chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.61. Concomitant products were not provided. On 11-Jan-2021, Excursion time was 02 PM, temperature was 35, total doses given for the day was not provided, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021. On 11-Jan-2021 no hourly temperature recordings available. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Mom states pt riding in car seat eyes rolled back w/difficulty breathing for about 2-3 minutes; mom placed finger in pts mouth then had full recovery; pt taken to ER; neurological exam nl;
Patient reported feeling tightness/numbness in arm after injection. Upon observation, she said she also felt it in her back. Injection was correctly placed into the delt (made the "c" with my hand). I made sure she was having no numbness, she could feel me touching her. No bruising or redness. Patient did divulge that she had severe pain with first pfizer dose as well (had trouble moving arm for a few days).   Followed up with patient on 8/7, she said the numbness was okay but that she was having "pain in her skin everywhere". She described it as feeling like the flu, when I pressed her she said it was not muscular but the skin itself. Injection site is also sore again, she is unable to lift arm.  Reported normal adverse reactions such as malaise and fever.   She said icing the injection site helps. She is alternating ibuprofen and acetaminophen but doesn't feel it's helping.  Advised patient to continue analgesics and icing and to check in with physician if continues.
fatigue, nausea, fever, headaches, joint pain, chills, dizziness
Patient developed numbness and tingling in feet followed by weakness.  Nerve conduction and EMG showed evidence of a sensory neuropathy with absent sural response and prolonged F-waves.  Lumbar puncture did not show elevated protein or cells.  Her symptoms have persisted since June.  She has been unable to return to work.  She packs and ships orders.  She is recovering her strength with physical therapy and plans to return to work in October.
expired dose of act-hib was given to a 9-year-old male patient with no reported adverse event; Initial information was received on 13-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 9 months old male patient who experienced expired dose of act-hib was given to a 9-year-old male patient with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (Rotateq) for Prophylactic vaccination.  On 11-Jan-2023, the patient received a dose of suspect hib (prp/t) Powder and solvent for solution for injection vaccine at dose of 0.5 ml  lot UJ600AA via intramuscular route in the left thigh.  On 11-Jan-2023 the patient developed a non-serious event of expired dose of act-hib was given to a 9-year-old male patient with no reported adverse event (expired product administered) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of act-hib was given to a 9-year-old male patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired dose of act-hib was given to a 9-year-old male patient with no reported adverse event.   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 guidelines. 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.
t103-104 24hrs post vax lasted 203 days; pt devel gastroenteritis; hospitalized x 2 days;
Pt received 2 vaccines & developed nausea, abd pain, aches & headache. Felt feverish - did not take temp. Also notes soreness & redness at site of vaccines. Symptoms began 12 hours after vaccine administration.
Mobile clinic nurses vaccinating at residence of homebound person.  Vaccinated family as well and failed to catch that young male family member was not 18 years of age but was 17 years of age.  No adverse reaction to vaccine at time of administration but EUA not does not allow for vaccinating under 18 with this vaccine.
Patient stated that upon injection they felt a tingling on their tongue with a metallic taste in their mouth that went away after a minute or two on its own. Patient also experienced some mild nausea during the 30 minute waiting period post vaccination, felt well enough to go home and would treat with some ginger ale and saltines.
DTaP expired 04/29/2023, was administered on 05/05/2023.  Nurse did not realize error until after immunization had been administered.  Parent notified at 1809 on 05/05/2023, immediately after error was caught while nurse finished charting for the day.  Local reaction of redness, hardness, and area raised started 05/06/2023.  Area of redness increased in size 05/07/2023.  Redness has mostly resolved as of 05/10/2023.
Patient was scheduled at Clinic on 02/08/2018 for 5 year old vaccines. Child presented to clinic accompanied with his mom and mom's boyfriend. Immunization record received and reviewed.  Nurse determined child needs Dtap, MMR, Varicella, Flu and Hepatitis A#2. Nurse completed immunization assessment. Mom denied any serious complications from previous vaccines, NKA. Temp 98.4, WT=44lbs.  3:17pm Vaccines administered per protocol. Child asked to wait. 349Pm  CSR comes back to nurses and informs nurse child has a rash on abdomen. Client brought back to exam room. Noted child's ears are red, rash on abdomen and child is scratching his head NP and RN enter exam room with emergency kit. V/S taken B/P 84/62, pulse 120 Benadryl 0.5ml drawn up by NP, administered by RN in the right deltoid Epinephrine 0.2 ml drawn up by Np and administered by RN on right deltoid 350pm EMS is called by RN speaks to 911 operator. Operator gave instructions of no food or liquids, to lay child on side if vomits> nurse informed EMS on their way to the clinic. 355pm Ems arrives, escorted to exam room child's pulse 88 356- 400pm EMS with child and parents. Parents have declined to have EMS take child to Emergency room for monitoring 405pm EMS leaves 0406pm parents and child in lobby 412pm NP assessment sleepy but rousable, lungs clear, easy respiration, No rash on abdomen, truck or back, face 422pm pulse ox 97-98, no rash noted sleepy pulse 90 waiting in lobby 430pm pulse 90, lungs clear, no rash on abdomen, face or trunk, sleepy, discharged F/U on 02/09/2018 telephone call @355pm to patient, to cell number listed in profile. Spoke to step father. States child had a temperature in the morning , he was given Tylenol. Temperature resolved, sent to school. child is fine.
