chrisvoncsefalvay/vaers-outcomes huggingface dataset:
but would go from hot to cold; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number: EM9810) via an unspecified route of administration on 03Feb2021 (age at vaccination: 71 years) as single dose for COVID-19 immunisation. History of all previous immunization with Pfizer vaccine considered as suspect was reported as None. Additional vaccines administered on the same date was None. Patient did not had received prior vaccinations within 4 weeks. Adverse events following prior vaccinations were None. She said that she had a cortisone shot in her hip before to treat her hip bursitis. It was on 21Dec2020, prior to her vaccination. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number: EL8982) via intramuscular route of administration on 13Jan2021 in left arm (age at vaccination: 71 years) as single dose for COVID-19 immunisation. Concomitant medication was not reported. The patient experienced but would go from hot to cold on an unspecified date. She stated that she never had a fever. It was reported that that when they were going over the side effects for her second vaccination, she said that it was everything she had been experiencing the last 3 weeks since her first injection. She reported that she would be going back to physician on 09Feb2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
pt recvd flu vax & was observed x 30mins then sent home;@ the time of vax pt denied allergies;later that noc felt distressed & went to the ER dx sepsis was made;reporter states pt died that day p/being seen in ER;
On 3/3/00, the pt experienced a temperature of 101.5. On 3/6/00, the pt developed a few lesions on his arms and back.
Fever, Chills, Shaking, VOMITING from 6 pm to 3 AM. Chest tightening, Throat closure, Headache, Body Aches, Severe Abdominal cramps, and Pain. Weakness, to the point of needing assistance to walk, arms tingly and numb.
Fever, Left arm paiN + swelling, cellulitis of  left upper extremity
After receiving the vaccine I had flu like symptoms. I had chills, a slight fever, and I felt tired. At the end of December 2021 I developed pain in my lower left abdomen that started on a Saturday afternoon. That continued after I seen the doctor at the first part of the week. After doing a CAT Scan the doctor told me that I need to see a specialist. The doctor also said that he wanted to do a colonoscopy in January 2022 to confirm if I have diverticulitis. When I got the colonoscopy it indicated that I do have diverticulitis. I wasn't prescribed any medications.
swollen lymph node; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and LYMPHADENOPATHY (swollen lymph node) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concurrent medical conditions included Depression.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced MYALGIA (sore arm). On 23-Jun-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, MYALGIA (sore arm) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        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.   Concomitant products included psych meds and anti-depressants (unspecified name). Treatment medication were not provided.
Sleeplessness night; itchy area at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site). At the time of the report, INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact
Hives all over body. Shortness of breath. Chest pain. Gut pain. Diarrhea.
Mother states that patient was losing eye brows and eye lashes starting 2 months after GARDASIL. The eyelashes and eye brows growing back.  Mother states that patient is feeling flushed. But patient denies recovering.
5 days post vaccine patient developed symptoms of cervical transverse myelitis, workup revealed Multiple Sclerosis
Immediately following vax mom states pt had spasm, went pale & c/o stomach ache, became chalk white, blue around lips, always responsive; Did have incontinence of urine; MD notified;
Period came a week early despite being on birth control for the last 16 years and having a consistently regularly timed period
elevated CRP; Pain free in legs; elevated CRP, which she later clarified as C-Reactive Protein, and ESR sedimentation rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "multiple bleeding stomach polyps" (unspecified if ongoing), notes: multiple bleeding stomach polyps.; "Erythema Nodosum" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: She continues to experience arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, she maybe had chills when she woke up in the night and just put an extra blanket and went back to sleep and had no ill effect), administration date: Jan2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "Chills"; Bnt162b2 (DOSE 2, The CRP has been going up back in Jun2021), administration date: Feb2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "CRP has been going up". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Pain free in legs"; C-REACTIVE PROTEIN INCREASED (non-serious) with onset 29Dec2021, outcome "unknown", described as "elevated CRP"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "elevated CRP, which she later clarified as C-Reactive Protein, and ESR sedimentation rate". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Same eye pain happened again but this time much more pronounced; Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Same eye pain happened again but this time much more pronounced) and VITREOUS FLOATERS (Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Same eye pain happened again but this time much more pronounced) and VITREOUS FLOATERS (Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read). At the time of the report, EYE PAIN (Same eye pain happened again but this time much more pronounced) and VITREOUS FLOATERS (Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read) was resolving.            No concomitant medication information was provided.  No treatment medication were provided.  It was reported that patient had trouble reading for three months as the floaters would settle in front of letters as patient was trying to read.   This case was linked to MOD-2021-434452.
