chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right hand pain and left hand swelling.  Seen by my hand doctor.  Had an Mri and blood work  .  Mri cam back Mri with effusion right wrist.  ANA Positive for autoimmune disease.  Seeing a rheumatologist asap .  Prior to the vaccine I had none of these problems.  was given a 6 day prednisone pack which reduced the sweeling inthe left hand but swelling cam back immediately after stopping the pack
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 16-JUL-2010, the patient received an expired dose of PNEUMOVAX23 25/0.5 (lot # 662747/1086X, exp. date 06-JUN-2010) 0.5 ml intramuscular. Concomitant medications were not reported. No adverse effect reported. This case is linked to case 1307USA013390, 1307USA015840, 1307USA015841, 1307USA015842 via same patient link. Additional information has been requested.
This spontaneous report as received from certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M040412, expiration date 30-JUN-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 15 minutes. Also there was previous temperature excursion from 32 Fahrenheit (°F) degrees to 35 Fahrenheit (°F) degrees for 19 hours and 30 minutes and from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 1 hour and 45 minutes. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA010094: US-009507513-1709USA010095: US-009507513-1709USA010756:
Pt received vaccine and walked to the front of the office. Father reports he stated he felt dizzy while checking out and his knees started to buckle. The father lowered him to the ground. His pulse was 84 and he stated "'I'm fine." He sat up on the floor for a few minutes and then walked to a chair.  He was then escorted to a patient room where he drank a cup of pop. BP 114/86. Patient walked to the car.
The pt developed redness, swelling, heat at left deltoid and denies pain. Treated with ice and Triamcinolone cream.
Beginning four or five hours after receiving pneumonia vaccine, I had excruciating pain in my arm and shoulder, and a fever, for about 18 hours. On a scale of 1 to 10, I would have rated that pain a 10. It was still severe enough to be crippling for about a week and a half (very painful getting clothes on and off, painful trying to sleep in any position, very difficult to get up off couch or toilet). By a month after receiving the vaccine, the pain was occasionally a 3 or 4, more often 1 or 2--with, often, no pain for hours. Now, three months after receiving it, I still have minor aching in that shoulder every day, but it's no longer a significant problem. If this is permanent, I can live with it. (I never attempted to "treat" it in any way.)
Very stiff shoulder continuing for several months. Gradually improving with stretching. Still pain when stretching.
No adverse event; HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.; Excursion took place 15Dec2022 through 27Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022). On 20-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. It was reported that first time excursion started on 15-Dec-2022 and HCP reported that they had given 16 doses of the vaccines between the 15-Dec-2022 and the 21-Dec-2022 and then following that the vaccines were marked not to use and also no reports of side effects had been reported to them. No treatment information was provided.
Pt received Yellow Fever vaccine on 22Jan08. On 28 Jan 08 pt noted flat, red, non-itchy lesion on his left thigh. By 30 Jan08 pt had multiple lesions on his upper arms, stomach and legs. Tx with lidex with some improvement. Then on 11Feb08 pt had rash on entire body (including soles and palms) except for face, neck, scalp and mouth.
Muscle and joint pain, fever, chills, swollen lymph node left arm, tiredness, nausea, arm pain and overall feeling of being unwell (lethargic).
who suffers from tinnitus and got the Pfizer COVID-19 vaccine and had elevated tinnitus.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "who suffers from tinnitus and got the Pfizer COVID-19 vaccine and had elevated tinnitus.".  Additional information: Caller who does not want to provide any information at all and has three concerns. Agent reports reporter said patient had tinnitus and said patient does not want what happened to a friend of hers, who suffers from tinnitus and got the Pfizer COVID-19 vaccine and had elevated tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bad chills; Muscle aches; After taking the 1st dose I experienced such bad chills, muscle aches that it triggered my sciatica it was had for me to move, get out of bed, bend or use the bathroom; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 39 years as dose 1, single and the patient also received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 39 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sciatica"  (unspecified if ongoing). The patient did not received any concomitant medications. The following information was reported: CHILLS (non-serious) with onset 24Jan2022, outcome "recovering", described as "Bad chills"; MYALGIA (non-serious) with onset 24Jan2022, outcome "recovering", described as "Muscle aches"; SCIATICA (non-serious) with onset 24Jan2022, outcome "recovering", described as "After taking the 1st dose I experienced such bad chills, muscle aches that it triggered my sciatica it was had for me to move, get out of bed, bend or use the bathroom". The events "Bad chills", "Muscle aches" and "After taking the 1st dose I experienced such bad chills, muscle aches that it triggered my sciatica it was had for me to move, get out of bed, bend or use the bathroom" were evaluated at the physician office visit. Therapeutic measures were taken as a result of chills, myalgia and sciatica.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Treatment for the reported events included muscle relaxers and anti-inflammatory medications. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional (Practice manager). This case involves a 25 years old female patient who experienced an accidental skin exposure, dysgeusia and burning skin, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 26-Sep-2018, the patient exposed to a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6263CA, expiry date 30-Jun-2019 via skin contact. On 26-Sep-2018, it was reported that Medical assistant was drawing up a dose from single dose vial and when she was pushing out the air a small drop of vaccine landed on her left index finger and burning started immediately on that skin and she had a metallic taste in her mouth. The event outcome was reported as not applicable for an accidental skin exposure and as unknown for burning skin and dysgeusia. List of documents held by sender- none.
