chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from 68 year old female patient. The patient's medical history included multiple allergies. On 13-JUL-2013 the patient was vaccinated with PNEUMOVAX23 while in-patient and noted severe pain, lump all-over thigh redness on 14-JUL-2013. She stated now she can barely walk and also reported that she would not allow the nurse to administer the vaccine to her arm, so it was administered in her upper thigh. She was notified her primary physician wads not concerned and may not notified the physician. The patient did not seed medical attention. No treatment was given.The outcome of the events was unknown. The relatedness of the events with PNEUMOVAX23 was unknown. Consumer did not want follow up. Additional information is not expected.
Fever; Felt tired; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were unknown.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the OBGYN on staff reported a fever of 101.6F and that they felt tired the day after receiving the 2nd dose of Shingrix. The reporter consented to follow up.  The nurse did not have any specific data to report.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 08-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
seeing fluid under her skin and having a "black and blue" where the injection was given; was concerned about the soreness to her arm; seeing fluid under her skin and having a "black and blue" where the injection was given; when she received the injection she is convinced that it was given subcutaneously versus in the muscle; This is a spontaneous report from a contactable other hcp (patient) via Pfizer sponsored program. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en6205) via subcutaneous on 20Mar2020 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a registered nurse and stated that she received her first vaccine dose on 20Mar2021 at clinic but when she received the injection, she was convinced that it was given subcutaneously versus in the muscle. She reported that afterwards she remembers seeing fluid under her skin and having "black and blue" where the injection was given. She had gone to see her HCP because afterwards she was concerned about the soreness to her arm along with the fact that she didn't think she got the injection performed appropriately. She received her second injection on 10Apr2021 in muscle (Lot: er8727) and it went fine but was worried as she was not fully protected and was wondering if she should do a booster. She asked what to be done about an invalid dose and also asked about the studies being done on the efficacy after receiving 1 dose and what type of tests regarding antibodies for the covid vaccine are recommended to check for immunity. She asked If there was any plan to train people further or better qualifying people on giving an IM injection. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a 4 weeks old female patient with none allergies and none illness at time of vaccination. The patient was vaccinated with dose 1 RECOMBIVAX HB (lot# reported as 0384AE in validation process) (dose and route not reported) in the left leg on 01-OCT-2012 at 11:30 AM. No other co-suspects were reported. No concomitant medications were reported. On 02-OCT-2012 the patient experienced fever 101.6, lethargic 24 hours and was diagnosed with viral meningitis. The patient was hospitalized during 3 days. No treatment information was reported. On an unknown date complete blood count (CBC) and spinal fluid analysis were done (data not showed). On 05-OCT-2012 the patient recovered. The relatedness for diagnosed viral meningitis was not reported for RECOMBIVAX HB by reporting physician. Additional information has been requested.
fully vaccinated, gets shingles/ suspected vaccination failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included mycophenolic acid (Cellcept).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient got fully vaccinated with Shingrix 2 years ago and still got shingles. The patient had been taking Cellcept for 12 years and was also taking Valtrex. Whenever the patient stopped taking Valtrex she got shingles. The health care professional would like to know if the patient needed to get revaccinated with Shingrix. No further details were provided at the time of the call. The patient was vaccinated at a different facility, so health care professional did not have any vaccine  information. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting. The reporter did not consent to follow up.
Information has been received from a registered nurse concerning a 24 year old female patient with no  pre-existing allergies, birth defects, medical conditions and no illness at the time of vaccination who on 19-NOV-2009 at 15:45 pm was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot#663558/0819Y). On 19-NOV-2009 at 15:45 pm the patient experienced injection caused stinging sensation down arm. Since injection patient had pain, followed by numbness, when she lifted arm up high. The patient had sought medical attention by doctor visit. The doctor of medicine referred patient to physical therapy on 01-DEC-2009. At the time of report the patient's status was not recovered. Additional information has been requested.
