chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 77-year-old female patient who received SHINGRIX (batch number 2J4P2 ?, expiry date 7th March 2021) for prophylaxis. On 4th September 2018, the patient received SHINGRIX. On 6th September 2018, 2 days after receiving SHINGRIX, the patient experienced localized erythema, skin warm and local swelling. On an unknown date, the outcome of the localized erythema, skin warm and local swelling were unchanged. It was unknown if the reporter considered the localized erythema, skin warm and local swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and developed redness, swelling, and warmth 3 to 4 inches below the injection site.
Sore throat; He's still coughing; he has allergies to seasonal allergies; He was sick for at least 5 days; He had flu symptoms after getting the vaccine; This is a spontaneous report from a contactable consumer or other non hcp (parent).   A 23-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. caller called to let you know my sons received first dose and reaction to it. He was sick for at least 5 days. He had flu symptoms after getting the vaccine. fine now. Hes going to get the second one. Hes still coughing. he has allergies to seasonal allergies. Im allergic/have allergies all year round. I already reported this information on my son. His PCP told me to take him to urgent care which I did. The doctor felt it was the side effects from the vaccine. He has Sore throat too but they said that could be a side effect as well. Adverse events Sore throat, coughing, seasonal allergies resulted in emergency room visit. The outcome for the event he was sick for at least 5 days and he had flu symptoms after getting the vaccine was resolved on an unspecified date and for coughing outcome was reported as not resolved and for remaining events outcome was reported as unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT PRESENTED TO THE PHARMACY 10/30/17 AROUND 11 AM COMPLAINING OF LOCAL SITE PAIN SWELLING AND REDNESS AT THE VACCINATION SITE.
A pediatric dose was given to an adult client. The client was informed (called at home) and offered to come back at their convenience for to have the adult dose administered. Then client returned the following week and the adult dose was given.
Patient remained in the pharmacy and was monitored 15 minutes following the administration of the vaccination.  Patient showed no signs or symptoms of an adverse reaction.  Patient contacted the pharmacy approximately 20 hours following administration of the vaccine, and stated she noticed some minor facial swelling on the left side of her face.  Patient began alternating therapies of tylenol and ibuprofen. Patient stated that she felt it may be unrelated to the vaccine.  Patient called back approximately 2 hours later and stated the swelling had ben resolved.  The patient made a follow up call the following day (approximately 44 hours post vaccine administration) and stated she noticed a small facial "droop" near the left side of her mouth.  Patient continued tylenol and ibuprofen therapies.  Patient called back approximately 48 hours post vaccine, and stated that the facial swelling and droop seem to be getting better and mostly resolved.
Face is a little puffy, but it feels itchy all over my face. When trying to sleep last night, a little over 12 hours after the shot I had the chills  and  3 hours later I woke up with a fever of 101.8.  It?s a couple hours later and I still have the fever.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 58.86   Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40, 5 PM: 41  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Varicella lesions covering entire body.  Specifically upper back, arms, and left hand, afebrile- apparently not pruritic.
two days after the shot I developed severe back pain sciatica; my feet developed burning and tingling my back; my feet developed burning and tingling my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (P183645). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), on 13Jan2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Dec2021, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 15Jan2022, outcome "unknown", described as "two days after the shot I developed severe back pain sciatica"; BURNING FEET SYNDROME (non-serious), PARAESTHESIA (non-serious) all with onset 2022, outcome "not recovered" and all described as "my feet developed burning and tingling my back". The events "two days after the shot i developed severe back pain sciatica" and "my feet developed burning and tingling my back" required physician office visit.  Additional information: She had her second Pfizer vaccine on 13Jan2022 she did not have a reaction to the first one that she was aware of in Dec2021 two days after the shot she developed severe back pain sciatica since that time she had seen her primary care a chiropractor orthopedic podiatrist as her feet developed burning and tingling her back was not getting better she felt like no one cares no one was helping her sister had the same reaction to your vaccine she thought this needs to be investigated we need help please.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200554783 same patient , different drug and event
Case number PHEH2016US029276, is a combined initial and follow up spontaneous report received from a consumer on 10 Oct 2016. This report refers to a female patient. Past vaccination history included patient vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date 2 years ago and she experienced soreness at site, then limited movement of the arm which lasted 3 month, then resolved (see case: PHEH2016US026380). Concomitant medications were not reported. She was vaccinated with influenza vaccine (Manufacturer and batch number: not reported) on an unknown date last year. After vaccination, she had swelling and soreness at site which turned to bruising and lasted a few days. It was reported that she received unidentified preservative free influenza vaccine both seasons. The outcome, seriousness and causality of the events were not reported.
