chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a female in her early 20's who on an unspecified date in 2007 the patient received her first dose of GARDASIL injection. Concomitant therapy on the same date also included another vaccine (therapy unspecified). On an unspecified date the patient received her second dose of GARDASIL. The patient had a "nervous breakdown; some kind of anxiety or severe depression". The patient was admitted to the hospital and was found to have decreased serotonin levels and aluminum toxicity. The dates of the hospitalization are not known but the patient was discharged and was started on an antidepressant (therapy unspecified). The patient has not received her third dose yet. At the time of reporting the patient was recovering. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Patient with no pertinent medical history, drug reactions or allergies. On an unknown date in November 2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date in approximately November 2013, 2 days after the injection, the patient experienced a red and irritated injection site reaction. Pharmacist also reported that as of yesterday (22-JAN-2014, also reported as 22-JAN-2013), the patient's skin surrounding the injection of ZOSTAVAX was still a light pink. Pharmacist was able to confirm that the reaction was not a rash. There was not treatment given for the events. There were no lab diagnostics studies performed. The patient's present status was reported as recovering. Additional information has been requested.
Pt developed rash at injection site. Rash is itchy and red. Pt is getting better. Pt also developed flu like systems on 7/27/12. System went away in 1 day.
Attendee came to get 1st dose of vaccination, and when upon receiving a few minutes shortly, she became diaphoretic, and complained of blurred vision, light headedness, and dizzy.  She was then sent to a cot to lay down and she then complained of sharp pain to her shoulders and generalized muscle pain.  By the time of discharge at 11:25 she had a slight head ache and some of the ache to her shoulders remained but she stated she was ready to go home and wanted to rest.
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (PFS), (dosing details and route of administration unknown) (lot # M013156 with expiry date 15-OCT-2017; lot # N003997 with expiry date 20-OCT-2018) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of PNEUMOVAX 23 experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Tachycardia, chest pain for several hours. Outcomes: resolved on its own. Cardiac stress test, X-ray, echo and CT with contrast revealed no abnormalities.
Syringe mechanical failure at time of injection.  As I injected the needle and depressed the plunger, the needle retracted into the syringe. The needle punctured the skin, but the majority of the vaccine spewed over the patient's arm.  The patient was later re-vaccinated in the right arm at 10:42am with the same lot.
Two days after injection pain started at site of injection.   Pain increased daily for about 3 days.  Five days after injection a reddish-pink area started up.   Pain & red area persisted and after 3 weeks the left elbow developed a pain on a bone protruding .   In December went to Doctor... He said the elbow pain would go away (and eventually it did).  He diagnosed the pink area as the result of my scratching it and advised me to stop and put euricin cream on it which I continue to do today.  I favor the arm somewhat to prevent pain and to keep from dropping things.   The injection (and pain) site appears to me to be at the lower point of the deltoid muscle, well below the shoulder edge.  I seldom scratch it as it does not itch.  The doctor thought I was scratching it as every time I tried to show him where it was at he thought I was getting ready to scratch it.  The pain continues today.
Swollen lympnodes from 2 days afyer shot until now, continues to increase in size and sensitivity. Red itchy rash developing on arm, arm has become sore  and rash is inflamed.
High fever, chills, body aches, nausea, vomiting, extreme weakness, rapid heartbeat
102 fever, body aches. Left side of face and neck has a burning, hypersensitiveto touch sensation. "Feels like a bad sunburn", "aches".
I felt bad for about a day after receiving the vaccine. I did not have symptoms prior to testing positive for COVID-19. I tested positive for COVID-19 on 11/07/2022. I contacted my doctor, and she did not recommend taking PAXLOVID. I also talked to my daughter-in-law who is a doctor, and she did not recommend PAXLOVID either. My nose was really runny, I had body aches, no nausea and no sore throat. One day my oxygen level was below normal. I treated my symptoms like it was cold. Lots of rest and fluids. About a couple of weeks later, I developed a sinus infection. I went to an urgent care center, and I was given an antibiotic.
Admitted to acute care hospital 5/31/21 with chest pain consistant with pericarditis and reduced ejection fraction.