Data logger went out Max temperature reached: 48.2°F Low temperature reached: 40.3°F with no reported adverse event; Administered to a patient? Yes, to 26 patients with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves 26 patient of unknown demographics who were administered vaccine IPV (VERO) [IPOL] which experienced data logger went out max temperature reached: 48.2°f low temperature reached: 40.3°f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection dose, strength: not reported lot W1B511M expiry date: 08-sep-2025 (1 patient) Lot Number: W1A191M, Expiration Date :2025-02-16 (23 patients) Lot Number: Z1A021M, Expiration Date :2024-02-17 (2 patients) via unknown route in unknown administration site for prophylactic vaccination (immunization) and data logger went out max temperature reached: 48.2°f low temperature reached: 40.3°f with no reported adverse event (product storage error) and administered to a patient? yes, to 26 patients with no reported adverse event (poor quality product administered) on the same day.  Reportedly, She would like to know if the vaccine is still viable for use. She said that the vaccine was exposed to 13 temperature excursions from 07Sep2023 until today. She also said that the vaccine was administered to 26 different patients from 07Sep2023 until today. She currently does not have the patient list with her as it was her first day at the site. Product/s: IPOL Opened products? Yes Reason: Data logger went out Max temperature reached: 48.2°F Low temperature reached: 40.3°F Human error? No Does extended stability data cover the excursion? Administered to a patient? Yes, to 26 patients.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
It was a swollen lymph node and they couldnt give anything other than ibuprofen. Went to PCP where I got imaging done. It went away by itself.
The night of the vaccine I got hives on my chest which lasted for an hour. The first week after the vaccine I had severe flu like symptoms of fever, nausea and sweats for six days. The next week on 04/15/2021 I started to get pain over my left eyebrow and my Diverticulitis was flared up. My doctor sent me to get the headache checked out because it was very painful. The headaches were there all day every day and localized to the left side over my eyebrow. Migraine medicine made it worse Sumatriptan. The pain persisted but I was checked up for Glaucoma. My Neurologist advised that I take Indomethacin and it worked to relieve the pain. Regular pain killers did not work. It slowly improved over the course of two months. It had been twelve weeks and I am still getting headaches intermittently, It is more like a twinge.
Rash 2  inch diameter around injecitn site. 2 small spots on back and arm. Dr treating for itch. Cover area. If more develop return to Dr.
Vaccine accidentally drawn from an undiluted vial. Patient received 0.2mL of the vaccine without diluent added. No significant side effects reported.
hives; I have a dermatitis that covers almost all my body and it does not go away with any of the medicines I have been; This is a spontaneous report from a contactable other hcp (patient).   A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EJ1686), via an unspecified route of administration, administered in Arm Left on 08Jan2021 14:30 as 1stdose, single for covid-19 immunisation (age at vaccination was 54 years). Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (PANADOL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Zyrtec allergy. Allergies to medications, food, or other products was no. The patient experienced hives, i have a dermatitis that covers almost all my body, and it does not go away with any of the medicines i have been on Jan2021.  The patient underwent lab tests and procedures which included sars-cov-2 test negative   on Jan2021.Therapeutic measures were taken as a result of hives, i have a dermatitis that covers almost all my body, and it does not go away with any of the medicines i have been. Treatment received was yes (various topical and oral medications, such as Zyrtec) and there was physician office visit also. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Upon follow-up on 23Apr2021 new information has been updated. This is a follow-up spontaneous report received from a contactable other HCP. This 54-Year-old female other HCP reported for herself about reaction(s)/events, treatment received. The clinical outcome of the events was not recovered.  Follow-up (23Apr2021): This is a follow-up spontaneous report received from a contactable other HCP. This 54-Year-old female other HCP reported for herself about reaction(s)/events, treatment received.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient daughter called to say that after she got patient home on the 15th she got shaky and had trouble lifting the arm she got the shot in. I suggested she take her to a doctor as soon as possible and have her examined.
No Adverse event. On 11/03/2021 the Vaccine Refrig data logger showed a temperature excursion occurred on 10/29/2021 at 10:48 a.m. of +50.7 (F). The timeframe documented is 13 mins with n 5 min alarm notification totaling 18 min. The vaccine providers were not aware that the vaccine needed to be used within a 24 hour timeframe of the excursion prior to discussion with the health department on 11/3/2021. A clinic was scheduled for Moderna Booster doses at a High School for their employees for 11/1/2021. This clinic did occur with the Moderna Vaccine with Lot # 076C21A between the hours of 3:00-5:00 p.m. A total of 16 people received Moderna Booster shots 0.25ml.  The vaccine provider learned on 11/3/2021 in conversations with the health department that due to the excursion, the vaccine should be discarded if not used within 24 hours of the temperature excursion. With the instructional education provided via the health department, all remaining doses of Moderna with Lot# 076C21A was wasted.
