chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 5 minutes after receiving the shot on 11/24/21 at 5:45 pm, the patient's mom reported that her son passed out but was still alert and conscious. I went to check on the patient and realized that he was still alert and conscious but seemed to be very tired and could barely open his eyes so I told the front store staff to call emergency. EMTs arrived, tendered to the patient and took him to a nearby hospital.
shortly after patient received vaccine became flushed, bottom lip went numb, vitals were in normal limits. 911 was called emergency staff came and patient went to ER to be monitored.
Urticaria, nausea & vomiting, h/a & general achy feeling p/booster;
PATIENT REPORTED RASH ON BACK AND PATIENT REPORTED ITCHING ON SKIN.
Plunger broke loose and vaccine leaked while administering; Given less or more of the dose; A spontaneous report was received from a physician concerning a patient who received Moderna's Vaccine (mRNA-1273) and experienced syringe issue and incorrect dose administered by device.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection, and during the administration of the vaccine, the plunger broke loose, and the vaccine leaked out. The patient was likely given less than a full dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events, syringe issue and incorrect dose administered by device, were considered resolved on unknown date.; Reporter's Comments: This report refers to a case of syringe issue and incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
chills; headache; dizziness; diarrhea; incontinence; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was not reported), via an unspecified route of administration, on 20Feb2021 (age at vaccination: 71 years), as dose 1, single dose for COVID-19 immunization at hospital and acetylsalicylic acid (NUPRIN, lot number: 9GRO711, expiry date: May2021) for an unspecified indication. The patient's medical history included diabetes, asthma (she used an Inhaler), Covid-19 (she also reports having had Covid19 infection in January) in Jan2021. Concomitant medication included semaglutide (OZEMPIC). The patient reported that on Sunday, 21Feb2021, she had normal chills, dizziness, a horrible headache, diarrhea, and incontinence "all day long" and stated it was a "horrible 18 hours" and, she couldn't she went to, she peed on herself all day. She hadn't seen incontinence listed anywhere, and she's hesitant to get her second shot due to her experience after receiving the first. She also reported having had Covid19 infection in January and asked were these normal reactions and should she get the second dose. The patient wanted to know what would happen if she didn't get the second dose and should she get an antibody test. Maybe she "has too many antibodies" since she has a recent Covid19 infection in January. The second dose was due on 13Mar2021. There was a Product Complaint and description of product complaint included the patient stated for the headache she did, it didn't help at all she still have some headache this week she didn't, it's Tylenol. Product details (NDC# UPC#): consumer stated, " Yes, you want all of that? You want me to give you all those numbers? I am not doing that." Outcome of the event chills was unknown and for all other events, it was recovered on 21Feb2021.  No follow-up attempts are possible. No further information is expected.
Swollen lymph nodes in throat; Sore arm; Tenderness on the injection site; Throat hurts; Sweating; Fever 99.9 °F; Injection site swelling on and off; A report was received from a consumer concerning a 23-year-old, female patient of unknown race participating in the mRNA-1273 Emergency Use Program and experienced swelling on the injection site, low grade fever 99.9 Fahrenheit, sweating, sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain.   The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 28 December 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 injection for prophylaxis of COVID-19 infection.     She developed swelling on the injection site on 28 December 2021. That was resolved that day.  The next day 29 December 2020 she developed a low-grade fever 99.9 Fahrenheit and sweating. The patient stated that all symptoms went away.  On 30 December 2020 the patient developed a sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain. She states the soreness is not going away. There was no treatment taken for the events.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the swelling on the injection site, low grade fever 99.9 Fahrenheit, and sweating were all reported as resolved on 30 December 2020. The events of sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain are considered unresolved.  The causality assessment of the reported events swelling on the injection site, low grade fever 99.9 Fahrenheit, sweating, sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain has not been provided.; Reporter's Comments: This case concerns a 23-year-old, female patient. The patient's medical history was not provided. The patient experienced the expected events of pyrexia, injection site swelling, injection site pain, pain in arm, lymphadenopathy and unexpected event of hyperhidrosis and throat pain. The events occurred over the period of 1 day to 3 days after the first dose of mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 19-year-old male patient received the second dose of TRUMENBA on an unknown date, at single dose, for immunization. The patient concomitantly also received the last dose of HPV vaccine, administered at the same office visit. Relevant medical history was unknown. On an unspecified date (at 2:00 AM in the morning), after the vaccination, the patient awoke with whole body pain and tachycardia. He had hallucination and high anxiety. Patient's father, a cardiologist, reported he was better by morning. The patient was recovering from the events at time of this report. The information on the lot number has been requested.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-OCT-2012 11:20, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. the outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
arm was sore for first 5 days, then on April 8 left arm became red, swollen, very sore and itchey and hot,  area of swelling is 2 and half inches wide, 4 and a half inches long took benadryl,   1 tablet nite of 4/8, next morning, no change
patient developed chills, headaches, fatigue and unable to do normal school work tasks for 2 days due to weakness and nausea.
