chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; burning at injection site; swelling at the injection site; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FX6073) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at the injection site". Additional information included: there are three patients were given Prevnar 20 from the same lot number FX6073 and all three patients had the same adverse events. Rash, burning at injection site, and swelling at the injection site. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200066036 same drug and AE, different patient;US-PFIZER INC-202201170677 same drug and AE, different patient;
ringing/tinnitus in Rt ear 2 hours after 2nd dose; tinnitus is still ongoing  eyelid swelling/edema - two weeks after 2nd dose; continually happens approx ever two weeks
Knot at inject site, redness surrounding area about the diameter of a baseball (not swollen to size of baseball). Pt has appointment scheduled with dermatologist today & will ask him to evaluate. Pt advised cold pack and BENADRYL. Redness and itching progressing over last 6 days.
Nauseous; Knee arthritis; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and ARTHRITIS (Knee arthritis) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (severe).   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous) and ARTHRITIS (Knee arthritis). At the time of the report, NAUSEA (Nauseous) had resolved and ARTHRITIS (Knee arthritis) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of arthritic condition on left side of knee was not provided. the reporter's causality for the event(s) of felt nauseous with the second Moderna covid-19 vaccine with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs Not Reported.  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  Company comment: This spontaneous case concerns an elderly female patient with concurrent severe rheumatoid arthritis, who experienced the unexpected non serious AESI of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent severe rheumatoid arthritis could be confounding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an elderly female patient with concurrent severe rheumatoid arthritis, who experienced the unexpected non serious AESI of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent severe rheumatoid arthritis could be confounding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I did not have an adverse reaction to the vaccine. I had tested positive for COVID-19 in 06/2022.  I got a prescription for Paxlovid. I tolerated the medication without any complications.  Since having COVID-19, I have had difficulty with breathing and fatigue. I have seen my doctor and a cardiologist, but they can't determine the cause.  I am scheduled to see a pulmonologist in May.
Within 15-minutes of vaccination, the patient reported a pruritic, erythematous rash to their bilateral hands and legs. EMS evaluated patient on-site. EMS administered 25mg IV Benadryl and transported the patient to the Emergency Department. In the ED, the patient reported that their throat felt tight, but that the pruritus has improved. No labs were ordered. The patient was discharged with an allergic reaction and prescribed Benadryl 25mg PO and Prednisone 20mg PO dose pack.
weakness and r hip joint pain, itching, l low back pain, bruising, diarrhea, difficulty swallowing liquids, r mid abd pain severe,shoulder pain r,  intra-hepatic bile duct cance. Dates from  late september, october, november, and december 2020 to current.
Narrative: COVID infections following completion of COVID vaccine series 12/31/20 COVID vaccine dose #1 01/21/21 COVID vaccine dose #2 07/26/21 Pt presents to ED reporting chills, minimal productive cough; treated with APAP; CXR suspected bibasilar bronchovascular crowding and atelectasis/scar, otherwise, no radiographic evidence of acute cardiopulmonary disease; COVID POSITIVE; discharged home 07/27/21 Pt reorts chills, cough, fever, headache that started 07/21; rx given for DM/guaifenesin, acetaminophen 07/29/21 Pt reports mild symptoms and is improving
Confusion, night sweats, blurred vision. Added fatigue per conversation with patient-reporter./awb
1st shot - headache when I lowered my head, but did not hurt at all when I sat up, Swollen lymph nodes lasted for 10 days, really tired  4/20/21 Lot ER 8735 -2nd shot - had fever 99.9 for 1 day, body aches for 1 day, terrible lower back pain for 7 days,  very tired, developed a dry cough and sinus drainage on day 6 after the 2nd shot.
Pt had a flu-like syndrome with sore throat, cough, subjective fever, back pains.
