chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can cause you Guillain-Barré Syndrome, have a niece flat of her back with that; She got cushions; Germ there and it imflamed it; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female 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 guillain barre syndrome (serious criteria GSK medically significant), mass and inflammation. On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved and the outcome of the mass and inflammation were unknown.   It was unknown if the reporter considered the guillain barre syndrome, mass and inflammation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that they really do not know what caused his/her nieces, but she got cushions and physician stated that the patient already had the germ there and it was imflamed it someway. The physician stated the patient also cause Guillain Barre syndrome and her niece had flat of her back with that now. Additional supportive information: Follow-up would not possible as no contact details were available. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2022AMR193091:Same reporter US-GSK-US2022AMR193110:Same reporter US-GSK-US2022AMR193098:Same reporter
Fatigue headaches cognitive issues (neuropsych testing confirmed no A.D.D. & no processing disorder).
Shingles on stomach and back. Officially diagnosed on 01/25/2013 but started on 01/18/2013.
HAIR LOSS TO THE POINT OF BALD SPOTS ON SCALP/NOTICED EXCESSIVE HAIR LOSS ON BACK OF HEAD/NEW PATCH OF HAIR MISSING FROM FRONT OF MY HEAD; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced hair loss to the point of bald spots on scalp/noticed excessive hair loss on back of head/new patch of hair missing from front of my head. The action taken with covid-19 vaccine  was not applicable. The outcome of hair loss to the point of bald spots on scalp/noticed excessive hair loss on back of head/new patch of hair missing from front of my head was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046106.
Fever started at 7:30 PM on the same day. About half an hour later I started to get chills, and could not stay warm. Every time I got up to use the bathroom I got goosebumps and I was shivering. I went to bed around 9:30 and was still shivering and could not get warm. Woke up to a mild fever, a headache, and a metallic taste in my mouth. Symptoms seem to be gone now on 05/01/2021 in the morning.
itching at injection site; redness at injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site). At the time of the report, INJECTION SITE PRURITUS (itching at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) outcome was unknown.        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 concomitants or treatment medications were reported.
pain in left leg; dry heaving; bloating; headache; paiin in left hip; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating), HEADACHE (headache) and MYALGIA (paiin in left hip) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating), HEADACHE (headache) and MYALGIA (paiin in left hip). On 22-Jan-2021, PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating) and MYALGIA (paiin in left hip) had resolved. At the time of the report, HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2020, SARS-CoV-2 test: positive.     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 concomitant medications were reported. Treatment details include Tylenol daily and a few doses of tramadol for pain..   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
very tired; very hot sweaty night; chills; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for two patients. This is the second of two reports.   A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on 04Feb2021 at SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Patient tested positive for the antibodies for COVID and they believed patient had a mild case of COVID (it was prior to COVID Vaccine). On the morning of 05Feb2021, the patient (and her husband) had chills most out of that day. That night, patient (and her husband) was very tired and then we went to bed at that night, they had a very hot sweaty night. They confirmed that they both had reaction and added that she was chillier than her husband during Friday. They assumed that was the reaction to the vaccination. Outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171538 Same reporter/ drug and event; different patients
Symptoms - diffuse rash on scalp, neck, upper chest and behind ears. Signs - macular, papular, pretubal rash sparing hands, lower extr. and lower abdomen; pustular lesions were only on the neck, no ulcerations/blisters/scale/oozing. Not oily or flaky in appearnce. Non-pruritic. Time - 10 days past small pox vaccianation  Treatment - cloberasol 0.054 solution to scalp; triamcinalone 0.1% cream to other regions.
On day 1 after the vaccine the employee began having muscle aches and sore joints.  By day 4 she felt like she had an improvement in symptoms.  On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR).  She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that "even her toes were painful".  She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.
Patient hospitalized for Spontaneous Vaginal Delivery within 6 weeks of receiving covid vaccination. Per doctor's notes, "baby is doing well and pt is breast feeding. Baby has a cleft lip (it was known from ultrasound)."
COVID 19; COVID 19; Vaccine brand other=Moderna, Vaccine administration date=10May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 11Feb2021 as dose 2, single (Lot number: EL9266), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10May2022 as dose 4 (booster), single (Lot number: 0561721A), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 16Sep2022 as dose 5 (booster), single (Lot number: 042H22A), in right arm and on 25Apr2023 as dose 6 (booster), single (Lot number: A57145B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "premature ventricular contractions" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Mar2023, stop date: 30Jul2023; METOPROLOL SUCCINATE, start date: 01Feb2022; ASA, start date: 01Feb2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10May2022, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine administration date=10May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2023) Positive, notes: positive antigen test 5 days after completing a course of Paxlovid; (2023) Negative, notes: tested negative; (2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as Covid-19 treatment from 30Jul2023 to 03Aug2023. After symptoms resolved and tested negative, patient experienced a return of sinus congestion and scratchy throat and positive antigen test 5 days after completing a course of Paxlovid.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccinations with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756539A, A0756541A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Both of my Moderna injections were in my left arm.  Following my initial injection of the vaccine, my only side effect was soreness in my left arm and around the injection site on the day after.  This second injection bled (unlike my first dose) and my arm was immediately sore not only at the injection site but in different localized locations on my left arm.  The day after, I had a nasty headache and was feeling exceptionally fatigued, had a few bouts of nausea with chills and slept through the entire day.  The soreness and tenderness in my left arm is still present as I type this report with one new side effect.  This morning, I noticed the sudden appearance of red blotches  in two locations between the injection site and my elbow.  Neither of the blotches are near the injection side and they do not itch.  Interestingly enough, they don't even appear to be a "rash" but just red spots that are very tender to the touch.
