chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized dimpling in skin of thigh with associated 2cm or so subcutaneous nodule, 2 weeks after vaccine administration. Possible early fat necrosis, will observe.
No additional AE/PQC was reported; patient was administered MMRII and VARIVAX on 1/12/2023 that were reconstituted using lidocaine in lieu of the supplied Merck sterile diluent; patient was administered MMRII and VARIVAX on 1/12/2023 that were reconstituted using lidocaine in lieu of the supplied Merck sterile diluent; This spontaneous report was received from medical assistant and refers to a 4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JAN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot #W023072, expiration date: 05-APR-2024, administered subcutaneously into right arm; and with varicella virus vaccine live (oka/merck) (VARIVAX) lot #W021740, expiration date: 10-JUL-2024, administered subcutaneously into left arm, for prophylaxis (dose was not provided). Vaccines were reconstituted using lidocaine in lieu of the supplied sterile diluent (vaccine incorrect diluent use, wrong product administered). No additional adverse event (AE) was reported.
Vaccine was not diluted prior to administration so patient received higher than indicated dose. Reported runny nose and mild cough.
Fever started on 8DEC t102 w/APAP, 9DEC t105 presented to ER crying, told t103 probably viral-caused, ears OK; 10DEC t103 & subsided in afternoon cranky; 11DEC rash appeared, t102; 12DEC t102;
fever off the thermometer w/in 24 hrs p/vax of #4 DTP & #3 OPV;
After the vaccines we administered and parents were getting the baby dressed, they came and notified me that her lower legs were swelling and turning bright red. I went and got the Doctor, who examined the baby. By that time the swelling and redness were diminishing. The Doctor observed the baby for 20 minutes and let them go home.
Administration into  triceps instead deltoid; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2022, the patient received Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 5th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-AUG-2022.  Reporter's Comments: Medical assistant and manager reported that the patient received a dose of Bexsero that was administered into the triceps muscle instead of the deltoid muscle. The vaccine administration facility was the same as primary reporter Did not consent to follow-up. Additional Supportive Information: As patient received Bexsero into the triceps muscle instead of the deltoid muscle, which led to vaccine administered at inappropriate site.
Child had DTAP #4 & Hib #4 onset 2/1/03 started having high fever on 2/3/06 fever 104t and 103 degrees.
It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Got both other vaccines as Pfizer also. Unlike my other two shots (the 1st was no symptoms)), for Covid-19 immunization, reaction(s): "the 1st was no symptoms"; Bnt162b2 (Dose=2, Got both other vaccines as Pfizer also. 2nd was flu-like symptoms for a day), for Covid-19 immunization, reaction(s): "2nd was flu-like symptoms for a day". The following information was reported: ANGINA PECTORIS (medically significant) with onset Oct2021, outcome "unknown", described as "It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area". Clinical course: The patient got both other vaccines as Pfizer also. Unlike other two shots (the 1st was no symptoms, and the 2nd was flu-like symptoms for a day), the shot instantly felt different being injected. It felt as it was instantly spreading. Within 30 seconds, patient started to get a sharp stabbing pain in the heart area. That lasted all day every few minutes. The patient was wanted to see if get any insight from the company about patients medical problems after getting the Pfizer booster back in Oct2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received the vaccine at 10:40am on 3/24/2021 and felt normal. At 1:20pm anaphylaxis set in - experienced tingling then tightness in throat, tongue swelled, swallowing would cause me to choke and tongue would get stuck blocking air passage. Hyperventilating began as I could not get enough air into my lungs. For 15 minutes tried drinking water and laying down to help open airways. Breathing slightly eased for 2-4 minutes and then the anaphylaxis would spike again. This happened 3x getting worse,  I called my Primary Care Physician's office and was advised to go to the ER immediately. At 2:15pm I arrived at the ER and at 2:30pm I was given a 1mg shot of EPINEPHrine, and intravenous shots of diphenhydrAMINE, methylPREDNISolone, and famotidine along with oxygen. Anaphylaxis finally dissipated around 3:30pm and by 5pm I was breathing more normally. I was discharged at 7:00pm, and was feeling very energized. I was also given a prescription for an epipen incase I should have any further issues.  The next morning, 3/25/2021 I woke up after 5 hours of sleep feeling extremely energized. I had a virtual doctor's appointment with my allergist, Dr. at 12:00pm. My doctor was surprised at how well I seemed to be doing and we made arrangements to do further allergy tests in 2 weeks. We came to the conclusion that I am most likely allergic to POLYETHYLENE GLYCOL. This ingredient is also in a cold medicine that I was taking in January and I was experiencing minor anaphylaxis (which I thought was due to the extreme congestion I was experiencing with the cold). It is also an ingredient (aka PEG) in an eye cream that caused a severe eczema patch under my eye in January.   