chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # L040419 with expiry date on 14-OCT-2017, lot # L043622 with expiry date on 11-MAR-2017 and lot # M000761 with expiry date on 01-JAN-2018. No adverse event was reported and no product quality complaint was involved. Temperature: 18.5 Fahrenheit degrees. Time Frame: 5 hours. Previous excursions: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia, Arthralgia & NauseaVomitting Narrative: 4/6- Sore at injection site. Slightly nauseated. Body aches. Chills. Joint pain, mainly bilateral knees. Runny nose. Took ibuprofen. 4/7- Very fatigue. Body aches. Chills. Soreness to entire upper left arm, left shoulder and L side of chest. Joint pain
03/07/2021: After 15-45 mins of receiving vaccine, felt dizzy and light-headed sensation, which subsided after 1 hour. Later in the evening, around 19:00 pm; skin started feeling itchy which lasted overnight and adhoc period the next day - would describe ad mild to moderate.  presented as fine rash on stomach and tors, itchy back, arms, face around cheeks and jaw line, and ankles. Also felt slightly nauseas from around 10pm on 03/07/2021. On 03/08/2021: Skin itchiness continued, describe as mild.  Called Primary care doctor who recommended taking 1 Zyrtec per day to alleviate the itching; registering the adverse reaction, and seeing an allergist prior to considering taking the second dose of Pfizer.
Localized reaction at RUE with erythema, induration, and generalized edema from DTaP, treated symptomatically.
Information has been received from a registered nurse concerning a female who in September 2000 and in February 2001, was vaccinated with measles virus vaccine live. In 1979 and 1989, she was vaccinated with MMR II. The nurse reported that serology tests performed a few months after each measles virus vaccine live administration were equivocal. Additional information has been requested.
Initial report received 23 May 2008 from a health care professional.  A 21 month-old male patient received an intramuscular right thigh injection of DAPTACEL and 15 to 20 minutes later he developed wheezing, a rash on his chest and back and red blotches.  The patient received corrective treatments with albuterol and prednisone.  The symptoms resolved after treatment and the patient recovered from the event.  The patient had a history of milk allergies and had not been ill at the time of vaccination.  According to the reporter, the patient was new to their practice and they were unsure what vaccines the patient had received in the past.  No further information was provided at the time of the report.
Moderna COVID-19 Vaccine EUA   I received my first dose of Moderna vaccine on 2/17/21, the arm of the injection site was tender for about two days and it eventually went away.  On 2/25/21, I developed a reaction on my deltoid area near the injection site, it is red, firm and edematous. The redness and swelling measures about 12cm x 5cm. The area feels warm, tight, and tender to touch. I have been taking Advil and Loratadine to help with the symptoms, as well as ice to relieve the swelling.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 16-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # confirmed to be L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
On June 12th, 4 days after second dose of the Covid-19 vaccine, I developed a ringing in my right ear along with very brief deafness, an hour or so after waking up. A few days later, I developed the same ringing sound in my left ear. Then, a few days after that, the ringing got worse, along with painfully sharp pain in my ear canal. A few days after that, I developed something akin to vertigo. I couldn't keep my balance and kept falling over, but I didn't feel dizzy or notice myself losing balance. Within a month from the second dose, I had developed several more symptoms, such as flashing lights in my peripheral vision, unexplainable fatigue, swollen tonsils with holes and bumps all covered in white, chest pains along with chest numbness, a significantly higher resting heartrate (my usual resting heartrate is in the low 60s, but since the vaccine my resting jumps to 150 or higher even when laying down, and stays there for an hour or so), feeling my heart beat much harder but staying at the same heartrate. sometimes feeling like I cant enough air when breathing, unexplainable disgusting sweating, blurry vision along with broadband type visual snow. I am definitely missing a few symptoms here, but am nearly out of time on forum, none of these issues have resolved.
