chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has not felt good since; rash on wrist/ rash on forearm/ rash on back; headache; nausea; vomiting; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Has not felt good since), RASH (rash on wrist/ rash on forearm/ rash on back), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (codeine), High cholesterol and Contrast media allergy.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MALAISE (Has not felt good since), RASH (rash on wrist/ rash on forearm/ rash on back), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, MALAISE (Has not felt good since), RASH (rash on wrist/ rash on forearm/ rash on back), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medications were reported.  No treatment was provided.   This case was linked to MOD-2021-074965 (Patient Link).
My blood pressure was getting really high, and I've always been on the Mediterranean diet and they couldn't figure out why, so they put me on a medication to lower blood pressure and all it did was make my cheeks swell so they put me on a water pill. They told me to start taking blood pressure daily, and what I didn't realize was that I was supposed to get my pulse too, and my pulse was high and started getting awful in July. I was having an infusion monthly and the infusion nurse said there was something really wrong in October, and that my readings were jumping all over the place. In November, I had an infusion and the nurse said I needed to call my doctor, and so I did, and I finally got an appointment and the Doctor said I needed to go the ER and get admitted. By this time, my atrial fibrillation got bad. I went to the ER and stayed there for almost a day and then went to cardiac floor and they did lots of tests and said I had afib even though I'm not a candidate. It was out of the blue. November 10, 2021, I had the cardioversion and it worked, but then later on it came back and I got another cardioversion on 03/10/22. As it stands, they're not sure why it has happened. I see the Doctor soon (in April) again. I felt better after the 1st and 2nd dose, but not the 3rd.
A dose of Pfizer 5-11 is given to Patient over 12 yo. No adverse effect reported. Patient and parents are aware of the incident happened. No treatment required.
Information has been received from a healthcare worker concerning a female patient who was vaccinated with a dose of GARDASIL (lot# not provided). Subsequently the patient experienced arm discomfort after receiving the vaccination, related to the vaccine feeling cold. Unknown medical attention was sought in the physician's office. The patient's outcome is unknown. No product quality complaint was involved. This is one of two case from the same source (WAES# 0805USA06180). Additional information is not expected.
Pt vaccinated with DTP/OPV then cried 3 hrs after DTP very difficult to console.
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 20-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Vaccine moved from freezer to fridge on 06-May-2022. No adverse events were noted. No treatment information was provided by the reporter.
Mixed Series. Incorrect mRNA COVID-19 vaccine product administered for second dose in 2-dose series
pins and needle on her feet, calves, arms and wrists; rash on arm at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (pins and needle on her feet, calves, arms and wrists) and VACCINATION SITE RASH (rash on arm at the injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on arm at the injection site). On an unknown date, the patient experienced PARAESTHESIA (pins and needle on her feet, calves, arms and wrists). On 28-Jan-2021, VACCINATION SITE RASH (rash on arm at the injection site) had resolved. At the time of the report, PARAESTHESIA (pins and needle on her feet, calves, arms and wrists) 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.   The treatment information was unknown.
A 17 months old male patient received on 30 January 2009 at 15:00 the third dose of ACTHIB (lot# UF578AB, corresponding to lot# B0395-1) and the third dose of IPOL (Sanofi Pasteur lot# reported as B0075). The patient experienced within 24 to 48 hours "high fever" of 103. 4 Fahrenheit degrees (rectal), loss of appetite and crankiness with crying. Fever continued and he saw a physician on 02 February 2009 and was treated with MOTRIN and extra fluids. Outcome was unknown. The patient received on 06 January 2009 a dose of measles vaccine. The patient had slight runny nose at the time of vaccination. The patient had allergy to walnuts. The patient had no siblings. Follow up information received on 01 June 2009 from a consumer. The patient received ACTHIB and IPOL both in the upper arm intramuscularly (Specific arm not specified). ATTENUVAX (manufacturer Merck) in the right upper arm intramuscularly on 05 January 2009. The patient' parent stated that the patient had one time incident with walnuts at 7 months of age, which was previously reported as walnut allergy. A topical dermatitis was suspected when the skin was in contact with residue. The patient was treated with a single dose of BENADRYL and recovered. An allergy to walnuts was never confirmed. The patient was treated with TYLENOL for event of fever. The patient recovered 4-5 days after the event onset.
