chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been having headaches; feeling tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I have been having headaches) and FATIGUE (feeling tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (I have been having headaches) and FATIGUE (feeling tired). At the time of the report, HEADACHE (I have been having headaches) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was provided.  No treatment medication was provided.
Entire household had COVID-19 on 12/22/2022. She had fever for one day with a high of 103 and minor cough/congestion. Was much better the next day with mild congestion and persistent cough.  Did not take her into PCP at this time because she was improving and they require a COVID-19 test to be seen. 12/27 took  her to an urgent clinic because cough was not improving. Urgent clinic tested her for COVID-19 and she was positive. Was instructed to treat symptoms and monitor her condition. Was instructed to return in 3 days if not improving
This spontaneous report as received from an office manager refers to a 14 years old female patient. The patient was vaccinated with the first dose GARDASIL (lot # 667930/1561Z, exp 23-MAR-2013) on 10-MAY-2012, and the second dose on 31-JUL-2012 (lot# 0459AE, expiration date unknown). Vaccination route was not provided. It was reported that the patient developed plantar warts at an unknown date after either the first or second dose of GARDASIL. The patient present status was unknown. The patient's mother had called physician's office to seek medical attention. Additional information has been requested.
Caller took Tylenol for his head before and after the 1st dose; This is a spontaneous report from a contactable consumer via Pfizer sponsored program Pfizer First Connect. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took Tylenol for his head before and after the 1st dose. The outcome for the event was Unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Within a few hours after receiving 4 vaccines, patient developed a rash over both upper arms that spread to lower arms, back, and face. He had no respiratory symptoms. He received benadryl for symptomatic relief of itching.
Expired dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 31-MAY-2023, the patient received Boostrix. On 31-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Tinnitus started five days after shot. Pressure, fluid, pain in ears. Severe vertigo ten days after shot. Scalp pain (like a sunburn feeling) ten days after. Most have resolved but the ear issues remain.
low grade fever, pale lt arm above infect site & going down arm to elbow is red & painful; c/o pain w/movement advised to seek eval of sx;
Presented to ED w/SOB, fever, & confusion; admitted for COVID-19 pna; tx w/abx, remdesivir, Vit-C, zinc,Vit-D3, steroids, O2; pt weaned to 1L O2/NC and discharged on home O2.
Rash on the face and neck, becoming more generalized; Abdominal pain; fever; vomiting; chills; extreme fatigue; nausea; body ache; headache; shortness of breath; loss of taste; loss of smell; chest pain; A spontaneous report was received from nurse, concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck (becoming more generalized), headache and body ache.   The patient's medical history included hypothyroidism, morbid obesity, chronic lower back pain and urinary incontinence. Concomitant medications included levothyroxine and oxybutynin.   On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, within 2 hours of administration, the patient experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain and chest pain. A few days later, on unknown date, she developed rash on the face and neck and it became more generalized.   On 30 Dec 2020, the reporter saw the patient and stated that she was still having shortness of breath with exertion and feeling tired. Treatment included over the counter ibuprofen and paracetamol.   Action taken with mRNA-1273 in response to the event was not reported.   The outcomes of the  events, extreme fatigue, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck, headache and body aches, were considered recovering/resolving.   The outcome of the event, shortness of breath, was considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Symptoms of Mastitis started showing in right breast roughly 18 hours after vaccination. Symptoms included red, tender spot on right breast with an inflamed vein going up the breast. I stopped breastfeeding mid-August 2021.
18AUG98 red whelp rt arm day p/vax;ice for 20-30min TID;19AUG98 pt came to clinic dec redness no swelling left @ site;
1/14 vaccine, code blue in hospital 1/15, discharged 1/20
Within a hour finishing my chemo treatment. I start having severe back pain that lasted for about a week later. I had a MRI done for my liver that day. Then the pain keep come, I went to the ER the next day. I had blood work done. I had CT scan done. They said that I had left hydronephrotic. Then a few weeks, starting having severe right leg pain. I went to my doctor, they diagnosed me with DVT. I went to the ER and was diagnosed with emulsion pulmonary. I still get SOB.
