chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, swelling,(hardness) itching in arm below the injection site . Second day of injection.  I thought it would go away or get better.  I have never had a reaction to any vaccine before.  On the fourth day I called my Health Care provider, was called into the office, checked out, and given a prescription for Methylprednisolone Tablets.  I should be fine by  Monday.
Large hard lump at injection site, roughly the size of an orange with pain to touch and extreme itchiness, and hot.
24hrs post vax pt experienced inject site rxn which included pain, swelling, erythema & hot to touch, rxn still present & getting worse @ time of this report; Also has swollen lymph nodes in the groin area; Tx Keflex; No biopsy;
Injection went fine, no pain or anxiety. Walked about 50 feet, immediate flushing and dizziness, tingling skin. Almost fainted; had to lie down. Blood pressure fluctuated. Twitching muscles, strong body shakes, chattering teeth. Lasted about an hour and a half after injection. Given benadryl. Clinic recommended ER visit. By time arrived at ER, symptoms subsided. Day after - injection spot pain, headache, high anxiety and panic attack, ringing in ears. Day 2 after - twitching muscles, high anxiety and panic attack, headache, fatigue, body aches, diarrhea.
Signs/Symptoms: Faint, macular rash  on arms and chest. Pain going distal down left arm and creating sharp pain in arm.   Treatment: Benadry PO
Patient reported swelling around the injection initially, but has now progressed to several "silver dollar sized" welts/hives all over her torso.  Patient reported a low grade fever of 100.6 degrees Fahrenheit. but no other symptoms.
My son had covid in Dec 2020. He was given 1 shot of J&J vaccine on March 20, 2021 (had a low fever for a few days.) He was given booster of Moderna on 11/20/2021 and had a fever/ chills for a few days...  then on day 5 his hands swelled up and became very red and itchy, and his feet became very sensitive on the bottoms. He said walking felt like his feet were totally bruised. He couldn't bend his fingers easily bc they're so swollen. The pediatrician told him to take one Zyrtec a day and it should feel better within 2 weeks. Day 6, a fever spiked again. 101.7. We are now on day 7. He isn't awake yet, but this is pretty awful.
Patient stated he felt light headed/dizzy. He was unable to specify exactly when his symptoms started. Patient speaks another language so there is a slight language barrier.  I asked if it started since his vaccine and he said he thought that might be it.  I looked in his medication profile and he did start amlodipine 2.5mg and was prescribed meclizine the day before his vaccination, so it appears these symptoms were present prior to the vaccine.  He said he felt that maybe his blood pressure was elevated, I asked if he had checked it, and he said he had not.  I told him I would report this event and I notified his PCP.  I recommended he go to urgent care.
This is a spontaneous report from a contactable consumer (patient). A 51-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL3247), at the age of 51, via an unspecified route of administration, in the left arm, on Mar 11, 2021, at 11:00, single dose, for COVID-19 immunisation. Medical history included known allergies to oysters. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified medication within two weeks of vaccination. On Mar 11, 2021, at 18:00, patient experienced soreness at the injection site and fatigue. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the reported events. The outcome of soreness at the injection site and fatigue recovered on an unknown date in Mar 2021. No follow-up attempts needed. No further information expected.
head was woozy; her stomach felt weird; tingly arms and feet at night; dull headache; sensation that something was stuck in her chest; 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 CHEST DISCOMFORT (sensation that something was stuck in her chest), HEAD DISCOMFORT (head was woozy), ABDOMINAL DISCOMFORT (her stomach felt weird), PARAESTHESIA (tingly arms and feet at night) and HEADACHE (dull headache) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced CHEST DISCOMFORT (sensation that something was stuck in her chest). On 07-Feb-2021, the patient experienced HEADACHE (dull headache). On 08-Feb-2021, the patient experienced HEAD DISCOMFORT (head was woozy), ABDOMINAL DISCOMFORT (her stomach felt weird) and PARAESTHESIA (tingly arms and feet at night). On 06-Feb-2021, CHEST DISCOMFORT (sensation that something was stuck in her chest) had resolved. On 11-Feb-2021, ABDOMINAL DISCOMFORT (her stomach felt weird) had resolved. At the time of the report, HEAD DISCOMFORT (head was woozy), PARAESTHESIA (tingly arms and feet at night) and HEADACHE (dull headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Details regarding concomitant and treatment medications were not provided. The patient confirmed that she was feeling improved, however was still experiencing headache. She wanted to know if the symptoms she had were a delayed reaction to the vaccine and she also wanted to confirm if the Moderna vaccine contained aborted fetus cells or not.
