chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Got shingles, less severe; still had sores and pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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 and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter's husband received the vaccine and still got shingles.  The pharmacist told that like covid, it would be less severe.  The patient experienced still had sores and pain, but lasted only a few months. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Information has been received from a physician concerning a 16 year old female who on 01-JUL-2008 was vaccinated intramuscularly with the third dose of GARDASIL. On the same day, the patient developed a fever of 102.6 and had chills and just felt achy. The patient was taken to the emergency room where she was given medication for the fever. At the time of this report, the patient's symptoms persisted. Additional information has been requested.
she tested positive; she tested positive; Moderna Dose Number: 4 ... Pfizer Dose Number 3; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 31 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Exposed to COVID-19", start date: 2023 (unspecified if ongoing), notes: exposed the week before she tested positive. The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jun2022, outcome "unknown", described as "Moderna Dose Number: 4 ... Pfizer Dose Number 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Feb2023, outcome "unknown" and all described as "she tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events interchange of vaccine products, drug ineffective, covid-19 and BNT162B2.
Itchy, Hives rash softball size around the injection site. Would travel down one vein at time and up neck. That hand would become very sweaty at times. Softball are around injection site would also get hard and very hot on and off throughout day. Very very itchy.
Patient has had reaction to vaccines in the past, 3+ years earlier. She had the flu vaccine last year without complication. Flu vaccine given IM Rt. deltoid, patient was observed for 10-15 minutes post-vaccination, with no adverse reaction. Patient return to my office 27 minutes after receiving the vaccine and stated that she did not feel well "all shaky inside". VS 191/117 pulse 71, no SOB or chest pain. Injection site swollen, she was taken to ED. Irregular heart rate second VS 183/98, P-76, R-22.
Patient called the pharmacy this morning (12/16/2019) and stated that her lymph nodes on the side of her body that she received the vaccination are swollen.
2/1/05 started with rash which progressed today 2/2, plus papules of various sizes some with fluid.
Onset 5x7 erythematous raised urticarial lesion to left deltoid around injection site.  Received FLUARIX Lot AFLU145AA 10-31-05 IM to LD.  Developed swelling at injection site within 24 hours.  No fever, chills, purulent drainage or axillary LAD present.  C/o mild itching.
The side I received the mmr and meningitis shot somehow the shot caused pigmentation and now I have bandaid tattoos. Only on left arm. So it was something in the shot.
Complained of being lightheaded after receiving vaccine, first set of vital signs taken B/P 142/82; HR 76; R-18 p Patient kept an additional fifteen minutes. Second set of vital signs taken  B/P 158/60; P -73; R-16. States that she no longer feels light headed.
Sudden, extreme diarrhea and headache starting 6 hours after vaccine was given. I have body aches and overall feel absolutely terrible. It all came on super suddenly.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 20th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient experienced a sore arm due to which she could not sleep. No further details were provided by the pharmacist.
SEEN AT UNIVERSITY HOSPITAL ER, PATIENT HAD SOME FACIAL CHANGES AND PROBLEMS BREATHING, PT WAS GIVEN FLUIDS FOR DEHYDRATION AND TOLD TO FOLLOW-UP WITH PCP TODAY.
PAIN/STIFFNESS IN RIGHT ARM, SHOULDER AND NECK WITH LYNPHADENOPATHY AND SORE THROAT ON RIGHT SIDE.  TREAT IN AN OCCUPATIONAL HEALTH CLINIC WITH INJECTION OF CORTISONE AND PO MEDICATION
No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 18-MAR-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) ) injection, lot # S028920, expiration date 16-SEP-2021 (route of administration was not reported) for prophylaxis. Concomitant therapies included sterile diluent. No adverse symptoms were reported.  On an unknown date, there was unknown temperature excursion for a time frame of 1 second. Previous temperature excursion was from 6 to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes. The digital data logger was involved.
all of them in their family got the Pfizer vaccine and just didn't feel well for a day but was fine the day after; Arms hurt; had a low grade fever that evening, 99.2F to 99.4F; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Caller was calling for her 14-year-old daughter who received her 1st dose of the Pfizer COVID vaccine on Friday, last week at 16:15. She had come down with a 99.2F to 99.4F fever since then and had been going on. She mentioned that she was also tired, has flushed cheeks, and just feels like crap since then. This morning, her temperature was 99.4F. She mentioned that today was the 5th day that it had been going on. She mentioned that all of them in their family got the Pfizer vaccine and just didn't feel well for a day but was fine the day after. She was asking if lingering fevers that go away was a side effect specifically for adolescents. During call reporting on her daughter, caller also mentioned she, herself, got the COVID Pfizer vaccine, arms hurt and had a low-grade fever that evening. The next day it was gone. It was like one day. The patient underwent lab-test included fever 99.2F to 99.4F low grade fever. The clinical outcome of the events, all of them in their family got the Pfizer vaccine and just did not feel well for a day but was fine the day after, Arms hurt, had a low-grade fever that evening 99.2F to 99.4F was resolved in 2021 and outcome of all other events was unknown.  Information about lot/batch number has been requested.
