chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Getting more irritated; Getting itching in the arm; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Getting more irritated) and VACCINATION SITE PRURITUS (Getting itching in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Dust allergy. Concomitant products included LOSARTAN for Hypertension.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced IRRITABILITY (Getting more irritated) and VACCINATION SITE PRURITUS (Getting itching in the arm). The patient was treated with HYDROCORTISONE (CORTIZONE 10) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, IRRITABILITY (Getting more irritated) and VACCINATION SITE PRURITUS (Getting itching in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's medical history includes unable to drink milk (no details provided).
mom states pt appeared limp & cold & clammy;parents were undecided whether or not there was color change noted;lasted 30mins
Vaccine Administration Error:  15 yo male received  incorrect formulation (5 -11 years of age formulation 0.2 ml  (orange cap))  for  second dose of Pfizer-BioNTech COVID-19 vaccine. Patient should have received adult Pfizer dose 0.3ml.  Patient did NOT experience an adverse reaction.
Patient had her first dose of Moderna on 5/26/21.  Per patient, about 8 days later, she developed rash on on her arm and went to see doctor for it.  Prescriber wrote her prescriptions for antibiotics but she doesn't remember what they were.  It was at a clinic.  Symptoms resolved and she has no issues now.  Per patient, prescriber told her to let pharmacy know.  She let us know today 6/23/21 when she came in for her 2nd dose.  Reaction was after her first dose of Moderna.  She went to see doctor on 6/3/21.
20JUN97 mom reported pt had t104 & rash on face 4 days p/vax;fever was controlled w/APAP & only lasted two days;afeb today;advised to see MD for f/u;
I had tingling in my face. Its on and off and has been going on since the day of the vaccine. Its sometimes on the right side of my face then goes away but mostly its on my lips/mouth area. the tingling comes and goes. Its wierd.
PRN symptoms. Tingling, Numbness, small fiber electric shock, weakness, balance in feet.
Syncopal episode; This is a spontaneous report from a Pfizer Sponsored program. A non-contactable male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient had syncopal episode after receiving his shot on an unknown date. The patient was then transported to the emergency department (ED) as 911 was activated. Then, the patient was discharged from the ED with diagnosis of syncope. Outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
3 days following vax pt devel fever 101 ax & was seen by MD 6JUN92; strep cult of throat pos; temp went to 105, no appetite, irritability; ATB given;
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L039141, expiration date 16-AUG-2017, oral (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 46 hours. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
The day after my vaccination booster, I started to fell migraines and my lower armpit area started to hurt.  By Sunday, my armpit area was swollen and had mild pain, and continued migraines. Monday, the symptoms worsened and by today, Tuesday, it is painful where my arm cannot go down and it is still swollen, a little bit more. I do not have a temperature and continue to have on and off headaches.
Initial report received from a consumer who is also the patient on 18 December 2012. A 78-year-old male patient, had received an intramuscular dose of FLUZONE (Lot number, dose in series, side and site of administration were not reported) on 10 October 2012. Patient had environmental allergies and no illness at time of vaccination. Concomitant medications and medical history were not reported. About 2.5 weeks after vaccination, the patient had come down to flu, coughing up mucus and his body produced a tremendous amount of mucus. Patient could not sleep well, the muscle in his shoulder tightened and he could not lift the arm up. It was reported that, the patient was running a temperature and had not measured it. It was reported that patient was improving. Corrective treatment were not reported. No laboratory investigations were done. On an unspecified date, the patient outcome was recovered. Documents held by sender: None. Follow up information received from a healthcare professional on 09 May 2013. This case is linked to case number 2013-06242 for same patient. The FLUZONE lot number was UH719AB and site of administration was deltoid right. The patient had not return to office with complaint of reaction until all problems were resolved. The patient had flu vaccine previously with no report of reaction in 2009, 2010 and "documented in 2006, patient reported that the flu vaccine always made him sick and had not taken one for 10 years".
SInus; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (SInus) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMIN 15 for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (SInus) and HEADACHE (Headache). At the time of the report, SINUSITIS (SInus) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.    This case was linked to MODERNATX, INC.-MOD-2021-078456 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078456:DOSE 2
This non-serious initial spontaneous case, was received on 05-Sep-2017 from pharmacist, concerning a 57-year-old, adult, male patient. The patient's current condition included smoker (since an unspecified date). The patient's concomitant medications included diazepam and methylphenidate. On an unspecified date, it was reported that, FLUCELVAX QIV was stored at 55 F (Fahrenheit) overnight from 9 PM to 10 AM next day (first excursion), which was considered as incorrect product storage. On 05-Sep-2017, the patient was administered with FLUCELVAX QIV (batch number: 195210A, expiry date: Mar-2018, dose, route of administration, anatomical location: not reported). The patient was administered with vaccine which was stored at 55 F, approximately 11 hours, instead of storing at 36-46 F. It was reported that patient did not experience any adverse event following administration of the vaccine. The outcome of the events was not reported. Follow-up received on 01-Nov-2017: It was reported that patient did not experience any adverse event following administration of the vaccine. Narrative amended accordingly.
