chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had arm, legs, hand, thigh and general muscle cramps; Shaking; Stomach aches; MUSCLE CRAMPS; Chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (had arm, legs, hand, thigh and general muscle cramps), TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach aches), MUSCLE SPASMS (MUSCLE CRAMPS) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030N720A and 025J20-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (had arm, legs, hand, thigh and general muscle cramps), TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach aches), MUSCLE SPASMS (MUSCLE CRAMPS), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, MUSCLE SPASMS (had arm, legs, hand, thigh and general muscle cramps) had resolved and TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach aches), MUSCLE SPASMS (MUSCLE CRAMPS), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported
Arms tingling, throat tingling, short of breath, palpitations brain fog ,weakness , chest pain , chest pressure,  anxiety,  still with intermittent numbness, tingling face , weakness.
took second capsule & devel stomach cramps, diarrhea, chills, fever & h/a;  vax was not refrigerated x 4 days;
On 2/10/2023, I began to have symptoms of what I now know was COVID-19. I had a fever, chills, body aches, and slight difficulty breathing. I treated my breathing difficulties with a nebulizer. I took TYLENOL for my fever and body aches. I also had a cough and fatigue, sore throat, and nasal congestion (my most bothersome symptom). On about 2/12/2023, I took a PCR test and got a positive result. I also took a home antigen test on 2/11/2023 and got a positive result. On 2/13/2023, I had a telehealth appointment with a PA. She prescribed me prednisone and nirmatrelvir-ritonavir, plus, she refilled my albuterol inhaler. She advised me to keep an eye on my pulse oximeter, because it was averaging between 93 and 96. If it ever went below 90 and was persistent, I was to contact my doctor's office. I think that the antiviral stopped the symptoms in their tracks; it took a couple of days for the symptoms to subside, but the antiviral helped keep them from worsening. The steroids also helped my breathing, and I was able to overcome my breathing difficulty pretty quickly. I used my nebulizer maybe about two or three times a day for the first three days. After that, I switched to my albuterol inhaler, which I used every four to six hours. I spent much of the time napping, because I was so fatigued. I was out of work until 2/20/2023. I'm doing okay now. This is the third time I have had COVID-19, and I think I recovered more quickly this time than I did the two previous times. After this last bout of COVID-19, though, I began getting headaches one to two times a week. They were sometimes migraines that characterized by sensitivity to light. I have also had occasional lightheadedness. At the time of this writing, I still sometimes experience the headaches and the lightheadedness.
Doing well kp. after given the immunizations pt pass out c/o dizziness, upper chest pain BP 123/83 110 given him cold compress move pt to room #1 wait x 5 min vital signs: BP 116/60 83 after 10 min pt start craying for upper chest pain around shoulders. Also vomiting 2 times. HCP call 911 pt reflused to go to the ER said feeling ok after vomit.
Nausea, vomiting, fever, chills, muscle aches, lethargy, headache
Headache; Eyes ached; Nausea; Faint feeling; This is a spontaneous report received from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERV6208) via an unspecified route of administration on 17Mar2021 at 11:45 (at the age of 68-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma. The patient was allergic to sulfa (sulfonamide allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17Mar2021 at 12:45, the patient experienced headache, eyes ached, nausea, faint feeling. It was reported that, the patient could not sit up because of headache, nausea and feeling faint. Therapeutic measures included unspecified anti-nausea and pain medications. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, eyes ached, nausea, faint feeling were resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Amended Patient data, product data and Medical History data.
The night after my first COVID vaccine, my Poly Myalgia Rheumatica (PMR) flared up.  My joints and muscles hurt so bad I couldn't sleep.  I experienced weakness and pain in my neck, shoulders, arms, back, hips and knees.  Reported to my Rheumatologist and she increased my Prednisone from 1mg to 10mg.  It has not completely eliminated my pain and weakness.
Information has been received from a health professional concerning a 2 week old female with no pertinent medical history who on 09-OCT-2007 was vaccinated intramuscularly into the left leg with a first dose of hepatitis B virus vaccine rHBsAg 9yeast) (+) Hib conj vaccine (OMPC) (Lot #656520/0435U). Concomitant suspect vaccination on the same day included ROTATEQ. Other concomitant vaccination on the same day included PREVNAR and PEDIARIX. On 09-OCT-2007 the patient developed an increased temperature of 102.5. A urine analysis, urine and blood culture and complete blood cell counts were performed, results not reported. Subsequently, the patient recovered. No further information is available.
