chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Nurse Practitioner refers to an unspecified patient of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with CERVARIX followed by a dose of GARDASIL intramuscular injection (strength, dose, frequency, lot number, expiration date and indication were not reported) on another unspecified date. There was no adverse experienced reported. Additional information has been requested.
16 year old presented to clinic with parent for first Covid vaccine, patient was administered Moderna instead of Phizer. Parent was notified and no further adverse signs or symptoms reported by parent.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was reported. treatment Medication was notreported.
devel redness & swelling @ inj site & elbow;dx was cellulitis;tx w/rocephin gm x 2 days & ceftin x 4 days w/complete resolution;
X 1 wk. after H1N1 nasal vaccine, grandmother described raised small bumps all over body, areas without redness or itching. Has not seen his doctor.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX23 and was it possible that this lot of PNEUMOVAX23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
temperature excursion for VARIVAX/administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 07-DEC-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038698, expiration date 01-DEC-2021, 0.5 ml, administered subcutaneously (SQ), 1 dose prophylaxis. The temperature was 32.4 degrees Fahrenheit (F) for 4 hours. There was no previous temperature excursion. Data logger was involved. The outcome was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA010446: US-009507513-2101USA009977: US-009507513-2101USA010358: US-009507513-2101USA010369:
Pt developed rash, beginning circular and then spread down to elbow. "Erythema, warm and raised." Pt treated with prednisone 5 mg 3 x daily for 3 days and then qd x 3 days.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 2 month old male patient. Patient had no history of chickenpox. On 01-OCT-2014, the patient was vaccinated with first dose of ROTATEQ (dose: 2 ml, orally) (lot #J013589, expiration date: 06-JUN-2015) which was incorrectly stored. Concomitant therapies included DTaPHBIP (default manufacturer GlaxoSmithKline reported as "GSK"), HIB (default manufacturer: Sanofi reported as "AVP") and PCV 13 (default manufacturer: Pfizer reported as "PFI"). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested .
1:00 am to 5:00am the night after vaccine in morning. Chills and shivering severely. Body ache. Headache.  No fever. Chills subsided. Mild Headache only symptom for remainder of day.
Case number PHEH2014US025120, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 78-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Second dose not administered and it has been more than 37 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not administered and it has been more than 37 days) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C12A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered and it has been more than 37 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not administered and it has been more than 37 days) 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.   Patient refused to take the second dose 28 days later.  No relevant concomitant medications were reported.  No treatment information was provided.
On 7/21/05 Left deltoid (mid) injection site, 1.5 inch x 1.5 inch area of redness, warmth, non tender area, a local allergic reaction. 7/22/05 1.5cm x 1.5cm area of induration, redness and tenderness.
Patient complained of hives on her right arm and internal bruising that spread on her upper arm where the shot was given.
Post 2nd Pfizer vaccination side effects  FYI, my body temperature averages between 97.1 and 97.5 the year around.  On Wednesday, February 24th at 10:45am  I received my 2nd Pfizer Covid shot with no immediate side effects. Later that night there was some soreness at the injection site.The next day the injection site was tender with skin tight. -------------------------------------------------------  On day 1, February 25th after my 2nd Pfizer Covid-19 vaccination It was a normal day with soreness at the right arm injection site only  On day 2, February 26th, after my 2nd Pfizer Covid-19 vaccination Another normal day with some soreness at the shot site.  On day 3, a
Patient was given vaccine on 9/25/18 and called on 9/27/18 stating after she got the vaccine on 9/25/18 that she felt dizzy and kept passing out and this last 3 hours and didn't seek emergency services.
Itching/burning rash beginning in the night following vaccination. Given hydrocortisone ointment, oral prednisone, oral diphenhydramine- two hours later, significant reduction in symptoms.
Breakthrough case admission after 3 vaccines pfizer 2/26/21 Lot# EN602;  Pfizer 3/17/21 Lot# ER8727;  Pfizer 11/12/21 lot# 30135BA
Patient developed supraclavicular swelling, and tenderness, the day after her second vaccination; she was examined and confirmed to have  Left side lymphadenopathy, supraclavicular.  Sheis now 2 months since 2nd vaccine and has persistent supraclavicular tenderness and lymphadenopathy on the L side., no axillary lymphadenopathy      Upon history, she feels that the 2nd Moderna vaccine was placed unusually high in her deltoid as compared to her first vaccine.   She was not found to have any other additional LAD on exam.