At first I thought I was overreacting. The site swelled to about the width of a tennis ball - red and hot. Throbbing w/pain I googled - used warm heat packs, took some aspirin. After Sunday - friend saw it - has a medical family background took me ASAP to ER - confirmed cellulitis. ER PA prescribed KEFLEX and to follow up in 72 hrs. w/my MD. I called today, left VM requesting to be seen in the next 48 hrs. Other adverse symptoms: terrible rock hard and inflammed vaccine site and large red circumference area surrounding site approx. 3 to 5 inches out. Fever, chills, muscle aches, terrible itching on and around site. All symptoms began early Sat. AM approx. 1-2 AM except, itching. Itching began approx. Sat. 11:00 AM - 12 PM. I thought it was a normal reaction until friend(s) looked at site. Fever 99 degrees approx. 10:00 AM 2/24/2018, 100 degrees approx. 1:00 PM 2/24/2018, 99 degress approx. 4:00 PM 2/24/2018.
PT IMMUNIZED 7-25-89; EXTREME FATIGUE 7-31; ON 8-3-89 HAD PAIN, SWELLING, INCREASED WARMTH, INDURATION AND ITCHING AT SOI.  STILL HAS 10mm INDURATION 14 DAYS LATER.
Severe Pain in right jaw 24 hours after injection of Tdap 0.5ml IM in left deltoid. No swelling, fever or other complaints including no pain at site.
Two hours after receiving Fluarix (8/23), the patient stated that her left arm started to feel sore and heavy. In response, the patient self administered two tablets of over the counter Tylenol. Around evening time, the symptoms had progressed (red and warm to touch). By the next morning (8/24), the swelling had become the size of a soft ball and it was hot to touch. Today (8/26), the patient states symptoms had subsided a little. The reaction site is not as hot, there is less swelling, and now there is bruising on top of the site of administration.
arm started itching where shot was given, then hives, now big red circle rash and itchy
On 3/11 notice hardening of muscle tissue below injection site.  on 3/12, muscle tissue hardening and swelling continues to expand with  some redness, slightly uncomfortable if touched.  On 3/13, muscle tissue soften slightly, swelling continues and redness traveling towards my left elbow.  No breathing problems associated with localized site reaction.
Information has been received from a registered nurse concerning a 4 year old male who on 1/19/01 was vaccinated with a dose of varicella virus vaccine live (lot number was unavailable). On 3/29/04, he was seen with shingles on the left arm and a few spots on his chest. No treatment was required. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live and developed chicken pox breakthrough/shingles. No further information is expected.
got both shingles shots last september, now shingles/suspecte vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the both the Shingles vaccine last year from our pharmacy. The patient got the last one last September and the patient was in his/her 7th week of shingles. As per the patient, one of the most painful thing and had to endure and hopes that did not happen to anyone. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Information has been received from a nurse concerning a female pt who on 07May98 was vaccinated with a dose of varicella virus vaccine live. On 10Aug05, the pt developed break through chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Lactose intolerance.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN) and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tamsulosin 4mg (MANUFACTURER UNKNOWN), finasteride 5mg (MANUFACTURER UNKNOWN) and duloxetine 30mg (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. On 04Apr2021 at 05:30, the patient experienced lactose intolerance. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lactose intolerance was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Face was flushed; Lost her appetite; Delayed swelling; Arm was tender to the touch; Chills; Could not lift her arm; Arm started to hurt; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling) and TENDERNESS (Arm was tender to the touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included PPD skin test positive (Medical history of a positive PPD.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm) and PAIN IN EXTREMITY (Arm started to hurt). On an unknown date, the patient experienced FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling), TENDERNESS (Arm was tender to the touch), PYREXIA (Fever of 102F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SULINDAC (CLINORIL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling), TENDERNESS (Arm was tender to the touch) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Arm started to hurt) and PYREXIA (Fever of 102F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f (abnormal) 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs provided.  No treatment drugs provided.   This case was linked to MOD-2021-238129 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Additional information received included the patient did not consult the primary care physician for the events.No new information added. On 28-Jun-2021: follow up received: 2nd dose AE's reported
Extreme lethargic reaction for a period of four days and nights. Uncontrollable screaming for two days and nights upon being awoken for feedings. Throwing up following every feeding for a period of a month following vaccine. Abnormal stools filled with mucus and a pungent unusual odor.
