chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 month old female patient administered QUADRACEL vaccine, no AE; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a Physician via non-healthcare professional via Medical Information (Reference number- 00855626).  This case involves a 15-month-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], (product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 12-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA and expiry date: 26-Aug-2022) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on same day).    It was reported "Caller stated that they administered QUADRACEL to a 15 month old. Caller said that when she put the QUADRACEL in the Florida shots, it shows that the polio counts as a dose and the dtap counts a dose, but she wants to double check that the QUADRACEL is okay or if they need to revaccinate with DAPTACEL. A clinic reporting a 15-month-old female received Quadracel and not the prescribed DAPTACEL. The caller reported that the Practitioner order was correct, but a staff member used the incorrect vaccine".  At the time of report, no adverse event was 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 the 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.
vaccinated with Pfizer in March 2021. Having, headaches, chest congestion, coughing and body ache. Has no fever.
fever of 102, watery eyes for 4 days; seen by MD on 2FEB92 put pt on pediaprophin;
legs felt like jello; pressure on chest lasted for 4-5 hours; sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCULAR WEAKNESS (legs felt like jello), CHEST DISCOMFORT (pressure on chest lasted for 4-5 hours) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (legs felt like jello), CHEST DISCOMFORT (pressure on chest lasted for 4-5 hours) and PAIN IN EXTREMITY (sore arm). At the time of the report, MUSCULAR WEAKNESS (legs felt like jello), CHEST DISCOMFORT (pressure on chest lasted for 4-5 hours) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Pt. called nurse hotline on 9/28/2022  (5 days after receiving vaccines). He stated that he hade the senior Flu vaccine and the BioNTech COVID vaccine 5 days earlier, 9/23/2022. He reported that the day after the vaccines, he noticed some hives. By 9/28/2022 the hives had gradually progressed from head to toe. Said he saw the doctor and was prescribed Zyrtec and Steroid Cream. He said he just wanted to call us to report the incident.
Headache, Myalgia, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, chills, fatigue, arm soreness with swelling, redness and itching at inj site  Narrative:  Chills, fever, headache, arthralgia, myalgia, fatigue, nausea, swollen glands (so SOA), red swelling itching at injection site. Took tylenol, kept hydrated; feels s/s are resolving.
Patient reported generalized warmth five minutes after vaccine administration that resolved within 2 minutes.   She reported R finger paresthesias about 7 minutes after vaccine administration that resolved within   2 minutes. Patient did not develop any worsening symptoms throughout 15 minute observation period.   She remained well appearing throughout and was reportedly asymptomatic upon leaving.
suspected vaccination failure; shingles / have them now; 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.   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 was unknown and the outcome of the shingles was not recovered/not resolved.   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. The patient received Shingles vaccine couple of years ago from the date of reporting. Ater receiving Shingles vaccine, the patient had shingles. The patient stated that, it sucked. 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 confirmation of shingles were not provided. This case had been linked with case US2021AMR184719, reported by the same reporter.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # K007977, expiry date: 03-JUN-2016) (route: subcutaneous) (expired vaccine used). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Client phone call 1/15/10 to this interviewer - had chest pain 1 day after getting shots. Pain on left side chest and arm. Described no dyspnea or diaphoresis states pain "off and on" unable to define number of episodes per day. States improved when lying down. Has not seen physician or gone to ER. Advised to contact physician and got to ER if further symptoms.
I'm 63 years old and have not had a menstrual period in 6 years, but on March  9th I started spotting after having two days of sore breasts. The spotting turned into a full-on period, lasted 6 days, and came back again the following month.  I had called my GYN and she tested me for cancer etc. and put me on progesterone, however that seems to not be working just yet.  Most of all this is super annoying.
After receiving the 2nd dose (Phizer-BioNTech) on 2/19 at approximately 2:50pm, I felt fine, until the following day, when I woke up on 2/20 at 8:00am. At that time, I felt extremely tired/groggy/fatigued with an intense headache. I also experience some slight muscle/joint pain. Tylenol seemed to help dull the pain, but not fully relieve it. I am not prone to headaches or migraines. I slept for most of the day on 2/20.  On 2/21, the headache and muscle/joint pain subsided with the exception of some mild fatigue.
Arm sore. Arm remained warm/hot to the touch for approx 36 hours. Headache started Friday pm (12 hours after Vacc). Ibuprofen ineffective. Saturday, 5 am (21 hours post vacc), migraine headache conditions: Sensitive to light, nauseous, unbearable  headache. Ibuprofen ineffective. Could not eat or drink all day. Used ice packs on head. Sunday. Headache persisted throughout the day. Ibuprofen ineffective. Used ice packs. Was able to go outside and run errands. Started consuming drinks. Ate something at 1 pm. Monday morning, Woke up and headache was mild. Ibuprofen effective. went to work, able to eat and drink. Extremely tired and still feel muddle-headed. Forgot to bring ibuprofen, headache started reappearing at 1 pm. Arm soreness lasted approx 12 hours.
