chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my shot on Wednesday, March 24th at 2 pm.  On Saturday, March 26th ,  I woke up to stomach cramps, chills, and fatigue which lasted throughout the day on Saturday and subsided by the next morning. However, the tinnitus in my left ear had increased to a more noticeable and distracting noise level. Previously, I would describe my tinnitus on a scale of 1-10 (with 10 being most severe) as a "2". Since Saturday, March 26th at noon the tinnitus has reached a level of 4 or 5. It can be distracting when I am in a quiet environment trying to work, something I have never experienced before. I am concerned that this will continue to worsen.
This spontaneous report as received from a medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of VAQTA (Lot # M011116, expiry date: 17-JUN-2017/Lot # M009786, expiry date: 26-MAY-2017) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
My 12 year old daughter received her second GARDASIL shot Wednesday, September 30, 2009. She complained of her tongue itching later that night. I started giving her ZYRTEC. The next day she was complaining of itching her face around her eye. I gave her ZYRTEC twice a day until Friday night when she developed a rash on the right side of her face around her eye. At that point I started giving her BENADRYL every four hours. Her face was significantly swollen on the right side by Saturday night. Sunday morning, her eye was swollen nearly shut. The right side of her face was swollen so severely, she was unrecognizable from her profile. I applied cool compresses, continued BENADRYL, and gave TYLENOL for the discomfort. I tried to get an after hours appointment but was told by th on-call nurse to continue the BENADRYL and that unless she had blister, there was no reason to see the doctor. Monday her eyes were completely swollen shut, and her skin was so lightly swollen the itching had subsided. I did get her a doctor's appointment that afternoon but was told it was contact  dermatitis, and that it had nothing to do with the second GARDASIL shot that she had five days earlier. I asked the doctor to document the possibility that it was a reaction to the shot in her records. She said it was worth noting but that she had not seen any such reactions. I do not believe she documented it. She prescribed 60mg of PREDNISONE a day for five days and told me to continue to giver her the 50 mg of BENADRYL every four hours. By Monday night the very raw and irritable rash had spread to the other side of her face. Tuesday the swelling on the right side had lessened but her cheek and eye were still puffy and the hives were still very raw. Tuesday night the rash had spread to cover most of the left side of her face, behind both ears toward the back of her neck, and under her chin, down her neck and onto her chest. I continued to following doctor's instructions giving her the BENADRYL and PREDNISONE. Wednesday morning the redness had subsided some, but her eye was swollen almost shut again. Wednesday night the swelling was significantly reduced with just slight puffiness on the right cheek and eye. The hives were no longer an angry red but were still evident and itchy.
Injection site pain, swelling, tenderness,  fatigue, headache, muscle pain, joint pain, chills, fever
This case was reported by a physician and described the occurrence of HEPATITIS B surface antigen in a male subject aged between 30 and 40 years old who was vaccinated with ENGERIX B, (GlaxoSmithKline).  The subject's medical history included foreign travel and unprotected sexual intercourse.  Previous and/or concurrent vaccination included HAVRIX; (GlaxoSmithKline); unknown given on an unspecified date.  In January 2008 (six weeks prior to this report) and in February 2008 (2 weeks prior to this report) the subject received 1st dose and 2nd dose of ENGERIX B (20 mcg, unknown).  In February 2008, 1 day after the 2nd vaccination with ENGERIX B, 4 weeks after the 1st vaccination with Engerix B, the subject experienced HEPATITIS B core antibody, in which the subject has been negative "the entire time" and was positive for HEPATITIS B surface antigen.  In February 2008, the events were resolved.
Experienced urticaria on neck, axillas, waist resolved on own after 24 hours.  Concurrent respiratory complaints of nasal congestion , cough , ear pain, sore throat which began 2 days after vaccine
This spontaneous report was received from a nurse concerning two unspecified patients. There was no information about patients' concurrent conditions, medical history or concomitant medications.  On unspecified dates, the patients ware vaccinated with PNEUMOVAX 23 lot # N024385 with expiration date of 18-MAY-2019, (route of administration and anatomical location were not reported) for prophylaxis. On an unknown dates, the patients experienced localized pain (injection site pain), swelling (injection site swelling) and warmth at injection site. The outcome of injection site pain, injection site swelling and  injection site warmth and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Awoke with left cheek swelling (parotitis) w/o signs of other infection (i.e. otitis/mouth infxn)
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with doses of improperly stored GARDASIL (dose, strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
NO ADVERSE EVENT. PATIENT WAS PREGNANT AND SHE RECEIVED THE REGURAL FLUVIRIN MDV INSTEAD OF THE PRESERVATIVE FREE FLU SHOT.
