chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent  condition, medical history or allergy/drug reactions were reported. On 21-AUG-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a female consumer refers to herself of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lt/batch #, dose and route were unknown). The patient stated that she had an "unspecific allergic reaction" after receiving PNEUMOVAX 23. It was unknown if patient sought medical attention. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
He received 3 anthrax vaccinations in 2008, 2009. He developed a mild headache following the 1st dose that lasted a few days. After the 2nd and 3rd doses the headache was more severe and occurred 2-3 times per day for the next couple of years. Now, they are 3 times per week and feel like a severe brain freeze. The intensity is 7/10 and seem to occur at random. He is troubled occasionally by vertigo and he has found that a headache will develop immediately after.
Severe hives began 6/30/08.  Received Gardasil #2 6/9/08.  Hives several days = at office with hives, chills and headache 7/9/08 = 10 days.
ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/6/2023 & 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Ringing in ears, starting in late afternoon, worsening every evening.  Started about a week ago and happens every day.
scratchy throat; blisters on the roof of mouth; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route of administration on 15Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy, environmental allergy and exercise induced anaphylaxis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced scratchy throat, not a big deal but also got blisters on the roof of the mouth, the kind of burn in the mouth from a hot beverage, and sore arm until day 3. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore throat, pain in arm and blisters was not recovered. No follow-up attempts are needed. No further information is expected.
Patient started experiencing fever, chills, nausea, vomiting, and body aches at approx 10:30pm the evening the vaccine was administered.  Patient woke up the next morning at approx. 6am with hives from head to toe.  Patient took Benadryl by mouth and used caldryl topically.  Patient stayed the same.  They did make an appointment with urgent care and on their way there his face started to swell.  Instead patient detoured to the ER.  AT the ER they gave him iv Benadryl and a steroid vaccine.  Patient was then sent home with more steroids and antihistamines, and pepcid.  Patient started to improved but last night 10/31/2021 patient started to get worse again and returned to the er last night and they gave him another steroid vaccine and oral Benadryl.  They also sent him home with another rx of steroids.  Patient seems to be doing a little better this morning around 5:30pm.
Fatigue, headache, achiness, arm tingling. Arm/shoulder pain increasingly worse over time and continues to date.
More pain on spot on chest; caused more pain on the spot on chest; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of painful rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (4 years ago). Previously administered products included COVID VACCINE with an associated reaction of rash (Spot on chest more painful.), Shingles vaccine with an associated reaction of rash (The patient received old shingles shot on an unknown date) and Shingles vaccine with an associated reaction of rash (received new shingles vaccine 1st dose on an unknown date, refer case US2023AMR041272). Concurrent medical conditions included painful rash and skin irritation.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced painful rash (Verbatim: More pain on spot on chest) and condition aggravated (Verbatim: caused more pain on the spot on chest). Rechallenge with Shingles vaccine was positive. The outcome of the painful rash and condition aggravated were not reported.   It was unknown if the reporter considered the painful rash and condition aggravated to be related to Shingles vaccine.     It was unknown if the company considered the painful rash and condition aggravated to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR041272   Additional Information: Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles four years ago and still had some pain on chest. Most time it was just a very mild irritation, but when patient got a flu shot, or Covid shot the spot on his/her chest was more painful.  The patient had both the old and two new shingles shots since and they also caused more pain on the spot on his/her chest.  The follow-up could not be possible as no contact details were available. This case refers to additional dose of singles vaccine. This case had been linked with US2023AMR041272 and US2023AMR041283 for single patient.; Sender's Comments:  US-GSK-US2023AMR041272:Same patient
Within 10 minutes of getting the vaccine, the pt experienced dizziness, turning pale, became blue, diaphoretic, headache and stomach ache. Got better over the next 1/2 hour. He was laid down and he got better. Probable vasovagal response.
felt fine till 10PM evening devel progressive SOB, gasping for breath over period of 2hr worsened by lying down;went to ER given 02;adm next day noticed red blotches on legs not itchy;MD unsure if linked to vax;
Non-injection site zoster like rash developed around trunk and anterior side of left arm 5 to 7 days after injection. Treating itching with topical medication. Not treating pain as patient not uncomfortable from rash.
