chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at the injection site; redness; hot to touch; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (rash at injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 50 milligram and METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) (intramuscular) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (rash at injection site) outcome was unknown. Not Provided          Treatment medication also included tagament
localized red rash w/induration & c/o burning 5min p/vax;area iced, pt seen by ARNP & given & claritin PO observed in office for 30min & sent home w/instructions to call if inc problems;
After supper on 10/26/15 I noticed my arm was sore and hurt when I moved it. This pain and restricted movement has not changed since then. I have seen doctors and done their exercises. I received a cortisone injection in Jan 2016.
Dose administered at ~31 hours post vial puncture and at room temp; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered at ~31 hours post vial puncture and at room temp) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered at ~31 hours post vial puncture and at room temp). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered at ~31 hours post vial puncture and at room temp) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter  No treatment medication were provided by reporter; Sender's Comments: This report refers to a case of medication error, administration of expired Covid 19/mRNA vaccine with lot number/batch number 006D21A with no known adverse event associated reported.
The patient had syncopal episode after first dose; The patient had syncopal episode after other dose of vaccine; This spontaneous report was received from an office manager via company representative and refers to a 14 year old female patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.  On unknow date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for routine immunization. After vaccination the patient had syncopal episode (syncope).  On 04-AUG-2020, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for routine immunization.  On the same date after vaccination, the patient had syncopal episode (syncope) again.  The outcome of the events and the relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were unknown.   Upon internal review, syncope was determined to be medically significant.
Bell's Palsy (left side) , began 9/11/23, client went to ER that day had blood work and CT scan.  States that he had a lot of soreness in his knees and elbows that started in the week after receiving vaccine on 8/14/23.  States that he had some soreness in the joints after previous dose of vaccine, but it was mild and resolved.  Reports no local vaccine reaction or signs of allergic reaction to vaccines received.
pt mom noticed swollen eyelids & hives on p/vax;pt taken to ER & given DPH by  mouth;
Complaint of cough, elevated temperature, runny nose/congestion, loss of taste/smell, myalgia and malaise
COVID-19; COVID-19; hidradenitis Suppurativa breakout; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4281671-00 (RA).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single and intramuscular, administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1 , single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; HIDRADENITIS (non-serious), outcome "unknown", described as "hidradenitis Suppurativa breakout". The action taken for adalimumab was unknown. Clinical information: No known allergies.  The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.
booster; booster messed up system; terrible red rash, kind of hot & a little painful; terrible red rash, kind of hot & a little painful; terrible red rash, kind of hot & a little painful; covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization, reaction(s): "No reaction"; Bnt162b2 (dose 2), for COVID-19 immunization, reaction(s): "No reaction". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "booster messed up system"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious), RASH (non-serious), outcome "unknown" and all described as "terrible red rash, kind of hot & a little painful"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "covid arm". It was unknown if therapeutic measures were taken as a result of immune system disorder, rash erythematous, feeling hot, rash, limb discomfort.  Additional information: patient reported that booster messed up her system; covid arm; terrible red rash, kind of hot & a little painful; showed up 5 days after getting the booster. No reaction to either first or second dose at all.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt vaccinated. On 3/12 exposed . Symptoms of cough, loss of taste/smell, HA, runny nose. Tested + for  and inconclusive for quest.
pt devel urticaria following the 1st dose of Hep B vax; pt was treated w/DPH; No further details were provided;
My upper arm got red, hot, kind of hard and very itchy about 6 days after I got the shot.  My arm had hurt before that, but that?s what happens when I get a flu shot, so I didn?t think twice about it.  But this itching is bad!!!  It?s 6 days after the onset of the redness and itching and it?s not worse, but it?s not better either!!!  I took Benadryl for two nights to help me sleep, but it doesn?t seem to have helped.
Chills, ache all over, headache, fatigue, injection site red n painful.
Aches and chills night after vaccine administered. Rash and hives 2 days after rash administered.
sore at site of injection with circle of red skin about 4 inches in diameter  fading slightly by 3rd day (today) area is hard and skin sensitive to touch  No other symptoms
After 2+ days of pain, soreness, swelling at injection site this abated. Today, 4 days after dose I have cold-like symptoms ... runny nose, watery eyes and slight sore throat. Been outside twice and maintain social distancing, wear mask.