I started running a fever of 100.0, when I woke up and had a sore throat that lasted maybe a half hour.  I also had some congestion with headache, more like a sinus headache and that was it and I basically took a home COVID-19 test and it was positive. Called the doctor next and picked up the anti viral that afternoon and started it that evening. I was sick for about 4 days. I was actually working in the yard on Saturday and I hadn't completed the antiviral.
I contracted COVID-19 on 06/20/2022 with symptoms of headache, sneezing, sore throat, cough, congestion, chest tightness, fatigue, and diarrhea. I tested positive after returning home from a trip. I received Monoclonal Antibodies on 06/22/2022. I was ill for 5 days before my symptoms began to improve, but I am not fully recovered as of yet.
Small fever; A spontaneous report  was received from a Consumer concerning a 60-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  small fever.  The patient's medical history was not provided. Concomitant medications reported were Plavix, Baby Aspirin for drug use for unknown indication.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events small fever.  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, small fever was resolved.
This spontaneous report as received from a registered nurse refers to a 56 year old female patient with hyperlipidemia, basal cell carcinoma and no drug reactions or allergies. On 07-JUN-2012, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneously (lot # 672559/1657AA, expiration date 21-JAN-2013). No other co-suspects were reported. Concomitant medications included: atorvastatin. The patient complained of swollen lips for the last 2 months, since approximately August 2012. The patient was recommended BENADRYL as a treatment for swollen lips. No laboratory tests were performed. The patient was feeling better since the day before (date of report 04-OCT-2012). At the time of the report the patient's outcome was recovering. The patient sought medical attention, called office. The relatedness for swollen lips was not reported for ZOSTAVAX. Additional information has been requested.
Dizziness; Light Headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Light Headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Light Headed). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Light Headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-074818 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074818:
ran fever (101 degrees) after receiving vaccine  but doesn't believe he had still had fever still at the time of the seizure, no treatment; he then felt better, but seizures started again in June. He saw the doctor and was put on Topamax. He had no seizures for a period of time. Then they returned. Still having seizures  - some days 3 or 4 big and small.
has rash to lower back/ribs/hips/back of neck - itchy - denies trouble breathing - "tongue feels tingly", no itchiness in throat
sore arm; flu like symptoms; tired; achy; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, tiredness and general body pain. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, tiredness and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: Patient received the 1st dose of Shingrix and experienced a sore arm and flu like symptoms consisting of being tired and achy. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253321:same reporter
Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Period was unusually heavy and had lot of clots. Not normal for her-Severe, Additional Details: Pt had to get a Toradol shot for a migraine in the left arm 6-7 days after the shot in the left arm that was vaccinated. She ended up getting a red , ropey looking line starting from the injection site up her arm that also had knodules going up that line as well. So she thinks that the heavy period with a lot of clots was caused by the injection and that the phlebitis of the left arm was possibly from the shot as well because she has had other IVs in her arms before that did not cause reaction
Hep B vaccine dose 04/29/2013 10:47 AM 1-weakness, fatigue. Hep B vaccine 05/30/2013 01:47 dose 2 within days I Rt. Shoulder, arm and wrist pain as well as Rt. Leg pain. Hep B vaccine 12/18/2013 09:20AM within 30 (01/2014) days I developed mushy lumps on my scalp that broke down into ulcers...like a cold sore. As of today 10/16/2014 I still have Right Shoulder and Arm pain requiring Steriod inj. My scalp requires Clobetasol Propionate Topical Solution, USP, 0.05% W/W to control scalp ulcers...they never go a way.
6/2, complained of feeling hot and sick, no fever. Joint aches and leg weakness 6/3 had a strange bruise like spot on the back of his neck. Continues leg aches and weakness 6/4 had a strange bruise like spot near corner of mouth. Neck was better though. Never pain at the bruise like spot sites Spot on face is fading, but still present on the face as of today. All other symptoms resolved besides the spot on his face
Fever, chills, severe body aches, generalized weakness, tachycardia.
