chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax 2NOV92 & 3NOV92 devel a fine irritating urticarial rash; seen by MD;
Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   The patient's past medical history included shingles.   On 26th April 2019, the patient received Shingrix (intramuscular). On 26th April 2019, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. The patient developed a shingles rash on her trunk the day of vaccination.  The rash had not been verified by a physician to be shingles.  The patient does not think it was caused by the Shingrix, she thinks it was coincidence.
I received my first Pfizer booster for COVID-19 on 11/25/2021. On about 12/21/2021 or thereabouts, I began to experience joint pain in my knees, elbows, and the thoracic vertebrae. The pains were sharp and were intermittent at first. However, around January and February 2022, the pains became milder but more constant. From the date of the booster until 2/13/2022, I gained 31 lbs. The strange thing about the weight gain is that I was on a strictly plant-based diet at the time, plus I had been restricting my caloric intake to 1700 a day. Not only that, but I was also working out 4 times a week and for 2 hours on each occasion, and I was focusing especially on cardio. I've also experienced anxiety of an unspecified cause from 1/1/2022 to 7/30/2022. Also, from the time of my booster, I began to deal with more frequent insomnia, and this issue continues to the present day. I had a telehealth visit with my doctor on 1/20/2022 to address these issues. At this point, the doctor adopted a "wait and see" attitude. On 2/14/2022, I underwent a physical that included blood work to see if there were maybe issues with my thyroid or other parts of the endocrine system, and no anomalies or hormone imbalances were detected. The doctor believes that the DESCOVY I was taking likely played some role in the weight gain, but it doesn't explain everything. The doctor had me stop taking the DESCOVY, but I still didn't lose any weight. Ever since then, the doctor and I have been on the lookout for signs of further weight gain, and so far, I have not gained any more. My doctor gave me some hydroxyzine to treat the anxiety. It made me sleepy and helped with my insomnia, so I would say that it was an effective treatment. At the time of this writing, I am still taking hydroxyzine as needed. Since the doctor has taken me off of DESCOVY, I have been receiving APRETUDE intravenously in place of it. Regarding the joint pain, my elbows and my vertebrae are fine. However, I'm still having trouble with my knees. The doctor prescribed me meloxicam for the joint pain, and I currently take it as needed.
Vaccine was administered outside of recommended storage guidelines--it was frozen under normal temperatures, not ultra cold temperatures, then thawed for administration.  Per Pfizer stability data the vaccine is still safe and effective for up to 14 days under these conditions but the use is considered off label.
The pt received vaccines on pm of 04/30/2002. Early evening same day, the pt found pale with facial twitching. Mother gave two recessive  breathes and gentle sternal massage. Child resumed breathing less than 2 mins. Afebrile. Examined in ER and was observed over night.
Cellulitis of upper right arm/deltoid area. Area red, raised, warm. Skin marked w/ marker. Treatment included warm compresses TID, TYLENOL and clindamycin on 6/25/14.
Infjection on Thursday, March 26, 2009. Initial itching within minutes. Friday, March 27 area around injection site was swollen, red and hot. Evening Friday, March 27 had flu-like symptoms, extreme fatigue, area around injection site was significantly swollen, red and hot (about the width and length of a handprint); and entire arm was tender and arm movements were painful. All fo these symptoms persisted throughout Saturday March 28. Sunday, March 29 injection site was slightly less swollen, but arm continued to be sore & tender and fatigue continued. Monday, March 30 arm is slightly less sore and swelling reduced. However, there continues to be an area about 3-4 inches wide & long that is swollen and tender, and how itching. Treatment has been self-administered, rest & aspirin.
Woke abruptly early morning of 4/27 with a racing heart, palpitations, and numbness in hands and feet. Ambulance arrived and discovered my blood pressure was very high (157/104) and took me to the ER. Bloodwork and other diagnostic tests (EKG, chest x-ray) did not reveal an emergent heart issue and palpitations resolved, though blood pressure remained somewhat elevated.  Discharged same day with directive to see cardiologist. Followed up with cardiologist  two days later. Blood pressure remained elevated. Additional tests (echocardiogram, stress test, holter monitor) were ordered and I was instructed to monitor my blood pressure at home and return to the office in a few  weeks. Test results came back normal. At home blood pressure monitor revealed elevated and fluctuating blood pressure  readings lasting  another 9 days. On the 10th day (exactly 14 days after receiving second vaccine dose), blood pressure completely normalized and has remained normal and not fluctuating since that date.  Prior to this incident my blood pressure has always been normal at annual physicals, and was last elevated 14 years ago  (in 2007) when I had preeclampsia in connection with my daughter?s birth, which resolved within a few weeks of the birth.