Mom states he c/o itching at injection site when he got home apprx. 3:45pm, then arms, chest, and back became itchy with blotchy pink- red areas. Mom called ER who advised OTC Benadryl. Mom gave 2 tabs (25mg each) Itching began to subside within 1/2 hr. Still c/o some itching of palms and soles of feet this am, more Benadryl given.
Information has been received from a registered nurse referring to a unknown gender patient of unknown age. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 02-APR-2019, the patient was inadvertently administered a dose of VARIVAX which expired on 24-MAR-2019 (lot #: N009766, expiration date: 24-MAR-2019, dose, frequency, route were not reported) for prophylaxis(expired product administered). No adverse effects reported.
Patient fainted about 10 minutes after vaccine administered. He came around almost immediately and we monitored him for about 45 mins before he left with his dad
Informed of patient recently passing  within 24 -36 hours of vaccine administration.  patient had no signs of adverse side effects while at pharmacy.
Information has been received from a 75 year old male consumer concerning himself with morphine allergy who on 04-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included " NEURONTIN, and many more". On 12-MAY-2010 the patient developed shingles. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. The patient's shingles persisted. No further information is available.
This is a spontaneous report from a contactable nurse.  A 57-year-old female patient received PREVNAR 13, intramuscular in left upper deltoid on 24Oct2016 as 0.5 ml, first single dose for immunization. There was no medical history or concomitant medications.  The patient previously took QUADRIVALENT FLU VACCINE; (lot 185285 (manufacturer Seqirus)) administered intramuscularly in right upper deltoid for immunization. The patient experienced red itchy rash at the site of injection on 25Oct2016. Therapeutic measures taken as a result of red itchy rash at the site of injection was reported as just ice packs for now. The outcome of red itchy rash at the site of injection was not recovered as if the reporting on 27Oct2016.
After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as muscle pain in the arm where she received the vaccine. Progressed to diffuse myalgias on 4/27 and 4/28. Was having a slight cough that is typical for her during this time of year due to allergies, no other respiratory symptoms. Then acutely developed severe jaw pain that radiated to the throat and into her chest when she woke up on 4/29 in the morning. She had 10 out of 10 crushing chest pain.
Pt, (MD), recv vax (Mfr unk) approx 2 yr ago. Pt believes may have had previous dose of tetanus toxoid 1 - 2 yr prior to 1955.10/95 pt devel "polytendonitis", bilateral elbow & knee pain.Pt devel myalgia 1 anterior bicep;SEE comments
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (gave some pediatric 6m-5y after the BUD, the vial was initially stored in the refrigerator on 23-Dec-2022).    No concomitant medication were reported.  Vial size was 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022.  Dates of administration of vaccine were 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.  This case is of patient 32 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
pt recvd vax & exp severe h/a & nausea; resolved in 24 hrs;
Extreme lightheadedness or dizziness with any activity which began approximately 24 hours following the second dose on 07 March 2021.  Treating with OTC meclizine 12.5 mg (3 to 4 times daily), or 25 mg (as needed) but seems to barely take the edge off the symptoms.  I am forcing  hydration and forcing myself to rest periodically during the day to help ease the discomfort.  Some days I feel the dizziness/lightheadedness are resolving but there are days when the symptoms are just as intense as the first day.
moderna arm; little red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (moderna arm) and ERYTHEMA (little red mark) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (moderna arm) and ERYTHEMA (little red mark). At the time of the report, VACCINATION SITE REACTION (moderna arm) and ERYTHEMA (little red mark) outcome was unknown.            Concomitants were not provided. No treatment information
Hives within 3 hours lasted 12 hours. Left Arm edema and erythema 24 hours
Chills and fatigue for 3 days,fatigue and lightheadedness x10 days. Seen at the walkin 3/15/21 sent to ER for two units of blood. Acute anemia-seen at Hospital 3/15-3/16/2021.  3/24/2021 stool tested and no blood found. Next test is on 4/22/21-endoscopy
Approximately 6 minutes after receiving vaccination, the patient fell backwards. He was out cold for a couple of minutes and would not respond to his name. After elevating his legs for about 5 minutes he regained consciousness. The patient then felt nauseated, dizzy and weak. The patient recovered in about 1 hour.
