chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throbbing pain in both arms, pain from fingertips to one side and excruciating pain; Excruciating pain and bleeding; Overdose accidental; 6 chills in one minute; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Throbbing pain in both arms, pain from fingertips to one side and excruciating pain), INJECTION SITE HAEMORRHAGE (Excruciating pain and bleeding), ACCIDENTAL OVERDOSE (Overdose accidental) and CHILLS (6 chills in one minute) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Throbbing pain in both arms, pain from fingertips to one side and excruciating pain), INJECTION SITE HAEMORRHAGE (Excruciating pain and bleeding), ACCIDENTAL OVERDOSE (Overdose accidental) and CHILLS (6 chills in one minute). On 09-Mar-2021, ACCIDENTAL OVERDOSE (Overdose accidental) had resolved. At the time of the report, PAIN (Throbbing pain in both arms, pain from fingertips to one side and excruciating pain), INJECTION SITE HAEMORRHAGE (Excruciating pain and bleeding) and CHILLS (6 chills in one minute) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event "He got invalid dose" was Not applicable and not reported for other events.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Follow-up information received on 10-Mar-2021 included no new information.; Reporter's Comments: This report refers to a case of Accidental overdose for mRNA-1273, lot 003A21A with associated adverse events. 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.
Redness at injection site; Injection site warmth; Injection site swelling; Sorness; itchiness; This non-serious case was reported by a other health professional and described the occurrence of injection site erythema in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD, expiry date 07-DEC-2024) for prophylaxis.   On 07-SEP-2023, the patient received Arexvy (intramuscular) .5 ml. On 08-SEP-2023, 1 days after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Redness at injection site), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling), pain (Verbatim: Sorness) and pruritus (Verbatim: itchiness). The outcome of the injection site erythema, injection site warmth, injection site swelling, pain and pruritus were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, pain and pruritus to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site warmth, injection site swelling, pain and pruritus to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter stated after administration of Arexvy vaccine around injection site patient experienced Redness, warmth, and mild swelling. She also had some soreness and itchiness. These symptoms were not treated. The patient was not pregnant. The reported did not consented to follow up.
A few minutes after receiving vaccine, patient was leaving store, felt dizzy and walked into a door. Stated her vision blacked out for a moment. She came back to pharmacy, sat down for a few minutes and drank some water.  Was able to leave store on her own power after about 10 minutes
Moderately severe local reaction:  red rash about arm at vaccination site.  Some itching at first for a couple of days.  At 8 days, rash is dry, reddish, and fading.
Information has been received from a 19 year old female patient with no pertinent medical history and allergic to ZANTAC who on 05-OCT-2009, at 10:00 am was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number not reported). Concomitant therapy included daily birth control (unspecified). Later the same day, the patient had a runny nose and within 36 hours of the vaccination, on 06-OCT-2009, the patient developed "a cough, an earache and a sore throat". Unspecified medical attention was sought. There were no lab studies performed. The symptoms improved after the therapy was stopped. At the time of the report, the patient was recovering. Additional information has been requested.
Starting out feeling like I was gonna pass out, then got nauseas and vomiting, then the cold set in my whole body was painfully cold, then was having seizure like shakes till 3am, had cold and shakes set in every time I moved the whole next day along with nausea and severe headache, the shakes were horrible., then body aches for three days
not received the second dose yet due to product shortage/it has been 49 days since his first dose; not received the second dose yet due to product shortage/it has been 49 days since his first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (not received the second dose yet due to product shortage/it has been 49 days since his first dose) and PRODUCT AVAILABILITY ISSUE (not received the second dose yet due to product shortage/it has been 49 days since his first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (not received the second dose yet due to product shortage/it has been 49 days since his first dose) and PRODUCT AVAILABILITY ISSUE (not received the second dose yet due to product shortage/it has been 49 days since his first dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (not received the second dose yet due to product shortage/it has been 49 days since his first dose) and PRODUCT AVAILABILITY ISSUE (not received the second dose yet due to product shortage/it has been 49 days since his first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Patient given Flumist at 18 weeks gestation.  Was not known that she was pregnant until after Flumist was given. Patient was 18 weeks gestation.
Local reaction upper arm (deltoid muscle) area appeared dark red. Was given Tylenol and cold compresses.
Muscle pain starting 3 days after injection of vaccine increasing week after week until a pain level of 9 was reached.   First left arm then right arm then neck then both upper legs then lower back.
Intermittent itchy rash that migrates throughout the body including his bl wrists/ue, LE and face since receiving his 2nd moderna vaccine 5/2021. Rash appeared within minutes of getting vaccinated. Symptoms completely abate w/10 mg of cetirizine daily.  Still continues to get hives on a daily basis since receiving his 2nd Moderna vaccine and continues to take Cetirizine 10 mg daily.
The first 2 days I woke up nauseous, it went away as the day progressed.  I have not been nauseous in years. Last night, May 20th, about 10:44 PM  my heart started racing and I took my ECG on my Apple watch.  My heart rate was 182. It said it was too high of a heart rate to complete the ECG.  I took my nightly dose of Metoprolol 25 MG and then about 30 minutes later took another dose. I did some relaxation and breathing exercises and I was able to finally get the rate down to 143.   I tried one more time for the ECG on my phone at 11:01  and it said I was in Atrial Fibrillation.  At 11:12 PM my heart rate was  102 but it did not report Atrial Fibrillation, it reported "High Heart Rate" This morning  May 21, 2021 at 7:19 AM  it reported Sinus Rhythm  75 Beats per minute.  At 11:34 Sinus Rhythm, 95 Beats per minute.  Right now, I'm in Sinus Rhythm 92 Beats per minute
Background: Pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the Pharmacy MOB has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
This is a spontaneous report from a noncontactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER2613), at the age of 43, via an unspecified route of administration, left arm, on Mar 31, 2021, at 09:30, single dose, for COVID-19 immunisation. Medical history: none. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 31, 2021, at 10:30, patient experienced nausea, chills, low fever and fatigue for 72 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures not taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of nausea, chills, low fever and fatigue resolved on Apr 3, 2021 (after the duration of 72 hours). No follow-up attempts possible. No further information expected.
