chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial  was stored at room temperature of 69 for 23 hours.; vaccine administered to 2 patients more than 12 hours post puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered to 2 patients more than 12 hours post puncture.) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 067F21A, 016M20A and 029K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (sulfa), Drug allergy (Prednisone), Oil allergy (castor oil), GERD and Hypertension. Concomitant products included TOPIRAMATE, METOPROLOL TARTRATE (LOPRESSOR) and AMITRIPTYLINE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-Jun-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-Jun-2022 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered to 2 patients more than 12 hours post puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered to 2 patients more than 12 hours post puncture.) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date the vial was initially stored in the refrigerator was 15-Jun-2022. It was first punctured on 16-Jun-2022 at 2:00 PM. Then it was stored at room temperature around 69 F post puncture. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range was 23 hours.  The patient had not tested positive or diagnosed with COVID-19. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as no. The event did not cause the patient to seek medical care. The patient did not experience a similar event in the past.  No treatment medication was reported.
Headache; Very sore arm; Achiness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm), PAIN (Achiness), CHILLS (Chills) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication, AMLODIPINE.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very sore arm), PAIN (Achiness) and CHILLS (Chills). On 23-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very sore arm), PAIN (Achiness), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Treatment included Tylenol was reported.
After my second Covid-19 vaccination I immediately felt fine. There was minimal injection site tenderness. It all started to worsen approximately 8 hours after my shot. I lost the capacity to regulate temperature (not to the point of hospitalization), am experiencing muscle fatigue, have severe injection site soreness, and have a massive headache.
pt recvd vax 27JUL95 & 7SEP95 titer test showed a neg result @ 0.02;reporter stated pt failed to seroconvert & conversion would be 0.12 or greater (IgG);
9/12/21 Pt had a hospital admission for a positive COVID test; was treated with ABX; dc'd to SNF for continued care; pt admitted to hosp on 9/28/21 via ambulance with weakness, FTT, coughing, difficulty eating; PEG tube placed; dc'd back to SNF for continued care where she passed away on 11/16/21
Severe tenderness and swelling at site. Lasted for 2 weeks. Required medication for several days - ADVIL
Negative Mammograms for over 23 years.   Negative mammogram in 2020.  Now 09/2021 mammogram show "calcifications bilterally".  As a rule I always get my vaccinations in my left arm.  But I did receive my second vaccination in my right arm because the nurse was left handed and it was more comfortable for her.
Vaccine misadministration - client should not have received nasal H1N1 due to age.
Severe tooth ache on lower right molarand severe head ache. I feel it's due to increased pressure.
Location: flu shot clinic set up in grocery store. Received flu shot around 4:30 pm.  I started feeling nauseous and fatigued around 8:30 pm or so.  Around 10 pm I sat down on the sofa and noticed I couldn't stop shaking and shivering, and my teeth were chattering. I pulled a throw blanket over me, thinking maybe I was just cold. But I couldn't stop the shaking and teeth-chattering. That continued for 1 1/2 hours until I fell asleep curled up on the sofa at 11:30 pm. Before I fell asleep I felt feverish, and took my temp.; it was 99.6. When I woke up an hour later at 12:30 am, the shivering had stopped, but my temperature was up to 100.9, and I was still nauseous and aching. The injection site looked normal, but I couldn't tell if it was warm because I was so feverish. I took an extra-strength Tylenol and went to bed. This morning I feel fine, just fatigued. My temperature at noon today is 99.0. Injection site appears normal.
"allergy bumps"  around injection site, itchy, red, reaction about the size of a nickel currently, very fatigued, dizzy
Sore arm and her arm hurt; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm and her arm hurt) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure and Cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) for Blood pressure management, ATORVASTATIN for Cholesterol, METFORMIN, GLIPIZIDE and SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm and her arm hurt) and CHILLS (Chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm and her arm hurt) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-218784 (Patient Link).
Within about 1-2 hours I was extremely thirsty, severe headache, fatigue, lightheaded and rapid heart by 3pm I had shortness of breathe and chest pain and went home from work.  On day 2 started body ache and low grade fever, on day 3 started with nausea and diarrhea as well.  My blood pressure has also been sporadically elevated throughout.  Went to family doctor on October 8th told me to treat diarrhea with Imodium and see if that helps thought I might be dehydrated.  I felt better but still having issues with shortness of breathe and chest pain as well as not being able most normal activities (housecleaning,  walking the dog, etc.)  I am following up with my family doctor on October 19th.
