chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unknown date in Jan2021 as single dose for covid-19 immunization. The patient experienced sore arm on an unknown date. The report received as, the patient receiving both doses of the COVID-19 vaccine manufactured by Pfizer. Caller experienced a sore arm after receiving the vaccine. Caller reports the first dose was administered on an unspecified date in Jan2021 and the second dose on an unspecified date in Feb2021. It is unknown if the consumer experienced as sore arm after both doses or just one dose. No clarifying details were provided. No PQC. No additional information provided. Outcome of the event was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient is an 80-year-old female with history of Normal pressure hydrocephalus, diabetes, hypertension and a solo kidney after donating 1 to a family member presenting to the emergency department via EMS from home for altered mentation and weakness, concern for possible stroke.  Patient was at home when a puzzle with her caregiver, when she rested her head down on the table, and did not want to engage anymore, she seemed only 1 to go sit in her chair.  The caregiver called patient's daughter who is a nurse, and she came quickly to assess her mom.  When she got there she thought she appreciated a left-sided facial droop along with some right-sided weakness, so she quickly called 911.  It sounds like the symptoms started at 10 AM.  Patient only takes a baby aspirin daily for a blood thinner.  Per EMS, patient's blood sugar was 259.  Upon arrival to the ED, patient has no facial droop, and is moving all extremities.  She does not seem to want to answer questions. I was able to discuss case further with patient's daughter, who is a nurse and case manager here at our facility.  She does state patient's baseline is usually alert and oriented to herself, she usually knows her birthdate.  She states due to her NPH, she does have a shuffling gait and sometimes becomes confused with stressors.  She also notes she does have compression fractures in her spine.
Patient was given incorrect dose of Moderna booster shot.  patient should have received 0.25 milliliters but received 0.05 milliliters in error.
All night I felt very sick, chills, fever, sweating, couldn?t sleep my whole body was hurting, the morning after the vaccine I woke up with a terrible headache that didn?t improve with medications.
There is no adverse reaction.  Patient was under the age of 12.  Mother states that she has immune compromised person in the household and need to get everyone vaccinated, so she misstate the date of birth of patient to received the vaccine.
Information has been received on 08DEC2014 from a registered nurse who reported that an unspecified number of unspecified patients received doses of improperly stored PNEUMOVAX 23 on unspecified dates. No adverse effect reported. No further information was provided. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant medications were reported. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of (M-M-R II) (lot numbers: M006544, Expiry date: 03-FEB-2018) (dosing regimen and frequency unknown). The administered vaccine underwent a temperature excursion at 49 F for a time frame of 7 hours 9 minutes. There was no previous temperature excursions. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Mixed Series.  Patient ran into the Moderna 2nd does vaccination clinic stating she her son was having an emergency in . She stated she was due to receive her 2nd dose on Friday, but requested to get it early due to the need to travel out of state for an extended time. This was approved and she was sent to the verification process. At the scribe station she gave her name and DOB. While the scribe was pulling up her record she proceeded to receive her vaccine (instead of waiting for the scribe to complete the process as she should have.) Post vaccination, she was instructed to wait 15 minutes. She got up to leave. The clinic team lead was alerted and stopped her. She stated she was going to get something from her car and would be right back for the 15 min observation. The scribe had continued to attempt to complete the documentation of her vaccine. The order would not populate. At this point, it was discovers that she had received her first dose of Pfizer vaccine on 4/19. The patient did not return from the trip to her vehicle. We did attempt to call her with no answer and no mail box
first dose on May 11th 2022 planning to receive second on Jun 29th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter
Itching at injection site occurred after 10 min - no redness or warmth - denied throat/mouth itching or swelling, VSS 30 min after injection c/o nausea and dizziness, VSS - 1230 evaluated by ED provider, VSS - 1356 Discharged home stable DX: dizziness, vertigo.
patient tested positive for Covid virus, after being fully vaccinated; patient tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. This case is for 21st patient of 37 patients. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6203) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unspecified date to ongoing. The patient concomitant medications were not reported. The patient tested positive for Covid virus, after being fully vaccinated on 01Aug2021. The reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller stated she has 37 patients with partial identifiers. Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The patient underwent lab tests and procedures which included NAAT Covid test (sars-cov-2 test): positive on 01Aug2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Patient was due for 3rd PFIZER 8 weeks after second dose, however received the 3rd dose early. Dose #1 was given on 8/1/22, Dose #2 was given on 8/22/22 and 3rd Dose was given on this date of 9/12/2022.  Patient was supposed to get 3rd Dose at the earliest the week of 10/17/22. Dose #3 given too early according to the guidelines. NO adverse effect noted 30 minutes post vaccination.