I experienced  a sore throat ad ending up losing my voice for approximately 1 week. I went to see my PCP on  04/31/2021 via a video appointment and I was sent for a COVID test on 09/04/2021 which came back negative; therefore, my PCP prescribed antibiotics to treat my sore throat. I went to see another Physician more painful and heavier than normal menstrual cycle  on 09/132021 and again on the 15th. My Ob-gyn gave me a Depo shot ( rec'd on 09/13/2021 which did not work) to stop the heavy I ended up going to the ER ER immediately after the appointment on 09/15/2021 where blood work was done to ensure that my iron and blood levels were normal. bleeding that I was experiencing. I had additional blood work done on 09/17/2021 to check my levels again which came back with results showing low iron levels. I was given Potassium bills to take help with the dizziness.
3MAY devel itching on palms of hands, between fingers, soles of feet & groin area;5MAY began Medrol dose pack by PMD x 24hr w/o improvement;had subjective fever 6MAY PM;7MAY AM Medrol d/c DPH ordered;13MAY improved;
NAUSEA, VOMITING, FEVER, SORE TO INJECTION SITE, BODY MALAISE, FATIGUE
Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Engerix B (intramuscular) 1 ml and Engerix B Pre-Filled Syringe Device. On 8th February 2022, unknown after receiving Engerix B and Engerix B 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 reporter called to report that the patient received an expired dose of Engerix-B in his left deltoid which led to expired vaccine used.   The reporter consented to follow up.
pediatric dose administered to adult; pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 38-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 20th September 2022) for prophylaxis.   On 24th March 2022, the patient received Engerix B pediatric. On 24th March 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date:24-Mar-2022 Reporter's Comments:  Reporter consented to follow up. Reporter declined to provide date of birth (DOB )for patient Additional Supportive Information: The pediatric dose of Engerix-B administered to an adult patient, which led to adult use of a child product and underdose.
Itching from a swollen, firm, red oval shaped welt (~2 inches across and 1 - 1 1/2 inches tall). So far it's been 15 hours and symptoms persist.
but it triggered my brain to dissociate. DP/DR (Depersonalization/derealization disorder); had really bad "Vax-fog" or "brain fog"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Jun2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "known allergy: Hydrocodone". The following information was reported: DEPERSONALISATION/DEREALISATION DISORDER (non-serious), outcome "not recovered", described as "but it triggered my brain to dissociate. DP/DR (Depersonalization/derealization disorder)"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "had really bad "Vax-fog" or "brain fog"". Therapeutic measures were not taken as a result of depersonalisation/derealisation disorder, feeling abnormal.  Additional information: lot unknown reason =Misplaced/discarded; No other vaccine in four weeks. Patient stated to have had really bad "Vax-fog" or "brain fog" as people are calling it (which was fine it's a normal side affect), but it triggered her brain to dissociate. DP/DR disorder (Depersonalization/derealization disorder). Patient got the first dose on 02Jun, never got the second dose because it was so bad. It's been over 3 months and it hasn't gone away. Patient stated she never had DP/DR in her life so it was 100% from the brain fog. Patient don't know where the vax-fog ended and where the dissociation started. No covid prior vaccination, no covid test post vaccination.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : 202101198312 Same drug/reporter/patient, different dose
Nausea, restlessness, headache, dizziness. I continue to experience tingling on left extremities, i.e. side of face, arm, hand, leg, and foot; nausea and headache when tingling intensifies; tingling increased during evening hours to point of soreness in leg by time I go to bed; subsides during the night; begins again as I start moving around in the morning and when sitting position. During the day the tingling sensation goes across my chin at various parts of the day.
