chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can't move left arm  and Can't lay on left arm; Pain Left Arm injection site; Fatigue; Fever; Chills; Nausea; Body aches; Headaches; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm), VACCINATION SITE PAIN (Pain Left Arm injection site), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 303807772) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Oct-2022 at 11:30 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm), VACCINATION SITE PAIN (Pain Left Arm injection site), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headaches). On 30-Oct-2022, FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headaches) had resolved. At the time of the report, MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm) outcome was unknown and VACCINATION SITE PAIN (Pain Left Arm injection site) had not resolved.      No concomitant information provided It was reported that, patient called the Nurses hotline and she stated to place heat on it. Patient had been treating the left arm with heat. No treatment information provided.   This case was linked to MOD-2022-669096, MOD-2022-669124 (Patient Link).
has a brown oval spot at the injection site of both arms.  It is not black and blue.; This is a spontaneous report from a contactable consumer or other non hcp (Patients wife).  A 66-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Mar2021 16:30 (Age at vaccination: 66-years-old) as single dose for covid-19 immunization. Vaccination Facility was Hospital. Medical history included leukaemia (Diagnosed about 5 years ago). Concomitant medication included nilotinib hydrochloride (TASIGNA) taken for leukaemia from an unspecified start date and ongoing (Started taking 4-5 years ago). Patient did not receive Additional Vaccines on Same Date of the Pfizer Suspect. Prior vaccinations within 4 weeks was reported as none. It was reported that caller is speaking on behalf of her husband. Her husband received the Pfizer vaccine. On 25Mar2021 patient experienced has a brown oval spot at the injection site of both arms. It is not black and blue. It was reported that a week ago he started rubbing his chest at boobs and went down to his knees. He said it was hurting bad. This has happened several times in the last 2 weeks. caller looked online and saw that this could be side effects. When providing weight caller adds that her husband has lost weight because of pain. They saw the doctor the other day and didn't know what to do. The doctor said he would give him some Tramadol. Her husband said he would get it for her if she had pain because it doesn't do anything for him. Caller thinks he started having this pain about three weeks ago. Adds that her husband has leukaemia. He was diagnosed prior to getting the vaccine. His numbers are going down. He received the second dose on 19Apr2021. It was given in his left arm. Caller does not have the vaccine card to provide NDC, Lot or Expiry. Caller asked if the second dose was scheduled for 26 days later after the first dose. stated that her husbands arm was black and blue and is still there. Then clarified that he has a brown oval spot at the injection site of both arms. It is not black and blue. Adverse event resulted in physician office visit. The outcome for he event was reported as not resolved at the time of this report.   Information about lot/batch has been requested.
Feeling hot; Itchy; Red line; soreness; Redness; A spontaneous report was received from a healthcare consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Itchy/ Pruritus, Redness/ Erythema, Feeling hot, soreness/ Myalgia, Red line/ Erythema.   The patient's medical history was not provided. Concomitant medications Prednisone, Simvastatin, acetylsalicylic acid (baby aspirin), colecalciferol(vitamin D) used for unknown indication were reported.  On 03-FEB-2021, prior to the onset of events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 10M2OA) via Intramuscular route for prophylaxis of COVID-19 infection.  On 03-FEB-2021, the patient experienced the event(s) Redness/ Erythema, soreness/ Myalgia patient started feeling jittery 24 hours later after receiving 1st dose.On 11-FEB-2021, the patient experienced Itchy/ Pruritus, Red line/ Erythema, Feeling  hot.   No treatment information was provided.The patient did not receive any treatment. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient Itchy/ Pruritus, Redness/ Erythema, Feeling hot, soreness/ Myalgia, Red line/ Erythema was unknown.
L entire buttocks warm and red, R buttocks w/ quarter sized firm induration. Cellulitis? Fat necrosis? Granuloma?
HE REPORTED TO ME ADVERSE EVENTS OF REDNESS, SWELLING, TENDERNESS AND WARM TO TOUCH. HE STATED THAT IT WAS AN ALLERGIC REACTION.
Pt. received 3 vaccines in one day. Called back to report (R) arm was very red and painful Kw/ raised skin (L) arm painful to touch and red. Pt. saw doctor 10/29/14, was prescribed steroid for inflammation.
