chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. started c/o face, body and leg itching also she had some red patches on face and body. Notified NP and ordered BENADRYL 7.5 mL PO given pt. Wait 30 minute to be reevaluated by NP. Pt was reevaluated and d/c by NP. Pt. went home in stable condition.
Case number PHEH2015US027172, is an initial spontaneous report received from a medical assistant on 24 Dec 2015. This report refers to a 24-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) at a dose of 0.5ml intramuscularly on an unknown date which was stored out of recommended temperature range (temperature excursion of 55.6 degree Fahrenheit/at 7:50am the temperature was 38 degrees and at 3:50pm the temperature was 38.3 degrees). No adverse event reported following this medication errors.
Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:15 at left arm, at single dose for covid-19 immunization. Medical history included history of seizure, known allergies: topical Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included (ascorbic acid) (VITAMIN C), (sambucus nigra) (ELDERBERRY), (linum usitatissimum seed oil) (FLAXSEED OIL), (allium sativum) (GARLIC). The patient previously took lamotrigine (LAMICTAL) and known allergies: LAMICTAL. The patient was not pregnant at the time of vaccination. The patient experienced palpitations, chest pressure, lightheadedness and nausea on 23Dec2020 14:15. The patient received Zofran and Meclizine given. Event resulted in: Emergency room. The outcome of the events was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
already had 1 dose of Bexsero; already had 1 dose of Bexsero and Menactra; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENACTRA for prophylaxis.   Concurrent medical conditions included infusion (had infusion called Solaris).   In October 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of MENACTRA. In October 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and interchange of vaccine products. On an unknown date, the outcome of the inappropriate age at vaccine administration and interchange of vaccine products were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was on an infusion called solaris and received dose of Bexsero and Menactra, which led to inappropriate age at vaccine administration and interchange of vaccine products. The reporter consented to follow up.
Patient said the right side of her body was cramping and said that she couldn't walk for a while because she was hurting so bad from it. I dont know if this is really a direct effect of taking the flu shot. She said she was fine now except her right calf muscle was still cramping. Patient said that the area of injection was red and achy the day after the flu shot was given.
diarrhea, confusion, hives given diphenhydramine 50 mg (given at 20:56), famotidine 40 mg (given at 20:56), and methylprednisolone 125 mg (given at 20:57)(all IV)
vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that was given after the expiration date.) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 24-Sep-2021, the vial was initially stored in the refrigerator. The vaccine was administered between 24-Oct-2021 to 27-Oct-2021. The vial had not undergone any temperature excursions. Concomitant medication information not provided. Treatment information not provided.
Approximately 1 hour 25 min.  after injection,  a raised pink approx. 1.5 cm hive developed on right waist area.  Approx. 5 min. later, 4 smaller erythematous 1/2 cm hives on  flexor surface of right forearm.  Also, hive left lower leg above ankle anterior. Then few min later  raised hive medial left wrist. Also 1-2, small hives abdomen. No sore throat, wheezing, or shortness of breath associated. Did develop ?stomachache? approx 40 min after injection as well.
pt recv vax 15JUL98 630PM & pt vomited & was pale;pt cold & clammy, diaphoretic;pt listless, HR 84 & regular, RR 24;
Cold sore; Didn't feel normal; Felt achy; Felt flu like symptoms; Was tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th July 2019, the dose was an unknown dose. On 17th July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and tiredness. On 18th July 2019, the patient experienced pain. On 19th July 2019, the patient experienced feeling abnormal. On an unknown date, the patient experienced cold sores. On an unknown date, the outcome of the influenza-like symptoms, pain, feeling abnormal and cold sores were recovered/resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, pain, feeling abnormal and cold sores to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and felt flu like symptoms and was tired. He rested the whole day. The second day he stayed in bed and felt achy and then the following day, he didn't feel normal and didn't do a lot. He also reported a cold sore several days after receiving the first shot of Shingrix.  All his symptoms were resolved. For tolerances of 2nd dose, refer case US2019AMR174145, reported by same reporter.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, couple of days after receiving SHINGRIX, the patient experienced shingles, rash and pain in arm. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles, rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was a patient who received a SHINGRIX about 4 weeks before the time of reporting. The patient reported that he experienced a sore arm which had resolved. The patient reported that within a couple days after the shot, he developed a shingles outbreak on his chest. The patient reported that he was seen by his doctor and put on 10 day course of Valacyclovir and that the rash resolved. The patient was unable to provide phone number for pharmacy or his physician's office.
an expired dose was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   On 22nd February 2023, the patient received Havrix. On 22nd February 2023, 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: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Nurse reported an expired dose of Havrix was given to a patient.  the reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received Havrix on 22nd February 2023, which was already expired on 16th February 2023.
