chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was injected by the pharmacist in upper right arm in fatty tissue on 4/5/13 at 11:00 am. All symptoms were on my right side. About five hours after the shot I noticed that breathing deep breaths were becoming painful in my right rib cage just below my right breast. Felt like I had a cracked rib though nothing was particularly painful to the touch. To avoid pain I restrained my breathing to shallow breaths, but stomach hiccups and yawning were painful. By 7:00 pm that evening, the "cracked rib" pain became so painful I had to breathe in extremely shallow breaths. Pain level was about a 10, same as  a kidney stone. Wrapping my upper chest with an ace bandage helped. Could only lay my back to avoid rib area pain. Slept only a few hours off and on during the night. By 7:00 am the next morning pain subsided and I could breathe almost normally as long as I didn't take deep breaths, and I slept for six hours. By six pm later that day, I could breathe normally without pain, but deep, sudden breaths would create discomfort in my rib cage and neck area. Painful symptoms continue to subside, but now deep breaths cause some pain in the sinews in my right neck going from my shoulder to my head. Also during the same time frame, my right shoulder became painful like I had slammed it against a brick wall. No particular position relieved the pain. Shoulder pain also subsided at about the same pace. Pain in both areas subsided over next few days and pretty much undetectable for four days later.
Erythematous vesicles scattered on face, torso, extremities and diaper area, started 7/7/06. Seen on 7/11/06 then followed up with doctor on 7/12/05.  Treated with Benedryl (12.5 mg/5 ml) 4 ml po q6h.  Also with secondary infection treated with Cleocin (75 mg/5 ml) 5 ml po TID.  Calmoseptine to help with pruritis.  Doctor felt condition was improving upon discharge.
This spontaneous report as received from a 62 years old male consumer with "Donatell" allergy reporting on himself. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) on 28-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 04-OCT-2012, the patient experienced joint pain in his upper shoulders, knees and upper arms, and red raised rash 3/4 in length and half inch in width on the same arm, however it was the opposite side of the injection site. No treatment information was reported. The patient did not seek medical attention. No labs/diagnostic studies were performed. The outcome of the events was not reported. The consumer stated he did not associated his joint pain at first with taking the ZOSTAVAX, but now after reading the add, the consumer felt his joint pain was a side effect of the vaccine. The relationship between red raised rash 3/4 in length and half inch in width on the same arm and ZOSTAVAX was not reported. Additional information has been requested.
There was no adverse event reported by the patient. She came in to the Health Center as she scheduled herself for a 3rd dose of the Pfizer, COvid-19 vaccine. Upon review of the previous vaccine administration it was noted that she received a 3rd dose on 7/30/2021 by another nurse, which was before the FDA approved the 3rd dose of the Covid-19 vaccine.  I explained to the patient that she has received a third dose and in fact received the 3rd dose before she should have. She denied any adverse events. She also wanted to receive a fourth dose which I explained was not recommended at this time. I informed her that I would need to complete a VAERS report for a vaccine administration error. She gave me permission to include her name and address but declined to provide an email or phone number.
On the first night after receiving the shot I woke up 1 hour after falling asleep with extreme chills. I had to get up and did not sleep again that night. I also experienced a slight difficulty in taking deep breaths. All of my muscles were sore and continue to be so 36 hours later, though that is improving. I did get normal sleep the following night.
10/05/2009 clt received flu vaccine 10/02/2009. Today is complaining of itchy rash that began 6 hr afterwards. He states there was no rash at inj site but was present on varied areas of body: lower back, side of stomach, buttocks (bil). top of L foot & inner & outer ankle. Reported chills & cold sweats pm 10/2 & 10/3. Used Benadryl & symptoms relieved. On Sat & Sunday am no rash noted then symptoms worsened as day progressed. PHN saw rash on clt left side of stomach 1 quarter sized patch with smaller spots around the area. Inner & outer ankle & top of foot slightly reddened. No room on left or right arms. Clt told if rash not gone in 1-2 days receptive to see PP - referrals given. 10/8/09 TC follow up to client. Rash is gone today no need to see PP.
