chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster; cold; skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms; muscle aches/still achy; in general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold), RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms), MYALGIA (muscle aches/still achy) and FATIGUE (in general fatigue) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Skin reaction (History of skin reactions (hives, etc.)).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold), RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms), MYALGIA (muscle aches/still achy) and FATIGUE (in general fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 milligram; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold) and FATIGUE (in general fatigue) outcome was unknown and RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms) and MYALGIA (muscle aches/still achy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided by the reporter Patient had strep and mono test on 18-Nov-2021, but they were negative. He has a body rash on his trunk and arms. He was prescribed steroid that he took for a couple of days, but it was causing him stomach issues.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up received on 20-NOV-2021 contains no new information On 20-Nov-2021: Follow up information received on 20 Nov 2021 contains event pertaining to first dose and medical history
Signs/symptoms: Headache Time course: occurred the night of and day after administration of the immunization. Treatment: Ibuprofen, taken as directed on bottle.
3/23/21 pt developed red circular rash the size rash the size of a grapefruit around the injection site on the right arm. 3/25/2021 pt  developed a red circular rash the size the size of a grapefruit on his right bicep. 3/26/2021 pt went to PCP where he was told he thought he had dermatitis and was told to take cortisone cream. Pt still has some pain redness in the arm.
Severe neck, left shoulder and arm pain to just past my left elbow. SOB, tired, no energy and brain fog, insomnia, nausea/vomiting.
Insomnia. Muscle aches, headache, fever, chills, hives, itching
itching/itching in the mollero (biceps) and in two fingers; Not being able to sleep; Pain in the injection site; Right hand and elbow gets tired; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching/itching in the mollero (biceps) and in two fingers), INSOMNIA (Not being able to sleep), VACCINATION SITE PAIN (Pain in the injection site) and FATIGUE (Right hand and elbow gets tired) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065r21a and 202521a) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis. Concomitant products included LISINOPRIL for an unknown indication.   On 28-Apr-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced PRURITUS (itching/itching in the mollero (biceps) and in two fingers), INSOMNIA (Not being able to sleep), VACCINATION SITE PAIN (Pain in the injection site) and FATIGUE (Right hand and elbow gets tired). At the time of the report, PRURITUS (itching/itching in the mollero (biceps) and in two fingers), INSOMNIA (Not being able to sleep), VACCINATION SITE PAIN (Pain in the injection site) and FATIGUE (Right hand and elbow gets tired) outcome was unknown.            Concomitant medications were reported as unspecified arthritis and cholesterol medication and pain medication for his arthritis.  Treatment included pain medication- 2 different kinds, icepack ,hot water and cream for the pain   This case was linked to MOD-2022-588250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Translation document attached event verbatim updated.
I jumped when the nurse injected the vaccine and the needle pulled out.  She said I was leaking and tried to stop it with her finger.  It continued leaking and she put a bandaid on it.  I do not believe I received the full dose; I was leaking and tried to stop it with her finger. It continued leaking; bruise where the needle jerked in my arm; This is a spontaneous report received from a contactable female consumer (patient herself) of age 68-year-old (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number; EL3246) via intramuscular route of administration on 21Jan2021 to right arm and second dose with lot number: EL9266 via intramuscularly on 12Feb2021 05:00 PM to left arm both as single dose for COVID-19 immunization. The patient medical history included Sjogren's and CAD. Concomitant medications were not reported. On 12Feb2021 at 05:00pm the patient reported that she experienced bruise when the needle jerked in her arm. Also said that she was jumped when the nurse injected the vaccine and observed leakage when the needle pulled out and kept band aid to stop the leakage. She believed that she doesn't received full dose. No other reaction was observed. No treatment was received for the event. Patient received other vaccines within 4 weeks prior to the covid vaccine. Patient received prescriptions and vitamins within 2 weeks of vaccination. The outcome of the event was unknown.  Ethnicity information is available and Race information is available.
Information has been received from a physician concerning a 1 month and 7 days old male who on 26-Nov-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq.  It was unknown if medical attention was sought.  No adverse event was reported.  Additional information has been requested.
Doses were giving to 4 patients from a vial that was pierced after 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT CONTAINER ISSUE (Doses were giving to 4 patients from a vial that was pierced after 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRODUCT CONTAINER ISSUE (Doses were giving to 4 patients from a vial that was pierced after 12 hours). On 12-May-2021, PRODUCT CONTAINER ISSUE (Doses were giving to 4 patients from a vial that was pierced after 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.   The reporter stated that she could not provide patient information without consent. Consent given for safety follow up via email.
