chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site redness and warm to touch; area as oval shaped measuring approximately two inches out; area as oval shaped measuring approximately two inches out and around site as well as some itching; swelling and soreness at the injection site; Redness, swelling and soreness at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out), VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching), VACCINATION SITE SWELLING (swelling and soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) in a 66-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.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling and soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out) and VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching). At the time of the report, VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out) and VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching) outcome was unknown and VACCINATION SITE SWELLING (swelling and soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
severe allergic drainage from nasal cavity into chest; had pneumonia; collapse of the right middle lobe; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 30Jan2021 at 12:00 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and rosuvastatin.  The patient developed shortness of breath and severe allergic drainage from nasal cavity into chest. Cough has ensued. Went to medical doctor (MD) today (13Feb2021 at 21:00) and received chest Xray and office said he had pneumonia with collapse of the right middle lobe. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 23Feb2021, heart rate: 78 and oxygen saturation (pulse oximeter registering): 91-94 on an unspecified date. The patient was prescribed with antibiotic pending result of COVID test. The outcome of the events was not recovered.
Fatigue; Headache; myalgia; Shivering; local Pain in arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm, fatigue, headache, myalgia and shivering. On an unknown date, the outcome of the pain in arm, fatigue, headache, myalgia and shivering were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, headache, myalgia and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had local sore arm for 2 days and myalgia, fatigue, headache, shivering day after vaccination. For tolerances of 2nd dose refer case US2019AMR158281, reporter by same reporter.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild
Elevated blood pressure; Panic anxiety attacks; Panic anxiety attacks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2022 as dose 3 (booster), single (Lot number: FJ639) at the age of 63 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT. Vaccination history included: BNT162b2 (Dose 1, Lot number: EW0178, Anatomical location: Right arm), administration date: 04Aug2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EW0178, Anatomical location: Right arm), administration date: 25Aug2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 09Mar2022, outcome "not recovered", described as "Elevated blood pressure"; ANXIETY (non-serious), PANIC ATTACK (non-serious) all with onset 09Mar2022, outcome "not recovered" and all described as "Panic anxiety attacks". The events "elevated blood pressure" and "panic anxiety attacks" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure increased, anxiety, panic attack.  Additional information: No additional vaccines were administered on same date of the Pfizer suspect. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that he was calling about the Pfizer COVID vaccine, adult, booster shot. He did fine with all his previous COVID vaccines. He took his booster shot when he was eligible. About a week or two after getting his booster, he experienced an elevated blood pressure and panic anxiety attacks. He had taken Zoloft 50mg a day for twenty years and he had been very steady and the medication worked well. After his panic anxiety attack he was prescribed generic Xanax, Alprazolam 0.25mg and it was working well. The patient experienced adverse event after the booster shot. The patient went on a trip and experienced elevated blood pressure. He went to an emergency room and he was evaluated. The patient stated that nothing wrong could be found. He was given the generic Xanax and a blood pressure medication called Enalapril. He stated that both medications were effective. He stated that it still occurs every now and then. Panic anxiety attacks, he stated he had another one happen on 25Mar2022. He had only had one booster. The outcome of the events was persisting.
Pt called this afternoon stating has had numbness in rt arm since yesterday p/receiving TD shot; complains of chest pain & pain around heart this afternoon; does not have PMD-advised to go to ER ASAP for evaluation of above sxs;
Initial and follow-up information has been received from a nurse concerning a 17 year old female with asthma and no allergy who on 17-JUL-2008 was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot number 660042/1899U) subcutaneously to her right arm and a dose of HAVRIX in the left arm. On 25-AUG-2008, the patient developed red, swollen area on her red right arm at the injection site. The patient went to the doctor's office. ON 28-JUL-2008 the patient developed a 4 and 1/2 by 3 inch area of redness and swelling at the injection site. This area on her arm also contains two draining lesions in the center of redness. Five other lesions were on other unspecified areas of her body. On 29-JUL-2008 the size of redness increased and swelling decreased. Four draining lesions were noted. The primary care physician gave the patient antibiotic and steroids intramuscularly. Oral steroids were also given by PCP. Laboratory test included lesion culture which was no growth. On 30-JUL-2008 the patient's swelling was much improved. On 31-JUL-2008, the swelling resolved and lesions were dry. The patient was seen by PCP, and she no further needed to see PCP unless further issues of concern. Additional information is not expected.
