chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site pain, injection site erythema and injection site rash. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site pain, injection site erythema and injection site rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site pain, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient experienced red, swollen, sore, itchy rash at the site of injection the next day after receiving the SHINGRIX vaccination on right deltoid. At some unknown time, the redness started to track down her arm but still above the right elbow. She was prescribed an antibiotic and the tracking resolved. At the time of reporting, there was a residual pink rash at the injection site. Reporter's call was transferred to medical information.
Left-eye burning and had blotches under my eye. Went to sleep and after an hour whole face was swollen and had pain all over my body and had swelling of hands & feet, prescribed steroids and BENADRYL.
18 hours after Moderna shot 2 my eyes swelled up and became itchy and red. My eyes are sill inflamed as of now 3/06/2021. Also I have been running a low grade fever, and have headaches. These symptoms are managed with Tylenol.
Redness and soreness at site of injection. A lump formed and has not subsided since innoculation approximately 1 1/2 years ago.
Had shingles vaccine shot at noon on Friday. Sunday evening noticed lots of red blotches on upper torso on left side,under arm, on breast and on front of both thighs, with a few red spots spread a little on the right shoulder and legs. Monday morning around 9:00 AM, left side of face and cheek was swollen and the red blotches were not raised welts. By 10:00 AM, upper lip was beginning to swell and by 11:00 was completely swollen over the lower lip. I had no problem with my throat or breathing. Went to an emergency clinic nearby to see the on-call doctor and he gave me a claritan pill and a prescription for a steroid, Prednisone. I took the first steroid pill at 1:00 PM and by evening the swelling was starting to go down.  Tuesday morning the swelling was almost completely gone and the red welts were pretty much gone. I took the second steroid pill and by afternoon I was pretty well cleared up. The doctor called the State Epidemiologist and felt that the reaction appeared to be a result of the shingles vaccine I had gotten Since I had had no change in my regular medications that I take for the last five years. He was just surprised that the reaction did not occur closer to the time I had the shot.
Patient tolerated vaccine just fine at first but then proceeded to say he felt light headed. I raised the back of the bed up to a slight incline and raised his feet. Patient stated he was getting hot and more light headed to the point where he thought he was going to pass out. I did not leave his side, preparing myself for him to pass out. A couple seconds later he started to have seizure like activity, body completely shaking, eyes in the back of his head and spit coming out of his mouth. He started to slide down the bed. I was in there by myself so I yelled for help but the door was shut and I was unsure if anyone heard me so I kicked the door handle with my foot to open the door and yelled again. I was just getting ready to ease him to the floor because I could no longer hold him myself and staff came in and helped me. As she was running in, he stopped the seizure like activity and also stopped breathing for a couple seconds and then suddenly gasped for air. He finally started to open his eyes but then became very disoriented and started sweating profusely. Staff stayed by his side and I ran to grab his mother who was sitting in the car and I told Staff to find Dr. Dr. came in, we did a set of vitals 99/59 bp first time with heart rate of 51 and 111/60 second time with heart rate of 63. Also checked his glucose which was at 87 after giving him juice and water. Dr. stated he probably became very hypoglycemic which would explain the seizure like activity due to lack of oxygen to his brain. He felt much better after drinking some water and juice. Dr. let him leave after watching him for about 15-20 minutes.
This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included Crohn's disease from an unknown date and reported that patient has been in remission. The patient's concomitant medications were not reported. On an unspecified date, the patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and his C reactive protein was elevated. The outcome of the event was unknown. The following information on the batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6207), in right arm and on 02Apr2021 as dose 2, single (Lot number: ER8734) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: known allergies: Amoxicillin erythromycin; Erythromycin, reaction(s): "Allergy", notes: known allergies: Amoxicillin erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received paxlovid as COVID 19 Treatment.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, vaccination failure and the administration of the vaccine cannot be excluded.
Dizzy/slightly dizzy; Sweating; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/slightly dizzy), HYPERHIDROSIS (Sweating) and PYREXIA (Feverish) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy/slightly dizzy), HYPERHIDROSIS (Sweating) and PYREXIA (Feverish). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy/slightly dizzy), HYPERHIDROSIS (Sweating) and PYREXIA (Feverish) outcome was unknown.            Concomitant product use was not provided by the reporter.
