chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WAS AWAKENED WITH FEELING OF TERRIBLE PRESSURE IN MY HEAD, FEELING OF MY EYES BULGING ALONG WITH SEVERE PAIN, NECK PAIN ESPECAILLY ALONG THE LEFT SIDE OF MY NECK. FELT AS IF THE TOP PART OF MY HEAD WAS FULL OF AIR, AND THE TEMPLES RIGHT AND LEFT WERE ACHING AND PAINFUL!!! THIS HAD GONE ON FOR 3 WEEKS.! MY PCP WAS CONTACTED AND I VISITED HER, AND SHE ORDERED A STAT CT SCAN OF THE BRAIN, AND LAB WORK LOOKING FOR INFLAMMATION AND TEMPORAL ARTERITIS... SHE PLACED ME ON 50 MG OF PREDNISONE X 4 DAYS. AND I DID HAVE POSITIVE RESULTS WITH THE USE OF THE PREDNISONE. STILL HAVE SLIGHT RESIDUAL FUNNY FEELING IN THE HEAD BUT NOTHING LIKE IN THE BEGINNING. VERY SCARY!! BRAIN SCAN WAS NL, LABS WERE NL, AND IT HAS BEEN 4 DAYS SINCE THE TREATMENT TOOK PLACE,
Within 4 minutes of injection, patient's left side of neck became red, itchy, and began spreading down onto the chest.
The vaccine was given out of the recommended schedule. Patient was monitored for a period of time. No adverse events resulted
12-24 hours after injections - left thigh swollen, red, sl tenderness. 48 hours after injection left thigh double the size q right thigh. 7" area of erythema
On April 18, 2021 approximately 48 hours after receiving dose 2 of the Pfizer COVID-19 vaccination, I experienced intermittent moderate abdominal cramping and liquid yellowish diarrhea which lasted approximately 12 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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: "Htn" (unspecified if ongoing); "myasthenia gravis" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: None. The patient received COVID 19 treatment with Paxlovid orally from 09Dec2022 to 13Dec2022.   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.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Patient received her COVID-19 Vaccine. Before receiving her vaccine I asked all proper questions regarding history of reactions or if she felt ill at the moment (proper screening questions). The only thing the patient mentioned was that she had asthma and had been feeling it acting up recently but no current issues at the moment. I assured her that it was still ok to receive vaccine according to CDC guidelines. After the vaccine, the patient started getting an immediate headache. Soon after that she felt a wave of nausea. Right after that patient began stating that she felt her asthma attack coming on. I triaged the patient accordingly and checked her breathing/circulation/etc. I also asked her if she felt like she couldn't breathe or if she felt her throat closing up. She could still talk and said she did not feel her throat closing up. She just kept saying it was her asthma attack coming on (the same feeling she gets with her asthma acts up). I grabbed epi-pen in hand and came to her side assessing the reaction. She then began to have a light wheeze/hyperventilation and stated her asthma was the culprit. I immediately ran to pharmacy and grabbed albuterol inhaler which she also stated she uses. She used the inhaler did 2 puffs immediately. I stood by her side and kept assessing the reaction. She still had a light wheeze and was very anxious/emotional. I kept asking if she felt her throat closing up and kept asking her questions to make sure she could still talk. She said she just felt very dehydrated and severe asthma symptoms. Stood by her side for a few more minutes kept assessing with Epi-pen in hand ready to inject. I told her to do one more additional puff and after a few more minutes she could breathe more easily and felt a huge relief. Received emergency rx from her physician in order to fill prescription for her albuterol.
Narrative: Admitted: JAN 3,2022 Discharged: JAN 5,2022 71yoM with PMHx HPL, T2DM, CVA (with residual UE paralysis) who presented to Emergency Room 1/3/22 from home. The patient is vaccinated x2 against COVID- 19 and had a sick contact (wife, +COVID) at home. Per wife, his behavior was altered from norm, including increased drowsiness, decreased appetite and confusion. The patient reportedly had onset of cough and upper respiratory symptoms on Friday 12/31/21, which continued to worsen. On Monday morning 1/3/22 patient was very difficult to arouse and very lethargic, which is off his baseline. Patient was admitted with COVID infection which may likely be contributing to encephalopathy, however ruled out superimposed infection, structural causes, electrolyte imbalances. Not candidate or dex/remdesivir given no O2 requirement. This improved by discahrge. At discharge, he was oriented x 3 and mentating appropriately, following commands, and was at baseline. He was not hypoxic on day of discharge. O2 sat was checked and was 98% at rest. Given that he was not hypoxic and his encephalopathy improved, he was deemed stable for discharge.
Pt is experiencing brain fog and difficultly finding words.  It has not improved and it has been now 8 days.  She feels her brain has swelling and feels like her brain often needs to rest.
MMR vaccine administered in RUE SQ in posterior upper arm approximately 3" above elbow. By early evening had developed a large knot and swelling and redness of RUE posterior where vaccine was given. 12 hour later area of redness the size of 25 cents
VACCINE ADMINISTERED AT 12 YEAR AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 12 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced vaccine administered at 12 year age. On 24-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine administered at 12 year age and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210548034.
