chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness. Redness on feet. Dilated pupil 5 mins after admin. Paramedics came and checked vital. No special treatment given. Pt recovered in about 30 mins.
Ill defined neurologic event. Neck extension and rigidity approximately 5 hours after shots. High fever for 6 days. Information for missing data report states Prevnar lot # misdocumented, we do not have the lot # for the Prevenar with any currently.
pt stated that 2wk p/vax lt deltoid area started itching & became reddened;states it has cont to itch;& there is a 3mm area that is pink raw skin area;mom states has cont to pick @ the area;did not seek MD eval;
Information has been received from a registered nurse (R.N.) concerning a 17-year-old female who on 12-APR-1994, 11-MAY-1994 and 17-NOV-1994 was vaccinated with her first, second and third doses (respectively) of RECOMBIVAX HB (lot# 610111/1414W, 610111/1414W, and 611786/0450A respectively). Concomitant vaccinations given on 11-MAY-1994 included: MMR II, poliovirus vaccine inactivated (unspecified), tetanus toxoid vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Subsequently, while hospitalized "for other concerns on 06-AUG-2007" the patient tested positive for hepatitis B surface antigen. It was reported that the patient was Hepatitis B IgM core antibody negative. Unspecified medical attention was sought. Liver function tests were performed and were negative. No outcomes were reported. No product quality complaint was involved. Additional information has been requested
Parent noticed the injection site was red and swollen on 6/16/09, mother marked the swelling with a pen and over the course of 2 days it was increased. Very warm to touch. Swelling started at KINRIX injection site. Pt. stated he wasn't in any pain.
I initially noticed that my face and chest were slightly read about 90 minutes after the injection.  The soles of my feet began to itch and then, very quickly, my face, ears, upper torso and arms (down to finger tips), suddenly turned bright red (think ripe tomato).  My skin became exceedingly warm,  and I got the chills.  My pulse was elevated and I could feel my heart pounding.  It spread to my legs somewhat, but not as much as my upper torso. The soles of my feet continued to itch.  I did not have a fever at any point. I took some acetaminophen  and got under the covers to warm up.  I slept for about 2 hours, at which time the symptoms seem to have receded somewhat although the injection site became sore.    Now, one day later, the symptoms are completely gone except that my are is exceedingly sore at the injection site.
Swollen hands and foot, bilateral; Swollen and tender joints (with erythema) ankle, wrist and elbow; low grade fever x 1 day. Erythema macular rash hip area, lower back. Sign and SXs tested(?) for ??, guia Atarax / Restrin. (inject site normal)
Fever, extreme leg and joint pain, chills. The worst of the symptons had let up around 3:00 AM on the 27th. Still dealing with headach and tiredness at 11:00AM on the 27th.
After receiving vaccine, I was really tired, took a nap the day of. The next day started experiencing severe headaches and the headache comes and goes all day everyday since the day after vaccination. I have reported to a couple different doctors I have.  My anxiety has increased. My head and eyes hurt all the time.
Patient received one dose of Moderna vaccine on 05/11/2021. Patient was inadvertently given 1 dose of the Pfizer vaccine on 06/08/2021 in place of the Moderna vaccine. Patient was notified of event and we will continue to follow up with him over the next 4 weeks to monitor for adverse reactions.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
suspected vaccination failure; got the very painful shingles; very painful shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got the very painful shingles. The reporter stated that, they let him know they lingered after many, many months of having them. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180191:Same reporter
3 HRS AFTER VACCINATION - uncomfortable 4 hrs sneezing 5 hrs shivering 7 hrs propulsive vomiting after vomiting 14hrs (on/off) sleeping
Patient contracted COVID-19 approximately 2 weeks after receiving 1st dose of the Pfizer vaccine. Pt was hospitalized for 2 days for oxygen requirement and oral intolerance. She recovered and was discharged home
Joint pain; Swelling of the lymph nodes; Vomiting; Fever of 102; Bad side effect neurological; Lymph node hurts and in the arm; Lymph node hurts and in the arm; There was wired feeling on her neck that will be neck; Extreme exhaustion all over her body specifically neck part near her arm; Short term memory is very bad/not able to put words together or recall words; Nerve pain at her back of neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200354704 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 11Feb2022 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NERVOUS SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "Bad side effect neurological"; VOMITING (non-serious) with onset 11Feb2022, outcome "unknown", described as "Vomiting"; PYREXIA (non-serious) with onset 11Feb2022, outcome "unknown", described as "Fever of 102"; ARTHRALGIA (non-serious) with onset 12Feb2022, outcome "unknown", described as "Joint pain"; LYMPH NODE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2022, outcome "unknown" and all described as "Lymph node hurts and in the arm"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "There was wired feeling on her neck that will be neck"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Extreme exhaustion all over her body specifically neck part near her arm"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "unknown", described as "Short term memory is very bad/not able to put words together or recall words"; NEURALGIA (non-serious) with onset 2022, outcome "unknown", described as "Nerve pain at her back of neck"; LYMPHADENOPATHY (non-serious) with onset 12Feb2022, outcome "unknown", described as "Swelling of the lymph nodes". The events "bad side effect neurological", "vomiting", "fever of 102", "joint pain", "lymph node hurts and in the arm", "lymph node hurts and in the arm", "there was wired feeling on her neck that will be neck", "extreme exhaustion all over her body specifically neck part near her arm", "short term memory is very bad/not able to put words together or recall words", "nerve pain at her back of neck" and "swelling of the lymph nodes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
blisters; This spontaneous case was reported by a pharmacist and describes the occurrence of BLISTER (blisters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (blisters). At the time of the report, BLISTER (blisters) had 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.   No relevant concomitant medications were reported.  No treatment information was provided.  The blisters resolved after 2 days   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: NNI received
patient developed itching shortly after receiving vaccine. Standing order protocol followed including administering benadryl 25 mg PO x1, patient observed, vital signs stable, no progression of vaccine reaction.