On 17NOV22, patient came to the local Clinic. She was screened by a Nurse at this time the patient did not indicate that she had a history of vaccine reactions. She then proceeded to the vaccine administration area and received a Moderna Bivalent Booster Vaccine, lot # 016H22A, around 10:15.   After receiving the vaccine, she started to feel ill and sat down on the floor. Her husband, then approached the staff and said his wife was not doing well after receiving the vaccine. At this point, staff volunteers and the triaged patient. Vital signs were BP: 150/90, HR: 120, RR: 30, SAT: 99%. She stated that she takes a GI stimulate medication everyday but no other medications. PT stated she was allergic to Sulfa medications. Patient stated that she didn?t feel right, and this had never happened before. She stated, that the last Moderna vaccine she had received had made her arm tingle all the way up to her shoulder.   Local ambulance and HCP were called. Staff volunteers and HCP continued to assess patient until EMS arrived on scene. The EMS arrived on scene and reassessed vitals: BP: 148/94, HR: 86, RR: 22, SAT: 99% and determined patient should be transported by ambulance to another Clinic locally.
Information has been received on 03-DEC-2014 from a registered nurse concerning an approximately 37 year old male patient. On 03-DEC-2014 the patient was vaccinated with expired adult formulation RECOMBIVAX HB (Lot # J00358 expiration date 07-NOV-2014), 1 ml, intramuscular in the left arm. No adverse effects were noted by the patient. The registered nurse reported "potency supported." No further information was provided. Additional information has been requested.
arm blister; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced arm blister after Shingrix vaccine. The reporter wanted to know what caused it. Additional Supportive Information: The follow up would not possible as no contact details were available.
Information has been received from a physician concerning an approximately 1 year old female patient with no past medical history and no allergies who in approximately 2001 was vaccinated with a dose of MMR (lot # not reported). Secondary, concomitant therapy included a dose of varicella virus vaccine live (lot # not reported). Nine days after vaccination the patient developed a febrile seizure, duration unknown. She had no further seizures. No treatment or ongoing medications was required. The patient fully recovered. Unspecified medical attention was sought. Upon internal review, febrile seizure was considered to be an other important medical event (OMIC). Additional information has been requested.
Could not move my arm where I got the shot; This case was reported by a consumer via interactive digital media and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced injected limb mobility decreased. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingles vaccine several years ago, within a few days, the patient could not move my arm where he/she got the shot. The patient could not pick up a gallon of milk. The patient ended up having physical therapy 2 times a week for about 12 weeks, they hooked up electric wires to his/her arm then put a hot blanket on it for 20 minutes at a time. The patient reported that, eventually it got better.
pt recv vax 1SEP95 & 1MAR96 a titer was drawn which showed the pt did not seroconvert;
Pt admitted on 8/17/2021 with hx of Alzheimers dz; He was admitted by police due to being combative and fighting with wife. Kept in the facility x2 days. Son stated all their family had been tested negative; unsure where he was exposed.  Pt was discharged back to home on 08/19/2021.
Paresthesia after rec'd injection then shivering and few minutes, recurred 2d later. Paresthesia of arms and occasionally of legs persists. Headache 8d after vaccine and recurrently day 10. Dx received 3 wks after vaccine rec'd.
No adverse event occurred, reporting vaccine administration error.  Customer was given Booster Shot of Pfizer too early.  Circled 3rd Dose on intake form, but later indicated this was booster they were seeking.  Patient's representative was unaware of 3rd dose/immunocompromised requirements and that there was a difference in timing.    Patient did not meet criteria for 3rd dose, only booster.  Last dose 4-7-21, would be due 6 months after (10/7/21), was administered early on 9/28/21.
Patient presented to the ER and was subsequently admitted for evaluation of stroke like symptoms of left sided weakness and numbness that started the day after her second vaccination with Moderna Covid 19 .  She has associated headache and was admitted to evaluate for possible stroke or other neurologic event.  Her first injection was April 17.
This spontaneous report was received from an office manager refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reaction/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # K011314, expiry date: 14-FEB-2016) (incorrect product storage). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
very tired --sleepy--- had to leave work.  later in evening arm pain-- relief taking tylenol--every 5 hs - 2nd day--- back pain-- under shoulder blades == better 24 hrs later.
Developed right inguinal lymphadenitis starting 10/16/2019, requiring PO antibiotics. Improving, but not presently resolved. This same problem occurred in January 2018 following Influenza vaccine then. Because of the 2018 event, he did not receive Influenza vaccination for the 2018-2019 season.
19 month old was given QUADRACEL with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old male patient who was given Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine (Influenza vaccine) for Prophylactic vaccination.  On 28-Sep-2022, the patient received a Dose 2 of suspect Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) vaccine at dose of 0.5 ml, with standard strength  (lot C5970AA, exp date: 02-Feb-2022) via intramuscular route in the right thigh for immunization at inappropriate age with no adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data was reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
(R) axillarly lymphadenitis, lymphadenopathy and lymphedema.
Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. Information about patient's concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were not provided. The pharmacist mentioned that the patient's son/daughter reported to her that the patient developed Guillain Barre Syndrome on an unspecified date after receiving ZOSTAVAX. The outcome of the event was unknown. The causality was not provided. Upon internal review, Guillain Barre Syndrome was determined to be medically significant. Additional information is not expected since the reporting pharmacist did not want to be contacted.
Upon waking the day after receiving the Spikevax, the patient awoke with intense pain in the upper center of her back and could barely lift her arms. She went to urgent care and was sent to the hospital wher bloodwork was done.  She was treated for pain and told to return on 9/28 for follow- up, possibly more bloodwork.
Tenderness after first two Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness after first two Moderna vaccines) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Over many years). Past adverse reactions to the above products included Vaccination site tenderness with Flu shot. Concurrent medical conditions included Penicillin allergy, Hypertension (Normal readings with medication. Lowered to 150 mg) since 06-Jan-1999, Asthma since 04-Jan-2006 and Sleep apnea (changing from CPAP to oral device) since 03-Jan-2020. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA) from 04-Jan-2006 to an unknown date and MONTELUKAST from 04-Jan-2006 to an unknown date for Asthma, IRBESARTAN from 06-Jan-1999 to an unknown date and HYDROCHLOROTHIAZIDE for Hypertension, COLECALCIFEROL (D3) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness after first two Moderna vaccines). At the time of the report, VACCINATION SITE PAIN (Tenderness after first two Moderna vaccines) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-367382, MOD-2021-385495 (Patient Link).
Friday 19th sore arm and fatigue  Sat the 20th diarrhea, nausea Mon 22 vertigo Tues 23 vertigo and fatigue  Wed  same Thurs 25th vertigo and fever
Two visual hallucinations  ( within a one hour time span)  starting at approximately  4 am on March 4)  each lasting  three or four minutes, followed by  a third hallucination identically to one of the two previous ones, on March 5 at approximately  2 pm.( twenty four hours after 2nd Modera vaccination.) I called for an e visit with my physician and was referred to an on call doctor who questioned  me about the events and   decided that the hallucinations were probably not a a reaction to the vaccination but to report it  as a possible reaction.
Immediately after the vaccine was administered, the patient's arm turned blue and purple. The discoloration spread and did not improve over the following 2 days. A knot formed under the skin where the injection entered the arm. There was also prolonged pain associated with the injection.
Full body hives/rash. Began 8 days after injection, covered 70% of his body in rash that was itchy and painful. When the rash cleared up after 3 days of using benadryl and famotidine, it left scabs and small pimples and peeling skin behind.
Feeling fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (Feeling fatigue). At the time of the report, FATIGUE (Feeling fatigue) outcome was unknown.            No concomitant medications were provided. The patient had no adverse reactions after first and second dose of Moderna Covid-19 vaccine. The patient is immunocompromised and has received 3 full Moderna Covid-19 vaccines. No treatment medications were reported.
Follow-up information received from the physician provided illness at the time of vaccination and even outcome (patient recovered). Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a physician regarding a 9-year-old male patient who developed a cough and fever. The patient received a dose on 15-Dec-2003. Medical History: The patient's concurrent illnesses included pyrexia (fever to 101 deg. F), fatigue and pain (body aches) for 24 hours. Product Details: Indication for Flumist (2003-2004 formula) was immunization. Product was administer on 15-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event details: On 20-Dec-2003, 5 days post-immunization, the patient developed a cough and a fever. On 22-Dec-2003, the patient was seen by the physician; his fever at that time was 102.5 deg F. The patient recovered.
Bilat under arm urticaria states new deodorant made urticaria worse. Tx: BENADRYL 50mg QHS, triamcinalone .1% crm BID Prednisone 20mg x 5d.
Pain at 12 hours Redness,  at 24 hours Redness and induration at 48 hours (peak), 7x7 cm Symptoms resolved in 5 days Temperature went up 1 degree to 99 F
Patient stated that 4 hours after he received the flu vaccine (he received the shot at 3:55pm), he felt nausea and had trouble seeing.  He stated his blood pressure became low and and he was dehydrated. He was taken to the emergency room by his daughter and was released about midnight.  His blood pressure was 70/43 when he first arrived, but was brought up to 111/57 before discharge.  He also stated the emergency room staff let him know that the flu shot causes red blood cells to dilate and significantly lower the blood pressure.
Patient reported extremely sore throat to the point where she can't talk, starting Friday, May 11th.