chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J004058, expiration date 22-JUN-2014 (dose was not reported). No adverse effects were reported. Additional information has been requested.
It was reported that a female pt received a TD Adult on 8/22/00. Reportedly, on 8/23/00, the pt complained of 6-8cm of redness, swelling and warmth to the touch at the injection site. Pt's last booster was less than 10 years ago.
Vasovagal Syncope 19 hours after receiving booster. Patient (me) went to remove band-aid from very sore arm and felt faint and immediately passed out. Tensed up and blood rushed to face at beginning and remained unconscious for about 1 minute. Patient did not feel very sick upon waking up, just normal fatigue with sore arm. Patient had stayed hydrated but had not eaten breakfast yet. Upon syncope, patient had extremely low blood pressure and remained orthostatic when attempting to sit up. Patient went to hospital and had to receive 2 bags of saline before feeling well when sitting up. Patient was discharged and returned home and felt fine after 48 hours.
Approx 5:00pm noticed first "hive". By 5:15pm noticed "hives" all over (L) arm and soreness at site of injection. By 9:00pm, noticed "hives" all over body and very itchy - had hard time sleeping. Put CALAMINE type lotion on skin to relieve the itchy. Itchy with hives over weekend, also sore throat. By Monday had developed "cold sore" on lip. Hives/itching gone by Monday.
Acute intractable generalized abnormal movements. Writhing, choreiform movements x3 days until presented to hospital. Given Ativan 2 mg IV and Keppra 1g IV with resolution
Swelling of the right side of the tongue and possible swelling on the right side of the throat.  It felt strange when swallowing liquids.
flu like reaction; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given outside recommended storage guidelines. Multi-use vial had been thawed and punctured greater than 12 hours from first dose.
Had IZ 9/23/14, on 9/24/14 in for noted red, swollen mass - no fever - only painful to touch.
Started feeling ill on 6/17/22 with slight productive cough, tired and headaches. Treatment includes observation and lovenox. Not a candidate for paxlovid.
Missed second dose (extended time between doses)/ It has been 5 months; This spontaneous case was reported by a nurse and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Missed second dose (extended time between doses)/ It has been 5 months) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Missed second dose (extended time between doses)/ It has been 5 months). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Missed second dose (extended time between doses)/ It has been 5 months) had resolved.        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.   No concomitant medication was provided No treatment medication was provided
2 days after receiving vaccinations below mom noticed tiny bumps and redness both lower extremities. Pt had similar rxn after vaccinations at 2 mos of age.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored (Merck) VARIVAX (dose and route not provided). Lot information of (Merck) VARIVAX was provided as lot# J014131, expiration date: 07-NOV-2015 and/or lot# K016132, expiration date: 24-SEP-2016. No adverse effects reported. This is one of several reports received fr0m the same source. Additional information has been requested.
On October 15, 2018 at around 11 am patient was injected via IM both FLUZONE HD and PNEUMOVAX 23 on the left arm 1 inch apart. But, came back on the 17th and showed her pinkish swollen tender left arm and it felt warm around the injection site. I told her to put some ice pack (4 inch band) and she said it disappear the following day. And she said until the 20th of October it was a little bit itchy.
patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad that evening , had 1 emesis episode and felt "crummy" with fatigue/weakness/sweats/malaise for 3 subsequent days without recorded fever, rash , change in color of urine but decreased oral intake and began to feel better 3/14 Sun, she then awoke with Heart racing and presented to our ER 0300 3/15 with A fib with RVR which resolved after approx 30 min while receiving IV fluids in ER without other treatment.  She was treated and released to followup here today 3/17/21 at our office.    I noticed on routine ER labs that she had elevated transaminases (ALT/AST)  in 300 unit range (normal up to 40-50) which she has never had on previous panels with normal bili, alk phos , and otherwise normal CMP.  At the time of followup her EKG was normal and she has had no further symptoms but transaminases are redrawn and she is advised not to get her second Covid shot.    Patient is elderly CHADS VASC score is 1, nonsmoker , family hx of heart disease.
hip pain/Arthritic pain; This case was reported by a physician via sales rep and described the occurrence of pain in hip in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included ulcerative colitis. Concomitant products included mercaptopurine.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in hip. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the pain in hip was recovered/resolved.   It was unknown if the reporter considered the pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had receive the 2nd dose and within 3 days he experienced hip pain. No trauma was identified till the time of reporting. The pain was described as arthritic pain. The hip pain was treated with anti-inflammatory and resolved after three weeks. The reporter consented to follow up. This case has been linked with case US2019227101, reported by the same reporter.
two month old female patient received Pentacel vaccine in the inner thigh; bleeding during administration, hit a femoral vein because blood came out; Initial information received on 22-Jul-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a two month old female patient who experienced bleeding during administration, hit a femoral vein because blood came out (vaccination site haemorrhage), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE via an oral route for prophylactic vaccination.  On 15-Jul-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ018AAA and expiry date: 10-Dec-2020) via an intramuscular route in the right inner thigh for prophylactic vaccination.  On 15-Jul-2020, the patient developed a non-serious hit a vein because blood came out, bleeding during administration (vaccination site haemorrhage) on the same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was a case of actual medication error due to vaccine administered at inappropriate site. A two month old female patient received Pentacel vaccine in the inner thigh.  Details of laboratory data not reported.   Final diagnosis was vaccination site haemorrhage.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was not reported.  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.
