chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like arm was going to fall off; Swelling where got the shot; Redness where got the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site swelling (Verbatim: Swelling where got the shot), injection site erythema (Verbatim: Redness where got the shot) and arm discomfort (Verbatim: felt like arm was going to fall off).  The outcome of the injection site swelling and injection site erythema were resolved (duration 10 days) and the outcome of the arm discomfort was not reported.   It was unknown if the reporter considered the injection site swelling, injection site erythema and arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the injection site swelling, injection site erythema and arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. Th patient reported that the shot did not hurt but he/she had swelling and redness where he/she got shot for 10 days and felt like his/her arm was going to fall off. The patient got second shot on another arm and had no problem. The had got shingles before he/she got shots which were painful. The follow-up could not be possible as no contact details were available.
The following paragraphs will outline an adverse reaction, Guillain Barre Syndrome, which my husband has following an H1N1 vaccination received at your clinic.   On June 23, 2010 at 12:30.  My husband had an appointment with Dr. and received the H1N1 vaccination. Shortly after receiving the vaccination he began feeling ill with pain and numbness in his hands and feet and tongue.  He returned to the clinic on July 14th and saw a chiropractor at 9:00 am.  The chiropractor instructed him to see a neurologist.  He was informed that a Cat Scan would be scheduled but no appointment date was given, nor has there been any follow up from the clinic. Patient tried to schedule an appointment on the 15th but was denied, so he went to Urgent Care.  His illness was progressing and the pain was getting worse as well as the numbness.  Dr. prescribed him Vicodin and Soma and he returned home. On July 16th, my husband phoned Dr. as the prescriptions gave him no relief and his illness was progressing.  Dr. instructed patient to go to the ER.   Since that time my husband has been to the ER twice, once on the 16th and a second time the 18th when he was finally admitted and diagnosed with Guillain Barre Syndrome.  He was hospitalized until July 27th when he was transferred to Rehab where his still is today.  He is improving slowly and receives help from a speech therapist and physical therapist.  He can not yet walk, but is talking and beginning to stand.
Could not raise arm after injection; Rash on stomach across from belly button like a strip; Tiny Rash at injection site; Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Could not raise arm after injection), RASH (Rash on stomach across from belly button like a strip), INJECTION SITE RASH (Tiny Rash at injection site) and INJECTION SITE PAIN (Sore at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced MUSCULAR WEAKNESS (Could not raise arm after injection), RASH (Rash on stomach across from belly button like a strip), INJECTION SITE RASH (Tiny Rash at injection site) and INJECTION SITE PAIN (Sore at injection site). At the time of the report, MUSCULAR WEAKNESS (Could not raise arm after injection), RASH (Rash on stomach across from belly button like a strip), INJECTION SITE RASH (Tiny Rash at injection site) and INJECTION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Day after- significant left arm soreness, severe fatigue and muscle aches, painful red spots on palms. Raised redness at injection site, significantly itchy still on day 18 post injection. Has not gone away.
Extreme tenderness, swelling, redness left arm since 24 hours after vaccination. Also, joint pain, muscle achiness, fatigue.
3/10 10 minutes after vaccination itching began.  By 11:50 severe itching over scalp, arms, chest and neck.  1203 Benadryl 50 mg IM administered with relief.   On 3/11 at 2000 itching returned and throat felt tight and Karah became short of breath.  Took Benadryl 50 mg PO at home and 2 puffs of inhaler.  Karah went to local ER where Epi was administered.  Pepcid and Prednisone given IV.  Karah was kept in ER for 5 hours for observation.
Sore injection site arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Low grade fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.   This case was linked to MOD-2022-461997, MOD-2022-462001 (Patient Link).
