chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and Treatment medication information was reported. It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was also reported that the administered doses experienced an unknown temperature excursion during unspecified time frame on unknown dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was not involved.; Sender's Comments: US-009507513-1707USA007394:
This spontaneous report as received from a health care worker refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Merck) (Lot#0306AE as reported) instead of ZOSTAVAX  sometime between the dates of 07-JUN-2012 thru 29-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse events reported at time of the report. It was unspecified if the patient had sought medical attention. This is one of two reports from the same source (the other report MARRS # 1207USA010810). Additional information has been requested.
Dizziness; I can't breathe either; It's very hard to sleep/can't sleep/insomnia; This is a spontaneous report from a contactable consumer (patient) reporting himself. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration in left arm on 12Mar2021 11:00 AM (age at vaccination was 60 years) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included bipolar disorder from an unknown date and unknown if ongoing. Concomitant medication included clonazepam (CLONAPAM) 0.5 mg orally every day taken for anxiety from an unspecified start date and ongoing. The patient previously took Depakote for sleep disorder. On an unspecified date the patient was feeling how long the dizziness from taking the vaccine lasted. How long can a dizziness from the vaccine lasted. She also felt like she could not breathe either. The patient also reported that she should not be dizzy and informed she did not take anything to be dizzy. She was feeling very dizzy. On 12Mar2021 at night he could not sleep; It was very hard to sleep. The doctor added Trazodone three days ago and he still could not sleep. He felt energized but he was only getting two to three hours of sleep at night. He was scheduled to get the next dose of the vaccine on 01Apr2021. Patient had not received any other vaccine within 4 weeks. No investigation assessment reported. Outcome of the event very hard to sleep/can't sleep was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Got the vaccine, within 24 hours she started running fever that was 100-101.5 which she took Ibuprofen for and it disappeared.  Every part of her body that is normally painful became worse from aching.  Both of the vaccine injection sites felt like somebody was stabbing her in the arm.   The injection site itself was swollen the majority of the time, sore muscle.  After she got over the physical pain of the vaccine, she ended up with sciatic nerve issues and still trying to get over that.  She did take Ibuprofen for the pain and aspirin.   Everything has calmed down except for the sciatic nerve pain.  She is back to her baseline from before the vaccine.  She would say that the pain from the vaccine was bad as her mother's shingles.   She did notify her doctor but had power outages and problems, but did take her pain medicine which helped.
TOTAL BODY RASH IMMEDIATELY AFTER VACCINES GIVEN NO OTHER ADVERSE REACTION
Administered 8-6-07 reaction started this morning. Redness and heat to right arm.
Patient developed hives on his R thigh and his back the evening after receiving the vaccine. No other symptoms.  By the next day, the hives on his back had dissipated, but the R thigh (at the location of the vaccination) persisted with an urticarial lesion.   Patient had a very similar episode (documented only by a phone call to our clinic, not a clinic visit) the year prior with the seasonal influenza vaccine (Fluzone Quad)
Information has been received from a physician (also reported as a nurse) concerning a 9 week old male with no pertinent medical history and no drug reactions/allergies who on 15-JAN-2010 was orally vaccinated with the first dose of ROTATEQ (2ml, lot # 663144/1449X). Concomitant therapy included PREVENAR, DTaP (unspecified) (-) Hib vaccine (unspecified carrier) and IPOL. The patient experienced diarrhea on 20-JAN-2010 and loose bowels on 21-JAN-2010. On 21-JAN-2010 the patient was also fussy, spitting up and not eating. The patient was seen in the office and a stool specimen was sent to the lab on 21-JAN-2010. The lab report was positive for rotavirus. At the time of report the patient had not recovered. Additional information has been requested.
Pt has allergic reaction with hives / rashes all over body predominently around the NECK and BACK area. Rash slowly spread and Pt visited Dr after a month 10/20 and Dr prescribed Steriod to help with rash and helped sustain the reaction and visited Dr again on 11/01 to get a steriod cream to help with Itching and rash
This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm), PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift), CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm) and MYALGIA (After 2nd dose, he had more soreness.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy.On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced MYALGIA (After 2nd dose, he had more soreness.). On 03-Aug-2021, the patient experienced PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift). On an unknown date, the patient experienced LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm) and CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm). At the time of the report, LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm), PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift), CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm) and MYALGIA (After 2nd dose, he had more soreness.) had not resolved. The patient stated that he had worsened pain in arm  and could feel the soreness on a daily bases. Patient race information contain Black. The patient stated that some time in late July early August, his pain in my arm became unbearable, while he was helping unload a container. He stated that it has gotten to the point where he can't lift anything weighting around ten pounds above his waist without experiencing severe pain. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-295912 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:  On 01-Sep-2021: Significant Followup. Vaccine information updated. Patient's race information and relevant history updated. New event-condition aggravated included.
