chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening the immunization was received baby was irritable and parents felt he was running a fever.  The following day, late afternoon, mom noted hives in the armpits, navel, and around the hairline. Mom and grandma brought baby to the ER where they say, "lab work was done". No treatment was given, baby is now well.
Area of erythema at VARIVAX site - 1-2 in diameter - no treatment - observe only.
Injecton site warm; Injection site hard; redness in arm she got her shot; swell in arm she got her shot/swelling in bump form; hives; itchy; arm redness; Arm swelling; pain and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2022, the patient received Shingrix (intramuscular). On 23rd June 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 28th June 2022, the patient experienced injection site swelling, hives, pruritus, erythema of extremities and swelling arm. On 29th June 2022, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site induration, hives, erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the injection site swelling and injection site pain were unknown and the outcome of the pruritus was recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site warmth, injection site induration, hives, pruritus, erythema of extremities and swelling arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: The reporter reported on behalf of his wife. AE (adverse event) filed.  The reporter was wondering if it was normal to have a reaction to the Shingrix vaccine 5 days after receiving it. The reporter's wife had redness and swell in the arm where she got her shot. The patient received a dose of Shingrix vaccine into unknown arm and less than a day patient experienced pain and soreness at the injection site.  The reporter reported that patient experienced swelling in bump form and redness that looked like hives and was itchy.  The reporter reported that the itching had going down but on the day of reporting the injection site was red, warm and hard.  The reporter inquired if there was any information about delayed reactions.  The reporter spoke from content and PI (package insert) and referred to HCP (health care professional).  The reporter consented to follow up. The case US2022099909 was identified as duplicate of this case. The case US2022099909 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Rapid heartbeat; Fever; Chills; Mobility decreased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), PYREXIA (Fever), CHILLS (Chills) and MOBILITY DECREASED (Mobility decreased) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heartbeat), PYREXIA (Fever), CHILLS (Chills) and MOBILITY DECREASED (Mobility decreased). At the time of the report, HEART RATE INCREASED (Rapid heartbeat), PYREXIA (Fever), CHILLS (Chills) and MOBILITY DECREASED (Mobility decreased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swelling, redness, stiffness, itching in left shoulder. Is hot to the touch.
Fever, chills, lethargy subsided after 24 hours. Shooting pain on my left arm that radiates, and also leaving pinching/aching pain to side of left breast.
I had fever over 100, chills, headaches, fatigue I took tylenol.  It lasted for 24 hours
Red, raised 3 x 3 3/4 inches area on upper R deltoid, warm to touch. Pt give script for BENADRYL and told to ice area.
Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-JUL-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # J013555, expiration date 02-MAY-2015, strength, dose and route unknown) (expired vaccine administered). No adverse events were reported. Additional information has been requested.
A week after the shot, my ears were very full, clogged, and sounded like they had fluid. After a week straight of those symptoms, I began to hear a high pitched ringing in both ears, that has continued to this day.
10/06/2023 1:19 PM Reporter: Patient came in and showed me a bruised area on her arm where she received her Covid vaccine yesterday. She said her arm is very sore. Her face was flushed last night and this morning, but she thought it might be due to worrying about why she had a bruise. She did not have any other sx. Her face was no longer flushed. Advised her to f/u with Dr just to be sure. Her arm did not appear to be swollen- just bruised at the injection site. (She did raise her arm to show me how it would swell and I explained that was her muscle and showed her how my arm does that too.) Reassured pt and encouraged her to f/u with PCP so she didn't have to worry. She was very thankful for everything.
Initial unsolicited case received from a consumer on 07 Oct 2016. This case involves a female patient (age was not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QIV (Batch number: UT5673KA, expiry date-30 Jun 2017 (dose in series, route and site of administration was not reported) on 04 October 2016. The patient illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within four weeks of vaccination was reported as none. The patient Concomitant medications were not reported. On 04 Oct 2016, 30 minute after the vaccination, the patient had developed a metallic taste in mouth. The patient relevant laboratory data was reported as none. The patient corrective treatment was not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by the patient via interactive digital media. The patient received the Shingles shot and now have fever. Follow-up would not possible, as no contact details were available.