Patient reports that since yesterday, she has had redness of the injection site and pain.  States that she did not have this reaction with the first dose.  Denies chest pain, shortness of breath, and worsening/spreading of the redness.  Has not done anything for it.  Advised her to mark the borders of the redness with a pen and to monitor if the redness spreads.  Also advised her to apply a cold compress to the area and to take ibuprofen/tylenol for the pain.  Advised her to follow-up with urgent care/ER if symptoms worsen or do not improve in the next few days.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Apr-2021. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided          No concomitant medication was reported. No treatment medication was reported.
Information has been received from a physician concerning a 4 year old female with asthma and unspecified allergies who on approximately 03-FEB-2006 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. On approximately 03-FEB-2006, the patient had an anaphylactic reaction to the vaccination. Her symptoms included difficulty breathing. Epinephrine was administered and her symptoms improved. She recovered on an unspecified date. No diagnostic laboratory tests were performed. A product quality complaint was not involved. It was noted that the patient had no symptoms with her first vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Anaphylactic reaction was considered to be an other important medical event (OMIC), immediately life threatening, and disabling by the reporter. Additional information has been requested.
Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood pressure was 198/91. Per clinical nursing director, EMS called. EMS checked vitals again and blood pressure was 130/82. At that time EMS and patient decided that patient did not need to be transported to hospital at this time. Patient left with husband. At time of departure patient was oriented and reported feeling well.
PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC.
Patient experienced lightheaded/dizziness/feeling faint immediately after receiving the vaccination.  Patient was allowed to lay down and feet elevated.  Symptoms resolved after approx 8 minutes.  She was monitored for an addition 15-20 minutes and released without issue.
Pain manifested in the right arm; Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain; Pain spread to the other side of the body; Pain; Osteoarthritis; Loss of memory; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, CLONAZEPAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced AMNESIA (Loss of memory). On 17-Jul-2021, the patient experienced OSTEOARTHRITIS (Osteoarthritis) (seriousness criterion disability) and PAIN (Pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain manifested in the right arm), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body). At the time of the report, OSTEOARTHRITIS (Osteoarthritis), AMNESIA (Loss of memory), PAIN IN EXTREMITY (Pain manifested in the right arm), PAIN (Pain), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine)( Intramuscular), the reporter did not provide any causality assessments.   Laboratory investigations performed included blood test, MRI (Magnetic resonance imaging), urine test and X-Ray test all performed on an unknown date whose results are not provided.  Additional information reported included that the patient visited emergency room on 17 Jul 2021. The patient also reported that pain started to manifest the right arm and she had to keep it in a certain position for it to subside.  Company Comment  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. Very limited information regarding this events has been provided at this time. No further information is expected at this time   This case was linked to MOD-2021-265771 (Patient Link).; 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. Very limited information regarding this events has been provided at this time. No further information is expected at this time
pt had rash all over back, rash, and itchiness. pt took benadryl and used cortisone cream. per pt symptoms came and went over the past 20 days.
No additional adverse events reported; one patient received V ARIVAX reconstituted with sterile water for injection; This spontaneous non-valid report as received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions,  pertinent medical history, drug reactions and allergies and concomitant medications were unknown.  On 08-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), reconstituted with sterile water for injection. No additional adverse events were reported.
sore throat, runny nose intermittent chills & aching 3-5 days x 3 episodes this winter;
Fainted after receiving flu & HPV #1. Felt foggy and had some odd behavior and ? mental status changes. Being worked up by neurologist.