Patient felt tigling in left arm the injection arm. Patient has Anxiety issues . Anxious wanted to be checked.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 09:30 (Lot number: FD8448) at the age of 49 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "completed chemotherapy 2 years ago" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Actually I received first dose of Pfizer vaccine on 18Mar2021, lot no EN6208 ), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Also 2nd dose on 08Apr2021 , lot no EWO150), administration date: 08Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Swelling"; ERYTHEMA (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Redness"; SKIN DISORDER (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "bubbling"; WOUND (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Wound"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "black spotty around the area of received arm of the 3rd dose vaccine"; PAIN (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Bad shore". The events "swelling", "redness", "bubbling", "wound", "black spotty around the area of received arm of the 3rd dose vaccine" and "bad shore" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of swelling, erythema, skin disorder, wound, vaccination site discolouration, pain. Additional information: No other vaccine in four weeks. Other medication in two weeks was tab ibuprofen 400mg/ aloe vera ointment. Patient had COVID-19 prior vaccination. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for self). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular (right arm) on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history included sciatica and Allergy: sulphur drugs. Concomitant medication included Multivitamins (unspecified). The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that initially after the vaccine (Jan2021; unspecified date), she experienced soreness in injection site and muscles aches, but these symptoms were mild. On 11Jan2021, the patient experienced intense abdominal cramps, chronic diarrhea, muscle aches, chills, and feeling unwell (also reported that these symptoms developed 5 days after vaccine). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination: Covid test type post vaccination was Nasal Swab, Covid test name post vaccination=Pcr; Covid test date=13Jan2021; Covid test result=Negative. The outcome of events was not recovered.
This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD for prophylaxis (route, lot # and expiration date were unknown); as an adult and outside of the prescribing information because it was required as part of her volunteer work at hospital to get vaccinated with PROQUAD or get titers taken to test for protection.
pt described T of 104 ax @ 1030AM 27JAN99, vomited x 2, fever dropped;taken to MD seen by RN stated cont APAP & ice on back of neck-fever dropped to 101 & returned home;
RN reported that patient became flaccid after her vaccination, then became rigid, crossed her legs, and lightly slammed her head back against the wall. He reports that she fainted but had some seizure-type activity, but minimalized. She was monitored by both RN and myself. She was lowered to the floor to lay on the floor, was fanned, and her BP and pulse were monitored by RN. She was accompanied by her mother, and her mother declined having EMS contacted. Once patient regained consciousness, she was alert, laughed and talked to us, and regained a sitting position. We then gave her cold water to drink, and she was able to get up into a chair. After sitting for several minutes, she was able to walk out of the room and into one of our monitoring cubicles for an extended monitoring timeframe. We kept her here for 30 minutes for further observation, then left accompanied by her mother. Due to RN's report of the seizure-type activity, mom is going to contact patient's pediatrician to see if further treatment is needed.
received Pfizer vaccine as booster;Janssen as initial dose; received Pfizer vaccine as booster;Janssen as initial dose; contracted the covid-19 virus; lungs are still hurting; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "received Pfizer vaccine as booster;Janssen as initial dose"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "contracted the covid-19 virus"; PULMONARY PAIN (non-serious), outcome "not recovered", described as "lungs are still hurting". Therapeutic measures were taken as a result of suspected covid-19, pulmonary pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200321927 Same reporter/Patient, Different event/Drug
After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after vaccination and intermittently x 5 days after the vaccine. Following day had tingling to the right side of my upper lip and right side of face felt somewhat numb. Had pain to right side of face up to right ear.
Appendicitis and appendectomy on July 24, 2021  My spouse, had same 2nd does from Pfizer lot ER8731 and he also had appendicitis and appendectomy on  Sept 24, 2021.
Student sent to Health Office at school; this nurse observed student's left deltoid where he received Meningoccal vaccine; significant redness measured 10cm x 4.5cm in size;  right deltoid where he received the Tdap vaccine; significant redness measured 6.0cm x 5.5 cm in size.  Student reported slight itching in right deltoid, but denied any other symptoms.
Pt had red swelling of right arm at site of injection, a diameter of 2-3 inches. Pt states pain was radiating through her entire right arm. Pain was most severe the day after immunization and the following day the pain has subsided. Currently the pain is only at the injection site. Report body ache and low grade fever on 8/12. No reported body ache or fever on 8/13/18.
Resident sent to hospital on 01/20/2023 for change in mental status, unable to communicate at baseline, yelling out Received a call today from hospital that he expired there this am 01/23/2023
Pt recvd vax on 10OCT90 & on 12OCT90 was inadvertently vax w/ 2nd dose.As of 10DEC90 pt was asymptomatic.