Severe body aches; chills; fatigue; headache; light headedness; sore throat; joint pain; This is a spontaneous report from a contactable other HCP (patient) reporting for herself. A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ENU199), via an unspecified route of administration, administered in Left arm on 10Mar2021 09:45 at the age of 32-years-old as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Left arm on 17Feb2021 at the age of 32-years-old as single dose for covid-19 immunisation. The patient previously took acetaminophen and experienced allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 11Mar2021 at 01:00, the patient experienced Severe body aches, chills, fatigue, headache, light headedness, sore throat and joint pain. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
flare up of irritable bowel symptoms; flare up of irritable bowel symptoms; This is a spontaneous report from a non-contactable consumer (the patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via unspecified route of administration on 02Mar2021 (at the age of 64-years-old) as a single dose for Covid-19 immunisation. The patient's medical history included quadriplegia from an unspecified date, irritable bowel syndrome from an unspecified date. Allergies to medications, food, or other products included patient had known allergies to Sulfa drugs. Concomitant medications included unspecified multiple medications. List of any other medications the patient received within 2 weeks of vaccination reported as Yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 11Mar2021, the patient experienced flare up of irritable bowel symptoms. Adverse event resulted in emergency room visit. The patient received treatment for the reported event. The patient underwent lab tests and procedures which included Nasal Swab (sars-cov-2 test): negative on an unspecified date. The outcome of the flare up of irritable bowel symptoms were recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's name added in general tab. Protect Confidentiality checked since reporter is the patient self. Patient's first name updated. Patient's Country was added as United States. BNT162B2 Stop date/time added. Dose description was updated as "1ST DOSE, SINGLE DOSE". Lot# UNKNOWN was removed from dosage regimens tab. Concomitant therapy updated as Yes since "take multiple meds" was provided. Emergency Room Visit checked. Treatment received was ticked as Yes. "known allergies: sulfa drugs" was added as relevant med history. County of Primary reporter should be leave blank not US.
Every joint in my body hurt.  Was in excruciating pain and was extremely cold.  Had to have 4 blankets on me.  Not sure if I had a fever or not.  Did not take my temperature as I hurt too much to find thermometer.  My injection site is large and very red with the redness radiating out more and more on 11/14/12.
2 weeks after getting second shot I started getting white spots on hands and face.; 2 weeks after getting second shot I started getting white spots on hands and face.; Vitiligo; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 60-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EN6208; Expiration Date: 30Jun2021), dose 2 via an intramuscular route of administration, administered in arm left on 15Mar2021 at 09:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunisation. Medical history included ongoing high blood pressure and ongoing cholesterol from an unknown date. Historical vaccine included first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EN6201, Expiration Date: 30Jun2021) via an intramuscularly administered in left arm on 22Feb2021 at 09.00 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation and received two doses of chicken pox vaccine, dose 1 on 01Aug2021 and dose 2 on 02Aug2021 (Formulation: injection) in left arm (at the age of 61-year-old) for chicken pox. Concomitant medications included pravastatin 20 mg via oral taken for cholesterol from Feb2021 and ongoing and amlodipine 5mg via oral taken for blood pressure from an unspecified start date and ongoing. The patient was not received other medications within 2 weeks of vaccination. No any other prior vaccinations within 4 Weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced 2 weeks after getting second shot he started getting white spots on hands and face on 05Apr2021 at 08:00 and vitiligo on 30Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 03May2021. The patient received treatment for the adverse events with cream to put on spots/ hands (2x day). The outcome of events reported as not recovered.  Follow-up attempts are completed. No further information is expected.
7/16/21: patient presented to ED with altered mental status. found to be PCR COVID-19 positive. Patient received J&J COVID-19 vaccine on 4/5/21.  Diagnosed with septic shock secondary to bacteremia and UTI, acute hypoxic and hypercapnic resp failure requiring mechanical ventilation, resp metabolic acidosis, COVID-19 infection.  7/20/2021: Patient expired
Shortly after receiving the shots she became exhausted. Then when she woke she was inconsolable; crying without stopping in agony with her back arched. She had a lot of difficultly calming down and cried intermittently in a high pitched cry for hours.  She fell asleep again around 7:30 PM after a dose of Tylenol given at 4:00 PM and a warm bath at 5:15 PM.
