chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 1 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M039904, (dose, dose number, albumin status, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587.
Within 36-48 hours after receiving SHINGRIX, arm receiving SHINGRIX swelled to twice its normal size and patient had fever, severe arthralgias and myalgias and spent 3 days in bed.
the day he got the vaccine, he started having symptoms of light-headedness, frontal headache, fatigue, generalized body aches and these have progressed since getting vaccinated
pt recv vax & w/in 3hr pt devel nausea, vomiting & diarrhea;
Fever, chills, headache, fatigue and soreness in the arm where I got the shot; started feeling worse about 8 hours after getting the vaccine.  Lasted about 36 hours.
Pt given Hib IM 0.5ml, varicella SQ 0.5ml, MMR SQ 0.5ml, Pediarix IM 0.5ml at 1510 on 01/05/04. Pt started to have scattered hives on trunk, face, scalp, lips became swollen at 1517. Dr worked epinephrine 1:1000 dose 0.1mg given SC at 1530, Benadryl 125mg given IM. Respiratory treatment update 0.25mg Albuterol.
PATIENT STATED THAT ~ 1HR AFTER ADMINISTRATION, SHE DEVELOPED ACNE-LIKE GOOSEBUMPS ON HER WHOLE ARM; IT ALSO HAPPENED AFTER HER 1ST DOSE. WHEN IT HAPPENED THE 1ST TIME (AFTER HER 1ST DOSE), IT WENT AWAY AFTER 5-6 HRS.
Client complained of ringing in ears and feeling anxious. He felt cold and clammy to touch, was sweating and was pale. 2 RNs walked client a little ways. Client began to pass out so RNs lowered pt to ground. Pt appeared flushed. Pt was oriented and still complained of ringing in ears. About 10 minutes of client laying on floor, he was able to sit up in chair. After another 10min client stood up and stated he did not feel dizzy. Client was released to personal vehicle.
Cough; fever; chills; muscle pain; severe nausea, vomiting and diarrhea; fatigue
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE  4/12/2022 --  RECURRENCE OF SAME SYMPTOMS
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-JAN-2017, the patient was treated by a healthcare provider at an emergency department for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Rebound COVID, sx started 06/02/2022, tested positive on home test again; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Rebound COVID, sx started 06/02/2022, tested positive on home test again) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no known allergies.  Concurrent medical conditions included Hypertension and Depression. Concomitant products included FAMOTIDINE, OXYBUTYNIN, AMLODIPINE, LOSARTAN, FLUTICASONE and FLUOXETINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced COVID-19 (Rebound COVID, sx started 06/02/2022, tested positive on home test again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID, sx started 06/02/2022, tested positive on home test again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Device Date was reported as 03-Jun-2022.  Company comment: This spontaneous case concerns a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. She tested positive for SARS-CoV-2 at home, diagnosed with Covid-19 Rebound and was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome was reported as not resolved. Details of symptoms, start date, clinical course, further investigation reports were not provided. Details of Vaccination history and prior Covid-19 infection were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. She tested positive for SARS-CoV-2 at home, diagnosed with Covid-19 Rebound and was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome was reported as not resolved. Details of symptoms, start date, clinical course, further investigation reports were not provided. Details of Vaccination history and prior Covid-19 infection were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Headache.  All my normal aches and pains/muscle soreness are intensified.  Sweating profusely and chills overnight. I?ve never taken hard drugs like heroine or cocaine but I imagine how I felt overnight was what it?s like coming off  one of those highs.  Every part of me was overly excited and not in a good way.  Mind racing.  Every movement was tingly.  Couldn?t get comfortable.   when I first get up I?m good. Feel great. But partway through brushing my teeth, the aches pains soreness etc started registering.   Even now sitting in bed typing this I?ve had to pause a few times because I get lightheaded.  I?ve taken 2 Tylenol 500 every 8 hours beginning at about 9am on 5/5/21
I was generally feeling fatigued and lightheaded and shaky. I had a rash in the beginning of July. I made an appointment with my doctor, and she ran some test, and it came back for mono. I had mono when I was younger in middle school.
gave a second TDAP one was given 3/27/2023 for a nail in foot and was not noticed so during yearly PE was given again no reactions
Patient came to office for visit with physician. Was offered and accepted booster dose of Pfizer vaccine. After administration, it was discovered that the booster dose was given too soon (second dose of Pfizer was in August 2021 and patient is not immunocompromised).
