chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drowsiness; Heavy head; Ear stuffed up; Flu like symptoms; Whole body aches mostly when laying down in bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), HEAD DISCOMFORT (Heavy head), EAR DISCOMFORT (Ear stuffed up), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Whole body aches mostly when laying down in bed) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included COVID-19 in February 2020.   On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 21-Feb-2021, the patient experienced SOMNOLENCE (Drowsiness), HEAD DISCOMFORT (Heavy head), EAR DISCOMFORT (Ear stuffed up), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Whole body aches mostly when laying down in bed). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Drowsiness), HEAD DISCOMFORT (Heavy head), EAR DISCOMFORT (Ear stuffed up) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and MYALGIA (Whole body aches mostly when laying down in bed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. patient still had whole body aches when she laying on bed
patient was sick; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional.  This case involves adult female patient who was sick (illness), while she received vaccine INFLUENZA VACCINE [Flu shot].   It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, she had the flu shot every year and she was sick every year no shot for her husband never had never would.   There were no lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
Patient who was previously administered with an unspecified PNEUMOCOCCAL Vaccine '10 years ago' was administered the PNEUMOV AX 23 Vaccine at '87 years old' on unspecified date; No additional AE; This spontaneous report was received from a healthcare business partner (HBP) on physician behalf.  HBP was reporting on 87-year-old patient of non-informed gender. There was no information about the patients concurrent conditions, drug reactions or allergies and concomitant therapies provided. The patients medical history includes pneumococcal vaccination 10 years ago, exact date was unknown, with unknown pneumococcal vaccine.   On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. According to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prescribing information, the vaccine should be administered as a single dose (product use issue).  No additional adverse events were reported.
Saturday 1/9/2010 at 1130 Am he received the injection, he had dinner at home, did not eat out. The next morning at 0600 he began vomiting, until 1230 pm on 1/10, he also had dry heaves and diarrhea.  He did not initially have a fever but that afternoon he developed a fever, it broke Monday afternoon.  By Tuesday he was up and moving but was achy.  Everyone else in the family remained asymptomatic.  He states he did not need to see a Doctor. Everyone in his family ate the same foods but he was the only one ill.
Was covid positive on 9/4/2020.   Reactions were similar to those  symptoms I had in September    Diarrhea  first night only. Chills ,  severe headache,  night sweats , loss of appetite.    Began  to feel better after 3 days.
pt recv vax 19JAN94 & pt reported sl inc in SGPT & SGOT;enzymes have been elevated since that time;enzymes did not inc p/3rd dose of  vax;
Stated that her knees are killing her. Clarified that her knees are hurting; This is a spontaneous report from a Pfizer-sponsored program XELSOURCE. A contactable consumer (patient) reported for herself that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 26Mar2021 as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ 5mg tablet, Batch/Lot Number: EH1886; Expiration Date: Jun2024), oral from an unspecified date 7 to 8 years ago to 26Mar2021 at 5 mg twice daily for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient previously took adalimumab (HUMIRA injection) for rheumatoid arthritis, started 15 years ago and stopped taking it 7-8 years ago permanently, unknown dosage injection to her arm every two weeks and she did not like the shot that she is a big baby; it quit working because she did not take it like she was supposed to. Patient was off of the tofacitinib citrate since last Friday (26Mar2021) since she got the Pfizer Covid vaccine. Stated that her knees were killing her, she could feel her knees when she bended and it was annoying. Clarified that her knees were hurting. It started Sunday night (28Mar2021) that she realized it. When she got up she could feel it. Stated normally she does not have any problems with her knees. When standing from sitting position that she noticed them. She should have said they were not killing her but that they were noticeable. This has been happening without the medication. Stated that she took the medication Thursday night to take the shot Friday morning. Stated that it was about three days later that they started annoying her. She would start back on it on Friday. The doctor wanted her off of it for seven days. The action taken in response to the event for tofacitinib citrate was post-therapy. Outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Pt.'s Grandmother states that after receiving the 1st dose of Moderna 09/20/2021, started experiencing symptoms 09/23/2021 of dental gums bleeding * oozing. No other symptoms noted. Still continuing to experience symptoms.
The day after my first dose of the covid vaccine I had stomach cramps starting late morning and lasted throughout the day.  I had several BMs as well due to all the cramping. Not diarrhea just BMs. The cramps became worse in the afternoon.
