chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered a expired dose of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 19-OCT-2023, the patient received the 1st dose of Bexsero. On 19-OCT-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: patient was administered a expired dose of Bexsero). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 The pharmacy technician reported that a patient was administered a dose of Bexsero which was expired which led to expired vaccine used. At the time of reporting, the dose had not been repeated. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
face swelled; upper body was covered in hives; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 39 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 14:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Raynaud's phenomenon from an unknown date and unknown if ongoing, milk allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included propranolol (PROPRANOLOL) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; quetiapine (QUETIAPINE) taken for an unspecified indication, start and stop date were not reported and vitamin D, ma taken for an unspecified indication, start and stop date were not reported. The patient experienced swelling of face on 11Mar2021 14:30 with outcome of recovered, upper body was covered in hives causing urticaria on 11Mar2021 14:30 with outcome of recovered. Therapeutic measures were taken as a result of this with Benadryl.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23, lot # N003993 with expiration date on 20-OCT-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1705USA011819:
Extremely itchy red bumps around ankles and feet. Also on palms of hands and on tops of fingers. Also reoccurrence after 3rd dose 3-5-11, not as intense.
The caller has received 4 shots; The caller has received 4 shots; She mentioned that she had some moderate diseases as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "The caller has received 4 shots"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "She mentioned that she had some moderate diseases as well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Transferring agent stated, "I have caller on the line she is a consumer. So, she mentioned after getting vaccinated she was travelling outside the company and she had some adverse events. She mentioned that she had some moderate diseases as well (no details available regarding the disease hence, captured as event as per the verbatim). She had some side effects after getting vaccinated so, she also wanted to reported this because she mentioned that even though that she got vaccinated she still experienced or she had some experiences for an adverse event".  QR Comment: As manufacturer name could not be probed over the call hence, is this a Pfizer product tab left unchecked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: updated event from Extra dose administered to "off label use' and booster". Updated dose description.  Follow-up (21Apr2022): This is a follow-up spontaneous report received from a contactable consumer (Patient) reported for herself that: Program ID: [159558]. Updated information: Classification added, Protect Confidentiality Unticked. New event She mentioned that she had some moderate diseases as well added, LRN added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient inadvertently received a third; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On 3rd September 2021, the patient received the 3rd dose of Shingrix. On 3rd September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported. The patient received a 3rd dose of Shingrix which led to extra dose administered. The reporter denied to follow-up.
Moderna Vaccine 1/6/21 at 9:15 am.  At 4:00 that afternoon, patient started complaining of slight cough and diarrhea. Later that evening, patient stated he started with body aches, shortness of breath, chilling, and inability to sleep.  Patient did not take temperature that night.   The morning of 1/7/21, patient had 100 degree F temp, feeling exhausted, with nausea.  Patient went to work but was unable to stay due to exhaustion and nausea. Patient went home and slept most of day.  Patient went to work on 1/8/21, only complaining of headache.  Pt feeling much better on 1/8/21.
Severe inflammation around eyes lasted four weeks; heart palpitations lasted four weeks; upset stomach lasted two weeks; GERD lasted two weeks; tongue and throat swelling lasted three weeks; pain in back lasted three weeks
Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 2 patients. This is 2nd of 2 reports.  A 25-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer stated his main concern was even though the vaccine had been authorized. The vaccine was only given vaccine on the side of the road. People were dying from the vaccine more than from the virus. He gave out some percentage of people that could die from the virus vs from the vaccine. The percentage of death rate was 0.00045% from the virus. The percentage of death from the vaccine was 6.6%. There were many people reporting side effects such as bell's palsy, whole body convulsion. Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who died 15 minutes after receiving the vaccine. He said it's sad these were front line worker who were facing all these side effects. The outcome of the event was fatal.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021155151 same reporter, drug, event, different patient; Reported Cause(s) of Death: Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.
LEFT DELTOID SWOLLEN RED HOT, PINPOINT RASHES ON BOTH ARMS, NAUSEA Narrative:
no additional AE; ROTATEQ  was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-SEP-2023, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis after temperature excursion (lot# 1968393, expiration date: 24-MAY-2024; strength was not provided). The vaccine was improper stored at 8.9 degree Celsius for 12 hours 20 mins on 14-AUG-2023 and at 9.4 degree Celsius for 8 hours 20 mins on 28-AUG-2023 (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sudden onset of lower leg weakness bilateral with numbness and absent DTR's in lower extremities occurred while awaiting to dance hula in a hotel, was taken to hospital 7/8-9/10 observation overnight, discharge the fd - AM walking. FHX - Father with viral illness contact with daughter x 2 days.
Two days post vax, pt experienced a fever of 103F, a total body rash and a red, hot, swollen leg.
