chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"About 10 spots on clients back, chest and arms". Began on 12/4/07. Mom using Caladryl lotion, no fever. Child acts like he feels no illness per Mom.
Itching and risen rash over trunk of body front and back.  Face itches but no rash. Benadryl.
no adverse event; PNEUMOVAX 23 was mistakenly given to a 2 month old instead of Prevnar 13; input error by the prescribing HCP; This spontaneous report was received from other health professional and refers to a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-SEP-2022, the patient was mistakenly vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U039928, expiration date: 31-JAN-2024 (strength, anatomical location, and route of administration were not provided) administered for prophylaxis, instead of pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) (wrong vaccine administered). It was stated that this was not a product confusion but an input error by the prescribing health care professional (Product prescribing error). No adverse event was reported.
That I got the first two shots and still got covid; That I got the first two shots and still got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (age 50 without unit) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "That I got the first two shots and still got covid". The patient said another shot is not going to do anything. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 12 year old female who on 30-AUG-2007 was vaccinated with her first dose of GARDASIL (lot number reported as "14267F"). Concomitant therapy included VARIVAX, VAQTA and MENACTRA. On 30-AUG-2007 the patient experienced nausea and vomiting which lasted for 2 days. On 18-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot number 659439/1267U) and she experienced nausea and vomiting which lasted for 2 days. Additional information has been requested.
Tiredness; little fever; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tiredness) and PYREXIA (little fever) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (first dose, batch number: 012A21A) on 27-Feb-2021, MODERNA COVID-19 VACCINE (first dose, batch number: 012A21A) on 27-Feb-2021, MODERNA COVID-19 VACCINE (second dose, batch number: 039A21A) on 27-Mar-2021, MODERNA COVID-19 VACCINE (third dose, batch number: 66F21A) on 03-Nov-2021, MODERNA COVID-19 VACCINE (fourth dose and batch number: 048L21A) on 05-Apr-2022. Past adverse reactions to the above products included Fever with MODERNA COVID-19 VACCINE; No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE; and Tiredness with MODERNA COVID-19 VACCINE.    On 10-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness) and PYREXIA (little fever). At the time of the report, FATIGUE (Tiredness) and PYREXIA (little fever) outcome was unknown.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that with the booster, the patient was pretty good, just a little fever and tiredness.  No treatment medication was reported.   This case was linked to MOD-2023-746964 (Patient Link).
After her 15 min observation she appeared ataxic. Patient stated she felt dizzy, had some water and rested while under observation until dizziness subsided and she walked without losing her balance
Pain in left arm about 20-30 minutes after injection. Excruciating pain during the evening that night. I am currently a week out from receiving that vaccine and still have excruciating pain when moving my arm and a decrease range in motion with the left arm. The pain has caused lack of sleep. I woke up around 2:00 AM on 3/12 and my left arm was numb. I mentioned these issues to my doctor, who suggested giving it more time and if it?s not improved in a week, then she recommended a referral to a sports medicine specialist. I am currently 32 weeks pregnant with an estimated due date of 5/4/2020.
This case was reported by a healthcare professional via a representative and described the occurrence of contusion in a subject of unspecified age and gender who was vaccinated with INFLUENZA (manufacturer unspecified). On an unspecified date the subject received unspecified dose of FLU vaccine (unknown). Cosuspect medication given on an unspecified date included SUMATRIPTAN and TREXIMET. At an unspecified time after vaccination with FLU vaccine, the subject experienced severe contusion and hemorrhage. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Temp. started at 101.2 took Tylenol that was at 5pm and 9pm had a temp of 102, soreness in arm that I was given shot that was so bad it was all the way up in my neck and hard to move that arm, by 11pm I had a rash that was red and my arm that I had the shot in was red and hot, the rash was red with bumps and I had small blister in my mouth and I took Benadryl, by Friday morning I was sore all over my body and it was not until the next day that the rash and blisters had gone a way, still have a sore arm with a knot, but no redness today. Reported to the hospital nurse who gave me the shot this a.m this is the hospital where I work, and I have never had a reaction before.
