chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills. Aches- legs- muscular cough and copius plucous from deep in lungs. Headache-fogginess. Fever 99.5. Going to doctor!
Facial numbness and eye twitching x 8 hours (until went to sleep). Resolved upon waking. No Treatment necessary.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (mother) reported that a male patient of unknown age and ethnicity/race received on 27Jul2017 a single dose of TRUMENBA for immunization. In Jul2017 the patient had upper arm swelling and fever at 99.6 F. Outcome was unknown.
On 3/26/99, the pt received her first injection of Lymerix. She received her second injection on 4/27/99 and her third on 3/7/00. Three hours post vax (3rd), the pt experienced flu-like symptoms, body aches, and fatigue.  The most recent information received on 3/15/00 reports the outcome of the events as resolved after one day.
After vaccine, patients arm got very swollen, red and hot. She felt very tired and achy. Later that evening she blacked out and no pulse could be found. Ambulance was called and patient was monitored at hospital overnight.
swelling of under the tongue; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the arm left on 31Mar2021 at 08:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillins. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced swelling of under the tongue. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event swelling of under the tongue was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe Headache After the Vaccine was given.  I experienced Chills the following evening and a Fever the following evening on August 4th.  Also nausea and extreme fatigue the following day.  SEVERE Arm pain at the injection site, still existing nearly 48 hours after injection.  Fatigue and general body soreness is also experienced nearly 48 hours after the injection.  Rapid breathing and tightness in lungs is also felt (mild).    I am vey healthy and never get these symptoms, the vaccine caused these symptoms.
Patient experienced hives all over the body 4 days after receiving the COVID vaccine. Patient was seen in dermatology clinic and was prescribed Cetirizine 20 mg BID, Famotidine 20 mg BID, hydroxyzine 25-50 mg qhs prn, provided information regarding slow taper off antihistamine regimen. Was advised to reach out if no significant improvement over the next 48 hours (so that he can work and sleep), but wouldn't expect him to be able to go off medications until at least 4-6 weeks.
This spontaneous report as received from a other health professional (Immunization Coordinator) refers to a three unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX23 (route, lot number, expiration date were not reported, dose 0.5 ml). Concomitant therapies included ADACEL. On an unknown date the patients received PNEUMOVAX23 and ADACEL in different arms during the same office visit. On an unknown date the patients experienced severe pain, swelling and tenderness at the injection site. It was unspecified by reporter if the severe pain, swelling and tenderness at the injection site occurred in the arm where the PNEUMOVAX 23 was administered. The patients did not seek medical attention. The outcome of the events were not reported. Additional information has been requested.
SEVERE pain in the arm. Not where the vaccine was given but farther down. For 2 days couldn't even move my arm. It is now nearly a month later-and I still have a sore arm. It doesn't always hurt now-seems to be cyclical. After about 3 or 4 days I could move it-but with pain. No rash, feeling fatigued.
Patient received Moderna 1st dose on 1/17/2022, but is currently underage for Moderna (patient is17 yo, not 18)  Called patients father and left message. No response back at this time.  Called drs office said to follow guidelines and give second dose when the time comes.
7NOV96 onset of tingling sensation in hands & feet;8NOV96 unable to walk;hosp x 10 days;discharge dx GBS;Annual follow-up dated 10/23/00 states that the pt has aching and burning of lower extremities from knees down.
6JAN97 nauseated in evening;7JAN97 sl itching & hives;8JAN97 hives all over legs w/some on buttocks;stomach & arms also very light headed & felt like floating;8JAN97 called & advised to see MD;10JAN97 felt better so did not see MD;fel
After receiving the Booster shot on 11/12/21, I developed shortness of breath and started retaining fluid.  I couldn't walk more than a few feet without losing my breath.  I went to the doctor who immediately gave  me an echocardiogram then sent me for a stress test which I failed.  From the stress test I was admitted to the Emergency Room at Hospital. Severe Heart Arrythmia
12:01PM  BEGAN TO FEEL SHORTNESS OF BREATH, CHEST PRESSURE, LIGHTHEADEDNESS.  AFTER RECEIVING 2ND DOSE OF PFIZER VACCINE LOT # EN6200.
Date of Service Nov-01-2022 0752  Date of Admission Admit Date: Oct-29-2022  Date of Discharge Date of discharge Nov-01-2022  Allergies LATEX - Not Specified  Tegretol - Not Specified  Chief Complaint flu-COVID symptoms  Procedure(s) Performed None  Lab Results Nov-01-2022 0445 Hematology WBC  5.9RBC  2.76HGB  7.5HCT  23.2MCV  84.1MCH  27.2MCHC  32.3RDW  16.3RDWSD  49.8PLT  137MPV  11.8AUTONEU%  75.6AUTOLYM%  10.5AUTOMON%  9.3AUTOEOS%  0.2AUTOBAS%  0.2AUTONEU#  4.5AUTOLYM#  0.6AUTOMON#  0.6AUTOBAS#  0.0AUTOEOS#  0.0NRBC%  0.3NRBC  0.0HGB/HCT  3.1IG#  0.25IG%  4.2 Nov-01-2022 0445 Chemistry GLUCOSE  135BUN  20CREAT  0.9MDRD GFR  64NA  132K  4.1CL  97CALCIUM  8.3CO2  28.3OSMO  269.2ANION GP  10.8BUN/CRE  22.2CRP  1.00
I think it was a couple days after the vaccine. I started noticing really sensitive nipples. Brushing against it was very uncomfortable. I felt what felt like menstrual cramps. It was on the right and left side of my pelvic area. I just happened to be going to my OBGYN and the nurse said the breast sensitivity, recommended a mammogram after getting the covid vaccine. My reaction to both vaccines were very minimal. I normally react very poorly to any other vaccine. It was very surprising. I will be getting the protein test in a few months, just to make sure that it worked. This was advised by my OB doctor. I am immuno-suppressed. I have nothing else to add at this time.