I have had 4 COVID shots to date. About a month after the first shot I developed conjunctivitis that appeared to be related to Meibomian gland dysfunction. It was treated with steroid drops and antibiotic drops. After the 2nd, 3rd and 4th  shot I had  repeat episodes of conjunctivitis,  Eyes burning, lashes stuck together in the am, light sensitivity. Up until today I never thought the vaccine was related to the eye problem. I was reading about how to treat and prevent dry eye issues and ran across an article which correlated some eye issues with COVID cases and the COVID vaccine.  It may just be a coincidence that I developed a chronic eye problem over the 2 years I have been getting the COVID vaccines and boosters but I felt it was worth putting in a report in case you. have seen this occur in other vaccine recipients.  My last booster was a month ago and I had an eye flare up about 2 weeks after the injection. It was treated with steroid eyedrops and my eyes seem OK now. I am using fish oil, warm compresses, and 5x/day PF eyedrops.
several health conditions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (several health conditions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and COPD. Concomitant products included BUDESONIDE for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced VACCINATION COMPLICATION (several health conditions). At the time of the report, VACCINATION COMPLICATION (several health conditions) outcome was unknown.            No treatment medication was mentioned.
Child had reactions of redness at injection sites for the MMR (L) VL/SQ and varicella (R)VL/SQ. Advised mother to give infant TYLENOL and alternate w/childs MOTRIN as recommended. On bottle, to continue to watch her for fever. To exercise her legs for soreness and use warm compress.
Excessive menstral bleeding. Blood Transfusion required. Severe menstral cycles for years, with pain. Miscarriage. Ovarian cysts. Loss of ovary.
Fainted; This is a spontaneous report from a non-contactable nurse. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 01Mar2021 (at the age of 36-years-old; Batch/Lot number and expiry date were not reported) as single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient fainted on 02Mar2021 and recovered from the event on an unspecified date. No treatment was received for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Panic attacks with hyperventalating, sweating at bed time.  Occurs nearly everynight after 7:30 PM and has lasted as long as 2:30 AM.
Initial report received from a health care professional in the USA on 05-August-2005. A 4 year old female child developed redness, swelling (11x16cm), warmth and slight pain at the injection site four hours after receiving Daptacel lot number C169AA in the left thigh, (route of administration not reported) on 01-August-2005. The patient received concomitant injections of IPOL lot #X1040-2 in the right arm and MMR lot #0314P in the left arm. (Route of administration not reported for either product). There was clear erythremic lesions on the left leg. Patient did not have vomiting, no nausea and no fever present. At the time of this report the patient had not recovered. Follow-up information received on 14/Oct/2005. There were no diagnostic test or lab work performed. As per the reporter, there is no additional information at this time. Follow-up information received on 31/Oct/2005. As per reporter the reaction involved the injection site of the left thigh when Daptacel was administered. The patient recovered. As per the reporter, there is no additional information at this time.
This case was reported by another health professional via interactive digital media and described the occurrence of Asperger's disorder in a male patient exposed to DTPa (Reduced antigen) (Tdap Vaccine) in utero. The parent received the product for prophylaxis.   On an unknown date, the mother received Tdap Vaccine. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed at an unknown time during the pregnancy. The patient was diagnosed with Asperger's disorder (serious criteria GSK medically significant) and Tourette's syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Asperger's disorder and Tourette's syndrome were unknown.   It was unknown if the reporter considered the Asperger's disorder and Tourette's syndrome to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Twenty-six years before the date of reporting, the patient had a reaction to TDap then diagnosed with Asperger's and Tourette's syndrome (TS). The reporter push vaccines unless high risk patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074518: same reporter Deleted case
(No check-ups since 4 mos of age). Pt seen in office for 15 mo check-up on 5-19-16. Behind on imm. Fever (103 degrees max), vomiting, loose stools began approximately 05-27-16. Rash began approximately 2 days ago. Also dx'd with BOM at 5-31-16 O.V. For above s/s (questionable viral-vs-secondary to MMR given 5/19/16).  TX with AMOXIL 400/5x10 d for BOM.
red-swollen-knot size of quarter (abscess);pt recv med 7MAR97 & lt deltoid abscess cult gram stain 10MAR97;
Patient reports having headache and dizziness. Vitals are taken pulse 65, BP 80/40 at obscuration clear lungs were heard, equal and reactive pupils were observed. She reports having an upset stomach. Observation and monitoring of vitals continues for approximately 45 minutes. Doctor indicates discharging patient.
BAD REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad reaction. This report was non-serious.
Patient presented to clinic as walk in for a COVID-19 vaccine and flu vaccine.  Patient received both vaccines as indicated above.  Patient stood up and proceeded to the door in which she became faint with syncope response.  Evaluated by Dr. with monitoring 30+ minutes following episode. Patient left with family to home.  Patient did later present to hometown ED for evaluation due to concern of concussion from fall.
This spontaneous report as received from a Registered Nurse concerning multiple unspecified patients of unknown age. The nurse reported that on unknown date, multiple unspecified patients were vaccinated with improperly stored ROTATEQ, RECOMBIVAX HB, (1510USA003586), PNEUMOVAX 23, (MARRS# 1510USA010024) or M-M-R II (MARRS# 1510USA010025). No adverse effects were reported. No further information was provided. Additional information has been requested.
Numbness down the left arm after 2nd Covid vaccine. Then after booster, patient developed bilateral numbness of face and still has residual L sided facial numbness and occasional L sided arm numbness.
Describes low-grade fever with malaise which began 3d after vaccine. Eventually evaluated in Urgent Care clinic on 4/3/10...labs drawn but no tx given....f/u on 4/6 with repeat labs and eventually given Cipro 500mg bid x 7d. Seen on 4/12 by PCP for f/u with approx 85% recovery.
