chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia & Fever Narrative:  Noted fever and myalgias following 1st dose 1/7/21. Received 2nd dose 2/7/21. Noted sore arm, headache, flu-like symptoms and myalgias. Symptoms lasted 24 hours. Missed work x 1 day. No known prior COVID infection.  Other Relevant History:
On Sunday afternoon, March 14, I received the first dose of the Pfizer vaccination. On the morning of March 16 I had a sudden hit of fatigued and my left leg started going numb while doing some menial work in the yard, The numbness cleared when I went inside and laid down but some form of the fatigue persisted for several days. Then, on March 28, two weeks after the vaccine, I woke up to a leg severely swollen from toe to hip. I waited two days to see if it went down but it only got worse, swelling to double the size by volume. I went to the doctor and they sent me to the hospital for ultrasound, suspecting a blood clot. No blood clot was evident but there were multi swollen limp nodes in the upper leg area. The problem worsened and two days later I was sent in for a CTscan which now showed multi blood clots near the swollen limp nodes. I was barely able to walk as major pain persisted with no signs of decline. I am now on blood thinner. It has been 2 months since the vacination and my leg is still swollen the same amount (2X by volume).
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 81-year-old, elderly patient of an unspecified gender. It was reported that, FLUCELVAX QIVc underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 12-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805486 was crossed linked to original case 201804863 due to same reporter.
Symptoms were basic, I had a very sore throat which lasted 3 days 24-26th. Nasal congestion and a slight cough. I had some fatigue and muscle fatigue but I'm not sure if it was related to COVID-19 or Paxlovid. I had muscle aches which were related to Paxlovid. I had chills 1 evening but no fever. I ran 97.7 body temperature.
mother received her first SHINGRIX vaccine sometime in 2019 and has not yet had her 2nd dose.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: mother received her first SHINGRIX vaccine sometime in 2019 and has not yet had her 2nd dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-Aug-2023 The patient's son reported that the patient had not yet had her 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
On injection felt shooting pain down, sore immediately gave ibuprofen/ice worked then stopped after 2 days so changed to TYLENOL and ice still using and symptoms are getting worse.
vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER2613, second dose) solution for injection intramuscular in the left arm on 23Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included ARMD (age-related macular degeneration), high blood pressure, and anxiety. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and AREDS vitamins. The patient had no known allergies. Historical vaccine included BNT162B2 (first dose, lot EN6202) for COVID-19 vaccination on 02Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 07:00, the patient experienced stomach pain, nausea, chills, and body ache. On 26Mar2021, the patient experienced vomiting and chest pain. In Mar2021, the patient experienced acute pancreatitis and stomach pain more intense. The events resulted in emergency room/department or urgent care visit and hospitalization for 10 days in 2021. Lab test in Mar2021 included CT scan: revealed acute pancreatitis. Treatment for the events included antibiotics, fluids, and oxygen. The outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.
I was vaccinated at 11am. By 3-4 pm on the same day I was experiencing muscle spasm and fluttering all throughout body. My stomach muscles were all spasming along with persistent muscle spasms all over. The waves of fever had returned along with blurred vision and sweating. I fell asleep exhausted and woke up feeling fatigued and wiped. I went to the shop that day after feeling like I was hit by a truck. It felt identical to having faced an actual wave of the actual virus. I could hardly move when halfway to the shop. I feel weak and felt terrible heart palpitations.  I couldn't finish my shopping and felt feint the entire time.  The heart problems and cardio problems lasted months. I couldn't exercise or do basic activities for ages. Even trying to do up my shoes or pick up my daughter would leave me bed ridden again. I tried to get back to work around May 2021 and forced myself into very compromising situations with the long-term effects of the virus and then the added symptoms with the first dose of virus. The blurred vision was far worse and aggravated by the initial dose. The muscle spasms and muscle flickers were magnified A LOT. I now faced 1+ year of debilitation as a long hauler and made my situation way worse by vaccinating. My cardio and ability to exercise is still a mess to this day. Minor activities leave me bed ridden and fatigued.
patient experienced throat getting tight and closing, lightheadedness ,palpitations.    oxygen administered, rapid response called and patient taken to Urgent care on site for treatment and monitoring.
Received Bivalent Booster that went through temperature excursion; Received Monovalent Vaccine that went through temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion) and NO ADVERSE EVENT (No Adverse Event). On 21-Nov-2022, NO ADVERSE EVENT (No Adverse Event) outcome was unknown. At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion).    No concomitant medication details were reported. It was reported that 27 unknown patients received Moderna COVID-19 vaccine that went through excursion. 7 vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator from 8-NOV-2022 to 21-NOV-2022 and there are 2 unpunctured Monovalent vials were remaining in the refrigerator. Unbroken carton vials were used. Maximum 48.1 F and minimum 42.5F temperatures reached. Excursion duration was 312 hours. Vials moved from the freezer to refrigerator every morning. No Visual inspection was done. They noticed the excursion on 21-NOV-2022. No treatment medication details were reported. On 28-Nov-2022, this case was found to be invalid as there was no single patient identifier.   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Live Significant follow up- Email added.