Latex allergy; Urticarial rash; Red rash; Itchy rash; Rash over arms; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RUBBER SENSITIVITY (Latex allergy), URTICARIA (Urticarial rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash) and RASH (Rash over arms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 26-Apr-2021, the patient experienced RUBBER SENSITIVITY (Latex allergy), URTICARIA (Urticarial rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Rash over arms) and RASH (Rash). At the time of the report, RUBBER SENSITIVITY (Latex allergy) had not resolved and URTICARIA (Urticarial rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Rash over arms) and RASH (Rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treatment information was not provided.
On 9/20/22 I started feeling pain and swelling around my knee joints. On 9/25/2022 I went to urgent care and they prescribed OTC pain medication and a knee brace.
Pt recvd vax & devel pain @ the inject site which lasted aobut 7 to 8 mins a/resolving; pt c/o sore & heavy arm all day;
None-the report is to indicate that a Varicella vaccination was given mistakenly in place of IPV in a 6 month old infant.
This case was reported by a consumer via call center representative and described the occurrence of cough aggravated in a 73-year-old male patient who received SHINGRIX. Concurrent medical conditions included cough. On 26th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced cough aggravated. On an unknown date, the outcome of the cough aggravated was not recovered/not resolved. It was unknown if the reporter considered the cough aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The patient had pre-existing cough that worsened after receiving SHINGRIX. The patient has denied permission to contact their physician.
MENACTRA and TDaP placed in (R) arm 8/31/10. (+) Swelling/erythema started that evening and has persisted through 9/3. (+) Mild tenderness. Swelling and erythema at site - 8.5 x 9 cm on (R) deltoid.
nausea/feel like vomiting; he went straight to bed; he started to feel sick; sweated all night; havenot eaten; body shaking; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking) and NAUSEA (nausea/feel like vomiting) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TAMSULOSIN and LISINOPRIL for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking) and MALAISE (he went straight to bed). On an unknown date, the patient experienced NAUSEA (nausea/feel like vomiting). At the time of the report, ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking), NAUSEA (nausea/feel like vomiting) and MALAISE (he went straight to bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment details was reported.
pt recv vax 22JUL97 1030AM & fatther states pt was crying from around 1130PM-7AM every 20-30min & that never cries;today pt a little better;
5 minutes later I had a rapid heartbeat, blood pressure was 184/113. My head got foggy and everything felt weird and I felt off. My heart felt like it was going to come out of chest.
This spontaneous report as received from a nurse refers to a 62-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2017, the patient was mistakenly given a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported) instead of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Patient reported adverse reaction on 05/31/2018. Patient states that beginning night of vaccination (05/30/18) her upper right arm began to swell, became red, warm to the touch and achy. Patient states that she iced the injection site night of vaccine. Patient called pharmacy the next morning, around mid-morning to report reactions. Patient stated that she was still having pain at injection site, redness, swelling, area was warm to the touch. Patient was advised to monitor for signs of infection and to call MD if she began to experience any symptoms described to her by pharmacist signifying infection. Patient was advised by pharmacist to take ibuprofen, BENADRYL by mouth and ice are as needed.
Pt reports abnormal blood tests at his provider's office - caregiver - (post booster shot) - Approx End of October. Caregiver instructed him to report to County Health Dept
Information regarding Prevnar was received from a  physician regarding a female patient (under 2 years of age) who experienced invasive pneumococcal disease resulting in hearing loss. The patient received a dose on an unknown date in 2007. The patient experienced invasive pneumococcal disease resulting in hearing loss on an unknown date in 2007. The serotype was unknown. The patient was hospitalized. Laboratory test results and treatments were not reported. The outcome for pneumococcal disease and hearing loss was not recovered. The events resulted in a persistent or significant disability. No additional information was available at the time of this report.
Area on L upper arm reddened et indurated with scabbed area noted.  Pt had SOB 2 hours after varicella immunization et went to ER.  Pt put on MEDROL DOSE PACK, loratadine 10mg #30 with l.  Increase fluids.  Go to ER if SOB becomes worse.
Fever up to 103.2. Fever over 24 hours. Severe nausea and vomiting. Shortness of breath. Diarrhea, fatigue, extreme muscle pain and some joint pain. Confusion at height of fever. Fever is 100.7 at 32 hours after injection. Treating with Tylenol.