Reported paresthesia on the left side of her face and swelling of the lower part of her mouth an hour after administration of the Moderna COVID-19 vaccine.  These symptoms resolved by this morning.  She was observed for 15 minutes (as directed) following the vaccine and symptoms were not observed by clinic staff.  She was advised to contact her personal physician for recommendations.
painful rash on back & arm 3-4 area of redness;also rash on wrist & belt line;will be seen;
crap for a month / had weird symptoms for a month straight; felt better after the second vaccine; weird flush feeling; sore arm; breast pain; tachycardia; lymph node under arm pain; tired; shortness of breath; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm) and DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postpartum disorder.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain). On an unknown date, the patient experienced FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Blood test: normal normal. On 18-May-2021, Body temperature: 100.5 (High) High. On 18-May-2021, Computerised tomogram: normal (normal) with oral contrast. On 18-May-2021, Echocardiogram: normal (normal) soft echo to look for blood clots. On 18-May-2021, Heart rate increased: 120-130 (abnormal) Abnormal. On 18-May-2021, SARS-CoV-2 test negative: negative (Negative) COVID test-negative. On 18-May-2021, White blood cell count: double to normal (abnormal) Double to normal. On an unknown date, Heart rate increased: 138 (abnormal) 130-Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Due for second dose of vaccine on 26 may 2021and rescheduled. Lab data-blood test and chest x-ray were performed Event reported-mother in law also had the same experience No concomitant medications were reported Antibiotics  are used as treatment medications   This case was linked to MOD-2021-213408 (Patient Link).
The patient was 17 years old at the time of administration with parents signature.  Patients are not eligible till the age of 18
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
Got the shot and got worse shingles/Suspected vaccination failure; worse shingles than before; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and got worse shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: worse shingles than before). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-MAR-2023 The case was received from the patient via interactive digital media. The patient got the vaccine shot and got worse shingles than before. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a physician concerning a 12 month old Caucasian female pt with no allergies and no past medical history who on 10/21/03 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (Lot # 644249/1146M).  Concomitant vaccination on 10/21/03 included a first dose in the right thigh of MMRII (Lot # 639512/0471N) and a fourth dose in the left thigh of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (Lot # 646074/0369N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. Ten days post vaccination on 10/31/03, the pt developed a fine, raised, red, macular rash, mostly on the abdomen and some on the legs, arms and neck with a red nodule at one injection site on the left thigh. That day, the pt returned to the medical office for a doctor visit. The pt was afebrile. The reporter noted that the adverse experience was "most likely with varicella virus vaccine live". Lab tests were not performed. Subsequently, the pt recovered. Additional information is not expected.
Pain and muscle ache runs down to my elbow.  Wasn't concerned until 3 days later and it still aches like a toothache and the aching runs down to my hand.
tiredness; arthritis flare up; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included arthritis.   On 10-SEP-2023, the patient received Arexvy (left arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: tiredness) and flare up of arthritis (Verbatim: arthritis flare up).  In SEP-2023, the outcome of the tiredness and flare up of arthritis were resolved (duration 5 days).   It was unknown if the reporter considered the tiredness and flare up of arthritis to be related to Arexvy.     It was unknown if the company considered the tiredness and flare up of arthritis to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter was the patient who received Arexvy stated that after he got his dose, he was very tired for the entire week. He also stated that his arthritis flared up on his hands and wrists. The patient had history of arthritis in hands and wrists, but it got worse after receiving Arexvy. The symptoms of tiredness and arthritis flare up lasted about 5 days. The reporter did not consent to follow up.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for  acute hypoxemic respiratory secondary to COVID-19 pneumonia. Received remdesivir, steroids, antibiotics, supplemental oxygen, and anticoagulation. Discharged to home medically stable.
Paratrex to kill of parasites; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 12Jan2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included bismuth subsalicylate, calcium carbonate (PEPTO BISMOL). The patient reported that she and her husband got the vaccination yesterday (12Jan2021) and she was taking Paratrex to kill of parasites. She was also taking Pepto Bismol. The patient inquired if this will interfere with the vaccine. The outcome of the event was unknown.  The following information on the batch/lot number has been requested
This case was reported by a consumer (the subject) and described the occurrence of sore throat in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced sore throat and malaise. At the time of reporting the outcome of the events was unspecified. The consumer reported that both she and her mother received FLULAVAL on the same day and experienced the same symptoms. The consumer had asked for information regarding FLULAVAL in people with auto-immune disease. She did not provide any further information. See case ID A0952199A for details of the other case.
Redness, swelling and itching at injection site Dx of cellulitis Tx with BACTRIM DS 1 tab by mouth 2 x daily for 10 days.