Information has been received from a healthcare worker concerning a 46 year old female patient, with no known drug reactions/allergies and with a history of therapeutic phlebotomy for polycythaemia, who on 19-FEB-2009 was vaccinated with the first dose of PNEUMOVAX (lot number was unknown). The reporter stated that on 20-FEB-2009, the patient "felt ill". She also experienced soreness, redness and swelling at the injection. The patient sought medical attention via telephone. At the time of the report, the patient had not recovered. Additional information has been requested.
I had a seriously sore arm (Same as first dosage when given) that did not go away.  Three weeks after the injection a large hematoma  (bruise) appeared and my arm has continued to be achy and my hand with tremble occasionally if my arm rests in a certain position.  I live part time in State and discussed this my doctor in City.  It should be noted that the injection site was way lower than first shot.
Received DTAP and IPV on 05/05.  On AM of 05/06, mom noted significant swelling at DTAP site.  Estimates swelling at ~5in diameter, with ~2in diameter redness at center.  Patient complained of itching at site.  Given Benadryl by mom with some relief.  Otherwise gets well.
Information has been received from a consumer, who is the mother of the patient, concerning a 14 year old female who on 02-APR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 02-APR-2008 the patient experienced pain at the injection site. The mother reported that the next day the patient came home and had a bad headache, so she was given TYLENOL and was lying around the house. The consumer reported that later on that night, the patient was still complaining of the headache and that she felt nauseous, so the mother had taken the patient's temperature and it was 98.7 degrees. The mother stated that the patient was lying around the house and around 10:30 PM the patient had felt unusually warm and she had a fever of 101.3. The consumer reported that throughout the night, the patient's temperature went up and down, but she was warm all night. Per the consumer, on 04-APR-2008, the patient stayed home from school and she still feels a little warm. The consumer has not yet spoken with the physician. No further information is available and the patient has not yet recovered. Additional information has been requested.
About 2 or 4 hours after the injections, I got so tired I couldn't function or wake up. This was followed by vomiting, headaches and a general feeling of 'wrongness' physically, like I was going to get worse. Because of my history with chronic pain, vomiting is particularly painful for me because it causes my back and neck muscles to spasm.  Remove that issue and the level of vomiting was akin to the standard flu. I had to call in sick to work the next day because I couldn't wake up enough, or stop vomiting long enough, to work.  The worst of it passed in under three days. I was ready to work by the following Monday.
arm sore at site of injection with some swelling and redness - this increased the next day with some fluid accumulation beneath skin
5 1/2 hrs p/vax pt had shaking of arms, legs lasting 30 sec; cried out prior "like trembling" had 4-5 episodes; seen in hosp t102 7 was transferred to another hosp for ? of sz;
The only adverse event is that the 4th dose on this immunocompromised patient was 0.5 ml vs recent CDC guideline of 0.25 ml.  Patient reported absolutely no issues about 7 hours after administration and had no reaction, not even sore arm, after first 3 doses.  This is purely and administration error.
Information has been received from a family nurse practitioner concerning a 72 year old female patient with no known drug reactions or allergies who two years ago, in approximately 2008, was vaccinated with a dose of PNEUMOVAX 23. On the same date, the patient received concomitantly a dose of tetanus injection. It was reported that within the same day or so, the patient experienced a generalized rash, aches and felt "really sick". At the time of the report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sore arm; Minimum fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) outcome was unknown.            No relevant concomitant medications were reported.    No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) outcome was unknown.            No relevant concomitant medications were reported.    No treatment information was provided.
Pt developed severe case of chicken pox. Rx Zonimax 20 mg bid
Patient came in for flu shot but administered moderna shot. There were 2 people with similar first names. When pharmacist called for Patient, patient stepped up ( she upset because she was waiting for 20 minutes ) Pharmacist told her that I am going to give you covid vaccine vaccine, she may be did not pay attention she was upset. Patient had 5 pfizer shorts in the past, but she said she was not going to get this new vaccine.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
approx 6 days p/ vax pt exp herpes zoster rash. treated w/(MSD) & acyclovir. on 9/14/98 pt exp 4-5 lesions on hand & 5 lesions on leg.