Started getting a headache the same night of taking the vaccine. Had a temp of 102 degrees. Nausea and arm was very sore.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown demographics. On 24-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J006921, expiry: 09-AUG-2014, dose: 0.5 ml (milliliters) injection. On 24-SEP-2014, patient received an expired dose of PNEUMOVAX 23. No adverse effect has been observed or reported. The pharmacist was hesitant to provide the patient's identifying for information due to corporate regulations. The outcome of received expired dose of PNEUMOVAX 23 and no adverse effect has been observed or reported is unknown. There was no product quality complaint involved. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of fatigue (became a little tired) and vaccination site pain (it was a little painful in her arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041L20A) for COVID-19 immunization. The patient's past medical history included COVID-19 August 2020. On Jan 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 11, 2021, patient experienced fatigue (became a little tired) and vaccination site pain (it was a little painful in her arm). On Jan 13, 2021, fatigue (became a little tired) and vaccination site pain (it was a little painful in her arm) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment provided: Tylenol. Sender's comments: Very limited information regarding these events have been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Received vaccinations at approx. 1030 on 7/30/2020. Mom states at approx. 2230 on 7/30/2020, he started having some itching and redness to the injection site on his right arm. He noted generalized hives and his throat felt "scratchy" shortly after this, but denies any swelling, difficulty breathing, or further symptoms. Mom gave an initial dose of Benadryl 50mg at symptom onset, then another dose of Benadryl 25mg the following morning (7/31/2020) at approx. 0800. She reports the hives and all symptoms had improved as of 0800 on 7/31/2020.
Severe Deltoid muscle pain in the left arm, inability to move my left arm without pain in the muscle when it contracts even in slightly, unable to lift the left arm or move it away from my side without severe pain, the left arm feels extremely heavy when I try to move it and I have swelling of my left arm and hand, the injection area is not sore or painful when touched but the arm muscle is  even after 4 days from when I received the vaccine
Per employee at Assisted Living, patient woke up the day after her influenza and COVID vaccination with elevated blood sugars. Employee stated that it happens usually when patient has an infection. Highest blood sugar was 350. The next day she woke up with a rash on her right arm.  It was red and swollen.  She was taken to Urgent Care and diagnosed with Cellulitis. She was prescribed Cefalexin 500mg for 10 days as well as Floragen for 10 days.
On 2-19-08 received Tdap instead of Td, patient's age is greater than 64 years.  There were no adverse events.
Pain at injection site and then maculopapular rash developed anterior to injection a few days later exam: Skin: non-icteric erythematous, maculopapular, patchy dermatitis over left upper arm anterior to site of injection. Mildly indurated, warm and tender.
After vaccines given, MA checked pt and she  noted  patient to have redness on r thigh. Ma then went to get provider and when provider entered patient room , she  noticed that left thigh also had redness. PA placed ice packs to area and monitored pt .   Pt continued with redness and was released by provider.
Patient received pediatric dose of Havrix 720 U/ 0.5ml; claim was processed and accepted fine through pharmacy system.  When patient came back to pharmacy in Jan 2023, an additional claim for second dose was processed, but rejected by computer system.  This is when error was noted.  Patient reports no issues, concerns.  Pharmacy verified with GSK that patient will need to restart Hep A vaccine series.
Patient started feeling dizzy and sweating almost immediately after the vaccine. Patient requested water and an alcohol swab to smell.