BLOOD CLOTS  : Two days after receiving Pfizer dose 2 my mother had difficulty breathing and had chest pain. She was hospitalized for six days due to blood-clotting in the lungs.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD albumin status of rHA (recombinant human albumin), lot # M007961 (expiration date 15-AUG-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was stored in 15.4F for 13 hours 30 minutes. There were no previous excursions. Temperature was back in range at the time of this report. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter's source. Additional information has been requested.
Tenderness in his arm; Did not feel well at first 2-3 days; Swelling on his body; Headache; Chills; Aversion to food; His stomach did not feel well; This is a spontaneous report received from a contactable consumer (patient) from Pfizer sponsored program.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Unknown) via an unspecified route of administration on 18Apr2021 as a single dose for COVID-19 immunization. On Apr2021, after first dose of vaccine, the patient experienced tenderness in his arm, but he wanted to ask if it is okay that it continues for a week. He said he did not feel well at first 2-3 days, somewhat swelling on his body, his stomach did not feel well, headache, chills and aversion to food; when he saw food commercials, he does not have any interest to look at them. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax & 4-5 hr p/vax pt exp lightheadedness, dizziness, fatigue, achiness, & sleepiness;tx APAP & fluids;sx resolved;
Patient complaining of light headed, dizziness and flushing within minutes of receiving flu vaccine. No rash noted. Patient blood pressure was normal and pulse was normal. Also had slight nausea, episode lasted 15 minutes.
PT GIVEN FLU INJECTION LFT ARM.  PT STATES HE FELT PAIN DOWN LFT ARM AND RADIAT TO CHEST.  PT ALSO STATES HE HAS HAD RAPID HEART RATE, UNABLE TO SLEEP.  HE ALSO STATES THAT HE HAS BEEN FEELING VERY ANXIOUS,  SINCE FLU INJECTION.
Within 5 minutes of receiving the shot I fell incredibly nauseous, staying nauseous for two full days and then periodically off and on. It has been 6 days since the vaccine and I have random muscle and joint pains, leg pains, nausea, and still have an extremely hard painful lump in my arm. The worst of symptoms is over.
Developed chicken pox like rash on 3/20/03. No fever noted by mom. Rash diminished by 3/24. Follow up on 07/31/2003: "Information is not available 07/22/2003."
Narrative: 73yo male patient with newly discovered systolic heart failure & AFib on 8/16/2021 died on 8/22/2021 in his home. Pt had received covid vaccines from an unknown location . Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Patient's parents forged age to make patient 16 to receive Pfizer vaccine. Pharmacy staff asked for birthday upon arrival and before vaccination. Parents stated birthday written on consent form both times. Later that day the vaccine was submitted to insurance and was rejected due to patient less then 16. Our Technician called to verify birthday with insurance company. The insurance company gave a DOB. The consent form and parents said it was an earlier date. The parents were called and asked about the age. The patient's mother hesitated and then said that her husband may have entered in the scheduler incorrectly. Then proceeded to tell our technician that she was unaware that a 15 y.o. could not receive the vaccine.
usual monthly allergy shot with systemic response of watery itchy eyes, itchy hands, itchy throat.  Happened again 2/17/22.
This spontaneous report as received from a nurse via company representative refers to her nephew who was a male patient of unknown age. The nurse reported that the patient became ill after receiving live, oral, ROTATEQ (Lot#, dose, route and duration unspecified) on an unknown date. The patient received two out of the three doses of the vaccine and became ill after each administration. The patient was seen by unspecified physician and an unspecified "GI Specialist". The "GI Specialist" did "blood work" and found that the patient contracted rotavirus. The "GI Specialist" recommended that the patient should not receive the third dose of the live, oral, ROTATEQ series. No treatment information was reported. The outcome was reported as recovering/resolving. Additional information is not expected.
Smallpox vaccine administered 25 Aug 04.  On 1 Sep 04 pt developed a diffuse rash consisting of numerous erythematous plaques several of which are edematous.