Low grade fever; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on February 2020).   On 22nd June 2020, the patient received the 2nd dose of Shingrix .5 ml. On 22nd June 2020, 6 hrs after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and approximately 6 hours after receiving his injection, he developed a low grade fever, of which he did not provide the temperature and a headache.   The reporter requested to know how long these side effects would last.  Information provided per Shingrix PI in Content.   The medical disclaimer given to caller and PI offered to be mailed to caller. The reporter did not consent to follow up. The reporter did not know who administered his injection of Shingrix, only the name and address where he received it.
Patient is a 18-year-old, female. No known medical history. No known allergies. At 3:18 pm, the patient received her first dose of Pfizer vaccine (lot number EW0179, expires on 08/2021) on left deltoid, given by RN. Patient informed RN that she has a history of fainting after vaccines. RN recommended the patient wait in the zero-gravity chair. Patient continued to be A&Ox3, walked herself over to the EMT waiting area with a steady, balanced, and sat down in zero-gravity chair. At 3:20 pm, patient checked in with EMT and stated she feels "fine". At 3:27 pm, while waiting in observation area, patient stated "I don't feel good" and went unconscious. EMT reclined patient into supine position. Patient remained unconscious for approximately 10 seconds. RN called 9-1-1 at 3:28 pm. Patient regained consciousness at 3:28 pm and stated "I need something sweet". At 3:30 pm, the patient's BP 69/44, RR 8/min, HR 63 bpm and weak, skin dry and cold to touch, lips pale and cyanotic. At 3:33 pm, the patient's BP was 87/60. Fire Department  arrived on site at 3:34 pm. Patient was transferred to gurney by FD. Patient left facility at 3:34 pm .
He got his vaccine.  He instantly after the MMR he was talking and he literally went mute and he has not talked since. His eye was turning to the side, became a dead eye, started twitching and jerking, always crying like he was in pain, always banging his ears, and they could not tell her what the problem was.  He became very sensitive to foods, would not eat certain foods, doing sudden movements.  A few months later he started spinning, standing in the floor and spinning.  His head and hands were jerking immediately after that vaccine.  The doctor sent mother for further testing, and informed her that nothing was wrong with his eye and that he was having temporary things.  That doctor left that office, and was then and now seeing a different pediatricians.  He started having high fever, and rashes and was told that he was fine.  He had 3 sets of 5 different shots 9/11/19 at 2 months, the Rotovirus, polio, Hep B, Hip, PCV and Dtab.  Then 11/12/19 he had the same vaccines, then on 1/14/20 he had the same 5 vaccines again.  They did not tell her at that time that they were multiple shots at one until she requested a copy of his records.  She would not have allowed it as it was too many at that time.  Each time after those reactions he was reacting different ways, but the worst one was the MMR.    He was diagnosed with autism at 21 months after testing from reaction to the MMR vaccine.  He was evaluated by the developmental pediatrician and had testing that showed that he had very high levels of aluminum in his system.  He was developing normally, talking, pointing, interacting, social, no eye problems, no twitching prior to this vaccine.  He is not able to talk at all, and prior he was saying 30 words.  He is still having the abnormal jerking and twitching movements, his eyes are going in and out.  The MRI showed that he had internal damage to his ear canal.  He still has high aluminum levels, and has not had any vaccines since then.  They have been waiting for therapy for him as there are no services available for him, there is a waiting list and noone available to give those services.  His blood work prior to this vaccine was normal, and now a lot of his levels are  high and abnormal.  He also has very very dark circles around his eyes.  He is not gaining weight, he is very very picky and does not tolerate textures of food, he does not feed himself, they have been potty training him every day for years, and he is still not potty trained.  He was eating prior to the vaccine.  He was admitted to the hospital and was supposed to have an MRI but the schedule did not accommodate that.  He was crying in pain for his ears, and the jerking movements is why he was admitted, and the MRI showed that he has chronic inflammation and internal damage to the ear canal.  He had no ear issues prior to that vaccine and would respond before.
No adverse event; HCP reported GARDASIL 9 was administered after a temperature excursion to a patient; This spontaneous report was received from a medical assistant referring to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 25-SEP-2022, the medical assistant reported that dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1780878, expiration date 02-DEC-2023 who had been verified to be a valid number, once) (dose and strength were not provided) was administered after temperature excursion to a patient. The excursion occurred with a temperature and time frame of 1.4 degrees centigrade (°C) for 0 hours 56 minutes; 1.2°C for 4 hours; 0.7°C for 17 hours 30 minutes; 0.9°C for 18 hours 47 minutes; 0.9°C for 13 hours 32 minutes. No additional adverse event was provided.