Case number PHHY2013US117224 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 494372) on 15 Oct 2013. This report refers to a 30-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination, she experienced anaphylaxis and rash. No further information was provided.
Patient received covid-19 booster vaccine at earlier date than recommended. Patient received first series of Pfizer vaccine on 11/4/21 and 11/25/21.  No apparent Injury noted.
Injection site is now red and there?s a hard knot. Also experiencing fatigue and headache.
numbness in her throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL HYPOAESTHESIA (numbness in her throat) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PHARYNGEAL HYPOAESTHESIA (numbness in her throat). On 01-Feb-2021, PHARYNGEAL HYPOAESTHESIA (numbness in her throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient could breath and swallow. The patient was using inhaler for seasonal allergies. The patient did not want to receive diphenhydramine.
Moderna COVID-19 Vaccine EUA pain at injection site, swelling of lymph nodes in same arm, joint pain, fatigue, headache, fever, muscle pain, pain in jaw and teeth
Member received 0.25 ml Moderna vaccine IM: according to CDC guidelines should have received 0.5 ml Moderna vaccine
Received vaccines around 12:00pm 03/26/2003.  Began itching at 1:30pm.  At 3:30pm area began to swell, turn red, acquire warmth.  Raised to size of a grapefruit.  Left outer thigh.
I had a rash that formed on all four of my limbs that looked like a poison ivy rash. The rash was under my arm and legs. It wasn't spreading but it became very painful. It is slowly starting to go away with the medication that the doctor provide.
Right leg red, tender and swollen. Area affected 6-7 inches diameter increased from time of admission. No fever, no chills, no headache. CBC is WNL, no results from blood culture; still pending. Patient received Benadryl, topical Cortisone and antibiotic creams and IV treatment of Ancef.
Felt very dizzy; the room was spinning when I lied down to go to sleep. Upon awakening at 6 AM, I still felt dizzy and slightly nauseated. Symptoms have subsided (it's 12:45 PM) but I still feel waves of dizziness if I lie down or move my head too suddenly.
Pt administered PENTACEL, PREVNAR and ROTATEQ 3/16/09. Pt had 5 generalized seizures on 3/17/09. Temp 100.1 rectally.  4/2/09 MR received for DOS 3/17-19/2009 with DX:  New onset seizures. Pt found by parent in bed with shaking arms and legs and eye deviation. Pt appeared to not be breathing and was limp and unresponsive.  Initially thought to be choking, so when pt recovered in ~ 2 minutes, no tx was sought. Similar event later in the day where pt was taken via EMS to ER where pt had 2 more witnessed generalized tonic-clonic activity. Transferred to current facility for tx. PE WNL on arrival.
Started with bad heart burn to wake me up from a sleep. Then started with nauseous and vomiting. Unable to control blood sugar.
After the 1st injection April 13, 2022 and the second injection on May 4, 2022, the patient experienced severe burning sensation of the head, dizziness for one month, still has nausea, vaginal bleeding, poor appetite, hives and swelling both feet and ankles, difficulty with blood draws the needle and tubes clot off, multiple bruises of BUE and BLE easily and severe fatigue.
Reaction in injection site.  Headache pain in the right arm and shoulder and neck, fatigue, soreness, tingling, eye pressure pain.
Patient presented to hospital on 10/14 with rhabdomyolysis (CK to 38k) for which patient began to have symptoms on 10/10 after 6 mins of strenuous activity that day. He had covid booster 4 days prior.
I got the 1st dose on Thursday March 15 around 1:00 PM at the hospital. Around 7:00 PM that evening, I developed a rash across my belly. My husband took me to the ER at the hospital (where I received the vaccine) at about 8:00 PM, and by the time I was seen at about 10:00 PM, the rash was spreading. According to the ER doctor: "Warm, Dry, faint pruritic erythematous rash mainly on the anterior abdominal region blanchable,, not raised, scattered and not confluent patient is scratching at her arms as well and there is a faint erythematous rash is nonraised.  Nonconfluent."  The doctor gave me 50mg of IV Benadryl and 20mg of IV Pepcid and the rash went away within the following hour.  At the time, I was exactly 31w pregnant with my first. They also monitored the baby's heartbeat for 20min and did not find any sign of distress. I had no signs of premature labor or anything else that indicated the baby was in danger. I am due May 27th.  The rash is inconsistent with my allergic reactions to the two medications listed. With the tetracycline, I also developed swollen hands/feet and hives.
