chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness in my chest, in my arm, between the shoulder and on my ear; I feel like warm/ it is like getting hot/ My body getting hot; I also feel itching; This is a spontaneous report from a contactable reporter (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 26Jul2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that, on 30Jul2021 had redness in my chest, in my arm, between the shoulder and on my ear, I feel like warm/ it is like getting hot/ my body getting hot and I also feel itching. Reporter stated, "I did get the vaccine on Monday this week, I was fine until today that is Friday, so I have like redness in my chest, in my arm, between the shoulder and on my ear, it is like getting hot and my body getting hot, so I feel like warm, and I also feel itching." It was the Pfizer, the first shot yeah. Reporter stated, "No, 'just want to know what's going on' (incomplete sentence), yeah yeah." Reporter stated, "What I am going to do 'this is what I want to understand, what medicine should I take or what I am going to do?" Reporter seriousness for the events were unspecified. Outcome of all the events were unknown.  Comment: Reporter type could not be probed hence captured as reporter or other non-health profession in tab.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Immediate local reaction at the injection site.   Bleeding of less than 1 cc and raised 2x2 cm bump.  Benadryl and symptoms resolved.
I received my first dose of the Moderna COVID-19 vaccine on 12/29/2020 and to date, have had mild symptoms, which I have reported via the V Safe Check Ins. To date, I experienced some injection site soreness with redness for a few days post vaccine and had minimal swelling on the day after vaccination.  This evening, I noticed a sudden onset of severe swelling at the site of the injection accompanied with redness, which as noted above, had previously resolved approximately 3 days post vaccination. In addition, the area surrounding the injection site is now warm to the touch and is mildly itchy. In taking  the temperature of the injection site versus the rest of the arm, it is running about 3 degrees warmer than the rest of my arm.
Blood clots in left leg. Put on Eliquis until August and told to stop. Blood clots returned 11/11/2021.
Doctors appointment on May 18th to address right arm swollen lymph node identified on May 13th.  On May 19th I experience the lost of my sense of taste and after my doctor's visit,  Steroids and NAC were prescribed.   It is now June 7th and I have yet to regain my sense of taste.
Employee was receiving her booster for Covid vaccine.  Janssen vial was opened and one dose was extracted and administered to employee.  It was then discovered that the vial expired on 12/21/21.  Date vaccine given was 12/28/21.  Pharmacy provided vial to me in error as some had been extended in expiration date but this was not.
complained of shortness of breath, HR 122, BP 130/80  O2 84% long hx of COPD 2 puffs albuterol (pts own) immediate improvement to 97% sat HR 115 husband with pt advised to contact pulmonologist re: 2nd dose
Vivotif capsules internal packing had a line, and it was partially open; A spontaneous report was received from a pharmacist on 19MAY2023 regarding a female patient of an unknown age who found that the "Vivotif capsules internal packing had a line, and it was partially open" (PT: Product packaging issue) prior to the administration of Vivotif (Typhoid vaccine live oral Ty21A) capsules (lot number: 3003832, expiry date: 29FEB2024) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 10MAY2023 at 09:16 PM, the patient received her Vivotif capsules pack from pharmacy. Reportedly, the capsules internal packing had a line, and it was partially open. Additionally, the patient would be traveling next month, so vaccination course was not yet started.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: Vivotif capsules internal packing had a line, and it was partially open (product packaging issue). Considering the nature of event, the causality of product packaging issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment. No follow-up is required as there was no administration to consumer and no associated adverse events. Quality assurance is aware of the product complaint.; Sender's Comments: Vivotif capsules internal packing had a line, and it was partially open (product packaging issue). Considering the nature of event, the causality of product packaging issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment. No follow-up is required as there was no administration to consumer and no associated adverse events. Quality assurance is aware of the product complaint.
NO ADVERSE REACTION. BUT THERE IS A HIGH CHANCE PATIENT WAS GIVEN ZOSTAVAX INSTEAD OF VARICELLA NO ADVERSE REACTION.