Dr. informed her to take the vaccine, had COVID in October .   Arm was sore around 4:00 PM, started running fever, took Tylenol and it was 102.  Had body aches, headaches, weakness in legs.  Felt worse than having the COVID.  Went to bed, took Advil, Tylenol at around 9:00 AM went to work, left work at 2:00 and could barely drive.  Came in the house and she still had fever.  She had chills last night with shaking chills, tired and her arm is extremely sore.  Still running mild temp.   Said she would not take the 2nd vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male 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 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.14  Concomitant products were not provided.  On 11-Nov-2021, the vial underwent the excursion on the following timings: at 2 PM temperature was 35. On 11-Nov-2021 vials were moved to clinic. On 08-Jan-2021 the vaccines were moved to fridge. The vaccine beyond use date was reported as 07-Feb-2021. 9 vials sent to clinic.  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 traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a healthcare professional concerning a 10-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 02-Feb-Jan-2010 and was administered to the patient on 19-Feb-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Pt. started to become agitated during her observation period. Stated she felt dizzy and might pass out. She appeared pale, but was coherent at all times. Her blood pressure = 160/90. She was given a cookie and water. She remained sitting for another 15 minutes. Blood pressure reduced to 135/78. She later relocated. 1 hour later, she reported feeling dizzy again and had a tingly face and lips. Was given 1 tablet 25mg diphenhydramine. After 30 more minutes, she felt fine and all symptoms had resolved.
sudden attack of pain in the same evening I received the vaccine; at night got a strong pain down into right hand; Very good side effect, Since the day after vaccination patient never had knuckle pains anymore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sudden attack of pain in the same evening I received the vaccine), PAIN IN EXTREMITY (at night got a strong pain down into right hand) and THERAPEUTIC RESPONSE UNEXPECTED (Very good side effect, Since the day after vaccination patient never had knuckle pains anymore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     The patient's past medical history included Pain. Concomitant products included LEVOTHYROXINE, RIVAROXABAN (XARELTO) and VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 PAIN (sudden attack of pain in the same evening I received the vaccine), PAIN IN EXTREMITY (at night got a strong pain down into right hand) and THERAPEUTIC RESPONSE UNEXPECTED (Very good side effect, Since the day after vaccination patient never had knuckle pains anymore). At the time of the report, PAIN (sudden attack of pain in the same evening I received the vaccine), PAIN IN EXTREMITY (at night got a strong pain down into right hand) and THERAPEUTIC RESPONSE UNEXPECTED (Very good side effect, Since the day after vaccination patient never had knuckle pains anymore) outcome was unknown.            No treatment information provided.
30 minutes post vaccination complained of chest pain which did not resolve after 15 minutes of rest. Reported having anxiety attack approximately 3.5 hours prior to vaccination and taking BENADRYL. Reported feeling this event was another anxiety attack initially. Reported pain 10/10 to epigastric region and back, sweating, nausea, with history of enlarged heart and family history of cardiac issues.
4/11/2021 @ 3:00p. S/P Administration of JNJ Janssen; the patient reported having a "flushed feeling" and states "I can tell that its getting into my system". BP 150/104 HR 120. Sats 100%. RR 16. Flushed lasted about 30 seconds.  After 15 minutes, BP 146/105 HR 104 RR 16. Pt asked to wait additional 15 minutes (totaling 30min). During wait time, the patient was conversating with her husband. There was no signs of acute distress. RR remained within range 14-16. Following wait time, the patient denied flushed feeling and stated "feeling okay".  4/15/2021@4:45pm Pt returned to clinic and stated that she continues to have the "flushed feeling". She reports going to ER the night before for elevated BP. She had a dedicated CTA to rule PE and LE doppler for DVT. According to her. both test were "fine". She did report that her BP was around 200s. She denies hx of HTN and current meds use.  She was discharged home with clonidine.
got the shot then a year later had Shingles anyways /Suspected vaccination failure; had Shingles, agony with Shingles; This 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot then a year later had Shingles anyways /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had Shingles, agony with Shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comments: This case was reported by the patient's relative via interactive digital media.  The reporter stated that the Shingles belong on a roof.  The reporter stated that the patient got the shot then a year later had a massive Shingles attack. They had wasted a thousand dollars. Like Covid vaccine, no promise that it would work.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
when I called patient to let them know they were due for their second dose, he said he had an allergic reaction from the first dose. He said about 24 hours after receiving the vaccine, he got a headache, broke out in hives and his joints become tender and sore. he said his symptoms last for 3-4 days
After administration of Moderna COVID vaccine to left arm. patient reported itchy throat and tingling from left arm to back of neck.
Developed fever that cont. for 2 days. Taking TYLENOL given MD. Myalgia, body aches (localized), red, swollen, itchy at injection, cold compress applied. Developed rash on face 3/11P (L side inly), rash cont. slowly reduced but still present 3 days later. Treated with antibiotic.