Positive COVID test; Positive COVID test; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 09Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown), in left arm and on 09Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 04Apr2021 as dose 1, single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 14Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Positive COVID test 5 days after completion of Paxlovid after having tested negative; (unspecified date) Unknown results, notes: COVID 19 Treatment; (27Jun2022) Positive, notes: Positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID symptoms returned 5 days after completion of Paxlovid. Positive, COVID test 5 days after completion of Paxlovid after having tested negative immediately following Paxlovid course. Adverse event start date 27Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
diarrhea; Feeling the urge to go to the restroom; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient) reported a 61-year-old-male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an 28Feb2021 as a single dose for COVID-19 immunization. Medical history included a negative COVID-19 test in Jun2020. Three days later he showed symptoms of COVID-19 with no taste and a slight fever but never had a test to confirm he had COVID-19. Concomitant medications were not reported. On 28Feb2021 the patient experienced the urge to go to the restroom. The patient used the restroom before his appointment and did not have diarrhea but when he got home he had diarrhea real bad. The event was reported as non-serious. The patient also wanted to know if he should not receive the second dose of BNT162B2 because he had COVID-19 before. The outcome of diarrhea was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
About 20 minutes after shot I got a sudden headache. About 45 minutes after shot I got sudden sweats, weakness, dizziness, and diarrhea. I couldn?t eat for the remainder of the day. Very tired. Note: I did have Covid-19 back in July 2020.  The day after the shot I felt a little better in the morning, but by late day I got a low grade fever, and felt like flu. Body aches, particularly in legs, chills, and very tired.
Information has been received from a 29 year old female with an allergy to horse serum who on 05-DEC-2001 was vaccinated with a dose of Hepatitis B vaccine recombinant (yeast). There was no concomitant medications. In December 2001, the patient developed swelling at the injection site in left arm, redness, and it was described as the size of an quarter, tender to touch and he experienced shoulder pain. The patient applied ice to the site. unspecified medical attention was sought.  Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced general body pain, fever and hot feeling in feet. On an unknown date, the outcome of the general body pain, fever and hot feeling in feet were unknown. It was unknown if the reporter considered the general body pain, fever and hot feeling in feet to be related to SHINGRIX. Additional details reported as follows: The patient experienced some achiness and fever, along with her feet was feeling hot. For tolerance after 2nd dose refer case US2018GSK150555. This case has been linked with US2018147868 and , reported by same reporter.
Right arm and hand tingling and numb going on threes days as of today 03/17/2017.
After the booster on 4/27, headaches and brain fog, memory loss worsened.
Information has been received from a occupational therapist concerning her 5 year old daughter with pertinent medical history and drug reaction/allergies reported as none who in 2003 was vaccinated with a dose of PEDVAXHIB and concomitantly with PREVNAR.  In 2003 later that day, the patient experienced a high fever and breathing irregularities that lasted one week.  Unspecified medical attention was sought.  Subsequently on an unspecified date, the patient recovered from high fever and breathing irregularities.  No product quality complaint was involved.  Additional information has been requested.
pt states that her arm got hot, and red and inflammed below the area where the shot was given
My menstrual period  was due a day or two after the vaccine but didn?t arrive until cycle day 40. Then I got a period two weeks later (I?ve never had a two week cycle) and then two weeks after that - unless it was a cycle with bleeding in the middle of it for a few days. Then the next period I had was incredibly heavy with lots of clots and very painful for about 4 days. I?ve never experienced that.
Extreme fatigue, dizziness, chills, brain fog, headache, left arm weakness, left arm pain.
inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 Pharmacist had a patient who received the first dose of Shingrix 3 years ago, and never got the second dose, which led incomplete course of vaccination. The reporter consented to follow up.
pt was vaxed on 8APR93 w/DTP vax & hospitalized on 19APR93 w/confirmed pertussis; d/c 25APR93;
Noticed knot in arm at injection site in the morning during shower. Throughout the day, knot increased in size, became red, warm, tender and itchy.  Continued to increase in size and pain, being three inches in diameter at largest. Pain rated a 3 on a 10 point scale. PCP was contacted 01/13/21. She said it was an expected reaction and suggested Benadryl. I can't remember if I took anything for the pain. I took Benadryl throughout the day as the spot was really uncomfortable. Knot was largely resolved by 1/15/21.
This spontaneous report was received from a healthcare worker (also reported as VFC employee) regarding an unknown number of patients. The patients demographics were unknown. There was no pertinent medical  history and drug reaction or allergies of the patients reported. On an unknown date, an unknown number of patients was vaccinated with ROTATEQ (product lot and expiry date was not reported) orally that had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same source.  Additional information has been requested.
shortness of breath at Rest (Comes and goes)  After Second Dose; Chest Pain at Rest and when Deep Breathing (After Second Vaccine); Became dependent on others after second dose; Headache; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose), HEADACHE (Headache) and NAUSEA (Nausea). On 20-Mar-2021, the patient experienced DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) (seriousness criterion hospitalization). On 24-Mar-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose), CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) scan of lungs and Cardiac scan showed clear, all tests were normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reporter by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
lower back muscles exhibit "more pain than usual"  when going from a sitting to standing position and vice versa after receipt of the vaccine; This spontaneous report was received from a consumer referring to herself as a 69 years old female patient. The patient's concurrent condition included drug reaction/allergy to unspecified antibiotic, and lower back muscles pain. Her medical history included pneumonia. Concomitant medication was not reported.  On an unspecified date in July 2019, unspecified lab diagnostics/studies were performed (results not reported). On 04-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot number and expiration date were nor reported; route of administration reported as injection) for prophylaxis.         On an unspecified date in September 2019 (reported as after receiving the vaccine), the patient's lower back muscles exhibited more pain than usual when going from a sitting to standing position and vice versa (back pain). No treatment was given for this event and the patient did not seek medical attention. At the reporting time, the patient had not recovered from back pain. The reporter stated that she was not sure if the event was related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or not.