Pt recvd vax & approx 1 month p/vax exp arthralgias from 15FEB93 to 23FEB93; also exp a non-itching, pink, flat rash on wrist, forearm, knees & ankles;
sleepy; soreness around the arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 77-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER6955, Expiration Date- Jun2021) via an unspecified route of administration in left arm on 05Apr2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in left arm on 03May2021 as dose 2, single (at the age of 76-years-old) for COVID-19 immunization. Patient medical history included ongoing seasonal allergies, never had an actual diagnosis. He thought there was something wrong with his lungs and said that he was wheezing and the doctor prescribed him something that he did not want to take. Picked up leaves and his throat constricted on him and he said that he diagnosed himself. The concomitant medications were not reported. On an unspecified date in 2021, patient stated he has had both doses of the Pfizer COVID-19 vaccine and reported that the vaccine made him sleepy. He stated he would sleep for 3 to 4 hours after the vaccine. He reported soreness around the arm. He stated he felt great after the nap. He stated he took the Pfizer covid 19 vaccine and feels more at ease now. He stated that his eyes were bad prior to the vaccine and it had no effect on his eyes. He does not like taking medication, but every once in a while would take Benadryl for his allergies. It might have been that he just laid down after the vaccine. He said that he is a old man and can sleep all of the time. The outcome of the events was unknown.   Follow up are attempts needed. Further information is expected.
12NOV93 pt recvd vax & 13NOV93 awoke 6AM w/h/a, not feeling well on Sunday t101 & devel a red raised whelp below the inject site;-painful;
Patient presented with c/o of chest pain which started on 24 December 2006. The symptoms of pleuritic and positional chest pain continued and on 31December2006 was admitted for observations.  He was evaluated by a cardiologist and was diagnosed with pericarditits related to Smallpox vaccine.  He was discharged on 1Jan2007 with a follow-up on 5January2007. 02/13/07-records received and reviewed for DOS 01/18/07 DC: Pericarditis.
Received anthrax and approximately 24 hours later noticed swelling of right upper extremity.  This progressed over next 24 hours. No accompanying symptoms such as fever, chills, N/V/D, etc.  Denies history of trauma or insect bite.  No history of similar sx in past.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to Crosslinked cases-MOD21-110132,MOD21-110133,MOD21-110134,MOD21-110135,MOD21-110137,MOD21-110141 (Patient Link).
I had shingles vaccine and had shingles 4 years later/Suspected vaccination failure; I had shingles vaccine and had shingles 4 years later; Pain is horrific and hasn't gone away; Not comfortable with shingle vaccines right now; The sight of vaccine was red,covered ,under my upper arm; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site erythema, pain and discomfort. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injection site erythema was recovered/resolved and the outcome of the pain and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site erythema, pain and discomfort to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and 4 years later had shingles. The patient stated the pain was horrific and had not gone away and was been told it might never go away. The patient stated he/she know vaccines were not 100 percent protective and the shingles he/she had, might had been worse had he/she not had the vaccine and also mentioned that he/she had a reaction to last one where the sight of vaccine was red covered, under his/her upper arm for 3 months. The patient stated he/she could not get any other shots, i.e., allergy shots and was not comfortable with shingle vaccines at the time of reporting and the COVID 19 vaccine was important at the time of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Difficulty in the abdominal; She did not sleep properly; Really bad dark circles under eyes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Difficulty in the abdominal), POOR QUALITY SLEEP (She did not sleep properly), DARK CIRCLES UNDER EYES (Really bad dark circles under eyes) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Difficulty in the abdominal), POOR QUALITY SLEEP (She did not sleep properly), DARK CIRCLES UNDER EYES (Really bad dark circles under eyes) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (Difficulty in the abdominal), POOR QUALITY SLEEP (She did not sleep properly) and HEADACHE (Headache) had resolved and DARK CIRCLES UNDER EYES (Really bad dark circles under eyes) outcome was unknown.            No concomitant medications reported.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-062235 (Patient Link).
