chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a 60 year old female patient with hypertension, who was a pharmacy employee. On 19-MAR-2016 the patient was vaccinated with PNEUMOVAX 23 (intramuscularly in left arm, lot# reported as M000386 with expiration date of 17-AUG-2-17 for vaccination. Concomitant therapies included lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On 21-MAR-2016, the patient developed a large, tender limp, "like a boil", in her left axilla. The patient self-treated with hot compresses to the area. The patient sought medical attention via coming to pharmacy. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected as the reporter did not want to contacted.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 22nd March 2019, the patient experienced leg pain and Achilles tendonitis. On an unknown date, the outcome of the injection site pain, leg pain and Achilles tendonitis were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, leg pain and Achilles tendonitis to be related to SHINGRIX. Additional details were provided as follows: The patient reported that injection of SHINGRIX was very painful. The next day she woke up with bad leg pain and felt like she ran a marathon. About 2 weeks after getting SHINGRIX she developed Achilles tendonitis. Her arm and legs still ache. The pain in her arm comes and goes, but if she touches the area she can feel where she got the vaccine. The patient has not had to take ibuprofen for her legs for several days, but they still ache. The patient Achilles tendon has not improved. The patient was a runner, and was running prior to getting the vaccine. The reporter consented to follow up.
Approximately 15 minutes after vaccine was administered, pt experienced redness, itchiness, and swelling at site of injection. Pharmacist recommended oral antihistamine to relieve symptoms. Pharmacist called pt to f/u 8/14/12; pt stated the swelling and itchiness had not decreased, but she was not concerned or bothered by it anymore.
ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.; upset stomach; really sick.; he got a fever,; This spontaneous case was reported by a non-health professional and describes the occurrence of TINNITUS (ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.), ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick.) and PYREXIA (he got a fever,) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced TINNITUS (ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.), ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick.) and PYREXIA (he got a fever,). At the time of the report, TINNITUS (ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.) had not resolved and ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick.) and PYREXIA (he got a fever,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan brain: everything was clear (normal) everything was clear.         Treatment information was not provided. Medical history was not provided by the reporter. Patient weight is 142.   This case was linked to MOD-2022-447286 (Patient Link).
Patient that was 11 years old was given 0.2 ml of adult Pfizer COVID vaccine.
8:00pm-arm started to be sore 4:00am-chills and warm head 12:00pm-extremely tiredness when chills and a warm head 9:00am-feeling like i need to puke/extremely low energy
Severe arm pain, rash and raised bumps on neck,  chest and face.  Itching
Fever, Vomiting, Abd pain, Arm pain. TX: Rest, Motrin, hydration.
Had a D Dimer test 2 weeks (14 days) after 1st Pfeizer Covid19 Shot results were over 4200..way higher than my last test in 1700 range before shot..note that another D Dimer test about 10 days later resulted in a D Dimer result back down to 1900.making me think the D Dimer was affected by the Covid shot which since the number was over 4200 landed me in the Hospital ER for a CT scan...I had no other clinical symptoms but the elevated D dimer..this appears to me should be looked at carefully as CT scans might be being done without real need if the Covid 19 Vax is throwing D Dimer test numbers out of normal range by large enough amounts to result in exposure and cost of uneartented CT Scans..
I had a heaviness in my chest, shortness of breath. The doctors are calling it exercise intolerance. I am unable to keep up with doing my normal activities without feeling fatigued. My sister and cousin were visiting, I was not able to keep up with them while we were out and about. I went to the doctor who did chest x-ray that came back showing that everything looks normal for my lungs. I will be going to see a cardiologist soon.
red hot raised area tender to touch since Monday a few hrs after injection Chills, and fever subsided Tuesday Still  has headache and pressure on face and back of head
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium
Patient reports feeling nauseous after receiving vaccine, no dizziness or lightheadedness. Cleared by EMS
Pain at injection site since evening of injection, continued pain at injection site with any exercise or touching site  since date of injection to present.  Severe headache for 4 days after injection.  Chest discomfort for 1 week after injection.