100.1 fever at 2am.  Received Pfiezer shot at 6pm the previous day.  Also had a sore arm for about 24 hours.  Pain when lifting the arm up to put on and off a shirt.
7 days after VARIVAX - red raised area with superimposed papules around site of VARIVAX, also has Temp 101.5.
My daughter was expose to COVID-19 in January. When she was tested, it came back negative. She came back with an ear infection. I started feeling sick. I went to see Telehealth. They said it was Upper Respiratory. I felt bad for 3 weeks and I felt better. Then, I felt bad again and tested positive for COVID-19 on Feb19. I was sick for Jan - the middle of March and due to the fact that I was coughing so much, I had to sleep sitting up and was given scripts. I am starting to feel better but any type of cough that I have, have stop my surgeries and they can't put me under. So that's about it. It's the most long standing illness I have had with the cough and the congestion.
on 2/16/21 PM home health nurse administered 1st COVID vaccine Moderna dose to the patient - patient had no immediate reaction in the first 30 minutes after the vaccination.  on 2/17/21 AM visit (about 8:50am) - same nurse - patient was found confused, unable to speak in full sentences, repeating herself , "really off". Patient had tremors throughout her body, had abnormal vital signs - temp 98.8, HR 112, RR 24 and labored breathing, BP 88/42, O2 saturation variating constantly between 88-96% on 4 liters O2. Patient initially refused to have 911 called. Nurse has called patient's PCP and PCP spoke with patient who then agreed to call 911 to go to a hospital. 911 was called, report given to paramedics, the patient taken to local ER.  Per patient and family - some tests were done in ER (?including CT of head from patient's description). Patient's cognitive status and vital signs have improved and patient was sent home. Per ER, they think this was a reaction to the COVID vaccine.  Today 2/18/21 AM visit, same nurse - patient's cognition is at baseline. Patient seems very tired but vital signs are better.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
As I left pharmacy after shot I felt like I could pass out. I was able to keep walking and the feeling passed. 2 days later, I was playing golf. I again felt like a cold pass out. I need to sit down and call for a ride home. As I am a runner, I do not consider golf strenuous exercise.
5A Male pt developed generalized rash and pruritus following prophylactic vaccination and inoculation against rabies. He was being treated for an animal bite from a dog that had been bitten by a raccoon. The pt received RabAvert on 03Nov03, and HRIG on 04Nov03. He received HRIG on 03Nov03 as well. He developed a full body rash with pruritus on 04Nov03. It was unk if the rash had resolved at the time of the report.
Site: Pain at Injection Site-Medium, Systemic: Lymph Node Swelling-Severe, Additional Details: Multiple painful swollen lymph nodes to left axillary, supraclavicular, and cervical areas as well as single swollen lymph node in right axilla. Onset occurred 9 hours after vaccination. Advised to take ibuprofen for pain relief.
Initial report received from a healthcare professional 07-NOV-2014. A pediatric patient whose age, gender, medical history and concomitant medications were not reported, had received a dose of TDAP (manufacturer; unknown, batch number, expiration date, dose in series, route and site of vaccination was not reported, on an unspecified date. On an unspecified date, the patient had a reaction to Tdap vaccine. At the time of this report, the outcome of the event was not reported. Laboratory investigations and corrective treatment were not reported. Documents held by sender: none.
Following the first dose, the pt experienced fatigue. It was reported that "she now has good days and bad days related to fatigue." Additional information has been requested.
1600L Chills, fatigue, muscle aches, sore injection site, 101.3° temp Aleve at 2300L