chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt came in at approximately 12:30pm on 11/22/2017 to  report swollen, discolored left arm, fever and chills following vaccination, which have since subsided. Upon visual inspection, patient's left arm appeared heavily swollen from the injection site down and brownish-red in color in contrast to right arm. Recommended pt to seek medical attention from his primary doctor. PCP called in Keflex and Motrin on 11/24/2017. Will follow up with pt in 3 days.
a leaky vial of Shingrix; leaked out of the vial and got on her hands; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number Zg744, expiry date 28th August 2023) and (batch number AY7BP, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   On 7th September 2022, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 7th September 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 07-SEP- 2022 Reporter's Comments: The reporter stated that they have a leaky vial of Shingrix. She stated that after reconstituting the vaccine, she went to pull up the vaccine and it leaked out of the vial and got on her hands. The lot number on the adjuvant vial was AY7BP. The reporter inject air from the syringe into the vial during preparation. About 0.6 mL of air was injected into the vial when going to pull up the reconstituted vaccine, the leak was coming from the stopper at the neck. The reporter said there was no vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation. The reporter said the metal skirt was still intact. The plastic flip top was removed prior to reconstitution. There was no any evidence of leakage in package or carton. The pharmacist was an experienced user of Shingrix. She stated that she shook the vial to reconstitute the vaccine and then held it upside down to withdraw the vaccine. The picture did not need to be sent in this case. The reporter did not consent to follow-up. Additional Supportive Information:  The reporter stated that after reconstituting the vaccine, she went to pull up the vaccine and it leaked out of the vial and got on her hands, which led to Occupational exposure while administering product and Exposure via skin contact.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 13-year-old adolescent patient of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored, dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 15-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, batch number: 195236, expiry date: 31-May-2018, dose and anatomical location: not reported) which was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. On 05-Mar-2018, the patient was re-vaccinated with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018 and dose: not reported). Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Pfizer-BioNTech COVID-19 Vaccine EUA Events: Severe chills, body aches, headache, tension headache, palpations, fever, lightheadedness.
I have a stiff wrist and hand only on left arm since the second vaccine and is always the worst in the morning and during night while I am sleeping becomes very stiff as if I have been sleeping on my hand and arm.
Fever Soreness at injection site Narrative:  Per nursing report: "low grade temp, arm hurting"
Shingles; Nerve pain down the arm; Blisters; Painful shot, intense pain; Came me the shot wrong, took her awhile to inject it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), nerve pain (Verbatim: Nerve pain down the arm), blister (Verbatim: Blisters), injection site pain (Verbatim: Painful shot, intense pain) and wrong technique in drug usage process (Verbatim: Came me the shot wrong, took her awhile to inject it). Shingles vaccine was discontinued. The outcome of the shingles, nerve pain, blister and injection site pain were not reported and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the shingles, nerve pain, blister and injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles, nerve pain, blister and injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that, it's a two shot series and very painful shot, will not be getting the second shot.  The patient had shingles, it started with nerve pain down my arm for first couple days then throwing up, then blisters. The patient got shingles but 6 months later doctor said to get the shot got the first shot, will not get the second The patient  don't know if doctor came her/his the shot wrong but it was very intense pain when she did and it can handle sore arm patient use to pain but the shot was different. she probably did it wrong  The follow-up could not be possible as no contact details were available. The patient shot wrong, took doctor awhile to inject it, which led to wrong technique in drug usage process.
Since administration of 6 months immunizations (Pediarix,HIB,PCV) child has had hard nodules to muscle masses with discoloration at site. No other distress noted or reported. Small nodule reported on 4/19/06 at site of previous injection.
Developed severe headache 3-4 days after 1st rabies vaccine - developed into a "dull" headache x 6 weeks. Unknown if headache related to Rabies vaccine.
My arm has been numb from the shoulder to my fingers since the day of the vaccine. It is  a constant numbness.
A pharmacist reported that pt developed a "significant" local reaction post vax. The reporter noted that the reaction looked as though it was possibly cellulitis. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar.
