chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired / Not myself; Redness; Itching; Itching at injection site; Redness at injection site; Sore at the injection site; Didn't feel real great; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didn't feel real great), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel real great), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Sore at the injection site). On 08-Feb-2021, the patient experienced PRURITUS (Itching). On 09-Feb-2021, the patient experienced ERYTHEMA (Redness). On 10-Feb-2021, the patient experienced FATIGUE (Tired / Not myself). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION COMPLICATION (Didn't feel real great), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Sore at the injection site) had resolved. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching) and FATIGUE (Tired / Not myself) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Patient seen on 07/05/2022 and vaccinated without incident.  VS:  BP 124/86   P 68   T 98.6F.  No concerns. Parent requested to space out Immunizations needed. Parent/Pt presented for another set of Immunizations on 07/12/22 and Parent commented of noting some redness on Pt's Left deltoid the day before but has since resolved. Denies ever noting any SOB, pain or fever on Pt.  Parent decided to wait another week for f/u Immunizations.
Patient woke up at 5 am the morning after receiving the shot and was talking about things that weren?t there. He was asking for ammo and saying everything was moving so fast and that we were all in a line and no one would give him ice water. His heart was beating really fast. His temperature was 98.4. He was shivering and sweating. This lasted about 2 hours and then he fell asleep. Today he remembers everything that he said and that happened.
Patient complained of "racing heart beat, dizziness" BP noted 141/92 P104 oxygen 99 repeat temp 97.6 BP 145/89 P96 repeat BP 145/95 Pulse 104 taken to ER for further evaluation and treatment. Temperature rose to 101 while in ER. Patient reports symptoms resolved approximately 1 1/2 hours after injection "feels fine" now Discharged home steady gait.
Tiredness and chills next day. Severe headache and night sweats evening of the next day. 2 days later an itchy, raised, red rash appeared on arms and some spots on torso when I went outside. They went away shortly after returning inside. This continued to happen any time I went outside for greater than a 15 minute duration and lasted for 2-3 weeks.
This spontaneous report as received from a other health professional referring to an unspecified number of patients of unknown age. On 06-SEP-2017, the patients were vaccinated with ROTATEQ orally for prophylaxis. On 06-SEP-2017, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA003179: US-009507513-1709USA003178.
VACCINE WAS GIVEN 3 DAYS AFTER EXPIRATION. NO ADVERSE REACTION HAPPENED.
Fever from 100.5 up 101.7.  Fever had been for 4 days continuously.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302), via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously took clarithromycin (BIAXIN) and azithromycin (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. On 13Apr2021 at 13:30, the patient experienced fever from 100.5 up 101.7.  Fever had been for 4 days continuously. Therapeutic measures were not taken as a result of the event. On 13Apr2021 at 13:30, the patient underwent lab test and procedure which included body temperature and result was shown as from 100.5 up 101.7 (units unspecified). On 16Apr2021, the patient underwent SARS-CoV2-test (nasal swab) and the result was pending. The clinical outcome of the event fever from 100.5 up 101.7, fever had been for 4 days continuously was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
my afib was a lot more intense and I stayed afib longer for weeks.... Did not seek medical help. I thought it was my regular afib at the start. Didn't associate with shot till later. Much later.  Wondering if I had myocarditis now???????? I did not seek medical help so I can't say. The further away from the shot, the better I feel. It could have been life threatening. I don't know. I wasn't sleeping and felt tired to the point of no energy.
