chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning her daughter, a 26 year old female with depression, asthma exercise induced and allergy to nuts who on 31-JUL-2008 was vaccinated with a third dose of GARDASIL (route and administration site not reported).  Concomitant therapy included EFFEXOR.  On 01-AUG-2008, within 12 hours of the vaccination, the patient experienced facial swelling and puffy cheeks.  The patient then had tenderness of her neck and enlarged lymph nodes.  She was treated with BENADRYL, ZYRTEC and ice packs.  It was mentioned that the patient had no adverse reaction after the first 2 doses of GARDASIL.  The patient's facial swelling and tenderness of neck and enlarged lymph nodes persisted.  She sought medical attention in the office.  Follow-up information was received.  The patient became progressively worse on 01-AUG-2008 and 02-AUG-2008 with continued facial swelling and enlargement of both lymph nodes and salivary glands, and difficulty swallowing.  The patient underwent CT scan, ENT evaluation and was admitted to the hospital.  IV steroids and pain medicine were given.  An antibiotic was also given to which she had an allergic reaction.  An infectious disease consult was called.  At the report time, the swelling has just started to regress slightly, but the parotid glands were tense and obstructed.  Additional information has been requested.  08/28/2008 MR received for DOS 8/2-5/2008 with D/C DX:  Sialadenitis, likely 2' to allergic reaction. Depression. Pt presented with facial swelling and pain which began the pm of HPV4 shot. Pt developed lip, eyelid and neck swelling initially, then shooting pain with neck movement or touch. Pt then developed difficulty swallowing and eventually difficulty breathing. On PE in ER voice is hoarse, swelling of eyelids, face, lips and neck. Tender to touch. Tonsils enlarged, touching uvula. Decreased neck ROM 2' to pain. Started on abx and steroids with allergic rxn to Clindamycin. Continued steroid tx with clinical improvement. To f/u with PCP, Allergist and ENT.
Dizziness, Fatigue Narrative: missed work and several days fatigue following second dose
increased liver function / affect the liver; This case was reported by a consumer via call center representative and described the occurrence of liver disorder in a 87-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced liver disorder. On an unknown date, the outcome of the liver disorder was unknown.   It was unknown if the reporter considered the liver disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced increased liver function and affect the liver.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 12-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 10-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the right upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Headache; Loose stool; This is a spontaneous report from a non-contactable other non-healthcare professional. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) dose via an unspecified route of administration on 22Mar2021 (at the age of 49-year-old) as a single for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to any medications, food, or other products. The patient did not receive any medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 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 22Mar2021, the patient experienced headache and loose stool. The patient did not receive any treatment for the events of headache and loose stool. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events headache and loose stool was resolved on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot number cannot be obtained.
WENT TO SLEEP SATURDAY (JUNE 19TH) WITH NO SYMPTOMS AND WOKE UP ON SUNDAY (JUNE 20)  WITH SYMPTOMS.  I (AS THE REPORTER OF THE EVENT) AM UNAWARE OF ANY MORE DETAILS AT THIS TIME.
Only the sterile diluent was administered to a patient; Only the sterile diluent was administered to a patient; This case was reported by a consumer via other manufacturer and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter stated that only the sterile diluent was administered to a patient and not the Shingrix with the diluent. The reporter disconnected quickly after realizing she needed to call other company and all questions were not answered. The reporter did not consent to follow-up. Additional supportive information: The patient received only the sterile diluent and not the Shingrix with the diluent, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.   No additional details were available. No additional adverse events reported.
Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 with chief complaint of fatigue, chest pain, shortness of breath on exertion. Patient reports fatigue of 2 week duration associated with right-sided chest discomfort, dyspnea, and night sweats. He reports approximately 1 week ago onset of pleuritic R-sided, nonradiating chest pain, with provocative factor of cough and palliative factor of lying supine. He additionally reports dyspnea on exertion and at rest and night sweats of 1 wk duration.  CT chest angio showed Large Pericardial effusion, moderate Left pleural effusion, mild right pleural effusion, ascites. On 5/24/2021, patient underwent pericardiocentesis with 800cc of reddish fluid drainage, and left thoracocentesis with transudative fluid. Cytology is pending.