Multiple cold sores; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression and ADHD (attention deficit hyperactivity disorder). Concomitant medications included Amphetamine aspartate, Amphetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL), propranolol (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), butalbital, caffeine, paracetamol (FIORICET) and ethinylestradiol, levonorgestrel (OVRAL-LO), all from unknown date for unspecified indication. The patient previously took oxycodone (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced multiple cold sores. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of multiple cold sores and included treatment with acyclovir (MANUFACTURER UNKNOWN) from unknown date. The clinical outcome of the event multiple cold sores was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax & immed p/vax pt exp a fever of 104 & devel a quarter size lump @ the inj site; 30 to 60 days p/vax pt devel autism;the quarter size lump persisted for approx 6wk;
A patient with no past medical history presenting with Myocarditis following Pfizer-BioNTech COVID-19 vaccination. The patient received Colchicine 0.6 mg daily with subsequent resolution of symptoms.
After the 15 minutes, but within the hour of having the vaccine , I returned to my classroom to give a semester exam. On my way to the room, I stumbled a bit and used the wall to help me balance. When I sat down at my desk, I made sense to me, but not to anyone around me.  I don't remember, but the teacher next door said that I stumbled into her room, crying and babbling, but she had no idea what happened. The front office was called. EMS as well. I was admitted to the hospital  and two days later I woke up there with most of my memory restored. At the time, they tested my heart and my kidneys, but no one would test my brain.   I wasn't until I caught COVID last year and the same thing happened my brain last year that anyone took me seriously about COVID affecting my brain.
Menstrual cycle started 2 weeks early and is extremely heavy.; Menstrual cycle started 2 weeks early and is extremely heavy.; I never experience cramping and have had very intense cramping since the morning after my 2nd dose was administered.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and psoriasis on unknown dates. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. 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: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient's menstrual cycle started 2 weeks early and was extremely heavy. She never experienced cramping and had very intense cramping since 23Apr2021, the morning after her 2nd dose was administered. The events 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events menstrual cycle started 2 weeks early, heavy menstruation and cramping was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 10 days after my vaccine, my temperature went up to 101 degrees overall didn't feel well, I was feeling tired, headaches, and overall unwell. No prescription was given for symptoms and doctors stated that it was most likely not due to COVID. I went to get a COVID test which was negative. After about 2 days post vaccine, my symptoms began to clear up. Symptoms have completely gone away.
gen rash-face, chest, stomach, some on arms & legs @ 22 hrs p/vax; itched; lasted 24 hrs like hives reddened & rasied took nothing; had red lobster combo meal 1 1/2-2 hrs prior to onset;
Received vaccine on 2/1/15 pt returned on 2/10/15 to pharmacy with area from area of immunization to inner arm towards elbow red, hot, swollen advised to PCP.
Shingles rash on the same arm as injection, starting within 1 week of vaccine
Didn't have any reactions.  Should have received the monovalent vaccine not the bivalent since she had not received any covid vaccines in the past.
This spontaneous report as received from a registered nurse refers to a 27 year old female patient. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscular for prophylaxis. Dose and lot number were not provided. On an unknown date the patient received her second dose of GARDASIL. Dose and lot number were not provided. The nurse reported that the patient received her third dose of GARDASIL 12 days after her 27th birthday. Dose and lot number were not provided. No adverse effect was reported. Additional information has been requested.
Patient came in for second Booster shot , over 50,for the Pfizer series and received the monovalent formulation instead of the bivalent formulation that the patient would have preferred and the monovalent was supposed to be discontinued for boosters and bivalent should have been administered.  Patient was educated on the fact that he should have received the bivalent and was ok with receiving the monovalent.  Patient said he will come in after the 2 months and receive the bivalent formulation.
nauseous; tired; arm is extremely red; fever; cold chills; cold; was given the wrong shot; 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), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ERYTHEMA (non-serious), outcome "unknown", described as "arm is extremely red"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "not recovered", described as "cold chills"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "cold"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "was given the wrong shot".  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
one of 2 children who recv dtp/hivtiter devel a macular type rash beginning at one of the inject sites and spreading to rest of body. unclear which vax given at site of origin.