Pt's mom scheduled patient for 2nd dose saying that Moderna was given at first dose. I confirmed with her at appt that Moderna was to be given. After I gave the vaccine and signed off on shot I saw that Pfizer was given at first dose.
Information has been received from a physician concerning a patient who was vaccinated subcutaneous with a 0.65 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse reaction. A product quality complaint was not involved. Additional information has been requested.
felt like knife going through heart; felt like knife going through back; Nausea; arm was sore; pain on left side of jaw; esophageal spasm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt like knife going through heart), PAIN IN EXTREMITY (arm was sore), PAIN IN JAW (pain on left side of jaw), OESOPHAGEAL SPASM (esophageal spasm) and BACK PAIN (felt like knife going through back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Morphea. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA), MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), LISINOPRIL, URSODEOXYCHOLIC ACID (ACTIGALL), GABAPENTIN, LORAZEPAM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN JAW (pain on left side of jaw) and OESOPHAGEAL SPASM (esophageal spasm). On 08-Feb-2021 at 6:30 PM, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Feb-2021, the patient experienced CHEST PAIN (felt like knife going through heart), BACK PAIN (felt like knife going through back) and NAUSEA (Nausea). On 08-Feb-2021, PAIN IN EXTREMITY (arm was sore), PAIN IN JAW (pain on left side of jaw) and OESOPHAGEAL SPASM (esophageal spasm) had resolved. On 11-Feb-2021, CHEST PAIN (felt like knife going through heart), BACK PAIN (felt like knife going through back) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the events has been provided at this time. The events were consistent with increased risk associated with elderly age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
No additional AE; HCP called to report TE. The only product that was administered during the excursion was ROTATEQ. TE case number 02493530. No additional AE/PQC.    ?   ROTATEQ LOT:1965644 EXP: 10/02/2024 ?    15.9c for 4 hours 0 minutes 0 seconds  ? no previou; This spontaneous report was received from a nurse and refers to a 3-month-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-OCT-2023 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1965644 and expiration date 02-OCT-2024, 2 milliliters for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event). The temperature excursion lasted for 4 hours in 15.9 Celsius degrees.
greater than 35 days between Moderna Covid-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines) had resolved.        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.   Concomitant medications were not provided.  Treatment information was not provided.
Awaken with multiple lesions to upper arms, 1 on back and 1 on face, has progressed since then and now covering most of body.
Creatinine increased and today is up to 4.0.  It was 1.1 at the time of the vaccine.  No other nephrotoxins were given.
Pt received dose 1 of Pfizer Covid 19 vaccine on 09 April 2021.  Pt received dose 2 of Pfizer Covid 19 vaccine on 23 April 2021.  It has only been 14. days between doses.
Patient complaining of feeling light headed with vertigo and feeling as though she will faint.  Vital signs taken and as follows: 126/90, HR 94 pulse ox 100%.  patient given some juice, water and a package of graham crackers because she had not eaten more than an apple all day.  Patient began to feel an increase in light headedness so patient put in supine position and feel elevated on a chair.  Started to feel better in this position immediately.  repeat vital signs taken and 130/90 HR 92, pulse ox 100%.  Patient did not feel well when back in a sitting position so supine position resumed and Move Team called to evaluate further.  Patient continued to feel poorly when in sitting position for about 20 minutes while move team assessed but vitals signs remained stable.  Patient refused to go to the ER and signed waiver.  Patient began feeling better and decided to go home.  Patient said that she would call an Uber instead of driving.
I started having visions issues.  I went to the emergency room.  At the Hospital everything look normal - but it was detected that I had an Hemorrhagic Vitreous.   I have been sick since.