Injection site red, hard and hot first two days; Injection site red, hard and hot first two days; Injection site itching; sore throat; hoarseness; Injection site hard and hot first two days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 13:45 (Lot number: ER8732) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "A-Fib" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "hashimoto's disease" (unspecified if ongoing); "sulfa" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; ROSUVASTATIN; SYNTHROID. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EN6206, Administration date: 25Mar2021,, Administration time: 11:00 AM,, Vaccine location: Left arm, Dose number: 1), administration date: 25Mar2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "injection site hot", "injection site hot, red, hard, swollen for 3 days", "Felt nauseous the first day", "injection site hot, red, hard, swollen for 3 days". The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 19Apr2021 06:45, outcome "not recovered" and all described as "Injection site red, hard and hot first two days"; VACCINATION SITE PRURITUS (non-serious) with onset 19Apr2021 06:45, outcome "not recovered", described as "Injection site itching"; OROPHARYNGEAL PAIN (non-serious) with onset 19Apr2021 06:45, outcome "not recovered", described as "sore throat"; DYSPHONIA (non-serious) with onset 19Apr2021 06:45, outcome "not recovered", described as "hoarseness"; VACCINATION SITE INDURATION (non-serious) with onset 19Apr2021 06:45, outcome "not recovered", described as "Injection site hard and hot first two days". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site erythema, vaccination site pruritus, oropharyngeal pain, dysphonia, vaccination site induration  Additional information: COVID prior and post vaccination was reported to be none. Other vaccine in four weeks was reported to be none. Injection site red, hard and hot first two days. Injection site itching on fourth day. Woke up with sore throat and hoarseness on fourth day. Has lasted all day, no improvement.  No follow-up attempts are possible. No further information is expected.
arm is red; arm is hot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red) and FEELING HOT (arm is hot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371921B) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, METOPROLOL, FOLIC ACID, CALCIUM, VITAMIN D NOS, ASCORBIC ACID (VITAMIN C ASC ACID), MULTIVITAMIN [VITAMINS NOS], COLLAGEN and BIOTIN for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced ERYTHEMA (arm is red) and FEELING HOT (arm is hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (arm is red) and FEELING HOT (arm is hot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included, cold compress. Action taken with mRNA-1273 in response to the events was not applicable.
Jaw pain; Syncopal episode/Syncope; Fell; Dizziness; Nausea; Felt flu-like; Injection site pain; Fatigue; Headache; Muscle pain; Chills; Fever; Felt unwell; A spontaneous report was received from a nurse concerning a female 28 year old, patient who experienced same day injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. .    The patient's medical history was not provided.  Concomitant product use was unknown by the reporter.     The patient received their second dose of mRNA-1273 lot 028L20A on 28-JAN-2021.  On 28-JAN-2021 approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 Lot number 028L20A intramuscularly for prophylaxis of COVID-19 infection.    A patient received her second dose of Moderna vaccine on 28/Jan/2021 at 8 AM, lot 028L20A. Same day at 17:00, she experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed pain. She was seen in the emergency room (ER) and released with a diagnosis of syncope and jaw pain. Resolution dates not reported. Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; Reporter's Comments: This report concerns a 28--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and within 2 days, experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like, dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD21-024340:Crosslinked: Same Reporter MOD21-024360:Crosslinked: Same Reporter MOD21-024368:Crosslinked: Same Reporter MOD21-024387:Crosslinked: Same Reporter MOD21-024396:Crosslinked: Same Reporter MOD21-024411:Crosslinked: Same Reporter
Chest pain, palpitions, shortness of breath and tachycardia office visit, blood tests and ECG referral to cardiologist as ECG abnormal
15 month old child was brought in urgently by his grandmother for the acute onset of unresponsiveness after collapsing to the floor while she was watching him about 15 minutes prior to being seen. When she received him from his parents earlier this morning, he seem fine except for seeming a little lethargic. He demonstrated mild shaking of his arms but no obvious tonic-clonic movements. He was seen in the office last evening for his routine 15 month exam at which time he appeared well and had a normal exam. He received his PENTACEL and PREVNAR vaccines. In the office today, he appeared unconscious, with slight response to painful stimuli. His temperature was 102.7. He was transported to the ER by ambulance.