Redness, swelling, tender to touch on left arm x 2-3 days tx: Keflex 500mg 1 tablet PO TID x 7 days.
Pt broke out in hives from the torso down. Mom gave her Benadryl that night and the hives went away.
Redness, pain, itching, flu like symptoms, headache, dizziness, nausea, chills and joint pain.
17 years old and received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose). On 22-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) had resolved. Not Provided      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.   Concomitant product use was not provided. Treatment information was not provided.    This case was linked to MOD-2021-090234, MOD-2021-228590 (Patient Link).
No Adverse event happened. The patient received inadvertently received 2nd updated Pfizer bivalent shot
fever; chills; weakness; vision changes; blurry vision; runny nose; nose bleeds (with clots); This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), VISION BLURRED (vision changes), VISION BLURRED (blurry vision), RHINORRHOEA (runny nose) and EPISTAXIS (nose bleeds (with clots)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ASTHENIA (weakness), VISION BLURRED (vision changes), VISION BLURRED (blurry vision), RHINORRHOEA (runny nose), EPISTAXIS (nose bleeds (with clots)) and CHILLS (chills). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), VISION BLURRED (vision changes), VISION BLURRED (blurry vision), RHINORRHOEA (runny nose), EPISTAXIS (nose bleeds (with clots)), PYREXIA (fever) and CHILLS (chills) was resolving.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Child received varicella vaccine on 1/25/05, on 2/12/05 the child developed a rash on his face and back without fever. On 2/18/05 the child saw Dr and was Dx with varicella. Rx of Acyclovir and Calamine lotion.
caller got Pfizer covid vaccine first dose on 28Mar, caller tested positive for covid on past Sunday,; caller got Pfizer covid vaccine first dose on 28Mar, caller tested positive for covid on past Sunday,; This is a spontaneous report from a contactable consumer (the patient) via Pfizer-sponsored program.   A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 28Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in April 2021, caller tested positive for covid on past sunday. The second covax was due on 16Apr2021 but she couldn't go she was positive for COVID. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
8/29/12 11:15am pt had KINRIX (DTaP/IPV combo), MMR and varicella vaccines. Mother called the provider on call 8/30/12 5:30am that pt was delirious, vomiting and had a fever of 103. Given Acetaminophen suppos. and told to give ice pops.
Pt. was given Pfizer 30mcg/ 0.3 ml purple cap when he was 11 years, and 11 months old. He did not have any reaction to this being given. No adverse reaction was noted or reported at that time. He should have received the Pfizer orange cap 5-11year 10mcg/ 0.2ml dose. He was not yet 12 y.o. at the time the first dose was administered.
Local pain; Fever; This non-serious case was reported by a physician via call center representative and described the occurrence of pain localized in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain localized (Verbatim: Local pain) and fever (Verbatim: Fever). The outcome of the pain localized and fever were unknown.   It was unknown if the reporter considered the pain localized and fever to be related to Shingrix.     It was unknown if the company considered the pain localized and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR038112   Additional Information: GSK Receipt date: 09-Mar-2023 The physician reported that he had received the Shingrix series.  After 1st dose he experienced common reactions such as fever and local pain.  The reporter consented to follow up email. For tolerance of 2nd dose refer linked case US2023AMR038112, reported by same reporter; Sender's Comments:  US-GSK-US2023AMR038112:Same reporter
dizziness; arm pain; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FL9261), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (at the age of 84-year-old) as single dose for COVID-19 immunization. Medical history included flu (The patient went to (place) for winter. Last year when they both got home, they were really sick. Both patient and her husband, had to go to the Emergency room. Were sick for 3-4 weeks. Believes they had the COVID virus. Can't say for sure if it was COVID but was told they both had the Flu. Patient mentioned this to the doctor and some say she and her husband might have had the COVID virus. Confirmed this was a year ago, prior to receiving the COVID vaccines). Concomitant medication included heart pills and a blood pressure pill (unspecified). She takes two pills a day. The patient did not receive additional vaccines on same date of Pfizer suspect. The patient did not receive prior vaccinations within 4 weeks and had no AEs follow prior vaccinations. The patient had no family medical history. The patient received first dose of the Pfizer Covid vaccine on 26Jan2021. She experienced dizziness after the first dose and arm pain. The patient had no relevant tests. Outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Swelling of upper arm, redness in a demarcated band 5 inches wide around entire circumference of arm below injection site and 1 inch above,  severe pain and tenderness including underside of arm near armpit, pain when raising arm, bruising
Fatigue, muscle soreness, feeling warm and bruising at the vaccination injection site. I?ve tried to drink water and have taken ibuprofen.
extreme heartburn; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (extreme heartburn) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (extreme heartburn). At the time of the report, DYSPEPSIA (extreme heartburn) outcome was unknown.            No concomitant medication was reported. Treatment drug information was not given.
