chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt weak and at times could barely walk; I felt weak and at times could barely walk; After my first vaccination my first period was a week late, but I received bad cramps the whole week; After my first vaccination my first period was a week late, but I received bad cramps the whole week; I felt inflammation in my uterus, chest and all over my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes: I've spent 50-60% of this past year being bed ridden and unable to live my life. It's been awful. The specialist found a fibroid and I had surgery to remove it, but fibroids have nothing to do with my symptoms(which I knew going into it). The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (disability, medically significant), DYSMENORRHOEA (disability, medically significant) all with onset 03May2021 at 12:00, outcome "not recovered" and all described as "After my first vaccination my first period was a week late, but I received bad cramps the whole week"; INFLAMMATION (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", described as "I felt inflammation in my uterus, chest and all over my body"; GAIT DISTURBANCE (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", ASTHENIA (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered" and all described as "I felt weak and at times could barely walk". The events "i felt weak and at times could barely walk", "after my first vaccination my first period was a week late, but i received bad cramps the whole week" and "i felt inflammation in my uterus, chest and all over my body" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (03May2021) looks fine; SARS-CoV-2 test: (05Jan2022) Positive, notes: Other. Therapeutic measures were not taken as a result of gait disturbance, asthenia, menstrual disorder, dysmenorrhoea, inflammation.  No follow-up attempts are needed. No further information is expected.
Pain, stiffness, tingling in hands, wrists, shoulders, ankles, knees, calves
within 1-2 days of vaccine, he developed confusion/dizziness/myalgia/weakness. He also had intractable headache which had been persistent for the past month. Patient underwent outpatient MRI 4/14 and was found to have new subacute right MCA ischemic infarction with hemorrhagic conversion. Patient continues to be apraxic with continued cognitive effects. He has recovered from the transient weakness and dizziness.
Dizziness (intense); Nausea; minimal pain at injection site; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 14:15 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 03Mar2021 15:30, outcome "recovered" (Mar2021), described as "Dizziness (intense)"; NAUSEA (non-serious) with onset 03Mar2021 15:30, outcome "recovered" (Mar2021), described as "Nausea"; VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 15:30, outcome "recovered" (Mar2021), described as "minimal pain at injection site". Therapeutic measures were not taken as a result of dizziness, nausea, vaccination site pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 03Mar2021 at 15:30, the patient experienced dizziness (intense), nausea, and minimal pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vision loss; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. In or around October 2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for  routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), Plaintiff suffered shingles and vision loss. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), Plaintiffs symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of Zostavax, the pt sustained severe and permanent personal injuries. The pt 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 Defendants' conduct, pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was not recovered. The reporter considered the events to be disabling as the pt suffered  serious, progressive, permanent, and incurable injuries.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, vision loss was determined to be medically significant.
6 days after, noticed itching at vaccine site. By the next day, 3 inch wide area was, raised, red, hit to the touch, very itchy and moderately painful. Symptoms continued for 3 days, and then slowly subsided for the next week.
patient first had a metalic taste in mouth  then started with a dry constant cough/  dry cough was persistant/ started to run a fever of 99.2 and started with a runny nose and chills too patient had zyrtec  at home and took 10mg 1 hour later symptoms resolved called patient twice on 1-17-21 and followed up 1-18-21 / patient was back to normal
Tender to touch Injection Site; Very Sore Injection Site; Big Red Circle Injection Site; Itchy Injection Site; Sore Arm Injection Site (A Little); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)), VACCINATION SITE PAIN (Tender to touch Injection Site), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tender to touch Injection Site), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 18-Mar-2021, VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (Tender to touch Injection Site), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Developed headache, fever, earache, vomiting. Diagnosed with right otitis media 24 hours after nasal flumist. Temp in office 101.7 F.
Sore; Body aches; Chills; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Sore), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) 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 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 PAIN (Sore), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event NOS, at a dose of 650 mg, once or twice daily. At the time of the report, PAIN (Sore), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Sore), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) to be possibly related.    No relevant concomitant medications were reported.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R017642, expiration date 20-JUN-2020 (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 6°F to 14°F (7.3 F) during 1 hour and 30 minutes. There was a previous temperature excursion of 6°F to 14°F (10.4 F) for 4 hours. It was reported that digital data logger was involved. The vaccine was reconstituted with properly stored sterile diluent lot # M044950, expiration date 30-MAY-2019. No adverse effect was reported.