Breakthrough Covid19 Infection - Headache, sore throat, fatigue, congestion, muscle pain. Started 6/29/22 with mild symptoms, home test negative on 6/30/22, stronger symptoms and positive test 7/1/22. Had video conference with Dr. 7/2/22 (have never seen him otherwise) who prescribed Paxlovid 300/100 5 day treatment. 7/2/22 and 7/3/22 were bad days, as sick as I have been in years though certainly not hospital worthy. Symptoms decreasing 7/4/22 and 7/5/22. Feeling back to normal but took another test 7/6/22 and still showing positive so continuing to isolate. 7/7/22 feeling fine. 7/8/22 fine. Will take another test today but still isolate for 5 days
This spontaneous report was received on 12-JAN-2017 from a medical assistant who reported that a one year-old female patient received routine vaccinations of VAQTA (Dose, route of administration, site of administration, Lot number and expiration date were not reported) (Reference MARRS # 1701USA006001) and VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported). The exact date of vaccinations was not specified.  The female patient had a pertinent medical history of anemia. The female patient had no concomitant medications and no drug reactions/allergies. The medical assistant reported that the patient experienced redness and swelling at the injection site, followed by swelling of one eye after receiving unspecified doses of VAQTA and VARIVAX. Treatment of the events was unknown. The medical assistant reported that this occurred on an unspecified date "a couple of months ago," and the patient is now fully recovered. No additional information was available. Additional information has been requested. This is one of two reports for the same patient.
Tdap vaccine was given earlier than recommended. There was no history of pertussis-containing vaccination having been given, so Tdap was administered, before realizing that it was earlier than recommended since a previous dose of Td was received on 9/10/2022. Shortly afterwards, the patient's father (who was present in the clinic with the patient) was notified that the vaccine was given earlier than recommended. A phone call was placed to the patient's father on 11/7/2022 in order to follow-up. Patient had no adverse reactions, other than common side effects including soreness and weakness.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course : Antiviral treatment details product COVID 19 Treatment, brand Paxlovid for COVID 19 were started from 12May2022 to 16May2022, lot number fy7031 Patient received COVID-19 Vaccine. Reported Event: Metallic taste in mouth about an hour after taking the pills for about 3-4 hours. Then it goes away. Also, had symptoms return two days after treatment ended. Fever returned.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I seem to have had an extraordinarily positive response to my COVID vaccine(s); in fact, I believe it cured me of a horrific skin infection I've had for most of my life.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Horrific skin infection" (unspecified if ongoing), notes: I've had for most of my life. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I seem to have had an extraordinarily positive response to my COVID vaccine(s); in fact, I believe it cured me of a horrific skin infection I've had for most of my life.". The event "i seem to have had an extraordinarily positive response to my covid vaccine(s); in fact, i believe it cured me of a horrific skin infection i've had for most of my life." required physician office visit.  Additional information: Patient tried to report the miraculous improvements to local doctors, but they are apathetic towards the connection to the vaccine. Still, patient's skin radically changed exactly 10 days after the first vaccine and has never stopped improving since.   Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer concerning her 12 year old daughter who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st dose of 0.5ml Gardasil vaccine (lot # not reported). Post vaccination, the patient developed flu like symptoms and pain in the leg (which leg not specified). Per the mother, the patient was sick in bed approximately 5 days. The patient did see unspecified medical attention and recovered from these events. Mother is unsure if her daughter will continue series of Gardasil. Additional information has been requested. Additional information has been received from a nurse stating that she was not aware of any AE for this patient. No additional informatin is expected.
Within four days after receiving second Moderna injection, my right hip, leg and left hip began aching.  This would start early evening and progress into and through the night.  I met with my doctor in his office, had an x-ray of the areas involved.  Nothing noteworthy appeared on the x-ray.  His suggestion was to take ibuprofen and acetaminophen throughout the day and evening.  The pain in my hips and right leg is still considerable.  I will be seeing my doctor again about this problem.