redness & swelling of lt arm since 24hrs p/vax went to ER evening of 13FEB96 & was given ATB inj;
pt recvd vax & the next day devel maculopapular, raised, erythematous rash of the face, neck, chest, back, abdo & extremties; itching, urticaria, erythema multiforme; rash;
Patient reported to have developed a skin rash on his left arm around the injection site and on his back.
swelling on administration site, knot, ot to touch 3" in diameter-swelling of face especially under eyes;
Sudden breakout in hives on the evening of 12/24 followed by worsening symptoms on 12/25 and 12/26 leading to an ER visit. Rash/Hives move based on wherever patient scratches or touches. Given Benadryl, Famotidine, and Oral Steroid at ER on 12/26. Currently taking 7 day prednisolone taper pack, with 1x Zyrtec in the morning, and Benadryl as needed every 4-6 hours. Itching goes down with Benadryl, otherwise symptoms continue.
I started noticing constant fatigue about 3-4 weeks after my second dose, it was getting harder and harder to walk. It continued getting worse, to the point where I had to retire from my job. I couldn't make it from my car into work. I am getting pain in my chest and shortness of breath. I was given a new CPAP machine in case that was contributing to the factor, but it was not helping.  I pursued numerous tests through my doctor's, nothing was coming up conclusive. No medications were given since they could not find out what was going on. This is currently still going on, I feel like it is steadily getting a little bit worse.
consistently cold; had a fever of 101; chills ("heating pad on me"); tired; all she does was sleep; she could not breathe; she lost sense of smell and taste; she lost sense of smell and taste; The patient has been sick ever since the first dose; This is a spontaneous report from medical information. A contactable consumer (patient) reported that a female patient of an unspecified age (reported as 61; units unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose, for COVID-19 immunization.  Medical history included sinus infection. The patient's concomitant medications were not reported.  The patient has been sick ever since the first dose. Yesterday (08Feb2021), she lost sense of smell and taste. The patient has been consistently cold, had a fever of 101, chills ("heating pad on me"). The patient was also tired that all she do was sleep. Patient has a history of sinus infection, hoping it was that, but she could not breathe. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Patient Date of death: 7/4/2022 County: local COVID (+) Death Admitted to local MEDICAL CENTER on 6/27/2022 Tested positive for COVID on 6/29/2022 Admit reason: Acute respiratory failure with hypoxia. 3 DOSES COVID VACCINE PRIOR TO DEATH.
issue with her eye's; short-term memory issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US064130_NC (Agency).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "issue with her eye's"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "short-term memory issues".  Additional information:As you may be aware, the FDA Guidelines for Post marketing Reporting of Adverse Drug Reactions require that:"Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant."Additionally, the requirements concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section.We are, therefore, forwarding the information below relating to your product which was obtained by one of our staff during the normal course of business  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, headache, body aches, beginning 7 hours after vaccine, lasting 24-36 hours
J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 CANCER METASTATIC TO OMENTUM J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 CANCER METASTATIC TO OMENTUM J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 ABDOMINAL PAIN J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 CANCER METASTATIC TO OMENTUM J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 BILIARY COLIC W OBSTRUCTION J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 ABDOMINAL PAIN J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 GERD (GASTROESOPHAGEAL REFLUX DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 ABDOMINAL PAIN
Initially patient's blood sugars went high despite insulin administration. He became lethargic worsening at one week post vaccine and was hospitalized.  discharge summary as follows:  Hospital Course: 56 y.o. morbidly obese male with history of T2DM, HTN, CVA with left-sided deficits, follicular lymphoma, psychogenic polydipsia and prior episode of hyponatremia who was brought in by ambulance from home, presented in a somnolent, lethargic state, with family concern of multiple falls around the home this past week.  Patient denied any specific complaints other than his chronic pain.  He was mostly somnolent and difficult to arouse but did answer questions when he awoke.  He was found to be profoundly hyponatremic (serum sodium 97) and with marked leukocytosis of 33,000.  No other SIRS criteria met and no source or site of infection identified.  Head CT scan showed no acute intracranial abnormalities.  Patient was admitted to the ICU to manage his profound hyponatremia. With saline hydration and fluid restriction, serum sodium level started to go down slowly.  4 hours into admission, serum sodium was up to 100 and10 hours into admission, it was up to 102.  His mental status improved to the point that he was conversant towards the end of the second hospital day. Rounds at 12 midnight on 11/12/2022 revealed that patient had vomited and soiled his bed.  Staff then changed his gown and bedding and while repositioning the patient, he became unconscious and unarousable, diuretic, hypotensive.  No pulse was noted so CPR was started and CODE was called.  Patient had ACLS resuscitation including intubation and placement on mechanical ventilatory support  After the initial revival, patient continued to have tachycardia and PEA.  Chest compressions were the whole code process was done for more than 190 minutes.   With a rhythm of asystole, patient was pronounced dead at 3:02 AM 11/12/2022..