This spontaneous report as received from an other health professional refers to a patient of unknown age and gender, with no concurrent conditions and medical history reported. On 26-JUL-2017, the patient was vaccinated with improperly stored (18 hours in temperature -12 Celsius degrees) PROQUAD lot # M041083, therapy type RHA, expiration date 04-APR-2018 (route of administration was not reported), for prophylaxis. Other suspect therapy included sterile diluent lot # K019027, expiration date 07-AUG-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of four reports from the same reporter. Sender's Comments: US-009507513-1709USA000306: US-009507513-1709USA000305: US-009507513-1709USA000307.
8 days after COVID shot, itchy, swollen red circle tender to touch on day 9. (About 3 inches diameter) Taking Benadryl, icing.
Severe, nonstop shoulder pain since I got this second Pfizer shot at a Farmer's Market.  [No badge/ID; verbally identified] The whole shoulder joint is stiff and painful and I cannot use my arm normally.  I can't help but wonder if "Dr." knew he hit an underlying shoulder structure because mid-injection, unprompted by any words/actions by me, he asked me if I was OK.  The injection itself lasted a very long time, perhaps 5 seconds, and felt deep. My arm was not abducted out to the side, nor did he pinch the muscle up and away from the bone. Most concerning, however, is that the injection was placed in the upper 1/3 of the deltoid muscle, only 1.5 inches below the acromion.
Swelling and redness on left thigh measuring 13 cm L and 5.5 cm W hard and hot. Given BENADRYL.
Rash on leg and abdomen 48-72 hours after vaccine then temp 101.6 10 days following vaccine.
This spontaneous report was received from an health worker. She stated that her refrigerator had two different thermometers and she realized that a temperature of 31F had been recorded for the refrigerator storing PNEUMOVAX 23 (doses, route, indication and lot numbers not reported), (M-M-R II), and GARDASIL, which were exposed to 31F for 96 hours, on 04-NOV-2013, 31F for 48 hours on 18-NOV-213 and 31F for 72 hours on 21-NOV-2013. Improperly stored GARDASIL was administered on unknown dates to unknown number of patients. M-M-R II was supported, as it remained in recommended temperature storage range. PNEUMOVAX 23 was not supported after 21-NOV-2013. No adverse event and no product quality complained (PQC) was identified. This is one of several reports received from the same reporter. Additional information is not expected.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine injection) was received from a nurse regarding an 8 month old male pt who experienced a fever of 104 deg. F., and an injection site reaction characterized by a lump and redness at the injection site.  The pt received the third dose on 05/19/03.  The pt also received his second dose of Recombivax-HB (hepatitis B vaccine) on 05/19/03.  The pt had no medical history.  Indication for Prevnar was immunization.  Product was administered on 05/19/03.  Dose regimen was 1 dose (IM).  The pt was not taking concomitant therapy.  On 05/19/03, the evening of vaccination, the infant developed a fever of 104 deg. F.  The reporting nurse indicated that the pt's mother reported the infant developed a lump and redness at the injection site.  However, the specific site where the injection site reaction occurred was not reported.  The pt was not seen in the physician's office. The fever "gradually resolved" by 05/2/03.  Information regarding this event has been forwarded to manufacturer of Recombivax-HB.  No additional information was available at the time of this report.