Pain on the right side of jaw and teeth; Jaw was locking and couldn't open it; Cannot feel anything on the right; can't bite or chew; Bruise (greenish); This spontaneous case was reported by an other health care professional and describes the occurrence of CONTUSION (Bruise (greenish)), PAIN IN JAW (Pain on the right side of jaw and teeth), JOINT STIFFNESS (Jaw was locking and couldn't open it), SENSORY LOSS (Cannot feel anything on the right) and MASTICATION DISORDER (can't bite or chew) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CONTUSION (Bruise (greenish)). On 14-Jan-2021, the patient experienced PAIN IN JAW (Pain on the right side of jaw and teeth), JOINT STIFFNESS (Jaw was locking and couldn't open it), SENSORY LOSS (Cannot feel anything on the right) and MASTICATION DISORDER (can't bite or chew). On 15-Jan-2021, MASTICATION DISORDER (can't bite or chew) had resolved. At the time of the report, CONTUSION (Bruise (greenish)), JOINT STIFFNESS (Jaw was locking and couldn't open it) and SENSORY LOSS (Cannot feel anything on the right) outcome was unknown and PAIN IN JAW (Pain on the right side of jaw and teeth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment of the events included ibuprofen and hot compress.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Trismus updated to Jaw stiffness, Pain in jaw added as new event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning an 82 year old male patient who on 26-SEP-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 04-FEB-2009, the patient developed shingles after receiving ZOSTAVAX (Merck). On an unspecified date, the patient recovered from shingles. The patient sought medical attention, the physician saw the patient. Additional information has been requested.
New onset of tree nuts allergy 9 days after receiving vaccine.   Tingling of mouth, eyes became red, itchy, and watering, vomited twice, slight swelling of lips.  Symptoms relieved with benadryl.
Pt received 1 dose of Pfizer Covid-19 vaccine. On 12/13/21, pt developed SOB. On 12/15/2021 pt diagnosed with acute COVID-19.
Hard lump under in/under left axillary region, 5 cm diameter, painful, warm and tender on touch. Restricted movement/painful to move arm. Lymph nodes enlarged.
The morning after I received the vaccine, I started having chest pressure and acid reflux. There was a hard pressure in my chest and my heart was beating weird. I started to develop a headache. I had low blood pressure a couple days later. I went to the clinic and they said I may have a blood clot. I also went to Hospital and they took some blood and did an X-ray and they told me I was fine. I was told that it may be anxiety or stress. The chest pain started to go away, but now my teeth are hurting and are sensitive. I feel that the adverse event lasted for three weeks.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-NOV-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster dermatitis. The patient was prescribed erythromycin ointment for management of her painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received first dose of H1N1 on 11/04/2009 and second 12/02/2009.
COVID-19 home test Positive; COVID-19 home test Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "red food eye" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfameth, reaction(s): "known allergies: Sulfameth". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2022, outcome "not recovered" and all described as "COVID-19 home test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Nasal Swab.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events drug ineffective and covid19  cannot be excluded
patient had two witnessed tonic clonic seizures lasting about a minute with the first being on 12/18/2019 and another witnessed one 12/19/2019.
itchiness on the face, the eyebrows, their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin; 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 PRURITUS (itchiness on the face, the eyebrows, their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin) 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 10-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 PRURITUS (itchiness on the face, the eyebrows, their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin). At the time of the report, PRURITUS (itchiness on the face, the eyebrows, their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.   This case was linked to MOD-2021-060434 (E2B Linked Report).; Sender's Comments:  MOD-2021-060434:Valid case.
Just want to sleep; Aching; Upper part of my left arm is pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Just want to sleep), MYALGIA (Aching) and VACCINATION SITE PAIN (Upper part of my left arm is pain) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0736759) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Just want to sleep), MYALGIA (Aching) and VACCINATION SITE PAIN (Upper part of my left arm is pain). At the time of the report, SOMNOLENCE (Just want to sleep), MYALGIA (Aching) and VACCINATION SITE PAIN (Upper part of my left arm is pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient reported that , her doctor suggested to take  650mg over the counter medication(unknown)   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Follow up information was received on 29 Jan 2021; no new information added in the follow up.
Left arm soreness, fatigue, headache, joint and muscle pain, nausea, fever and chills. Treated with ibuprofen.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of several reports from the same reporter. Additional information has been requested.
No symptoms or reactions immediately.  Injection site was very sore the following day. Followed by body aches, chills, headache, muscle and joint pain. Tired.
15 month old female patient was administered expired dose of PENTACEL, no AE; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 month old female patient who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 15-Apr-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ230AAA and expiry date: 04-Apr-2021) (Frequency: Once) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that nurse asking if there is a time frame that they should wait before repeating the PENTACEL dose. Additional Description of event adverse events: Caller a nurse, stated she has questions regarding expired PENTACEL that was administered to a patient. No additional information was provided. Caller requested a call back to her mobile number today. The lot number and expiration date that they previously provided was from the box (PENTACEL). They do not have the patient date of birth with me. They do not have the route and site, concomitant vaccinations. No further information was provided. Note: The expiration date was previously documented in the Expiration Date field as 01Apr2021, but the nurse stated during call that the PENTACEL expired on 04Apr2021. Reporter relationship: health care professional (HCP) Product used: used   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 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.
Swollen eyes noticed on 7/24. Became worse as the day progressed. Took pt to MD on 7/25, had blood work done. Diagnosed as viral infection. Pt went to the shore and on return on 8/2 condition was much worse. Went to clinic on 8/3. Given Prednisone and Zyrtec. Diagnosed as an allergic reaction (Family history of autoimmune disease in the family-nephew (21) has MS, niece (20) arthritis). Still some swelling and swollen lymph nodes.