Vaccine administered 11/12/2008 12:30pm.   At 1:30pm  patient became sleepy, tongue tingled and lips became edematous.  At 2pm he went to his pcp.  Was evaluated for 3/4 hr all tests normal.  Symptoms persisted.  At 4:30 to St Lukes Hospital ER evaluated.  Received IV BENADRYL and PREDNISONE.  Sent home at 7- symptoms resolved.  To continue oral PREDNISONE daily x5 days and f/u with pcp.
1/26/2023 I was really exhausted and thought I was dehydrated. I progressively got mentally duller and weaker. My heart rate was between 107-120 after resting for 30 minutes. My blood pressure was high. My heart rate would not go down. I went to the hospital. My temperature was 101.8. I was tested for Flu, COVID, bloodwork and gave me an IV and some TORADOL and TYLENOL. Flu was negative, COVID was positive. I never received results on my bloodwork. I felt much better after they treated me. I had some coughing and some upper respiratory congestion. I was prescribed PAXLOVID and started taking it 1/27/23. I finished the five day course and still had some upper respiratory congestion and runny nose for a few days. 2 days after I finished the PAXLOVID, I had a temperature of 100. It went back down and I was fine. I have been fine ever since.
01/02/2022: History of Present Illness: The patient presents with SOB, cough and positive for COVID-19 at the PCP yesterday per EMS. Patient had productive cough. EMS called earlier in the week, but patient declined transport. Degree at onset mild. Degree at present moderate. Exacerbating factors: none. Associated symptoms: Fever, chills and cough. Denied vomiting and denies abdominal pain. H&P Chief Complaint: SOB X 1 week, DX with COVID-19 4 days PTA and history of CHF. An 88-year-old male with past medical history significant for CAD status post CABG and CHF presented to the hospital with complaint of cough and shortness of breath. The patient recently had a positive COVID-19 test (done with his primary care provider). He continued to have significant shortness of breath so he decided to seek emergency evaluation. The patient found to be hypoxic on arrival to the emergency department with O2 saturations around 84% on room air. The patient's respiratory status declined while in emergency department eventually requiring BiPAP (noninvasive ventilation for support). The subjective data difficult to obtain due to the acuity of the patient's illness.
pain and soreness in upper shoulder area, pt stating she does not have full range of motion in left arm. some weakness. Still ongoing 1 month after receiving vaccine
12 hours after flu shot, child awoke with severe headache, abdominal discomfort, vomited once. No fever, diarrhea, respiratory or local reaction repoerted.  Described head feeling like it would explode & said it was different than the migraine headaches he experiences.  Child received no treatment & was fine after 4 hours.
Client given normal saline instead of COVID-19 Pfizer vaccine. Client re-vaccinated 4/24/2021 at 1350. Given ER8735 IM in right deltoid. Expiration 7/31/2021.
Heat, tenderness, erythema left upper arm no fever- probable allergic reaction.  Could not rule out cellulitis.
Patient experienced dry throat, felt anxious and dizzy. EMS was called and a banana and benadryl were administered by the clinical team.
Information has been received from a consumer concerning her daughter who on unspecified dates was vaccinated with the first and the second 0.5ml dose of GARDASIL (lot #, route and site of administration not reported) respectively. On an unspecified date after the second vaccination, the patient developed a hot, baseball sized lump on her shoulder near the injection site which took several days to go away. Unspecified medical attention was sought via called the physician. At the time of this report, the patient had recovered. No further information is available.
Brought here by mother because of edema and erythema of LLT. He has been scratching this site since then. Lower grade fever during the night. Pain of left thigh. Skin Sx erythema on left lower thigh. Musculoskeletal Sx.Edema and erythema on left dorsal left lower thigh. Small dry scab of the skin on site of past injection. knee intactr, passive and active movement are preserved. Minimal limping on left side noticed, able to jump without any problems.
Patient noted rash on trunk.  No itching.  Rash still apparent on Monday 12/5 when he returned to health dept for evaluation.  Rash has not gotten worse since first noted.
