chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of papular rash in a 71-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Vitamin D3 Liquid for an unknown indication and Nature Thyroid for an unknown indication. On 25th September 2018, the patient received the 1st dose of SHINGRIX. In 2018, the patient started Vitamin D3 Liquid at an unknown dose and frequency and Nature Thyroid at an unknown dose and frequency. In September 2018, 2 days after receiving SHINGRIX, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the papular rash was not recovered/not resolved and the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the papular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired physician. The patient reported that, he experienced a papular rash on his forehead. It was itchy but not red. The itching lasted 4 to 5 days before resolving. There were still some traces of the rash present. The patient was not sure if SHINGRIX was the cause because he started the two concomitant medications a couple of days prior to getting the vaccine.
Myocarditis   Patient presented to the hospital with one episode of troponin positive chest pain. She was diagnosed with an NSTEMI for which she had a coronary angiogram which showed no significant coronary artery disease. She subsequently had CRP (normal)/ESR (mildly elevated) and DDIMER. Ddimer was elevated thus a V/Q scan was done which showed no pulmonary embolism. She went on to have a cardiac MRI which showed evidence of myocarditis.
Red, hot to touch, swollen from elbow to over shoulder, nausea, tingling in fingers.
Large amount of edema under left armpit (size A cup) with very sore glands in same position.
had one flu shot 10 years ago and got sickest ever in life; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown demographics patient who had one flu shot 10 years ago, got sickest ever in life while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2012 (10 years ago), the patient received a suspect influenza vaccine at an unknown dose via unknown route produced by unknown manufacturer (strength, frequency, batch/lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the patient developed an event had one flu shot 10 years ago, got sickest ever in life (illness) (unknown latency) following the administration of influenza vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (illness)  Outcome: unknown for illness
This case was reported by a nurse via call center representative and described the occurrence of hair loss in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included stem cell transplant (underwent 14 years before the date of reporting, for multiple myeloma) and multiple myeloma. In January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown. It was unknown if the reporter considered the hair loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 5 weeks before the date of reporting and experienced hair loss within 1 week. The patient asked if hair loss was a side effect of the vaccine and if the hair loss was permanent. The patient wanted to know before she would receive 2nd dose of SHINGRIX, which was due on 13th March 2019. The patient's oncologist advised her to receive SHINGRIX.
Sore arm; Soreness in the lymph node area on left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and LYMPH NODE PAIN (Soreness in the lymph node area on left side) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and LYMPH NODE PAIN (Soreness in the lymph node area on left side). At the time of the report, PAIN IN EXTREMITY (Sore arm) and LYMPH NODE PAIN (Soreness in the lymph node area on left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.      This case was linked to MOD-2021-065886 (Patient Link).
Arthralgia, Joint pain in the pinky and ring finger. Stiffness in wrist Narrative:
Received vaccine at our 10/12/23 evening flu clinic.  Stated a few hours later she developed a rash.  Went to her doctor (date unknow), was put on meds.  They didn't work so she went to the ER (date unknown).  She sees an allergist soon.
Within 5 minutes of the injection I developed a headache. That progressed and became stronger. There was paramedics on the site and a physician that came to help me. I had my blood pressure taking 190/95. They wanted to transport me to the hospital but I wanted to try to take BENADRYL first. It took almost a full day to get my blood pressure down. I took a water pill and that helped get my BP down. My normal BP is 120/65 and has always been normal. I had muscle aches as well too. Then on 3/16/2021 I had my 2nd dose of Pfizer, lot number EL9267. Within the first 5-10 minutes the same event happened with high blood pressure. My BP was 180/85. I waited there for 45 minutes. My BP stayed high for most of the day. I contacted my doctor and was suggested to take 2 water pills to lower the BP. Then within 24 hours it was back to normal. Also, before I went to get the vaccine, I took BENADRYL. I also had muscle aches as well. I had my 3rd dose on 12/15/2021, lot number FD8448. I took BENADRYL and 2 water pills before I went. I went to the hospital to get that dose due to having previous reactions. My BP was 160/78. I stayed there for 45 minutes. I had a mild headache but no muscle aches. I have to take hydrochlorothiazide for the blood pressure issues. I got COVID-19 on 5/18/2022. I was prescribed PAXLOVID. I had COVID symptoms for 4 days and the symptoms went away. I took a COVID-19 test a week after and it was negative. The next day, I had a headache and felt like I was getting COVID-19 again. I called my doctor and she said it could be rebound COVID-19. I tested and I was positive again. This is my 3rd week and I feel bad. I am still weak and fatigued with sinus issues.
