chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at the injection site; Swelling at the injection site; Bumps at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 11-year-old male patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number KH3N5, expiry date 16th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th October 2022, 1 days after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling and injection site mass. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site mass were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site mass to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   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: 11-Oct-2022 Reporter's comment: The healthcare professionals reported that the patient received the Flulalval Quadrivalent on left deltoid. The patient experience local redness, swelling, and bumps at the injection site.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
The pt experienced a low platelet counts, numerous IV gamma globulin's, finger sticks, bruising, steroid treatment and finally remover of his spleen three years later. The annual follow-up states that "he is watched for signs of bruising and any fever is cause for concern since he lost his spleen due to chronic ITP, and he's on penicillinf for life and he's six."
Chills, fever, aches, tiredness.  Gone within 36 hrs.  Arm soreness for two days.
On 14MAR91, devel sudden onset of high fever up to 103.7, convuls generalized for 2-3 minutes;
Patient came back 2 days after vaccination and stated the RN that gave her vaccination gave it too high on her shoulder. She experienced pain, numbness, decreased mobility in the arm. Patient stated pain is decreasing and mobility has improved. CDC was called to confirm what next steps would be in regards to vaccination. They advised report the incident, do not repeat first dose, and receive second dose as scheduled. Patient was notified of CDC recommendation, she will return for her second vaccine, and was advised to contact Physician if shoulder symptoms worsen or persist. Patient confirmed understanding and was thankful for the prompt attention to this matter.
10 days after receiving the Pfizer booster, I was diagnosed with a blood clot in my R calf below the knee .  My original covid shot was J&J on 3/10/21
Patient complained of pain and stiffness at injection site on the evening of the injection (09-Apr-2018). Acetaminophen was given at bedtime. Patient woke up on 10-Apr-2018 with an extremely swollen upper right arm and shoulder from elbow to collar bone. Arm was red, swollen, and hot to the touch. Patient had low grade fever and complained of painful arm and headache. Ice pack was applied to the arm and acetaminophen was given throughout the day. On 11-Apr-2018, patient's arm continued to be swollen, red, hot, and painful. Ice pack and acetaminophen regimen continued to be followed per doctor's orders. On 12-Apr-2018, patient awoke with cellulitis-type swelling of the arm. Arm is still swollen, painful, and hot to the touch. Patient is returning to the doctor today.
pt recv vax 24NOV98 & a pregnant test was positive on 15DEC98;LMP 27NOV98;EDD is 3SEP99;f/u was recv from RN. pt had an elective abortion on 4FEB99 @ 9 1/2wk from LMP;
Pt's nurse suspects brown spot all over right arm maybe the result of flu vaccination given to him back in Sept.
Reported by mother to PHN: patient had lower back pain with stomach ache within 2 hours of vaccine administration. Lower back pain progressively worse and parent took daughter to local hospital ER. Doctor diagnosed attributed the symptoms as side effects of the GARDASIL. ED doctor prescribed relaxant med; Symptoms relieved and gone by 3rd day. Had no reaction from 1st HPV given.
The second day after the vaccination  was administered I had a migraine type of headache, which lasted two days. I've had non-stop headaches from the 15th of February until the 28th of February, along with a low grade fever of 98.8, muscle aches, joint pain, lower abdominal cramps, loose bowels, felt like influenza symptoms.
Patient reports full body itchy rash commenced 2 -3 days after vaccine administration.  Patient came to clinic for evaluation on 10-5-07 and was given benadryl and hypoallergenic lotion for treatment.
This is a spontaneous report from a contactable nurse. An unspecified patient (age and gender unknown) received the fourth dose of PREVNAR 13 on an unknown date at 18 months of age. It was noted that the patient received doses at 2, 4, 6, and 18 months of age. Relevant medical history and concomitant medications were not provided. On an unspecified date, the nurse stated that the patient experienced ear and sinus problems. Laboratory test results were unknown. Outcome was not provided.
Patient received vaccine on 3/4 and 3/6 was admitted to hospital for oxygen desaturation.
Patient-reported an allergic reaction to the vaccine on 8/8/2018 - stating pain and tenderness at the injection site. Patient came in for physician evaluation with Dr. PHYSICIAN ASSESSMENT:   Allergic reaction to chickenpox injection Suspect secondary infection. PLAN OF CARE: Findings explained to the patient, injection was given in the lower one third of the arm lateral aspect Report to the nurse clinic has been done. The patient is to take a loratadine 10 mg daily Empirically given a prescription for Bactrim DS 1 tablet 2 times a day for 7 days. She will follow-up in MD office if any worsening of symptoms or not clinically better.
suspected vaccination failure; mild case of shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (before the shot).   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 details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got mild case of shingles. The patient was glad, he/she got the Shingles shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirmation were not provided.