1300 Recipient had transiet HR of 136 sustained for 5 min. Tachycardia started during 15 min. observation period. HR stabilized to baseline 80's by 8PM.
This is a spontaneous report from a contactable nurse practitioner received via a sales representative. A 18-year-old female patient received the first single dose of TRUMENBA (lot R56652) on an unspecified date, in left deltoid, for immunisation. The patient medical history included sensitive skin. Concomitant medications were not reported. The patient experienced red all the way down her arms after getting the injection on an unspecified date, about 3 days after vaccination, with unknown outcome.
Moderna vaccine administered to client on 10/05/2021, vaccine expired 10/01/2021.
head feels like it is splitting open; bedbound; developed a headache; sharp pains in temples; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head feels like it is splitting open), BEDRIDDEN (bedbound), HEADACHE (developed a headache) and PAIN (sharp pains in temples) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (head feels like it is splitting open), BEDRIDDEN (bedbound), HEADACHE (developed a headache) and PAIN (sharp pains in temples). The patient was treated with DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM) for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (head feels like it is splitting open), BEDRIDDEN (bedbound), HEADACHE (developed a headache) and PAIN (sharp pains in temples) outcome was unknown.
Pt recv vax on 10/19/98; on same day pt exp swollen/red/hot LA at vax site; tx=Cefadroxil
Vaccine dose administered after 24 hours at room temperature; The vial was kept at room temperature 69-72 degrees F in the clinic from September 2, 2021 at 9 am to September 3, 2021 at 3:45 pm; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose administered after 24 hours at room temperature) and PRODUCT STORAGE ERROR (The vial was kept at room temperature 69-72 degrees F in the clinic from September 2, 2021 at 9 am to September 3, 2021 at 3:45 pm) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose administered after 24 hours at room temperature) and PRODUCT STORAGE ERROR (The vial was kept at room temperature 69-72 degrees F in the clinic from September 2, 2021 at 9 am to September 3, 2021 at 3:45 pm). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose administered after 24 hours at room temperature) and PRODUCT STORAGE ERROR (The vial was kept at room temperature 69-72 degrees F in the clinic from September 2, 2021 at 9 am to September 3, 2021 at 3:45 pm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received includes Added Patient demographic details, other relevant history, Added dose number of suspect, Concomitant medications,  Added new event.
Sat 10/23/10 9:05 AM - FLUZONE injection administered, 9:35 AM - felt like becoming congested, slight cough and fatigue. 9:35 pm - felt a little "winded," and fever of 99.4 (degrees). Sunday (10/24/10)- AM- fever of 100.4 (degrees). Pt taking ibuprofen & acetaminophen for body aches. Her daughter had flu sx on Sunday so pt wondering if she was coming down with the flu at time of her shot - (She had donated blood on 10-22-10).
No additional AE/PQC.; Product was administered after TE.; This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAY-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, lot number and expiration date were not provided) for prophylaxis (product storage error).   No adverse event was reported.
chills; aches; This case was reported by a pharmacist and described the occurrence of chills in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st on 15th November 2019 refer case US2019231625).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced chills and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills and general body pain were unknown.   The reporter considered the chills and general body pain to be probably related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had chills and general body pain and no more difficulty in breathing with 2nd dose.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female 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 3:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:07 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.92 for dose administered on 11-Jan-2021. No concomitant medications were reported. Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 01-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of 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. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
My lymph node in my left arm swelled extremely large when I first got my second shot, to the point where my entire armpit was distended. It went down after a few weeks to where it wasn't physically noticeable. However, when I went to get a mammogram in August (5 months post shot), the lymph node was still quite large on the scans. It was evaluated for cancer with a biopsy. However cancer diagnosis came back negative from the biopsy. Doctors and nurses advised it may be lingering effects from the covid shot.
Erythema and warmth to touch in 6" x 3" area just below site of MENVEO and TDaP injection 2 days ago on 7/22/17. Seen by MD. ZYRTEC and BENADRYL. Advised for possible allergic reaction to return if Pt becomes febrile.
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 10-SEP-2023 The case was received from the patient interactive digital media. The patient got his/her shot on Thursday and had sore arm but was protected. The follow-up could not be possible as no contact details were available.
Swelling of LUE peaking about day 9 with pain and stiffness. Also intermittent pain in the R knee.