chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018 (initial and follow-up processed together), concerns a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper. As the secured lock was popped off the vial the rubber stopper was dented in and off a little. It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. The vials leaked and only 4 vials were leaking so far. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from a leaked vial. There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-gauge needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. No adverse events were reported after administration of the vaccine. The reporter assessed the case as non-serious. This case 201804367 was cross-linked with the original case 201804366 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
had Adacel on Thurs (5 days ago). Noted redness spreading on arm on Sunday. Arm has been achy since shot. Swelling also noted. Warmth on upper arm as well. 8x10 area of erythema on left arm. Will be treated with Keflex 500 mg three times daily for 10 days.
2nd dose received was expired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose received was expired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003c21a and 045b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose received was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose received was expired) had resolved.            Concomitant information was not reported. Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up information received on 30-jun-2021 Contains No New information
One day post vax, pt awoke with chills and emesis (lasting 1 day), temperature of 101.8, diarrhea (lasting 15 days), malaise and headache.
Arm became swollen, red and had little bumps in at. Broke out in a rash from the neck to the ankles. She felt real bad. Went to see her pcp
11-15-13 Immunization given. 11-16-13 Red, hot, swollen (L) deltoid, eyes dilated, tired, no energy and a fever. 11-20-13 All symptoms gone except tired and no energy.
Flushing and itching occurred after ~10 minutes.  Nonverbal, so unable to ask about further s/s, but erythema to hands, chest, and face (brightest on cheeks).  Scratching self.  Given benadryl.
Chest pain with initial workup showing troponin elevation and ST elevation inferior leads. The patient received TNKase at peripheral ED prior to transfer to our facility. Upon arrival taken for LHC with normal coronaries. It was suspected patient had thrombotic event that resolved with TNKase since coronaries were normal on LHC vs myopericarditis in the setting of receiving the vaccine 1 week prior.  The patient chest pain resolved and was discharged the following day of admission.
At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially bleeding and unconscious and was brought by EMS to the hospital. Upon arrival at the hospital he had a temperature of 40 C. He was found to have 2 small left temporal hemmorhagic contusions on CT scan. He had a seizure during the hospitalization. He was initially treated for HSV encephalitis but it is not clear if that was confirmed. The hospital team may not have known of the recent vaccination. He improved during the hospitalization, but remained with a very unsteady gait. He could not return to the group home. He was transferred to a rehab facility to receive PT on 02/16/2021. He remains at rehab. Prior to the fall, on the 3rd day after vaccination, on 2/8/21 at about 10 am, the patient coughed and had a small blood on the inside of his face mask while at his day program. He was seen by his PCP and had no abnormal findings. He had a CBC, BMP and CXR and all were unremarkable.
Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ6738) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot number: EK4176), for COVID-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (DOSE 2, SINGLE, lot number: EL9261), for COVID-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (DOSE 3, SINGLE, lot number: 3055BA or 30155BA, the writing is not very clear.), for COVID-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (DOSE 4, SINGLE, lot number: FJ4895 or 85), for COVID-19 immunisation, reaction(s): "soreness in the arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm". Additional information: When probed to clarify consumer did not experienced side effect after previous Pfizer COVID-19 Vaccines, consumer stated, "The previous, no, just soreness in the arm. I guess the usual common side effects but nothing unusual.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
5/8 to 5/9: sore arm, low-grade fever, chills, muscle aches, general malaise, diarrhea. 5/10: muscle aches, including chest pains, severe headache, numbness and tingling in left arm, diarrhea, nausea, vomiting, dizziness, malaise. Thought I was having a heart attack at first. 5/12 to current: occasional muscle aches, headache, fatigue, diarrhea, "tightness" in the chest. Swollen lymph node next to left side of clavicle since first Moderna dose 4/9; GP administering second dose joked I should wait before getting my next mammogram.
Information has been received from a registered nurse concerning a 9 year old white male who on 01-DEC-1998 was vaccinated with a dose of Varivax. On an unspecified date, the patient developed a generalized rash with less than 50 lesions. It was unknown if the patient had a fever or cough. The patient was evaluated by a physician. Follow-up received on 03-AUG-2006 stated that no further information was available.