Patient experienced injection site pain with arthralgia and myalgia after receiving a Td injection due to a cut.  At 48 hours after injection, the pain persisted with tenderness at the shoulder.  Patient could not abduct his arm due to pain.  On 04/30/07 patient was feeling better.
Patient reports he had redness to bilateral cheeks, redness to bilateral arms, generalized itchiness and flush feeling about 10 minutes post vaccination.  By the time he got to the ED around 11AM, he still has redness to bilateral cheeks and generalized itchiness, but no obvious urticaria and does not have the flush feeling any more.  He denies pain, difficulty breathing, has no swelling  of lips, tongue or soft palate.
Myalgia, Arthralgia, Gastrointestinal reflux symptoms, Injection site pain, Dyspnea  Narrative:
Date of Vaccine: June 10th 2021 Onset of Symptoms: June 13th In the evening headache June 14th- threw up 3 times during the day.  In the late evening severe headache and light sensitivity during evening of the 14th severe throwing up, dizziness and weakness Early morning of June 15th-More throwing up(uncontrollable). weakness. room spinning, noise sensitivity and light sensitivity. LEFT TO GO TO EMERGENCY ROOM Admitted right away.  Suspected Meningitis CT scan, Lumbar punch IV fluids.  drugs to reduce vertigo symptoms.   ADMITTED TO HOSPITAL IV continued, more medicines, continued room spinning 16 and 17th in hospital Released 10PM from hospital  with severe Labyrinthitis and Vestibular Neuritis diagnosis.  Continues to be weak and dizzy.
seen in ER 23SEP95 via EMS 130AM; mom described toddler as having hard BM, some vomiting x 2, went limp; normal activity 22SEP 6PM-1AM 23SEP; exam WNL; APAP suppository given
Fussiness, loss of appetite, only wanting to sleep.  No dinner.  8.5 hours later, at 03:00 AM on 10/27/16, wanted water, & back to sleep.  Woke up at 07:00 AM ate breakfast.  Began vomiting large amounts 4x in one hour beginning at 08:00 AM.
Vaccination site began swelling, turning red and itching the morning 9 days after the first dose injection. I experienced minor discomfort for the first 72 hours, then completely normal than the swelling on Day 9.
Enormous swelling, redness, pain at vaccination site. Muscles pains.  Started evening of 67/29/2021
a few minutes after shot while patient waiting in waiting room they started to faint/have a seizure and then urinated on themselves. she came back to consciousness soon after. called EMS to come check out patient and her vitals were fine. she did not go with EMS and left on her own with patient representative once cleared by EMS.
Fever, chills, severe muscle and bone pain lasting for 8 hours and treated with IBU.  Followed by swollen glands in then neck lasting 5 days and general fogginess lasting about 1 week.
7/6/22 Noticed chills in the evening along with a scratchy throat and sinus congestion.  Tested at home COVID 19 test, negative.  7/7 tested with an at home COVID 19 test, positive. Fever, Sinus drainage and heaviness in chest with cough with extreme fatigue.  This continued for 5 days.  The next 5 days had fatigue and felt chills off and on.  7/16, at home COVID 19 test, positive.  7/7 Telehealth with Doctor, who advised to rest for a few days.  Still feeling fatigue and heaviness in chest when going up stairs.