rash flared up, making it worse than before; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection; not sure if she got J&J, but did not say Moderna - it was either Pfizer or J&J COVID Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history included an ongoing rash. Concomitant medications were not reported. The patient was previously on crisaborole (EUCRISA) for an unspecified indication. On an unspecified date, about 10 days after developing a rash, the patient received a COVID vaccine and the rash flared up, making it worse than before. The patient might have applied crisaborole to get it under control, but really flared up when she got the vaccine. She had been on crisaborole before and then ran out of it. The patient has not recovered from the event.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 22-MAY-2007, the patient was inoculated with ZOSTAVAX at a public health clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JAN-2014, the patient was treated at a community health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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.
5/17/2021 Several hours after vaccine, started having unusual muscle twitching throughout my body (arms, legs, abdomen). Resolved by next morning.  5/17/2021 - 5/19/2021 soreness at injection site. No treatment. 5/24/2021 soreness at injection site returned along with slight swelling and redness. Also tenderness in left axilla. No treatment. Resolved. 5/26/2021 - 5/27/2021 Swollen and painful nodes in right axilla. Pain in multiple joints. No treatment. Resolved. 5/24/2021 - 5/26/2021 abdominal pains. No treatment. Resolved.
Body Chills; body aches; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261, expiration date unspecified), via an unspecified route of administration on 16Jan2021 08:30 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19, prior vaccination. The patient was not pregnant. Concomitant medications were not reported. Patient had other medications in two weeks. The patient previously took codeine (reported as codine) and experienced allergies. On an unspecified date, the patient experienced body chills, body aches and nausea. There were no treatment for the events. There were no other vaccine in four weeks and patient was not Covid tested post vaccination. Outcome of events was recovered in Jan2021.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-SEP-2022. Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and reported when he/she got vaccinated his/her arm hut like when he/she was little. Additional Supportive Information: The follow-up would not possible as no contact details were available.
2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Extreme itching on shoulders, upper arm and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EW0167) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRENA. The following information was reported: PRURITUS (non-serious) with onset 01Jun2021, outcome "unknown", described as "Extreme itching on shoulders, upper arm and neck". The event "extreme itching on shoulders, upper arm and neck" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was Morena IUD. Patient had extreme itching on shoulders,upper arm and neck. The itching began on shoulders and upper arms. The itching started to get unbearable 8/6 and at that time called the doctor. They cannot figure out what it was. Patient got covid 28Dec2021 and at that time the itching moved to front and back neck areas. There was no adverse reaction at the time of the vaccine. Patient did not had a rash and all blood levels are good. Patients covid antibody level is 5812.3 AU/ml. Treatment received for the adverse event was with Creams. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
On July 1 2022 I had the Shingrix shot and on July 2, 2022, I had severe, savage anal itching and the next day I had bumps on both buttocks. The savage itching lasted for about 4 days and then subsided. I went to Clinic on Thursday, July 07, 2022 and was examined by a nurse practitioner for intestinal worms and she said that I had none.  My illness was probably a reaction from the Shingrix injection. The NP prescribed a hydrochloride cream for my anal itching that had subsided, but I had a faint itch every now and then.
April 6th, at approximately 10:55am, I received a Moderna Covid-19 vaccination at clinic.  After the vaccination, I felt fine; no side effects for about 5 hours.  At approximately 4:30pm, I got the chills, body, muscles and back aches, fever - 101.2, sore throat, my eye balls hurt and a sore scalp.  All of these effects came one like a wave. My entire body ached and I felt as though I was run over by a steam roller. I took Tylenol, 500mg at 5:30am and the next day, April 7th at 11:30am and still had a fever. My entire body was in  pain and discomfort and I could barely move and was unable to work for 4 days and laid up on the weekend.  To-date, I am still feeling tired, achy and lethargic.
Injection site swelling, full body itching, mild fever, nausea, diarrhea, joints aching bad, dizziness, headache
Fever (101), Chills, Headache, Dizziness, Swollen and painful injection site
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient reports immense redness and itching on bilaterla sites of hands breasts, and genitals, took 1 week to resolve, wrapped hands and used benadryl