the right hand. She refused ZOFRAN. It was also reported that she was treated with aspirin (manufacturer unknown) and phenergan as needed. The patient was discharged home, with a diagnosis of dehydration, myalgia and arthralgia. She was prescribed DARVOCET and a clear liquid diet. The patient was reported as recovered on 28-JUN-2008. Additional information has been requested.
Caller received her 1st dose and in less than a week she was infected with Covid-19; Caller received her 1st dose and in less than a week she was infected with Covid-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her 1st dose and in less than a week she was infected with covid-19 on an unspecified date with outcome of unknown.  The patient was asking if she needed to have the 2nd dose.  Information on the lot/batch number has been requested.
Patient called the pharmacy today 12-22-14 at about 2:50 PM reporting body aches and high temperature 102.3 (last night). Wheezing, tiredness.
History of asthma. Chest and throat tightness, pain in chest, facial redness. Very swollen injection site and shortness of breath.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 21-DEC-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
After my second dose, I have developed allergic reaction to peanuts.  I ate Pad Thai which contained peanuts few days after my second dose and developed itch all over my body.  I take Allegra for seasonal allergies, so I took it and the itch went away.  Today I ate Protein Peanut Butter Dark Chocolate bars and again developed severe itch all over my body.  I have eaten Pad Thai and the cereal bars many times before the vaccine and never had any issue.
Patient reported that he has a lump in his right armpit that started yesterday.  This is the same arm that he received his J&J COVID vaccine on 5/13/2021.  The lump is dime sized, red, appears to be filled with yellow exudate.  Lump appears infected.  Started Doxycycline 100mg PO BID x 5 days and instructed patient to notify medical if it becomes larger, or shows no improvement with the antibiotic.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (dose and frequency were not provided), lot # reported as K022993, expiration date 20-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; began feeling sick again and have been testing positive ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 05Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. There were no concomitant medications, reported as, no other medication received in 2 weeks. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 21Aug2022, outcome "not recovered", described as "began feeling sick again and have been testing positive ever since"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started from 14Aug2022 and stopped on 18Aug2022. Therapeutic measures were not taken as a result of disease recurrence. Clinical course was reported as, the patient took Paxlovid as directed for 5 days and felt much better and tested negative. About 3 days after last dose, on 21Aug2022 she began feeling sick again and have been testing positive ever since. she have been so sick now for over 10 days.
I started with severe stomach digestive issues in March. Very different from anything I've ever experienced before. A lot of pain. I didn't do much with being diagnosed because I was on a trip. When I came back, I was diagnosed with pancreatic cancer in April. Prior to that, I had no problems prior to that event. All my blood tests were normal. I had been in very good health except for the SIBO and IBS which are common. All of a sudden, I was just knocked out by this diagnosis and it came out of nowhere. I had no idea that I had it until then and I feel like it was exacerbated by the vaccine.
fever; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.  The patient was down in bed for 2 days.   This case was linked to MOD-2021-042782 (Patient Link).
This spontaneous report as received from a consumer. The consumer was very vague. It was reported she had shingles before and was vaccinated SC with 0.65 ml ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The patient reported she was having another episode of shingles and wanted to know how to define shingles. She stated she no longer had persistent pain that she had with previous bout of shingles and stated that the HCP would no longer identify her problem as being another round of shingles because of the non-persistent pain. The reporting consumer would at times say that this case was about her and at the other times, she denied having vaccine and was alluding to talking about a friend of hers. The outcome of shingles is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Additional information is not expected.
Aching, HA and temp of 101.8, fatigue beginning night of 1/15.  On 1/16, was fatigued, had swelling of hands and face.  Now resolved.
SLEPT FOR 18 HOURS STRAIGHT; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever, slept for 18 hours straight, and fatigue.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, slept for 18 hours straight, and fatigue. This report was non-serious.
Shortly after vaccination, pt. started to complain about rigging in his ears which lasted approx. 10 min.  He also complained of dizziness.  He was already here for an office visit so the provider when back in to see him after vaccination and follow him the 20 min and then released him.
Day 0: Vaccinated Day 1: Woke up with body pain all over; weakness all over; loss of appetite; some fever; cold, inability to think; some dizziness; took 1 advil in the morning which made me feel a little better but after a few hours symptoms got worse and worse; then felt extreme coldness (wore full thermal underwear, fleece, t-shirt & sweatshirt plus needed 2 thick blankets) along with extreme tiredness (slept for ~16 hours starting mid-afternoon with short periods waking up); Day 2: other symptoms from day 1 went away except still had loss of appetite; but new symptom appeared which was unsettling - experienced sudden, sharp pain all over my brain when sneezing or with quicker head movements, it felt like my brain was going to explode; took 1 advil in late afternoon; Day 3: mild pain with quick head movements, headache at temples but otherwise feel pretty much recovered