chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccine was accidentally administered to 5 patients with no reported adverse event; Initial information was received on 05-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 1 years old female patient who experienced expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was accidentally administered to 5 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 22-Jun-2023, the patient received a dose 4 of expired suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at dose of 0.5 ml total once (lot number: C5893AA) in the right thigh (strength, route, expiration date: Unknown) for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  It was reported that "The doses were all administered by medical assistants. It was not the same medical assistant who gave the expired doses to the five patients."  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event expired vaccine was accidentally administered to 5 patients with no reported adverse 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.; Sender's Comments:  US-SA-2023SA206040:01679483 US-SA-2023SA206040:01679488 US-SA-2023SA206010:01679494 US-SA-2023SA206040:01679504
red rash with bumps and some small blisters on right side of face near lips, chin left side, up across the left cheek, left ear, and part of the neck; Feels slight burning; Itch; Left ear lope got very swollen; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6204) via an unspecified route of administration in the right arm on 23Mar2021 at 12:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN) sustained-release and estradiol, estriol (BI EST), all for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 31Mar2021, the patient had rash on face, that started on right side near lips and spread to the chin to the left side and up across the left cheek and to the left ear and then part of the neck. The rash was red with bumps and some small blisters. The patient felt slight burning and itch. The patient had very swollen left ear lope. The events lasted for 6 or more days. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red rash with bumps and some small blisters on right side of face near lips, chin left side, up across the left cheek, left ear, and part of the neck, felt slight burning, itch and left ear lope got very swollen were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
onset fever range w/in 24hr p/vax inc tremulousness, emesis x1;?cyanosis lips & extremities;diarrhea x 2;hosp for observation;amoxicillin,APAP,Ibuprofen for fever;
extremely swollen lymph nodes under the right arm under left arm lymph nodes remain slightly swollen from first dose administered on 11/27
24 hours after injection, body aches, fever of 98.7.    26 hours after injection, body aches, chills, dry cough, fever of 100.8  Ice cold hands.  36 hours after injection, temperature drop to 99. 2.    48 hours after injection, temperature to normal.  Hands and feet ache.
Sore arm, heavy bleeding for a week following despite not menstruating in years due to IUD placed.
The evening p/vax pt cried w/high pitched cry for 4 hrs; had fever for 2 days of 104; right leg was red & swollen;
HEART PALPITATIONA  after vaccine 2 FAINTING                                 after vaccine 3
Pt waited 15 min after 1st Covid shot. She was going to  stand but fell back in chair & fainted. Unconscious approx. 20sec. Came to. Was clammy. weak, needed water. We made sure she was ok before going home.
Patient received first J&J vaccine and within 5 minutes or so started seizing, shaking, breathing heavy and slumped over in the chair. He woke up quickly but could not remember what had happened. He reported tingling in his fingers and toes. EMS was called and evaluated him. He went home in stable condition.
pt recvd vax 29OCT93 & the next morning devel a pruritic, red rash on the shoulder near the inject site; rash spread from nipple to nipple & also had a rash from knee to groin; pt went to ER & was treated w/DPH for relief;
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 62-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: 210122-137), in left arm, on 15Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid. There was no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (21Sep2022) Positive, notes: Return of positive home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included Paxlovid from 13Sep2022 to 17Sep2022.
On 04/16/2021 I started experiencing migraine and jaw pain. On 04/20/2021 I experienced lost of vision, migraine, increased blood pressure and jaw pain. On 04/21/2021 I was diagnosis IIH. On 04/22/2021 I received a lumbar puncture and had fluid drained. On 04/28/2021 I was back in the hospital for the jaw pain. I was told the jaw pain was related to the IIH. On 09/09/2021 I was admitted into the ER for blurred vision and increased migraines. 09/11/2021 I had another spinal tap. 10/07/2021 I had an appointment in which we scheduled a surgery 12/15/2021 for a VP shunt.