Patient tested + for covid on 7-17-22 and was later transferred to Medical Center and deceased 8-4-22.  HE had multiple chronic medical problems see previous VAERS data.  He had covid pnuemonia, resp failure requiring ventilation and new onset seziure  .  prolonged MV risk of resp failure decreased functional status , was DNR code status and comfort care measures taken.  He had h/o VRE bacteremia, septic shock and severe covid 19 pneumonia
This is a spontaneous report received from a contactable pharmacist. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number: T08483, expiry date: Sep2019), intramuscular (arm left) on 23Oct2017 at single dose to prevent pneumonia. The patient's medical history was not reported. Concomitant medication included influenza vaccine on 23Oct2017 (arm right) at unknown dose for immunization. On 23Oct2017, the day of vaccination, the patient got rash at the site that was about 50 cm and now it is recording at 220 cm.
Severe chills, shivering, headache, whole body aches, nausea, low grade fever
Shingle bumps - right hand side (back) of my scalp and came around to my face and jaw - the right hand side of it. I used an OTC cream and I also got the shot for Shingles but it was probably a little late for that. The symptoms showed up on Friday and I didn't get to dr until Monday. Dr gave me a single shot of Shingles vaccine - anti-viral. The blisters began to dry up. But I suffered fatigue for a couple of weeks.
Information has been received from a registered nurse referring to a 13 month old male patient. The patient's concurrent conditions and drug reactions/allergies were not reported. Before vaccination, there was no adverse event. It was reported that vaccine was verified viable at time of the call. On 02-NOV-2015, the patient was vaccinated with improperly stored doses of PROQUAD (Merck), lot # L023114, expiration date 24-DEC-2016, (dose was not provided). On the same day the patient was vaccinated with Hep A vaccine (strength, dosage, frequency and route unspecified) and pneumococcal conj vaccine (unspecified) (manufacturer unknown, strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Rash developed all over body 5/22/16, low grade fever 5/21/16 (99.0 F).
No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11).    Concomitant medications were not reported. No treatment information was provided by the reporter.
States had flu shot today 10/18/12 at 930/A in right deltoid. States about 5 minutes after injection entire right arm began to itch. Felt some shortness of breath. States episode lasted about 1/2 hr. Came to Occupational Health 10/18/12 at 220/P as shortness of breath returned. Has hx of asthma. Used inhaler x 2 while in Occupational Health. Observed in office for 1 1/2 hrs.
Diarrhoea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) 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 23-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, DIARRHOEA (Diarrhoea) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
On Sunday, 4/4, I woke up feeling very lethargic. As the day progressed, I developed a dull headache which turned into a bad headache. I became nauseous and dizzy and started throwing up which lasted for about 8 hours. On Monday, 4/5, I was still very lethargic, achy, and dizzy. I had a dull headache and a fever of 99.9 degrees. On Monday, 4/6, I woke up feeling better.
Red swollen area about 4 inches in diameter around the injection site.  Patient said it felt a little tender, but no more than any other injection site would.
I started having a stiff middle part of my back after have the first shot on March 25 and been taking a over the counter 650 MG Arthritis Pain for the pain and using a heating pad for the past weekend and it is not working and I still have the pain in the middle of my back but I have reported to the VA this morning..
w/in 48 hrs exp tenderness @ inject site, nausea, & mild generalized aches; resolved spontaneously;
REC'D VACCINE 1-4-21. 1-6-21 DEVELPOPED LUMP, WARM TO TOUCH, RED, TENDER. RESOLVED. 1-14-21, PATIENT DEVELOPED RASH, BRUISING, ITCHING AND WARMTH TO INJECTION SITE. TOOK BENADRYL. 1-16-21 RESOLVED
08/23/2023 at 15:10 had increased confusion, temp 99.3, SOB with 02 sats 88% on R/A. applied 02 at 2 liters.  At 15:30 c/o fatigued, and body aches.
This case was reported by a pharmacist via sales rep and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chills, fever and malaise. On an unknown date, the outcome of the chills, fever and malaise were recovered/resolved. It was unknown if the reporter considered the chills, fever and malaise to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced general adverse reactions like, chills, fever, malaise for approximately 7 days. The pharmacist recommended the patient not to receive the 2nd dose. The reporter agreed to be followed up.
1 hour after vaccine left arm became "very" sore, right arm a "little sore".  Then had difficulty sleeping all night because she was hot. In the am while getting ready for school at 05:30-06:00 on 04/02/2021 she began getting dizzy then sat on toilet, she states she passed out, however she woke up in same position on toilet. She has not eaten since dinner last night. She states headache, with dizziness continue. Pt refusing snack.
