chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose 1 of Shingrix / large rash at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (diagnosed in 2003, and had outbreaks since then every 2-3 months).   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was reported. The patient had a medical history of Shingles, diagnosis in 2003 and shingles outbreaks since then every 2-3 months. The patient was allergic to many different medications. The patient received 1st dose of Shingrix in April 2019, and 2 days after developed large rash  at the injection site and lasted for 4 days and resolved till the time of reporting. For further tolerance of 2nd dose of Shingrix, refer case ID US2020AMR195837. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR195837:same patient, same reporter, different dose
a single family member of 4 that received a dose of saline instead of the yellow fever vaccine with no reported Adverse event; Initial information received on 11-Jul-2022 regarding an unsolicited valid non-serious case received from a physician. Agency number: 01184696  This case involves an unknown age and unknown gender patient who experienced received a dose of SALINE [SODIUM CHLORIDE] instead of the YELLOW FEVER VACCINE - [YF-VAX] vaccine with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. This case is linked to cases 2022SA278536, 2022SA278093 and 2022SA276277.    On an unknown date, the patient took Saline [Sodium Chloride] at (unknown: strength, formulation, dose, frequency, batch number and expiry date) for unknown indication. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE at lot: UJ563AA, expiry: 23-May-2023 (with an unknown strength, formulation, frequency) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient developed a non-serious event of received a dose of saline instead of the yellow fever vaccine with no reported adverse event (wrong product administered) (latency: unknown).   Action taken: Not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a medical assistant concerning a patient who on 03-JAN-1992 was vaccinated with a first dose of MMR II prior to 12 months old. The patient received the second dose of MMR II on 29-MAY-1996. The patient was going to college and had a negative titer for the mumps. The mumps titer was 0.82. The patient sought medical attention through a phone call. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 52-year-old female patient who received SHINGRIX (batch number 75GJ5, expiry date 2nd February 2021) for prophylaxis. Concomitant products included Amoxicillin. On 17th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 17th July 2018, 3 hrs after receiving SHINGRIX, the patient experienced muscle pain (serious criteria disability). On 18th July 2018, the patient experienced fatigue (serious criteria disability) and general body pain (serious criteria disability). On an unknown date, the outcome of the muscle pain, fatigue and general body pain were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, fatigue and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to VAERS by the pharmacy. The patient received SHINGRIX vaccine on right arm. The pharmacist reported that the patient had to take the next day off of work because of the muscle pain, fatigue and full body pain.
Menstrual bleeding for a duration much longer than usual (usually 5 days, currently on day 17 and counting)
This was my first pregnancy. I was 7 months pregnant and went to immediate care to get a flu shot. Called OB and immediate care today for specific dates. Called OB on 11/11/16 complaining of Rheumatoid Arthritis symptoms. Hot to touch, pain and extreme stiffness in hands/fingers. Didn't make the correlation until I found studies confirming the strong link between vaccinations and RA.
Infanrix administered instead of Boostrix; 17 years old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-JAN-2023 Reporters comment: The medical assistant called and reported that a dose of Infanrix was administered to a 17-year patient instead of a Boostrix dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive information: The Infanrix was administered to a 17-year age patient instead of a Boostrix dose which led to inappropriate age at vaccine administration and wrong vaccine administered.
Pt states that began to have SOB, increased pulse (avg 105), increased BP (172-178/98-102), and fever (Tmax 101.5) beginning the morning of 2-7-12. Saw hives on back, chest and bilateral dorsal arms 2-10-12. He does state that he did have chickenpox as a child, but needed vaccination as requirement for nursing school.
pt felt weak, nausea, abdominal pain s/p IM injection moderna covid vaccine; pt was immediately evaluated and treated with PO challange, v/s, bgl, P/E stable; obs for 30 minutes; pt symptoms completely resolved; repeat v/s improved; deferred ems transfer to ED, wanted to go home, return precautions given; recommended 2nd vaccine at hospital
(L) hand swelling, redness and itching since 7:00pm on 2/2/12. No fever, chills, SOB, tongue swelling or throat swelling. No apparent reaction at injection site either (L) or (R) arm. Per pt swelling and redness subsided within 48 hours. (2/9/12 back to normal).
Severe dizziness 8 hrs after shot.  Then dizziness , lightheaded, and vertigo continuously starting  May 3rd, 2021.
local rxn-redness & swelling systemic;myalgias, chills, sweats, h/a for 5-7 days slowly improving by pt hx-not examined until 10APR96 when mostly better;
Headache, Myalgia & NauseaVomiting Narrative:   Other Relevant History:
August 24th I tested  positive for COVID. Headache, nausea, cough, shortness of breath, Dr. Called in steroids
10x5cm warm induration on lt thigh medially to inj site of DTP/HIB w/in 24hr;t thigh circumference 2cm larger than rt;
Nothing very serious. Cold chills, mild headache, some back and muscle pain, fogginess. All side effects were completely gone within 30 hours after onset.
