chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a dose of the Janssen Vaccine after having received a single dose of Moderna two months prior from a alternate provider. it was not disclosed until the Janssen dose was being input to the vaccine system.
Father took pt to ER with CC of seizure & fevers. Fevers started 8-22-11 and escalated with seizure on 8-24-11, EMS called & pt taken to ER. 106F on ER admission with emesis in ER. Tx incl. TYLENOL and fluids; fever then diminished. Lethargic condition steadily improved. Discharged 8-25-11 - stable and VS were WNL.
Arthralgia, NauseaVomiting, NAUSEA, CHILLS, ACHE, SORE, JOINT Narrative:
After the vaccine per the caller she no longer has COPD; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) from an unspecified date. The patient's concomitant medications were not reported. It was reported she did have COPD. After the vaccine per the caller she no longer has COPD on an unspecified date. The outcome of event was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Post vax, infant was in bed with parents - found with mucus and blood in mouth early in the morning on 12/07. 911 was called. Unable to resuscitate. Both parents smoke. Moved into new trailer recently.
Patient received her first dose of the Moderna Covid-19 vaccine on 1/20/21. She then reported 28 days later on 2/17/21 to the wrong site for her second dose. The site to which she reported was a Pfizer-only vaccine clinic. At this Pfizer clinic, she was administered a Pfizer vaccine as her second dose. This error was discovered by clinic staff in our observation area when the patient looked at her vaccination record card and saw that she had received Pfizer for her second dose and not Moderna.   Patient was monitored for the normal length of time (15 minutes) and displayed no adverse events during this period. Patient was informed of the error and left after her 15 minutes was completed. Patient was informed that a VAERS report would be filed on her behalf and that, per the CDC instructions, she would not need to get any additional doses to complete her series.
1148 Pt felt heart rate starting to increase. BP 188/81. Dr on site made aware. Monitored VS, All WNL. Pt has hx HTN and take lisinopril. Discharged at 12:15 with Dr advising pt to follow up with PCP for HTN. No meds given.
Brain fog, fatigue, dizziness and slight confusion and soreness at the injection site 4 hours after- lasted until bed at 11:00 pm. Shot was on a Friday- everyday after had a symptom- headache on Saturday- mild muscle soreness- upset stomach/diarrhea- fatigue- Friday the following week felt fine, no symptoms until about 11:00pm. Right are started itching and by Saturday morning injection site was sore again, warm to the touch and an elevated rash developed around the injection site- rash lasted 24 hours- was still warm to the touch and tender on Monday 04/19/2021. Those symptoms disappeared by Tuesday morning.
Back of Lt arm red and edematous. Soft to touch. Cool compresses to site every 4 hrs. RTC if sx worsen.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot# reported as N1046004, expiration date: 18-NOV-2018 (dose and route of administration were not reported) or lot# M049127, expiration date: 15-DEC-2018 and/or an improperly stored dose of PROQUAD lot# N013864, expiration date: 31-OCT-2018 or lot# N001490, expiration date 12-JUL-2018 (dose and route of administration were not reported). The vaccines were stored in the temperature of 13.4 degrees Fahrenheit for 1 hour. Digital Data Logger was involved. There was no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA000520: US-009507513-1710USA002215: US-009507513-1711USA000519.
Mom states that pt's injection sites became red and swollen after they arrived home on 5/8/13 at 6PM. The areas increased in size since then. Parents were instructed to give pt CLARITIN, Ibu, and cold compress at his appt. today w/ Dr.
Fever up to 102.4 Body aches Headaches Chills Back ache Cough
Felt generalized itching. (Has hx of itching has rashy spots on forearms - itching previous) but the face became reddened and he reported increased itching.
Arm was swollen, warm to touch, and painful 2 days following Tdap vaccine
tachycardia, chills, SOB,  shaking, high BP,  difficulty swallowing, Medications give benydral 100mg po, claritin 10 mg, pepcid 20mg,. Staff  member symptoms resolved after medication and eating.
Generalized Rash; Patient developed a generalized rash following each dose; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.This consumer or other non hcp reported information for both mother and fetus/baby.This is a Mothers report.A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8783 and Expiry date: Unknown), via an dose 2 intramuscular, administered in Arm Left on 03Apr2021 15:00, at the age of 34-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included abortion spontaneous from an unknown date and unknown if ongoing, live birth from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within prior to the Covid vaccine. The patient received other medications of vaccination. On 03Apr2021 the patient experienced patient developed a generalized rash following each dose. On 08Apr2021 the patient experienced generalized rash. The mother reported she became pregnant while taking bnt162b2.The mother was 32 Weeks pregnant at the onset of the event.The mother was due to deliver on 24May2021.The mother delivered the pregnancy on 24May2021.Therapeutic measures were taken as a result of generalized rash. The outcome of event generalized rash was recovered while the outcome of event patient developed a generalized rash following each dose was unknown.