Red, raised rash on skin of left underarm. Pt complains of itching. Pt complains of pain. Pt encouraged to see her PCP, apply hydrocortisone cream over the counter, and take Benadryl 25 mg if itching persists.
RECEIVED PFIZER VACCINE AFTER BEING FULLY VACCINATED WITH JANSSEN COVID 19 VACCINE; This spontaneous report received from a consumer 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905638 and 20210909424.
After receiving the 6th vaccine, client slid off chair and slumped on the floor but did not completely pass out. He was pale and clammy. A 2nd nurse and myself helped get him to a supine position with knees bend and a pillow propped behind his head. He stated feeling dizzy and nauseated. When questioned, he admitted to not having eating anything yet that day. I turned a fan on to have air blow on his face. After 5 minutes, he wasn't feeling nauseated, and a 3rd nurse got him a juice box to drink. He voiced feeling better once he finished the juice. We continued to have him lay in supine position for 5 minutes longer. At that point, another nurse and myself helped him to a chair where he sat for an additional 5 minutes. Before client and parent left, multiple nurses (myself included) reinforced that he needs to eat a good meal before coming to future immunization appointments.
PATIENT STATES FELT LIGHTHEADED BUT RESOLVED. WATCHED AN ADDITIONAL 5 MINS TOTAL 20 MINS
Chills and red rash that appeared on vaccinated arm starting the night the vaccines were given. Patient presented to pharmacy the Monday following and the rash had almost diminished completely
I got a fever and chills really bad the night I got the vaccine. It's been two days and I still feel bad, but I think it's getting better.
flu one time; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media.  This case involves a patient of an unknown demographic who experienced flu one time (influenza), when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu one time (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Adverse Event that happened:  11/18/2021 I was woken up out of my sleep by my brain feeling like it was being electrocuted.  It was extremely painful, i thought I was going to die.  All I could do was moan and pray for it to stop.  It continued for approximately 2 minutes and kept coming back for 10- 15 second shocks.  This happened for 30 minutes.  They continued throughout the day.   11/19/2021 - one at approx 9:45 am. 2 pm. another zap.  7:10 p.m. Lasted approx. 2 minutes, I remember my dog staring at me.   11/20/2021 woken at 3:30 a.m for approx. 2 minutes with zaps, 6:30 am woken  for another 2 zaps, one came and then when it ended another one started.  6:40 a.m. another zap for approx 1 minute, 10:08 a.m. a few more zaps lasting 10-15 seconds 11/21 7:37 am - a short one, 6:36 p.m. a 10 second zap,  6:47 p.m. a 7 second zap, 7:50 p.m. another 15 second zap, 9:18 p.m. a 20 second zap, 9:25 p.m. a 10 second zap, 9:42 p.m. 8 second zap and 11:17 p.m. 5 second zap. 11/22 some happened during the day too busy to write down all 11/22. 4:15 10 seconds 11/22 11:20 pm 15 seconds 11/22 11:28 been having them off and on for last 8 minutes 11:38 pm 1 minute     11/23 8:31 am. 8 seconds 11/23 9:37 am 11/23 9:54 am  11/23 2:34 pm 11/23 3:06 pm 11/23 3:14 pm 11/23 6:11 pm More happened but didn?t keep track  11/24. 6:03 am.  11/24 10:09 am  11/24 11:07 am 11/24 1:49 pm 11/24 3:50 11/24 6:50 11/24 8:04 11/24 9:27 11/24 9:57  11/25. 1 am 11/25 4:30 am. 20 seconds 11/25 4:50  11/25 4:56 11/25 3 more times  11/26 sometime during the night 11/26 11:41 am 11/26 7:31 pm 11/26 11:00 pm off an on for 15 minutes   11/27 woken up a few times through the night 11/27 9:17 am lasted at least 30 seconds.  11/28 - no zaps  11/29 10:37 pm  Pressure on right side of brain.   11/30. 12:51. A few zaps 11/30. 9:52 pm. About 5 in a row  12/1 9:33 am  top back of right side  12/2 sometime during the night 12/2 3:41 a couple of zaps 12:2 3:50   12/3. 10:25 am they are quick shocks now not the long and bad ones at first. More toward the back top right corner of my head.     12/5  4:30 pm had a little pressure on the left side and then went to the right ride  12/6. 4:05 pm  12/7. 8:21 pm. A few quick jolts. Right above right ear toward the back of the head  12/7. 11:09. Pressure on top right side of head and behind right eye 12/7. 11:29. Quick zap  12/8. 9:44 am couple of zaps  12/9- 12/12 I didn?t keep track  12/13. 8:25 very strong one    The largest one felt like someone was electrocuting my brain from the inside out.    I had pressure behind my right eye after. Its always on the right side.  My right eye has constantly been dried out. Not usual. Been wearing contacts for years.  A little nauseous at times.   Treatment, went to see Dr. (neurologist), she processed blood tests and had me get an MRA.  Both the tests came back normal
-Immediate redness and itching along with rash -Treated in the ER with Pepcid and went home and took Benadryl for 48 hours -Sent home with an EpiPen  -Injection site is red, swollen, and itching still (10/9/23)
itching & rash (both arms & chest)  started 10  minutes after injection; treated by paramedics on site with benadryl 25 mg po; VS monitored for approx 15 minutes- remained normal, slightly elevated temp, lungs sounds clear,  hot flashes throughout afternoon. About 45 minutes after injection took 1000 mg tylenol and 800 mg ibuprofen.  additional 50 mg benadryl  and 800 ibuprofen at bedtime for continued rash & itching. Next day symptoms still present, but minor. injection site became red, warm,  tender to touch with small knot,  8-00mg ibuprofen taken in the morning and then 50 mg benadryl & 800 mg ibuprofen taken at bedtime.  Day 3, slight itching, faint rash remains,  injection site remains red, warm,  tender to touch with small knot,
Patient fainted about 5 minutes after administration.  Patient became aware within 30 seconds. Paramedics arrived and did vitals.  Patient was then released on his own accord.