After getting COVID vaccinations, I do not need to take Valtrex. I do not get shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: EL9269) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing). Concomitant medication(s) included: VALTREX taken for herpes zoster. Vaccination history included: Bnt162b2 (1st dose, Lot number: EL3302), administration date: 13Jan2021, for COVID-19 immunisation, reaction(s): "back pain", "joint pain", "stress-related". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After getting COVID vaccinations, I do not need to take Valtrex. I do not get shingles".  No follow-up attempts are possible. No further information is expected.
Information has been received from a 61 year old male registered pharmacist who in October 2009, was vaccinated with the first and only  0.5ml dose of PNEUMOVAX 23 (lot number not provided). The patient reported that as far as he got the PNEUMOVAX 23, he had a headache and felt achy for 3 days. He also experienced a high fever and his whole arm was red and swollen, for 3 days as well. The patient did not seek medical attention. It was unspecified if he got any treatment for the adverse event. No lab diagnostics studies were performed. The patient reported he recovered as of 3 days after got the vaccine. The registered pharmacist considered it was a significant disability due to the fact that he was on bed rest for 3 days as a result of his symptoms. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized on 4/29/2021  for pneumonia due to COVID-19. Patient presented to the ED and was subsequently hospitalized on 5/5/2021 for pneumonia due to COVID-19. This was within 6 weeks of receiving COVID vaccination.
Initial unsolicited report received from a patient's parent on 23-FEB-2017. This case involves a 7-year-old female patient who was subcutaneously vaccinated with a dose of MENOMUNE (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 19-SEP-2007. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none and Illness at the time of vaccination was reported as no. Any other vaccinations within four weeks of vaccinations and concomitant medications were also not reported. On 20-SEP-2007, one day following the vaccination the patient had experienced a severe headache which was diagnosed as migraine. The patient had a doctor visit (Neurologist) on an unknown date. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Pain L side of scalp & eye area, rash & redness of L eye.  Shingles +.  Treatment Valtrex 1 gm 1 >/= 1.  Dr (ophthalmology) exam - no evidence of ophthalmic involvement.
10mins into waiting in post vaccine room, Patient developed patches of redness in her bilateral upper extremities-skilled nurse gave IM Benadryl in Rt  gluteal per Patient request-Effective. No other complain or side effect until Patient left, she stayed in post-vaccine for 30mins monitoring. SN educated Patient on taking Tylenol for pain and if symptoms persist to follow up with primary physician-she verbalize understanding.
Kind of itchy all over my body; Warm; Injection site was very itchy; Red welt with a white center about 2.5 inches, oval shaped; Nose skin burned; Red spots on either side of nose; Injection site was swollen; Felt a little crummy; A little redness at the injection site/injection site was very red, about 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), MALAISE (Felt a little crummy), PRURITUS (Kind of itchy all over my body) and VACCINATION SITE WARMTH (Warm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (Felt a little crummy) and VACCINATION SITE ERYTHEMA (A little redness at the injection site/injection site was very red, about 3 inches in diameter). On 25-Jan-2021, the patient experienced SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Injection site was very itchy), VACCINATION SITE URTICARIA (Red welt with a white center about 2.5 inches, oval shaped) and VACCINATION SITE SWELLING (Injection site was swollen). On 26-Jan-2021, the patient experienced PRURITUS (Kind of itchy all over my body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Jan-2021, MALAISE (Felt a little crummy) had resolved. At the time of the report, SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Injection site was very itchy), VACCINATION SITE ERYTHEMA (A little redness at the injection site/injection site was very red, about 3 inches in diameter) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown, PRURITUS (Kind of itchy all over my body) had not resolved and VACCINATION SITE URTICARIA (Red welt with a white center about 2.5 inches, oval shaped) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had had 2 red spots on either side of her nose. The one on the left side of her nose was the size of a penny and the one on the right side was the size of the quarter and burned.   Treatment using fluorouracil/calcipotriene 5%/.005% cream was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow Up received and contains  non-significant information
The morning after receiving my 2nd dose I experienced elevated resting heart rate. 104 bpm laying down 120 bpm after standing still for 2 minutes.  Normal resting heart rate is 72bpm. Returned to normal resting heart rate 2nd morning after receiving the vaccine.
