chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid19 breakthrough.  1st vaccine received on 01/04/2021.  87 y/o female with PMHx Breast Cancer s/p bilat mastectomies, DM, HTN, Hypothyroid, Thrombocytopenia presents to ED with c/o Chest burning radiating to back and down her arms.  Pt states she also has had chronic fatigue and cough since originally had Covid in January 2022.  Pt afebrile, room air sats 97% and CXR consistent with Pneumonia.  Pt treated with IV abx.
Arm hurt/Both arms hurt/ her calves were also achy; She didn't sleep well last night; In the night woke up with aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt/Both arms hurt/ her calves were also achy), INSOMNIA (She didn't sleep well last night) and MYALGIA (In the night woke up with aches and pains) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02/A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt/Both arms hurt/ her calves were also achy), INSOMNIA (She didn't sleep well last night) and MYALGIA (In the night woke up with aches and pains). At the time of the report, PAIN IN EXTREMITY (Arm hurt/Both arms hurt/ her calves were also achy), INSOMNIA (She didn't sleep well last night) and MYALGIA (In the night woke up with aches and pains) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  This case concerns a 71 year-old female patient with no reported medical history who experienced the unexpected non-serious events of pain in extremity, insomnia, and myalgia. The events pain in extremity and myalgia occurred approximately the same day after the third dose of Moderna COVID-19 Vaccine, and the event insomnia occurred on an unknown date. The rechallenge was not applicable as no additional dosing will be administered.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report   This case was linked to MOD-2021-372414, MOD-2021-372106 (Patient Link).; Sender's Comments: This case concerns a 71 year-old female patient with no reported medical history who experienced the unexpected non-serious events of pain in extremity, insomnia, and myalgia. The events pain in extremity and myalgia occurred approximately the same day after the third dose of Moderna COVID-19 Vaccine, and the event insomnia occurred on an unknown date. The rechallenge was not applicable as no additional dosing will be administered.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacist via online chat. The age at vaccination was not reported. After receiving SHINGRIX, the patient developed shingles.
1 of 2 nurse employees vaxed from the same vial in mid-November who exp nausea, h/a & inj site rxn w/in 24hrs;inj site rxn consisted of erythema & swelling;covered entire deltoid muscle;rx:APAP/warm compresses;w/in 72hrs rxn had resolved;
2 weeks after having shot on 10/1/2009, I started losing my very full head of hair, in 1 month I had lost all body hair from head to toe. Drs. said bp med, then alopecia. In Aug 2010 started getting hair back, body first then started head and face. 9/29/2010, had flu shot and 2 weeks later all hair gone.
I got my shot at 2:10 pm yesterday it just burned and itched a bit at first.  Then later at 6 pm I got chilled, then super hot at 8 pm,  then the itching and burning feeling came back and at 9pm began to spread across my shoulders and upper back with a prickly rash.  At 10:30 pm the itching was also on my face and upper back. I took a Benadryl and a Tylenol at 10:10 pm.  I'm feeling fine this morning with the exception of the sore shot arm.
RASHES ON FACE AND BODY; FELT OFF BALANCE; COULD BARELY KEEP AWAKE; FEELING BAD; FELT A WARM SENSATION TO MOVE UP SHOULDER; PAIN AT INJECTION SITE; HEADACHE; FEVER; NEEDLE LIKE FEELING IN FEET,RIGHT ARM AND HANDS; SORE THROAT; STUFFY NOSE; KNUCKLES IN FINGER FELT STIFF; VERY ACHY; HEARTBURN LIKE PAINS; SLIGHT HEAVY BREATHING; VERY RAPID HEART RATE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 10-APR-2021 10:45 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight heavy breathing. On 10-APR-2021, the subject experienced very rapid heart rate. On 10-APR-2021, the subject experienced needle like feeling in feet, right arm and hands. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced stuffy nose. On 10-APR-2021, the subject experienced knuckles in finger felt stiff. On 10-APR-2021, the subject experienced very achy. On 10-APR-2021, the subject experienced heartburn like pains. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 102 beats/min. Treatment medications included: paracetamol. On 10-APR-2021 10:45, the subject experienced pain at injection site. On 10-APR-2021 11:00, the subject experienced felt a warm sensation to move up shoulder. On 10-APR-2021 20:00, the subject experienced feeling bad. On 11-APR-2021, the subject experienced felt off balance. On 11-APR-2021, the subject experienced could barely keep awake. Laboratory data included: Body temperature (NR: not provided) 101.1-101.4. On 12-APR-2021, the subject experienced rashes on face and body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very rapid heart rate on 11-APR-2021, and fever on 12-APR-2021, had not recovered from headache, sore throat, and stuffy nose, and the outcome of pain at injection site, felt a warm sensation to move up shoulder, feeling bad, slight heavy breathing, needle like feeling in feet,right arm and hands, knuckles in finger felt stiff, rashes on face and body, very achy, heartburn like pains, felt off balance and could barely keep awake was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
lack of energy off and on; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lack of energy off and on) 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 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (lack of energy off and on). At the time of the report, ASTHENIA (lack of energy off and on) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-302164 (Patient Link).