This spontaneous report as received from a 48 year old female patient regarding herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient reported that she was prescribed with GARDASIL 9 by her physician and received the first dose of GARDASIL 9 (lot, expiry date and route of administration were not reported) 0.5 milliliter for prophylaxis, at her pharmacy. There was no adverse reaction reported. No product quality complaint was filed.
Patient has had constant pain, ache in arm since injection, no swelling, no bruising, no itching.
10 weeks pregnant at vaccination time. Woke up the next day with large red and swollen lump art vaccine site about 4 inches in diameter. Very nauseous, dizzy, and had the chills. Took Tylenol twice throughout the day. Could not eat. Went home from work early to sleep.
On same evening 10/26/19 after receiving vaccine patient developed itching and hive-like rash on her legs. Took Benadryl at home, which decreased itch enough for her to sleep. When rash and itching started spreading to rest of body came back to hospital on evening of 10/30/19. Given 50mg IV Benadryl which improved symptoms but not complete.
Information was received company representative. On an unspecified date, a patient in the 30's with multiple unspecified comorbid diseases received PNEUMOVAX 23. No adverse effect reported. No further information was provided. Additional information has been requested.
This case involves a 27 year old female patient who experienced injection left hand started to tingle (paraesthesia), left arm weak (muscular weakness) and injection site warm to the touch (vaccination site warmth), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient had no medical history, concomitant disease or risk factor. Medical treatment, vaccination, concomitant medication and family history were not provided. On 06-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7000DA and expiry date: not reported) (Injection) via an intramuscular route in the left deltoid for prophylactic vaccination. On 06-Oct-2020, the patient developed a non-serious injection left hand started to tingle (paraesthesia) and left arm weak (muscular weakness), (also reported that 20 minutes) on same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. In Oct-2020, the patient developed a non-serious injection site warm to the touch (vaccination site warmth) (few day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported that It was unknown if patients physician provided consent to be contacted. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the patient had not recovered from the paraesthesia (also reported that today left hand still tingling) and the outcome of event muscular weakness and vaccination site warmth was reported as unknown.
A report has been received from a Pharmacist concerning a 12 year old, Female patient, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown. Pharmacist realized that only around half of the FLUMIST volume was delivered to the 12 years old patient after the patient had left the pharmacy. The outcome of ONLY A PARTIAL DOSE DELIVERED TO THE PATIENT was unknown. The report was considered to be non-serious.
This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 25-year-old female subject who was vaccinated with (FLULAVAL, GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL, (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced left shoulder pain, pain going down the left arm and it was painful to move the arm.  At the time of reporting the outcome of the events was unspecified.
Got the shot and still got the shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Mar-2023 The case was received form the patient via interactive digital media. The patient got the shot and still got the shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not improves with NSAID. Tachycardia, headache, insomnia, fatigue, chest pressure.
Face broke out in red welts as well as on abdomen and leg immediately after oral vaccination. By morning the next day she had a fever of 101 and started vomiting and diarrhea.
Patient is 85y.o. male who was admitted to the hospital with mid back pain after a fall at the home few days prior. He has moderate-advanced dementia. Retired psychiatrist. Lives in - memory care unit.  Found to have T12 fracture. Ortho spine recommended surgery (considered an unstable fracture with small chance of fragment mobilization). Family decided against surgery in the complex context of advanced age and dementia. Eventually a vertebroplasty was performed. He has no pain. He needs to wear CASH brace unless in bed or sitting.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tachycardia-Mild
Developed headache, muscle aches, faint feeling & nausea 30 min after getting vaccine.  Pt felt this way the next morning also.  Pt left work sick & went home @ lunch & slept the rest of the day.  Pt felt better by lunch time on 12-9-09.
Heavy flu-like symptoms for about 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Heavy flu-like symptoms for about 12 hours) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Heavy flu-like symptoms for about 12 hours). At the time of the report, INFLUENZA LIKE ILLNESS (Heavy flu-like symptoms for about 12 hours) outcome was unknown.            No concomitant drugs were reported. No treatment medications were reported.