Have cracked vaccine vial that was administered; Vaccine administered from cracked vial.; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.) and NO ADVERSE EVENT (no adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.).    No concomitant medications were reported. The crack was discovered after the administration of the vaccine, crack was just enough for the vaccine to start leaking. The vial was cracked or broken on base of the vial. Upon receipt of the shipment, it was stored in the freezer right away. Stored in the refrigerator for 2 weeks now and it might have been that someone stacked the separate container individual vial carton for 2 weeks set into a separate cardboard container 2 days ago. The temperature of freezer was set at -21C. The temperature of refrigerator was set at 3C. The vials transported to the site by courier, no they stay in the fridge they are moved from shelf to shell. They got the shipment on 06-Feb-2023 and they inspected the vials and no issues were noted. They stored the 40 vials in the freezer right away. The vial with a crack was moved to the fridge 2 weeks ago and it was moved to a container inside the same fridge 2 days ago. The crack might have happened when someone returned the container in the fridge with a strong force. The vial had been disposed, no pictures were taken. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Mar-2023: Live follow-up received contains narrative part updated.
Covid 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in right arm, on 26Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: Ba30130) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Inflammation severe allergies" (unspecified if ongoing), notes: Type 2 Inflammation severe allergies and asthma; "Asthma" (unspecified if ongoing), notes: Type 2 Inflammation severe allergies and asthma. Concomitant medication(s) included: DUPIXENT, start date: 19Apr2022. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin"; Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "Covid 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: The patient had received other medication in 2 weeks. Anti-viral details product COVID 19 Treatment, brand Pfizer, the treatment start date was 21Apr2022, lot number: Fx4466 sn998227446683, indication was treatment of COVID-19. On 22Apr2022 09:00 PM, patient had Loose stool, a Bitter Metallic taste in back of mouth, General feeling of weakness and off balance (but that could be attributed to COVID).  No follow-up attempts are possible. No further information is expected.
tingling Narrative: 2 30 second episodes of right upper lip tingling, self resolved. within 48 hours of injection.
Developed periodic pain (no swelling or stiffness) mostly at the injection site and in the left hand. Sometimes the entire left arm would hurt. Episodes typically occurred once or more daily, lasting from one to two hours. Symptoms diminished in intensity after about two weeks, continued at lower level of intensity. As of the writing of this report, symptoms are occasional (2-3 times/week), at 10-20% of original intensity; recovery is not complete. Administering pharmacist was consulted. Pharmacist advised that the vaccine required several weeks to develop the immunity and is active in the body during this time; and suggested that symptoms would last while vaccine is active, then gradually abate.
Patient was administered vaccine following improper storage (vaccine was left in freezer too long and was considered expired per manufacturer due to lack of stability study data). Patient acknowledged recommendation but will do additional research and probably wait until Fall before revaccinating.
Received seasonal flu vaccine in left arm during annual provider exam.  Next day experienced pain at the injection site, worse with movement of affected arm.  Pain has continued at various levels dependent on activity for 9+ months since the date of the vaccine.  Pt experiences pain when raising left arm to shoulder level and above and when lying on or putting pressure on left arm.  Patient is left-handed and cannot lift as much weight with the left hand as she can with the right when exercising, which was not the case prior to this vaccine injury.  Patient went to Dr on 10/03/2023, and he recommended trying Voltaren cream.
Mother came to Health Dept. on 10-28-11 reporting that her daughter started vomiting on 10-24-11 (the evening after receiving vaccinations). She called & visited with the E.R. nurse about the child vomiting every 10 min. & then took her to the E. R. Child was given medication to stop the vomiting & blood work done. Sent home with Dr. appt. scheduled for 10/26/11.
Numbness, tingling arms, shoulders, face, scalp. and developed short of breath.