Per Admit HPI: "(Name withheld) is a 81 y.o. female patient of (name withheld) MD with history of COPD, hypertension, hypothyroidism, and hyperlipidemia presented with COVID.   Patient reports she started feeling unwell with body aches about 2 days ago and tested positive for covid yesterday and that is why she came into the ED.  Patient reports she has been SOB for a few years and that is not new for her.  She had her first two vaccines with the last one being a couple years ago, but she has not had any boosters.   In the ED vitals are as follows, temperature 98.2, blood pressure 143/84, heart rate 81, RR 18, and oxygen saturation of 99% on 2L NC. Labs results were significant for creatinine 1.53, H/H8.9/27.8. The rest of the CBC and CMP were within normal limits. Troponin negative. Chest x-ray showed no change in the right upper lung scarring. CT pulmonary arteries showed no acute PE, aortic dissection, or other acute cardiopulmonary findings, COPD with several scattered foci of mild pulmonary parenchymal scarring, most prominent in the right upper lobe surrounding a surgical clip, unchanged. Patient was given dexamethasone and symbicort. Patient admitted for observation."   Clinical Summary Patient was admitted to hospital and treated with supplemental oxygen.  She maintain sats greater 90% on her home dose of 2 L.  Once confirmed that she is already on home oxygen her remdesivir was stopped.  She was treated with dexamethasone and will complete course at discharge.  She was also started on Mucinex, vitamin C, vitamin D, and zinc which will be continued at discharge.  She will continue her home Symbicort and Spiriva.  Anemia profile was obtained and was unremarkable.  Prescription for p.o. ferrous sulfate was provided as patient ran out.     Patient was seen and examined on day of discharge and is safe for discharge to home.  Patient states that she is feeling much better and is ready to go home today.  Labs and vital signs reviewed and are stable. Discharge instructions were provided to patient and all questions were answered. Patient is to follow-up with PCP in 5 to 7 days.    Discharge diagnosis COVID Chronic Hypoxic Respiratory Failure Hyponatremia Normocytic anemia COPD HTN HLD Hypothyroidism Alcohol Abuse
Moderna vaccine was expiring at 4:22AM on 5/19/21 (but it was till in the refrigerator), on the same day at about 11 AM the pharmacist inject patient with the expired vaccine. Attention was brought to patient the following day, no adverse side effect per patient. A pharmacist spoke with a representative at Moderna (case #MOD21-091951), we were advised against revaccination. We will follow up with patient in the next week.
Patient was unsure of actual date of reaction. Only reported it to the office on 6/23/20 Pain at injection site is mild-moderate. Worse when using the arm but does not affect ROM. Noted red mark at site of injection, about 3 inches in length. Site is warm to touch with mild itching.
Hearing loss in right ear; Feeling of losing equilibrium; This is a spontaneous report from a contactable consumer (patient) via a company representative. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number not reported), as dose number unknown, single, for COVID-19 immunisation. On an unspecified date, the patient experienced a feeling of losing equilibrium and hearing loss in right ear occurred shortly after receiving the COVID vaccine. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Swelling on one side of the jaw; Hardness on one side of the jaw; Warmth on one side of jaw; Redness with no swelling on the other jaw; huge mass on her chin noticed about a month ago; mass is warm to touch,one area on left jawline,4 raised areas on right jawline, one area on each upper cheekbone; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling on one side of the jaw), JOINT STIFFNESS (Hardness on one side of the jaw), FEELING HOT (Warmth on one side of jaw), ERYTHEMA (Redness with no swelling on the other jaw) and MASS (huge mass on her chin noticed about a month ago) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, INSULIN LISPRO (HUMALOG), INSULIN ASPART (NOVOLOG), DILTIAZEM HYDROCHLORIDE (CARTIA XT) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling on one side of the jaw), JOINT STIFFNESS (Hardness on one side of the jaw), FEELING HOT (Warmth on one side of jaw), ERYTHEMA (Redness with no swelling on the other jaw), MASS (huge mass on her chin noticed about a month ago) and FEELING HOT (mass is warm to touch,one area on left jawline,4 raised areas on right jawline, one area on each upper cheekbone). At the time of the report, SWELLING FACE (Swelling on one side of the jaw), JOINT STIFFNESS (Hardness on one side of the jaw), FEELING HOT (Warmth on one side of jaw), ERYTHEMA (Redness with no swelling on the other jaw), MASS (huge mass on her chin noticed about a month ago) and FEELING HOT (mass is warm to touch,one area on left jawline,4 raised areas on right jawline, one area on each upper cheekbone) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicine :Zyrtec, Doxycycline , steroid injection   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: New AE added in Follow-up
Severe chills, body aches, 101 fever, swollen lymph nodes, sore throat, headache, diarrhea, exhaustion, extreme arm pain, lasting 72+ hours
Pt. stated, "I felt fatigue, like fainting, 5 minutes after getting vaccinated."  Vital signs taken, BP 108/67, HR 81, O2Sat 100%, R 18.  At 3:30pm, pt. reported feeling better, fatigue is almost gone.  At 3:55pm pt. stated, "I feel better, I think I'm good to go home."  At 3:37pm pt. went home with family member.