1st Vaccination on 3/4; Symptoms began 3/11 - itchy rash on upper back and left underarm; underarm rash became tingley and burning; rash has spread to the rest of my left arm and onto my right arm; very little itching on arms, more on back; only left underarm tingles and burns
24JAN97 pt presented w/rash on hands & trunk;Imp: mild varicella s/p varivax MAY96;
73 years old male called to report an dverse reaction after he received his second moderna dose on 03/23/2021 @1045. patient reported that the second day 03/24/2021 @1500 developed black purple red arm but now it start to go away.. patient denies any allergies. patient takes escitalopram and bupropion for anxiety. patient reported that he takes hydrochlorothiazide for high blood pressure. patient reported that he takes pravastatin for cholesterol. patient was instructed to apply cold compress to help with the healing process. patient was instructed to seek medical attention if the symptoms got worse.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in an elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 79 or 80 years old. The reporter did not have batch number of SHINGRIX at the time of call. The patient experienced mild case of shingles after receiving a dose of SHINGRIX. The reporter consented to follow up.
Reported rash on face and upper body this past weekend. She called her doctor and he referred her to us. Not having trouble breathing. I recommended Benadryl to help rash.
She fainted; Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer. A female patient of unspecified age 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 unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Reporter stated, "One of my family members had the vaccine, her second dose of vaccine and she today (14May2021) at 4:00 in the morning she started having chills and fever and body ache and then took like, like in less than an hour she fainted. Is that normal or she has to go to the, her doctor or the emergency room?" Reporter confirmed it was the Pfizer Covid19 vaccine. The outcome of the events was unknown.  information on the lot/batch number has been requested.
Day 1 I came home and had a sore arm. 24/48 hours I had severe fatigue where I couldn?t really get out of bed. 72 hours I started feeling very strong palpitations that would not stop with my Valium. These were so severe I could see my left side of my chest jerking. I was hospitalized where they could see palpation going every few seconds. This lasted for 5 days ... I am now 9 days out and they stopped 48 hours ago. My doctor and I talked , Er doctors and I talked and nothing really triggered anything we could think of other than the vaccine . I am scheduled now to see a cardiologist to give me clearance if the second dose would be ok .
heart was racing and pounding and her breathing was labored; She decided to go to bed as she wasn't feeling well; but was unable to sleep well that night as she kept waking up every 2 hours; heavy breathing; got "achy"; This is a spontaneous report from a contactable consumer (patient) received from a initiative; CEP 159558. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, caller received the first Pfizer covid vaccination in the morning and that night about 8 PM experienced side effects, after first dose her heart was racing and pounding and her breathing was labored. She decided to go to bed as she wasn't feeling well but was unable to sleep well that night and got achy as she kept waking up every 2 hours. These symptoms subsided on their own, without intervention. The caller was scheduled to receive her second dose tomorrow but was worried about these side effects happening again and being more pronounced as this will be the second dose. The caller wanted to know whether the side effects would be worse in the second shot. Stated that, she heard that people have worse side effects after the second dose. The caller stated that, her physician had the Moderna COVID vaccine (she was fairly sure as this was the only one her family physician's office was offering) and couldn't sleep the night after he received it. She wanted guidance from Pfizer as to whether she should receive the second dose and when she needed to seek medical attention if the side effects occur again. Any unaddressed medical questions referred or forwarded to Medical Information was reported as yes. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
About 3 minutes after Gardasil was given patient stated that she felt as if a bunch of shots were sticking her in her left neck.  Vital Signs were rechecked and WNL.  Patient then stated that her posterior middle back started to feel the same way.  I had her lay down.  Vital Signs were WNL, and provider was notified.  Once provider was at the bedside she began to have left arm numbness right leg numbness and tingling with complaints of her right leg beginning heavy to left on assessment.  Patient was able to move all extremities and denied pain on touch and movement.  Ice pack was applied to affected areas and patient was given water.  Patient recovered in less than 20 minutes.
Booster; Temperature excursion; Booster shot, they got was in a temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 16Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Sep2021, outcome unknown, described as Booster; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 16Sep2021, outcome unknown, described as Temperature excursion; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 16Sep2021, outcome unknown, described as Booster shot, they got was in a temperature excursion.  Additional information: About a week later pharmacist called and said the booster shot wife and caller had been in a temperature excursion and wondering if they were having any side effects. Caller said they both had same side effects after boosters as they did after both doses of covid vaccine. Wondering if we have any records on file of the booster they received. Also wants to know if they should be revaccinated. And if booster shot, they got was in a temperature excursion, is that ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pneumococcal vaccine administered to left deltoid. Pt had erythematous rash to medial left arm and left mid-forearm.