1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this document 1/14/21 08:00 07:30 increased dry cough, scratchy throat 08:30 sore throat 09:30 mild headache and muscle aches, sore throat, cough when talking 10:30 increasing muscle aches and headache, laryngitis, cough resolving, mild intestinal discomfort 11:00 left work 11:30 all symptoms at 10:30 continuing, increasing fatigue; took 1000mg acetominophen slept most of the time noon - 4 pm 4pm cough resolved, muscle aches continued, headache improved, laryngitis continued.  mild fatigue  6:00 pm noted loss of smell (could not smell cooked garlic - my husband could) Laryngitis & muscle aches continued throughout evening  7:30 pm 2nd dose 1000mg acetaminophen  1/14/20 - 06:00 am laryngitis resolved Ongoing scratchy throat, mild muscle aches, mild nausea/intestinal discomfort.  Laryngitis and cough mostly resolved - but i am not talking much; speech is an irritating factor for both symptoms.  Fatigue improved.  Headache mostly resolved. Took 1000 mg acetaminophen.
Patient received COVID vaccine at approximately 9AM this morning. Stayed 15 minutes after injection for monitoring, felt fine and returned to department. Employee returned at approximately 11:45AM with possible symptoms of reaction. Admitted to a headache that started approximately an hour after injection. Symptoms now include heaviness of arm, chest, feeling emotional, light headed. Vitals taken at 11:48  BP 150/86, P 79, R16 Pox 97. Oral Benadryl 25mg administered PO 11:50AM. EKG run. Patients symptoms progressed to include difficulty breathing and swallowing. Epi pen adult 0.3mg administered IM Left thigh at 12:13PM. Vitals checked at 12:13PM BP 188/90, pulse 97, pulse ox97. Called for emergency response for transport to ER. Pt remained stable until transport by EMS to ER. Employee health informed of patient transport. ER informed of patient transport.
ULCERATIVE COLITIS FLAIR UP; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 total dose administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced ulcerative colitis flair up, and fever. The patient said he was 100 percent while reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ulcerative colitis flair up and fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210843019- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Ulcerative colitis flair up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE.
received booster dose instead of full first dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose). On 22-Jan-2022, ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported.
No adverse effects from vaccine - Vaccine was potentially frozen upon receipt from manufacturer, then thawed prior to administration.
Around 5:00 pm after receiving injection a tickle started in my throat and I started coughing. Became short of breath with center chest pain/ pressure and radiating to underarm area. Started using Provential inhaler 2 puffs every 4 hours and cough syrup. Symptoms not improving after 2 days. Started Zithromax 500 mg  x5 days and Medrol dose back. 6 days this medication was started on 3/16/22. After one day started having severe pain from Fibromyalgia. As of today, 4/1/22, the Fibromyalgia Flare has resolved but continued to have coughing , short ness of breath on exertion, and slight lung pressure evidenced by feeling pressure in armpit area. Still having to use Proventil Rescue Inhaler 2 or 3 times a day verses every 4 hours.
Fever , Chills,  headache, vomiting starting at 11:30 pm day of vaccination.  Headache was not as bad after taking Tylenol.  Most symptoms were gone by Monday morning but then had diarrhea.  Thought it was over but still had diarrhea as of 2:30 Monday.
Vaccine 3:45PM.  Intestinal cramping/pain started 11:50PM.  Midnight to 2am Nausea/Vomiting/ Diarrhea/ Incontrollable shaking/ sweats/heart racing/temp dropped to 95.0/ cold could not get warm/weakness/dizziness 2am-4am rested.  4Am  watery diarrhea/nausea and pain returned.  Temp 99.7 5am-6am rested. 6am watery diarrhea contained blood, chills, temp 101.1 12/31/20 Continued bouts of bloody diarrhea.  Weakness and shaking.  Temp with 1000mg of tylenol 99.0, raises to 101 when medication wears off.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was receiving 2 vaccines (flu+covid). She fainted immediately after receiving 2nd vaccine. Patient was seating during administration and vaccinator caught her as she was slumping forward. Patient was extremely fatigued and hot after episode. It was 10:30am and patient had not eaten anything yet all day. Patient was given orange juice and crackers. Blood pressure 97/50. Continued to monitor for 15-20 mins. She was able to correctly answer what her name is, where she was, and what happened
6:05PM AFTER THE VACCINE WAS ADMINISTERED HE SPECIFIED THAT HE FELT WEAK AND THREW HIS HEAD BACKWARDS.
