chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump develop on his arm that has not gone away; This spontaneous report was received from a pharmacist and refers to a male patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unspecified date, the patient received unspecified Coronavirus disease (COVID) vaccine (exact dose, route of administration, lot number and expiration date were not provided) and on an unknown date (reported as at least a month later), the patient had a pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient had a lump develop on his arm that has not gone away. This occurred after his pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  The outcome of the event was unknown. The causality assessment was not provided.  This is one of three reports from the same reporter.; Sender's Comments:  US-009507513-2110USA006319: US-009507513-2110USA006333:
pt recvd shots 7PM; woke up 13APR93 @ 11PM w/high pitched screaming; screamed 5 mins & then got pale & unresponsive for 5 mins; no temp; then came to was groggy; no other episodes;
vaginal pain; redness and burning pain especially when urine hits the affected area; redness and burning pain especially when urine hits the affected area; white spots; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for Injection, Lot number: EW0164) dose 2 via an unknown route of administration, administered in Arm Right on 20Apr2021 04:30 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Approximately 40 hours after injection, Patient experienced, I had exterior vaginal pain. The entire exterior vaginal area was tender to the touch, so clothing was irritating, sitting uncomfortable and wiping really hurt. I wouldn't have thought that this was a side effect except for the fact that my 18-year-old daughter had the same vaginal pain come on at the same time and we got the vaccine together. I have intense redness and a big purplish looking mark that burns and is tender to the touch. It lines the left side opening of my vagina. My daughter also has redness and burning pain especially when urine hits the affected area. She has white spots instead of the dark red purplish mark that I have. We are two days out from noticing these vaginal symptoms with no relief yet. All events on 22Apr2021 11:00 AM. Since it is a weekend, we are just watching it but debating if we need to see a healthcare professional if our symptoms remain come Monday. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Evening of second vaccine got chills, then 11 pm got terrible aches and pains, next day fever 101 and cough, very tired.  A little better next day, but must have done too much because I relapsed.  Woke up with a huge fever blister in my right nostril and got a rash on chest, shoulders and back around the 12th day.  Still have the rash.
blood clots in both legs; heart attack/blood clot in heart; Blood clots in lungs/shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in both legs), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 8077727310 and 012LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced THROMBOSIS (blood clots in both legs) (seriousness criteria hospitalization prolonged and life threatening), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) (seriousness criteria hospitalization prolonged and life threatening) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on 09-Apr-2021 due to MYOCARDIAL INFARCTION, PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots in both legs), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) outcome was unknown.            No concomitant medications were reported.  Treatment of the events included Xarelto and unspecified IV medications.  Action taken with mRNA-1273 in response to the events was not applicable.   Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
This spontaneous report was received from a physician via company representative concerning a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9, (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date, the patient experienced Guillain-Barre syndrome. The outcome of Guillain-Barre syndrome was reported as recovered on an unknown date. The reporter did not assess the causality of the event with GARDASIL 9. Upon internal review Guillain-Barre syndrome was determined to be medically significant. Additional information is not expected since the reporter did not wish to be contacted for further follow up.
How many people have side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (How many people have side effects) 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 VACCINATION COMPLICATION (How many people have side effects). At the time of the report, VACCINATION COMPLICATION (How many people have side effects) 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 treatment medication was reported. No concomitant medication was reported.
While working only an hour at my normal job not doing anything unusual or extraordinary, it became increasingly difficult to breathe.  Chest felt very heavy and I became lethargic, not able to take a deep breath.  Left work and became a couch potato the rest of the day and evening.   Today symptoms about the same.  Breathing still a problem and although it does not feel good, I am forcing myself to take an occastional deep breath. Did not report to work.
Skin tear noted at midnight, roughly 9 hours after receiving the injection.  Felt pain at the site, took off her bandage (slowly) and saw skin off of her arm.  No bleeding.  Didn't notice the swelling or redness until just prior to visit.  Skin tear was concerning to the patient, and states that it did not occur when removing the bandage.
Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Side effects- 30 mins after vaccine left leg was numb  Left thigh had burning sensation on the 2nd day after vaccination and dull pain throughout the left leg Intense chills and fever on 4th night after vaccination  Left arm pain and left pain for 3 weeks following vaccination
Left deltoid (injection) site became red, warm covering complete deltoid with induration on upper half of deltoid.  Hurt to raise left arm more than parallel to floor.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (reported as 15 mcg, subcutaneous) and experienced inappropriate route of vaccination, injection site soreness lasting more than 5 days, and injection site redness. The nurse reported that between 8 to 80 healthcare workers at this institution received FLUARIX SC (subcutaneously). Subjects complained of injection site soreness lasting more than 5 days. This subject complained of injection site redness. No additional information is known at this time. At the time of reporting the outcome of the injection site soreness and injection site redness was unspecified.