12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tenderness in injection site. No adverse effects until 2 pm (dizziness, headache, fatigue, nausea, chills).  Got home by 5pm. Worsened symptoms. Temperature hit 40C. Myalgias and joint pain started. Took Tylenol 1gm. Recurrent fever and chills.   Symptoms did not get better. 12/30/20 started having pressure and stabbing chest pain. Went to ED for dehydration and nausea. Negative chest xray and troponin. COVID PCR also negative.  As of 1/4/2021, writer is still experiencing same symptoms to a lesser extent.
sore left injection site arm; some swelling in the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm) outcome was unknown.        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 concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-323677 (Patient Link).
Pt says he is continuing to have muscle pain/stiffness in left arm as of 12/13/17.
No adverse effects reported; The patient received a dose of VAIVAX which expired on 08/09/2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 12-AUG-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # N021581 and expiration date 09-AUG-2019 (dose, frequency and route were not provided) for prophylaxis (expired product administered). No adverse effects reported.
17 years of age patient given the Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient given the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient given the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient given the Moderna vaccine) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Skin rash (blotchy red on thighs and torso); Swelling of hands, feet and knees; Swelling of hands, feet and knees; Mild generalized pruritis; Sensation of facial "tightness; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees), JOINT SWELLING (Swelling of hands, feet and knees), PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Spinal surgery for Kyphosis a number of years ago) since an unknown date.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees), JOINT SWELLING (Swelling of hands, feet and knees), PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees) and JOINT SWELLING (Swelling of hands, feet and knees) was resolving and PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness) had not resolved.            No concomitant medication was provided.  The patient  was seen at a urgent care center on two occasions last week and was administered some kind of steroid injection on 29 Sep 2021 with mild improvement in his sympotms. Further evaluation(lab tests) were pending.
Breakthrough case admission after 4 vaccines moderna 2/28/21 Lot# 025A21A;  Moderna 3/24/21 Lot# 001B21A;  Moderna 11/4/21 Lot# 939906;  Moderna 5/5/22 Lot# 004M21A
1/30/04 approximately 4 am stated fever 102 degrees, complained of aching of entire body, no nausea no vomiting, headache. Approximately noon fever broke body still aching, unable to work for three days. 2/2/04 sickness resolved.
3-30-2021 received Phizer vaccine 4-1-2021  Sore gland under right jaw {pain negligible .} 4-3-2021  1" knot in gland in groin right side {sore to touch and when sitting} 4-8-2021  Elbows , Wrists and bones of arms sore-  Back of knees sore especially to touch, calves tight but not like muscle cramps, more like cement hard to the touch- tibias sore like badly bruised- ankles sore and tops of feet especially where ligaments in foot radiate to the toes very sore lege and feet hurt to stand or walk - legs and feet didn't hurt except to touch when elevated. 4-11-2021  legs and arms the same plus neck sore on both sides in back of ears and radiating down to shoulders. 4-12-2021 /visited MD. she perscribed Voltarin cream and melatonin Voltarin cr. didn't  help. I used organic Cannibis cream and that helped a bit with the pain. 4-16-2021 left ankle and foot extremely swollen - walking a lot more stiff.  4-17-2021 my cardiologist called - left message to stop the statin 4-23-2021 Left foot and ankle down to normal top of L. foot a bit puffy
Headache; Fatigue; This is a spontaneous report from a contactable physician (patient-pending clarification). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache and fatigue on 19Dec2020. The outcome of events was unknown.   Information on the lot/batch number has been requested.
"Moderna COVID-19 vaccine" Patient received 0.5ml instead 0.25ml COVID booster vaccine.
extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 24-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 FATIGUE (extreme fatigue). At the time of the report, FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Patient reports that 1-2 hours after the vaccination, he experienced a metallic taste in his mouth. This disappeared 2-3 hours after onset.
Varivax vaccine 4/14/08 L lat thigh and Hep A vaccine 4/18/08 L lat thigh.  By 4/25/08 had 20 mm area of erythema and 5 mm induration as well as 10 mm L inguinal node which seemed tender.  By 4/28 palpable granular-like firmness persists - no erythema or tenderness.  Never any systemic sx.