Narrative: At 12:21, patient reported a mild headache, She stated she was not sure if she had a headache when she came into clinic. Patient stated that she frequestly gets headaches. Headache sensation on the right side of her head and she said this was typical for her. Patient reported no other s/s. VS were taken again and patient was reassessed at 12:36. She reported no worsening of her headache and no additional signs and syptoms. Patient was release from clinic at that time. 12:21 VS --BP 125/84, HR 79, SaO2 97% 12: 36 VS---BP 113/77, HR 79, SaO2 96%: 04/16/2021 15:00
Received HEPLISAV-B for Second Dose and 3-Dose Hepatitis-B Vaccine for Third Dose; Initial Report Received on 02-Sep-2022  A registered nurse reported that a 23-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a second dose and a 3-dose hepatitis-B vaccine (unspecified) for the third dose.   Medical history and concomitant medications at the time of vaccination were not reported. The patient was allergic to sulfa and azithromycin.  In 1999, the patient received a 3-dose hepatitis-B vaccine (unspecified) for the first dose (Lot #, expiration date, NDC #, route, and injection site unknown).  On 21-Jul-2022, the patient received the second dose with HEPLISAV-B (Lot # 937230, expiration date 25-Sep-2023, NDC # 43528-003-05, route not specified) in the right deltoid. The patient did not report any adverse reactions.  On 20-Aug -2022, 31 days after having been vaccinated with HEPLISAV-B, the patient received an unspecified 3-dose hepatitis-B vaccine (unspecified) for the third dose (details unknown).   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not reported). Subsequently the patient experienced severe vertigo after vaccination. Unspecified medical attention was sought. It was unknown if lab studies performed. The outcome of the patient was not reported. No further information is available.
Information has been received from a physician and a registered nurse concerning a 19 years old female patient who was vaccinated with a complete series of GARDASIL (lot no. 658219/0755U for three doses) first dose given on 12-JUN-2008, second dose on 31-AUG-2008 and third dose on 07-JAN-2009. It was reported by the nurse that in April 2008 the patient had a  PAP smear that was negative. In March 2009 a PAP smear that was positive for atypical squamous changes and Human papilloma virus. No further evaluation has been done for this patient. The nurse considered this patient had not recovered. No further information is available.
Loss of push/pull strength in arm x 3 days.  Weak push/pull x next 2 days.  Painful push/pull x next 3 days.  Continues with slight pain at day 10.  Injection site itself was never tender.  Prodromal s/s x 10 days.
Developed marked erythema, swelling, and tenderness of L outer arm after receiving VARIVAX-got worse until appointment on 2/19/2010. (20 x 21 cm area of redness and induration) Rxd with cold compress and BENADRYL-resolved in 48 hrs.
1) itching reaction to bug bite lead to an itchy rash that traveled intermittently around the body: bite site on back of L leg; back of hands, right arm, back 2a) Primary physician treated with hydroxyzine hcl (itch) tablet and cephalexin (oral antibiotic) with Lotrimine, presumed dx fungus ("ring worm") and staph infection (no testing) 2b) dermatologist considered Lyme Disease, but felt that I had had a chemical exposure to a substance on school bleachers where I had sat close to the ground: treated with antibiotic and topical steroid/fungicide, diagnosed inflammatory response "to something unknown" 3) first blood test ruled out Lyme Disease.
pt recv vax 23MAY96 & 16JUN96 exp papulovesicular rash on face & trunk;no further details were provided;
rash came back but this time it was more of 2 or 3 inch in circle that started to appear outside of the site of the injection; swelling underneath arm; rash (bright red) look alike rash that was size of quarter; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling underneath arm), RASH (rash (bright red) look alike rash that was size of quarter), PRURITUS (Itching) and VACCINATION SITE URTICARIA (rash came back but this time it was more of 2 or 3 inch in circle that started to appear outside of the site of the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concomitant products included LORATADINE for Allergy, FAMOTIDINE, LOSARTAN, MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling underneath arm), RASH (rash (bright red) look alike rash that was size of quarter) and PRURITUS (Itching). On 31-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (rash came back but this time it was more of 2 or 3 inch in circle that started to appear outside of the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL CHILDRENS) for Vaccination site reaction, at a dose of 25 mg; PARACETAMOL (TYLENOL) on 22-Jan-2021 for Vaccination site reaction, at a dose of 500 mg once and LORATADINE (CLARITINE) for Vaccination site reaction, at a dose of 10 mg. On 25-Jan-2021, PERIPHERAL SWELLING (swelling underneath arm), RASH (rash (bright red) look alike rash that was size of quarter) and PRURITUS (Itching) had resolved. At the time of the report, VACCINATION SITE URTICARIA (rash came back but this time it was more of 2 or 3 inch in circle that started to appear outside of the site of the injection) outcome was unknown.        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.