Patient experiencing multiple swollen and sore lymphnodes on side of immunization site for multiple days following immunization
Next morning, child suddenly developed dizziness, headache, nausea,"passed out" and hit head.  Vomited shortly after, seen in my office with no specific physical findings. Prescribed Zofran. Vomited three more times at home per mom, by evening was feeling better and keeping down crackers, headache gone. Per mother, no sequelae and no one else ill at school with similar symptoms.
fever to 100.8 around 1pm on 12/25, lasted for 1-2 hours.
4 minutes after the vaccine my heart rate increased drastically.  I also felt faint.  I stayed with EMTs for 1.5 hours until I was comfortable to leave.  Heart rate came back to normal over this time period.  There were still moments when I felt flush/faint-like.
Black out, headache, fever, weakness, and dizziness.  9/22/08 WCC dated 9/3/08 and vax info received from PCP. Healthy adolescent with normal G&D. Vax given. ER record received dated 9/6/08 with Final DX: Drug reaction-medicinal substance given or taken. UTI.  Vaccine Reaction. Pt presented with c/o onset of fever, injection site pain, R hip/flank pain, severe dizzinessand profound weakness.  Pt passed out and fell at home with another episode of near syncope. PE (+) for CVA tenderness. Pt given pain meds and abx and D/c.
t105 26JAN95 sz-ER trip; 28JAN95 nl exam; 30JAN95 rash lasting 24 hrs; 6FEB95 seems OK; pt blue-still running fever-hard to wake once sleeping-sl twitching while asleep;
Had the two shots for it, they made me sick; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for himself/herself The age at vaccination was not reported. The patient received Shingrix shot and got sick. No other information was reported. For tolerance to 2nd dose, refer case US2021AMR137806.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137806:Same patient, Same reporter, 2nd dose
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 74-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash. On an unknown date, the outcome of the headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash were recovering/resolving. It was unknown if the reporter considered the headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced macular or papular rash. The patient had been in an out of doctor's office getting tests done for the symptoms she had experienced. No further details were provided. This case has been linked with case US2018124901 (husband's case), reported for by the same reporter. The reported batch number 3AF99 for SHINGRIX did not exist and updated to 3AF9E as per sales database.
Muscle pain, indigestion, painful joints, diarrhea, liver overload and rash.
Lightheadedness. Cold sweat. Similar to hypoglycemia. Slight pallor. BP and HR remained normal at ~108/68 and HR 82. Recovered after ~10-15 minutes. Took in fluids and was able to walk and leave after ~15 minutes.
Dizziness, severe headache; laid down in dark room for 2 hours, felt somewhat better
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: 32-36°F (Fahrenheit degrees) for 8 hours and 12 hours respectively. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005002: US-009507513-1702USA005003: US-009507513-1702USA005001.