Vaccine was administered 8/24. Two hours later, rash appeared and continued on for 2 days. Rash started from neck to face then spread all the way down to her feet (bottom and top of). Rash appeared to have hive-like appearance, claimed it was red and itchy all over her body. Systemic rash all over her body was still there after2 weeks. Patient also complained of feeling light-headed and having motion sickness along with a headache. Patient went to Urgent Care 2 weeks after her dose. Treatments from urgent care (shampoo, anti-itch topical) had no success. Treatments from home (tylenol, ibuprofe, benadryl, and claritin) did not help and showed no signs of improvement. Patient and pharmacist concerned about potential side-effects from second dose. Her body, 3 weeks after, is still itchy all over body.
Patient called complaining of swelling in her face and a weird pins and needles feeling in her mouth.  Having some difficulty breathing.  Sent patient directly to the ER.
Patient was informed that iIaccidentally administered the younger booster dose and provider was also aware of what happened. Patient left the clinic fine with no symptoms of any side effects. Also called patient to follow-up after three days of the incident and she stated that she was doing okay and feel normal,
Right shoulder pain with limited movement since her COVID vaccine 3 weeks ago. MRI - revealed a tendon tear -degenerative arthrosis- issues with rotator cuff Patient also has tingling in her fingers. Suspect SIRVA (Shoulder Injury received from vaccine administration) as an issue to her already present shoulder issues. Plays tennis frequently Spoke with patient and she is doing fine other than pain from the site
pain on her left arm; 8 inches swelling on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her left arm) and PERIPHERAL SWELLING (8 inches swelling on her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on her left arm) and PERIPHERAL SWELLING (8 inches swelling on her left arm). The patient was treated with IBUPROFEN for Pain in extremity and Peripheral swelling, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on her left arm) and PERIPHERAL SWELLING (8 inches swelling on her left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
After the third dose (booster COVID-19) the area where it was applied hurts constantly and I cannot lift my left arm without pain in the area and my neck in the left area is hard and like inflamed. I have taken muscle relaxants, it relieves the area, but when the effects wears off, the pain returns.
Patient called hospital call center. Pt stated that pt got covid vaccine Pfizer 12/20/2021 and pt got ili symptoms: cough, runny nose, nasal congestion, fatigue,sore throat, muscle aches the day after covid vaccine. Pt is taking OTC medication Theraflu now for the symptoms. Proceed with covid 19 vaccine side effects questionnaire. Noted pt has no emergency s/sx at this time. Noted pt has hx of hypothyroidism(graves dx) and pt is taking levothyroxine currently. Pt scheduled for covid test at 10:30am 12/23/2021. Pt is educated for covid vaccine side effects. Pt scheduled telephone appt with medical facility for consultations 12/24/21 Recommended pt to call 911 or go to ED if pt showed emergency s/sx. Pt agreed and verbalized understanding.
No additional adverse effect reported; an unspecified number of unspecified patients were administered a dose of improperly stored ROTATEQ; This non-valid, spontaneous report was received from a nurse and referring to an unspecified number of unspecified patients of unknown age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-MAR-2020 (reported as on or after 11-MAR-2020 ), the patients were administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S014947, expiration date: 10-DEC-2020, orally, (dose and frequency were not provided) for prophylaxis (PT: product storage error).   Administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced the temperature excursion above 9 degrees Celsius (C) (11C) for 30 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse effect reported.  The case is non-valid due to lack of the patients' identifiers.
received INJECTION ON 10/08/2019. On 10/14/2019 I woke up early, very dizzy and a little nauseated, headache in back of my head. I felt not well all week, foggy head and occipital headache. On 10/18/2019 I had my blood pressure checked and it was 220/140. My blood pressures has always been very well controlled  with Lorsartan. I contacted my PCP, who suggested that I has a systemic reaction to the flu shot and that I should double up on my medication. However, the next day my pressure was still very elevated, I went to my local emergency room. I was given IV Labatelol and sent home. On 10/21/2019 my pressure had not gotten any lower, so I called my PCP, he advised me to go back to the emergency room. I was again given IV Labatelol and IV Hydralazine and kept overnight. I was start on Norvasc, in addition to Lorsartan 50mg. Cardiac work-up was negative. CT head was negative. I am now on HCTZ 25mg in addition to those meds to keep me under control. After thinking about this, I recalled that last year approximately 1 week after receiving my flu shot, I was hospitalized with left upper and lower extremity numbness and slightly elevated blood pressure. Stroke and cardiac workup were negative and told I had a TIA, because they couldn't figure out what what was wrong with me.  So weird symptoms, 2 years in a row after a flu shot, I do not think is a coincidence.