On 10/15/2021, I started to have serve pain in my lower back, that completely crippled me to where I could barely walk. This lasted for about two days. Since then, I have repeated off and on of the same symptoms, once a week.
Patient was administered Hepatitis A #2 vaccine too early. No adverse signs symptoms were noted. Mother wanted this brought to the staff's attention.
Office visit - NP Chief Complaint: seen today, 3/4/2021, complaining of or following up for Fever (started today), Nausea (has nausea today), Abdominal Pain (c\o upper and lower abd pain has been constant for the last 3 days started on monday), Diarrhea (states she had diarrhea all day yesterday but has had no bm today), and Fatigue (pt states she is feeling very week today) . HPI Patient comes in to the office complaining of severe abdominal pain.  States the pain started on Monday and was less severe, stating the pain has escalated to a 9/10 today and "unbearable."  Pt. States she had diarrhea for a 24 hour period yesterday, but denies any bowel movement today.  Patient also complains of severe fatigue and states nausea with emesis a "few times over the last 4 days."  Patient states that on Tuesday her pain became "a little better," but states since that time it has worsened and is severe at approximately 1230 this morning."  Patient states she did not go to the ER because she "knew she had an appointment today."   BP 134/84 Pulse 104 Temp 101.6 °F (38.7 °C) Resp 20 SpO2 94% Abdominal:     General: There is distension.     Palpations: Abdomen is rigid.     Tenderness: There is generalized abdominal tenderness. There is guarding and rebound.     Comments: Tinkling bowel sounds noted to RLQ and RUQ with hypoactive bowel sounds to LUQ and LLQ.  Abdomen is rigid and guarding and rebound pain are noted with examination.     triaged to Emergency room:  HPI  75 y.o. female who presents with complaints of right upper quadrant pain since Monday reports is moderate to severe sharp better right upper quadrant without radiation better with rest and worse with movement   FINAL IMPRESSION     ICD-10-CM ICD-9-CM 1. Calculus of gallbladder and bile duct with acute cholecystitis without obstruction  K80.62 574.60 2. Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC)  A41.9 038.9     995.91   Final Disposition Transfer to Another Facility current inpatient at Hospital
Pain on my joints, arms & legs/anxiety/decreased libido, pain on my muscles/memory loss/memory trouble remembering recent info/vision problem/concentration: loss of/vision: blurred
Numbness and tingling : tips of all fingers (index worst) and toes: began three days after flu vaccine. History stage 4 ovarian cancer. Treated June 02 to Nov 03 with Caneoplatinum and Taxotene (No pain history or ongoing symptoms)
pt brought to ED by EMS; found to be positive for COVID; AHRF; COVID pneumonia; SOB and hypoxic (O2 saturation in the 70s) per EMS; found to have elevated troponin; ST elevation MI; respiratory status required intubated; still did not improve; transitioned to DNR; comfort care; hospice where he passed away
Administered HBV at 11:30 AM; immediate symptoms: itching in throat, ringing in ears, eye lid itching, cough. 45 minutes later, SOB with chills (after Epi pen, Benadryl, Cortisone). Sent to ER: O2, Prednisone.
Patient experienced neck pain following flu shot on the next day. Arms and legs began hurting and has continued for 2 weeks. No fever.
tested positive and also received the vaccine from COVID-19; tested positive and also received the vaccine from COVID-19; This is a spontaneous report from a Pfizer sponsored program. This contactable physician reported similar events for the physician herself and a patient. This is the second report, the patient report of 2 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The physician reported there was another person in her clinic that tested positive and also received the COVID vaccine on an unspecified date with outcome of unknown.    The information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021000799 Same reporter, same drug, different patients
This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Lot Number: ER8737) via an unspecified route of administration in Arm Left on 05Apr2021 as single dose for covid-19 immunisation. Medical history included blood cholesterol increased, back pain. The concomitant medication was not reported. On unknown date, The patient experienced my pain went away and so did is his. how did that happen therapeutic response unexpected, wrenched his back , soreness in his arm. Patient went through a screening process earlier. Her husband and she had first dose on 05Apr2021 within 5 min of each other. He didn't get much of a reaction but patient got nauseated, chills, and felt really lowsy for Thursday, Friday, Saturday and Sunday. But, here's the weird thing that happened to both. He threw his back out and was in acute pain, he was on muscle relaxers and all this other stuff. He could hardly move. In July 2017  she had a bad spell, and had a lot of chromic pain. Patient had to have surgery on shoulder, hit my left side pretty hard, stepped in a pothole. It happened around over the weekend. she noticed her husband was moving around a lot better. Not Tylenol or anything. Now his back went completely out the week before we went to get our shot. It's like you waved a wand and they are both pain free.  The outcome of the events soreness in arm and therapeutic response unexpected was unknown and the outcome of the event Back pain was recovered.  No follow-up attempts are needed. No further information is expected
fever 105 & beginning about 8PM 21JUN93 w/extreme fussiness; fever subsided by 24JUN93 & generalized rash appeared; given IM ATb in ER 21JUN93 for dx of ear infect; dx roseola & a severe otitis media;
Fussy, lethargic, stopped cooing-for 2 weeks after last shots.