Day 1 99.8 fever at 6:30. , Day 2 101.4 fever with meds, chilly, body ache fatigue, headache, rash on arm and leg. Day3: same as day 2. Day 4: blisters in my mouth and throat, the skin on the roof of my mouth peeled off, headache, nausea,, diarrhea , joint painDay 5, 6, 7 same. Day 8 Blisters in ears and throat blisters start to pop. Severe diarrhea, severe abdominal cramping, severe nausea, -Day 9, 10, 11 Diarrhea ends, severe abdominal cramping, joint pain still bad, short of breath, random severe sharp headache, random severe sharp arm pain. Blood oxygen dips to 94 occasionally. Occasional nausea.day 12: mild nausea, occasional severe cramping, joint pain, occasional sharp pain in head, occasional heaviness in lungs, slight congestion.
About 15 minutes after receiving vaccine, patient became dizzy, diaphoretic and lost consciousness briefly. Client was transferred to an antigravity chair, and regained consciousness but continued with severe diaphoresis, nausea and dizziness.  911 was called and patient was transported at 2:25. HR42, BP 84/62
Undetermined - Category II SIDS 9/15/06 Received autopsy report which reveals COD as Category II SIDS.  Patient cosleeping in adult bed between 2 adults & lay over could not be excluded/ss
Information has been received from a registered nurse concerning an approximately 27 year old female patient with a history of polycystic ovary syndrome, who in 1977 was vaccinated with a dose of "a measles vaccine" (manufacturer unknown) and in 1993 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Concomitant therapy included metformin.  On 10/28/2002 it was reported that "recently dose serology testing showed that she is not immune to the measles".  Unspecified medical attention was sought, but no intervention was done.  Additional information has been requested.
Slight injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201) via unspecified route of administration on 11Feb2021 at 13:15 (at the age of 67-year-old) in left arm as a single dose for COVID-19 immunisation. The patient medical history included Crohn's disease, and asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included Allergy Antigen injs (as reported), Humira pen and metoprolol succinate. The patient didn't receive any other vaccine within four weeks prior to the vaccination. The patient experienced slight injection site soreness. On a scale of 1-10, with 10 being the highest. The soreness was maybe a 3. The outcome of the event was recovered on an unknown date in Feb2021.
