chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 069H21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided (057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A). Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit. Treatment information was not reported.
Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose?
Initial misuse report received from a healthcare professional on 16 July 2014. A patient (gender and age not reported) had received an expiry dose of IPOL on an unspeicfied date. It was reported that patient was administered a dose that expired on 30 June 2014. No other information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
12-26-13 Facial rash and itching. 12-28-13 Body aches, leg muscle pain. 12-29-13 Headache, nausea, photosensitivity, dizzy. 12-30-13 Stomach cramps. 1-1-14 Back pain, chills, diarrhea.
Information has been received from a physician concerning a 23 year old female who was vaccinated with a third 0.5 mL dose of Gardasil vaccine. Concomitant therapy included Advair. Subsequently, the patient developed a hard lump in her arm where she was vaccinated. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The patient's hard lump in the arm persisted. Additional information has been requested.
This spontaneous report was received from an medical assistant and referred to a unknown age female patient. The patient's medical history, other relevant condition and concomitant medications were not reported. On 25-OCT-2018, the patient was vaccinated with an expired dose of VAQTA intramuscular, lot number: N020689, expiration date: 22-OCT-2018 for prophylaxis (dosage schedule and anatomical location were not provided). No adverse event was reported.
Information has been received from a physician concerning a 4.5 month old female with on drug allergies who at the end of December 2006, was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Concomitant vaccinations administered on that same day included a dose of poliovirus vaccine inactivated (unspecified, a dose of diphtheria toxiod (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of Hib conj vaccine (OMPC) (manufacturer unknown). The physician reported that in late December 2006, shortly after the first dose, the patient aspirated. It was noted that the patient had a full bottle of formula prior to vaccination administration. Unspecified medical attention was sought. No laboratory/diagonostic tests were preformed. Subsequently, the patient recovered while on therapy. The physician noted that, at the next recommended interval, the second 2.0 mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) was given with no issues. Additional information has been requested.
Patient reports arm pain, chills, cough, nausea, and gagging ever since receiving vaccine on 11/9/2016.
Flu like symptoms; Cant breath well; Dry throat, need to drink water; Mild fever (99.7F); Runny nose that goes to my throat and bothers; Headache; Arm  hurting; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild fever (99.7f)/pyrexia, flu like symptoms/influenza like illness, runny nose that went to throat and bothered /rhinorrhea, couldnt breath well/dyspnea, dry throat needed to drink water/dry throat, headache, arm hurting/pain in extremity.  The patient's medical history was not provided. Concomitant medications reported were fexofenadine hydrochloride, unspecified blood pressure, diabetes medications.  On 19 Jan 2021, the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) in the left arm for prophylaxis of COVID-19 infection. No adverse event reported related to the first dose of vaccine.  On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 024M20A) in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events mild fever (99.7F), flu like symptoms. On 22 Feb 2021, the patient experienced the events headache, arm hurting. On 23 Feb 2021, the patient experienced the events runny nose that went to her throat and bothered, she couldn't breath well, had dry throat, needed to drink water.  Treatment details included Tylenol.  Since patient received both the scheduled doses of vaccine action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events mild fever (99, 7f), flu like symptoms, runny nose that goes to my throat and bothers, cant breath well, dry throat, need to drink water, headache, arm hurting was unknown.
Myalgia & Diarrhea Narrative:  Patient received the vaccine on January 4th 2021 and had body aches and diarrhea that night and following day. Symptoms have since resolved when self reported today.
Patient unknowingly received Moderna Vaccine (1st of series) 1-8-21 and received Janssen vaccine at our clinic on 4-1-21.  Patient has been unable to be reached since April vaccination.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 11:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:09 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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.   Age of the patient was reported as 37.81.  Concomitant medication of the patient was not reported.  Batch number 025L20A underwent temperature excursion on 07-Jan-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM and 10:00 AM. These vials were moved to fridge on 05-Jan-2021 and beyond use date for the vials was reported as 27-Jan-2021. The vaccines moved to clinic on 07-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
L thigh -15cm x 12.5cm erythemic raised and hard. Pt c/o itching. Warm to touch. Sym-2/14 started to itch. 2/14 developed visible reaction.