Patient received moderna vaccine on 4/28/21, 5/26/21 and 11/19/21. Presented to ER on 6/2/22 and found to be covid positive. The patient came to  the emergency room again on June 2nd with a concern about acute congestive  heart failure, but the major problem seems to be acute kidney injury on top of  chronic kidney disease and a COVID-19 infection.  *** her creatinine baseline  used to be 1.9, and after discharge she was a little higher, but now this  hospitalization started going above 4.  The patient was seen by Nephrology.   She was hydrated.  Her p.o. intake was poor.  Yesterday, she became more  agitated requiring a dose of Haldol.  Today, she is much better.  She does  have reasonably good output.  She received monoclonal antibodies for COVID  infection.  She is currently on Decadron.  She has 2 more days left. Discharged on 6/9/22
5 hr after second shot ate dinner and had diarrhea. Felt ok and then went to bed. 1 AM awoke with stomach and back aching and cramping. Unable to find comfortable position. Nothing warranting intervention but clearly too uncomfortable to sleep. Some tingling on back of arms and thighs; similar to flu. May have slept briefly and woke saturday to similar tummy pain. No diarrhea or vomiting. Slight headache. Symptoms began to disappear soon with stomach ache dissipating throughout day. Able to sleep fine saturday night and 100 percent good today. Almost no symptoms after shot one; by the way.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 20-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of PROQUAD (Merck), (dose, frequency and route of administration were not provided), lot # L013545, expiration date 17-OCT-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. Additional information has been requested.
when goes outside, the rash gets worse; joints are angry; what felt like the flu; there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse; sort of looks like ringworm, edges are super raised and bumps are in there; a big knot under skin and now it's soft and looks gross; a discoloration in the skin; her arthritis is affected; pure exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (what felt like the flu), RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), RASH (when goes outside, the rash gets worse) and SWELLING (a big knot under skin and now it's soft and looks gross) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriatic arthritis and Rheumatoid arthritis.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (what felt like the flu), RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), SWELLING (a big knot under skin and now it's soft and looks gross), SKIN DISCOLOURATION (a discoloration in the skin), ARTHRITIS (her arthritis is affected) and FATIGUE (pure exhaustion). On an unknown date, the patient experienced RASH (when goes outside, the rash gets worse) and ARTHRALGIA (joints are angry). On 16-Apr-2021, INFLUENZA LIKE ILLNESS (what felt like the flu) and FATIGUE (pure exhaustion) had resolved. At the time of the report, RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), RASH (when goes outside, the rash gets worse), SWELLING (a big knot under skin and now it's soft and looks gross), SKIN DISCOLOURATION (a discoloration in the skin), ARTHRITIS (her arthritis is affected) and ARTHRALGIA (joints are angry) had not resolved.        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.   Prior medical history includes neck and back surgery. Her HCP suggested OTC allergy medication and ibuprofen which she has been taking but does not affect it.
Fatigue, weakness Narrative: Currently at home. On day 7 of symptoms. Patient is obese, Diabetic, and smoker considered High Risk for Covid 19 infection.
Fever reaching 101.4 for nearly 24 hours, starting approx nine hours after booster shot was administered. Migraine headache and severe nausea also started around nine hours in, continuous until present (over 72 hours after booster shot). These symptoms  were reduced after 36 hours, but got worse again after 48 hours and have stayed intense. Mild difficulty breathing, continuous until present - controllable with rescue inhaler. Extreme fatigue and body soreness, with soreness starting to taper off around 72 hour mark.
Headaches all of the time Ear aches just about every day  Tinnitus in left ear  Ringing in the head just about every day
PATIENT HAD NO REACTION TO THE IMMUNIZATION BUT WAS GIVEN THE BEXERO VACCINE GIVEN TOO EARLY. PARENT AND PATIENT ARE  AWARE A SECOND DOSE WILL BE REQUIRED WHEN SHE REACHES THE APPROPRIATE AGE.
Hospitalized with Covid 19 pneumonia, acute respiratory failure, AKI, Pulmonary embolus,  treated with aspirin, dexamethasone,
Patient developed high fevers 102.7 and local reaction 1 week following vaccines. fevers lasted 3 days and Patient developed hives on 4th day once fever resolved.
States reports to MD that she broke out in a red spotted itchy rash on Head, torso and upper legs.