flu-like symptoms; Fever; headache; muscle aches; Chills; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2021, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, fever, headache, muscle pain and chills. On an unknown date, the outcome of the influenza-like symptoms, fever, headache, muscle pain and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, headache, muscle pain and chills to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The age at vaccination was not reported. The patient received Shingrix vaccine about 6 weeks ago and reported that 12 hours after receiving the vaccine, began to experience flu-like symptoms, fever, headache, muscle aches and chills.. The reporter asked if a second vaccine was needed or if one dose would be sufficient. Referred to health care professional and consented to follow-up. The reporter gave permission to contact health care professional.
(unsure if this relates to vaccination) Had an extreme allergic reaction at 10 pm Monday night (Jan 4, 2021), then another at 3 am Tuesday morning. Took benadryl 25 mg with each episode.  At 6:15 am I passed completely out at sink, hitting my head hard on hardwood floor.  Went to ER for scans.  All scans were clear of brain and chest, awaiting heart results, with further testing for allergens coming up.
Suspected vaccination failure; Got the shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by patient's friend. The age at vaccination was not reported. The reported stated that the patient got shingles then she got the shot to prevent getting shingles again and then she got the shingles again after the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and as details regarding laboratory confirmation of shingles was not provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 47.37   Concomitant products were not reported.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 44, 5PM: 43  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Usual mild sting w/ administration, then increased deltoid swelling and beginning edema upper arm below deltoid. At 48 hrs deltoid almost 2x normal size.  Marked redness/heat of entire upper arm. Edema traveled down to wrist stopping @ hand. Marked pain in entire arm--have NEVER had that type of reaction to vaccine before.
Redness, Pain, and Heat below injection site - Left arm 4.5" x 5"
prolonged seizure disorder (infantile spasms) onset approx 36 hrs p/vax; required 2 wk hospitalization & ACTH therapy;
This spontaneous report was received from a registered nurse via pharmacist via office manager refers to a 11 year old female patient. The patient's relevant medical history and concurrent condition were not reported. On an unknown date, patient was vaccinated with first dose of GARDASIL 9 (lot number and dosage not reported). On 28-APR-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L018351 (expiry date: 11-AUG-2017) (dosage not reported), which had previously undergone a supported temperature excursion. Concomitant therapies were not reported. It was unknown if there was any relevant laboratory data. As of 04-MAY-2016, it was unknown if the patient continued to take GARDASIL 9 and the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with oral, ROTATEQ (dose, lot number and frequency was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from same source. No further information provided. Additional information has been requested.
Child seen in office 05/20/2003 and Dx with varicella. Rash started 7 days ago on trunk and proceeded to extremities.
asymptomatic, tested as f/u to known exposure on 1/4/2022 tested positive of binax rapid antigen 1/6/2022 has had 2 doses of Moderna COVID vax- 2nd dose listed above, no booster doses
Shock to body (hospitalized for 5 days); This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included treprostinil (Tyvaso) (batch number 2102219, expiry date 30th November 2023) for secondary pulmonary arterial hypertension.   Concurrent medical conditions included pulmonary arterial hypertension.   On an unknown date, the patient received Shingrix. On 27th January 2017, the patient started Tyvaso (inhaled) 90 ug 4 times daily (360 ug daily). On 9th October 2022, unknown after receiving Shingrix, the patient experienced shock (serious criteria hospitalization, GSK medically significant and other: serious as per reporter). The action taken with Tyvaso was unknown. On 11th October 2022, the outcome of the shock was recovered/resolved.   The reporter considered the shock to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: The patient received patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) currently delivered by Tyvaso Inhalation Device (TD-300/A), on 27 Jan 2017 for secondary pulmonary arterial hypertension. The current dose was reported as 90 µg (15 breaths), four times a day (QID) (off label use) via inhalation (IH) route. On an unreported date in Oct 2022, the patient was hospitalized due to issue with shingles vaccine causing a shock to his body (immunisation reaction, hospitalized and shock, medically significant, hospitalized) a month ago for 5 days. He said a nurse checks in with him weekly. On 09 Oct 2022, 5 years 8 months and 13 days after initiating Tyvaso, the patient was hospitalized due to issue with shingles vaccine causing a shock to his body. At the time of reporting, the outcome of immunisation reaction was resolved on 11 Oct 2022. Action taken with Tyvaso was not reported for the events of immunisation reaction and shock. At the time of reporting, the outcome of immunisation reaction and shock was unknown. The reporter did not provide causality for the events of immunisation reaction and shock with Tyvaso. The reporter's causality for the events of immunisation reaction with shingles vaccine was considered to be possibly related. The physician assessed the causal relationship between the Tyvaso and the events of immunisation reaction and shock as not related. The company had assessed the serious adverse events of Immunisation reaction and shock as not related to IH treprostinil and TD300/A device. The events were likely related to administration of Shingrix vaccine.