Patient collapsed while walking/running in the pharmacy waiting area.  Patient was incoherent for several minutes.  Asked if she would like ambulance called, in which she replied yes.  Ambulance was called.  They assessed the patient and left her at the pharmacy to recover.
Soreness right arm injection site and redness with lump.  Lump above collar bone inner aspect near neck.  Soreness of right arm.  C/O discomfort right side of neck when move head.  Advised to consult with healthcare provider - provided with resources.  Had viral infection 6 weeks prior to moving to another city.  Has been in city for 3 weeks.  Complains now of sore throat.
Patient recieved Moderna booster without omicron instead of the bivalent Moderna booster with omicron. no adverse reactions reported.
26 hrs - large red, hot area (5X3 inches). 48 hrs - deeper red - tender to touch. 72 hrs - add itching and a 2X1 inch hard painful area. 96 hours - lighter red, but area is now 7X4 inches and still has a hard painful center. 120 hrs - lighter color, even large 7X5 inch area - still with firm and hot center (which is diminishing in size).
Shot given right thigh SQ at 0930. At 0935 parent informed NCS of redness. Area was red and blotchy 5cm by 3.5cm. Ice applied. Doctor examined, no respiratory symptoms. Order 3/4 tablespoon Benadryl. (given) After 15 minutes redness decreased. Mom will monitor at home, Given samples of Benadryl.
COVID-19 TESTED POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced covid-19 tested positive. Laboratory data included: Body temperature (NR: not provided) 101 F, and COVID-19 rapid POC test (NR: not provided) Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 tested positive. This report was non-serious.
Pt RTC 12/13/05 to receive Je-Vax &  Rabies #2 in series.  Reports itchy rash to elbows, upper arms and waist x 5-7 days.  *Jevax and Rabies #1 were given on 12/2/05.  Pt instructed to D/C series and report to ER for increased symptoms.  *Pt also c/o numerous mild headaches x5-7 days-unusual for her to have headaches per report.
Within minutes post vax, the pt developed an anaphylactic reaction characterized by narrowing of the pt's airway, swollen tongue, and shortness of breath. The pt was treated in the ER. A week post vax the pt developed cold symptoms and a cough.
A report was received from a health care professional concerning a female vaccinee who inadvertently administered out of date Fluvirin formulation on 24Oct02. On 24Oct02, the vaccinee was inadvertently administered last year's Fluvirin formulation. No adverse event was reported as a result of the incident. There was insufficient information to determine the reporters causality assessment. Ref: PJP200200654; PJP200200652;PJP200200651; PJP200200650.
revaccination of PNEUMOVAX 23 vaccine that expired on 29-SEP-2020; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date in 2020, the patient was re-vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # reported as S001635, expiration date 29-SEP-2020, for prophylaxis (dose, route and anatomical location was not reported).  The primary reporter called in to request information regarding revaccination of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and was provided with the post expiry information for this product.
About 5 days after the Vaccine shot I noticed that my finger joints were stiff.  I couldn't make as tight of a fist, especially my right hand.  When I open my right hand my ring finger would hang up and not extend with the others.  It would lock up half way open  and then extend the rest of the way.  The condition has not changed since.  I had my second shot on 02/10/2021 at 2pm.  I didn't see a doctor about it since it is not critical except for a little lose of dexterity.
Pt calls at 15:30 states she has a rash from her face down neck and trunk. No SOB, some facial edema but not a lot according to pt. Pt states she was seen at Urgent Care per her physician. She was administered betamethasone and told to take BENADRYL for itching and to go to ER if pt experienced SOB.
Extreme headaches in the back of my head, then radiating to the frontal lobe. Second stage was dizziness/ vertigo seemed like my brain was going to explode.  Ringing in ears and then intense vivid dreams.  It?s been two weeks since the second shot and I am still dealing with the dizzy spells. The headaches have gone . Also another symptom was I would get weak at times not for long but in spells. Still trying to over come this pressure and dizzy feeling other than that now I am getting better.