1 year and 2 months old received IInfanrix and was supposed to be receiving at 15 months of age; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 14-month-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received Dtap-Pediarix on unknown date at 2, 4 and 6 month of age).   On 30th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, the patient of 1 year and 2 months old received Infanrix at an unknown location.  The patient received Dtap-Pediarix at 2, 4 and 6 month of age and was supposed to receive Infanrix at 15 months of age but received at 14 months of age, which led to drug dose administration interval too short.
SLIGHT HEADACHE STARTING AT 2330 ON FRIDAY 1/29/21.  SHAKING AND COLD WITH SEVERE MUSCLE PAIN FOR APPROXIMATELY 4 HOURS  PER PATIENT STATEMENT.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Developed acute swelling  and induration of L deltoid (11cm x 8cm) about 1 week after vaccine was given - unclear if cellulitis or vaccine localized reaction.  Started empirically on Keflex on 8/11/2017.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 35 years, in right arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN. Concomitant medication(s) included: LOSARTAN/HCTZ, start date: Jan2010; AMLODIPINE BESYLATE 10, start date: Jan2006; VITAMIN D [ERGOCALCIFEROL], start date: Oct2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid from 28Jun2022 till 03Jul2022 for treatment of COVID-19.
Rhabdomyolysis, (swelling, soreness), fatigue, hematuria.
Severe itch in area, when touched upper arm hot & tender, pink blistery area surrounding shot site. All shift other RN's concerned if I was ok as halting speech & losing train of thought, increased DIFFICULTY WITH VISION, HEARING & BALANCE. We all thought I was just exhausted, forgot about shot. Became increasingly agitated & disoriented after work. Severve occipital headache WHICH INCREASED WHEN TRIED TO LIE DOWN. TIGHT MUSCLE IN ABDOMEN, RIB CAGE & COLLAR BONE, NECK & LOWER FACE. I LIVE ALONE SO NO FAMILY TO HELP & SEE WHAT WAS HAPPENING. GOT BAD CHILLS ABOUT 5AM- TEMP 95.8 FOR 2+HR. CALLED md OFFICE WHEN OPENED. UNABLE TO COMMUNICATE clearly as this point so staff thought I was crazy. I just moved to area last year & had few contacts only while going thru my infection & recovery. My PAST physician group before I relocated, knew me for years & knew I had multiple allergic reactions & reactions to vaccines throughout my life. when tried to ask 11/12 if reacting to vaccine was told- "that doesn't happen to people."
Patient has had 'sore arm' since date of vaccination. Patient seen in followup for this issue 11/20/2018. 'CC: Patient presents presenting with pain in the left shoulder s/p flu vaccine injection related tenderness. Still able to move arm and shoulder up to 90 degrees abduction. Musculo: Admits to left shoulder joint and muscle pain, joint swelling but no redness of the joint. She stated it was worse with movement and abduction, with radiation of pain to the left hand and into the left shoulder muscle as well.' Provider Dr then contacted patient 1/6/2019 after she has left a message for return call. Patient states : she still has weakness in the arm and shoulder where she was given her flu vaccine. It has been painful, and since the day of the injection, it has been weak, with her having difficulty keeping her arm in front to use the computer, due to the pain and subsequent weakness.
Started to feel sick; Coughing; Very thirsty; Weak (she couldn't even walk); Diarrhea; Started vomiting; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)) and DIARRHOEA (Diarrhea) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic, Blood pressure, Cholesterol and Penicillin allergy.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)), DIARRHOEA (Diarrhea), VOMITING (Started vomiting) and NAUSEA (Nauseated). At the time of the report, MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)), DIARRHOEA (Diarrhea), VOMITING (Started vomiting) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was taking medications for diabetes, blood pressure, and cholesterol. After 20 minutes of vaccination, the patient went to a restaurant and ate shrimp. When she got home, she started to felt sick and started vomiting and was also nauseated. The patient just drank water, Gatorade, and milk.