supplied patient identifiers for the patient involved in the adverse event; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (supplied patient identifiers for the patient involved in the adverse event) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (supplied patient identifiers for the patient involved in the adverse event). At the time of the report, VACCINATION COMPLICATION (supplied patient identifiers for the patient involved in the adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that the caller then supplied patient identifiers for the patient involved in the adverse event initially filed by the previous agent. No concomitant medication reported.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient is a 79 yo who was transferred to the MICU for hypoxemic resp failure due to aspiration, SBO and septic shock. He has history of relapsing CLL, diverticulitis s/p Hartmann's with reversal, diastolic heart failure, A fib/flutter, Type 1 DM HTN, moderate aortic stenosis and adenocarcinoma now s/p adhesiolysis, and partial transverse colectomy in March 2021, recent dx of b cell NHL in the inguinal lymph node. Hepresentedon May 20 2021 for Abd pain. Prior to this admission, he was discharged on 5/17/2021 for SBO, requiring enemas and NG suction. Pt improved transiently, and again had worsening abd pain, distention, poor appetite and nause. Pt's abd CT showed air fluid levels. Pt admitted to the medical service, however, had difficulty placing NG tube. Pt followed by surgery, noted to have BMs, remained NPO. Yesterday, pt patient acutely became hypoxic needing NRB. This was accompanied by tachycardia to 130s and altered mental status. Pt had an episode of emesis, brought to ICU, NG placed with > 1L of gastric fluid removal, had markedly distended abdomen, hyoxic on NRB and HFNC O2. Overnight, pt continued to deteriorate, hypoxic, hypotensive on pressors. He became uremic and continued to deteriorate, through out the night. His daughter attempted to come early this am (3am) but was involved in MVA, transported to hospital. Per his daughter, he was adamant he did not want intubation or heroic measures nor additional surgeries. He was DNR. Due to his comorbidities, we will honor his wishes but continued aggressive measures short of intubation or CPR. Despite fluids, pressors, pt progressively deteriorated and died at 1157am
I got my 1st dose of vaccine on May 11th and after 2 days from receiving my 1st dose (May 13th)  I was rushed to ER because of severe back pain. I was at work at that time and was just tossing my lab coat in the laundry when I move my upper body up I felt a severe back pain, so severe that I could not stand up, put my weight on my back or feet because of the pain I was experiencing.  I could not walk or move my torso as the pain was excruciating. I was wheeled out of office using an office chair and was brought to the emergency room.   Right after being released from the ER my right leg calf and right arm  started hurting and feeling warm to touch. Aside from having severe back pain I had to deal with soreness and pain on my right leg calf and right arm. I could not cross my leg or point my toes as it hurts and felt like something is gonna burst when I try to bend my knee. My right arm hurts when every I try to move my fingers to use my computer and my elbow is sore and painful too.  I could not even lift my coffee mug or book without feeling in pain. I was in bed for 3 days to rest my back. I returned to work after 3 days but with very  movements and activity.  I was given morphine and tramadol when I was in ER and was advised to take ibuprofen 800 for pain management.  Today, 06/10/22 I am still wearing a lumbar support belt, compression arm sleeve and compression socks.
DTAP/IPV liquid inserted into the Acthib vial, powder became wet but did not re-suspend, no adverse event; she did administer to patient but an uncertain amount of powder remained in the vial, no adverse event; the liquid was not a short dose, powder just appeared hardened, no adverse event; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old male patient for whom it was reported that while administering DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] an uncertain amount of powder remained in the vial (underdose), dtap/ipv liquid inserted into the acthib vial, powder became wet but did not re-suspend (product reconstitution quality issue) and the liquid was not a short dose, powder just appeared hardened (product quality issue).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS A VACCINE (HEPATITIS A); and INFLUENZA VACCINE (FLU).   On 24-Mar-2020, the patient received a first dose of 0.5mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Lot number: vial:UJ197AA, diluent: U6615AA) (Expiry date: 02-Mar-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose, product reconstitution quality issue and product quality issue.  Reporter reported product complaint regarding reconstitution of Pentacel. Reporter reported that entire DTAP/IPV liquid was inserted into the Acthib vial, powder became wet but did not re-suspend. Reporter reported that she did administered to patient but an uncertain amount of powder remained in the vial. Reporter reported product was out of refrigeration for a few minutes, taken to patient's room where reconstituted. Reporter reported that the liquid was not a short dose, powder just appeared hardened. As per Q&A section: Appearance : white or gray clumps, flakes, sand like particles and/or difficult to resuspend.  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 Directive and Module VI of the 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.