TC from client.   states she got the meningitis vaccine on her right arm Friday morning ( 09.22.2023) at approximately 1030 AM.   Last evening (09.25.2023) late, she noticed she was having red, raised area below that injection site and called poison control.  Poison control told her to use hydrocortison cream and diphenyhydramine.  Client denies any shortness of breath, increased heart rate, etc.   Denies blistering - states rash 'sort of stings' and it is uncomfortable to raise her arm.  Advised continuation of hydrocortisone cream and diphenhydramine as recommended by poison control.  Advised if experiences shortness of breath, increased heart rate, dizziness, etc. to go to ER.  Advised client to follow up with her PCP or urgent care if rash not resolved in another day or so.  Client states she will have her dad call the doctor and make an appointment.
weakness, fatigue, nasal congestion, dyspnea on exertion The patient reported getting both doses the Moderna COVID-19 vaccine (12/27/20 and 1/24/21) from his work at a private hospital. He reported that his adverse reaction started the day he got the first dose, and have slowly progressed since then (sore arm, nasal congestion, weakness, fatigue). He is now experiencing significant weakness, fatigue, and dyspnea on exertion. In one instance when cleaning snow off his car, the patient reported that he nearly lost consciousness. He has refused any treatment to date.
Pt. feels hot, dizzy, not feeling well, headache 7/10. 134/74. 99%, 80, BG 95.  Pt. Stated that she's still feeling unwell but want to go home.  Pt. A+Ox3.  Pt. verbalized that she will go eat.  Pt. advised to call EMS if symptoms persist.  Pt. advised to f/u with primary doctor.  Pt. verbalized understanding.
belly cramps; watery bowel; Felt tired; No pain or red at injection site just little tender to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263 ), dose 1 administered in Arm Left on 29Jan2021 11:15  as single for covid-19 immunisation. Medical history included breast cancer from 1984 and it was fully recoverd and cured. The patient's concomitant medications were not reported.  It was reported that On 29Jan2021 03:00 PM after 3 hours of vaccination patient experienced felt belly cramps, watery bowel. Felt tired, had nap. Much better evening. No pain or red at injection site just little tender to touch. It was reported that all the events were recovered.
Chills, Extreme back, hip, neck aches, Dizziness, Extreme fatigue to the point of barely being able to move or get out of bed. Arm pain at injection site.
I had difficult breathing, I was dizzy, but all my bloodwork shows my red cells decreasing, chest pain, Knee weakness, went to care, 06/01/2021 and I was transferred to hospital and I received a blood transfusion. When I am working I still have shortness of breath.
Herpes virus infection; Herpesviral vesicular dermatitis; Information has been from a lawyer and a female patient of unknown age regarding a case in litigation on 16-NOV-2019. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or around 13-OCT-2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for routine adult health maintenance and for the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered from herpes viral vesicular dermatitis. As a direct and proximate result of the Zoster Vaccine Live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to vaccination; patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination with Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a consequence of vaccination, the patient had suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered herpes viral vesicular dermatitis as disability events.
erythemic raised whelps noted 4 dasy p/vax starting @ inj site first day spreading to trunk, arms, legs;
administered the Flublok vaccine who is outside of the advised age on the PI with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number-00382427) and transmitted to Sanofi on 04-Dec -2020 via call-center.  This case involves a 6-years-old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV on an unknown date (lot number and expiry date were unknown) on an unknown date via unknown route at unknown site who was outside of the advised age on the PI (Product administered to patient of inappropriate age) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to vaccine administered to patient of inappropriate age (latency: unknown).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Heart palpitations for several months after the 2nd covid Pfizer vaccine. No chest pain, dizziness, or other symptoms.
Information has been received from a registered nurse concerning her approximately 14 year old son with no known drug allergies who in 1996 was vaccinated with a dose of varicella virus vaccine live. On 03/18/2002 it was reported that "about 2 years ago" the pt developed chicken pox with more than 50 vesicular lesions and a temperature of 103 deg F. The pt sought unspecified medical attention. Additional info has been requested.
Arm had been sore off and on; Throbbing pain; She can barely lift the arm she had the shot in; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (She can barely lift the arm she had the shot in), PAIN IN EXTREMITY (Arm had been sore off and on) and PAIN (Throbbing pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ER2613) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, FISH OIL and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced MOBILITY DECREASED (She can barely lift the arm she had the shot in). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm had been sore off and on) and PAIN (Throbbing pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (She can barely lift the arm she had the shot in), PAIN IN EXTREMITY (Arm had been sore off and on) and PAIN (Throbbing pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a physician concerning a 31 year old female who was vaccinated with GARDASIL. The patient experienced severe  nausea and vomiting for about a week. The physician would not administer any more doses to the patient. The patient recovered from severe nausea and vomiting. The patient sought medical attention. Additional information has been requested.