After my appt, at 1:30pm I went into anaphylaxis again. My throat got tingley and began to close, my tongue swelled and again was getting stuck in my throat when I attempted to swallow. I laid down and tried to get in deep breaths. My husband bought children's BENADRYL, which does not have polyethylene glycol in it, and gave me 15ml at 2:15pm. I reached out to my allergist, Dr. and updated him. He advised that I immediately take an additional 5ml of the BENADRYL. Dr. prescribed me 60mg/day Prednisone for 2 days followed by 40mg/day of Prednisone for 4 days, 40mg/day Famotidine for 2 weeks, 10mg/day antihistamine (I chose loratadine) for 2 weeks. Dr. also shared that I should have been prescribed steroids when I was discharged from the hospital, but my energetic state gave the impression I was OK. My manic energy was a result of the epinephrine, which had finally worn off 23 hours later, causing my body to begin the allergic reaction all over again.  The evening of 3/25/2021 (after the first dose of 60mg prednisone, 40mg famotidine, and 10mg loratadine) and all three meals on 3/26/2021 I experienced minor anaphylaxis when I began to eat. Tightness in throat throughout the meal and lasting an additional 20 minutes following the meal. My throat has reopened after each incident on 3/26/2021 and I was able to breathe normally again.
describes whoosh sensation Narrative: Patient recieved Pfizer COVID 19 vaccination at 1119. At 1129 Patient c/o "whoosh" sensation and endorsed  dizziness (Category 1 Symptom). Patient experienced no LOC and was assisted to trendelenberg position with legs on chair. VSS, denied numbness, nausea, or SOB. Patient A&Ox4 and speaking in complete sentences. Continued to regularly monitor VS and Patient reported resolution of dizziness. Patient released at 1200 from monitor area. 1129: HR 95 BP 141/85 Temp 37C 1130: HR 81 BP 137/84 1200: HR 84 BP 131/85 POX 94% on room air
red dot near injection site; trouble sleeping; fatigued; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a day after receiving Shingrix, the patient experienced difficulty sleeping and fatigue. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient had received the first dose of Shingrix vaccine a few weeks ago (end of September 2021) could not remember exact date, on the left upper arm. The reporter stated that the same night his wife had trouble sleeping and was fatigued the next day. The reporter stated that he had  noticed a red dot near Shingrix injection site on the patient's left arm.. The reporter consented to follow up. This case was linked with US2021210526, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210526:same reporter
feels like she has a cold coming on; 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) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "feels like she has a cold coming on".  Additional information: Reporter (patient) clarified she did not have a high fever, she felt like she had a cold coming on, she had been skiing. This was why she needs to reschedule her booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse reaction. Patient was given a TD vaccine with an expiration date of 10 days prior (Expired 02JUL2016). Patient will be revaccinated.
Redness, swelling, hot to touch at injection site (L arm) for two days after shot was administered.
Small patch of itching that bounced all over body (one single cell at a time), would go away for days at a time.
Rash, itch, and swelling at sight of injection. Spoke with client on again on 01/17/13, she stated no improvement, her symptoms were actually worsening. Advised to go back to the doctor for re-evaluation.
Info has been received from a pharmacist concerning a female pt who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent. Vaccination on the following day included a dose of influenza virus vaccine in the other arm. Subsequently, the pt developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent. The pharmacist reported 2 other pts who had similar experiences following vaccination with pneumococcal vaccine 23 polyvalent (MSD) (WAES #0211USA01830 and 021USA01470). Additional info has been requested.
On 1/15/2021 I started having joint pain, muscle pain mostly back pain & headaches. I'm still having this symptoms.
Red Injection Site; Itchy Injection Site; Rash Baseball Size on the Inje ction Site; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) and INJECTION SITE PAIN (Sore Left Arm) in a 66-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore Left Arm). On 23-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site). On 17-Jan-2021, INJECTION SITE PAIN (Sore Left Arm) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received on 24-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) and INJECTION SITE PAIN (Sore Left Arm) in a 66-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore Left Arm). On 23-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site). On 17-Jan-2021, INJECTION SITE PAIN (Sore Left Arm) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Patient came in on 10/16/2017 and received the MMRV vaccine. He is 14 years old and was not suppose to receive vaccine because the age limit is 12 months and 12 years old. Patient is fine, he is not having any rash or fever. Doctor spoke to mom yesterday about having abd pain, that is from the sickle cell disease.
rash-generalized fine, maculo papular pruritic rash-appeared 29OCT94 & 30OCT94 evenings-reappeared 31OCT94 @ 1PM; t99.0; BP 120/74; took DPH for itching;
pt recvd vax & lab eval in 1987 revealed anti-HBs neg; lab eval in DEC92 revealed a high nl SGOT level & a pos antibody screening for heaptitis non A non B; No further details were provided
Prodromal symp trigeminal nerve distribution day 7 after vaccination with rash development within 2 days. Valtrex 3 times daily initiated. Vital signs - T. 97.5, P. 80, BP 108/78.