severe torso pain/She had severe torso pain from below her rib cage to her pubic bone both times.; fatigue more severe/she was feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in thigh left, administration date 25Mar2021 (Lot number: ER8732) at the age of 62 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Mastectomy", start date: 2012 (unspecified if ongoing), notes: Verbatim: Mastectomy; "Lumpectomy", start date: 2006 (unspecified if ongoing), notes: Verbatim: Lumpectomy. There were no concomitant medications.  The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "severe torso pain/She had severe torso pain from below her rib cage to her pubic bone both times."; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue more severe/she was feeling tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: Caller is calling to report she had side effects after both COVID vaccines. She is glad she got them. She had severe torso pain from below her rib cage to her pubic bone both times. She has tried to trigger the pain since and cannot. She had a colonoscopy that showed she had little pockets in her intestines. She has never had any pain or discomfort from it. At first she thought the symptoms she had after the shot was a coincidence. She has ate popcorn and seeds that other people have reported having problems with, and nothing happened. This has happened after both shots. The first time it happened 12 hours after the shot. The second time it happened 1.5 hours after the shot. It lasted all day, 24 hours. It is really severe pain . After the second shot, she had a little pink area that was swollen and mildly tinder like with the flu shot. But it was not bad. She had no flu like symptoms or anything. She got both vaccines in her left thigh. That is where she gets all over her shots because she has lymphedema in her arms from a double mastectomy. She even gets flu shots in her left thigh. The caller's mastectomy was in 2012, and her lumpectomy was in 2006. The pain was constant for the 24 hours. It was just surprising to her. It lasted 24 hours both times.  No follow-up attempts are possible. No further information is expected.
shot #1 Dec2020, shot #2 01Aug2022.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on December 2020 received 1st dose via intramuscular route on Unknown deltoid).   On 1st August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 1st August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The reporter was the patient.  The patient received 1st Shingrix shot in late December 2020 and Shingrix 2nd shot on 01 Aug 2022 in unknown deltoid.  As per package insert  Shingrix was given: first dose at month 0 followed by a second dose administered 2 to 6 months later. The reporter consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
pt recv vax 24APR96 9-10AM when got home reported pt crying on & off & refused feeding;seen in clinic p/5hr;pt crying but consolable;cries if stork the legs;ant fontanelle flat, no nl cry;
wife was tired; did not feel like getting up and doing things; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (wife was tired) and IMPAIRED WORK ABILITY (did not feel like getting up and doing things) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (wife was tired) and IMPAIRED WORK ABILITY (did not feel like getting up and doing things). At the time of the report, FATIGUE (wife was tired) and IMPAIRED WORK ABILITY (did not feel like getting up and doing things) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-531854, MOD-2022-531858, MOD-2022-531860, MOD-2022-531849, MOD-2022-531857 (Patient Link).
Itchy at first on 8th; then red; now swollen & warm plus a larger amount of red; shape: size of tangerine & puffy.
Swollen arm, inflamed, rash spreading around injection site. Pain when touched (injection administered on 9/30/14).
Awaken  2:00 am next am face and mouth felt funny not able to hold water in mouth. Grew worse Left eye unable to close by 6 am on 11-04-06. Head left side face left side severe headache severe pain left eye and behind left ear and entire left head. Symptoms remained 11-8-06. 11/15/06-records received from facility: DX acute maxillary sinusitis. Bellys Palsy, IDDM, hyperlipidemia, peripheral neuropathy, depression, hypokalemia, chronic pain right hip, emphysema, urinary stress incontence, chronic right knee pain, GERD.
Child passed out shortly after the second vaccine was administered, similarly to their sibling. The Covid shot was administered first, followed by the flu shot. EMS called but children regained consciousness. No transport to medical facility was given.
Progressive full facial numbness and pressure feeling, took claritin before second shot since that helped with facial numbness, pressure after first Moderna shot. Claritin didn't seem to help with second but Benadryl took away numb feeling. I took Benadryl around 7:30 pm (about an hour after second shot). There was no visible swelling.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On unspecified dates, the patient received 2 doses of M-M-R II vial subcutaneous. Concomitant medications were not reported. On an unspecified date in April 2015, the patient had a blood titer that was negative for MMR antibodies (antibody test negative). It was unspecified if the patient sought medical attention. Action taken with the vaccine was not applicable. The outcome of antibody test negative was unknown. The causality was not reported by the reporter. Additional information has been requested.