This case was reported by a nurse via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, rigors, vomiting and nausea. On an unknown date, the outcome of the pain, rigors, vomiting and nausea were unknown. The reporter considered the pain, rigors, vomiting and nausea to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain, rigors overnight, then vomiting and nausea. The physician and nurse believed it was related to SHINGRIX. The physician would return after July 5. The reporter agreed to be followed up.
redness; headache; swelling on lymp node; fatigue; Tenderness; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), DIARRHOEA (diarrhea), FATIGUE (fatigue), ERYTHEMA (redness) and HEADACHE (headache) in a 69-year-old female patient 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.     Concomitant products included PRAVASTATIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TENDERNESS (Tenderness) and DIARRHOEA (diarrhea). On 18-Jan-2021, the patient experienced FATIGUE (fatigue). On 25-Jan-2021, the patient experienced ERYTHEMA (redness), HEADACHE (headache) and LYMPHADENOPATHY (swelling on lymp node). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Jan-2021, TENDERNESS (Tenderness) had resolved. On 23-Jan-2021, FATIGUE (fatigue) had resolved. On 01-Feb-2021, LYMPHADENOPATHY (swelling on lymp node) had resolved. At the time of the report, DIARRHOEA (diarrhea), ERYTHEMA (redness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A 17-year-old patient who is pregnant was given COVID-19 Moderna vaccine series.  Patient did not report any adverse reaction.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On an unknown date, the patient missed the third and final dose of GARDASIL 9 (strength and dose were not reported), intramuscularly (lot # L013429; expiration date: 21-JUL-2017) for prophylaxis, because the product was defective and needed replacement. No adverse effect was reported. A product quality complaint was involved. Additional information has been requested.
Swelling, erythema, induration, pain at injection site about 15 hrs. of swelling in left thigh.
Patient has pain in left forearm and sore and prickly feeling that began 1 day after receiving vaccine. Reports "Hot feeling" as well as "discoloration" (discoloration not seen by provider). Reports ongoing tingling as of present day.
extreme fatigue, migraines, nose bleeds, muscle & joint pain, sensitivity to light, mood swings, irritable, brain fog, dizzy spells, trembles, numbness, back pain, pins & needles, memory fog, skin rashes, pancreatitis, stomach ulcers, shortness of breath
Soreness at injection site, fever, headache, nausea  Advil/Tylenol, rest, hydration   Still feeling terrible/feverish
currently suffering from shingles/ Suspected vaccination failure; My husband is currently suffering from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's spouse. The age at vaccination was not reported. The reporter stated that the patient was currently suffering from shingles and he had the shingles shot but after his booster shot this happened. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting.
very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually starting to subside 1 week after 2nd vaccine . urination urgency. starting 1 week after the 1st vaccine shot. increasing for 1 week.  continuing after second dose. gradually subsiding 1-2 weeks after second vaccine dose.  eye pain, sensitivity to light only lasting 1-2 days 10 days after second dose. Pervasive anxiety either from circumstances or vaccine. i dont know. and a one time vaginal bleed a week after 2nd dose.
pt devel disorder diagnosed as polymyalgia rheumatica characterized by pain in hip, shoulder, upper arm & upper leg area;
Consistent non stop headache, sinus pain and inner ear ache, primarily on the left side of the body/ head.  swollen lymph glands on the left side of the neck.   Pain on sinuses and above eye on the left side of the head.   Headache and ear pain have been present and consistent for 7 days.  Abdominal pain started on day 6 and bloating of the upper abdominal area.
Student developed, headache, fever and body aches. Several hours after vaccine that lasted much of the next day.