Initial report received on 24 January 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL, lot number C3774AA received on 04 April 2011, lot number C3801AA received on 01 July 2011 and lot number C3930AA received on 26 August 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough with whoop on 20 December 2011, approximately 4 months after the last dose. Laboratory testing included positive PCR on 08 January 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 January 2012 for 5 days. The subject was not hospitalized. At the time of the final contact on 20 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient developed a rash/hives 14 minutes after receiving vaccine in left arm.  She was seen by the onsite medical provider, who requested that she stay on site for obseration for an additional 15 minutes.  The rash continued to spread, to the right arm and neck, in addition to the left arm.  The patient was re-evaluated, administered 0.3 mg of epinephrine IM, and sent to the emergency room at Hospital for observation.
Mom noted large area on right thigh. Swollen, red and bruised during bath on 04/24/05- Seen in ER then for f/u in office 04/25/05 9AM. RX Amoxicillin for cellulitis.
pain; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site pain and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter reported adverse event for her husband. The patient received 1st dose of Shingrix in his left arm. When the patient got the injection, it hurt at the injection site and had some redness on the left arm which resolved in a few days.  The patient was planning to not to receive the 2nd dose of the Shingrix vaccine. The patient consented to follow up and provided his physician's details. Additional information was not specified.
Worsening tinnitus, did not seek medical treatment since was unsure if vaccine was the cause and tinnitus is better some days than others After some time I realized that the tinnitus volume has become generally louder since receiving vaccine and is thus more bothersome. I feel strongly that the vaccine made it worse and am afraid to get a booster in the future for that reason. I feel this should have been mentioned as a possible side effect
Fatigue, groggy ness, sleeping for long hous, and eczema weeks later.
Sinus Tachycardia from potential hyperthyroid, stopped Cytomel, stopped Synthroid for 2 days and resumed at same dose, Beta blocker prescribed, symptoms not resolve yet.  Appointment with Endocrinologist pending.
MCV-4 (MenQuadfi) and Tdap were given at 11:30AM. About 5 minutes later she felt dizzy and then fainted and fell. She regained consciousness within one minute. BP checked at 11:36AM showed 77/57 and PR 65. She was awake and no cold sweat. Another BP taken at 11:40AM showed 90/72 and PR 69. She was comfortable then. Another check on 11:56AM showed BP 96/81 and PR 89. She was then discharged home in good condition.
Extreme irritability and fever approximately 24 hours after receiving DTAP, HIB, Hep B, pneumococcal, polio, and rotavirus vaccines.
5-15-10 patient seen in office for rash around injection site with itching located on the right upper arm. Description is 10 cm area of erythema mild edema over right deltoid.
When RN attempted to administer Varicella, child kicked and dislodged needle from injection site, causing two small needle scratches the size of pin points. RN changed needle, re-cleaned area, and reinserted and injected varicella vaccination without incident on second attempt.
Patient developed a rash starting from the site of injection (R-deltoid) to her bicep.
injection site feels sore and tender; had a rash on her arm; arm started to hurt; arm feels like fire; This is a spontaneous report from a contactable consumer (patient herself). A female consumer with unspecified age received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number/Expiration date) via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunisation. The patient medical history and Concomitant medications were not reported. On an unspecified date, Caller stated a week later after received the second dose her arm started to hurt, she had a rash on her arm and the injection site feels sore and tender. As she stated today the rash got bigger, her arm feels like fire. She would like to know if this has been reported and if she should speak to her doctor. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I received a Dtap vaccine in my right arm and a pneumonia vaccine in my left (per facility) on Aug.22 The next day in the afternoon, I started feely a little fuish. By the following day, Sun., Aug. 24, I had a fever of 102, felt faint whenever I stood up, had the chills and the sweats, and became dehydrated.  I went to urgent care that day at 3:30...by then, my fever had broke, and my temp was down to 100 plus. I received two bags of saline to get rehydrated.  BP was very low, Chest x-ray was normal. I felt a little better after the saline, but had a slight fenver and Headache for another day.On the 24th, a rash appeared on my left arm.. it lasted about 4 days..my left arm was sor, the rash was about 1 inch by 2 inches wide.