Vaccine stored in refrigerator on 14-Oct-2021, expired product on 13-Oct-2021 and administered on 08-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 14-Oct-2021, expired product on 13-Oct-2021 and administered on 08-Nov-2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 14-Oct-2021, expired product on 13-Oct-2021 and administered on 08-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 14-Oct-2021, expired product on 13-Oct-2021 and administered on 08-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Patient received the booster dose. Date the vial placed in refrigerator was on 14-Oct-2021. There was no temperature excursion. The patient had no adverse event.  No Treatment information was reported.
Left check of face red and flush, slightly numb, slight tingling. Left ear red/flushed. Numbness extended to left eye. C/O slight headache, dull pain. BENADRYL 25 mg po given.
Joint issues; Flu like symptoms; Fever; Nausea/ felt like vomiting; Muscle aches; This spontaneous case was retrieved on 22-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 897559-1), reported by other health professional and concerned an 85-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On 18-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one; route of administration: intramuscular; anatomical location: left arm; indication: not reported). The batch number reported was 290706.  On the same day, after receiving Fluad Quadrivalent, the patient had very severe reaction to the flu shot: fever, flu like symptoms, nausea, felt like vomiting, muscle aches and joint issues.  The outcome of the events was unknown.  The reporter did not provide causality assessment, but the patient's daughter assessed the events as related to Fluad Quadrivalent.  The case was assessed as non-serious.  Additional information received on 19-Jan-2021 via Product Technical Complaint (PTC) group: After batch number mapping, suspect product was re-coded from Fluad (TIV) to Fluad Quadrivalent. The narrative was amended accordingly.  Company comment: A 85-year-old female patient experienced arthropathy, influenza like illness, pyrexia, nausea and myalgia on the same day after administration of Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. Causality is assessed as possibly related for all events.; Reporter's Comments: The patient had very severe reaction to the flu shot.; Sender's Comments: A 85-year-old female patient experienced arthropathy, influenza like illness, pyrexia, nausea and myalgia on the same day after administration of Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. Causality is assessed as possibly related for all events.
The night it was administered I had severe pain and swelling in my left arm, febrile (101), headache, nausea. I took acetaminophen and zofran. Symptoms continued throughout the night and the next 3 days I continued to be febrile, pain in my arm (not as bad as first day), headache lethargic. Finally on the 28th of July my temp broke and I feel like I have had the flu. All over muscle pain, pain behind my eyes, and general feeling of being drained.
PATIENT REPORTED LEFT ARM SORENESS, PAIN, AND MOBILITY PROBLEM THAT LASTED FOR ONE WEEK WITH FIRST DOSE OF SHINGRIX VACCINE
PATIENT GOT PNEUMOVAX ON LEFT ARM AND FLUARIX QUADRIVALENT ON RIGHT ARM. SHE CALLED THE PHARMACY TO REPORT THAT SHE BELIEVES THAT SHE DEVELOPED A RASH ON HER ARMS AND STIFFNESS IN HER WHOLE BODY. SHE SAID THAT SHE WILL BE TAKING BENADRYL FOR THE RASHES AND WILL WAIT TO SEE HOW TEH COURSE GOES. SHE WAS ADVISED TO SEEK MEDICAL ATTENTION IMMEDIATELY TO FOLLOW UP WITH HER STIFFNESS. PATIENT STATED THAT SHE WILL BE WAITING 24 HOURS BEFORE SEEN A DOCTOR.
BIT SLEEPY; SORENESS AT INJECTION SITE; 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) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bit sleepy, and soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 02-APR-2021, and the outcome of bit sleepy was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route, lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that patient fainted shortly after receiving the GARDASIL vaccine on unspecified date. It was unknown which injection (in a series of three) the fainting was occurred. The patient was assisted back to an upright position and had no additional side effects. No treatment was given for the event. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were unknown. This is one of several reports received from the same source. Additional information has been requested.
I have experienced, headache, chills, fatigue, nausea, tingling sensation on my tongue. I have taken Tylenol and Motrin to counter these side effects however it has not been very effective.
Injection site rash; Injection site swelling; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Tenderness at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (Injection site rash), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Tenderness at injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (Injection site rash), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided     This case was linked to MOD-2021-066080 (Patient Link).