Patient received 2 doses of influenza vaccine this year. Patient chart was not checked prior to administration. No adverse events have occurred.
At injection site: redness, firm/indurated, very tender. Overall: severe headache developed at 3pm (3 hours after vaccine injection) with no other cause which was not otherwise responsive to acetaminophen or hydration.
Arm sour; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN4201; Expiration date was not reported) on 16Feb2021 (12:00) as dose number unknown, single, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 17Feb2021, the patient's arm was sore ("arm sour"). The patient did not receive any treatment for the event. The outcome of the event was not recovered. The patient did not have COVID-19 prior to the vaccination, and was not tested post-vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Admission Current   10/3/2021 - present (1 day) medical facility     Last attending ? Treatment team Pneumonia due to COVID-19 virus  Principal problem Hospital Problem List   Benign hypertension with CKD (chronic kidney disease) stage III (CMS/HCC)  Chronic kidney disease, stage 3 (CMS/HCC)  Malignant neoplasm of lymphoid, hematopoietic, and related tissue (CMS/HCC)  Caries involving multiple surfaces of tooth  Acute pulmonary embolism without acute cor pulmonale (CMS/HCC)  Pneumonia due to COVID-19 virus
Pain in the injection site; Redness in the injection site; Muscle pain; Tiredness; Headache; Shivering; Drug ineffective; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for muscle pain, tiredness, headache, shivering, injection site pain and injection site erythema.   On 4th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Tylenol at an unknown dose and frequency. On 4th October 2022, 8 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, muscle pain, tiredness, headache, shivering and drug ineffective. The action taken with Tylenol was unknown. On an unknown date, the outcome of the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering were not recovered/not resolved and the outcome of the drug ineffective was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The reporter was a patient's wife. The reporter reported that the patient received Shingrix vaccine in the right arm. The reporter stated in the last night patient had pain and redness at the injection site, muscle pain, tiredness, headache and Shivering. The patient received Tylenol as treatment and that did not help patient. It was unknown if the reporter considered the drug ineffective to be related to Tylenol. The reporter stated that he will contact healthcare professional if symptoms are not start to resolve in a few days. The reporter did not consent to follow up.
Severe dizziness. That has lasted almost two weeks; Dose 1 on 18Feb2021 and Dose 2 on 02Mar2021; This is a spontaneous report from a contactable consumer, the patient. A 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hashimotos disease, arthritis and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 14:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 at 09:00, the patient experienced severe dizziness that has lasted almost two weeks. The event resulted in and emergency room/department or urgent care. Therapeutic measures were taken as a result of the dizziness which included treatment with diphenhydramine hydrochloride (BENADRYL) and tests (unspecified) was given. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe dizziness was recovered on an unknown in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from a patient on 19 January 2017. This case involves a female patient (onset age unknown) who was vaccinated with 0.5 ml dose of TETANUS TOXOID (TETANUS TOXOID) (batch number: USS21BA, expiry date: 10 December 2018, dose in series were not reported) in the left arm on 26 December 2016. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient had developed swelling at the injection site which was red warm to touch and very sore and covered half of the arm. The patient required emergency room (ER)/ doctor visit on an unknown date. Laboratory investigations were not reported. Corrective treatment was prescribed as antibiotic. The outcome of event was reported as unknown. List of documents held by sender: none.
Arm sore within 24 hours, facial numbness, tingling in various body areas, chest pain within 1 week, metallic taste in mouth in 2 weeks, numbness and tingling in face seems to be worsening. Soreness only lasted about 1 day.  Extreme fatigue the following day but it subsided by the 2nd day.
Mother called left leg swollen to softball size 3 days after vaccines given, red and warm but improving, no complaint pain, no pain from injection area.
Painful, inflamed neck muscles and joints - "9.8 on 10.0 pain scale"; stiff neck; NO swollen lymph nodes; No fever; symptoms began around 2 AM in morning approximately 60 hours after injection of second dose of moderna; pain began on same side of neck that injection was administered into arm deltoid muscle (left) but then it spread to entire neck.  Felt painful pulsing sensation through neck.   Intense symptoms persisted for 24 hours along with periods of chills and perspiring but no fever recorded.  Then felt a sensation of something "opening up and relaxing" and intense pain let up.  Did not take any medication to relieve.  Still a small amount of tightness/pain/inflammation in neck after 96 hours after injection of 2nd dose (1.5 out of 10.0 pain scale).