1 - 2 minutes after vaccine administration, patient appeared very faint and lethargic. Per mother, patient has a frequent history of petite mal seizures that appear in the same way. Mother moved patient to floor, elevated her legs, and we apply a cool rag to her forehead. Patient never became unresponsive or appear to have respiratory distress. After remaining on the floor for 5-10 minutes, she was able to get herself up and sit upright in a chair. She remained in the chair for approximately 10 minutes. After the initial onset of symptoms, she never worsened and only returned to normal. Before leaving, she denied any difficulty breathing, chest tightness, or itchy throat. Before leaving, she appeared in as good of health of when she initially arrived for the vaccine.
Arm was sore for 3 days, then fine. On 1/7/20, arm was sore at bedtime. On 1/8/20, arm was sore and hot to touch. Stem also had large red blotches that looked like and allergic reaction. Became itchy evening of 1/8/20.  Benadryl was taken.  Today, 1/9/20, redness and soreness is still there. Redness is more solid instead of broken and splotchy.  Red Area is about the size of a fist.
Rash, fatigue, diarrhea, nausea, inflammation on my face, irregular heart beat.
BLURRED VISION; FLASHY THINGS AROUND EYES; NUMBNESS ON RIGHT SIDE; TINGLING ON RIGHT SIDE; PAIN ON LEFT SIDE DOWN TO THE BASE OF SKULL/SEVERE HEADACHE (HEADACHE UNBEARABLE); This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included contracted covid, and concurrent conditions included benign hypertension. The patient experienced drug allergy when treated with metformin, and amlodipine besilate for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced blurred vision. On 27-MAY-2021, the subject experienced flashy things around eyes. On 27-MAY-2021, the subject experienced numbness on right side. On 27-MAY-2021, the subject experienced tingling on right side. On 27-MAY-2021, the subject experienced pain on left side down to the base of skull/severe headache (headache unbearable). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, flashy things around eyes, pain on left side down to the base of skull/severe headache (headache unbearable), numbness on right side, and tingling on right side. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
On 9 April, I suddenly experienced joint and muscular pain, along with inflammation in both shoulders. My right shoulder was in far worse pain, with loss of strength, and range of motion when compared to my left. R Shoulder: 8/10, Left Shoulder 4/10.  The pain and inflammation initially set-in at a lesser strength, perhaps 65% compared to the above levels, but increased overnight to the above referenced levels. That pain has lessened over the weeks since, and currently diminishes at a slow pace. Currently the left arm is nearly 100%, with only some inflammation and joint pain left. The right arm is better, but if I do any manual work with it, it becomes inflamed and warm to the touch. Cooling the shoulder works, heat does not.  NOTE: in 2015 I fell in an accident and injured my right shoulder. The rotator cuff was torn, and the labrum torn as well, and the pain in the Right Shoulder has echoed that injury (which I had recovered from) greatly. It still feels as if my should was wrenched all over again - and I think that injury may be why the current pain in that shoulder is greater. I have no other explanation for the difference.   This isn't easy to figure out - feel free to contact me for more information.
muscle pain; shivers; was lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: 30Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; CHILLS (non-serious), outcome "unknown", described as "shivers"; LETHARGY (non-serious), outcome "unknown", described as "was lethargic".  No follow-up attempts are possible. No further information is expected.
Patient received the HPV vaccine . Tolerated well. Stood up from the examination table and went by the sink in the room to look at stickers. Within 2-3  minutes of standing up, Patient felt lightheaded and fainted, hitting her head on the edge of the counter during her fall to the ground. Patient's mom and Dr. were present in the room during this event. Patient was assisted to the examination table by Dr. and mom. RN was called to assist. Patient was awake and alert when RN arrived . Was responding appropriately to all questions. Ice pack was applied to back of Patient's head and Patient was inspected for any bleeding, bruising, swelling or abrasion. None noted. Vital signs were checked and documented. Apple juice was offered . Patient drank the contents of the entire bottle. Denied any symptoms of headache, dizziness, blurred vision, nausea or vomiting. Patient remained in the room and was observed directly by Dr. for the next 15 minutes. Once cleared to leave to go home, Patient's mom was given home care instructions  by DR..  All questions were answered to mom's satisfaction. Patient ambulated independently out of the clinic with her mother and younger sister. Was observed smiling and laughing while exiting the clinic.
Headaches, fever, vomiting, dizzy. Treated mostly with bed rest, limited ibuprofen for headache.