Case number PHHY2012DE052378 is an initial spontaneous report received from a physician via a Medical Information Center (MIC) (reference number: 1-299802609) on 19 Jun 2012: This case refers to a 34-year-old female patient. She was vaccinated with the first dose of RABIPUR (batch number: 496011A) on 29 May 2012. On about 05 Jun 2012, she experienced an infection and due to this infection the second dose was given on 18 Jun 2012. No other information was available.
fever; chills; A spontaneous report was received from a consumer concerning a 84-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, chills.  The patient's medical history was not provided. Concomitant medications reported were Inderal for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 12M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient developed fever between 99-99.9 Degrees Fahrenheit, as well as chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, fever and chills was not reported.; Reporter's Comments: This case concerns an 84-year-old female with NS expected events of fever and chills. Event onset occurred on Day 2 after the second dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient said she broke out in a rash and was itching.  The rash was on her trunk area.
High fever of 104.7°, stayed above 102° for three days with alternating ibuprofen and Tylenol. Continued for the next 4-5 days having 100° temperatures after initial 3 days. Ended up passing out from temp. Tired more than usual, achey body, sore arm, headache for three days.
Information has been received from a physician concerning a 15 month old patient who on an unspecified date was vaccinated with MMR II (no lot number and expiration date provided). Subsequently the patient had a stroke as "a result of receiving the MMR II". Therapy with MMR II was discontinued. It was unknown if the patient sought medical attention. At time of the report, the patient's outcome was unknown. Upon internal review, stroke was determined to be an other important medical event. Additional information has been requested.
Moderna COVID?19 Vaccine EUA Rash all over upper torso. Painful. Achy body. Shortness of breath
Myalgia Fatigue, Chills, Swollen Gland-left armpit, Stomach cramps Narrative:
Patient developed hives (urticaria) within 30 minutes of receiving his kindergarten booster doses of DPaT, IPV, and MMR.  Returned to clinic where urticaria was documented.  No face or tongue swelling, stridor or wheeze.  Vital signs stable.  Given Benadryl and observed for 45 minutes with resolution of hives.  Advised to continue treatment with Benadryl PO qid prn one week
achy muscles and joints high fever 103.2 cough headache delusional at night
PATIENT FELT DIZZY INTERMITTENTLY AFTER VACCINE ADMINISTRATION. SHE ALSO HAD VOMITTING. SHE WAS ACCOMAPNIED BY MOM. MOM SAID SHE HAD FELT DIZZY IN THE PAST AS WELL AFTER INJECTIONS OR BLOOD DRAW. SHE DID NOT HAVE ANY KNOWN HEALTH CONDITION AND WAS NOT ANY MEDICATION EITHER.
No adverse symptoms. Patient received monovalent vaccine, and was due for bivalent. This was the 3rd monovalent for this patient.
15 min. Observation ended at 4:08pm; patient complained of minute skin elevation on his left lower arm radiating to his upper arm. Patient voiced no itchiness on his arm. Benadryl P.O. given at 4:15pm. At 4:45pm, patient verbalized of slight dizziness. ER notified for further evaluation. Patient's vitals as follows: 182/101 ; HR-105/min; SPO2-96-98%. To ER per stretcher. Patient is alert and oriented, accompanied by ER nurse. ED Note: Patient is a 39 y.o. male with no significant medical history presents with an allergic reaction after his second Pfizer COVID-19 vaccine dose earlier today. Patient and his mother reports that patient received second dose of Pfizer COVID-19 vaccine shot today at about 15:50. Before the 15 minutes observatory period was complete, patient and his mother noted that his arms became red, he was diaphoretic, and he developed "'chills and goosebumps."  He denies itchiness or shortness of breath. He was given Benadryl at 16:10 today and requested a bed to observe him. His reaction prompted transfer to the ED. Patient reports he feels improved at this time. He denies taking any new medications and notes he had no issues after the first vaccination dose. Reevaluated patient. Patient feels improvement and is ready for discharge. The patient is comfortable with further observation of his symptoms at home.  I discussed our workup, answered all questions and made sure there were no other concerns.  I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms. Discharge Meds: famotidine 20 mg BID, fexofenadine 180 mg daily, prednisone taper x 6 days.