died in his sleep; This is a spontaneous report from a non-contactable consumer.  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient died in his sleep (death).  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died in his sleep
Redness ( 9 days and counting) Fever at injection site (9 days and counting) Soreness ( 9 days and counting) Itchy at Injection Site ( 9 days and counting) Chills ( for 5 days ended Jan 21st) Diagnosed with cellulitis at injection site antibiotics perscribed)
pt devel severe pain @ site radiating down to fingers w/cont pain in area & limited ROM 2 wks late; physical exam tenderness;
On 9/4/01 the pt received vax and that afternoon was very fussy and crying allot. When the infant was not crying, she was sleeping. The mother was informed that it may be a side effect of vax. Instruct to administer Tylenol and to see primary MD if symptoms increase or last longer. The pt experienced a rash which was very red, blotchy but not raised. Went to ER for evaluation. the pt had a fever of 101 which increased to 104.
Baby started vomiting and diarrhea and fever 1st week. effected by swelling of hands, feet, reports splenomegaly, fever resolved. Admitted to med center. Dx Kawasaki, + coronary aneurysm, fever not responding to IgG x 4 courses, steroids and eventually  ? in 1 month. Discharged with aneurysm readmitted for thrombus treated at hospital. A follow up report received 6/30/2003 adds: Coronary aneurysm still persists at 8mm diameter. Follow up in 2004: No information reported. Huge coronary aneurysms still persists. Under cardiologists care. On Aspirin & Coumadin, check INR of monthly.
Body aches all over on 4/10/21, Took Aceteminophen throughout the day. On 4/11/21 woke with hives. Took Zyrtec during the day and Benadryl at night. Woke up 4/12/21 with worse hives and swollen lips. Went to urgent care clinic.  Treated with Epinephrine, Dexamethasone and Benadryl injections and given a prescription for prednisone.
One day post vax, pt developed redness and swelling.  Warm to touch. Treated with Augmentin, Benadryl, and Tylenol.
Pain in stomach; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in stomach) in a 37-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in stomach). At the time of the report, ABDOMINAL PAIN UPPER (Pain in stomach) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow-up information received on 25-Apr-2021 contains no new information.
Exactly 12 hours after vaccination, I had6 hours of extreme chills and fever.  When this subsided, I had a headache for four hours with nausea. This was followed by 24 hours of fatigue.
Fatigue; Chills; Fever (101.4 degrees Fahrenheit); Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever (101.4 degrees Fahrenheit)) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, LOSARTAN, POTASSIUM CITRATE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever (101.4 degrees Fahrenheit)) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever (101.4 degrees Fahrenheit)) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Body temperature: 101.04 (High) 101.04.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Additional information received, new event Headache was added.
Patient received Pfizer Vaccine in December from the hospital, she then contracted COVID and was very sick 3 weeks later. There was no issue with the Pfizer Vaccine. The issue was she couldn't get the 2nd dose because she was actively sick with COVID.  She then went to a vaccination clinic at the local pharmacy where she received a janssen vaccine on the 31st of March. Again seems to be well tolerated at this time. However she received 2 immunizations that were different, not studied together, and not allowed per the EUA. The patient was aware it wasn't the correct vaccine, however they could not get the Pfizer vaccine as it is not offered in the area. So she opted to get the Janssen vaccine. It was pointed out to the individuals involved in the vaccination that this was technically not correct and needed to be reported to VAERS. At this time there are no health issues or concerns. We were just asked to report this.
Patient has needle anxiety. She seemed fine during the vaccine administration. After receiving all 4 vaccines, she had syncope and fell face down from the sitting position. We called 911 but patient refused to be taken to the ER. Patient's roommate picked her up.
fever, chills, body aches, nausea, diarrhea, and headache started around 12am 12/30/2020 and lasted until 1/1/2021. Rash on face, neck, arms and itching and burning on the palms of my hands and feet began around 2:30 am on 01/01/2021 and lasted until 01/02/2021. Still experiencing fatigue and headache as of 1/4/2021.
Approximately  04:35 p.m. received 2nd Moderna dose. Approximately 05:30 p.m. experience very mild fever in cheeks. Approximately 06:30 p.m experienced mild brain fog. Approximately 07:30 p.m. experienced moderate pain in injection site and mild body aches lasting only seconds in random parts and joints in my body. Approximately 08:00 p.m. I experienced moderate lower back pain/stiffness  ( I was lying in bed tossing and turning. Could not get comfortable)  Approximately 10:30 p.m. after taking a hot shower and sitting upright for about 2 hours I no longer had any adverse affects. I was able to sleep soundly through the night. No affects the following day or since.