09/28/2021 COVID test was positive;only symptom was mild cough.  Narrative:
Tongue "feels thick", tight red swollen (L) arm, Diffuse macular rash of the trunk and extremities with some tenderness over the Left upper arm. -Denies chest pain, SOB, diaphoresis, nausea/vomiting & palpitations, fever, chills
No adverse event; Patient received Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049G264, 066H264, 006M20A and 064A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to MOD-2023-712185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Non-significant follow up received.
On 06/03/2005 patient developed red, flat rash all over her back, down sides of armpits up into neck.  Patient acted fine.  No fever.  Symptoms were gone on 06/04/2005.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 12-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 12-Apr-2022 but it had got expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 12-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reporter. Pharmacist called to verify an expiration date for lot number 026L21B. The pharmacist mentioned that they thought the vaccine was expired in Jun-2022. However the vaccine expired on 01-Apr-2022. Caller stated that 155 patients were vaccinated with expired doses from  02-Apr-2022 to 19-Apr-2022. The date in which the vial was initially stored in refrigerator was 04-Apr-2022. The vial did not undergo any temperature excursions. No treatment medications were reporter.
One of three healthy, young, adult pt who developed vasobagal syncopal episode within 5 minutes of immunization.  Recovered uneventfully.
WHEN PT CAME IN TO GET 2ND SHOT, PT TOLD ME 2 WEEKS AFTER GETTING HER FIRST DOSE  IN THE SERIES, SHE BROKE OUT WITH SHINGLES ON HER LEFT SIDE.  SHE HAD HORRIBLE PAIN AND RASH AND WENT TO THE ER TO GET TREATMENT.  SHE WAS TREATED WITH ANTIVIRALS.
I was feeling really body aches my arm aches for  a few hours and just tired and sleepy.
1) Left arm is swollen and very sore 2) Left underarm now has a lump/ pain at the left breast 3) By 8pm, had a bad headache 4) By the following morning, had fever (100.4), chills, muscle ache. Headache continued all day 5) Had loss of appetite and was extremely lethargic all of Friday 6) Symptoms continued all of friday, but all went away by Saturday morning
I received my third (booster) dose on Dec 31, 2021 and felt fine for about 12 hours. After that, I awoke with chills and fever around 1AM that prevented me from returning to sleep. By 3AM I experienced muscle aches as well. By 5AM the chills and fever had decreased, but the aches continued and I began to experience severe headaches and mild upset stomach. By 7AM the headaches had decreased to moderate. The headaches fluctuated from moderate to mild by 9AM, and the upset stomach dissipated. I continued to experience moderate muscle aches throughout my body as well as fatigue, headaches, and chills throughout the rest of the day. The second night (Jan 1) was better, I was able to sleep though still experienced continued aches, chills, and sweating. The next day (Jan 2) I had some muscle aches, but no further headaches or chills and I felt ready to resume normal daily functioning. I felt fully recovered by Jan 3.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: el9264), on 23Feb2021 as dose 2, single (Lot number: en6201), in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: fh8020), in right arm and on 22Jul2022 as dose 4 (booster), single (Lot number: fp7100), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin, shell fish; "Known allergies: shell fish" (unspecified if ongoing), notes: Known allergies: penicillin, shell fish. Concomitant medication(s) included: LIPITOR, start date: 01Jan2000, stop date: 24Aug2023; PROZAC, start date: 01Jan2000; D3, start date: 01Jan2000; B12 [CYANOCOBALAMIN], start date: 01Jan2000; FISH OIL, start date: 01Jan2000; CALCIUM 600 + D, start date: 01Jan2000. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) positive, notes: I tested positive for COVID on Friday; (04Sep2023) Negative, notes: Tested negative for COVID on 04Sep; (06Sep2023) positive, notes: tested positive for COVID 06Sep2023. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 25Aug2023 to 30Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc. (Manufacturer Control Number: 00556191). The primary reporter was a nurse reporting that on 17Aug2017 a patient of unspecified age and gender was given a single dose of PREVNAR 13 for immunisation. Nurse reported that the patient had an unspecified allergic reaction following administration, and received unspecified treatment. Event outcome was unknown. This information had not been reported to the FDA. No follow-up attempts possible. No further information expected.