Information has been received from a nurse practitioner concerning an 18 year old female who was vaccinated with the second dose of GARDASIL intramuscularly 0.5mL in approximately September 2008 ("about 4 months ago").  There is no concomitant medication.  In approximately September 2008 ("within 24 hours of administration), the patient experienced severe headaches and had a large lump at the injection site.  She was found by her mother in bed holding her head, hollering and thrashing.  She was taken to the emergency room and had a scan of her head taken.  The test came back benign.  The headache lasted for about 5 days.  The patient recovered 5 days later after onset.  Additional information has been requested.
Broke out with shingles; Broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had two times in an unmentionable spot). Previously administered products included Valtrex and Ointment.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles and hives. On an unknown date, the outcome of the shingles and hives were unknown.   It was unknown if the reporter considered the shingles and hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had Shingles first time, the patient thought it was insect bites. The second time patient took a picture and sent to the doctor, and patient got ointment and Valtrex. The patient decided to get the Shingles shots, it was a series of two shots. After receiving vaccine, the patient had every stinking side effect listed, the patient experienced broke out in hives and a week later patient had Shingles for third time. The patient would not get the second shot, patient never had an adverse reaction to any vaccine before this caught him off guard. The patient was not telling not get vaccine, patient asked please do research on it first to know the possibilities of reaction and could made informed decision. Additional Supportive Information: Follow-up would not possible as no contact details were available.
noticed an itch on her left outer arm; an itchy welp there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER: UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER: UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 07Apr2022 at 13:45, outcome "unknown", described as "an itchy welp there"; PRURITUS (non-serious) with onset 07Apr2022 at 13:45, outcome "recovering", described as "noticed an itch on her left outer arm".  Additional information: The patient got administered second booster of Pfizer Covid-19 Vaccine which she was administered on 06Apr2022 (reported as last night). Over her lunch hour 07Apr2022 at 13:45 (reported as today), she noticed an itch on her left outer arm and an itchy welp there. It does not itch now like it did at onset time of 13:45.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt with a history of varicella who was exposed to her son after being vaccinated with varicella virus vaccine live developed herpes zoster. The vaccinee did not experience a post vax rash, however the vaccinee's mother began to develop a rash on her buttock six days after exposure. Pt was diagnosed with herpes zoster.
Approximately 5 minutes after HPV, VZV, Hep A administered patient had syncopal episode, fell back, brief loss of consciousness, recovered fully
First injection area became hard (in 24 hrs) then it became red and hot lasted for 10 days. I used cold compress.
Patient called into the clinic 8 days after receiving flu shot stating that she was having soreness in the L deltoid. This nurse informed her to see her PCP for continuing discomfort.
This spontaneous report as received from a nurse refers to a 49 year old female patient. In 2009 the patient was vaccinated with her first dose of PNEUMOVAX 23 (lot#, dose, route not reported). On 29-AUG-2014 the patient was vaccinated with her second dose of PNEUMOVAX 23 (lot # K004281, expiration date 22-MAR-2015, dose 0.5 ml, intramuscular). Concomitant therapies included SYNTHROID, Phentermine, Losartan potassium (manufacturer unknown), Vitamin D (unspecified) (OTC), BENADRYL, Sumatriptan, PROAIR and magnesium (unspecified) (OTC). The nurse reported that the patient reported to her a low grade fever and pain, swelling, warmth and redness from the injection site down to her elbow on an unspecified date in 2014. The nurse reported that the patient called to physician who sent her to an urgent care center. The patient was not admitted to the hospital. The patient was prescribed unspecified steroids and antibiotics which had begun to improve symptoms. Additional information has been requested.
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
rash all over body (2 hours after shot until the following day at evening.) , Rash on area of injection ( still present ), Rash on some areas on back and cheeks, head, and certain arm area still present. Fever from night of shot for almost 36 hours. Body ache from 2 hours after shot until 3 days later.
My left leg feels numb on 4/17/2021 after I got the first does Pfizer vaccine at 4/8/2021 . It's  been going over a week and my left leg still not getting any better.
Initial report received from a health care professional (nurse) on 09 Jun 2010: This patient was vaccinated with MENVEO (batch number: 100001), (dose: unknown) intramuscularly on an unspecified date. The patient was vaccinated with only the diluent component without reconstitution. The patient was re vaccinated with all 4 serogroups. No further information provided at the time of this report.
p/sitting on GM lap fell to floor & appeared to lose consciousness;taken to exam room & lay down on table became alert & responsive accurately to questions;appeared to be unconscious about 1 1/2-2min;no injuries noted;
My injection sit became very red, swollen to size of half- dollar and skin started to weep and was very itchy. I also experienced hoarseness with a slight cough and a raspiness when I spoke. I received this vaccine on 8/2/2012. I experienced these symptoms within 2 hours of injection. As of this date (8/13/12) I still have the swollen area on my arm.