He's just had a pulmonary embollisim with clots in both lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (He's just had a pulmonary embollisim with clots in both lungs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, 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 experienced PULMONARY EMBOLISM (He's just had a pulmonary embollisim with clots in both lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (He's just had a pulmonary embollisim with clots in both lungs) outcome was unknown.      The  concomitant medications on use were not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Very limited information regarding these events has been provided at this time. Further information has been requested.
This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route were not reported) lot # M006708 with expiration date of 02-JUN-2018 and lot # L040458 with expiration date of 04-FEB-2018, for prophylaxis. The temperature of the RECOMBIVAX HB was of 35 °F for a time frame of 72 hours. No previous temperature excursion occurred and no data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013166:
Patient developed rash, redness on injection site. Felt tired  and weak for 2-3 days. Suspected cullilistis , patient went to PCP and was prescribed  with Cephalexin
She got the vaccine and was sitting around that evening and discussing with the family over the phone and was explaining that everything was fine, could barely tell where the shot went in, and the next morning around 10:00 to 11:00 AM she got deathly ill.  She had diarrhea but not too bad, and then started throwing up uncontrollably, violently, projectile.  She goes to where she was disoriented and did not know where she was.  She was reaching to touch things to figure out where she was.  Her husband called the ambulance, and she went to the hospital and got her normalized but does not know how or what they did.  A woman came in to register her and started talking to her and was not making any sense.  They treated her in the ER, took a bunch of tests, and sent her home.  They told her that she had food poisoning and hadn't had anything but some biscuit and gravy and had some crackers when she got the vaccine as she was weak.  They gave her Ondansetron for her stomach to stop the diarrhea, but she is still having that.  She is still having the weakness, and not back to her normal self.
Left thigh swelling after MMR. Itching the night of administration and then swelling the next morning.
Red rash that burns about 3-4 inches in diameter at site of injection on left arm. warm to touch.
Throat constriction, flu-like symptoms first 5 days pain in right hand occasionally, trouble breathing after discharged, arm pain and jaw achy, left leg pain at times. Tx-Precnisone, Xanax. The follow up received on 11/20/03 states loss of short term memory, weight gain, sore joints, numbness and tingling in extremities, being seen at neurology clinic, and moving to another state. Discharge summary states vertigo, encephalitis, dizzy, vomiting, neuropathy and tremor. msv
5 mins after Covid vax given, pt reported vertigo. Hx of vertigo. Ate breakfast, but few hours before. Reclined seat, gave water & snack BP: 116/70 After 10 mins (11:20am) felt better - released.
Mom had appt. today for sick visit . Mom informed MD of reaction to vaccines given on 8/22/06. She told him that baby was sluggish/lethargic on the day of vaccines so she took him to the hospital ER.
This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to a 713 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration date not reported). On unknown dates, the patients experienced a life threatening adverse event. The outcome of adverse event was unknown. The relatedness between the event and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
A spontaneous non-serious report of FLUMIST squirted into a child's eye has been received from the patient's mother who is a nurse concerning a 6 year old female patient. No medical history or concomitant medications were reported. On 24-Nov-2008, the patient received FLUMIST in the pediatrician's office. During administration, the patient moved and FLUMIST was squirted into the child's eye. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Hives outbreak approximately a week following injection, suddenly appeared on feet and hands, thought it resembled ringworm initially.  Quickly spread and appeared nearly symmetrically as itchy raised red patches, moving  on both arms (shoulder/bicep) and legs (inner thigh).  Individual areas quickly resolved as it spread further down the limb until reaching the hand/foot and disappearing leaving no trace.  Experienced three (3) flareups starting in similar areas of the hand/foot, arms/legs, with each recurrence pushing further up the limb/body until stopping around the abdomen/back/neck.  Largely ceased after about 48 hours, but still observing occasionally on sides of feet/ankles days later.
COVID-19; Initial Report Received on 11-Jul-2022  A registered nurse in the self-reported that she, a 38-year-old female (race and ethnicity unknown), contracted COVID-19 after receiving the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination was reported as none. Allergies were reported as unknown.  Concomitant medications at the time of vaccination were unknown.  On 25-May-2022, the patient received the first dose of HEPLISAV-B (Lot # 937232, expiration date 04-Mar-2023; NDC #; route, and injection site unknown).   On 20-Jun-2022, 27 days after having received the first dose of HELISAV-B, the patient subsequently contracted COVID-19. She had not received her second dose of HEPLISAV-B yet. No other adverse reactions were reported.   No other information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient received her flu shot and in the week following the shot, she developed a pimple where the shot had been administered and a swollen lymph node in her armpit. A week later she went to the ER for unrelated abdominal pains which turned out to be diverticulitis, but while she was in the ER they discovered she had pericardial effusion/pericarditis. She believed she could have contracted a viral infection from the flu shot to which we reminded her that the virus in these vaccines is inactivated.