Patient receive Hepatitis A Vaccine Adult IM, then she started complaining of pain and numbness at injection site. Patient was able to move both arm above her head, flex and extend both arm, hand grip was strong in bilateral hands. Patient deny numbness or tingling in hand or finger. No redness or swelling noted at injection sited. Ice pack was applied and patient was encouraged to take Ibuprofen or Tylenol for pain and apply ice at home.
Device use issue; Needle popped off and some vaccine leaked on arm; A spontaneous report was received from a surgical technician who was a 48-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the needle popped off and some vaccine leaked on her arm and not sure if she got the full dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received ther first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, during administration of the vaccine, the needle popped off and some of the vaccine leaked on her arm. She thought that the needle was not on tight and she was not sure if she got the full dose. There was no reaction on her arm and her healthcare provider was not aware of the incident. Her provider told her to come back for the second dose in one month. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, the needle popped off and some vaccine leaked on her arm and not sure if she got the full dose, were resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 48 year old female subject  who experienced an unexpected event of not sure if she got the full dose.  The event occurred on 29 Dec 2020 during administration of the first dose of the mRNA-1273 vaccine .  There were no reported AEs associated with this case of not sure if she got the full dose.
The medical assistance gave MMR vaccine instead of the Varicella. No symptoms, Patient waited in the office for 15Minutes. Patient Mother was informed.
Pt recvd 1st dose of engerix-B on 5MAR92 & 5 days p/the initial injection of vax exp night sweats lasting approx 10 days;
pt devel a h/a 5 to 6 days p/vax;16OCT96 pt contacted the reporter & stated that pt had been dx w/viral meningitis;pt believed this event to be r/t vax;reporting nurse stated that out of 500 vaccinees, this was only person who reported rxn
Severe pain on right side back of skull,  headache, blurred vision , nausea, fatigue
I am gonna not take my vaccination tomorrow that I am scheduled; Nauseous; my chest tightened up; Chest pain; Heart rate fired up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0175, Expiry Date: Not Reported), via an unspecified route of administration, administered in Left Arm on 23Apr2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. There were no medical patient history and no concomitant medications. There was no investigational assessment. The patient stated that the patient received 1st dose of the Pfizer it was 23Apr and so the patient wanted to tell what the patient experienced. The patient was administered vaccine around 9:15 and waited the allowed time to make sure this did not have any side effect, So the patient left. During that day, well around to experience for some time the patient was out to walk with that patient mom and all sudden. The patient was feeling nauseous and the patients chest tightened up like bite breast and the patient thought what the heck and the patient just sat on last and the patient just try to settle down and then the pain subsided but then the patient felt dry heat and again that pain came back and tightened up the patient chest and after done dry heat and didn't have pain the patient just rested and thought of lean on something and then it just went away and the patient had not had a problem since then. But the patient just wants to make aware that the patient had a rapid heart that was it felt when the patient felt dry heating obviously, gotten fired up but the patient has never experienced anything like that. So, and the patient had a normal day and normal schedule nothing but that's the first and only time the patient experienced that, but chest pain was, the patient mean it was hurt like. The patient stated that heart rate was only started getting fired up when the patient had a dry heat but the pain in the patient chest was like, the patient was saying you said that correct. When probed for further questions: the patient stated the patient will ask to not to take vaccination tomorrow that the patient was scheduled because the patient do not want to take a risk. Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
PATIENT GOT VACCINE ON 5/16/2019 AND CAME ON 5/29/2019,REPORTING AFTER HAVING IMMUNIZATION NEXT DAY HAVE REDNESS ON LEFT ARM,SWELLING AND PAIN, CAN'T LIFT ARM FOR 5 DAYS,ASKED DID YOU CONTACT DOCTOR AS PER HER NO AND AFTER 5 DAYS SWELLING GO AWAY
Experienced fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A contactable consumer reported for her husband.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Experienced fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. presented two days post vaccination with left arm deltoid area red and warm to touch.  Mom reports using tylenol for pain and fever.  T-97.8 at time of evaluation.
Member completed her 15 minute observation period. Went to bathroom and c/o dizziness and tinnitus upon standing. Was assisted to chair. Ongoing dizziness. Did not eat prior to arrival to clinic. Juice and crackers provided. Escorted to car where husband was waiting to pick patient up. Encouraged to drink plenty of fluids and rest. Member verbalized understanding.