Patient was vaccinated with Moderna on 2/10/21 and 3/10/21. Patient was admitted to the hospital, COVID positive, on 7/29/21 for respiratory failure with hypoxemia secondary to COVID 19 pneumonia. Hospitalized for 5 days.
Prior to receiving her COVID-19 vaccine, the patient was already having symptoms from anxiety/nervousness about the vaccine. Patient was given her injection and within 1-2 minutes, she began feeling dizzy and lightheaded. The vaccine administrator came to me (pharmacist on duty) to notify me that she was not feeling well. I went to go check on her and she stated that she felt as though she was going to faint. I advised her to stay seated, asked if she would like an ice pack and water, and stepped out to get those for her while remaining vigilant (because I wanted to be in the same room as her for observation/safety). I brought her the ice pack, she held it on her chest and head and said it felt nice. After about a minute I stepped out again to ask a technician to get a water for her. When I came back, the patient was still seated but had a blank stare and her mouth was slightly open. I repeated her name out loud and nudged her shoulder several times, however the patient was unresponsive completely. I immediately looked for the red emergency kit in the consultation room but did not see one (I later found out that there was an EpiPen on the table in the room, but I did not see it at the time due to the urgency of the situation). I rushed back into the pharmacy, told the technicians to call 911, and took an EpiPen off the shelf in the pharmacy. I ran back into the room and the patient's face was very red, her eyes were bulging slightly, and it looked like she was trying to reach her hand up or move it, but was unable to. I injected her with the EpiPen immediately, and within roughly 5 seconds she came back to consciousness and looked at me and said "I'm sorry". EMS arrived extremely fast and was there a few minutes after using the EpiPen. She was then taken by ambulance to the hospital. Patient had a friend, with her at the store who was scheduled to receive the vaccine as well, but after the incident she decided otherwise. Later that evening I gave patient's friend a phone call to check and see how patient was doing, and to also let her know that patient's vaccination card was at the pharmacy if she wanted to pick it up. That evening around 6:30-7pm, patient's husband came to the pharmacy to get her card, he updated us that she was being discharged from the hospital and that she was okay.
A Knot formed below injection sight 10 day after vaccine.  There is pain in the whole arm.
Fainted; Feeling dizzy; Weak; Exhausted; A spontaneous report was received from a consumer concerning a 66 years old female patient who received Moderna's COVID-19 (mRNA-1273) and experienced fainted/syncope, feeling dizzy/dizziness, weakness/asthenia, and exhaustion/fatigue.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 11 Feb 2021. The patient received their second of two planned doses of mRNA-1273 (Batch number: 036A21A) on 11 Mar 2021 intramuscularly for prophylaxis of COVID-19 infection.    On 12 Mar 2021, the patient felt so weak and exhausted, she didn't have the strength to brush her teeth. She remembered feeling dizzy while standing in the bathroom. She fainted shortly after. She felt like couldn't stand up because she was so weak and was very scared. Treatment of the event was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events fainted, feeling dizzy, weakness, and fatigue were considered resolved on 13 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 2/2 I woke up with extreme fatigue, headache, body aches, joint pain, and temperature of 100.5. This lasted for 24 hours. On 2/3 my arm felt very warm, so I looked at it in a mirror and found a large, round/hexagonal area of swelling, redness, warmth, and tenderness. Today is 2/6 and it continues to spread the redness, swelling, and warmth down towards my elbow. It occasionally itches, but is usually painful and stings.
His 35 year old attorney, both kidneys shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "His 35 year old attorney, both kidneys shut down". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient had itching  on left arm, may have had a fine rash which then spread to left side trunk. No mouth or throat itching or airway symptoms. Symptoms subsided after 70 minutes of observation. EMS transport declined.
I received the 1st vaccine on 12/18/2020 in my left arm.  I experienced chest pain in the left side of my chest for at least 4 days. I took Bayer baby aspirin to ease the pain.  I had swelling and redness and rash, the worst about 2 inch in diameter from the injection site, extending down to my elbow.  I had intense throbbing pain for 3 days, which lessened  on day 4.
Pt c/o's dizziness, migraine, abd cramping, nausea, diarrhea, increased fatigue am after receiving injection. Symptoms continued Sat and Sunday. Painful inj site. Denied SOB, wheeze, throat swelling or fevers.