Developed hypothyroidism.  Then also Developed polymyalgia rheumatica with corresponding extreme muscle pain in shoulder and hip girdle that significantly impaired my normal healthy ability to walk, do yoga, sit comfortably in a chair, put on shoes, sleep, etc.
Patient has a possible local reaction at the injection site. Patient has a red swollwen bump at the injection site on the Right arm.
7AM nausea w/o vomiting; t101.5 felt feverish all day; diarrhea (2 stools) had abd cramps the next day;
ZOSTAVAX vaccine given 8/30/12 patient called and reported arm pain 12/4/12 patient states arm pain has persisted since date patient received vaccine. Informed to follow-up with primary care provider.
I experienced fever, sweating, joint pain, muscle pain, swollen lymph nodes, diarrhea, fatigue, and all symptoms but the sweating and fatigue resolved after 2 months. I saw my old PCP 03/10/2021 after the excessive sweating caused a break out under my breasts and across my torso, which was diagnosed as Hidradenitis suppurativa. The fatigue is still lingering over a year later. There is some concern that I could have Occipital neuralgia, due to burning sensation, eye pain, headaches, and tachycardia, I had telogen effluvium reaction to the vaccine that caused hair loss for me as well. I am also presumed to have Postural tachycardia syndrome.
Patient was given to co vid injection- developed numbness and tingling inside bicep- speech- slurred speech- tongue speech- tongue not swollen- feels like novican. Takes lisinopril, novolog jardiance, lansoprazole, and mirena.
Patient experienced change in taste within a few minutes of receiving the second Moderna COVID-19 Vaccine and afterwards experienced metallic taste.
A FLARE AND RELAPSE ALL THE PROGRESS; SUSPECTED DRUG INTERACTION; This spontaneous report received from a patient by Pfizer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid, and other pre-existing medical conditions included: The patient was fine and was doing very well. The patient had no issues at all and did not relapsed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: tofacitinib citrate ( batch number: EJ9968 expiry: UNKNOWN, form of admin, route of admin were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On NOV-2021, the patient experienced suspected drug interaction. On an unspecified date, the patient experienced a flare and relapse all the progress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected drug interaction and a flare and relapse all the progress was not reported. This report was non-serious.
Pt Received vaccinations and 1 week later noted erythema and lumps at the site then about 1 month after vaccination abcesses with pus drainage was noted at the immunization sites.  No fever noted.  Pt otherwise well.  11/2/07 Received medical records from pcp which are only ER records of 10/18/07 & reveal patient experienced induration & ecchymosis at bilateral thigh vax sites, left greater than right.  D/C home on oral antibiotics & pcp f/u. FINAL DX: Cellulitis of thighs & local immunization reaction.
Raynaud's like symptoms; Numbness of finger tips; paleness of fingertips; flushing; tingling; This is a spontaneous report from a contactable nurse, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via intramuscular route in the left arm on 09Jan2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphocytic colitis. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EK5730) in the left arm on 19Dec2020 at 12:00 (at the age of 48-years-old) as a single dose for Covid-19 immunisation. Past drug history included allergic to TORADOL. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included PRISTIQ and budesonide (MANUFACTURER UNKNOWN) for unknown indications. On 01Feb2021, the patient experienced raynaud's like symptoms, numbness and paleness of fingertips, followed by flushing and tingling. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of the events raynaud's like symptoms, numbness and paleness of fingertips, followed by flushing and tingling was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
acute aches muscles and joints, moderate headache, fever of 100.7 for 3 hours each immunization.  Arm sore for 3 days at injection site.  Took 1000mg Tylenol after fever onset, was helpful but extreme fatigue for approx 24 hours kept me in bed.  After approx 36 hours from injection, 90% of symptoms were gone.  After 48 hours 95% of symptoms were gone.  Final symptom was lingering pain lower back.