Patient recieved Pfizer Covid vaccine on July 27, 2021 as the first in her series, she went to a different clinic and was not able to locate her card to get her second vaccine.  Pharmacy gave her Moderna as her second vaccination on November 3, 2021
- 30th Oct (day after vaccines):  headache, fatigue, no appetite,  slept all day  ... but felt OK on Oct 31st - Starting late Monday Nov 1:  significant sleeplessness that lasted until Nov 6 (probably unrelated to vaccines, but who knows?) .. OK by Nov 7th. - Starting Tue Nov 8: a skin allergic reaction (not at the vaccine site but in patches, shifting every 30 to 45minutes) with hive-like bumps or raised lines of irritation, very itchy;  went to walk-in clinic on Nov 12 and was informed this is very likely a skin allergy: like dermotagraphia.  I've never had anything like that in my life.  But successfully treated with antihistamines Zyrtek and Benadryl. NOTE:  I highly doubt this is related to the Moderna booster I had on 10/30, but thought I would report it
Fever (103 F) for two days, headache for 10 days, menstruated for 18 days in a row.  I had begun my period before the second vaccine dose and it should have ended 3-4 days before my second vaccine dose but it did not.  After the second vaccine dose on 5/6/21 my period became very heavy again and it lasted for a total of 18 days.  I have had a few minor menstrual irregularities in the past but have never previously had a period that lasted longer than  8 days.  After that incident my menstrual cycle has been normal.
Terrible pain in side after taking flu vaccine; Sick after taking COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after taking COVID vaccine) and VACCINATION SITE PAIN (Terrible pain in side after taking flu vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In February 2021, the patient experienced ILLNESS (Sick after taking COVID vaccine). In September 2021, the patient experienced VACCINATION SITE PAIN (Terrible pain in side after taking flu vaccine). In 2021, ILLNESS (Sick after taking COVID vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Terrible pain in side after taking flu vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient was administered with FLU Vaccine VII (influenza vaccine) and was unknown if patient was enrolled in a COVID-19 vaccine trial. The event of vaccination site pain resolved on 2021.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
3 doses were administered; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other-HCP reported similar event for 3 patient. This is 1st of 3 reports. This Other-HCP reported for a 48-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0186 and expiry date: 30Aug2021) via an unspecified route of administration on 20Jul2021 as dose 1, 0.3 ml single on left arm for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. It was mentioned that no other products were received, patient had no history and no investigation assessment was done. The transferring agent stated that she has a HCP on the line that reported that they received Covid-19 vials from a different office and realized that they were already expired since 15Jul2021. On 20Jul2021 the patient was administered 3 doses (overdose). The event outcome was unknown.  The caller verified the information provided by the transferring agent.; Sender's Comments: As there is limited information in the case provided, the causal association between the event overdose and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202100924476 Same reporter/SD/AE, different patient;US-PFIZER INC-202100924472 Same reporter/SD/AE, different patient
Narrative: Nurse reported ADR of erythema and swelling; no further documentation in chart and unable to contact nurse or patient for further information. Noted upon attempt to schedule patient for his second vaccine, he stated Dr instructed him not to have another due to severe reaction. Symptoms:  ErythemaMultiform & swelling, erythema
Pt received shots 9/25 and when he woke on 9/26 arm was very sore and he was unable to move it. Pt states he slept the entire day 9/26. Arm is still slightly red/inflamed today, 9/27. Pt taking OTC NSAIDs for relief.
infection at the site of injection; itchy - at the site of injection; redness - at the site of injection - size of nickel; swelling - at the site of injection; hot to the touch - at the site of injection; A spontaneous report (United States) was received from a consumer who is a 77-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness - at the site of injection - size of nickel/size of softball, swelling - at the site of injection, hot to the touch - at the site of injection, itchy - at the site of injection, infection at the site of injection.  The patient's medical history was not provided. Concomitant medications reported were Synthroid, Premarin, Xanax, Escitalopram, Losartan, Supplements, Vitamins for unknown indication.  On 16-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 24-Jan-2021, the patient experienced the events redness - at the site of injection - size of nickel. swelling - at the site of injection, hot to the touch - at the site of injection, itchy - at the site of injection. On 25-Jan-2021, the patient experienced the increase in the redness - at the site of injection - size of softball. On 26-Jan-2021, the patient was seen by a HCP who suspected a vaccine site infection and provided treatment.  Treatment details included an unspecified antibiotic and an unspecified topical ointment  Action taken with mRNA-1273 in response to the events was not available.  The outcome of events , vaccination site warmth, vaccination site infection, vaccination site erythema, vaccination site swelling and vaccination site pruritus  were unknown.; Reporter'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.
ITP dx 7JUL97;mom feels this was d/t DTP vax;
Provider ordered pediatric Hep B and M.A. gave to patient. Patient notified and will return to clinic for correct vaccine.
Rash on injection site, swelling on the arm, chills, rash on vaginal and anal area, hives on chest, back, and arms, fatigue, and muscle aches