she felt fatigue which she still feels today; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 1 via an unspecified route of administration on 08Apr2021 as SINGLE DOSE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient experienced she felt fatigue which she still feels today on 08Apr2021. On 08Apr2021 was her first dose of the covid vaccine. Within 3-4 hours she started experiencing fatigue and still has it as of 12Apr2021. She is wondering if she should still get the second dose. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Per Hospital notes, on 1/17/22 was admitted to Hospital and presented to the hospital with complaints of 1 week of weakness and malaise.  Diagnosed approx. 10 days prior to admission with COVID19 and has been progressively more weak with poor oral intake of food and fluids.  She intermittently had SOB and cough.  She c/o generalized diffuse abdominal pain that was currently being presumed lymphoma and had been discussing plan of treatment with Dr. of Cancer Center.  Complaint also received of patient loosing her sense of taste and smell approximately 1 month prior.  Patient also reported of having difficulty speaking for the past month due to laryngitis.  On 1/26/22 patient expired in ICU.  Notes state that patient's code status was to allow natural death therefore resuscitation was not performed and patient was pronounced dead at 1137.  Clinically patient appeared to have hematologic malignancy, lymphoma with significant uric acid and likely related to acute kidney injury.  Patient's decline noted to be rapid.  Death certificate listed cause of death as:  Cardiac Arrest with Asystole; Hypoxic Respiratory Failure-minutes Pulmonary Emboli;  Deep Vein Thrombosis-days Large B-Cell Lymphoma; Liver Cirrhosis-months to years
significant swelling of left axillae lymph nodes neck stiffness/tendereness brain fog metalic taste
Did not feel so great; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FEELING ABNORMAL (Did not feel so great) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder since an unknown date. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Autoimmune disorder, HYDROCHLOROTHIAZIDE and RAMIPRIL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Did not feel so great). On 23-Jan-2021, PAIN IN EXTREMITY (Pain in arm) and FEELING ABNORMAL (Did not feel so great) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information included Haif a Benadryl, Methylprednisolone and inhaler.    This case was linked to MOD-2021-027856 (E2B Linked Report).; Sender's Comments:  MOD-2021-027856:Same patient, 2nd dose
Patient fainted about 1 minute after vaccination. Patient was unresponsive for about 10 seconds. Patient was given ice pack. EMS came and patient did not want to go get treatment
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got 2nd dose of Moderna Covid19 vaccine 6 days apart) and EXTRA DOSE ADMINISTERED (3 weeks later the patient got 3rd dose of Moderna COVID-19 vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B218) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got 2nd dose of Moderna Covid19 vaccine 6 days apart). On 07-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (3 weeks later the patient got 3rd dose of Moderna COVID-19 vaccine). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got 2nd dose of Moderna Covid19 vaccine 6 days apart) had resolved. On 07-May-2021, EXTRA DOSE ADMINISTERED (3 weeks later the patient got 3rd dose of Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. The patient is not on any concomitant medications. The patient did not experience any symptoms and no treatment was given.
Next day woke up and had a bad headache and it was there all day, then the next day, started feeling sharp pains in right calf, legs and back of my neck, felt like it was shooting up her neck to head. The doctor said it was only from pulled muscle and didn't take me seriously. Felt extreme foggy-headed and dizzy. Still haven't fully recovered from foggy-headedness and dizziness. When I tried to reach out to the doctor even now, he doesn't take her seriously.
On the 2nd after the shot I had sinus problems with a sore throat. On the 3rd day and for 4 days after the violent un-controlled  coughing . Coughing up blood and fluid, not food.
Received the Janssen COVID-19 vaccine 3/19/2021 and reported no adverse events at that time. Received the Pfizer COVID-19 vaccine as booster 11/30/2021. on 12/6/2021, she fell in the shower while at PT and sustained a bruise on her RIGHT shin. Injured area became red and inflamed, so she was seen in ED on 12/22/2021 and was prescribed doxycycline x10 days for treatment of cellulitis. Imaging was not done at that time. She was seen in primary care on 12/28/2021 for failure to improve with antibiotics; pain and swelling of the calf were worsening. D-dimer was elevated and US positive for DVT of the right peroneal vein; questionable right medial thigh saphenous branch varicosity nonocclusive thrombosis. She was sent back to ED on 12/30/2021 after her US resulted and she reported chest pain and shortness of breath. No evidence for pulmonary embolism on CTA. She was started on Eliquis and discharged to home, where she has been recovering. Still having right lower extremity pain and swelling at ED follow-up visit on 1/5/2021.
experienced TGA (Transient global amnesia); This case was reported by a nurse via call center representative and described the occurrence of transient global amnesia in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 93JN5, expiry date 19th September 2022) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix. On 28th July 2020, 5 days after receiving Shingrix, the patient experienced transient global amnesia. On an unknown date, the outcome of the transient global amnesia was unknown.   It was unknown if the reporter considered the transient global amnesia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had experienced Transient global amnesia. The reporter consented to follow up.