Information has been received from a licensed practical nurse referring to an unknown number of unspecified patients of unknown age and gender. Concurrent condition, historical condition and concomitant therapy were not provided. On unknown dates starting on or after 24-JUN-2016, the patients were vaccinated with improperly stored ROTATEQ (lot # L027067, expiration date 16-APR-2017, oral; dose was unknown). The vaccines were stored under 32F for 4 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Hot where she got vaccinated; Redness on arm; Some discoloration; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot where she got vaccinated), VACCINATION SITE DISCOLOURATION (Some discoloration) and VACCINATION SITE ERYTHEMA (Redness on arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE DISCOLOURATION (Some discoloration). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot where she got vaccinated) and VACCINATION SITE ERYTHEMA (Redness on arm). On 30-Jan-2021, VACCINATION SITE WARMTH (Hot where she got vaccinated) and VACCINATION SITE ERYTHEMA (Redness on arm) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Some discoloration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Right after injection(which was given very high I have never had a vaccine given that high. I immediately  Felt pain in my muscle under my arm and like a zinger down to my elbow a little from elbow to wrist It just kept getting worse hard to lift arm very painful Would hurt if I picked anything up. It is now  9 weeks later I got a cortisone shot. Hoping this will help. I have had numerous vaccines throughout the years I have Never experienced something so painful.
This spontaneous report was received from a healthcare professional referring to an adult patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot# and dosage regimen was not provided) for prophylaxis. No adverse effects were reported.
Large DVT and pulmonary embolism requiring anticoagulation and hospitalization. Also found to have a large fibroid uterus compressing IVC which likely contributed to IVC. Patient ended up needing mechanical thrombectomy to help relieve clot burden.
inc temp, simple febrile sz;60 day follow-up dated 9/26/00 states that the pt had a rash as well as a fever following vaccination. Annual follow-up dated 1/2/01 provided no additional data.
Initial unsolicited report received from a nurse on 05-Sep-2018. This case involves a patient (age and gender not reported) who was vaccinated with a dose of ACT-HIB (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong solution used in drug reconstitution and it was reported that the reporter used another diluent besides the 0.4% diluent to reconstitute the ACTHIB. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
pt recvd vax & 21OCT93 devel hives 22OCT93 taken to ER by parent-resolved quickly w/o further treatment or incident;
Reported not feeling well, sent to ED. Per Ed note: Patient here from covid vaccine clinic. c/o throat tightness w/ small amount of dyspnea. states throat feeling better now, still having some tightness in chest. Patient received IV benadryl and IV famotidine and felt fine.  No need for treatment with epinephrine IM.  Was discharged home.
Extreme pain, crying, red streaks with in 3 mins of the red streaks he had swelling and very red and hot leg. From hip to knee.
it was very difficult to insert the needle and seemed confused; This created some worrisome on me on why it was so difficult for him to inject the needle; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 30Mar2021 10:15 (Lot number: EP7533) as dose 1, single and administered in arm left, administration date 20Apr2021 12:00 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NEEDLE ISSUE (non-serious), outcome "unknown", described as "it was very difficult to insert the needle and seemed confused"; ANXIETY (non-serious), outcome "unknown", described as "This created some worrisome on me on why it was so difficult for him to inject the needle". Therapeutic measures were not taken as a result of anxiety. Additional Information: The patient took supplements and birth control in two weeks. The patient has not been diagnosed with COVID-19 prior vaccination and has not been tested for COVID-19 post vaccination. The patient was not having an adverse reaction at this point. However, when she got the shot the technician mentioned that it was very difficult to insert the needle and seemed confused. This created some worrisome on the patient on why it was so difficult for him to inject the needle and she was concerned and would like to better understand if this is common or should she be alarmed.  No follow-up attempts are possible. No further information is expected.
Immun given 5-27-10. Started getting rash at 5:00 PM thought it was heat rash per mother. Had 102 temp. Gave TYLENOL-fever gone. Fri. morning, child still with rash. No fever. Sat. morning-rash covering entire body. Took child to ER Sat evening. Child was given 1 shot (?) + RX for BENADRYL and prednisone.
injection site pain; headache, head pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced injection site pain and headache. In February 2021, the outcome of the injection site pain and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a headache, head pain, and injection site pain. The headache and injection site pain resolved 4 days later. The patient did not want to provide any additional details for adverse event or give Health Care Professional  information. The reporter did not consented to follow up.
his spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 174th patient out of 190 patients as described by the reporter.  Concomitant medications were not reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
had them twice after the shots/Suspected Vaccination Failure; had them twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had them twice after the shots/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-MAR-2023 The case was received from the patient's wife interactive digital media. The reporter stated that you could still get shingles with the shingle shot but would not be as nervier. The patient's had them twice after the shots but was not as bad as could had been. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
The patient was administered the moderna covid 19 vaccine on 3/30/22. The vaccine had expired on 3/27/22 per the moderna website.