According to pt's mother he awoke at 7:30 am vomiting. Pt's mother reports that pt's temperature was 102.8 orally at 8:00 am. Pt's mother gave pt Tylenol (dose based on pt's weight) at 8:00 am. pt was taken to family doctor later the same day. According to pt's mother "PCP stated that it was a normal reaction and that the pt was possibly coming down with a cold".
This is a spontaneous report from Non Clinical Study Program for a contactable consumer. This female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at a single dose on an unspecified date. The patient history and concomitant medications were not reported. The patient experienced huge lump in the back of her arm and her arm hurts on an unspecified date with outcome of unknown. The consumer mentioned that she had seen her dermatologist for skin cancer check up and she mentioned that her dermatologist told her that it was not a reaction as it was not red. She also mentioned that her dermatologist think that the injection might have been injected into the fatty tumor of the muscle. Follow-up attempts completed. No further information expected.
arm hurt; having a very heavy period, being 2 weeks early; having a very heavy period, being 2 weeks early. She's still bleeding; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (having a very heavy period, being 2 weeks early), HEAVY MENSTRUAL BLEEDING (having a very heavy period, being 2 weeks early. She's still bleeding) and PAIN IN EXTREMITY (arm hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 031M20A) for COVID-19 vaccination.     Concomitant products included GLATIRAMER ACETATE (COPAXONE) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced POLYMENORRHOEA (having a very heavy period, being 2 weeks early) and HEAVY MENSTRUAL BLEEDING (having a very heavy period, being 2 weeks early. She's still bleeding). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, POLYMENORRHOEA (having a very heavy period, being 2 weeks early), HEAVY MENSTRUAL BLEEDING (having a very heavy period, being 2 weeks early. She's still bleeding) and PAIN IN EXTREMITY (arm hurt) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. treatment information not provided.No Concomitant medication was reported.   This case was linked to MOD-2021-226247 (Patient Link).
This spontaneous report as received from a physician via company representative refers to a 62 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose number, dose unit, route, lot number and expiry date unknown). On an unknown date a week after the patient received ZOSTAVAX, patient came back into the office with a rash that looked like shingles on his left side. The outcome of rash that looked like shingles on his left side was unknown. No further information was provided. Additional information is not expected.
After receiving the first dose of the COVID vaccine I was experiencing headaches, dizziness, lightheadedness, palpitations, and nausea. The first dose was on 12/21/20. These symptoms resolved around 12/26/20. I received the second dose of the COVID vaccine on 01/11/21. I began experiencing symptoms on 01/12/21. The symptoms I was experiencing were lightheadedness, dizziness, and brain fog/confusion. These symptoms got significantly worse from 01/13/21 - 01/24/21 and I began developing profound confusion/brain fog, diplopia, blurry vision, headaches, feeling like I'm swaying on a boat,  and the "feeling of being drunk". As of 01/25/21, the symptoms have seemed to get better and I am starting to feel more like myself. The drunk feeling and mild blurry vision are still present as of today 01/28/21.
Information has been received from a physician assistant concerning a 73 year old male consumer with a history of prostate cancer who on 14-MAR-2008 was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck). Subsequently, on 15-MAR-2008 the patient developed flu like symptoms and numb finger tips. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information from the physician assistant indicated that this 72 year old whit male consumer with rhinitis allergic, atrial flutter, atrial fibrillation, and mitral valve prolapse and a history of prostate cancer who on 14-MAR-2008 was vaccinated SQ in the left deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). There was no illness at the time of vaccination. Subsequently, on 15-MAR-2008 the patient complained of feeling shaky and feverish the day after vaccine administration. It was also reported that the tips of his fingers started feeling numb. The right side of his head was sore to touch and the skin on his right temple was slightly red. There was no site reaction. The patient was told to treat his symptoms with acetaminophen (TYLENOL). The patient recovered approximately 7 days after vaccination. Follow-up information indicated no new information. Additional information is not expected.