Watery diarrhea for 10 days; Rash on my chest and upper arms; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm  on 01Apr2021 at 16:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, migraine and depression. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Apr2021 at 20:00, the patient experienced watery diarrhea for 10 days and a rash on her chest and upper arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of watery diarrhea and rash on her chest and upper arms and included treatment with diphenhydramine hydrochloride (BENADRYL) and unspecified medication for diarrhea. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was  negative. The clinical outcome of the events watery diarrhea was recovered on 14Apr2021; while that of event rash on her chest and upper arms was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received the second moderna covid-19 vaccine on 4/1/21.  2 days later she developed a painful itchy rash at injection site that traveled down her whole arm to her hand.  Over the next few days she began to feel dizzy and weak.  She had an episode where she was parked in her driveway and felt she could not get out of the car due to feeling dizzy, weak, and faint.  She was able to get out of her car and to her bed were she remained for the next 8 hours.  She felt she could not get our of bed due to feeling so weak and faint and she feared she would fall.  She woke up the next morning able to get out of bed.  She then began to develop pain and weakness in both shoulders, both arms, both hands, both knees, and both ankles.  We ordered blood test on 5/11/21 including a CBC, CMP, CRP, urinalysis, ESR Wes+Fer, Rheumatoid arthritis factor, and ANA all blood test came back within normal limits.  Patient was seen in the office on 5/24/21 for a physical exam and was found to have loss of range on motion in both shoulders and arms, pain and swelling at both elbows, both hands, and both knees.  Patient also complained of general weakness, fatigue and a fullness or swelling in both ankles.  She has been doing physical therapy, is taking tylenol for the pain, and has been on 2 rounds of steroid medrol dose packs.  Patients continues to suffer with weakness, fatigue, muscle, joint pain in whole body. We have also contacted the moderna company and was told they could not help us and hand no treatment or other advise for us.  We have referred our patient to a Rheumatologist.
I was vaccinating a patient and received a needle stick. The patient and myself had labs at the emergency room at Medical Center and both were cleared of further action
Right thigh swollen, red, warm to touch - consistent with cellulitis. Will treat with SEPTRA 1 1/2 tsp BID X 10 days and BACTROBAN topical TID x 10 days.
By the day and half, 30 hours later I had a lot of burning in my urine, headache, fatigue and muscle ache lasted 24 hours except for the headache that lasted 2 days. Went to see the doctor on Wednesday. White blood cells and taking antibodies. I never had this before. I stayed well hydrated.
Headache; difficulty swallowing; rash at injection site; sore throat; Red body rash; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on an unknown date, for tolerance refer case US2021AMR194171). Concurrent medical conditions included multiple allergies (taking medication for allergy).   On 7th September 2021, the patient received the 2nd dose of Shingrix. On 8th September 2021, 1 days after receiving Shingrix, the patient experienced headache. In September 2021, the patient experienced swallowing difficult, injection site rash, sore throat and red rash. On an unknown date, the outcome of the headache, swallowing difficult, injection site rash, sore throat and red rash were unknown.   It was unknown if the reporter considered the headache, swallowing difficult, injection site rash, sore throat and red rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not provided but it could be 59 or 60 years. The patient had allergies and was taking medication for them (allergy pills). The patient received 2nd dose of Shingrix in her left arm and had headache the day after the injection. After 2 days of vaccination, the patient went to hospital emergency room because she had pain, sore throat, had difficulty swallowing and had a rash at injection site but also a red rash on her entire body. No other information was provided. The patient refused to provide name, date of birth or demographics. The patient did not consent to follow-up.
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK9896), on Feb 16, 2022, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient experienced chest pain and headache, onset Feb 2022, with outcome of unknown. Additional information: Reporter had concerns regarding booster side effects. "My little sister is 18. She got her third dose yesterday and has been having a headache. Also, she said she was kind of having chest pain, which she did not have when she got her second dose. She can breathe fine; but she said she has been having chest pain. Should I give her some medications, is it better to sleep it off or do you recommend I take her to urgent care?" Follow-up attempts completed. No further information expected.
high fever; arm swollen; very painful; suffered. Very sick; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, swelling arm and pain in arm. On an unknown date, the outcome of the sickness, fever, swelling arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and was very sick for 4 days, ran high fever, arm was swollen and very painful. For tolerance of 2nd dose, refer case US2021AMR190666.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190666:same patient/reporter
Second dose not received; every day is a "nightmare"; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received), FEELING ABNORMAL (every day is a "nightmare") and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received) and FEELING ABNORMAL (every day is a "nightmare"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received), FEELING ABNORMAL (every day is a "nightmare") and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. ? Treatment information included Excedrin    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event details updated and Second dose not given