the injection site started itching; the injection site started achiness; swelling in arm; 2-3 Inch irritated area; irritated area which was warm to touch; irritated area which was warm to touch and red; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch), ERYTHEMA (irritated area which was warm to touch and red) and VACCINATION SITE PRURITUS (the injection site started itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, BUPRENORPHINE, ESTRADIOL (ESTROGEN), PROGESTERONE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTIC 10 for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MYALGIA (arm was very sore). On 05-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch) and ERYTHEMA (irritated area which was warm to touch and red). On 08-May-2021, the patient experienced VACCINATION SITE PRURITUS (the injection site started itching) and VACCINATION SITE PAIN (the injection site started achiness). The patient was treated with NAPROXEN SODIUM for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch), ERYTHEMA (irritated area which was warm to touch and red), VACCINATION SITE PRURITUS (the injection site started itching), VACCINATION SITE PAIN (the injection site started achiness) and MYALGIA (arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was standing at desk, then fell over without warning, laid with eyes open and unresponsive for five seconds with no jerking movements or eye-rolling and then came to and sat up immediately and asked what happened.  Patient relates no memory of falling over or lying on the ground.  Patient comjplained of feeling light-headed and sweaty.  He was given some fruit juice and observed for 30 minutes without further complaints.  BP 10 minutes later was 100/70 (BP prior to vaccine was 90/60), HR 80.  Patient felt better and was sent home from the office.
I did feel light headed but those were the worst thing; I feel like I have the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 02Apr2021 (Lot number: EP7533) at the age of 39 years 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: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "I did feel light headed but those were the worst thing"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I feel like I have the flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated,  feel like I have the flu and I am surprised how is my fever been. After my first vaccination I felt like I was starting to come done with something the morning after but that was about the extent of it, I did feel light headed but those were the worst thing, the light headed and the next day felt like I was coming down with something but it never got bad. Patient underwent blood test on an unspecified date. I may have some immune condition but is not established yet but I have done blood work and I may have some autoimmune issues. There is evidence on my blood work but it is not diagnosed yet.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, 12 unspecified patients received doses of improperly stored (Oka/Merck) VARIVAX lot # L029469 expiration date: 06-AUG-2017 (dose, route and site of administration were not reported). There were no adverse effects reported. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a 54 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 18-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Facial swelling and redness was given BENADRYL and it resolved. Began the night after it was given (vaccines).
Information has been received from a published article. This literature case initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patient's was 29 years). The patients received RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #14 of 32, a 52 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 52 year old female on an unspecified date was vaccinated with the third dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Five days after vaccination, the patient developed uveitis and also experienced symptoms of paralysis. At the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with the experience of an additional 31 patients while on therapy with RECOMBIVAX (WAES #100USA01716, WAES # 1004USA02327 to WAES # 1004USA02338, WAES # 1004USA02340 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Red indurated area with itching developing in area of injection around 5-6cm in size.
24 hours post injection developed swollen lips and  developed uticaria on face, neck, and arms. These lasted for about 3 days.  Happened after both 1 st  and 2 nd shot
trigger fingers in both of my hands; stiffness both of my hands; arthiritis in my hands and finger; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 14Jun2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: TRIGGER FINGER (non-serious) with onset 2021, outcome "unknown", described as "trigger fingers in both of my hands"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "stiffness both of my hands"; ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "arthiritis in my hands and finger".  Follow-up (04Nov2021):This is a follow-up spontaneous report from a non contactable consumer. This 75-year-old female consumer (patient) reported for herself that after the second shot which was a 14Jun a few weeks later she started getting a trigger fingers in both of her hands and arthritis in her hands and stiffness both of my hands  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.