an expired ADACEL (31Jul2022) was accidentally given to a patient today with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 35 years old male patient who received an expired adacel (31jul2022) with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (lot U6767AA and expiry date: 310Jul-2022) via intramuscular route in the deltoid nos for prophylactic vaccination.  On 25-Oct-2022, (latency: same day) an expired adacel (31jul2022) was accidentally given to a patient today with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax & devel sterile abcess; redness at site 1x3/4 cm ecchymosis;
This spontaneous report as received from a physician refers to a 12 years old female patient with amoxicillin allergy and no pertinent medical history. The patient was vaccinated with the first dose of GARDASIL IM (Lot # not reported) on 19-JUL-2012, and received the second dose of GARDASIL IM (Lot # 0131AE, expiration date 26-OCT-2014). No other co-suspects were reported. Concomitant medications included CONCERTA, INTUNIV and ZANTAC. The physician reported that on 27-SEP-2012, the patient experienced felt dizzy, had a flushed face and stated that her arm hurt where she was vaccinated following the second dose of GARDASIL. The physician stated that patient was kept at the office and instructed to lie down and given fluids (juice). The patient's vital signs were stable while at the office (lying down). The patient stated that she felt fine after about an hour and a half and went home. The patient was called at home later on the same day and was reported to have recovered. There were no Lab diagnosis or studies performed. It was reported that the patient did not experience adverse events with the first vaccination of GARDASIL. The relatedness for felt dizzy, her arm hurt and had a flushed face was unknown for GARDASIL. Additional information has been requested.
received the first dose/in January 2020/ not received a second dose yet.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   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 case details were reported as follows: The case was reported by patient's wife. The age at vaccination was not applicable for this report. The reporter declined to provide any demographic information. Till the time of report the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2021101405 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021101405:wife´s case
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated by the same physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 12/07/2022. I had bad chills, restless legs and in general just didn't feel good. I contacted my doctor and got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I do not have any lingering symptoms.
dizziness; Severe shortness of breath; fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: Ep 7533), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:30 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. Medical history included none. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient not experienced COVID prior vaccination. On 08Apr2021, the patient experienced dizziness, severe shortness of breath, fever and body aches. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 13Apr2021. The outcome of the events was not Recovered.  No follow up attempts are possible. No further information is expected.
PT IS 12 Y/O BUT WAS GIVEN PEDIATRIC PFIZER VACCINE APPROVED FOR 5-11 YEARS. FATHER WAS INFORMED ABOUT THE ERROR THE SAME DAY AND HE WAS TOLD THAT THE PT. WILL RECEIVE ADULT PFIZER DOSE FOR HIS SECOND APPOINTMENT. THE SAME WAS INFORMED TO PHARMACY.
Tech  administered first dose of Moderna vaccine. About 10 minutes after, pt's mom came over the consultation window to say he was feeling dizzy and has a headache. I (pharmacist), immediately, asked if he would like to come back to the immunization room to lie down and elevate his legs up on the chair. Pt refused. I did ask if he wanted an ice pack and water bottle. He accepted. He started to feel better after 5-10 minutes.
Nurse stated the vaccine leaked out from the needle/patient's arm as soon as she started the ID dose in the left arm; patient did not receive the full dose. The same nurse administered another ID dose in the left arm (same arm) successfully.
Moderate to severe headache - same night. Mild abdominal pain. Given tylenol 3 / elavil.
About 6 hours after I got the 1st vaccine shot, my upper right arm was very sore, I had a headache, I broke out in hives, and my tongue started to swell up. As soon as I started to break out in hives, I immediately took 150 mg of benadryl. I took another 250 mg over the next 10 hours. I have had several allergic reactions in the past, and know how to treat and when my doctor recommends for me to go to urgent care or the ER. It did not get any worse, but it did not start improving until the next morning. After 2 days my tongue was no longer partly swollen and all traces of hives were gone. I did report this to my primary doctor and will be talking to both my primary and my rhuematologist about it at my next appointments with both.
sinus headache; pain from arm that has metal plate to fingertips; pain at injeciton site; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), SINUS HEADACHE (sinus headache), PAIN IN EXTREMITY (pain from arm that has metal plate to fingertips) and VACCINATION SITE PAIN (pain at injeciton site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Internal fixation of fracture (arm has metal plate).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain from arm that has metal plate to fingertips) and VACCINATION SITE PAIN (pain at injeciton site). On 29-Mar-2021, the patient experienced SINUS HEADACHE (sinus headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), SINUS HEADACHE (sinus headache), PAIN IN EXTREMITY (pain from arm that has metal plate to fingertips) and VACCINATION SITE PAIN (pain at injeciton site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included acetaminophen (Tylenol) and acetylsalicylic acid (Aspirin).
I gave an incorrect vaccine dose to the patient I gave her 0.3mL of an undiluted Pfizer Covid Vaccination that once diluted is 6 vaccinations.. Patient at this time has not had any adverse reaction or symptoms.