Rash-trunk, itchy, erythematous, some urticaria. Fever-100-102 x 2 days.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from healthcare professional regarding a 27-month-old female patient who received a dose on 09-Feb-2007, along with a dose of Hib-Titer vaccine and a dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (manufacturer unknown) (diphtheria/tetanus  toxoid/acellular pertussis vaccine. After injection with Prevnar it was reported that the patient experienced more bleeding than usual at the site of injection and it is not certain if Prevnar went directly into the child's vein. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 09-Feb-2007. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 09-Feb-2007, after injection with Prevnar, it was reported that the patient experienced more bleeding than usual at the site of injection and it is not certain if Prevnar went directly into the child's vein (injection site haemorrhage) (incorrect route of drug administration). The bleeding stopped in the office and the child went home without any further bleeding. No additional information was available at the  time of this report.
SWOLLEN FACE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen face. This report was non-serious. This case, from the same reporter is linked to 20210431325.
prostate cancer; This case was reported by a pharmacist via call center representative and described the occurrence of prostate cancer in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced prostate cancer (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Radio Therapy). On an unknown date, the outcome of the prostate cancer was unknown.   It was unknown if the reporter considered the prostate cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the 1st dose of Shingrix and less than 4 months after the vaccination the patient experienced prostate cancer. The patient was on radio therapy as treatment. The reporter consented to follow up. The pharmacist only knew that it was a new diagnosis for the patient. No further details provided. The pharmacist consented to follow up via letter in the mail.
I experienced a breakthrough case of COVID-19 with body aches, headaches, fatigue, loss of appetite and fever.
Witnessed syncopal episode that occurred approximately 5-10 mins s/p Moderna vaccine @ 12:05 pm. LOC lasted approx 30 seconds, pt regained full consciousness without painful stimuli. Pt was placed on cardiac monitor, and in trendelenburg position and vital signs obtained,BP 102/60, (see below). Pt initially reported improvement of symptoms however would experience worsening of symptoms nausea/vomiting, shakiness, and lightheadeness with any mild movement even after 30 mins observed. Pt had two episodes of vomiting total.  Since Symptoms of lightheadedness, shakiness nausea worsen with very minimal movement pt states unable to even get out of medical bed. Plan was discussed with patient and patients husband for further evaluation in ER due to persistent symptoms and inability to ambulate on her own without experiencing worsening symptoms. . Therefore EMS was called for transport @ 12:57pm. Pt alert and oriented x 4 , VSS throughout entire observation. Denies CP/SOB/ lip swelling. Outcome of the adverse event (if paramedic please list hospital taken to): EMS called at 12:57pm for transport to ER. EMS arrived on seen at 13: 32pm Pt transported to  hospital @ 13:40.
Pt vaccinated w/Meruvax II developed pain, tingling & numbness in the rt arm & hand.
ictching around injection site 6th day post-injection.  On 7th day post-injection it became a rash around the injection site, somewhat warm to touch, and very itchy.
Not an immediate reaction, but I have had a flare up of autoimmune symptoms since my COVID-19 booster (1st booster). These symptoms include dry eyes, dry mouth, and joint pain.
Pt received Anthrax vaccine and within two days had a local reaction at the site that consisted of redness swelling with mild heat. Pt wanted  (but was not required) to see his Primary Care Manager
Hot to Touch Sensation - Near Injection Site; Bumps - Near Injection Site; Sore Arm; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE MASS (Bumps - Near Injection Site), PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE MASS (Bumps - Near Injection Site), PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE MASS (Bumps - Near Injection Site), PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
1st dose was associated with standard flu-like side effects, as well as 3-4 days of sharp lung pain on inhale/exhale. All symptoms resolved within a week  One week after second dose, I woke from a nap with severe migraine, nausea, dizziness, and significant deficits of balance, coordination, and cognition. In the ~6 months following the general constellation of symptoms have remained unchanged, moderated only by careful attention to sleep, rest, diet, etc.   Headaches, nausea, fatigue, and persistent neck pain have persisted more or less unabated since the initial episode, often waxing and waning throughout the day but never resolving for even a full day at a time.  Other, more significant symptoms - migraine, dizziness, pronounced deficits of balance and coordination - tend to be triggered both upon waking from sleep and in cases of extended mental effort. These symptoms are more successfully moderated by lifestyle modifications (ie. plentiful sleep) but occur to some degree upon waking each day.   I am currently disqualified from my work as an air traffic controller.   The only significant adverse findings at this point are several abnormal autoimmune markers - ANA, homogenous pattern, PR3