5 cm round, red, raised, hard area around injection site that was warm, very painful and lasted 1 week. She ran a low grade fever as well.
31Aug90 pt vax;  01Sep90 devel soreness on both sides in back of neck w/ elevated temp.  05Sep90 devel left wrist pain w/ wrist & hand swelling.  06Sep90 x-rays showed no fractures.  Dx of arthritis was made.  See worm...
pt recv vax;rash & fever 102-104 per mom; 7jul95 to MD;red rash,red ears,red throat & watery eyes;8july throat & blood culture taken;MD thinks allergic rxn to vax;blood culture neg; no fever,but red raised rash cont;
severe pain in lower back lasting 14 days, on 15th day pain was gone  is getting second shot safe with this reaction
Swollen Arm, rash, some swelling next day which increased and peaked on 06/12/07 RX Benadryl
Case was hospitalized and passed away.     **2nd dose of vaccine was 2/5/2021
within a few minutes of being vaccinated, sitting in chair for observation lost consciousness, came around after a few minutes saying he thought he was ok, just felt a little funny. lost consciousness again for a few minutes. called 911 . patients heart rate was eratic so he was transported to the hospital.
Itchy arm; red blotch going to collar bone; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch going to collar bone) and PRURITUS (Itchy arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced RASH MACULAR (red blotch going to collar bone). On an unknown date, the patient experienced PRURITUS (Itchy arm). At the time of the report, RASH MACULAR (red blotch going to collar bone) and PRURITUS (Itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.
I received my first RZV vaccine for Shingles on a Friday...the following Wednesday I suffered a severe outbreak of Shingles all over my abdomen from left to right and on my left buttuck and down my left leg. I was unable to wear much for clothing for six (6!) days!
PATIENT CALLED AND STATED HE HAD SWELLING IN HIS LEFT ARM AND IT WAS HOT TO THE TOUCH. HE ALSO STATED THE SWELLING AND HEAT HAD TRAVELED DOWN HIS ARM AND HE HAD SWELLING UNDER HIS ELBOW. I ADVISED HIM TO TAKE SOME ANTIHISTAMINES OTC SOME ZYRTEC OR BENADRYL. OVERALL HE STATED THE SWELLING WAS GOING DOWN AND IMPROVING. HE STATED THAT HIS BLOOD PRESSURE DROPPED LOW AND HE WOULD'VE SEEKEED MEDICAL CARE IF IT DIDNT COME BACK UP. I CHECKED ON HIM CALLED HIM TWICE AFTER HE REPORTED THIS TO ME. I TOLD HIM TO SEEK MEDICAL CARE IF THE REACTION/SWELLING/HEAT DIDNT SUBSIDE HE WAS ABLE TO MONITOR HIS BLOOD PRESSURE AND EVERTHING HAD IMPROVED AS THE DAY WENT ON. HE WAS NOT UPSET OR SEEKING ANYTHING FROM PHARMACY. I TOLD HIM FROM NOW ON NOT TO GET 2 SHOTS IN THE SAME ARM. PATIENT WAS VERY THANKFUL I CALLED TO CHECK ON HIM.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 month old female patient who received vaccine PENTACEL as two injections. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medication includes FLUZONE QUADRIVALENT, PREVNAR 13, and ROTATEQ Oral vaccine (Lot number, expiry date, dose, route not provided) on an unknown date. On 05-Sep-2018, the patient received 0.5 ml Dtap-IPV, 0.7 ml diluent + Hib dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5409AA and lot C5552AA via intramuscular route in the left thigh. It was an actual medication error due to inappropriate reconstitution technique and wrong injection technique. It was reported that patient was given PENTACEL vaccine as 2 injections. Hib component diluted with sterile water and given separate from DTaP-IPV component. 0.5 ml Dtap-IPV, 0.7 ml diluent + Hib was given 1 inch apart. The patient did not experience any reported symptoms or need for treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender - none.
Later in the evening after receiving her third pneumovax, she developed severe pain, swelling, and warmth at the injection site.  She also developed diffuse arthralgias and fever.  She was initially treated by another physican for possible cellulitis but when I saw her the next day I treated for inflammation and arthralgias with prednisone.
I experienced significant pain with the introduction of the needle into my left shoulder followed by significant pain and pressure with the administration of the injection. On April 2, 2021, I went to OrthoNY Urgent walkin.  examined my left shoulder. Based on his written evaluation it appears that the injection was given to the anterior aspect of the shoulder in the area of the subscapularis as opposed to the deltoid muscle. He also states it may be in the patients best interest to have antibody testing performed. If any continued problems I was recommended to follow up with . I have the physicans written report if needed.
About fifteen minutes after receiving the vaccine participant was having trouble speaking , tongue was swollen, could barely breathe so she took Benadryl that her family doctor prescribe to her symptoms got worse by midnight so she went to the emergency room at hospital.
pt vax w/varicella on 8/4/95 & in 4/98 pt devel ``over 300 varicella-like lesions & low grade fever''