chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart pain; Shoulder pain; headache; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (heart pain), ARTHRALGIA (Shoulder pain) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Irritable bowel syndrome, Latex allergy, Allergy to metals (nickel) and Drug allergy (bactrim). Concomitant products included SENNOSIDE A+B (CLEARLAX [SENNOSIDE A+B]) for Constipation, ESTRADIOL (ESTRACE) and VITAMIN D NOS for an unknown indication.    On 14-Apr-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (heart pain), ARTHRALGIA (Shoulder pain) and HEADACHE (headache). At the time of the report, CHEST PAIN (heart pain) was resolving, ARTHRALGIA (Shoulder pain) outcome was unknown and HEADACHE (headache) had not resolved.        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.   Patient reported at follow up, has now had an "ekg" and a chest x-ray, no results provided. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and Event outcome updated and patient information updated
I started with numbness in my left side of extremities later throughout the body. Then muscle pain, heaviness in my extremities, stiffness in the muscle of my face. Difficulty getting up to stand  and walk. These symptoms progressed over several weeks. These same symptoms led me to develop anxiety. I went to the hospital where I was hospitalized and they carried out several studies, x-ray, MRI, laboratories and they did not find the reason for what was  happening to me . I was referred to a neurologist where I am at the moment.
I had a bad headache, felt like throwing up so I went to bed. and then I had chills overnight in addition to the other 2 symptoms. My arm is tender at injection site but not bad.
Adverse reaction occurred 2 weeks after MMR vaccine was administered. Symptoms included, bilateral conjunctivitis, extensive rash, severe fever (105 degrees), and severe headache for a duration of 5-7 days. All symptoms resolved within 10 days after onset.
Patient experienced redness and hives to face, bilateral arms, and chest, scratchy throat and swelling to throat prior to Emergency Department arrival.  On assessment the provider noted redness and hives to face, chest, lungs clear, airway clear, no sob, +slight chest pain.  The patient was given 125mg solumedrol and 50mg bendadryl IV by EMS enroute to the Emergency Department.  The patient was treated with steroids, epinephrine, and antihistamines in the ED.
SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse on 25-Oct-2017. This case involves a (age and gender not reported), who was vaccinated with FLUZONE QIV (batch number: UT5954LA, expiry date, dose, dose in series not reported) and PNEUMOVAX (batch number, expiry date, dose, route was not reported) in arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch, elbow to shoulder area was swollen. Lab test was not reported. Patient was prescribed with antibiotics. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: cellulitis. Documents held by sender: none. Sender's Comments: Cellulitis with swelling from shoulder to elbow and feeling hot are unlisted with FLUZONE QIV and PNEUMOVAX. Time to onset is compatible with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Pt arrived to the hospital with shortness of breath. He reports that he has had no energy. He has had a history of flash pulmonary edema, and was found to be COVID positive. Pt was admitted for acute hypoxic respiratory failure and sepsis and COVID pneumonia.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 19-OCT-2018 the patient was vaccinated with PROQUAD lot # R013125, 2 dosage form. On 19-OCT-2018, 1 day after onset of therapy the patient experienced accidental overdose and vaccination error. On an unknown date the patient experienced no adverse event. The outcome of accidental overdose, no adverse event and vaccination error is unknown.
My arm was sore and I  was very tired.  I notice started yesterday evening, I woke up from sleeping. My heart was pounding very hard and happen again today. It to a while for it to beat normal, after being uncomfortable for 5 minute it went back to normal.   Also tested positive for COVID-19 which I tested negative 5 times before vaccine. My vision became more blurry. I already was near sited but after the shot It felt like it did when I first was told about my vision.
more pronounced foot drop/limp, increased frequency and intensity of fatigue and weakness in limbs, tremors in arms and hands, extreme sensitivity to heat.
same day: headache, nausea, body aches (later that night) next day: headache, stomach ache, body aches, slight fever
Developed blue/cold b/l lower extremities almost 24 hours after vaccines. More prominent on (L) side (LE). Acting normally, eating and drinking and wetting diapers. No redness at injection site.
Sudden onset symptoms: non stop cough with wheezing, oxygen level dropped to 92% (room air), rash on face, chest area and bilateral arms. Tx: 5mg PRELONE PO, 20mg BENADRYL (L) arm IM, 5mL albuterol sulfate via nebulizer.
Second Moderna dose received to soon. Spoke with patient and he reports mild fatigue and chills evening of receiving vaccine and improved by the next day
Narrative: Completed Pfizer vaccination series in January 2021. Had 3 days of coughing before presenting to the hospital and tested positive 8/19/21. Treated for hypoxic pneumonia with dexamethasone and as needed oxygen. Discharged on 8/23/21/ Re-admitted for fever, coughing, and shortness of breath 8/24/21 and diagnosed with super-imposed bacterial pneumonia. Continued dexamethasone treatment and added enoxaparin. Discharged home 8/27/21.