Right facial/injection site numbness  Vital Signs: BP 150/100 HR 76 (84) Resp 20 O2Sat 98  Skin Signs: Clammy, diaphoretic  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Observation, patient remained AOx4. Assessed/evaluation by Doctor. 12:10 PM Vital Signs: BP 138/90 HR 74 Resp 20 O2Sat 93  Skin Signs: Clammy (mild), Diaphoretic  Circulation: Cap refill <2sec  Follow up Treatment: Patient states numbness in face has lessened in severity  Notes: Encouraged patient to continue hydration at home  Disposition: Home with friend
Sore arm; Fever of 100.4F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever of 100.4F) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever of 100.4F). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Pain in extremity, at an unspecified dose and frequency and IBUPROFEN for Fever and Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever of 100.4F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100.4 (High) 100.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a father regarding his 8 year old son who was described as messed up due to vaccine. The patient received a dose of an unspecified date. Relevant medical history was not provided. The indication for Prevnar was immunization. The product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The reporter stated that his son was messed up because of the vaccines he got (unevaluable event). No additional information was available at the time of this report. This is one of two patients who experienced this event following receipt of Prevnar. See related case HQWYE471915JUN05.
pt became limp and unresponsive for five minutes at home brought to ED and had another unresponsive episode. He maintained normal heart rate and respirations. Was pale but not blue.
INFLUENZA vaccine administered on 10-28-11 IM left deltoid, on Saturday, October 29, 2011 child arm began to swell, became hot to touch and red. Gave BENADRYL (mom). Treated at hospital.
pt recvd booster dose of MR vax in 1990; recently pt had rubella & rubeola titer performed; rubella titer was pos but the rubeola titer was neg; no further details were provided;
Info has been received from an LPN concerning a 13 month old male with an egg allergy and no other history who on 6/5/03 was vaccinated with a dose of MMRII (0.5 ml), SC. Concomitant therapy that day included a dose of varicella virus vaccine live. On 6/5/03, "twenty minutes after his MMRII vaccination", the pt became limp for half hour to hour and cried for three days. Unspecified medical attention was sought. The pt recovered on 6/9/03. No product quality complaint involved. Additional info has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 73-year-old male patient received BNT162b2 (BNT162B2), on 15Jun2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. In 2022, the patient had COVID-19. The patient received PAXLOVID (lot#: 300691085301) from 31Oct2022 until 04Nov2022 as treatment for COVID-19. Outcome of the events were unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Blurred vision; itching of face/arms and feet; ringing in the ears; ear pain; unable to stand or walk; knee pain; swelling of entire left arm from fingers to axilla; unable to lift left arm; unable to use fingers to grasp; fever of 101.5 for over 30 hours; cold sweats; enlarged lymph nodes for 6 months causing unreliable MRI results which caused the need for a follow up;  memory loss
No additional adverse events reported; Caller reported VARIVAX that had undergone temperature excursion was administered to a patient.; Product administered to patient of inappropriate age; This spontaneous report was received from a nurse regarding a 1-day-old patient of unknown gender.     There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 01-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot number W002601, which had been verified to be valid, expiration date reported and validated as 24-JAN-2024), as prophylaxis (Improper storage of product in use) (Inappropriate age at vaccine administration). The vaccine administered was stored with an unknown temperature for a time frame of 1 hour and 45 minutes. There was a previous temperature excursion. No additional AE were reported. It was not reported if a data logger was used.; Sender's Comments:  US-009507513-2210USA001538: US-009507513-2210USA001524: US-009507513-2210USA001533:
Initial and follow up information has been received from licensed practical nurse (LPN) and a healthcare provider concerning a 58 yr old white female pt, with hypertension, diabetes and gastrooesophageal reflux disease and unk drug reactions/allergies, who on 08Nov05 was vaccinated IM in the left deltoid with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot651329/1047P). On 08Nov05, follow up information from the healthcare provider indicated that the pt's left deltoid area became red, swollen, warm to touch, and sore. It was reported that the pt presented to the office and was instructed to use diphenhydramine hydrochloride (Benadryl) over the counter, cool compresses, amoxicillin (+) clavulanate potassium (Augmentin), and follow up if no better. On an unk date the pt recovered. No product quality complaint was involved. No additional information is expected.
No adverse event; Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use) 1 dosage form. On 27-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route).    Treatment medications were not reported.   This case was linked to MOD-2023-742833 (Patient Link).