Extreme ache, pain and stiffness in left arm, from elbow up into neck and shoulder area.  This began on Day 8 after receiving vaccine and has continued through today - 10 days after vaccine 2 Arthritis Tylenol 650 mg
over 4 weeks (period has not appeared yet); I have anxiety; Breast pain; I have restlessness; I wake up in the morning crying; This spontaneous case was reported by a non-health professional and describes the occurrence of AMENORRHOEA (over 4 weeks (period has not appeared yet)), ANXIETY (I have anxiety), BREAST PAIN (Breast pain), RESTLESSNESS (I have restlessness) and CRYING (I wake up in the morning crying) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 018B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LABETALOL, LEVOTHYROXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (over 4 weeks (period has not appeared yet)), ANXIETY (I have anxiety), BREAST PAIN (Breast pain), RESTLESSNESS (I have restlessness) and CRYING (I wake up in the morning crying). At the time of the report, AMENORRHOEA (over 4 weeks (period has not appeared yet)), ANXIETY (I have anxiety), BREAST PAIN (Breast pain), RESTLESSNESS (I have restlessness) and CRYING (I wake up in the morning crying) outcome was unknown.            Patient has no thyroid issues.  Blood work done and everything was normal.  Treatment information was not provided.
The morning after the vaccine, patient got red hives and rashes all over face. Reduced by noon.
Redness, swelling, warmness at injection site for about 4 weeks. Felt lethargic, shortness of breath, headaches, itching in feet and hands, pain in feet, body aches, hoarseness and scratchy throat, and at 4 week mark came down with 101 fever on and off for 72 hours. Shoulder has had increasing pain and discomfort since swelling went down. On October 19th 2023 went back to see Physician about increasing pain in shoulder that was preventing me from normal activities and sleeping well.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient was unconscious for few seconds after the shot administration. he then became conscious but was dizzy, weak, pale. He was given water and sat down for few minutes. we called 911 and he continued to feel weak and dizzy. EMS said he had high blood pressure, high heart rate , they thought he possibly was in cardiac arrest. Patient was taken to the hospital via ambulance
Joint pain (knees, elbows) problem with ligaments.  Body rash basically in all the body.  I've been treated with Celebrex for my joint pain, ice compress and for the rash some Benadryl and a sore joints (knees and elbow mostly).
Tingling and pain in both legs beginning 48 hours after shot. Still happening 4 days after shot
Received the shot and gave shingles to his wife. Viral shedding/Suspected vaccination failure; Received the shot and gave shingles to his wife. Viral shedding; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient gave shingles to his wife).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comments: This case was reported by the patient's neighbor via interactive digital media.  The reporter reported that the patient (his/her neighbor) had received the shot and gave shingles to his wife, it was called as viral shedding.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding the completion of primary immunization, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  Follow-up could not be possible as no contact details were available. This case was linked with US2022AMR128123 reported by same reporter. The case was kept valid in worst approach considering the patient had shingles and then it was occurred to his wife via viral shedding.; Sender's Comments:  US-GSK-US2022AMR128123:Same reporter.
This spontaneous report as received from a pharmacist refers to a 26 years old female patient with no pertinent medical history and no allergies. The patient was vaccinated with 0.5 ml PNEUMOVAX23 (lot # 1947AA, exp 20-OCT-2013, Intramuscular, left arm) on 01-OCT-2012 for Vaccination. There was no concomitant medications. On 01-OCT-2012 the patient developed welts and swelling of the left arm at the injection site in the evening. The patient sought medical attention. Treatment was Ibuprofen. The patient was recovered as reported. This is one of the two reports from the same source using the same PNEUMOVAX23 LOT. The other report was captured in marrs #1210US007540. Additional information is not expected.