HPV administered on 7-3-07, pt is 32 years of age at time of receiving vaccine
Started with fever. Rash appeared 4 days after, and AOM. Was treated with Zithromax and Atarax. The fever dropped and appeared again 3 days ago. Rash is maculopapular over her face and trunk (urticarial). Intact mucosa. Today treatment with Orapred (oral)
pt to walk-in clinic 5SEP97;related to rt shoulder & arm swollen dark red & painful to move;dx cellulitis rt shoulder & upper arm;T100;placed on ATB;
headache; low grade fever; This case was reported by a nurse via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had headache and low grade fever.  The reporter said that the patient would welcome GlaxoSmithKline to follow up if more information was needed. The reporter did not consent to follow up.
swelling and a lump at the injection site; swelling and a lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (swelling and a lump at the injection site) and VACCINATION SITE SWELLING (swelling and a lump at the injection site) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (swelling and a lump at the injection site) and VACCINATION SITE SWELLING (swelling and a lump at the injection site). At the time of the report, VACCINATION SITE NODULE (swelling and a lump at the injection site) and VACCINATION SITE SWELLING (swelling and a lump at the injection site) had resolved.            Concomitant medications were not provided Treatment information was not provided   This case was linked to MOD-2021-022879, MOD-2021-022868 (Patient Link).   Reporter did not allow further contact
My son came down with COVID from school exposure and I ended up contracting it as well. Tested positive on Jan 19 2022. The Following day I noticed pain and swelling in left calf. Went to emergency room on the 21st to have it checked for a blood clot. An ultrasound showed that it was in fact a blood clot.
dizziness; severe exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (severe exhaustion) and DIZZINESS (dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she previously had Covid-19 and already had antibodies.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (severe exhaustion). On 27-Feb-2021, the patient experienced DIZZINESS (dizziness). On 27-Feb-2021, FATIGUE (severe exhaustion) had resolved. At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Quarter size redness and swelling around injection site. Fever of 101 degrees during the night of 3/09/05.
07/27/2005 Received Menactra, arm became sore.  On 07/29/2005 large erythematous area on left arm.  Glands under left arm swollen.  No fever, no aching, no flu symptoms.  Treated with Benadryl, Tylenol.
Patient unsure if dose was given in deltoid muscle.  Did not see vaccination go in per patient but band-aid was lower than she expected and localized reaction was below deltoid muscle.
acute confusion; hallucinations; Second shot caused severe insomnia on 2nd day to present; dehydration; UTI; rash on left check/neck; This is a spontaneous report from a contactable consumer (patient's parent)   An 18-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 24Mar2021 09:15 (Lot Number: EN6204) as single dose for covid-19 immunisation. First dose (lot number EN6206) was administered on 03Mar2021 10:30 AM (left arm). No other vaccine was received in four weeks.  Medical history included periventricular leukomalacia, cerebral palsy, chronic liver disease. There were no concomitant medications. The patient previously took tylenol and experienced drug hypersensitivity. The patient experienced hallucinations on 30Mar2021, second shot caused severe insomnia on 2nd day to present on 25Mar2021 18:00, acute confusion on 30Mar2021 18:00, dehydration on 25Mar2021 17:00, urinary tract infection on 25Mar2021 17:00, rash on left check/neck on 25Mar2021 17:00. The patient was hospitalized for the events for 11 days to use meds to get her sleep, mind under control, and an antibiotic. Currently still in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Apr2021 and on 04Apr2021. The outcome of the events was not recovered.
PT states that 1 min after receiving the vaccine that she felt very hot from the neck up and left arm became very tingly. RN had PT recline in her car. HR 95. Hot sensation disappeared quickly. Tingling slowly improved. PT felt much better and stated she felt well enough to leave. Left lot at 4:16 pm.
Fever to 102.7, severe body aches & headache, chills, fatigue, nausea & vomitting.
More than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939911 and 056D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose). On 27-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Swollen and very tender lymph nodes on left side of the neck. Still dealing with this adverse event.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: probable anxiety response - patient recovered quickly and did not faint
Patient presented to the ED and was subsequently hospitalized for Closed displaced fracture of condyle of right femur within 6 weeks of receiving covid vaccination.
Injection site pain, swelling, redness, and itching extending the entire upper arm from the elbow up to just below the shoulder lasting for 5 days post injection. Treated with ice packs, Tylenol, ibuprofen and Benadryl.
Received booster 11/17/21.  On 11/20/21 developed numbness of left side of face and was diagnosed with a right middle cerebral artery stroke affecting her parietal lobe.  She was admitted.