Case number PHEH2014US025032, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 22-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 26 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
sickness for 2 days; fever 101.7; headache; couldn't open my eyes; This is a spontaneous report from a contactable consumers.   A 50-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in arm right on 13Apr2021 at 13:15 as single dose (at the age of 50) for COVID-19 immunization (Public Health Clinic/Veterans Administration facility). The patient's medical history was not reported. Patient took unspecified concomitant medications. Patient had no known allergies. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on an unknown date in Mar2021 at 12:00 as single dose (at the age of 50) for COVID-19 immunization and got the virus after first shot. Patient was not pregnant at the time of vaccination and has not received any other vaccines in four weeks. The patient experienced sickness for 2 days, fever 101. 7, headache so bad that patient couldn't open my eyes all on unknown date in 2021. Patient was not having COVID prior vaccination and not been tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.7 on 28Mar2021. Patient has not received any treatment for the events. The outcome of the events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021437457 same patient and reporter, different dose and event
night of vaccination: chills and fever Next day: fever, tired day 2: some neck pain and swollen axillary lymph node day 2 evening: minor headache around temple day 3: swollen axillary lymph node, sporadic temple pain
Flu; Initial information received on 02-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown demographic patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I know someone not me that got a flu shot every year and still got the flu and was out of work for a week every year."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
I was driving in my car and i felt my chest pounding fast.  I used my pulse ox machine to check my pulse, and it was at 160. I almost passed out driving. I pulled over, called an ambulance. When they got there 5 minutes later my pupse was 145. I was nauseous, light headed, dizzy and it felt like my heart was coming out of my chest. I went to the ER where they performed various tests. See below.  On 5/4.  I had another bad tachy episode while at work, where my pulse got to 160.  I was able to bring it down, but it took my 1 hrs to not feel dizzy and light headed again. I was again nauseous, dizxy, chest pounding, sweating.   I got an appointment with my PCP that day and had further tests.
got sick after getting vaccinated and a week later he was buried; This is a spontaneous report from a contactable consumer. This consumer (patient's friend) reported for a male patient (reporter's friend). A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got sick after getting vaccinated and a week later he was buried on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: got sick after getting vaccinated and a week later he was buried
Tinnitus from second shot after first day till present day. Both ears  Extreme high hart rate started around 5 days after second shoot. So extreme i went to the ER twice in one day. i thought i was having a heart attack.
after last booster shot 08Mar23, 2-days after shot i started breaking out on the front of the shoulders with small hard pimples; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 at 14:30 as dose 5 (booster), single (Lot number: GK1337) at the age of 86 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine: 1st COVID-19 , Lot Number: Pfizer EL3246, Date: 12Jan2021, Healthcare Professional or clinic site: (Withheld), DOSE 1, SINGLE), administration date: 12Jan2021, when the patient was 84-year-old, for COVID-19 Immunization; BNT162b2 (Vaccine: 2nd COVID-19 , Lot Number: Pfizer EL9265, Date: 04Feb2021, Healthcare Professional or clinic site: (Withheld)Healthcare Professional or clinic site: (Withheld), DOSE 2, SINGLE, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 04Feb2021, when the patient was 84-year-old, for COVID-19 Immunization; BNT162b2 (Vaccine: Other , Lot Number: Pfizer FF2588, Date: 10Sep2021, Healthcare Professional or clinic site: (Withheld), DOSE 3, SINGLE, Anatomical site of injection: RT Arm, Route of administration: Intramuscular), administration date: 10Sep2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (Vaccine: Other , Lot Number: Pfizer FJ6369, Date: 12Apr2022, Healthcare Professional or clinic site: (Withheld), DOSE 4, SINGLE, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 12Apr2022, when the patient was 85-year-old, for COVID-19 Immunization. The following information was reported: ACNE (non-serious) with onset 08Mar2023 at 16:00, outcome "recovered", described as "after last booster shot 08Mar23, 2-days after shot i started breaking out on the front of the shoulders with small hard pimples". Therapeutic measures were not taken as a result of acne.  Additional information: Reported as, After last booster 08Mar2023, 2 days after shot the patient started breaking out on the front of the shoulders with small hard pimples, about 5 on each sides some more on the side of the neck. The pimples would pop with little effort after about 3 days, then heal. After about 3 days the pimple would come back. After they back the second time they only lasted 2 days, and gone for good.
Patient received her vaccine and stayed for her required 15 minutes and when she rose to leave, she started to slump down.  One of the EMS staff rushed to her and assisted her to the floor.  She was unresponsive for about a minute.  Her hands were cold and clammy.  Unresponsive to verbal and physical stimuli.  When she began to wake, she stated she had a hard time breathing.  EMS on site for first aid and assessment.  Blood pressure elevated (160/92), Pulse 77 and Pulse Ox 99%. Patient was taken by ambulance to local ER - accompanied by her husband.
She went to school and ate breakfast. At 9 am ( 2hrs after the shot) she started having nausea and vomiting and shortness of breath and shaking all over.  She called our office and we sent her to the ER. She went to Hospital.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 26-OCT-2014 the patient was inadvertently vaccinated with the third dose of M-M-R II (dose, lot# and expiration date not reported) subcutaneously rather than VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Arm swelled and swelling moved up into neck area. Had trouble breathing. Emergency room gave epinephrine, antibiotic.