chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had received a Pfizer vaccine for my first 3 doses. My second booster (the one being reported) was Moderna. Within an hour of the injection, I started having tingling of my face which expanded to my lips. I also developed watery eyes. I did not have any respiratory problem or swelling of the lips or face.  This persisted for a few hours. In addition, I developed something analogous to dermographism in the front of my tongue where it came into contact with the back of my teeth. This was accompanied by modest swelling of the tongue. I took an antihistamine that evening and everything had returned to normal by the next morning. I did not have recurrence of any of these.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient did not have concurrent conditions, medical history, historical drugs or concomitant therapies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced rash, pain and swelling which went from injection site up to her shoulder. The event were recovered after three days. The causal relationship between the events and PNEUMOVAX 23 was not reported.
This spontaneous case initially received on 26-Aug-2016, was reported by a health professional and concerns a 65-year-old female patient. Administration of company suspect drug(s): The patient received AFLURIA on 26-Aug-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number WT53106. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Aug-2016 during AFLURIA PFS (pre-filled syringe) administration, the vaccine was leaking through the barrel of the plunger and not through the needle (outcome: not reported) and the patient only received some vaccine into the tissue (outcome: not reported, special circumstances: underdose). The RPh (registered pharmacist) believes that when the needle was screwed onto the PFS it was crooked, but he did not inspect it closely and was not sure what the problem was. Additional information received on 02-Sep-2016: PTC number added QA investigation results: The QA investigation for Lot number WT53206 (PRD-18098) was also extended to the sister lot WT53106. Bothe batches WT53206 and sister dispensed batch WT53106 are derived from the same formulated bulk lot (0906USF284). Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT53206 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
Narrative: 71yo female patient with the following problem list. PROBLEM LAST MOD PROVIDER Hypertensive disorder (ICD-10-CM 01/27/2016 I10) Peripheral vascular disease, unspecified (ICD-10-CM I73.9); Peripheral vascular disease Essential (primary) Hypertension 03/27/2018 (ICD-10-CM I10); Benign essential hypertension Chronic obstructive pulmonary disease, 03/14/2017 unspecified (ICD-10-CM J44.9); Chronic obstructive lung disease Other seizures (ICD-10-CM 03/14/2017 G40.89); Seizure Neurotic Depression (ICD-9-CM 300.4); Dysthymia 11/06/2002 Insomnia nec (ICD-9-CM 780.52) Pt received covid vaccines at non facility site on 2/4/21 & 3/4/21. Pt died on 12/31/2021. Not able to assess if covid vaccines were related to pt's death.
Low Temperature Excursion Product Administered; Initial Report Received on 23-Dec-2022  A pharmacist reported that a 55-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 01-Nov-2022, the patient received a dose of HEPLISAV-B (Lot # 937783, expiration date 29-Sep-2023 and NDC # 43528000305) intramuscularly in the left deltoid.   On an unspecified date, the reporter stated that they received information that Heplisav-B Lot #937783 had been involved in a low temperature excursion that went out of range. One of the doses from that lot had been administered to the patient.  The patient reported no additional adverse effects.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
PT FELT A LUMP THE SIZE OF A TENNIS BALL UNDER HER ARMPIT
6 month old female received a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 31-JAN-2023, the patient received Kinrix. On 31-JAN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 month old female received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUL-2023 The reporter was the medical assistant. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal mail. The patient received Kinirix vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration.
Received vaccine at 1000 and broke out in hives on both arms at 1600. Took some Benadryl  with good results.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 as dose 1, single (Lot number: EW0164), in right arm and on 10Nov2021 as dose 2, single (Lot number: FC3183) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (Aug2022) positive, notes: positive at home test for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid from 12Aug2022 to 16Aug2022 for COVID-19. On 22AUG2022, the patient was positive at home test for COVID-19. Been feeling like I have got a cold past 2 day. Headache, stuffy nose, sore throat, cough and chills.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th August 2018, 3 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a shingles rash on the left upper chest. It was a varicella or dermatome type rash. On 20th August 2018 Monday, the patient went to see her physician was a dermatologist and shingles rash was not resolved. The physician stated these types of rashes usually last about 3 weeks.
neck lymph node swelling after the 1st dose; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (neck lymph node swelling after the 1st dose) and PAIN IN EXTREMITY (sore arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (Patient had chickenpox as a child). Previously administered products included for an unreported indication: TUBERCULOSIS VACCINES (Patient received Tb injection as a child.). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LYMPHADENOPATHY (neck lymph node swelling after the 1st dose) and PAIN IN EXTREMITY (sore arm). At the time of the report, LYMPHADENOPATHY (neck lymph node swelling after the 1st dose) had resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    Treatment medication included Ibuprofen. Concomitant medications were not reported.   This case was linked to MOD-2021-071156 (Patient Link).