That morning, I saw blood in my stool. It wasn't a lot. I suffer from hemorrhoids so thought it was from that. I had diarrhea an hour later and then I had double the blood at that time. Another hour - no more diarrhea, but just blood. I went to ER - they actually  did a CT scan - and that did not show internal bleeding. The doctor diagnosed it as Diverticulitis. He gave me a cream for hemorrhoids and said to go home. I was in there for four hours. I didn't make it to my car - I passed out in parking lot. I had been bleeding steadily - - going to the bathroom for it every 5 minutes - while I had been in ER. They admitted me. They did an MRI and a colonoscopy and endoscopy and they gave me a pill - electronic pill and it takes pictures of my inside. There was no findings in any of the tests. They started me on antibiotic - and gave me a stomach coating - Pantoprazole. I bled the rest of that day but the next day, the bleeding stopped. I was discharged from the hospital on June 23. I was also showing - white blood count. The white blood count, from when I had been admitted to the next day, it tripled, it got really high. By the time they tested for it though, nothing came back in the test for what the infection would have been - came back negative. I received a blood transfusion for the blood lost. Have had no more bleeding. Continuing still for two or three times a week, my stools are totally different - they are really diarrhea - really loose. Two weeks ago, I got what I thought was COVID - headache, more diarrhea, throwing up and a cough. I got tested and had COVID test  - August 16 - result was negative on the 17th. Just quarantined a bit. Tylenol for headache and Robitussin for the cough. Those symptoms lasted for about 8 days. I think it was COVID.
This spontaneous report as received from a licensed Practical Nurse on 13-DEC-2016, concerning a 4 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 20-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number reported as: M015699) (dose number, frequency, route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1612USA008581: US-009507513-1612USA008582: US-009507513-1610USA010040: US-009507513-1612USA008584: US-009507513-1612USA008585.
chicken pox; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix. In May 2019, 1 day 12 hrs after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient experienced two rounds of chicken pox since receiving the Shringrix vaccination. The first chicken pox started about 36 hours after the injection. The second round of chicken pox began 2 days ago from the date of reporting. The patient asked, have you heard of this type of side effect before.
Numbness on right side of face (same side as shot).  Numbness around neck, especially the base of neck with a "heavy" feeling.  No loss of functioning.  Improvements seen approximately 20 hours following shot with reduced symptoms in these areas still persisting.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. The patient received second booster dose. It was reported that the HCP mentioned because of miscommunication as a coworker told that there were some lot number whose expiration dates had been extended, patient received expired dose. Treatment information was not provided.
Client had nausea and vomiting  begin 2 minutes after injection. Client vomited x2. Provided supportive care, juice, water. Symptoms alleviated within 5 minutes. No other signs or symptoms reported or noted. Client reported she had not eaten anything yet today - reports only consuming coffee. Observed for 30 min and released.
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer or other non health professional and concerns a 25 year old female local ID: VIV 9518. The subject's weight and medical history were unknown. On 10-JAN-1995 12:00, the subject received typhoid vaccine oral ty21a (capsule, hard) as prophylactic vaccination. Concomitant medications included unspecified hepatitis vaccine, polio booster and tetanus vaccine. On 11-JAN-1995 02:00, after receiving the first pill, subject experienced fast heart palpitations, numbness, tingling in arms and legs and chest cramping. She was taken to the hospital and given Benadryl and an unknown medication. One and a half hours later she felt better. Action taken with TYPHOID VACCINE ORAL TY21A was unknown. The outcome of fast heart palpitations, numbness, tingling in arms and legs and chest cramping was resolved on 11-JAN-1995. This report was serious (medically significant).
Palpitation; Heart is constriction; Hard to breathe sometimes; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), CARDIAC DISCOMFORT (Heart is constriction) and DYSPNOEA (Hard to breathe sometimes) in a female 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 PALPITATIONS (Palpitation), CARDIAC DISCOMFORT (Heart is constriction) and DYSPNOEA (Hard to breathe sometimes). At the time of the report, PALPITATIONS (Palpitation), CARDIAC DISCOMFORT (Heart is constriction) and DYSPNOEA (Hard to breathe sometimes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication reported  No Treatment medication reported
On 3/25/21 developed a painful rash on my left side of my chest and back that has blistered.  The areas were sore like a strained muscle days before the rash started.
Route: lntradermal; pain in her whole upper lef arm; pain at the injection site; This spontaneous report as received from a consumer, who was a friend of the patient, refers to a 75-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-OCT-2019 (reported as four days ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intradermally (dose, lot # and expiration date were not reported) (incorrect route of product administration) and with influenza virus vaccine inactivated (unspecified) (manufacturer unknown) intradermally (dose, lot # and expiration date were not reported) both for prophylaxis.  On an unknown date in 2019, the patient experienced pain at the injection site and in her whole upper left arm. The patient did not seek for medical treatment.   At the time of the report the patient was still in pain, the outcome of pain at the injection site and in her whole upper left arm was reported as not recovered.  The relatedness between the events and the suspect vaccines was not reported.
Patient called pharmacy eve of her shots & said her left arm (Pneumovax arm) was hurting and felt like there was an "egg-shaped lump" in her arm.  She took Tylenol & it felt "a little better, but still hurt".
Patient states she had increased heart rate, sweaty palms,trouble talking and felt like she may pass out for about an hour.  After that hour passed she states she felt perfectly fine.