Per patient she is experienced bronchospasms around 8pm and saw PCP today who gave her a breathing treatment and prescribed the following: Ventolin, Medrol dose pack, and Benadryl. She also stated that her blood pressure may have been elevated but is uncertain as she did not check her levels and also did not take her regular blood pressure medication once she experienced symptoms.  Patient stated that she felt better today especially after breathing treatment administered at doctor's visit but is not 100% recovered.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves eight patients of age between 30-40 year who were vaccinated with dose of (0.5 ml) INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UJ009AA, expiration date: 30-Jun-2019, via unknown route in right and left deltoid) on 19-OCT-2018. The patients' medical history and concomitant medications were not reported. No other vaccines for any of these patients. It was an actual medication error due to incorrect product storage. It was unknown whether the patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
I started to have severe chronic chap lips  that was not going away. It would crack on the corners of my mouth. I ended up seeing my doctor for a check up on 11/21/2021 and I mentioned my adverse events. She thought it may be fungal related. She prescribed Clotrinazole cream. It didn't seem to help. I still experience the chap lips, but it is not as intense and more like dry lips.
Caller stated the vaccine was improperly stored and administered to a patient; The product was placed in the refrigerator with MMRll and given to a patient that was to receive MMRll; This spontaneous report as received from a registered nurse refers to a 62 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 14-APR-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S035107 expiration date 03-MAY-2021, 0.5 milliliter for prophylaxis, but he was to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). Caller stated it was unknown how long the vaccine was stored in the refrigerator.       Digital Data Logger registered a temperature excursion of 40 Fahrennheit degrees up to 2376 hours.
1/16/2021: slight headache, 99.7F fever, pain (at site of injection) 1/17/2021: slight headache, 100-102F fever, drowsy, pain at site of injection)
Red & swelling, hardness at site of injection, Left deltoid. Instructed to ice pack & BENADRYL TYLENOL for pain.
no adverse event; a 10 year old patient was administered a MMR II vaccine that was reconstituted with expired DILUENT; This spontaneous report as received from a pharmacist refers to a 10-year-old patient of unknown gender.  On 02-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) that was reconstituted with expired sterile diluent(STERILE DILUENT) injection,  lot # N015479, expiration date 23-JUL-2019. There was no adverse effects.
Information has been received from a registered nurse (R.N.) concerning a 13-year-old male who on 11-APR-2007 was vaccinated subcutaneously in the right arm with a 0.5 ml dose of Varivax (lot# 656281/1504F). Concomitant vaccination included a dose of hepatitis B virus vaccine (manufacturer unknown). It was reported that on 11-APR-2007, prior to administration, the vaccine was exposed to 36 degrees Fahrenheit for 4 hours. On 13-APR-2007 the patient was diagnosed with cellulitis and was treated with an unspecified antibiotic. Unspecified medical attention was sought. The outcome was unspecified. no product quality complaint was involved. Follow-up information was received on 14-JUN-2007, indication that cellulitis was ruled out after pediatricians conferred with the CDC. The diagnosis was deemed to be an exaggerated "intense local reaction" after the second varicella booster in an older child. The reporter considered the patient's intense local reaction to be an other important medical event. Additional information has been requested.
Information has been received from a health professional concerning a 13 year old male with no medical history or allergies who was vaccinated with a 0.5 ml first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live on 10/118/1993 (lot # 605434/1141W) and on 08/11/1996 (lot # 615025/1310B). There was no concomitant medication. In November 2005, the patient developed mumps. Unspecified medical attention was sought. NO laboratory diagnostic test were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Rash on neck, trunk and arms. Due to time between vaccination and reaction, not sure if related, but decided to send forth anyway.
On 05/11/2022 I woke up with a strong sinus headache, with stiffness, and soreness and ended up testing positive for Covid. I am still dealing with this at this time.
Rash primarily on upper extremities and back beginning 1/02/2020.  Rash had not cleared as of 1/14/2020. Completed visit with PA at PCP?s office on 1/18/2020. Prescribed Prednisone  1x per day for 5 days.
right arm sore, 3 days later right arm and hand starting swelling and  developed rash with itching, also left hand swelled, with rash and itching.  Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.
Twenty-fours after injection, experienced fatigue, body aches, chills and high fever of 102.4.  Took two Aleve.  Fever kept spiking.  Took Tylenol PM (that was the only Tylenol I had); it took one hour for Tylenol to take effect, which finally brought fever down to 100.8 then 98.3.  Went to bed.  Woke with bad headache.  Took an Excedrin Migraine for relief from headache.  Body aches and fatigue gone.  Not looking forward to these symptoms again after the upcoming second dose on January 20, 2021, but will take the second vaccine shot in order to get the full effect.