This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (sensation in her toes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (sensation in her toes). At the time of the report, HYPOAESTHESIA (sensation in her toes) had not resolved. Concomitant medication not provided, treatment medication not provided
1st dose went alright, just sore muscles and fatigue. A couple weeks after the second dose I temporarily lost my eyesight in my left eye. Then ONE WEEK after the ?booster? the same thing happened?. I temporarily lost the eyesight in my left eye. This reaction was the worse, and I had multiple reactions for a couple of weeks. Been to an Urgent Care, the ER, saw my Primary care physician who referred me to a Neurologist, Cardiologist, Optomologist? cat scans, MRI?s, ultrasounds, and a lot of blood work has provided me with absolutely no suggestions as to the cause of my temporary loss of sight. Should I wait and get a 4th dose?.. just to confirm my beliefs that I had a significant reaction to the Pfizer vaccine?????
Injection site reaction. Patient states arm is tender, warm, and swollen. There is no bruising and it is not red.
I had  an optical migraine that began on Saturday March 20th at 2:30 pm which resulted in nausea and vomiting as well as chills and hot flashes
Fever; Fatigue; Dizzy spells every 15 minutes/dizziness; Chills/severe chills; Aches and pains, entire body is aching every muscle; Headache/severe pounding headache; Nausea; Sweats/really sweaty; Entire body is aching every muscle and bone; Hot flashes; Then getting really cold; Haven't been able to sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold) and INSOMNIA (Haven't been able to sleep) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), CHILLS (Chills/severe chills), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea). On 19-Aug-2021, the patient experienced DIZZINESS (Dizzy spells every 15 minutes/dizziness). On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), DIZZINESS (Dizzy spells every 15 minutes/dizziness), CHILLS (Chills/severe chills), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not provided   This case was linked to MOD-2021-292142 (Patient Link).
second vaccine, first dose two weeks prior; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 7th September 2022, the patient received the 2nd dose of Shingrix. On 7th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: The reporter stated that the patient came in 7th September 2022 and said he was there to receive his second Shingrix vaccine. The vaccine was given and afterwards they discovered that the patient had received the first dose only two weeks prior to date of reporting on 17th August 2022. Contacted the regulatory agency right away after discovering that the vaccine had been given too early. The person she spoke to informed her that the dose was invalid, and they need to give another Shingrix vaccine eight weeks from reporting date. The reported contacted the patient to let them know as well after speaking to the agency. The reporter was reported all errors to team as well. The reporter was consented to follow-up. Additional Supportive Information:  The patient received 2nd dose on 7th September 2022, 3 weeks after receiving 1st dose, which led to shortening of the recommended interval between vaccine doses. Note: As per reported information patient received 2nd dose 2 weeks after receiving 1st dose, but as per reported information interval between precise date of 2nd and 1st dose was 3 weeks, hence as per confirmation precise date 17th August 2022 was taken as vaccination date of 1st dose.
Information has been received from a registered nurse concerning a 4 month old male with no pertinent medical history or drug allergies, who on 03-JUL-2007 was vaccinated with his first 2.0ml oral dose of Rotateq.  Concomitant vaccinations administered on that day included a dose of ACTHIB, a dose of PREVNAR and a dose of PEDIARIX.  On that same day, the patient developed abdominal pain, fussiness and no bowel movement for 5 days. Medical attention was sought at the next office visit.  No labs or diagnostic studies were performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
hand started swelling up; hand got red/his knuckles turned red and everything else, including his joints; he's had achesand pains; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 20Jan2021 as dose 1, single for covid-19 immunisation and leflunomide via an unspecified route of administration, on an unspecified date, at an unspecified dose and frequency, for an unspecified indication. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient hand started swelling up because of his rheumatoid arthritis. It had been that way for 2-3 weeks and got red and went away. Patient stated that he never had a real flare up of rheumatoid arthritis as far. Patient had aches and pains and stuff like that, knuckles turned red and everything else, including his joints right after the first injection. Patient wanted to know if the medication he is taking did anything to his immune system, he doesn't know if it's affected or not. The patient will consult his Rheumatologist and is going to discuss it with him, whether it's the medication. The outcome of the event hand started swelling was recovered while the outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
pt denies any symptoms and is showing no reaction to being given the pfizer vaccine in place of moderna
My son had a fever of 103.5 and still had a fever hours later. Gave him Tylenol which helped. Has had fussiness and congestion. Called the Doctor.