A few days after receiving the flu vaccine, patient bumped his thigh on the edge of a glass table.  It was not sore to touch but ached near the bone.  Dr. said that perhaps it was a 'bone bruise' resulting in a bursitis.  A day later, the pain also involved the hip and got progressively worse.  On 11/6/07 an office visit with Dr.  Perhaps the bone bruise provided a weakened area for the virus to multiply.  Ten days after the flu vaccine was administered, the Zostavax injection was given at the doctor's office.  10/29/07 received flu shot from health dept.  11/6/07 office visit with Dr. because of pain in left hip.  Diagnosis; mild arthritis.  Lipid panel blood test ordered.  Physical therapy ordered.  Rx: ibuprofen 600 mg 3 times daily.  11/9/07 received Zostavax injection at Dr. office.  11/9, 13 and 16/07 physical therapy as ordered by doctor.  Therapist baffled since physical observation is not usual for arthritis.  11/21/07 office visit: pain from left hip moves to include right hip.  No reduction in severity.  Rx: 2 ibuprofen 600 mg and 1 Tylenol 3x's daily.  Dr. ordered blood work that MD (family friend) suggested; sed rate, complete blood count, CPK, rheumatoid arthritis, antinuclear antibody, Lyme titer.  11/21/07 sed rate 99.  11/22/07 (Thanksgiving Day) black stools.  Stopped ibuprofen myself.  Severe pain in upper abdomen/chest area.  Couldn't finish dinner.  Went to bed (head of bed elevated).  Pain continued for several hours.  11/23/07 Office visit with associate MD.  Diagnosis: polymylasia rheumatica.  Stopped ibuprofen and Tylenol.  Prescribed Prednisone 5 mg 3 tablets daily.  Aciphex 1 tablet daily at breakfast.  Ordered blood test.  Called few hours later to say that blood count was up slightly from previous test on 11/6.  Apparently no more bleeding.  11/23/07 bone density X-ray.  11/26/07 Prednisone increased to 10 mg twice daily.  11/27/07 sed rate 56.  Complains of pain in hips and burning in the upper leg; the same sensation experienced with 'shingles'.  12/06/07 sed rate 84.  12/07/07 upper endoscopy (gastroscopy) by Dr. who also ordered blood test and stool OB 3x.  12/21/07 office visit rheumatologist.  12/22/07 sed rate 26.
pt states that immediately after taking the vax she got light headed and her limbs felt very very heavy.  Her BP was up to 192/90.  They had her sit to monitor her BP and she became nauseas.  She went to the ER. They continued to monitor her BP and she was given IV Benadryl.  The heaviness in her limbs lasted many hours.  Once her dizziness, heaviness in limbs, and her BP was 141/67 and still coming down she went home.  Walking to her vehicle she had the dizziness, heaviness and was light headed again.  When she got home she went to bed.  Pt woke up having heart palpations.  No chest pain or SOB.  These palpitations lasted about 15 minutes.  On 3/30/2021 she has some fatigue and a tightness around the top of her head.  Pt has a FU appt w/ PCP on 3/31/2021.
Pain, swelling, bruising, edema arms and breast on left side of body only, rash.
Patient came to pharmacy to get their Second Moderna covid-19 vaccine but was given Pfizer covid-19 vaccine.
Under my right arm pit by my ribs I have broken out in Shingles. It's also on my back and on my chest.; had a high fever, along with chills; had a high fever, along with chills; back pain; congestion; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: Ew0181), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jun2021 at 12:00 (at the age of 35-year-old) as dose 2, single for COVID-19 immunization at Pharmacy/drug store. Medical history included Severe anxiety. Concomitant medication(s) included alprazolam (XANAX). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Ew0217), dose 1 via an unspecified route of administration in Left arm on 29May2021 (at the age of 35-year-old) for COVID-19 immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 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. On 28Jun2021 at 14:00, patient experienced under my right arm pit by my ribs patient have broken out in Shingles. It's also on my back and on my chest. Patient also had a high fever, along with chills, back pain and congestion. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient received Anti viral as a treatment for the adverse events. The outcome of events was not resolved at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Itching throughout the body, fatigue the next day of vaccination, head aches. and right eye a blood vessel rupture with both vaccinations recovered from the fist one and still have the redness in the eye from second doze.
Site was red hot and bumpy for 5 days, right after vaccine. On Saturday 4/17 I began to feel shortness of breath that would not go away as soon as I woke up.  I am still experiencing shortness of breath with palpitations if I am doing something/moving around. I have restlessness and am not able to sleep due to gasping for air. I have had a loss of appetite as well.  I feel extremely week to the point of now passing out.
Patient is diabetic; heart condition; This serious case was reported by a pharmacist via call center representative and described the occurrence of diabetes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diabetes (Verbatim: Patient is diabetic) (serious criteria GSK medically significant) and heart disorder (Verbatim: heart condition). The outcome of the diabetes and heart disorder were unknown.   It was unknown if the reporter considered the diabetes and heart disorder to be related to Shingrix.   It was unknown if the company considered the diabetes and heart disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter wanted to know if patient qualified as an immunocompromised patient in order to decide when to administer the second Shingrix dose.  The patient wanted to receive the second dose earlier than recommended.  The patient was diabetic and had a heart condition.  It was unknown if patient´s condition were before or after Shingrix first dose. The reporter did not consent to follow-up.