gained 3 pounds water weight; tired; Immediate pain upon injection; nose breathing very restrictive; Huge weird rush from neck and entire head; Very high heart rate and blood pressure; Very high heart rate and blood pressure; Very red face; Very hot in head, fever like feeling; Very hot in head, fever like feeling; very foggy in head; random sharp pains over body; on and off headache pain; face puffy; cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 09:15 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 58-years-old). Medical history included hashimoto's hypothyroidism from an unknown date and unknown if ongoing, Covid-19 (March-April 2020 sick with Covid19), allergies to some pain medicines and to some antibiotics from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen; colecalciferol (VIT D [COLECALCIFEROL]); cyanocobalamin (VIT B12); DHEA (5mg) and Thyroid medicine all were taken for an unspecified indication, start and stop date were not reported. Patient reported that Immediate after receiving the first dose of vaccine on 19Apr2021 at 09:15 pain upon injection and a minute or less, nose breathing very restrictive. Huge, weird rush from neck and entire head, feeling that she better lay down. Very high heart rate and blood pressure. Very red face. Very hot in head, fever like feeling. 1 hour after on 19Apr2021 had very foggy in head, random sharp pains over body, on and off headache pain, face puffy, cold. Next day on 20Apr2021 gained 3 pounds water weight and tired. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment on site nurse area to treat the events. Patient had no covid prior vaccination. Not tested for covid post vaccination. The patient was recovering from the events at the time of report.  No follow-up attempts are needed: information about lot/batch number/expiry date cannot be obtained.
At approximately 1052 client informed RN that her, "tongue felt dry" and she was "having difficulty swallowing".  Client denied having chest pain, headache, dizziness, tingling of face, difficulty breathing, or shortness of breath. At 1055 first set of vitals taken: BP 180/100, HR: 70, RR: 18, client A&Ox4, Lead RN visualized client's oropharynx which was red with slight swelling, skin was warm, dry and normal color for ethnicity. Client denied any pertinent medical history. Client stated she has a history of "panic attacks and anxiety" and stated she was, "feeling very anxious about the vaccine". Client stated she had history of anaphylaxis to penicillin, rocephin and an antidepressant she couldn't remember the name of, possibly Latuda. Client reported she takes an anti-anxiety medication but she couldn't remember the name. Client ambulated to zero gravity chair without assistance or incident. At 1100 client stated her throat still felt tight and continued to have difficulty swallowing, client continued to deny SOB, or difficulty breathing, capillary refill <2 seconds, skin warm, dry and normal color for ethnicity. Lead RN educated client on need for further intervention which client consented to.  At 1103 EMS activated by co-lead RN. At 1104 Lead RN administered 50mg IM diphenhydramine to client's right deltoid. At 1107 BP 138/98, HR 74, RR 12, A&Ox4, skin warm, dry and normal color for ethnicity,  client denied SOB, CP, HA, dizziness, difficulty breathing. Client stated her throat was, "feeling better".  At 1111 care turned over to EMS. At 1115 client signed AMA from EMS. 1121 vitals taken BP 136/90, HR 70, RR 16. Client reported resolution of throat tightness, dry mouth and difficulty swallowing. Client stated she felt, "much better". Lead RN educated client on ED precautions. At 1124 client ambulated away from the site accompanied by her husband, on her own accord and with a steady gait.
tested positive for Covid; This is a spontaneous report from a contactable consumer (wife). A 58-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14May2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19May2021, 5 days after vaccination, the patient was tested positive for COVID. She received her first COVID vaccine on 14May2021 but was exposed to COVID on the same day. The reporter asked for guidance on when she can receive her second vaccine dose. The reporter stated that they already spoke with her HCP who instructed her to get the second dose as soon as possible. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 12May2021, SARS-COV-2 test: positive on 19May2021. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
Normal day and everything was fine after 2nd dose. Got home and had a mild temperature early in the evening and so I took an ibuprofen and everything was fine, ate dinner, and then as the evening progressed my temperature went up and got as high as 106. I grew up in the era that if your temperature was over 103 it was serious. Here, for whatever reason, no one thinks it's serious. I continued to take ibuprofen so I could sleep. I slept until I tolled over onto my arm and it was pretty sore. Next day, my temperature dropped down to 103 and I spoke with my doctor and he wasn't concerned about anything major so he told me to drink lots of fluids and rest and that's what I did until my temperature was back to normal. Other than that, I had no cough, sneezing, only a fever. Altogether it lasted a week. No other issues because I knew what to do.