vaccines were also administered to patients post excursion with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA322724 and 2023SA324260.  This case involves an unknown age and unknown gender patient who reported that influenza quadrival a-b vaccine [Fluzone QUADRIVALENT] vaccines were also administered to patients post excursion 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 unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization. The information on batch number was requested.  On an unknown date the patient reported that vaccines were also administered to patients post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "Caller did not have the product and patient information for safety reporting at the time of call, but she gave permission to be contacted by Sanofi if further information is needed. Product/s: Unopened Fluzone QIV, Fluzone HD QIV and Adacel Reason: Refrigerator Malfunction Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours Human error? No Does extended stability data cover the excursion? No, unopened Fluzone QIV, Fluzone HD QIV and Adacel are no longer covered by the extended stability data. If negative advice, was the product administered to a patient? Yes. Batch/lot number requested, not available at the time of call. Follow-up with caller possible. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data; ; the vaccines were also administered to patients post excursion."  Action taken with QUADRIVALENT influenza vaccine (Fluzone QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event vaccines were also administered to patients post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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.
Headache, body ache, muscle fatigue, fever, chills, inability to speak, muscles locked up.  Person called 911 and carried patient to the ambulance to be taken to ER. Meds were administered via IV and prescriptions given to continue medication afterwards. Full recovery took 2-3 days.
Received 2nd dose a year later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose 1 year before receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: Reporter was the HCP (pharmacist) who stated that a patient received his first dose of shingrix and his second dose a year later.  The patient was looking to see if he could receive a third dose since it had been longer than 6 months between the first and second dose.  The patient was not given a third dose of shingrix. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose a year after 1st dose, later than the recommended standard schedule, which led to lengthening of the vaccination schedule.
pt recvd vax & devel macularpapular rash; pruritus;
A nurse reported approx. 12 pts from a single institution who received injections of Flu-Shield ('00-'01) on 11/6/00 and 11/07/00 developed injection site reactions characterized by redness, swelling and "spots" within a 2" diameter of injection. The reactions abated after 24 hours. The reporter indicated that approx. 12 pts experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up information received 01/25/2001 from the original reported revealed all the patients recovered within 48 hours of the events. No patient specific information was provided.
Patient reports that the next day after her 3rd dose that she experienced redness and extra swelling that she didn't have with her first 2 doses.  The swelling and redness has  passed her elbow and her arm feals hot.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored RECOMBIVAX HB lot# L023387 with expiry date: 22-JUN-2017, lot# M010212 with expiry date: 21-JAN-2019 and Lot# M001579 with expiry date: 05-OCT-2018 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Following the injection I experienced rapid heart rate up to 125, dry mouth, sweaty palms & feet.  RN monitored my HR & observed me until improved following the vaccine. These symptoms occurred again 24 hours later with rapid heart rate and also feeling off balance.
Within 2 hours of receiving the Flu vaccine I started to feel Nauseous and Dizzy. Today which is the next day I felt the same Nauseous and Dizzy and I took a sick day from work.
Moderna COVID-19 Vaccine  Itching at and around injection site, redness at and around injection site, warm to touch, swelling at injection site, soreness, body aches, fatigue.
Immunizations given on 7/17/12. Child presents today with red, sl. raised area 6-7 cm in diameter on (Rt) upper arm (site of varicella inj), c/o itching at site. Mother states symptoms started, "the day after shots & keeps getting bigger". BENADRYL 35 mg TID & prednisone 20 mg bid x 5 days order per dr.
Fever; Chills; Excessive sweating; Generalized myalgia; This is a spontaneous report received from a non-contactable nurse, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route in the left arm on 24Mar2021 at 10:45 (At the age of 50-year-old) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications administered within two weeks of vaccination included nasal spray (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL) both for an unspecified indication since an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route in the left arm on 04Mar2021 as single dose for COVID-19 immunisation. The patient was allergic to montelukast sodium (SINGULAIR). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the vaccine. On 25Mar2021 at 2:00, the patient underwent body temperature recording and the result was 102.8. On 25Mar2021 at 2:00, the patient experienced Fever of 102.8, chills and excessive sweating and generalized myalgia. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. Therapeutic measures were taken as a result of fever, chills, excessive sweating and generalized muscle aches which included treatment with ibuprofen. The clinical outcome of fever, chills, excessive sweating and generalized muscle aches was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated VAERS Primary Reporter Addl Qualification as patient, Relevant Med History updated, Age for Historical Vaccine removed, Patient Route of Administration updated as intramuscular and removed from Parent Route of Administration, vaccination Facility Country added and Lab data test as reported updated as Body temperature.