Menstrual spotting and vaginal cramps, runny nose and mild sore throat one week after vaccination. I had common side effects (headache, backache, high body temperature and fatigue) for a couple of days right after injection.
After I gave him his second dose, he stiffened up and started to fall out of the chair.  I called his name and he was unresponsive.  I had my staff call 911 and the store management.  After about 30 seconds he became responsive and I asked him what his name was, what day it was and where he was at.  He answered all correctly.  He had no memory of the inicident.  EMT's arrived to evaluate him.  He had a slightly low blood pressure but no other findings.  Pt refused to go to HCF.
injection site is blotchy and has small bumps like a little bit of a rash right over where I had it; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Feb2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 07Feb2023, outcome "unknown", described as "injection site is blotchy and has small bumps like a little bit of a rash right over where I had it". Additional information: the patient received Prevnar 20 last Wednesday and did fine after that. The morning of this report she woke up and looked in the mirror, and the injection site was blotchy and has small bumps like a little bit of a rash right over where she had it. The area was probably like maybe it extends like 2 inches down from the injection site.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Pt woke up @ 7PM fr nap; mom states pt turned white & began gag; mom states p/pt quit gagging, pt went limp; took pt to hosp; dx by ER md as vasovagal response due to fever; arrival @ ER t101.7;
Patient received second dose of Gardasil vaccine around 1400. At 2300 the same day while patient was at work, patient became very dizzy, hot and nauseous and states she almost passed out. There were no other symptoms reported. Pt works at a medical facility as an RN and to Zofran with relief.
Shooting left arm pain presenting approximately 3 days post injection lasting 7-10 days. Pt then progressed to diarrhea for 10 days (treated with IV fluids and oral antibiotics) and fecal sample was taken. Arm pain increased to a radiating pain from left deltoid to elbow. Diarrhea resolved after antibiotics and arm pain is still present. Fecal sample yielded campylobacter diagnosis.
This case was reported by a pharmacist via call center representative and described the occurrence of skin warm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced skin warm and swelling. On an unknown date, the outcome of the skin warm and swelling were unknown. It was unknown if the reporter considered the skin warm and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient advised the pharmacist that she experienced swelling and slight warmth to the touch. The pharmacist did not provide lot number and expiry date for dose 1 of SHINGRIX. For tolerance to 2nd dose of SHINGRIX, refer case: US2019032444, reported by the same reporter, for the same patient.
On October 9, around 11:00 am, I noticed I had a sore throat, then very tired, as day progressed, sore throat worsened. No fever though, at first. Cough that started on the 9th as well. Sunday, the 10th, the sore throat had dissipated. Still coughing and tired and not feeling well.  In that afternoon, started a fever. I called OB/GYN as a I was pregnant at the time. Sunday, the 10th, I only took two or three doses of fever medication, and the fever was gone on Monday, just lasting cough. I had a raspy cough and sinus congestion started bad on Sunday.  The cough lasted until about October 15th. The sinus congestion lasted until October 14th. I couldn't find any Sudafed that my OB said I could take when pregnant, so I just rode it out.   Expected due date: 3/17/2022 - Pregnancy History - Dec 2018 - Pregnancy with birth; Pregnancy that was lost Feb 2021. This is my third pregnancy.
This spontaneous report as received from a female patient of unknown age refers to herself. In 2008, the patient received first dose of an unspecified human papillomavirus (HPV) vaccine (manufacturer unknown). She received the second dose three months after the first dose and the third dose two years after the second dose. No adverse event was reported.
Patient mistakenly given Rotavirus vaccine after 15 weeks of age. No treatment required. Will continue to monitor patient via parents for any adverse reactions.
Experienced what felt like pain within normal limits for the first 48 hours after flu shot. On the 3rd day the pain was so bad I could not sleep. Pain was excruciating at times. Not able to shampoo hair, get dressed or move arm in any way without experiencing extreme pain. Decided to wait to see if there was any improvement over time. Pain has subsided some but I have very limited range of motion. I can only raise my arm chest high and not at all above my head. At times my shoulder will just start throbbing - without moving it at all. Brought this up to my physician on November 21 and physical therapy was prescribed. She was concerned that frozen shoulder would develop.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (dose and frequency were not reported). No adverse effect reported. It was also reported that the product was back in proper storage at the time of call. It was also reported that there was a previous excursion for same product Yes 1st excursion 48F for 5.5 hours 2nd excursion 56F for 28 hours 3rd excursion 61 F for 64 hours was it administered. The temperature range was 61 F and time frame was total cumulative time 97.5 hours. No further information was provided. This case is linked to case 1404USA014432 and 1404USA014697 (same reporter link). Additional information is not expected.