This is a spontaneous report received from a field representative who was told by the physician that an unspecified male patient who received ZOSTAVAX two years ago now has shingles. It was told to the representative that this patient had herpes at the time of vaccination. No further information was provided. Additional information has been requested.
pt recv vax 9APR96 & 9APR96 pt devel a rash, erythema & itching on lt arm below the elbow;
almost died; developed COVID severely; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (almost died) and COVID-19 (developed COVID severely) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (almost died) (seriousness criterion medically significant) and COVID-19 (developed COVID severely) (seriousness criterion medically significant). At the time of the report, NEAR DEATH EXPERIENCE (almost died) and COVID-19 (developed COVID severely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medical information were reported.  No treatment information was reported.  Company comment: Based on biological implausibility, causal association between the Covid-19 and the administration of mRNA-1273 is assessed as unlikely.  There is not enough information to assess the event of nearly died as the clinical presentation, signs and symptoms of the event was not provided.  I addition, the dates of vaccine administration is lacking.  Additional information has been requested.; Sender's Comments: Based on biological implausibility, causal association between the Covid-19 and the administration of mRNA-1273 is assessed as unlikely.  There is not enough information to assess the event of nearly died as the clinical presentation, signs and symptoms of the event was not provided.  I addition, the dates of vaccine administration is lacking.  Additional information has been requested.
Rt arm area were varicella vaccine given warm and redness noted. 11cm x 7cm no fever seen by physician and antibiotics given
Pt recvd vax & exp arthritis, chronic arthralgia, chronic myalgia & urinary tract infect following vax;
Sore Arm; This is a spontaneous report from a contactable consumer. (patient) A 45-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 19Feb2021 11:15 A.M (Batch/Lot Number: En6200) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has no known allergies. The patient received 1st dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 45-year-old on 29Jan2021 (lot number: En5318) at 11:00 AM for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 19Feb2021 04:00 PM, the patient had a sore arm. No treatment was received for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
On 3/31/2, I received the Pfizer ER8734 Covid 19 Vaccine.  Approximately 1 week later, on 4/7/21, I began feeling severe pain in my right calf, so I scheduled an appt. with my PCP for 4/15/21.  He advised me to ice and rest my leg, but the pain was steadily increasing and began to move into the right foot.  I scheduled a follow up with my PCP, who then referred me to an orthopedist.  During the time I was waiting for the appt. with the Ortho Specialist, the pain increased to the point I was barely able to walk.  Therefore, I returned to my PCP on 5/26/21, at which time he referred me to a HCF.  I met with then on 5/27/21 and they performed a Venous Doppler, which showed good blood flow to the lower calf and foot.  Prior to this vaccine event my health was good. I had no major medical issues and my lab results showed no blood pressure, blood sugar, cholesterol or any other problems. I had never had any cardiac, vascular, or blood clotting issues. I am now receiving care from a neurologist, a neuropsychologistc orthopedist, speech pathologist and a cardiologist. I continue to suffer both mentally and physically every day.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-OCT-2012 13:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Mild headache about 2 hours after shot; increased urination about 2 hours after shot and continuing at least 2 days; soreness; tiredness; groggy
Right upper arm swelled and turned red. Was given on ABD, steroid and pain killer about Fri PM 13/30/07. Seen again by NP - no meds given at that time. Arm by 4-1-07was red and swollen from elbow elbow to shoulder and was resolving.
Received DTaP right arm 6/30/04, arm getting progressively swollen: red, tender to touch. No fever noticed by parents. Marked swelling over right deltoid. Augmentin ES 1 tsp bid x 10 days. Aterox 10/5 3/4 tsp q 6 hours. Return to clinic 7/5/04 recheck.
had surgery on his spine, he has screws and cannot bend; diarrhea; fever; she stated that she fell in bed along with her brother; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Lot number: FL3209) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: CONGENITAL MUSCULOSKELETAL DISORDER OF SPINE (medically significant), outcome "unknown", described as "had surgery on his spine, he has screws and cannot bend"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FALL (non-serious), outcome "unknown", described as "she stated that she fell in bed along with her brother". Therapeutic measures were taken as a result of congenital musculoskeletal disorder of spine. Clinical course: The patient received the same booster dose as was given to reporter, on the same day in the same place, the same injection from the same nurse. Since patient was vaccinated, patient fell in bed. The patient was in bed for 4 days, woke up to go to the bathroom because patient had diarrhea, and had fever. The patient got up and continued to do his daily life, with his back condition, but he was able to get up. The patient had surgery on his spine, he was merged from L1 to sacral S1, S2, S3, S4, he has screws and cannot bend, and does not like to take medicines so the doctor gave him the option to use medical cannabis.