0.3mL dose of the vaccine was given to a 9-year old patient; 0.3mL dose of the vaccine was given to a 9-year old patient; Low grade fever; Sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2022 (Lot number: FL3209, Expiration Date: Jun2022) at the age of 9 years as dose 1 (tris), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 04Feb2022, outcome "unknown" and all described as "0.3mL dose of the vaccine was given to a 9-year old patient"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Low grade fever"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "Sore arm". No follow-up attempts are possible. No further information is expected.  Additional information:  Caller was calling regarding the Pfizer covid 19 purple cap vaccine. Caller stated that a 0.3mL dose of the vaccine was given to a 9-year old patient last Friday, 04Feb2022. Caller was asking if there was information on how long to wait to give the second dose, or if a second dose was still needed. Caller was asking if there would be any complication that would arise from the patient have a higher-than-authorized dose?  Follow-up (08Feb2022, 09Feb2022): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a 9-year-old female patient that: Updated information: New reporter was added. Patient initials, DOB, age, ethnicity was added. Relevant medical history was added. Vaccination start, stop date, lot number, expiry date, anatomical location was added. Events was added. Concomitant therapy was added.  Details: NDC number of Covid vaccine: 59267-1000-1. No investigation assessment. Patient height and weight was unknown.Caller states this dose was given to the patient on 04Feb2021, wants to know when the patient should get her second dose. States she called to check on the patient, states she just has a low grade fever and sore arm from the shot that was reported to the caller by her parents but states she is fine other than that. Email address is confirmed with the caller.  Follow-up attempts are completed. No further information is expected.
Mild received vaccine on 9/25/07-returned to office 9/26/07 with fever last night, fatigue, no appetite, and arm pain (deltoid) area.
Patient remained sitting in chair for several minutes after injection. Patient became pale, then lost consciousness, his back arched, he started twitching, mother eased him to floor from chair. Pharmacist administering vaccine noted his jaw was clenched.  Administering pharmacist brought him a cool towel, he regained consciousness and lay on the floor for 5 minutes.  He sat up in a chair, his color turned white and his eyes rolled back in his head again.  This time no arching, or twitching.  He rested another 5 minutes, and was able to depart.  He skiied the next two days and had no complaints.  He doesn't remember anything that happened in the pharmacy.  He has fainted from previous flu shots, I thought it was fear the first time.  That is why I had him sit in the chair at the pharmacy this time to wait and see what happened.
Patient received his second dose on March 13. On the 20th, patient started to have allergy like symptoms: congestion and coughing. He also felt like having a fever but he did not. One week later, patient started to get painful blisters on his leg. He went to his doctor and was diagnosed with shingles. Patient was prescribed an antiviral and gabapentin for pain. It took a week for the pain to resolve and the blisters are now clearing. Patient heard from one of his friends that there have been some shingles cases that were reported with the Covid vaccines. So he called us to report the adverse event.
Herpes; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00(at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes and celiac disease. The patient had no allergies to medications, food, or other product. The patient did not receive any other medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On an unknown date in Apr2021, the patient reported that the vaccine triggered an intense outbreak of herpes. Therapeutic measures were taken as a result of the event and included treatment with VALTREX. The event resulted in emergency room/department or urgent care. The clinical outcome of herpes was ongoing at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Expired vaccine is stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that vaccine did not undergo any temperature excursion and patient did not experienced any adverse event and the date vaccine placed in refrigerator was on 04-Nov-2021.
Patient received Pfizer COVID vaccine without diluent.  Pt. monitored for 15mins with no adverse event or outcome.
Headache, labored breathing with cough and congestion.  I ended up in the hospital for 5 days with pneumonia.  All came on slow but, increased intensity by April 1st.
Arm was fine first day but then extremely sensitive to touch for two days. On day7 the shot site became hard and warm to the touch. It was also very itchy and red.
4-5 inch redness and swelling of right upper thigh.  1-2cm hard area at site of injection.  Benadryl, Advil and FCE.
Little stomach upset; Arm pain; Fever100.5 to 100.7 after 2nd dose; Severe headache; Severe muscle pain; Joint pain; Fatigue; Nausea; Swelling at site of vaccine; Swollen lymph node under left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache) and MYALGIA (Severe muscle pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L208a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1000 mg and IBUPROFEN ongoing since an unknown date at a dose of 600 mg. At the time of the report, ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm) outcome was unknown and PYREXIA (Fever100.5 to 100.7 after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 100.5 (High) 100.5 F and 100.7 (High) 100.7 F. On 27-Jan-2021, Body temperature: 99 (Borderline) 99 F. On 23-Feb-2021, Hepatitis C antibody: 1.20 (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.   This case was linked to MOD-2021-051954.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: This Follow-up was received on 05-MAY-2021 which updated patient demographics.