Information has been received from a 78 year old female with no past medical history and no allergies who on Oct 08 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On Oct 08 2004 the patient experienced redness, soreness and swelling. the patient was reported to be recovering. No medical attention was sought. No product quality complaint was involved. There was no relevant diagnostic test or laboratory data. Additional information has been requested.
Sudden onset of confusion.  Treated for urosepsis.  WBC went from 19.1 down to 12.0.  Creatinine normalized.  Lactate normalized. 3/23 pt. became acutely agitated, requiring sedation, developed respiratory acidosis.  No improvement with Bipap, responded to Lasix. No improvement and transitioned to comfort care
Patient received vaccines on 12/7/11 - returned to clinic with complaints of rash on face per aunt. During the visit it was noted that patient had swelling of the left eye, c/o left side facial swelling & itching of left eye.
Per office note: 08/20/2021: FNP-BC Received picture Rt upper thigh  itching and it is hot to the touch. Instructed mother to apply cold compress, use Benadryl cream on it, and if no improvement to call the office. on 08/21/21 mother sent a picture that pts leg was getting worse with redness and swelling. Instructed mother to give Tylenol and/or Ibuprofen for the discomfort and Benadryl PO, Mother states she ended up taking pt to the ER to get it checked out and they gave her a shot of steroids and symptoms improved.
left side of throat became sore after 6 hours of administration, and lasted for 3 days; Headache started about 6 hours after administration; This is a spontaneous report from a contactable Other HCP (patient herself). The 23-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection) (lot number: EL1283; Expiration date: not reported) via unspecified route of administration on an unknown date as FIRST DOSE, SINGLE DOSE for covid-19 immunisation. The patient had medical history of known allergies of Jackfruit. The concomitant medications were not reported. The patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient had headache started about 6 hours after administration. Vaccine was administered on left arm and left side of throat became sore after 6 hours of administration and lasted for 3 days. Right side of throat was not affected. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
little soreness; Soreness in her arm and in the shoulder above where the injection was given; Soreness in her arm and in the shoulder above where the injection was given; low grade fever; feeling lethargic; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 74-years-old female patient (wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the first dose of vaccine a week ago and she had no issues with it and on an unspecified date she has very little soreness until the morning, aftre that she has soreness in her arm and in the shoulder above where the injection was given, a low-grade fever and feeling lethargic all day. Reporter was wondering about the likely hood that these side effects would occur a week after getting the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash develop in the patient, from the injection site down to the elbow; Rash develop in the patient, from the injection site down to the elbow; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that rash develop in the patient, from the injection site down to the elbow on an unspecified date. The outcome of the events was unknown.
May 2021 moderate rash over chest, back and shoulders. Was given an rx of steroid cream which is working to get rid of the rash.
Headache; Fever; Joint pain; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247), via an unspecified route of administration on arm left on 10Feb2021 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported and no known allergies.The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications in 2 weeks. The patient concomitant medications was not reported. the patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left on 20Jan2021 10:45 AM at single dose for COVID-19 immunization. On 10Feb2021 10:00 PM, the patient experienced headache, fever, joint pain. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Swelling within 6 hours, developed fever to 102, erythema, pain and induration of right thigh within 24 hours. Also viral URI symptoms and asthma exacerbation.
Diagnosed with Covid 19; Diagnosed with Covid 19; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included ongoing Sheehan's syndrome and ongoing hypopituitarism (she was diagnosed about 7 years ago and has no pituitary gland). Concomitant medication included somatropin (GENOTROPIN), she has been on this medication for about a year. On unspecified date in 2021, the patient was diagnosed with COVID 19 and was having difficulty breathing. The patient stated she was diagnosed with Covid 19 about a week ago. She stated that her vaccination card is upstairs, and she has been having difficulty breathing and is taking care of her daughter. She received both doses of the Covid Vaccine in Mar2021. The outcome of the events was not recovered.    The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.