Got 1st Shingrex then developed auto immune syndrome (PMR); This case was reported by a consumer via interactive digital media and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   The reporter considered the polymyalgia rheumatica to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comments: The case was reported via interactive digital media. The patient got his or her first Shingrix shot then developed an auto immune syndrome called PMR. The patient was on steroids for almost four years. Getting shingles would had been better and ended in months not years. The patient will probably have PMR flares for years to come, especially after receiving other vaccines. The patient said investigate your family health history before getting this vaccine. The patient said a text was received from a friend as she had shingles.  She then described how painful and uncomfortable her experience was.  The patient had read articles about shingles, learned about prevention and talked with his/her doctor.  After listening to his/her friend describe what she was going through, the patient took action. Learn more about the risk of shingles and take steps to prevent the painful, blistering skin rash. The reporter did not consent to follow. Additional supportive information: The onset date of event was given as 18th November 2022 however as per narrative it seems that the patient was taking steroids since 4 years for PMR. Hence onset date and end date was not captured for the event.
Sore Left Arm; A spontaneous report was received from consumer on 07Mar2021, concerning a  81-years- old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced   Sore left arm.  The patient's medical history was not provided by the reporter. Concomitant medications were not reported    80 year old male patient whom reported his wife's reaction and inadvertently he reported, on 06Mar2021 , prior to the onset of the events, he received their second of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 06Mar2021, he experienced sore left arm. He had no other side effects. Laboratory details were not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, sore left arm was resolved on 07Mar2021.
Narrative:  patient states: The reaction from the Covid-19 shot burnt my face severely. I need to see a dermatologist as soon as possible to address this matter on my face He complains of he had an allergic reaction from the first Corona Virus Vaccine. He reports it's started as a small area that mets to the rest of his body. He would like to know what happened in the inside of his body. He states he went to the ER and was given an itch cream. He states for the last 2-3 weeks
Day 1& 2 after - bad migraine-like headache Day 2-today horrible hot radiating rash
After getting the vaccine she immediately felt a stabbing pain in left shoulder. The arm was very painful and swollen and warm to the touch and she had a decrease in range of motion for the next several days. Although the swelling and redness subsided the pain has persisted to this date. On February 23, 2023 she went to orthopedic NP and she diagnosed her with tendonitis. Physical therapy was ordered to help improve movement. She will go twice a week to physical therapy.
Patient had alarms last night (02/19/2015), mother tried to stimulate and called 911. EMT's arrived and began transport to hospital, but patient arrested and was not able to be resuscitated in ED.
Not sure if this is related to covid     developed shingles outbreak  on April 7, 2021- requiring physician visit and medication  I was  vaccinated for shingles in 2013
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 07-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error: therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved.
This spontaneous report as received from a Nurse practitioner (also reported degree Pharmacist doctor) who refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL lot # J004197 expiration date 27-NOV-2015 (route and dose were not reported)that was stored as low 29F for about 6 days. No adverse effect reported. Additional information has been requested.
sudden onset of rash in face & extremities in PM of 9JAN97, per mom, visited a med ctr last PM & was told areas were insect bites;exam here on 10JAN97 revealed multiple round areas of erythema w/blanching center;dx erythema mult;
Pt recvd vax 31JUL91 pt had only low grade temp 1st 24-48 hrs & then had sx on 3SEP or 4SEP @ 10AM w/resp arrest & CPR; classic postictal sx; hospitalized 3 days;
This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by reporter.     On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant) and ROAD TRAFFIC ACCIDENT (car accident). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out) and ROAD TRAFFIC ACCIDENT (car accident) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She is taking concomitant medication not otherwise specified.  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.; 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.
arm was sore/there was pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore/there was pain in her arm) in a 63-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore/there was pain in her arm). At the time of the report, PAIN IN EXTREMITY (arm was sore/there was pain in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
doctor send me to emergency room for my heart; very bad reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (doctor send me to emergency room for my heart) and VACCINATION COMPLICATION (very bad reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (doctor send me to emergency room for my heart) and VACCINATION COMPLICATION (very bad reaction). At the time of the report, CARDIAC DISORDER (doctor send me to emergency room for my heart) and VACCINATION COMPLICATION (very bad reaction) 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.   No relevant concomitant medications were reported.  Treatment information was unknown.