This case is a cluster of 5 patients who experienced adverse events following administration of FLUZONE INTRADERMAL; lot number UT4163AA. The event for the other patients were captured in case number 2012-01380. Initial report was received from a company representative on 31 January 2012. A patient (gender and age not reported) had received an Intradermal (ID) injection of FLUZONE; lot number UT4163AA (site, route and date of administration were not provided). On an unspecified date, the patient felt nauseous and didn't feel well. No further information was available at the time of this report. The patient outcome was reported as recovered/resolved. Documents held by sender: No medical follow-up required. Follow up information receive on 30 April 2012. The patient's birth of birth was updated and gender as female. Vaccination date was added as 10 October 2012. Route of administration was updated as intradermal and site as right arm. Injection site redness and pruritus were added to the adverse events. Event onset date was added as 10 October 2011.
Patient received Zostavax on 10/15/2015 noticed arm/injection site itchy and warm-- red on exam-- presented to clinic 10/19/2015 for evaluation, had 5 cm x 2cm area redness and induration-- instructed to take antihistamine and use cool compress and follow up if not improving.
Dry lips; Body aches; Chills; Muscle pain; Joint pain; Fatigue; Fever; Pain in the arm, legs, other arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm, legs, other arm), LIP DRY (Dry lips), PAIN (Body aches), CHILLS (Chills) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm, legs, other arm), PAIN (Body aches), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced LIP DRY (Dry lips). At the time of the report, PAIN IN EXTREMITY (Pain in the arm, legs, other arm), LIP DRY (Dry lips), PAIN (Body aches), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter. No relevant concomitant medications reported.
6OCT vax given 1400;7OCT hot flushes started 630PM blacked out 9PM w/subsequent black outs;seen by MD;has 8 sec periods where heart stopped;adm to CCU w/6-7times, 8sec heart stopped;pacemaker considered-last episode 8OCT 130PM;
Information has been received from a consumer concerning a her daughter who on unspecified dates was vaccinated wit ha full set of GARDASIL vaccine (reported as HPB).  The consumer reported the patient is now positive for HPV and "her family is devastated".  The outcome of the patient was not reported.
Chest pains. Chest pains have persisted from 3 days after test until this day (3/29)
Pain on arm of area of shot was giving hurt so bad all night. Some numbness in my fingers were shot was giving on left arm
Pt. had her 2nd  Pfizer shot on July 14, 2021.  Two days later, on July 16, 2021 approximately 4:58pm, she developed chest pain and light  headache. She took 2 Tylenol pills and the 10- 15 mins the pain went away.
Information has been received from an office manager concerning an unknown number of unspecified patients unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. From 08-APR-2016 to 12-MAY-2016, the patients were vaccinated with improperly stored doses of M-M-R II (dose, route not reported, lot # L026551 with expiration date 16-JUL-2017 and L030162 with expiration date 11-AUG-2017, both therapy type RHA). The vaccines were exposed to 50.7F for 12 hours. No previous temperature excursion was reported. No adverse effect was reported. Additional information has been requested.
Patient was admitted for recent complaints of shortness of breath and back pain, patient was found to be anemic with low hemoglobin.  Patient was given a transfusion and admitted to the floor.
a Shingrix adjuvant vial was mistakenly used in November 2022 to reconstitute a Pfizer Bivalent Covid vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug administration error in a patient who received Herpes zoster (Shingrix) (batch number 4B3RH, expiry date 25-SEP-2023) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug administration error (Verbatim: a Shingrix adjuvant vial was mistakenly used in November 2022 to reconstitute a Pfizer Bivalent Covid vaccine). The outcome of the intercepted drug administration error was unknown.   Additional Information: GSK receipt date: 7-AUG-2023 Reporter was a pharmacist calling to report that a Shingrix adjuvant vial was mistakenly used in November 2022 to reconstitute a Pfizer Bivalent Covid vaccine NDC: 59267-0304-02. There was no patient involvement. The reporter did not ask for consent to follow up with HCP.
Vaccine given 8-28-06.  Bell's palsy 9-1-06.
pt recvd vax;exp swelling, pain & redness at inject site;tx w/ ice;no atb;rxn devel into darker red band of color around arm; itchy & painful; color resolving but induration size of an egg;
Pt got the flu vaccine at the pharmacy ar 13:06.  Around 13:15 she started having tingling lips, a red swollen left arm and red face and chest.  She reports that she had a reaction to a flu vaccine when she was a child but she doesn't remember it.  was making her get the flu vaccine in order to keep working.  She was monitored in clinic for about 40 minutes total and EMS was called as a precaution.  She decided not to be transported and left in stable condition.  Benadryl 25mg po was given in clinic.