Patient stated that he had been feeling sick but really didn't pay any attention to the symptom. He said he just stated to monitor himself. He was still working around the far but he was experiencing more fatigue. Around 7/23/2021 he did some work but he noticed that his stool was pale and his pee was concentrated. On the following Tuesday he could no longer take the pain He went to the hospital on 7/28/21 he was admitted to the hospital for pancreatic. He ended up getting his gallbladder removed. He had his liver checked. He does not drink or smoke. His liver count was high. Patient was released on August 5th 2021.
Patient received first dose of Pfizer Adult vaccine at 4:00 pm. Patient called pharmacy at 8:58pm to report adverse reaction of paralysis, vomiting and stomachache. Patient was still breathing fine and was advised to go to the ER to seek medical attention to decrease risk of health risk.
Skin rash, rash, erythema multiforme and urticaria pruritus. Loratadine 10 mg AM.
Flu like symptoms. Was exposed to Covid on Tuesday so thought that?s what I had. Got a negative test. Missed work on Thursday and should call out tonight because I?m still sick, but I have to go back to work. Still experiencing bad cough, body aches, sore throat and headache.
Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 UNDERDOSE (Vaccine underdose).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up received: patient age group and narrative updated.
Diarrhea for over 72 hours; Lump near the injection site; Arm pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for over 72 hours), VACCINATION SITE MASS (Lump near the injection site), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Extreme fatigue) in a 27-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 No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and FATIGUE (Extreme fatigue). On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea for over 72 hours) and VACCINATION SITE MASS (Lump near the injection site). On 03-Mar-2021, DIARRHOEA (Diarrhea for over 72 hours) had resolved. At the time of the report, VACCINATION SITE MASS (Lump near the injection site), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received first Moderna vaccine on 2-27-2021. Patient stated she had arm pain, and extreme fatigue. Patient stated that it was odd that she still had lump near the injection site today.Patient stated she had diarrhea for over 72 hours
REDNESS AND SWELLING TO LEFT ARM, SPREADING OVER UPPER ARM AND PAIN SPREADING UP NECK
Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fatigue, soreness in the arm from injection
Mercury poisoning; Lyme Disease; Bitten by a tick; Fertility issue; This serious case was reported by a nurse via call center representative and described the occurrence of mercury poisoning in a adult female patient who received HAV (Havrix) (batch number D94mk) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number Mf9ea) for prophylaxis.   In APR-2019, the patient received Havrix and Boostrix. On an unknown date, an unknown time after receiving Havrix and Boostrix, the patient experienced mercury poisoning (Verbatim: Mercury poisoning) (serious criteria GSK medically significant), lyme disease (Verbatim: Lyme Disease) (serious criteria GSK medically significant), tick bite (Verbatim: Bitten by a tick) and fertility decreased (Verbatim: Fertility issue). The outcome of the mercury poisoning, lyme disease and fertility decreased were unknown and the outcome of the tick bite was not reported.   The reporter considered the mercury poisoning, lyme disease and fertility decreased to be possibly related to Havrix and Boostrix. It was unknown if the reporter considered the tick bite to be related to Havrix and Boostrix.     The company considered the mercury poisoning, lyme disease and fertility decreased to be possibly related to Havrix and Boostrix. It was unknown if the company considered the tick bite to be related to Havrix and Boostrix.   Additional Information: GSK receipt date: 20-MAR-2023 The nurse stated a patient blamed Havrix and Boostrix for giving her mercury poisoning, lyme disease, and causing a fertility issue. The patient was also bitten by a tick after which she contracted Lyme Disease. No further details provided. The consent granted for safety to follow up.  Upon internal review the case was updated on: 20-MAR-2023 Summary of changes: age and age at administration updated.
Pt given PENTACEL RVL on 8/11/11 and on morning of 8/12/11 developed 50 cent size reaction around site.
Extreme burning while solution being injected.  Did not experience this with the first injection.  Extreme headache; inability to move arm; extreme fatigue - slept 30 hours; nausea with any motion; chills.
Patient did not have an adverse event. I accidently gave the booster shoot dose (0.25mls) instead of the 0.5 mls full dose. I discovered the mistake a couple hours after giving the shot. I requested the patient come back and he said no. he also did not come back the next day. The correct dose was submitted that he actually received.
Pt received PREVNAR 13 on 5/16/17 in the left deltoid 5 days later developed redness over the injection site, 7 days since the vaccination the redness spreaded over (L) upper arm, swelling increased, no pain or itching.