Approximately 4 hours after the vaccination the patient called complaining of "numb mouth". Patient told us she received her 1st COVID Vaccine this morning; once she returned home she said she felt a single sharp pain in her chest and it went away. As the day progressed she began to feel as though her mouth was numb. Associate reported her speech was a bit slurred, almost slowing down. Patient also reported she felt a "weird" sensation at the top of her head. Described the head sensation just as the sensation in her mouth. Also reported her ears have popped from time to time. Associate reported patient's speech was worsening as she was on the line. Pt denied chest pain, SOB, or difficulty breathing. At first I asked if someone could take her to the ER and she said her daughter would be home in 15 minutes to take her. However, after patient reported the worsening speech, I encouraged patient to let me call her an ambulance. She agreed. I called 9-1-1 for patient. She hung up with associate as she said she needed to call her daughter about the situation. The 9-1-1 operator informed me they were going to attempt to contact her as well. She was seen at the local ED where she had a red line on her tongue and swelling of the tongue as evidenced by scalloping on the edges. Treated with Benadryl (unclear if at home or in ED) and hydration in ED. Symptoms resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Reporter of event is an in home care giver, reports that the day following the vaccination pt had a low grade fever with right arm feeling hot to touch and red from just at injection site down to just above elbow. Red only and no rash. Denies any other issues. On Tuesday, 3/30/21, at time this was reported to health department, the reporter explained the right arm in less red but the area of redness was larger than it was on Monday, 3/29/21.  They have applied ice packs to area and believes pt symptoms may be improving.  Advised health care provider to report this event to pt's primary doctor as well.
exacerbated pulsatile tinnitus; This case was reported by a consumer via call center representative and described the occurrence of pulsatile tinnitus in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th December 2021, the patient received the 1st dose of Fluarix Tetra 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 5th December 2021, 1 days after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced pulsatile tinnitus. On an unknown date, the outcome of the pulsatile tinnitus was recovered/resolved.   It was unknown if the reporter considered the pulsatile tinnitus to be related to Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the patient. The patient stated that she woke up the morning following her flu shot with exacerbated pulsatile tinnitus in her right ear.  She also asked about getting a booster and what strains the vaccines covered.  The reporter was given medical disclaimer and referred to health care professional. The reporter was provided a copy of the product information (PI). The reporter consented to follow up.
Child vomited 3 times within 1-2 hours of receiving vaccine. Mom returned to office, child had abd pain on exam. Rx ZOFRAN.
COVID Breakthrough Case  Pfizer Dose 1 3/12/21 (EN6203) Pfizer Dose 2 4/7/21 (ER8737) Pfizer Dose 3 8/23/21 (EW0177) COVID Positive 10/13/21  10/13/21: 78-year-old female with rheumatoid arthritis on Rituxan and leflunomide, interstitial lung disease, chronic hypoxic respiratory failure on 2 L home oxygen, hypertension and hyperlipidemia presented with worsening shortness of breath and cough.  Patient had been hospitalized twice in the past 3 weeks initially with community-acquired pneumonia, later for MRSA pneumonia and influenza, discharged home on 10/06/2021 with oral doxycycline and 2 L nasal cannula oxygen.  Reports she felt better for few days after discharge and started having worsening shortness of breath, cough productive of yellowish sputum, fever with chills.  She has decreased energy and poor appetite.  Denies any chest pain, palpitation or dizziness.  No nausea, vomiting or abdominal pain.  Patient was reportedly saturating 60% on 4 L home oxygen when EMS arrived and had respiratory distress, placed on CPAP In the ED she had a T-max of 103.4°, heart rate is 130, respiratory rate 43 , blood pressure 96 over cysts 6. She was placed on BiPAP with significant improvement in her respiratory distress and shortness of breath.  WBC 4.7, lactic acid 3.0, pH 7.48 pCO2 20, PO2 97 patient chest x-ray showing bilateral infiltrates.  Patient received vancomycin and Zosyn, IV fluids, 125 mg of Solu-Medrol and 2 g of magnesium sulfate as well as DuoNeb.  10/26/21: Acute hypoxic respiratory failure currently on 8 L of oxygen via   OxyMask on top of 6 L of oxygen via nasal cannula.  Baseline she is on 2 L of oxygen.  COVID-19 pneumonia, slowly resolving but patient becomes hypoxic and desaturates easily with physical exertion. Patient currently on tapering dose of Decadron and levofloxacin oral.  Completed dose of remdesivir.  Elevated D-dimer previously on heparin infusion but now on apixaban 2.5 mg p.o. b.i.d..  Purpuric lesions on the skin, patient treated with acyclovir but not sure if it is herpetic.  Moderate to severe MR with normal LV function.  Repeat echocardiogram done on 10/24/2021 was inconclusive because of very poor echo window.  Interstitial lung disease/Pulmonary fibrosis patient on 2 L of oxygen at home.  Rheumatoid arthritis on leflunomide and Rituxan.  Recent MRSA pneumonia on 09/30/2021 treated with doxycycline per ID recommendation.  Enterobacter pneumonia on Levaquin.
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 06May2021 09:00 (at age 51-years-old) (Batch/Lot Number: EW0173) as 1st dose, single for covid-19 immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. There were no other medication received withing 2 weeks and no vaccine withing 4 weeks prior to vaccination. The patient was diagnosed with bell's palsy on 23May2021 09:00 which resulted in emergency room visit. Unspecified medication for 7 days was given as treatment. Outcome of the event was unknown. The patient was skeptical in taking the 2nd dose and her physician stated to postpone it. She was asking if she should take the 2nd dose. Patient was not diagnosed with covid prior to vaccination and has not been tested post vaccination.  Information on Lot/Batch number has been requested.