Flu-like symptoms lasting 7 weeks. (Cough, Sneezing, aches, intermittent fever,
This spontaneous case, initially received on 14-Nov-2017, from a physician, concerning a 48-year-old, adult female patient. The patient's medical history and concomitant medication was not reported. On 26-Oct-2013, the patient was administered with AFLURIA (dose: 0.5ml, batch number: R54607 (as reported), expiry date: 30-Jun-2014, dose, route of administration, anatomical location: not reported). On the same day of vaccination, patient experienced hives and facial swelling. The patient also experienced chest tightness. The patient received BENADRYL as treatment measure for the events. At the time of this report, the patient had completely recovered from the events. The reporter assessed the case as non-serious. Non-significant follow-up received on 23-Feb-2018: Added reference number in the additional information tab med info number (SEQ17-6144). Non-significant case-correction received 14-Nov-2017: Narrative sentence was corrected.
Itching on both ears, back of neck, left arm and behind both knees occurred after his first dose Pfizer Vaccine also.; This is a spontaneous report from a contactable nurse (patient's wife). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 (at the age of 73-year-old) (Lot Number: EN6203) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (in October). The patient's concomitant medications were none. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced itching on both ears, back of neck, left arm and behind both knees occurred on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Vials that were more than 30 days in refrigerator administered to patients; 125 individuals received 2 vaccinations that had a temp excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (125 individuals received 2 vaccinations that had a temp excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (125 individuals received 2 vaccinations that had a temp excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (125 individuals received 2 vaccinations that had a temp excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Significant follow up : new event was added. On 01-Sep-2021: Follow up received : included no new information.
The shingles vaccine Zostavax was administered in my right arm on 11/06/07.  That arm has been sore ever since.  The soreness has moved into the shoulder muscle and even into the neck.  The upper arm continues to be sore also.
Protein in urine; 3rd dose administered of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of protein urine present in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 3rd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered of shingrix). On an unknown date, the patient experienced protein urine present (Verbatim: Protein in urine). The outcome of the protein urine present and extra dose administered were unknown.   It was unknown if the reporter considered the protein urine present to be related to Shingrix.     It was unknown if the company considered the protein urine present to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The pharmacist called to inform that a patient believed that a 3rd dose of Shingrix had been administered to her back in March 2023 and mentioned that the patient was attributing presence in her urine to the third dose of Shingrix received. The reporter consented to follow up via mail. The patient received 3rd dose of Shingrix which led to Extra dose administered.
Experiencing an ice cold right hand with tingling fingertips; Tingling fingertips; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Experiencing an ice cold right hand with tingling fingertips) and PARAESTHESIA (Tingling fingertips) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL COLDNESS (Experiencing an ice cold right hand with tingling fingertips) and PARAESTHESIA (Tingling fingertips). At the time of the report, PERIPHERAL COLDNESS (Experiencing an ice cold right hand with tingling fingertips) and PARAESTHESIA (Tingling fingertips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Miscarriage; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable nurse (patient). This pregnant 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK5730), intramuscular at single dose in the left arm on 20Dec2020 for COVID-19 immunisation. Medical history included none. Concomitant medication included venlafaxine. The patient experienced miscarriage (medically significant) on 09Jan2021 with outcome of recovering. Treatment unknown. The event required a visit to the emergency room. The patient was pregnant while taking BNT162B2. The patient was 4 weeks pregnant at the onset of the event. Patient last menstrual period date was 27Nov2020. The pregnancy due to deliver was on 03Sep2021. The vaccine was administered at Workplace Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. She received the second dose of BNT162B2 (Lot number EL0142), intramuscular in the left arm on 13Jan2021.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be complete excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
CHILLS, REDNESS AT THE ADMINISTRATION SITE IS INCREASING. SORENESS INCREASED AT THE SITE OF ADMINISTRATION. ON SUNDAY 12/06/2015 SITE HAS CONTINUED WITH REDNESS INCREASING IN SIZE AND FIRMNESS. SIZE IS APPROXIMATELY 8 INCHES IN LENGTH AND 4 INCHES IN WIDTH.
07/26/17 Pt. c/o redness, tenderness, and a "knot" at injection site per pt's mother. 07/28/17 Spoke with pt's mother and she reports that redness is improving. 07/31/17 Spoke with pt's mother and symptoms were resolved on 07/29/17 - Pt. took loratadine and ibuprofen.