Axillary lump; large swelling on the opposite arm; large swelling underneath the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Axillary lump), PERIPHERAL SWELLING (large swelling on the opposite arm) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (large swelling underneath the site of injection). On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (large swelling on the opposite arm). On 22-Apr-2021, the patient experienced AXILLARY MASS (Axillary lump). At the time of the report, AXILLARY MASS (Axillary lump) had not resolved and PERIPHERAL SWELLING (large swelling on the opposite arm) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Computerised tomogram: swollen lymph nodes (abnormal) swollen lymph nodes.         No concomitant and treatment drugs were reported.  It was reported that he had a CT Scan early this month in Nov which revealed swollen lymph nodes on the same area but he mentioned that this was unrelated as he has other medical conditions. It was reported that a very large soft fatty tissue bulge developed under the arm and patient got his shot in one day after the shot.  A similar bulge developed under his other arm the next day. It was stated that they  were originally double the current but shrank and have remained stable for about 6 months now. They don't seem to be going away. His doctor tells him this was not related to the lymph nodes, but did not have any answer as to what may be the cause.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received and new events were added.
Pt. has cellulitis of (L) Deltoid per Dr. She was prescribed KEFLEX.
Pt had been having cold symptoms x ~3 weeks prior to vaccine administration, including a persistent cough.  Received vaccine 3 days prior to admission to hospital.  1 day after administration became "achy all over" and cough was worse.  Denies fever.  On day of admission pt began having fainting spells and came to ER.  In ER pt was found to be in A Fib w/ RVR and had periods of asystole.  (no previous cardiac history).  Pt spontaneously converted to normal sinus rhythem.  Cardiac work-up has been negative for any cardiovascular disease and pt has been diagnosed with sick sinus syndrome and a pacemaker placed.  Pt has also received antibiotics for a pneumonia.  She has remained afebrile.  Pt has been in hospital x 5 days and remains hospitalized.  NOTE:  unknown how many times pt has previously received this vaccine - she has received it at least once previously in 2002. Nurse follow up on 06/28/04 states: " ADD: tachycardia, atrial fibr, hypokalemia, infiltrate, Upper GI bleed, sick sinus syndrome."
This case was received from the foreign Health Authority on 18-Aug-10 under the reference number 20682333. This case is medically confirmed. A 21 years old female patient had received a dose of Rabies BP (batch number E0640-1) intramuscularly, site not reported on 02-Aug-10. One hour post vaccination, she experienced a headache and nausea and two hours post vaccination, the patient collapsed whilst at home. The patient had a medical history with juvenile absence epilepsy in 1995 and anxiety with depression in 2005. The patient was receiving concomitant medication of co-codamol, mefenamic acid, MICROGYNON and orlistat 120 mg for unreported indications. The patient recovered after four hours. According to the reporter and the agency the reaction was considered serious for other medically significant reason. The agency coded the events of headache, loss of consciousness and nausea.
June 13-malaise,sore arm   June 14-malaise, sore arm  June 15-same  June 16 dizzy spell/spinning while working out at gym?lasted  15-20 minutes? June 18 dizzy spell?room spinning June 19 severe spinning, felt faint, eyes displayed severe Nystagmus June 20 same symptoms
pt recvd vax; devel inject site rxn characterized by red hot swollen and itchy area from inject site to the elbow;
Three days following hepatitis A vaccine, patient developed headache, fatigue, followed by rash. Two weeks later she developed manic psychosis requiring hospitalization.
GAVE 2ND COVID BIVALENT BOOSTER - PATIENT GAVE WRONG INFORMATION ACTUALLY RECEIVED VACCINATION AT PHARMACY
NauseaVomiting 1518: VS 128/90 87 c/o nausea water offered,  FEELING BETTER AT END OF 15MINS OBSERVATION
Frozen shoulder, lack of mobility in left arm... can't stretch it over my head any more... when stretching, pain radiates through shoulder and down to my elbow and lasts several minutes.