Information has been received from a physician concerning a patient who was vaccinated PO with the second dose of Rotateq.  Subsequently the patient experienced diarrhea.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
pt recvd vax;MD states LOC,striking head on a door,hands clenched open & shut for a few secs; BP 96/58, given IV lactated ringers, remained hypotensive for 1 1/2 hrs; v few times, observed until approx 1pm;
pt recv vax 12JUL96 & the next day 13JUL96 it was reported that the pt lt arm & lt side of face became swollen;also numbness occurred on the lt side of face;pt began taking motrin;
Diarrhea all night; Didn't even want to eat because of the nausea; Achy all over from neck to nipples; Chilly at night; Headaches; Arm hurt where she got the shot; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Clostridium difficile infection, Anxiety and Depression. Concomitant products included VANCOMYCIN for Clostridium difficile infection.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night), HEADACHE (Headaches), VACCINATION SITE PAIN (Arm hurt where she got the shot) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night), HEADACHE (Headaches), VACCINATION SITE PAIN (Arm hurt where she got the shot) and NAUSEA (Nausea) had resolved.            Concomitant products used included anxiety medication and depression medication   The patient stated the events lasted a couple of days and then cleared up. patient was feeling very bad for two days and wanted to emphasize the severity of  feeling.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up received and event outcome is updated as recovered
Approximately one hour after receiving vaccines, baby developed a red bumpy rash to arms, legs and face.  No loss of appetite, but was fussy.  Benedryl was administered.
pt recv vax 3JUN96 & 26JUN96 pt exp t104, diarrhea, vomiting;28JUN96 pt devel a flat, red rash on back & chest;pt was examined & dx w/roseola;reporter felt that pt exp was not r/t vax;
pt recv vax 8SEP95 & on 11JUN97 pt exp shingles, which were dx by MD;
08/25 pt exp temp of 102.7, high-pitched cry, absent response to environ lasting > 1wk. 10 days later, devel stuffy nose & cough. 9/9 hospitalized for hyperventilation, diag w/ pneumonia . 9/12 admitted to ICU for 2 mos.
Pt states received SHINGRIX at Pharmacy 3/30/18. Had 3 days of intense muscle pain at site and red rash on both hands. Initially thought to be a reaction to MOBIC. See by PCP and questions reaction to SHINGRIX.
Swelling and pain at injection site initially; presented to ED following AM (0130) with pain on movement and shoulder abduction; no fever or numbness; received pain medication (Norco 5/325 X 2 tablets) and ice pack; all on left deltoid where received Pneumovax injection.
MONOVALENT BOOSTER WAS ADMINISTERED INSTEAD OF A BIVALENT BOOSTER
By morning of 4/17 injection area was hugely swollen, hard, hot to touch. He had trouble walking. Complained of pain. 4/18 injection area is still large hard and hot but is now also raised and red.
got infected with covid-19; got infected with covid-19; fractured a bone; got hurt; This is a spontaneous report from a contactable other healthcare professional (hcp).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date not reported), via an unspecified route of administration in Feb2021 as dose 1, single covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient got hurt and had fractured a bone around 3 weeks when she was due for 2nd dose (2021). So, patient waited to recover but got infected with covid-19 (2021). She was better now but asked what steps to take next regarding the dose if she should get the 2nd dose or not. She has an appointment this Saturday (date unspecified) so she would appreciate any guidance as soon as it is available. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded,  in acontext of LOE, for event Covid, other reported events unrelated.
I have had a constant spasm in my right eyeball as well as nausea and loose bowel movements ever since I received the first dose of the covid 19 vaccine.
Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired; vial was in the fridge for 3 days after the 30 day beyond use date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired), PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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 (Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired), PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired), PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use 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 (Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired) and PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use date).    No concomitant medications was reported. No treatment medications was reported.
t104 ax highest fever started 1.5 hrs p/vax-feverish off & on all night; cried & screamed @ 6AM on 11JAN92 104.5 ax starting shaking & jerking for about 15mins; was feeling much better later in day & afebrile later in day;
Vaccination 6/5/15 (R) arm; 6/7/15 sore to touch, 6/10 pain and tenderness worse, weak, lethargic; just laid around with ice pack, 6/12 gradually getting better but 4 x 8 inches redness.
This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 29-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Felt tired all day, and at night developed a painful rash around the shot area, treated with Tylenol and hydrocortisone cream.
Light headache; dizziness; Fever off and on; Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headache, fever off and on, sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Light headache, Fever off and on, Sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), light headache, fever off and on, sore arm was unknown.
The patient was very nervous prior to getting the immunization and stated that he had a fear of needles.  After receiving the immunization the patient  went to the waiting area to be observed. Approximately 5-10 minutes later he slid off the chair and hit  the back of his head. The observer alerted the staff and 911 was called. He appeared to have fainted and was unconscious for a few seconds. He opened his eyes and appeared to shake a little and sat up and began vomiting while 911 was on the phone. Paramedics arrived and tended to the patient and he refused further treatment.
p/ pt recv vax in 3/98 the pt devel approx 30 lesions all over body
Nose bleeds, headaches, low grade fever (tmax 100.1) s/p FLUMIST administration (3 days total).
Day after injection erythema and pruiritis localized to site 1X2 L upper arm. Oral antihistamine and steroid cream prescribed after days with injection.