Fever 102 degrees,  muscle pains, joint pains, dizziness, chills
Employee developed COVID-19 positive result on 3/9/21. S/sx began on 3/11/21
Left hand, specifically thumb, has numbness and tingling; Left hand, specifically thumb, has numbness and tingling; Unable to perform daily activities with this hand after vaccination.; muscle weakness in right thigh.; This is a spontaneous report from a contactable Other HCP (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in right arm on 06Feb2021 07:45 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included isotretinoin (ACCUTANE). The patient previously received first dose of BNT162B2 on unknown date 11:15 on right arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. On 06Feb2021 14:00, the patient had Left hand, specifically thumb, has numbness and tingling. Unable to perform daily activities with this hand after vaccination. Also muscle weakness in right thigh. It was unknown if treatment was received for the events. The events resulted in Disability or permanent damage. The outcome of all events was not resolved.  Information about lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to reported events cannot be fully excluded based on the temporal relationship and lack of alternate explanation at this time. Case will be  reassessed if additional information is received 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
Information has been received from a registered pharmacist concerning a male patient who on 25-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) at another pharmacy. The pharmacist reported that in the morning of 26-FEB-2009, 27-FEB-2009 and 28-FEB-2009, the patient fell upon arising. The patient did not sustain injury. The patient sought medical attention by calling the pharmacist. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to two unspecified patients of unknown age. On 19-JUN-2014, the patients were vaccinate with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
racing heart was less; shortness of breath; itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm; itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm; lymphedema; lymph node pain that was into the breast; tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07May2021 15:00 (Lot number: EW0167) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dry eye" (unspecified if ongoing); "GERD", start date: 18Sep2018 (ongoing), notes: Patient's Medical History: , Illness/AE: Gerd , Onset Date: 18Sep2018, Stop Date: Ongoing; "Lyme", start date: 18Sep2018, stop date: 18Oct2018, notes: Patient's Medical History: , Illness/AE: Lyme, Onset Date: 18Sep2018, Stop Date: 18Oct2018. Concomitant medication(s) included: B COMPLEX (B50); FISH OIL taken for dry eye; GATORADE ENERGY DRINK; LUMIGAN; VIT D3. Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0150 , Administered in left upper deltoid, rapid heart beat), administration date: 04Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "rapid heart beat", "tachycardia", "shortness of breath". The following information was reported: DYSPNOEA (non-serious) with onset 07May2021, outcome "recovering", described as "shortness of breath"; TACHYCARDIA (non-serious) with onset 2021, outcome "recovering", described as "tachycardia"; PALPITATIONS (non-serious) with onset 07May2021, outcome "unknown", described as "racing heart was less"; ERYTHEMA (non-serious) with onset May2021, outcome "unknown", PRURITUS (non-serious) with onset May2021, outcome "not recovered" and all described as "itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm"; LYMPHOEDEMA (non-serious) with onset May2021, outcome "unknown", described as "lymphedema"; LYMPH NODE PAIN (non-serious) with onset May2021, outcome "recovered" (2021), described as "lymph node pain that was into the breast". The events "shortness of breath" and "tachycardia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.  Additional Information: Patient got Flu shot on Oct2021  Follow-up attempts are completed. No further information is expected.
got her first dose on 11Feb2021 and Tested positive; got her first dose on 11Feb2021 and Tested positive; Influenza Type A; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization and Tested positive but wants to know if she can still continue to get her second dose as per schedule on 04Mar2021. As she was diagnosed with Influenza She wants to know if she can go through and continue the 2nd appointment. Upon follow up on 26Feb2021 said as patient received COVID-19 Vaccine on 02Feb2021. The patient medical history and concomitant medications were not reported. The patient experienced got her first dose on 11feb2021 and tested positive (drug ineffective and sars-cov-2 test positive) and influenza type a on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on an unknown date. The outcome of the event was unknown.  Follow-up (05Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation date of 1st dose of vaccine (02Feb2021) which was previously reported as 11Feb2021 and confirmed that the 1st dose of her vaccine was on 11Feb2021.  Information on the lot/ batch number has been requested.