This is a spontaneous report from a non-contactable consumer (patient).   A 25-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Mar2021 (at the age of 25 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included hepatitis b vaccine (HEPATITIS B VACCIN). Other vaccine that was given within 4 weeks included HEPATITIS B VACCINE.   On 30Mar2021, The patient experienced Loss hearing in one ear (medically significant) and now constant ringing in both.  Treatment was given  as a result of loss hearing in one ear, ringing in both which included Anti biotic and  steroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events was not recovered.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 strokes; Shingles of the brain; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced stroke (Verbatim: 3 strokes) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles of the brain). The outcome of the stroke and shingles were not reported.   It was unknown if the reporter considered the stroke and shingles to be related to Shingles vaccine.     It was unknown if the company considered the stroke and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient was reporter's step dad. The patient received Shingles vaccine one year ago and experienced shingles on the brain 7 months ago. The patient had 3 strokes in hours to days and it changed their lives forever. The reporter also had two doses of Shingles vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR041082:Same reporter
pt recvd vax & 5 mins p/vax 3 devel salty taste in mouth which lasted 10 dasy until 26MAR93;
Tested positive for COVID-19; More aches and pains; Tiredness; Sleeping more; Low-grade fever; A spontaneous report was received from a consumer concerning her husband, a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low-grade fever/MedDRA PT: Fever, Tested positive for COVID-19/MedDRA PT: COVID-19, more aches and pains/MedDRA PT: Pain, tiredness and sleeping more/MedDRA PT: hypersomnia.   The patient's medical history was not provided. Concomitant medication information was not provided.   On 14 Jan 2021, the patient developed a low-grade fever.  On 16 Jan 2021, the patient tested positive for COVID 19.   On 19 Jan 2021, the patient received the first dose of two planned doses of mRNA-1273 in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, patient developed "more aches and pains, tiredness and sleeping more. The patient was seen at Urgent Care. Treatment included Vitamin C, Vitamin D, azithromycin, zinc and "mucus relief".   He was hospitalized for 12 days.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of low-grade fever, tested positive for COVID-19, more aches and pains, tiredness and sleeping more was considered unknown.; Reporter's Comments: This case concerns a 69-year-old male was hospitalized for a serious unexpected event of COVID-19, as well as NS unexpected events of hypersomnia and pain, and NS expected events of fever and fatigue. The event of COVID-19 occurred 12 days after the first dose of mRNA-1273.  Treatment not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Not felt to good/haven't felt the same since; Feel like I have the flu; Felt like rundown; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not felt to good/haven't felt the same since), INFLUENZA LIKE ILLNESS (Feel like I have the flu) and FATIGUE (Felt like rundown) 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 19-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 VACCINATION COMPLICATION (Not felt to good/haven't felt the same since), INFLUENZA LIKE ILLNESS (Feel like I have the flu) and FATIGUE (Felt like rundown). At the time of the report, VACCINATION COMPLICATION (Not felt to good/haven't felt the same since), INFLUENZA LIKE ILLNESS (Feel like I have the flu) and FATIGUE (Felt like rundown) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was reported by reporter.   Reporter did not allow further contact
PATIENT RECEIVED THE ABOVE FULL SET OF VACCINES. UPON COMPLETION OF VACCINE ADMINISTRATION, PATIENT WAS LEAVING VACCINE ROOM WHEN HE EXPERINCED SOME DEGREE OF BODY SPASMS AND SYNCOPE, HE FELL TO THE FLOOR. PATIENT WAS IMMEDIATELY ASSISTED BY MEDICAL STAFF AND TRANSFERRED TO EXAM ROOM.  PATIENT WAS ASSESSED BY SITE AND  FOUND TO BE VITALLY STABLE, AAOX4, GCS 15. PATIENT STATED HE FELT FINE AND SPENT THE REST OF THE NIGHT IN OBSERVATION. PATIENT HAD A STABLE NIGHT WITHOUT ANY FURTHER INCIDENTS NOR COMPLICATIONS.
Wed -Overnight Developed Chills then fever to about 102.5, dry hacking cough- took Ibuprofen and symptoms subsided. Thur- Overnight Chills returned- less aggressive - Fever 100.6 and dry cough. took Ibuprofen - woke up later drenched in sweat. Fri evening 8pm 15 min period of chills went away then Temp of 99.9, again later woke up drenched in sweat. No further fever, some fatigue (cold be caused by lack of sleep) - persistent mild cough After talking to two nurses in family they suggested seeing a physician if the fever or chills returned - so far they have not.
Inadvertent administration of vaccine.  Client was 16 at time of administration, RN believed patient to be over 18 years of age.  Given 50 mcg dose.  Parent notified and reports no adverse reaction
Phone call from mom reports a hive like rash on abdomen 2-3 days after injection, lasting 2 weeks. Unresponsive to Benadryl. Not evaluated by physician. Resolved.  Referred to Allergist.