Narrative: COVID infection following COVID vaccine series 03/05, Pfizer, dose #1 (non-facility) 03/26, Pfizer, dose #2 (non-facility) 09/27, Pfizer dose #3 facility 08/17 pt cc: no symptoms exposure: unknown 08/17 COVID swab, result: detected 08/18 pt admit to medicine dx: ESHF and secondary dx: Asymptomatic covid infection LOS: 2 day 08/18 CXR impression: 1. Nonspecific increased basilar interstitial lung markings, age 2. Apparent asymmetric left hilar enlargement, unclear if secondary to perihilar infiltrate or adenopathy. Recommend PA and lateral chest examination when clinically appropriate.
Right arm redness around injection site 16 x 18 cm. Received Tdap and Flu vaccine in R arm, has never had Flu vaccine before, had Td and Dtap prior.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosus flare in a subject of unspecified age and gender who was vaccinated with influenza (unspecified manufacturer). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of influenza unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with influenza unspecified, the subject experienced systemic lupus erythematosus flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. SLE patients who exhibited disease flare had significantly (p <0.01) higher levels of BL pro-inflammatory mediators, including Th1, TH2, and TH7-type cytokines compares to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (BF/SNF) compared to SLE flare and HC, TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased a BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanisms of flare, therapeutic selection or development.
Itchiness all over, getting worse a week after the shot. Especially at injection site.  Swelling/rash at injection site, worsening a week after vaccine.  severe muscle aches in left arm and along back and neck,  day-of vaccine for two more days.
p/vax pt w/some edema;edema inc distal lt upper arm to lt elbow;some pruritus;given pred;
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received FLULAVAL TETRA 2018-2019 season for prophylaxis. On an unknown date, the patient received FLULAVAL TETRA 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced influenza-like symptoms and stinging. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the stinging was unknown. It was unknown if the reporter considered the influenza-like symptoms and stinging to be related to FLULAVAL TETRA 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms after receiving FLULAVAL TETRA 2018-2019 season vaccine which was lasting for 2 to 3 days. The patient also experienced stinging at time. The reporter agreed to be contacted for follow up.
Shortness of Breath; Aches; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), PAIN (Aches) and PAIN (Pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced DYSPNOEA (Shortness of Breath), PAIN (Aches) and PAIN (Pain). At the time of the report, DYSPNOEA (Shortness of Breath), PAIN (Aches) and PAIN (Pain) outcome was unknown.
On day 2 I had fever, chills, body aches, diarrhea and headache. Most of  Those symptoms went away by day 4 but the headache got progressively worse to the point that 9 days later I went to the hospital with severe headache, pain down my arm Abbas in my chest and severe dizziness and brain fog. Almost 2 weeks later and  these  symptoms still persist. Taking prednisone, meclizine, nurtec and zofran. Currently  as well as back to taking an albuterol inhaler.
No additional AE/PQC.; HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Product expired on 09/30/2023 and was administered on 10/03/2023. No additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 30-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #W019533, expiration date: 30-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 03-OCT-2023, HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Product expired on 30-SEP-2023 and was administered on 03-OCT-2023. No additional AE/PQC.
Recieved expired vaccine. Event previously reported by phone to MERK (case# 00820160). it was determined the vaccine was considred potent a viable based on return email I recieved from MERK.
Tightening throat, eyes injected & watery, cough. 50mg BENADRYL IM & prednisone PO dose pack.
Patient became unresponsive for 10-15 seconds.  Medical emergency called, along with 911.  Upon reobtaining consciousness, patient was diaphoretic and clammy.  Vital signs obtained - SBP in the 70s and HR in the 40s.  Patient transport to the ED.
Patient returned to clinic 7 hours later with a deltoid that was swollen and warm to the touch.  Provider examined arm and advised patient to ice and take ibuprofen. Instructions given that should patient experience any swelling of the lips, redness at the site or any respiratory distress to take diphenhydramine and either return to the clinic or dial 911.
Post vax, each Anthrax, has flu-like symptoms for up to 1 week. Constantly tired, aching joints, muscle pain in lower extremities.