Moderate pain around heart that has persisted since the first COVID-19 vaccine shot (4/16/2-21, over 8 months), as well as mild pain in the left arm at the injection site that has persisted over 8 months since the first shot.
severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (severe nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and CLOPIDOGREL for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced NAUSEA (severe nausea). At the time of the report, NAUSEA (severe nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Used ondansetron for the nausea treatment.
full body onset of hives with severe itching in ears, throat.  hives noted to neck, anterior and posterior torso, bilateral lower extremities.  Benadryl 25 mg orally given.  methylprednisone 4 mg given.  Full recovery in 1 hour after medication administration  Parent of the patient is a nurse practitioner who managed care in the home setting
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender who on 31-MAR-2015 was vaccinated with a dose of ROTATEQ (lot # K016313) (expiration date, dose and route not reported) that was 12 hours in temperature excursion. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
2x2 inch red area raised tender. Started 7/21/17 right arm.
Shakes; Side effects coming in Waves; Pain all over the body; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), VACCINATION COMPLICATION (Side effects coming in Waves), PAIN (Pain all over the body) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shakes), VACCINATION COMPLICATION (Side effects coming in Waves), PAIN (Pain all over the body) and NAUSEA (Nausea). At the time of the report, TREMOR (Shakes), VACCINATION COMPLICATION (Side effects coming in Waves), PAIN (Pain all over the body) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: TCR form
Pt vaccinated w/Hepatitis B vax in MAR & MAY90 was found to have false positive Monospot test;
At home became pale, lethargic and lips turned gray to purple. EMTS called to home. Taken to hospital and admitted to Pediatric ICU.
Since 2 days after the first vaccine in Dec 2020 I have experienced migrating discomfort in muscles and joints. I had to take medrol dosepak on 2 separate occasions to allow me to function. The symptoms go away completely with the steroids. Otherwise I take Advil 2 tablets BID (I did TID for a while). I never had to take anything before in my life. I never had these symptoms prior to the vaccines. I took the second dose with persistent symptoms from the first vaccine.
Patient received vaccine on Friday. She stated she had  fever, swelling and redness around the injection site over the weekend. She contacted us Tuesday at which time the injection site reaction was resolving however she had developed itching around injection area and a non itchy rash on her torso and breast on the injection side of her body. Patient stated she has suffered from these symptoms periodically over the last 10 years with no diagnosis from any physician. She stated she had also had shingles many years ago. I counseled patient to take benadryl and famotidine together for allergic response treatment and advised I would call her in a couple days to see how she was feeling.  Followed up with patient on Thursday and rash is gone, arm is not swelled but is still slightly red. Patient stated she had taken the benadryl and pepcid mix twice since talking with me Tuesday.
Patient reported "feel really anxious"  "Feel my heart beating really fast".  Reported hx of anxiety.  Cheerful despite report.  VSS.  Within 20 min after reassurance patient reported feeling better and calmer.  By D/C patient reported he felt "fine".
the patient received a dose of GARDASIL 9 intramuscularly in the unspecified area of buttock; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications were provided. On 15-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) one dose, intramuscularly in the unspecified area of buttock (lot # 1637642, expiration date 28-MAY-2022; exact dose was not reported; captured as vaccine administered at inappropriate site) for prophylaxis. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Severe side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Severe side effects). At the time of the report, ADVERSE EVENT (Severe side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 79.37 (Inconclusive) Her physician sent her for antibody testing after two and a half weeks after her first shot and result was 79.37.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash - Information has been received from a registered nurse concerning a 32 year old female patient who on 11 Jul 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the patient developed a small, diffuse rash on her body including her trunk, face and extremities.  Additional information has been requested
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 23rd March 2018 (see case US2018GSK149542)). On 21st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and shooting pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the pain in arm and shooting pain were unknown. It was unknown if the reporter considered the pain in arm and shooting pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient was experiencing sore arm and shooting pain which was going up and down the left arm. As per pharmacist, the patient followed up with his physician a day before the date of reporting and was started on antibiotics. The patient was also scheduled for magnetic resonance imaging and electrocardiogram. No further details were provided. This case was linked with US2018GSK149542, reported by the same reporter.
Myalgia, low grade fever, headache, exhaustion, swelling heat and redness at vaccination site.  Developed several small papules on left arm around vaccine site, inside upper left arm, and on left leg.  Reaction lasted 2+  days.