Closed fracture of proximal end of Right humerus with nonunion. Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient described feeling lightheadedness, rapid heartrate, "frozen state", labored breathing, and sluggish   approximately 26 hours post Covid vaccine. patients wife helped him to the recliner and within a short time, patient felt better. No further episodes per patient since this episode. Patient and his wife did not call  the Dr. or an ambulance at the time.  When patient's wife contacted the health dept. on 10/25/23 at 0840,  nurse V. R.N., encouraged the patient and his wife to call the Dr.  patient went to the Dr.  on 10/25/23 at 3 p.m. and Dr. examined him and per patient's wife found "  no problems."  Patient had had a routine cardiology appointment last week and everything" was normal" per patient's wife at cardiologist. encouraged patient to let cardiologist know of episode. Patient's wife said she would call.
Within a few hours, my shoulder/top of arm was very sore, more so than I usually experience with a flu shot. Pain started the same day, shoulder issues gradually worsened - stiffness, loss of mobility. Over the next several months, I experienced pain in my shoulder that gradually worsened and the range of motion was significantly diminished and was getting worse., which led me to make an appointment with my physician. He diagnosed me with Adhesive Capsulitis (frozen shoulder), ordered X rays to confirm and prescribed physical therapy.
COVID Arm redness almost circumferential Arm pain and tenderness elbow to neck Should joint tenderness  Fevers,  severe headache,  nausea, severe body aches
patient had a large hard reddening on her right arm./area was big 5 inches; patient had a large hard reddening on her right arm./area was big 5 inches; fever for 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (patient had a large hard reddening on her right arm./area was big 5 inches), VACCINATION SITE ERYTHEMA (patient had a large hard reddening on her right arm./area was big 5 inches) and PYREXIA (fever for 3 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in March 2020, Knee operation and Back surgery.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE INDURATION (patient had a large hard reddening on her right arm./area was big 5 inches), VACCINATION SITE ERYTHEMA (patient had a large hard reddening on her right arm./area was big 5 inches) and PYREXIA (fever for 3 days). At the time of the report, VACCINATION SITE INDURATION (patient had a large hard reddening on her right arm./area was big 5 inches), VACCINATION SITE ERYTHEMA (patient had a large hard reddening on her right arm./area was big 5 inches) and PYREXIA (fever for 3 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 102 102 degrees Farenheight..         Concomitant medications were not reported.  The patient received her first booster dose on 29-Oct-2021 lot number 012F21A expiration date is 19-Jan-2022 The patient received this booster in her right arm. The patient reports a fever of 102 degrees Farenheight. The patient had a large hard reddening on her right arm. The area was big 5 inches .Fever lasted for 3 days.  Patient is on several and did not wish to discuss her medications.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-646120, MOD-2022-646134 (Patient Link).
I received a Tdap booster on 7/10/12 up high on my right arm/almost at the shoulder joint. The site was sore if bumped or I laid on it until 7/21/12 when I woke up and couldn't move/use the right shoulder. The injection site was warm and slightly swollen. Any motion or touch to the site or shoulder caused extreme pain, nausea, tears. Used ice, aspirin and Soma during the day.  After midnight 7/22/12 I finally went to the emergency room.  Treated with antibiotics and pain pills, a sling.  Follow up w/pcp 7/23/12, she ordered a shoulder xray, no work for 2 weeks, continue antibiotics, pain meds.
R upper arm erythema, heat, edema and severe pain began hurting several hours post injection.
Patient was seen in the office for her HPV and covid booster yesterday. This nurse administered 2 mls of the 6 month- 4 years bivalent pfizer vaccine instead of 2 mls of the 5-11 bivalent covid vaccines per age group. Provider to inform parents of administration error and reschedule patient to get the correct dose.
Large red/pink rash at site of injection, vertical oval shape, 3 inches tall by 2 inches wide. Itchiness at onset (~ 7 days after vaccination), gradually deepened in color to bright pink. Colored flesh feels hard to the touch. Very itchy. Red rash lasted 4 days, itchiness subsided after 8 days from onset.
Nausea, t102.4, myalgia & generalized malaise; onset 17 hrs p/inject lastd 48 hrs;
Client came into nurse of the clinic for a TST read and c/o (R) arm was hurting some. PHN observed said arm (R) to have a big red area, that was warm to touch. Client was advised to use ice and treating with BENADRYL. Is not resolved. Please contact physician. Size 3.5 in/4.5 inches.