This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route not reported). The Lot number of PROQUAD (Merck) was reported as L011079, expiry 01-OCT-2016; L016394, expiry 08-NOV-2016 and K011311, expiry 14-FEB-2016. No adverse was reported at the time of this report. This case is one of the several reports from the same reporter. Additional information has been requested.
12/11/21-Head ache, body ache, low grade fever, joint and muscle aches 12/12/21-Entire left side of body went numb, weakness.  Unable to walk properly. No pain.  This went on for about 20 minutes and then went away.  Called PCP who said if it happens again to go to ER.   This was not a normal side effect.  12/13/21-everything is back to normal today.  Patient wanted us to be aware of situation.
patient from home with past medical history of hypertension, hepatitis C, recently diagnosed stage IV adenocarcinoma of the lung with metastasis to bones and recently received 1 cycle of chemotherapy at the hospital, COPD, on 2-3 L of oxygen at baseline, chronic nicotine abuse presented to the ER on 01/29 complaining of shortness of breath, cough. Hypoxic in the ER, placed on BiPAP, tested positive for COVID-19-high oxygen requirement and multiple medical issues. Patient is being discharged to skilled nursing facility today-2/7. Patient is on 5 L of oxygen. If patient declines going forwards, will consider hospice.
pt devel hives evening of 1JUN95; pt had recv Hep B vax that same morning; No other sx devel other than itching;
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 16-SEP-2016, the patient received improperly stored doses of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. ; Sender's Comments: US-009507513-1610USA011245:
VACCINE ADM IN THE LEFT ARM AND THE NEXT DAY SHE STARTED TO HAVE PAIN IN HER RIGHT ARM AND ELBOW. SHE ALSO HAD RIGHT FLANK PAIN. SHE HAS CONTINUED TO HAVE JOINT PAIN OFF AND ON. DR. SUGGESTED THAT SHE NOT RECEIVE ANY FURTHER HPV VACCINE.  10/10/08 Reviewed PCP medical records & vaccine records. FINAL DX: none provided Records reveal patient experienced good health on 8/26/08.  RTC 10/3/08 & reported back & joint pain since 8/08.  Exam revealed reaction pain at injection site, right flank pain.  Tx w/nsaids & heat.  Provided flumist at that time.  No further records available.
I tested positive on 04/21/2022 for COVID-19 and my symptoms are moderate. I had a serve cough, running nose, joint ache, brain fog, sweats and sore throat. I had flu like symptoms.
received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
Pt admit to hospital 7/30 - COVID Positive Patient (s/p 4 Pfizer doses on 1/14/21, 2/4/21, 8/28/21, 4/22/22) -- pt was prescribed paxlovid on 7/30 by ED provider (however was not picked up d/t admit) - pt receiving steroids, but no other COVID therapy indicated at this time. [initial positive test was 7/27/22]
Inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient to whom inadvertently administered a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination.  On 10-Feb-2023, the patient received 4th dose at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot number: UJ682AAA and expiry date: unknown) via intramuscular route in the left thigh (leg) for Immunization and on the same day inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered), (product storage error).  It was reported. Registered nurse (RN) called for information on how to manage patients who were administered vaccines that had undergone temperature excursion, due to a refrigerator malfunction. This situation is reported as a medication error due to administration to the patient of a vaccine that had exceeded the stability data documented in the local labelling and additional supporting stability data. First time product used : No Still using product : No.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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.
Adverse effects not common.    Skin itchy, skin sore , raw feeling,  all  over body...No rash or redness. Started eve of vaccine. For 2 days now / present
Date and time adverse event started: 4/28/21 MORNING TIME METALLIC TASTE IN THE MOUTH CONSTANTLY. NO NEW MEDICATIONS.  USING PEPERMINT LOZENGERS WITH MILD IMPROVEMENT.  5/1-Pt reports that the metallic taste is still ongoing especially when she drink fluids (occurred more with water);  also reports that when she eats it seems to be better. She also reports feeling fatigue. Advised if the metallic taste continues to contact MD. Advised this ADE is not a contraindication to getting the second vaccine.
Follow-up information provided patient demographics, recovery status, concomitant vaccine, and dose details including lot numbers.  Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced injection site abscess in both injection sites.  The patient received the third dose on 26-Nov-2007.  The patient also received a dose of BOOSTRIX (GlaxoSmithKline) on 26-Nov-2007.  Medical History:  The patient has a past history of injection site abscess (after the previous dose of PREVNAR that diagnosed on 04-Nov-2007) (See related case US-WYE-H03187808).  The patient experienced injection site abscess on 17-Dec-2007 following his third dose of PREVNAR and a dose of BOOSTERIX.  The top of the abscess was surgically removed in the office and a large amount of pus was removed.  The  drainage was cultured but no organism was found.  The patient recovered.  No additional information was available at the time of this report.
extremely dizzy, passed out, took blood pressure 3 times over 45 minutes, 56/34,  62/43,  81/56
24 hours after vaccine running fever 101.1, with very sore and swollen injection site, and myalgia
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm hurt like she got punched after the vaccination. The reporter gave consent to follow up.