I experienced after my J&J vaccine headaches for two days. Then on 04-16-2021 upon waking up I had a red rash which was warm, hot sensation when touching my arm. This hot sensation radiated up to my neck, trachea and down my forearm. I got concerned about the red rash and because I felt my arm hot sensation and I went to see my doctor who asked me if I had trouble breathing or if I had any chest pain. I told him I could breathe and I was concerned about my rash. He prescribed Prednisone medication which I took several days to go away. To this day I still continue with the headaches that come and go and I take 2 acetaminophen to relieve the pain. I do not know if my headaches are related to the J&J vaccine and the rash  has gone away.
2:30pm - Vaccine administered.  Some muscle soreness at the vaccination site, but otherwise no noticeable side effects.  1am - 10 hours after vaccine.  All over body shaking.  Not unlike "chills" but didn't have the cold feeling with it.  No accompanying fever at the time.  Lasted until 5:30am.   6am - 15 hours after vaccine . Shortly after the shaking stopped, spiked a 101.5 degree fever.  That continued until approximately 5am the following day.  Took 500mg acetaminophen at 7am, and again at 4pm, and again at 12am.  Throughout the following day - 15 hours to 36 hours after vaccine - general body aches (most noticeable in the back), lethargic - but that could have been a result of no sleep the night prior due to shaking.   5pm following day - 27 hours after vaccine - bad headache.  That lasted until midnight 5am the next morning - most all side effects gone.  Some lethargy but temperature at 98.6 degrees, body aches no longer apparent, headache gone.
Patient required hospitalization due to breakthrough infection. He received the Moderna vaccine (2nd dose in series) on 03/11/21. Patient was hospitalized from 07/26/21 - 08/06/21. Below is copied from discharge summary:   HOSPITAL COURSE  71-year-old wheelchair-bound man with a significant history of diabetes, hypertension, obesity, spinal cord injury status post ACDF on 11/19 with chronic right-sided weakness is presented for chief complaint of weakness. He was fully vaccinated prior to arrival. Did not require supplemental oxygen. Required inpatient stay for generalized weakness due to acute viral infection. Worked with PT and OT. Recommended short term rehab however patient refused STR placement. Ordered for home health care with home health PT and OT. Constipation was resolved with lactulose 20 g TID. Abdominal pain resolved with bowel movement. COVID therapy included only zinc and pepcid. Continued patient's home antihypertensive regimen. Stable condition at discharge home
pt stated her tongue and partial throat were numb, not swollen.  provided two doses of liquid diphenydromine 25mg  20 minutes apart.  numbness went away by next day but then patient developed metallic taste in mouth.
Pt developed pain and swelling in feet, pain in legs, feet, back, shoulders and neck, in joints and muscles. He had difficulty concentrating, memory loss and headaches. He also had excessive fatigue and sleeping. The annual follow up states, "Inability to concentrate, fatigue, memory loss, pain and stiffness in leg muscles, stiffness in neck, pain at toe, knee, hip, shoulder, back and neck joints. Swelling of toes and bottom of feet at toes. Left arm can't be raised at shoulder above about 8 o'clock. neck movement limited to about 60 degrees arc left to right. The limitations seem to be physically constrained and not just limited because of pain. A follow up report received 11/13/2001 adds: Vaccine provider states that pt was a participant in a clinical trial for Lymerix. He received placebo in 1995 and 1996. He was in the Lymerix group for injections on 04/28/1997, 06/03/1997 and 04/29/1998. He was in a Lymerix booster group for injection on 11/01/1999. The pt's complaints have been communicated to trial contact, FDA, manufacturer, etc., per vaccine provider's office. Another follow up report received 11/13/2001 adds: Pt stated that he was evaluated by a rheumatologist who stated that pt's symptoms could not be the result of Lyme disease or Lymerix. He was treated by this doctor with pain medications. The pt was later evaluated by a Lyme specialist who told the pt he had chronic Lyme disease that was present prior to the Lymerix vaccination and was aggravated by the vaccination. Pt is being treated with antibiotics and has improved.
passed out; fall; Lower back pain; fever up to 102 F; Chills; nauseous; Head hurts; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced fever (pyrexia), chills, nausea and had passed out (loss of consciousness).  The patient's medical history was not provided. Concomitant medications were not provided.  On 28-FEB-2021, the patient received their first of two planned doses of mRNA-1273(Lot number- 012A21A) in the left arm for prophlaxis of Covid-19 infection.  On 01-Mar-2021, the patient experienced fever, chills, nausea and had passed out when she went to the bathroom. When she woke up, she was on her bed and reported that her lower back and head hurts after that fall. Treatment medications included acetaminophen for fever and chills.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events of fever (pyrexia), chills, nausea and passed out (loss of consciousness) resulting in fall and head and back hurts thereafter were unknown.; Reporter's Comments: 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.
No adverse effects; a patient received a dose of PROQUAD that was reconstituted with expired diluent; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.     On 30-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency and route were not reported) (lot # R015740, expiration date: 02-DEC-2019) for prophylaxis. It was used to reconstitute expired sterile diluent (strength, doce and frequency were not reported) (lot # N027625, expiration date: 19-MAY-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects were reported in the patient.