For 4 months after the vaccine I experienced extreme fatigue and "foggy brain".  For several more months I experienced a less severe form of fatigue and "foggy" brain. At the time of the vaccine I had a small ovarian cyst that was being followed via ultrasounds. for several years without significant growth. The appointment several months after the vaccine showed the cyst had more than doubled in size and it continued to exponentially grow until it was removed 18 months later at  a size of almost 5 ".
This case was reported by a pharmacist via call center representative and described the occurrence of flu like symptoms in a 65-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 20th March 2020) for prophylaxis. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms (serious criteria disability), fatigue (serious criteria disability) and fever (serious criteria disability). On an unknown date, the outcome of the flu like symptoms, fatigue and fever were recovered/resolved. The reporter considered the flu like symptoms, fatigue and fever to be related to SHINGRIX. Additional information was received as follows: At 11:40, the patient received SHINGRIX on left arm. The flu like symptoms (mostly fatigue and fever) resolved 10 days later. The healthcare professional stated that symptoms were disabling the patient, who felt like the flu. The patient did not want to come back for the 2nd dose of SHINGRIX. This case is one of 8 cases reported by the same reporter.
Symptoms occurred the night of 10/10/2022 after receiving vaccine fever; heart rate pvc;
complete hearing loss in left ear / partial hearing returned in left ear; strange noise heard inside the ear; This case was reported by a consumer and described the occurrence of deafness unilateral in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2020, the patient received Shingrix 50 mcg/mg. On 4th October 2020 07:00, 1 days after receiving Shingrix, the patient experienced deafness unilateral (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the deafness unilateral and ringing in ears were recovering/resolving.   The reporter considered the deafness unilateral and ringing in ears to be probably related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient received the vaccination Shingrix 50mcg in upper left arm. On 4th October 2020, the patient woke up at 7 am with complete hearing loss in left ear with strange noise heard inside the ear. The patient called the pharmacist and he/she told that that it was not a side effect and patient should seek medical attention. On 5th October 2020, patient woke up with partial hearing returned in left ear, as the day progressed the hearing in the left ear gradually returned and at 2 pm there was just a little noise in the ear when around sounds such as TV volume. No medical treatment received by patient. For patient it seemed a little odd that shot was received in left arm and she lost hearing in left ear so she made an assumption that there was probably a connection between shot and hearing loss. The patient was on the way to complete resolving of this issue. The patient was concerned whether this would happen again with the booster.
Muscle pain; Joint pain; isn't feeling very well; burning and sharp pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID 19 vaccine (Pfizer shot) last Monday (unspecified date). He was having some side effects including muscle pain, joint pain, and burning and sharp pain. He wanted to get a little information about that. He is scheduled for the second dose on 13Feb2021. The patient mentioned that this whole week, he has been going through this pain. The patient isn't feeling very well, and he doesn't want to stay on the phone. He doesn't want to report at this time. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a pharmacy technician concerning a patient who on 14-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (no lot# provided). On 14-JAN-2009 the patient experienced difficulty moving the arm where vaccination was given. The pharmacy technician considered "not being able to move the arm" to be disabling. At the time of this report the patient had not yet recovered. Additional information has been requested.
exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140237:Same reporter US-GSK-US2022140236:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter
4 days after vaccine developed Small red bump dotty rash starting on abdomen and middle back and spread to more areas on torso/chest/upper and lower back. Itchy. Not relieved by Benadryl. Attempting home treatments such as hydrocortisone cream and colloidal oatmeal bath for itching. Will go to MD if not improved after one week or continuing to worsen
second dose was Pfizer vaccine, not Moderna; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (second dose was Pfizer vaccine, not Moderna) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (second dose was Pfizer vaccine, not Moderna). At the time of the report, WRONG PRODUCT ADMINISTERED (second dose was Pfizer vaccine, not Moderna) had resolved. Not Provided          Blood pressure, Diabetes and arthritis medication are the treatment medications reported by reporter.  Patient stated when she came back home after the second dose she saw in the vaccination card that the second dose was not Modena's, but Pfizer's.
The pharmacist gave me the vaccine in my right shoulder and I commented that I thought it was a bit high and he said "no, it's right where it should be". It hurt quite badly and continued to hurt. I came back to talk to him a few days later. He said that was rather normal for that injection. It woke me up in the middle of the night on Tuesday night and hurt quite badly. It affected my shoulder and right arm and continued. I went to my doctor a few days later and he referred me to a doctor for joints etc. I eventually went to my heart doctor thinking it was a heart problem. I had suffered a heart attack in 2004 when the symptoms were in my right arm (not left). Dr. gave me many tests and said that my heart was OK and that the pain was probably due to that shot. I also have limited motion of my right arm at this time and some pain when I try to move it where it was quite normal before the injection. I cannot do the crawl (swimming) like I did before March 31.