Very swollen softball size lump in arm, hot to the touch, very painful, 5 days later and it has not gotten any better
This spontaneous report as received from a registered nurse refers to two patients (children) of unknown gender (exact age was not reported). On 04-FEB-2013, the patients were vaccinated with improperly stored M-M-R-II. No other co-suspects and no concomitant medications were reported. No adverse effects were reported. No other information was provided. Additional information has been requested.
Inflammation; Pain; More fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Oct2021 (Lot number: 123456) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose lot unknown reason: Unable to locate or read the details), administration date: 15Sep2021, when the patient was 78 years old, for COVID-19 Immunization, reaction(s): "Fibromyalgia".  The following information was reported: INFLAMMATION (non-serious) with onset 2021, outcome "not recovered", described as "Inflammation"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "More fatigue".  No follow-up attempts are possible. No further information is expected.
2nd vaccine shot April  8 2021 Pfizer LOT # ER8737 Left arm , elbows , both wrists L hip Also After effect is that my peripheral Neuropathy Of my feet , pain has increased  next day 5/9 8+ My elbows are in pain and cannot move , my Left Hip hurts , my hands are numb , neck hurts / stiff as well as my joints from time to time  I HAVE ALSO filed a Adverse Report  on 1st Shot 04/01/2021, I would Like a  permanent report number for both
I started to itch in different parts of my body at random times. I developed big patches of a rash.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: He came with his caretaker (sister) and was told side effects after vaccine administration. I also advised to remain seated for 15 minutes. The patient is special needs and got up anyways. I had pharmacy door open to watch patient while sister was in front of him watching him for reactions. I saw him through door standing against the wall. I ran to help him sit back down and he collapsed and hit his head on the floor . Sister said he has seizures. Called 911
Patient was given a 4th dose/second booster.  Patient is not immunocompromised.  Only 2 doses of the vaccine were recorded in the patients EMR.  The team did not verify through KidsNet, the state vaccine recording system to see if the patient had received his booster.  The patient presented with his COVID vaccine card.  It was reported that the card was placed on a table that was wet from a sweating bottle and the patient needed to be provided with a new card. The team did not verify the vaccines given by looking at the patients card, they only verified through the EMR which did not have the booster documented.
Pt came in for appointment for COVID vaccine, pt was instructed to have a seat in the waiting area. Only a few moments after, pt started to experience 8-10 minutes of nausea and light-headedness. RPH came over to provide care, asked more about past experiences - pt admitted that a long time ago she experienced nervousness and has had this feeling before. She states she has not had such a reaction since she was a child and was also embarrassed for the incident occurring in front of others.
On 9/25/01, the pt experienced erythema around injection site with hives at site. On 9/26/01 the pt experienced a 9 x 5 inch of erythema, indurated around site. No hives around site erythematous below injection site.
12/30 Wednesday  1330 administered  1700 soreness around injection site 2300 fever / chills / headache / 6/10 pain R deltoid   12/31 Thursday  0530 100.0 0930 101.4
Pain, redness and stiffness at injection site initially by 12/23/2010 fever of 104 white blood cell count in the 19,000s
Patient states that arm had redness and was itchy for 2 weeks after Adacel Vaccination.  Patient reported event 1 month after vaccination.
Initial pre-exposure rabies series given in Sept/Oct 1999. Dog bite on 9/26/00. Received 2 rabies boosting on 9/26/00 and 9/29/00. Pt developed urticaria over entire body on 10/9/00, which became more severe with pruritus on 10/10/00. No difficulty breathing or swallowing. Resolving with prednisone/Zyrtec.
Cellulitis like reaction, left deltoid area with lymphangitis streaks. Treated with augmention BID X 1 week.
Patient developed a fever of 103 degrees, neck pain, and sensitive to light. Patient did have doctor's visit on 10/17/2013.  Did receive antibiotic at the doctor's visit.