Pt received vaccine on 07/30/2021 about 9:15 am.  She went to a local ER around 9:25 pm.  She started experiences weakness, dizziness at about 6:15 pm and then it started to worsen to the point of having uncontrollable shaking, but not seizure like and a sensation like bugs were crawling all over her.  No rash. No fever. No other sign and symptoms.
Fever, body aches, fatigue, chills/shivers. Tylenol 1,000 times two (6/18/19 - 4:00 PM and 6/19/19 - 2:30 AM) All symptoms relieved by 6:00 AM on 6/19/19. Fatigue returned on late night 6/19/19 and stayed on till 6/20/19 AM
10/3 patient experienced discomfort and swelling of L arm between shoulder and elbow, which worsened by Friday 10/5 when she consulted us by phone.  Because of extent of swelling and discomfort we referred pt. to physician, who prescribed Keflex x7 days for infection.
Patient received vaccine on 01/25/2005. 14 days later he began having fever, chills, and malaise. 19 days after vaccine he developed a rash with vesicles and tingling on right thigh. Seen at emergency room 24 days after vaccine and diagnosed with shingles. Prescribed -100mg and prednisone 20mg. Seen by me 28 days after
1/13/22 Patient reports productive cough for 6 days. States at times coughing makes her vomit up mucus.  Chills for couple days which resolved.  States headache and body aches developed yesterday. Reports advil helping with symptoms.  Denies dyspnea/chest pain.  Hx of hypothyroidism.  covid vaccinated.  No ill contacts.  Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Head: Normocephalic.     Right Ear: Hearing, tympanic membrane, ear canal and external ear normal. There is no impacted cerumen.     Left Ear: Hearing, tympanic membrane, ear canal and external ear normal. There is no impacted cerumen.     Nose: Nose normal.     Mouth/Throat:     Pharynx: Uvula midline.  Eyes:     General: No scleral icterus.       Right eye: No discharge.        Left eye: No discharge.     Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds. No murmur heard.   No friction rub. No gallop.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No stridor. No wheezing, rhonchi or rales.  Chest:     Chest wall: No tenderness.  Musculoskeletal:     Cervical back: Neck supple.  Lymphadenopathy:     Cervical: No cervical adenopathy.  Skin:    Coloration: Skin is not pale.     Findings: No erythema or rash.  Neurological:     General: No focal deficit present.     Mental Status: She is alert.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.
started to experience hives/hives started out of the blue/break out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (started to experience hives/hives started out of the blue/break out in hives) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced URTICARIA (started to experience hives/hives started out of the blue/break out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (started to experience hives/hives started out of the blue/break out in hives) outcome was unknown.            No medical history was reported by the reporter. Patient had no allergies and did not eat anything different.
Patient fainted approximately 5 minutes after receiving his second Pfizer vaccine.  He was observed to have tonic-clonic jerking but this was not seizure nor does the patient have a history of seizures.  His mother reported fainting previously during stressful situations.  Ice pack was given and BP was taken at 11:20 and was 100/65 and pulse was 101.  When EMS arrived, patient's BP was 134/80 and pulse was 83.  Patient reported stomach pains post-fainting.  EMS cleared patient to leave and he signed off that he did not want to go to the hospital.
Post injection 2.5'' circle of redness and mild warmth. It continued for 6 days post-injection.
localized vasculitis to right 1st, 2nd, 3rd, and 4th distal metatarsals (see additional comments) Narrative:  12/28/2020 received 1st dose of Moderna Covid-19 vaccine. On 1/6/2021 or 1/7/2021 developed small hemorrhagic blister to tip of 3rd right toe, non-pruritic, sensitive to touch (blister still present). On 1/13/2021 developed hemorrhagic lesion to tip of 2nd right toe followed by development of blister that remains fluid filled, non pruritic. 1/22/2021 received 2nd dose of Moderna Covid-19 vaccine. On 2/5/2021 developed hemorrhagic lesion to tip of 4th right toe, non-pruritic, sensitive to touch. On 2/7/2021 developed hemorrhagic lesion to tip of right great toe, non-pruritic, sensitive. Employee has appointment with primary care provider 2/10/2021 for further evaluation to include bloodwork.  Other Relevant History:
pt recv vax; pt's mom reported that pt fainted few mins p/ vax; was diaphoretic w/ chills, v, severe HA; tx at hosp  but released same day;
Sore arm (entire arm), sore and swollen at injection site, swollen lymph node on injection arm
About 1 hr after flu shot administration, trouble breathing, tongue swollen, back pain, eye pain, lips felt prickly, burning, red/sore at injection site. She took BENADRYL right after and felt better  but scared.
Diarrhea that was greasy and poor digestion that lasted a month after the second dose