In the few days following  getting my second MPV dose, my forearm became increasingly more inflamed. At the peak of the inflammation,  the swelling took over about 80% of my entire forearm around the injection site.   About two or three weeks after this vaccine, the swelling was gone and only a scar was left. However, hives appeared around my injection site (within the bounds of where the swelling was, which was most of my forearm). These weren't very itchy, but they looked very bad, and keep reoccurring.  I also noticed I started having dermatographia at this time. Raised welts that looks like scratch marks usually appear on my buttocks, thighs, and sometimes on my upper arms.   It has been 2 months since I got this MPV dose, but these hives consistently continue to reappear every 5-7 days. I have pictures of these described symptoms. I am concerned that this vaccine caused some sort of allergy or autoimmune issue to flare up, and find it odd that the hives keep flaring up intensely every 5-7 days, only on the forearm where I had intradermal injection.
Dark spots in vision field, blurred vision, severe headache, vomiting, fatigue.
Enlarged lymph glands under left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN2600) via an unspecified route of administration in the left arm on 16Feb2021 at 15:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, hypothyroidism, cardiovascular disease and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate (FLOVENT HFA), levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (THIAZIDE) and me (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) on an unknown date for unknown indication and experienced drug allergy and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 26Jan2021 at 12:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021, the patient experienced enlarged lymph glands under left arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for enlarged lymph glands under left arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event enlarged lymph glands under left arm was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Approximately 35 minutes after receiving the vaccine, the patients daughter came back to the pharmacy (sobbing) and saying that her mom was complaining of dizziness and "not feeling well at all".   I offered to call 911  and did so after she consented.  The police arrived within two minutes and the ambulance arrived approximately 90 seconds later.  The police officer was interviewing the patient (who was still conscious and alert) about what was wrong.  I was asked what the patient received.  I responded that she had been given the Pfizer Covid-19 vaccine and was then told that I could go back inside by the EMT's who showed up relatively soon thereafter.
Immediate arm pain, redness, also HA, dizzy, fatigue 3-4 days.
Beginning with the 1st shot, dizziness, face twitching, tachycardia, erratic BP, chills, and random sweats. With each of these shots, my symptoms worsened, leading to a 911 call with a HR of 169 from a dead sleep.   I've also been to the ER as my heart was skipping beats, fluttering.  With many other symptoms and a dozen Doctors to rule out everything possible.  I've finally been diagnosed with POTS syndrome on 03/16/2023. there is no cure and very little treatment available to me.   The outcome is poor as I can no longer work or drive.
Foster parent had signed a consent for child to receive H1N1 vaccination at school thru a health dept clinic.  After completing the consent and turning it in, the foster parent went ahead and had the child vaccinated.  She didn't inform the school so the health dept nurse vaccinated the child as scheduled.  The child received H1N1 on 2-11-10 and then again at school on 2-19-10.
3 days post vaccination pt developed fever 101 degrees, chest cold, "hacking cough" & body aches. Cold & cough lasted over 1.5 months. Pt treated w/ TESSALON PEARLS, ROBITUSSIN w/ codeine. Chest x-ray negative. Lab work showed no significant findings. Dr. said it was "light or pre-pneumonia".
I got the shot then got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and then got shingles. The patient stated that it was not painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
fatigue for several months immediately following pre-exposure rabies vax; felt worse with each subsequent inject; recvd series in NOV93;
1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop rocks in mouth. I got extremely nauseous. Within 5 minutes, everything was spinning. Continued progressing. HR 180. Within 10 min, i was in ER. They gave  my epi pen but it didn't work right away. They were about to start an epi pen and to knock me out, they gave me Benadryl IV, Pepcid?, and they were 30 seconds from intubating me. My vocal cords; broncho spasms. I slowly started to get better. They monitored me for 7 hours.  *Still experiencing, daily, SOB. My voice gets harsh. I run out of breath walking, talking, etc. I use prednisone, 2 inhalers daily; Advere and Rescue inhaler. I also suffer from EXTREME HA since then and am on 2 medications for the HA.
Small nosebleed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    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 EPISTAXIS (Small nosebleed) 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 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced EPISTAXIS (Small nosebleed). At the time of the report, EPISTAXIS (Small nosebleed) outcome was unknown.            no treatment information was provided no concomitant medication were reported   Reporter did not allow further contact
pt became very limp, pale-lips & nail beds cyanotic; VS 12N BP 74/38, tachycardia; 1205PM; BP 66/36 12noon t97.6; P74, R16 still very pale; skin warm & clammy;