Client here states on 05/02/02 she noted a red area size of a grapefruit on her left upper arm. It itched and no care given. States on 05/03/02 at 7am the red area was twice the size it was the day felt hot. She called doctor and was seen in office, took blood test and given antibiotic Augmentin 875 mg BID x 5 days. 05/04/02 she noted that the red area extended down her arm elbow. She began taking Benadryl. States she laid down and rest the remainder of the day and read a book. She states that on 05/05/02 around 7am her left arm was still hot but except for her outer left arm which had gotten better and not as red. She continued to use ice to area, it seemed to help. She took an Ibuprofen tablet and then took a Benadryl cap later. She stated that on 05/06/02 she noted that there was no further extension of the redness and it was not hot, she did not need to take any Ibuprofen or Benadryl capsules but continued to take her Augmentin tablets. States the left arm is better today and only a little tenderness to hard spot on outer left arm and inner left arm redness almost gone. States she has checked her temp and it has been normal. States she received her last TD vaccine about 12 years or more ago and had no reaction. States will see regular doctor in two weeks. States she will leave on 06/01/2002 to travel and return on 06/15/2002. States she is unsure about returning for the hep B #2 dose. Client advised to discuss this with the doctor and to find out the blood test that was done and the results and ask MD whether or  not she should complete the hep B vaccine series.
Tingling on nose that lasted about 15-30 min. This happened with both vaccines the second dose 4/17/21 but second time lasted less time not sure how much. This went away on its own.
I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 01/24/2023. I contacted my doctor and got a prescription Molnupiravi. I tolerated the medication without any complications. I was really tired for about month and rested as much as I could.
Teary, watery and puffy eyes. Swollen cheeks. Hives on face. Treated with BENADRYL.
AFTER ABOUT 5 MINUTES  AFTER  RECEIVING THE IMZ patient SAID SHE FELT FAINT AND DIZZY. WE SAT HER BACK DOWN IN THE CHAIR, GAVE HER A BOTTLE OF COLD WATER AND THE TECHNICIAN APPLIED A WET/COOL PAPER TOWEL TO HER FOREHEAD. SHE ALSO SAID THAT SHE FELT  SOME NAUSEA SO WE BROUGHT HER A TRASH CAN JUST IN CASE. AFTER 13 MINUTES SHE SAID THAT SHE FELT BETTER AND THAT THIS HAPPENS SOMETIMES WHEN SHE GIVES BLOOD. WE OBSERVED HER FOR 10-15 MORE MINUTES AND LET HER GO. SHE DECLINED FOR US TO CALL 911. SHE WAS THANKFUL.
p/vax pt had pain in my rt shoulder, armpit & elbow;whole arm felt like the circulation & low;cold & finger were sl blue probably d/t swelling;T99.7;could not sleep;sore all over;T101.5;high fever d/t dehydration;cellulitis;redness;
We are running a clinic today and the person who administered the vaccine noticed that she gave the child the dose of moderna (0.5 ml) not pfizer at 0.3 ml. Moderna currently not approved for under age 18. The PIC, me was notified and I spoke to the family and child about what happened and what to look for as far as side effects go
1/30/ 2022 I was around friends and one tested positive for COVID-19.  I did not take a COVID-19 test, my husband tested positive, but I had all the exact same symptoms.  I had a really bad cold with really bad sinuses. This lasted about 2 ½ weeks.
This case involves a 2 months old patient (unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE (HEPATITIS B VACCIN) [lot and expiration date were not reported] for prophylactic vaccination. On 14-Dec-2021, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Solution for injection in pre-filled syringe, Total, lot 54C23 and expiration date: 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate age at vaccine administration (same day latency). At time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.