Fever, chills ~24 hours duration Headache ~6 hours duration (starting after fever/chills).  Ameliorated with ibuprofen
Erythematous rash at injection site as well as development of erythematous macular rash on abdomen, chest, arm of injection; flush cheeks; tachycardia.
mild runny nose; This is a spontaneous report from a contactable consumer (Patient).  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization.  Medical history included hypertension (HTN), diabetes and pacemaker.  The patient's concomitant medications were not reported. On 10Jan2021, after the use of the vaccine, the patient experienced mild runny nose (non-serious) with outcome of unknown.  Information on the Batch/Lot number has been requested.
Left bicep area red, hot, painful, itch. Tx: Warm Compress.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Chills, badly aches and fatigue  from 3:30 am for about 24 hour.
6 1/2 month developed ileocecal and ileocolic intussusception with resection of necrotic bowel. 12/3/2009 MR and DC summary for 11/10-11/15/2009. Dx Intussusception  Patient presents with projectile vomiting, unable to tolerate anything po, lethargic. Had a laparotomy with reduction and resection of intussusception.
Td given to left deltoid-reaction <240 includes swelling to site, red, warm, hives to deltoid muscle.  Patient treated at home with cool compress over the counter ibuprofin.  (-) effects noted.  Also, Td given prior to 2nd dose on 05/24/2002, but chart not chartable to verify.
Severe pain at injection site. Fever to 100.8, averaging 99.6 over one day - starting on second day after injection. Fatigue.
Very sore arm; redness; headache; unable to sleep that evening; three days later symptoms still present, including red band around arm at injection site.
Rash, red blotches all over back, abdomen, buttux,  chest and neck that itch. Started Friday 2/5 evening worsened Saturday 2/6 and has decreased but still showing symptoms through Monday 2/8.
she had soreness in her arm; Strong shaking for probably like 30 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200035131 (Pfizer).  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: 33025BD) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Strong shaking for probably like 30 minutes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had soreness in her arm". Therapeutic measures were not taken as a result of tremor.  Additional information: Patient had no other products, had no patient history and had no investigation assessment, consumer stated, she was calling because she received the first dose of the Pfizer vaccine yesterday and last night, she started having just like some really strong, like shaking, it wasn't chills but it was like really strong shaking for probably like 30 minutes. Had been seeing before, side effect to that something serious enough she should not get the next one, had no treatment. Had no prior vaccination (within 4 weeks), she reported feeling fine at first, then about 12 hours later, her body started shaking, and she couldn't stop. It lasted for about 30 minutes. When asked if it was similar to chills, she stated that she would compare it to something similar she experienced after giving birth. She also stated she had soreness in her arm. Also informed about timing as Monday to Friday, 08:00 to 21:00, est.  No follow-up attempts are possible. No further information is expected.
The infant inadvertently received an injection of Tetramune from a lot that had expired. The report was received 8 days post vax and no adverse experience had occurred at that time. Additional information received on 1/30/01 from the physician indicated that the infant developed a "slight" fever and "slight" redness at the injection site. She recovered after a "few" days.
This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blister and pain. On an unknown date, the outcome of the blister was unknown and the outcome of the pain was recovering/resolving. It was unknown if the reporter considered the blister and pain to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter said odd this popped up everything but all the blisters so blessed the patient had the shot or could had been worse. The patient do still had pain but was getting better. The patient said get your shingles shot if you had not. The patient would be getting a booster. Note: as shingles vaccine did not require booster,so here booster indicate to 2nd dose. No contact details were reported.
Severe local reaction including redness, swelling, heat, tenderness from elbow to shoulder and developed fluid filled pustule about 1
Mother called on 6/29/04. State pt had a red, swollen warm to touch left arm. Mother states gave Tylenol and applied cool cloth to arm. Pt also was in swimming pool several hours on 6/29/04 after. Coolness to arm 6/30 pt went to Clinic received prescription for Cefzil and to use Ibuprofen. Told by Clinic: allergic reaction to vaccine.