On March 22,2018 pt states she received both vaccines in left upper deltoid, during the injection she states she felt pain and as if the needle was going in a downward direction instead of going in straight. Pain was immediate and increased throughout the day. By night time patient states pain left deltoid was 10/10 and unable to sleep. Patient states she took TYLENOL alternating with Ibuprofen and ice first couple days without full pain relief. States pain is deep and achy constant worse with movement radiates to left hand. Denies numbness and tingling. Patient states she is still taking the alternating ibuprofen and TYLENOL sporadic thorough the day without relief.
it left a scar with death tissues of skin with red fluxes around it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SCAR (it left a scar with death tissues of skin with red fluxes around it) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAR (it left a scar with death tissues of skin with red fluxes around it). At the time of the report, VACCINATION SITE SCAR (it left a scar with death tissues of skin with red fluxes around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Exercise induced asthma" (unspecified if ongoing); "Known allergy: Bactrim" (unspecified if ongoing); "dishydrotic eczema" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL, start date: 01Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound - tested positive after testing negative; Positive, notes: Rebound - tested positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
sweating profusely; very dizzy; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating profusely), DIZZINESS (very dizzy) and NAUSEA (nauseas) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced HYPERHIDROSIS (sweating profusely), DIZZINESS (very dizzy) and NAUSEA (nauseas). At the time of the report, HYPERHIDROSIS (sweating profusely), DIZZINESS (very dizzy) and NAUSEA (nauseas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-MAY-2021.Added AEs has resolved and declined further Follow up as consumer stated.
11/22/23 Employee has denied taking FLU shot for the season 2023 at the time of FLU vaccine administration at 0815. Employee was monitored for 15 mins after administration. At the time of documentation, I found an entry for season 2023 in the database. I contacted employee to confirm the FLU shot. Employee admitted having previously taken the FLU shot before on 9/12/2023 with hospital and employee stated she thought this is the updated series. I asked employee if she is feeling ok ? Employee stated she is feeling fine no adverse or serious symptoms stated at the time of call at 1400. Employee educated to seek immediate medical care and call 911 if severe reaction or adverse reaction occurs. Educated employee about FLU shot that should be taken once every season per year. Supervisor notified.
swelling @ site (size of 1/2 tennis ball) h/a, joint pain x 5 days;
In addition to the normal side effects of fever, chills, headache and body aches, I developed severe chest pain approximately 34-35 hours after the second Pfizer dose. The pain lasted for a few hours and was severe enough that I had to crawl down the stairs to get to the kitchen in an attempt to find an antacid, in hopes that the pain was related to heartburn (which I don't typically have) and that they would help (they did not).
HOT SPOT ON ARM WHERE SHOT WAS GIVEN WAS TOLD COLD COMPRESS AND BENADRYL THEN WENT TO DR AND PRESCRIBED CLINDAMYCIN ON 11-6-2015.
pt stated that 3 days p/vax 27OCT94 devel flu-like sxs lasting 3 days, felt better for 1 day & exp same sx; pt unable to get out of bed x 1 wk; hospitalized 11NOV94 x 14 days; dx kidney failure & GBS:
Second day, redness and swelling below injection site.  Started size of quarter, grew to size of $.50.  Tender, especially to the touch  Warm to touch.
Pt developed six vesicles on his trunk on red base. Induration of 3cm around injection site with 3 vesicles within indurated area. Warm and red treated with antibiotics.
Breakthrough case admission after 2 vaccines Pfizer 4/24/21 Lot# Ew0150;  PFizer 5/15/21 Lot# Ew0158
Starting at 16 hours after vaccination, experienced mild body aches and low grade fever for 24 hours. Sore arm for 3 days.
got a fever of 102 and started hallucinating she has been seeing things off and on, having a bad pain in arm, bad headache and sensitive to light.