Feeling of warmth all over almost immediately following vaccination then 5 minute generalized tonic seizure 3 hours after administration
Pediatric dose (PEDS) (0.2ml) was drawn up from Adult Pfizer vial. 11 year-old patient received 0.2 ml of the 12+ Pfizer vaccine. The parent was notified on 12/3/21 that child was incorrectly given 0.2ml of adult Pfizer was discovered and told to monitor child for adverse effects. Patient developed 102 degree F. fever overnight. Feels fine on following day except achy.
Diffuse erythema, swelling, warmth on R arm extending from shoulder (deltoid) area to forearm below elbow on both flexor at extensor surfaces-to axilla on flex or aspect forearm. No palpable adenopathy; sweats/chills, resolving.
Patient tolerated injection well.  A Monovalent Pfizer dose was administered instead of a Pfizer BiValent Booster.
This information has been received from a pharmacist, via a company representative concerning several patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. In approximately 2016 (reported as "after receiving PNEUMOVAX injections last year"), the patient were vaccinated with PNEUMOVAX23 1 injection "yearly" (dose, dose number, lot number, expiration date, route of administration and anatomical location were not provided), administered for immunization against Pneumonia. The pharmacist reported that the patients "appeared in the pharmacy this year" with bruising at the injection site; however he did not report the dates that the patients received the vaccine, nor the dates that he observed the injection site bruising on the patients. In addition, the pharmacist did not report the dates that the patients received the vaccine, nor the dates that he observed the injection site bruising on the patients. In addition, the pharmacist did not report if the patients received medical attention or if any of the patients recovered from the adverse effect. No product quality complained was involved. The causal relationship between bruising at the injection site and PNEUMOVAX23 was unknown.   Additional information has been requested.
Moderna COVID-19 EUA  Swelling, pain around injection site, slight nausea
Pt was advised to begin rabies post-exposure treatment following a recent encounter with a bat. Pt presented to Urgent Care to receive day  0 doses of RIG and rabies vaccine. Pt reported she received no RIG instilled into her R hand where she had contact with the bat and received all injections in her left deltoid. Pt states she received both RIG and rabies vaccine in the same anatomical site. Contacted DOH who consulted with CDC. Pt advised to repeat day 0 dose of RIG and rabies vaccine, ensuring vaccine was given IM into the R deltoid and RIG given IM into the left thigh.
I had no symptoms immediately from receiving the vaccine. Monday I had chills, body aches, severe jaw pain, a headache, fever, sore throat, cough, nausea, dizziness, loss of appetite, and extreme exhaustion. I was down for 2 weeks. I was told by my doctor to take OTC Advil, cough medicine, fluids, rest, and stay off work. I'm still tired, but my appetite is starting to come back.
Pain in right deltoid since 08/01/17 after PREVNAR 13 was given, never had redness, swelling or warmth.
Am soreness around injection site; Rash around injection site; Got a dose that was 6 months expired; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received HBV (Engerix B) (expiry date NOV-2022) for prophylaxis.   In APR-2023, the patient received Engerix B. In APR-2023, an unknown time after receiving Engerix B, the patient experienced injection site pain (Verbatim: Am soreness around injection site), injection site rash (Verbatim: Rash around injection site) and expired vaccine used (Verbatim: Got a dose that was 6 months expired). The outcome of the injection site pain, injection site rash and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Engerix B.     It was unknown if the company considered the injection site pain and injection site rash to be related to Engerix B.   Additional Information: GSK Receipt Date: 27-APR-2023 The physician reported that he was notified by staff that a female patient was administered a dose of hepatitis B (physician believes it was Engerix-B) vaccine that was 6 months past expiration. The dose was administered about a week to 10 days ago, and had a November 2022 expiration date. The patient is in her 20s, and reported arm soreness and rash around injection site. The physician did not have any further patient or product information. The reporter consented to follow up. The patient was administered a dose of Engerix-B vaccine that was 6 months past expiration which led to expired vaccine used.
Mom states pt devel mild red rash irregular raised splotches 1/4-1/2 in on buttocks et legs which appear for 20-30 min then go away intermittently for 2-3 days p/vax (the last 2 doses); No MD documentation;
Headache, Chills, Nausea , Fatigue, muscle pain, Pain in injection site. 24 hours SIQ
This case was reported by a physician via call center representative and described the occurrence of pruritus in a 79-year-old male patient who received HAVRIX. Concomitant products included FLUZONE, Aspirin, COQ10, COREG, hydrochlorothiazide and PRALUENT. On 1st September 2017, the patient received HAVRIX. On 1st September 2017, less than a day after receiving HAVRIX, the patient experienced pruritus and contusion. On an unknown date, the outcome of the pruritus and contusion were recovered/resolved. It was unknown if the reporter considered the pruritus and contusion to be related to HAVRIX. Additional details were provided as follows: This case was reported by the physician who himself was the patient. Concomitant medication also included PROTONIX. The patient experienced itching and bruising.
possible rxn to pneumovax;pt recv vax 15DEC & w/in 6 to 8hr devel edema & erythema of the lt shoulder @ site;edema has migrated distally daily & now is localized just distal to elbow;some chills;allerg rxn;
warmth  in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour.  Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes.  I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal.  I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons.   I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart.  I am on day 6 now and I have joint pain and headache.