Irritability and abdominal cramps developed 7.29.2010 or 7.30.2010. Intussusception diagnosed 7.31.2010 at hospital.
2 weeks ago (10/14/19) was given flu vaccine right dominant upper arm. Employee is CRNA: felt injection was given "too high" Now having right shoulder bursitis (decreased ROM 5 pain) 0 lymphadenopathy or erythema. Prednisone 50mg PO x 7 days given. Improvement noter after 2 days
Could not walk for minutes; Pins and needles in feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's relevant medical history and concomitant medications were not reported. There was no other vaccines within four weeks. Vaccination history included: Bnt162b2 (Dose: 1, single), administration date: 01Apr2021, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "low back/sacroiliac joint inflammation", "tingling in feet and pins and needles in feet", "could not walk for minutes", "severe sacroiliac joint pain". The following information was reported: GAIT INABILITY (disability) with onset Apr2021, outcome "recovering", described as "Could not walk for minutes"; PARAESTHESIA (disability) with onset Apr2021, outcome "recovering", described as "Pins and needles in feet". The events "could not walk for minutes" and "pins and needles in feet" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: x-ray: (2021) unknown results; magnetic resonance imaging: (2021) unknown results. Therapeutic measures were taken as a result of events which included physical therapy, X-ray, magnetic resonance imaging. Steadily improved over the course of 7 months. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient received Twinrix first dose expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22-SEP-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Twinrix. On 26-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient received Twinrix first dose expired vaccine).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-SEP-2023 The Immunization technician reported that an patient received Twinrix 1st dose expired vaccine, which led to expired vaccine used. The reporter consented to follow up.
Report A0371250A describes Lyme disease in a 54 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee's spouse and has not been verified by a physician or other healthcare professional. On 4/4/99, the vaccinee presented to his physician with fever and a bull's eye rash. A diagnosis of LYme disease was reportedly made. The physician administered the first injection of LYMErix and prescribed a 20 day course of unspecified antibiotics. On 5/6/99 and 6/3/99, the vaccinee reportedly received his second and third injections of LYMErix, respectively. The third injection was administered two months after the first injection, rather than the recommended interval of 12 months. The vaccinee's spouse stated that, on 12/1/01 the vaccinee began to experience flu-like aches, joint pain, and a cough which reportedly lingered for several weeks. The vaccinee was reportedly given unspecified test for Lyme disease that returned a positive result. As of 6/10/02, the vaccinee's flu-like aches and joint pains were reportedly worse. The outcome of the cough was reportedly unknown.
pt recv vax 12JAN96 & 24JAN96 pt reporter arm was achy & warm @ the site of inj;9FEB96 pt devel a small rash around the inj site;pt recovered;
COVID VACCINE CAUSED ARM TO HURT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID VACCINE CAUSED ARM TO HURT) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (COVID VACCINE CAUSED ARM TO HURT). In 2021, VACCINATION SITE PAIN (COVID VACCINE CAUSED ARM TO HURT) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Vaccination received on 11/1/07 = Extreme Chills within and hour after receiving - could not warm up. Later warmed up but hyperactivity began to set in. That night I could not sleep because I was extremely cold and my heart was racing...had a slight fever (100 F) and headache also. Now, two days later I am feeling extremely light-headed and shakey - as though I am going to pass out (body temp is at 97 F).
Pt. was given an undiluted dose of ped pfizer bivalent vaccine on 3/13/2023 at 9:45 am.  Pt was monitored for 10 minutes after injection with no adverse reactions noted.  Pt and her dad were notified of error and given possible signs and symptoms to watch for. Possible for a more severe localized reaction, pain, swelling, redness.  Advised pt to keep her arm moving, she can use ice or heat if needed and tylenol or ibuprofen if needed.  Father states understanding.
has not received his second vaccination within the Moderna stated time frame; feel fatigued; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received his second vaccination within the Moderna stated time frame), FATIGUE (feel fatigued) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (feel fatigued) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received his second vaccination within the Moderna stated time frame). On 13-Feb-2021, FATIGUE (feel fatigued) and CHILLS (chills) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received his second vaccination within the Moderna stated time frame) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.        No concomitant medications were reported.  Treatment medications were not provided by the reporter.
little bit itchy; whole body rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little bit itchy) and RASH (whole body rash) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRURITUS (little bit itchy) and RASH (whole body rash). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (little bit itchy) and RASH (whole body rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided.  Patient did not have any reactions after the second shot.