I was speaking on the phone while getting the vaccine. Within 30 seconds of administration, my hands and feet immediately went cold and numb and dropped my phone on the floor. I blacked out for 2 seconds. (I was told I also flailed my arms and legs as it happened, this I do not remember). Following this, my heart rate was fast and blood pressure were elevated. I felt extremely dizzy for about 90 minutes following. It took approximately an hour for me to get taken to the emergency department.
Redness around injection site; Swelling around injection site; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE SWELLING (Swelling around injection site), FATIGUE (Fatigue) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE SWELLING (Swelling around injection site), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE SWELLING (Swelling around injection site), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
pt recvd vax;  devel blotchy rash on face, hot & red, some swelling; also, achy, malaise, irritable; now has cold/sinus sxs w/ stuffiness; 18oct93 f/u: recovered;
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: I waited with her until the paramedics arrived and had an EpiPen ready in case she needed it, but she was refusing. She did not faint or lose consciousness at any point. She refused transport, and the paramedics advised her to wait some more time until she felt ready to leave (her husband did come by this point as well) as her stats showed within normal range. I did still advise her to followup with immediate care at hospital or urgent care since she still felt anxious and her eyes puffy.
patient reports 10 days post vaccine started with edema ankles, and is increased in the last months.  New onset hyperlipidemia, hypertension, low albumin, proteinuria.  likely autoimmune response to vaccine causing glomerulonephritis.
Woke up at 4 am after vaccine from armpit pain under right arm. After waking up, armpit pain was under both arms and began to have neck stiffness. Began to have major nasal congestion and went to the urgent care thinking it was a sinus infection.
The client has been felt itching on his left eyelid since yesterday afternoon, then , through the night , his left eye becomes swollen and getting blisters. This morning, the blisters were diminished but the client feels itching sensation on his left eyelid and remains swollen around on left eye.
Near fainting, black out, no loss of consciousness, right after injections. Conscious, recovered after 15 min.
per manifactuere, they sent out short dated vaccines that were expired. but they did studies and as long as patient recieved the dose prior to 10/19/2022, it was still stable and ok to adminster.
This case was reported by a pharmacist and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline).  On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cases include A0947173A, A0947174A, A0947175A, A0947176A and A0974717A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. No additional information is available. An investigational report received via GlaxoSmithKline quality assurance on 31 October 2011 indicated that no sample was available for return. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. The FLULAVAL vaccine lot AFLLA679AA was produced in compliance with Good Manufacturing Practices and met the requirements of their specifications. This lot was checked by GSK Biologicals Quality Assurance and Quality Control accordingly.
joint pain; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (joint pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In April 2021, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Laboratory test abnormal: abnormal (abnormal) abnormal. In 2021, White blood cell count: low (Low) WBC count decresed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information on concomitant and treatment medication were reported.
patient admitted after several days of N/V/SOB/chest tightness shortly after getting  both monkeypox and flu shot. he had never had problems with flu shot. he was admitted for dehydration. He quickly recovered and was discharged after 3 days.
vial underwent temperature excursions; Expired vaccine stored and administered; vaccinated someone two days after the expiration date; vaccinated someone two days after the expiration date, vial was initially stored in the refrigerator on 15Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date, vial was initially stored in the refrigerator on 15Jul2022) and PRODUCT STORAGE ERROR (Expired vaccine stored and administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date) and POOR QUALITY PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date, vial was initially stored in the refrigerator on 15Jul2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent temperature excursions) and PRODUCT STORAGE ERROR (Expired vaccine stored and administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date, vial was initially stored in the refrigerator on 15Jul2022) and PRODUCT STORAGE ERROR (Expired vaccine stored and administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.              Number of doses/vials included as 4 doses (2 boosters and 2 second boosters). The vial was initially stored in the refrigerator on 15-Jul-2022. The vial underwent  temperature excursion.  No treatment information was provided by the reporter.
Frequent short spells of mild headache and dizziness (lasted for about 1 1/2 weeks), tired, (lasted over 2 weeks), sore arm (lasted a few days). Over 2 weeks before I felt normal. After the second shot, the symptoms were much more severe. It is over 4 weeks now and I am still not well  - longer lasting headaches and dizziness and tired.
Initial misuse report received from a healthcare professional on 24 JULY 2013. A patient (no information was provided regarding the patient) had received a dose of ADACEL that was 2 days expired. No adverse event was reported. Documents held by sender: none