Warm and hot; It is completely swollen; Itchy; So painful; A tiny bit red at the injection site; General soreness; Every bone and muscle hurt; Stabbing sharp headache; Feeling exhausted; Every bone and muscle hurt; Chills; Fever at 103.7F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General soreness), VACCINATION SITE WARMTH (Warm and hot), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills) and PYREXIA (Fever at 103.7F) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (She tested positive of COVID at the end of April in 2020) in April 2020 and Viral pneumonia (She also had community viral pneumonia back in January) in January 2020. Concurrent medical conditions included Allergy (iodine contrast dye, surgical adhesive).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful) and VACCINATION SITE SWELLING (It is completely swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted) had resolved and VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site) and VACCINATION SITE SWELLING (It is completely swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 103.7f (High) 103.7F. On 06-Feb-2021, Body temperature: 98.6f (Low) 98.6F. On an unknown date, Body temperature: 101f (High) Temperature decreased after taking Tylenol and ibuprofen.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Local erythema and swelling at site of injection of DTaP and IPV. Some itching and warmth. No treatment at this time.
Patient received her Fluad vaccine and walked to the registers to pay for her groceries.  She stated that she did not feel well and two front store employees assisted her in sitting on a bench and getting her drink of water with a straw.  The pharmacist came to assist and checked her blood pressure. It was 170/88. Patient stated that she did eat breakfast. We did give her a sip of orange juice with a straw.  Her face had a light sweat. She was extremely drowsy and in and out of coherence. She could state her name.  She asked us to call her boyfriend and he did arrive to help.  She did not want us to call 911, but we did.  The first responders checked her blood sugar and it was 120.  They analyzed her heart with an AED and no shock was advised.  She was then transported to the local hospital by the EMS.
A report received from a 42 year old female vaccinee who is a health care professional on 15Oct02, who experienced a red swollen hot arm and soreness, minutes after receiving Fluvirin vaccine on 15Oct02. The vaccinee had received the Flu injection for 14 years with no problems. She received 0.5ml to the left arm and within minutes she developed swelling of the entire arm, which also became bright red and hot. Ice packs were applied with no relief. Three hours later the same symptoms and soreness were present. The vaccinee stated that the events were resolving at the time of the report. The reporter has assessed the relationship of the vaccine to the events as probable. Update1 05Dec02: A report was received from a health care professional who was also the vaccinee. The vaccinee also experienced an inability to move her arm on 15Oct02. The vaccinee was given the Fluvirin vaccine at 8:45AM and by 9:00AM the vaccinees arm was red and warm to touch at the injection site. By 9:30AM the vaccinees arm was swollen and the red inflamed area was getting larger and painful. By the end of the day the vaccinee was unable to move her arm without pain radiating from the injection site to the wrist. It interfered with the vaccinees ability to perform her job requirements. The events resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment.
sore throat started day of injection  Severe pain starting one day after injection, especially in joints and abdomen Major headache starting day of injection Swelling and rash on injection site, starting two days after injection
reddened, sl swollen area @ inject site, sl tired; took APAP for sx;
Red area on (L) arm, BENADRYL helped but now back, warm to touch and red, itchy also.
Patient was admitted to the hospital on 3/29/21, then transferred to a different hospital on 3/30/21 within 6 weeks of receiving COVID vaccination.
fever up to 102.6 between 6/24/99 & 6/29/99 reduced w/advil;fine maculopapular rash to trunk 7 perineum 5 days p/vax;
Patient received 2nd dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 27th June 2022, the patient received the 2nd dose of Havrix. On 27th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: Receipt Date: 28-JUN-2022 Reporter's comments:  The reporter reported that the patient received expired dose of Havrix on 27th June 2022. At time of reporting, dose was not repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was expired on 18th June 2022, which led to expired vaccine used.
At an outpatient oncology clinic patient came in for B12 and decided to receive the influenza vaccine at the end of the appointment. Expired influenza vaccines were in an old supply refrigerator (no longer regulated by pharmacy) and the nurse was unaware of the new stock in the ADU refrigerator. The dose was pulled from the supply fridge (this was where the vaccines were kept last year) and administered. The order was entered and document after administration. The error was discovered when the RN went to document the lot and exp. number and was subsequently reported to pharmacy.