Don't know which flu shot I got. Got both at same time. Each arm. That night, I had unique coughing fit as it was 5th booster. Deep hard dry cough and would not stop. Could not drink water nor desired it. 9 min of this, during, felt heart beat faster. Then 1 final deepest cough ever, and felt heart stop beat. Sat down as I was standing to deal with cough.  Caught my breath and cough stopped,  just like that. Sipped some water after. My chest felt different. When cough started, I was in bed, lying down to sleep. No other symptoms before. A couple weeks later, went to general exam, diagnosed with a fib, then later, hospital emergency room.  Heart attach, and no one would believe me so MONA delayed, 11/16/ 23. 20% heart damage, waiting 7 months for cardiac rehab! Not avail until this June.
I had a large local reaction with redness, heat and tenderness.  Area of these symptoms was approximately 4 inches in diameter around area of injection of vaccine.  Treatment was cool packs, Ibuprofen and monitoring.  I spoke to the nurse and showed her my arm on Thursday (4/8/2021) and she recommended I fill out this form and let them know if I had any further problems.  I had no issues with first vaccine.
Pt was vaccinated and then left our clinic. Mom returns with son after going into parking lot and reports pt fainted in vehicle. Mom reports he regained consciousness very quickly and she walked him back into clinic. Pt is placed into wheel chair and is brought back to exam room. Pt reports when asked that he did not have any lunch. Pt is given some birthday cake as that is what was available.
SORENESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight was 76.4 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included macitentan, and selexipag. On an unspecified date, the patient experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211015198.
he felt a little weak / The next day he felt very weak / By the 3rd day he still felt weak; he felt a little cold / By the 3rd day he still felt cold; he felt very tired\ fatigue; he started having hematuria with noticeable redness in his urine; have a lot of shivering\ chills; He spent most of the next couple days in bed due to fatigue and chills; This case was reported by a consumer via call center representative and described the occurrence of weakness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hematuria and influenza (hematuria with influenza twice, at least once leading to hospitalization).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced weakness, cold, tiredness, hematuria, shivering and bedridden. On an unknown date, the outcome of the weakness, cold, tiredness and hematuria were recovered/resolved and the outcome of the shivering and bedridden were unknown.   It was unknown if the reporter considered the weakness, cold, tiredness, hematuria, shivering and bedridden to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix around late Jan or early Feb 2020 at 10 to 11 AM. The patient felt a little weak and cold on same night.  The next day he felt very weak and tired and had a lot of shivering.  He spent most of the next couple days in bed due to fatigue and chills.  By the 3rd day he still felt weak and cold, but it was tolerable.  That evening he started having hematuria with noticeable redness in his urine.  By the 5th day his symptoms had improved. The reporter consented to follow up.
First Shingrix shot two years ago. Can I still get my second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient himself/herself. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not applicable to this report. The patient received his/her 1st dose of Shingrix two years ago and till the time of reporting, The patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient enquired if the 2nd shot could be administered or if he/she had to repeat 1st shot. The follow-up would not possible as no contact details were available.
Similar to the first reaction I had (which I just reported through this form regarding the 1st dose), I developed a red blotchy rash at the injection site about one week after the injection. This time, the rash was also slightly scaly/rough. The rash comes and goes, just like the first one, and is most visible after I take a hot shower in the morning. Then if fades throughout the day to return the next morning after I shower. There is no itching or pain associated with the rash, I only know it's there because I can see it, or feel it with my finger.
After my second vaccine, I experienced mild headaches, chills and fatigue.  Today he states he has no symptoms.
20 minutes after vax, started having a headache, feeling hot, BP was 51/37, nausea, severe pain in lower back, felt paralyzed, couldn't stand up, diarrhea, collapsed on bathroom floor. Took Zofran for nausea.  went to lie down in bed and after a while, BP went back to normal.
Moderna vaccine was administered outside of the clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------------- HYPOXIA 9/23/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Patient reported feeling a lump in her left arm about 2 hours after vaccines. This progressed to a red, itchy rash that started on the inside of her arm and spread outward. The left side of her chest and arm was swollen from top down to forearm. She had trouble sleeping. I observed her left arm to be swollen and her elbow to be bright red.