Pt reports approx 5 days after vaccination - started having severe muscle and joint pain and swelling - "worst arthritis flare ever".  No other illness at the time, - no fever, chills or flu -like symptoms/ Lasted  approx 5-6 days. Concerned that she might have reaction if gets Tdap in future. (may need pertussis update since managing RN students in clinical).
Heart rate jumped after waking in the morning and never settled. 90 to 115, often above 100, though mostly sitting at home computer.
cleared by PCP to receive dose # 2 as she had rash on face after 1st vaccine.  She took 25mg benadryl at 2pm   Had vaccine at 2:45pm.  at 3:30pm started "itching all over."    Dr  present and gave order for hydrocortisone IVP.  this was administered at 4:15pm.  at 4:45pm itching greatly diminished.  Refused ER for observation so was released to home and OK'd per MD.  Reports mild fever 100.1 on 2/13 and fatigue.  reports continued itching today but manageable with OTC Benadryl.  She will f/u with her PCP before any further vaccines.
The child was being held by in his grandfather's lap with his arms securing the child's and mother was by their side. I was giving the covid vaccine, and the child jerked his arm upward, moving the needle but not removing it from the arm. There was a small, unknown amount of vaccine that was on the child's skin. The child's arm was also scratched during administration but it was a small, minor scratch.   I asked the family to wait after vaccination so that I could call the CDC regarding re-vaccination guidance. I spoke with staff from the CDC; she stated that it was recommended to give a half dose (0.1ml) on the same day. The family had left before I completed my phone call with the CDC, but I was able to call the mother back. The mother brought the child back into clinic at lunch time, and I was able to give 0.1ml IM in the opposite arm. The child didn't have a reaction from either dose.
Pt described having throat swelling. Gave pt EPIPEN shot, called 911 for ambulance. Pt received BENADRYL on the ambulance ride and received steroid treatment at the hospital. Discharged after a few hrs. (S/P to pt 10/4/15 2:19 PM).
SWOLLEN LIPS; BUMPS AND HIVES ON FROM HEAD TO REST OF HER BODY; ITCHY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, non alcoholic, non smoker, allergy to nuts, and allergy to fruits, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced itchy. On 25-AUG-2021, the patient experienced swollen lips. On 25-AUG-2021, the patient experienced bumps and hives on from head to rest of her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy, and bumps and hives on from head to rest of her body, and had not recovered from swollen lips. This report was non-serious.
Local Symptoms: Pain-discomfort, General discomfort: Fever, fatigue, other symptoms.  Narrative:
My hands started to itch, became hot all of a sudden stomach started to hurt. These things happened in about an hour.
Pt states he felt increase in pressure and warmth at injection site. Pt presented with swelling of the left shoulder with increased warmth and mild erythema. No axillary adenopathy. TTP.  Pt given IM 250 mg Solumedrol and Benadryl for po use. Pt was counselled on medication dosage and to RTC as needed if s/s worsened.
Left site after 15 minutes. 20 minutes after injection: felt hot, was flushed, got hives, dry mouth and thirsty, felt hard to swallow and to breathe. Called 911 on way home. EMTs said allergic reaction. Oxygen sat was 97 percent. They said to go to ER if symptoms continued. Went to ER, where I received injections of Benadryl and steroids. Released after a period of observation. Today I am still flushed and tired from vaccine but am otherwise okay.
Right arm DTaP #4 reaction 1" rom (redness/swollen). Left arm Prevnar #4 1/2" reaction (only swollen).
By 4PM that day I had extreme lethargy and pain in my left arm and body.  After a few days, I developed headaches and muscle stiffness and pain on left side of my body.  At the ten day mark, I developed severe joint and muscle pain in left arm and shoulder and continued headaches, feeling unwell.
Mother reports that during late yesterday evening that child developed fever and early this am [4:30]had a febrile seizure, which she described as childs body stiffening up and staring blankly, lasted appox 15 seconds. Has not had any seizure activity since that time. Has been fussy since that time. Mom is unable to give exact temp because her thermometer fell to the floor and broke while attemptint to obtain temperature.
Rec'd vaccine 4/14/08.  Mom reports today red, edema at Varivax site on L arm.
Complained of vision difficulty.  It was hard to see out of left eye followed shortly after with pain behind the right eye.
Patient was standing at the front desk approximately 5 minutes after receiving immunizations and told her mom that "things look funny". Patient't mom wrapped her arms around her and she started to collapse. Patient was eased to the floor and once she was horizontal on the floor she opened her eyes. She was then able to stand & ambulated with assistance to the exam room & laid on the exam table & was observed for 45 minutes. After that time patient stated she felt better, denied dizziness but said she hadn't had anything to eat & was hungery. Patient left the clinic with mom.