Patient came into the clinic for a Moderna booster (3rd shot). The actual vaccine given was 0.25 ml of Janssen. Patient was notified of the error on 2/17. Spoke with patient on 2/18 and she was not experiencing any adverse reactions.
Redness, swelling, and pain on left breast. Began day after vaccine and continues today.
Aches and pain throughout body (mild) same day as injection. Swelling at injection site, and redness 4 in across and 3 inches in height still on 5-5-21. On 5-4 SEVERE body, bone and joint pain. Swelling and pain in injected arm that went up through shoulder and neck. Lower back, rib, elbow joint, hip, tail bone and arm pain. Low grade temp 100.7. Fatigue and headache Body pain ended on 5/5, swelling,redness and pain, itching still at injection site.
Progressive redness and swelling of left thigh over 2 days to 18x22cm then resolved. Treatment was Zyrtec and Ibuprofen.
Patient is 62 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Case number PHEH2015US026945, is an initial spontaneous report  received from a nurse on 22 Dec 2015. This report refers to a 47 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 12 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Shingles; This is a spontaneous report from a contactable physician reporting on behalf of 6 patients. This is the 6th of 6 patients reported. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. It was reported that event took place after use of product. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
School Nurse reported VR was anxious, saw reddened blotch on VR's neck and noted the VR was touching the area a lot on when walking the VR to the school-based clinic, before VR was vaccinated. Reddened area was again noted when entering observation, the clinic station that follows vaccination. VR was closely monitored for 30 minutes in the observation station. No change was noted during the 30 minute observation. When the mother was contacted she said that she was not surprised and that she also gets red botches in the same area when anxious.
My daughter has a allergy to eggs, yesterday june 16  2008 she received her 4 years vaccine (MMR), (POLIO) and (DIPHTHERIA, TETANUS and PERTUSSIS) and shortly after having her vaccines (15-20) she had and allergy reacction to the medicine I was told the she react to the MMR vaccine the contains egg, she was coughing, stomach cramps, itchy rash, swelling of the eyes, face, ears. this happen in my way home, when back to the facility and the give her, epi, benadryl and openex. after that they call, 911 and send us to the Hospital where they give her albuterol 3 treatments, and prednisolone. the Primary Provider there was MD, ED Attending, and the Primary Nurse was RN, Registered Nurse. 7/21/08-records received for DOS:6/16/08-DC DX: Anaphylaxis. Presented to ED with shortness of breath times two hours. Wheezing, peri-oral urticaria, non-productive cough, face and ears turning purple.
achiness; really sore arm; small headache; spikes a low grade fever every night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), VACCINATION SITE PAIN (really sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), VACCINATION SITE PAIN (really sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night). At the time of the report, PAIN (achiness), VACCINATION SITE PAIN (really sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 F.         Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-054611 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054611:for first dose
CO came to me at 1105 C/O fast heart beat and feeling a little SOB, thinking she was possibly having an anxiety attack. She was scared to get the COVID-19 vaccine. Then she said she did feel SOB and throat feels tight. I grabbed the EPI pen and injected 0.3mg into lateral right thigh. Brought patient to our emergency room, administered Benadryl 25mg (2 caps) po. Started IV NaCl 1000 mL in RAC. Administered famotidine 20mg/2ml IPV over 2 minutes. Currently on slow IV drip, 2nd bag. Patient is doing well. She was initially shaky after the EPI pen but throat did not feel tight less than 10 minutes after injection. Currently is relaxed as I monitor her. Vitals have been stable.