He became deaf a month after receiving 2nd dose.; She saw him shivering and he couldn't hear anything.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (He became deaf a month after receiving 2nd dose.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dementia.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced DEAFNESS (He became deaf a month after receiving 2nd dose.) (seriousness criterion medically significant) and CHILLS (She saw him shivering and he couldn't hear anything.). At the time of the report, DEAFNESS (He became deaf a month after receiving 2nd dose.) and CHILLS (She saw him shivering and he couldn't hear anything.) outcome was unknown.            One of the patient's concomitant medications is a dementia medication.  No treatment was given for symptoms.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, elderly age and underlying condition of dementia could be risk factors for the event of deafness.   This case was linked to MOD-2021-273358 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, elderly age and underlying condition of dementia could be risk factors for the event of deafness.
About a month after the vaccination, I went for a physical and the doctor mentioned I had arrhythmia. I didn't think too much about it until later when I had more issues. A few months later, another doctor also mentioned my pulse was really low and my heart rate was erratic and to see a cardiologist. I went for a follow up for a sleep test and again my pulse was very low and my heart rate was erratic and I was sent to the ER. My symptoms, I could feel flutter in my chest and SOB and couldn't get a full breath. In the ER they did a bunch of tests, EKG, ECHO and recommended a 24 hour heart monitor.  I was discharged with a diagnosis bigeminy which is 2 extra heart beats and to follow up with PCP and cardiologist. I did do a 24 hour heart monitor and I am waiting for consult with cardiologist.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no medical history or allergies. On 15-SEP-2011, the patient was vaccinated with a dose of ZOSTAVAX (unspecified Lot # and expiration date, dose, frequency and route not reported) and then received another dose of ZOSTAVAX (lot # reported as 0236AE and unspecified expiration date, dose, frequency and route not reported) on 05-OCT-2012. There was no concomitant medication. Approximately in October 2012, a "couple of days after" received the ZOSTAVAX, on 05-OCT-2012, the patient developed shingles. The patient sought an unspecified physician on an unspecified date regarding the reaction. The outcome of shingles was recovered. Additional information is not expected.
mom reports that pt woke up w/high pitch screaming 2wks p/vax; mom gave pt Amoxicil & 1 hr later hives devel seen by MD 9DEC92 & dx of bronchitis, ear infect & pneumonia was made; pt had elevated temp 3 days p/inject;
Swelling redness and heat of deltoid, pain of 5 (0-10 scale), stiffness, inability to lift arm above past 45* angle, inability to move arm behind abdomen, inability to rotate shoulder. Unable to assess at this point if further medical attention required. Will see provider if symptoms last longer than a week from date of vaccine.
After having the 2nd dose she developed bumps on her face that is very hard and hot to touch. It started to grow on the temple area and spread towards the nose, left eye, and left ear; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. An 82-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Jun2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 on 18May2021 single dose for covid-19 immunisation. On an unspecified date, after having the 2nd dose she developed bumps on her face that is very hard and hot to touch, it started to grow on the temple area and spread towards the nose, left eye, and left ear. Bumps are similar to size of a walnut- asking if it was a reported side effect of the vaccine and wants to get some recommendations from Pfizer. She mentioned that after the second dose, she had on her skin a bump on her face. Now it had spread in the direction of her eyes to her left ear. Patient confirmed that everything was on the left side of her face. She said she needed to know what to do about it. She wondered if she needed to go to the emergency room or if she needed to have surgery. She said she did not know what to do. She does not know how far it was going to spread. Patient stated that she did not want to do safety report and wanted to be transferred to Medical Information to find out what to do. Patient was very upset because of the side effects that she had, and she mentioned that she encountered big problem because of the vaccination. Investigation assessment was not provided. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Syncope and whole body flushing one minute after vaccine was given, lasting a couple of minutes. Patient walked upstairs to primary care provider to be monitored for 30 minutes.
Ongoing loss of smell, loss of taste, post nasal drip, runny nose, double vision, and jaw pain when swallowing. Dr. did not resolve these issues. Remarked that maybe I had COVID-19 and was not aware of it.
Information has been received from a physician concerning a female who was vaccinated with Gardasil.  After getting the Gardasil, the patient developed Guillain Barre syndrome.  Therapy with human papillomavirus vaccine was discontinued.  As of 26-SEP-2007 the patient was not recovered.  Upon internal review, Guillain Barre syndrome is an Other Important Medical Event.  No further information is available, because it was not the reporting physician's patient.
When adding vaccination history as provided by patient's records, public health nurse misinterpreted "Refuerzo" as refused instead of the correct interpretation, reinforced (or additional). This resulted in a non-indicated, additional dose of DTap and IPV being administered to the patient.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient had a flare up of asthma. Once she used her inhaler symptoms subsided
After receiving 2 vaccines in my left arm, I had nausea, fever, chills, and extreme pain in my arm. My arm was very red and swollen & I was weak.