Patient was administered full vaccine dose, but when attempting to remove needle, it fell off and stayed in the patient's arm. Patient was taken to the ER for treatment.
soreness at injection site; discomfort on left side of body; felt the solution going doing the left side of her body; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On 31st May 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, arm discomfort and feeling abnormal. On an unknown date, the outcome of the injection site pain, arm discomfort and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the injection site pain, arm discomfort and feeling abnormal to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced soreness at the injection site on her left arm, she felt the solution going doing the left side of her body and some discomfort on that side, which went away after 1 day.
PATIENT HAD HIGH FEVER  AND HAS REST  LESS LEGS , HAD 2 WEEKS OF CHILLS AND LOSS OF APPETITE
woke up feeling exhausted; experienced light headedness; Fever 100 at noon; Arm soreness overnight; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV and high blood pressure. Concomitant medications included emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide fumarate (GENVOYA), lisinopril (MANUFACTURER UNKNOWN), rosuvastatin (ROSUVASTATINE) and acetylsalicylic acid (ASPIRIN 81). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) and AUGMENTIN were taken for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, overnight, the patient experienced arm soreness. On 09Apr2021 at 06:00 the patient woke up feeling exhausted and experienced light headedness. On 09Apr2021, at noon, the patient experienced fever 100. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm soreness, fever 100, feeling exhausted and light headedness were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Passed out; Nausea; Fever; Chills; A spontaneous report was received from an other healthcare professional for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fever, chills, nausea and passed out for a short duration.  The patient's medical history was not provided. No concomitant product use was reported.  On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient had experienced chills and fever overnight. On 27-Feb-2021, the patient developed nausea and reportedly passed out for a short duration while coming out of shower which was followed by a second episode of passing out while dressing. As per the patient this could be related to dehydration and low blood pressure in general.  The patient was feeling fine at the time of this report. Treatment information was unknown.  Action taken with mRNA-1273 was not applicable.  The outcome of the events, fever, chills, nausea and passed out for a short duration, were considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-029837:Same reporter, Male patient
Swelling of lymph-nodes neck and front of collar bone, arm-pits swollen to a lesser degree. No pain. Subsiding dramatically now.
Initial misuse report received from a healthcare professional on 07 May 2014. A 03-month-old patient received 0.25 ml dose of FLUZONE. (No other information ws provided regarding the patient). No adverse event was reported. List of documents held by sender: none
4 days after my second vaccine dose I came down with an extremely painful UTI, I haven't had one of these in the past 20 years or more. Two friends of mine in their 50's also came down with a UTI infection within 2-4 weeks of second covid vaccine dose.
Tingling Sensation in the Head; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling Sensation in the Head) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ATORVASTATIN, LISINOPRIL and CARVEDILOL for Blood pressure high.    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 PARAESTHESIA (Tingling Sensation in the Head) and HEADACHE (Headache). On 14-Mar-2021, PARAESTHESIA (Tingling Sensation in the Head) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Breast swelling; Severe R breast pain; Side pain; severe pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (Severe R breast pain), PAIN (Side pain; severe pain) and BREAST SWELLING (Breast swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced BREAST PAIN (Severe R breast pain) and PAIN (Side pain; severe pain). On 07-Jan-2021, the patient experienced BREAST SWELLING (Breast swelling). At the time of the report, BREAST PAIN (Severe R breast pain), PAIN (Side pain; severe pain) and BREAST SWELLING (Breast swelling) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided  by the reporter. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up information was received onv31 Mar 2021: included information about second dose.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
By dinner time I became very tired. Went to bed about 7 PM and wasn't able to get up until nearly 4 PM the next day (the 31st). I had no energy for the remainder of the day and well into the next day (Nov 1). Periodically felt a bit nauseated and had a couple of episodes of chills that lasted  about half an hour.  Began to feel better by the evening of the 1st and by the morning of the 2nd was back to normal.
Left arm swelling, redness. Rx Orapred 15/5 7ml po daily x 4d. Cephalexin 250/5 5ml q 6 hrs x 7 days.