I had the horrible vaccine and still got shingles/ suspected vaccination failure; shingles started on forehead and went down into my eyes; still got shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the horrible vaccine and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles started on forehead and went down into my eyes) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and pain (Verbatim: painful).  The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.   Additional Information: Gsk receipt date 17 Sep 2023 This case was reported by a consumer via interactive digital media. The patient had horrible vaccine and still got the shingles. It started on forehead and went down into his/her eyes. It was really painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported
very sore muscle (deltoid) for 2 days;cont to be sore @ site w/repetitive movement & pressure;c/o awakening @ HS if lays on lt side;taking advil w/relief;MD notified by PHN;pt to call MD for f/u if pain persists;
This spontaneous report was received from a 53 years old male pharmacist. On 13-SEP-2012, the pharmacist went to administer the patient with ZOSTAVAX (lot number reported as 0070AE expiry 03-APR-2013) and the syringe plunger auto retracted and the ZOSTAVAX splashed into his left eye. He immediately used an eyewash to flush both of his eyes for at least 15 minutes. No adverse events were reported. Lot number verification has been requested. ZOSTAVAX splashed into the eye was considered to be medically significant by the reporter. The is one of the several reports received from the same reporter. Additional information has been requested.
Low grade fever, shivering, exhaustion, swollen lymph nodes, very painful injection site.
got Covid after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid after being vaccinated) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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 COVID-19 (got Covid after being vaccinated). At the time of the report, COVID-19 (got Covid after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter stated that the niece of the reporter got Covid after being vaccinated. Both of them  got a very mild case. But the children of theirs who are 10 and 6 did not get the vaccine. No treatment medication was reported.   Reporter did not allow further contact
c/o feeling like she was going to faint                                                                                                                                                                                                                                                                                                                 Date: 3/23/2021  Problem: c/o feeling faint Notes: Pt was being observed after injection. Pt stated she began to feel like she was about to faint. VS taken BP 78/40 P42 BS 102 O2 98 %.  Pt alert and talking to nurse . Legs raised in chair. Water and granola bar provided  to pt and she stated she was beginning to feel better. Pt states she's never had any previous reactions after injections but she thinks she didn't eat enough breakfast. VS rechecked after 5 minutes. BP 98/58 P64 O2 99%. Pt states she normally has low BP. Mom at pt side as nurse continued to monitor. Pt VS checked BP 124/70 P55 O2 99% AOx4. Left with private vehicle with mother and stated she was feeling good at that time.
On 03/16/01, the patient started having systemic rash. Not experiencing sore throat, or other URI symptoms. On 03/19/01, her physician diagnosed Rubella disease.
The patch they put on my arm itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The patch they put on my arm itches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (The patch they put on my arm itches). At the time of the report, VACCINATION SITE PRURITUS (The patch they put on my arm itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided concomitant medications were not provided
COVID "arm" - swelling, red, itchy, spreading, 8 x 4 in.
Patient has been in pain every since the shot.  He alleges that the shot was given too high.
PT REPORTS BEING PREVIOUSLY ACTIVE AND HEALTHY, 4 DAYS AFTER RECEIVING VACCINE SHE PRESENTED TO ER WITH A. FIB AND HEART FAILURE. PT UNDERWENT CARDIOVERSION ON 3/15 AND REPORTS 4 NORMAL EKG'S SINCE.  PT DOES NOT REPORT A RE-EVALUATION OF INJECTION FRACTION SINCE.  PT RECEIVED 2ND DOSE ON 3/4 BUT THOUGHT THEY MIGHT BE RELATED SINCE SEEING REPORTS OF HEART ISSUES FOLLOWING VACCINATION
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Patient came in for her second dose of the Covid-19 immunization. She stated that the arm had hurt since her last shot, was swollen and she thought had a foreign body left inside the arm. She believed the needle had broken off in the arm. I reviewed her paperwork from the previous shot and no notes were made regarding the integrity of the vaccine administration. I examined her arm by touching and feeling the area of the vaccine but could not feel anything inside the arm. She was referred to the ER for evaluation, In the ER they performed an Xray but did not find anything inside the arm.  She was diagnosed with cellulitis and was prescribed antibiotics.
8/10/07 After JEN complain of tingling tongue - light headed - neck stiffness lungs clear and hives, VS 110/60 - HR 60 in clinic 40 minutes felt ok to drive home - told call 911 as needed. 8/13/07 AM - F/U cell - felt ok just tired; 8/14/07 said yesterday couldn't breath - called 911 and ER and O2 constricted breathing, ok today 8/17/07.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with two improperly stored GARDASIL (lot# K006449 exp. 19-JUN-2016) and one dose of improperly stored GARDASIL (lot# L001442 exp. 04-NOV-2016). Concomitant therapy was not reported. No adverse effect was reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.