Had a slight headache a few hours after the injection, three hours later felt tired and headache worsened but improved with 500mg Tylenol.  That night fatigue got worse but headache improved.  Went to bed at 9pm and had severe chills and shaking, heart was beating fast.  Chills lasted for several hours.  Increased heart rate all night and could not sleep at all.  Fitful night sleep and started to sweat in the Early morning.  Woke up for work at 5:30 am and had headache, dizziness, and flu-like symptoms with joint and muscle aches.  Had sweats all day today.  Went home early from work and slept from 9:30 am to 4:30 pm.  Most symptoms improved now but feel like I still have a fever and sweats.
Pt recvd 3 Hep B vax on 27JUL89, 6SEP89, & 23JAN90; Following these, titer=12; p/one yr, titer was neg; 4th dose of vax Engerix-B recvd on 16APR91; following this titer=19;
Arm was sore; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired) outcome was unknown.        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 was reported. No treatment drug details was reported.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Nausea, chills times 6 hours in duration, fever of 102 degrees, vomiting x1. Client experienced chills after last yrs flu vaccine. On day 3 her fever is now absent but nausea and malaise persist.
My periods started occurring later and lighter, which is cause for concern because I'm usually very regular and heavy. I also started developing boil-like small pustules all over my body, which are painful and unseemly. The boil-like pustules are red on the outside and developed on my thigh, arms, abdomen, underarms, neck and shins.
I WAS RUNNING A FEVER AND I WAS VERY NAUSEOUS & ACHY ALL OVER AND IT WAS A GENERAL FEELING OF UNWELLNESS. I STARTED FEELING BAD AGAIN IN DEC & WAITED FOR ABOUT A MONTH & I GOT TESTED FOR COVID & IT WAS NEGATIVE.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Rash on hands; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. Medical history included back pain. It was unknown whether the patient received any other medications within two weeks of vaccination. It was also unknown whether the patient had any allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown that the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced rash on hands. It was unknown whether any therapeutic measures were taken as a result of the reported event. The clinical outcome of the event rash on hands was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe joint pain Along w muscle pain I have NEVER had joint pain before this! Symptoms started 03 / 08/21
From telephone contact with the reporting nurse it was stated that a 27 year old female patient received an IPOL, a Td Adult, a Yellow Fever and a Hepatitis A vaccination on 5/18/01. Ten days after the vaccinations the patient developed generalized red rash over body, except face. Further information is requested. From mailed correspondence received on 7/2/01 additional vaccine, vaccine administrator and responsible physician information was provided. From additional correspondence received on 9/7/01, it was reported, reviewed, no additional information at this time. This case is closed.
expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 52S9R, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 details were provided as follows: The patient received an expired dose of Fluarix QIV, which led to expired vaccine used. The reporter consented to follow up. The case has been linked with the case US2020093493 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093493:same reporter
Pt reported to ED on 9-19-12 at 12:50 pm w/painful/swollen right proximal arm. No fever or reported itching. Pt tited for allergic rxn w/MEDROL dose pak. Onset began 12-hours prior to presenting.
In late April/ early May 2021 I started having issues of brain fog after working more than 5 hours. On September 15, 2021 I had my lipid Panel done by my doctor and my Potassium level was 5.0, I self imposed myself to a 1400 MG Potassium diet and no longer suffer from the brain fog like symptoms unless I consume Potassium more like a normal person.  Last week I accidently ate around 750 MG of Potassium at work during break and was having similar brain fog issues by the time I left, although they were not as bad as I had before. (Several years ago this March I had an elevated Potassium because of using Glucerna shakes to keep my blood sugar up during work as a delivery driver, but a low Potassium diet for a week the re testing showed the Potassium was no longer elevated).
CHANGES IN VISION; HEADACHE; This spontaneous report received from a patient concerned an 80 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced changes in vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of changes in vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521409.
Ringing in both of my ears that has not stopped.  The ringing progressively got louder until Day 12-14 when it prevented me from sleeping at night.  I am seeing an ENT doctor now.
Patient developed rash at site of vaccine administration. Rash was macular and erythematous with some pruritus. No vesicles or varicella-like lesions were present. Rash has been self-resolving with time. No medications were applied for management.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.