On day 2, I had chills and mental confusion  On day 2 -4 days, I felt all the following symptoms:  Fatigue headache dizziness brain fog nausea (no vomiting)  day 5 - brain fog
4 days after jab symptoms of  nausea, headache, fever, deep lung congestion, hypoxia, fatigue.  Study shows 10-20 fold antibody increase after jab one with prior covid vs no prior covid. I had covid in nov 2020.  10 fold increase in covid antibodies after jab 2 with prior covid vs no prior covid.  WHY DID CDC WITHHOLD THIS CRITCAL INFO FROM PUBLIC? WHY CDC SO ANTI SCIENCE? THIS IS RECKLESS DISREGARD FOR PUBLIC SAFETY. STUDY SAYS OVERDOSE OF ANTIBODIES, A WASTE OF VACCINE.  ALSO CDC WITHELD CRITCAL NO INFO ON - HOST - MICROBIOME AND COVID - COVID LIFE SAVING BREATHING EXERCISES BY PULMONOLOGITS AND LUNG THERAPISTS - NO INFO ON NUMBER ONE CRITCAL ISSUE OF COVID COMPLICATIONS OF OBESITY AND OVERWEIGHT - NO CDC INFO ON HOW TO DEAL WITH COVID OR HOW TO PREPARE WITH SIMPLE CRITICAL TIPS LIKE OTHER COUNTRIES GAVE. MICROBIOME AND COVID.  CDC IS INTO SCIENCE OF LIES AND PROFITS FOR THEIR MASTERS, BIG CORRUPT PHARMA.  HIIT, HIGH INTENSITY INTERVAL TRAINING ON EXERCISE BIKE,  SAVED ME FROM GOING TO HOSPITAL WITH COVID FROM BREATHING PROBLEMS. iT SIMPLY MOVED THE DEEP LUNG PHLEM TO HIGHER PART OF LUNG WHERE IT COULD BE REMOVED WITH COUGHS AND OXYGEN EXCHANGE.  NO INFO FROM CDC ON CYTOKINE STORM FROM OVRER ACTIVE IMMUNE SYSTEM. LUNG MICROBES CROSS TALK WITH GUT MICROBES, TURN ON A HUMAN GENE THAT MAKES INTERFERON IMMUNE PROTEIN THAT STARTS FIGHTING COVID VIA FULL 48 HOURS BEFORE OUR HUMAN IMMUNE SYSTEM IS AWARE. ROOT CAUSE = DISRUPTED MICROBIOME AND THUS DEADLY CYTOKINE STORM.   THIS WEBSITE FORM, IT WIPED OUT MY PRIOR STATEMENTS.   CDC IS A COMPLETE CORRUPTED DISGRACE  CDC IS A LYING DISGRACE, NO EXCUSES.
pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt, out of 30 vaccinees who exp this rxn p/vax;
Feeling like something is crawling in my right ear; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (Feeling like something is crawling in my right ear) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 FORMICATION (Feeling like something is crawling in my right ear). At the time of the report, FORMICATION (Feeling like something is crawling in my right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not provided. Treatment was not given.
Received only the liquid adjuvant portion of Shingrix; Received only the liquid adjuvant portion of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient might had received only the liquid adjuvant portion of the Shingrix vaccine without it being reconstituted with the powder component. The reporter stated that this could had been 1 or 2 doses of adjuvant only for these patients, the reporter was unsure at this time, the review of the medical records to confirm was pending. The reporter did not had the dates of administration, lot number, expiration date and any patient information at the time of the reporting. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The reporter gave by error Shingrix liquid adjuvant diluent portion only withput powder component ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022159157:same report, other patient US-GSK-US2022AMR159619:same report, other patient
Constant tinnitus both ears.  The noise wakes me up for time to time.  If hasn?t gone away since the 2nd shot.
I received the fifth dose of Moderna Bivalent 09/27/2022 and I started to experience symptoms of COVID-19 on 10/13/2022. My boyfriend had symptoms and tested positive on 10/09/2022 and I was taking care of him. My symptoms were that of a sinus infection and when I tested myself there was a faint pink line. I had a PCR test completed and that came back positive. I was not prescribed anything because my symptoms were so mild. My doctor did not want to have to mess with my current medications so I could take Paxlovid. As of today, I am on day 5 of quarantine, but I feel good.
The day after receiving my vaccine I had a pain hit my lower spine. It wasn't in the area of my fusion. It was an excruciating pain. It was very difficult to lift my legs and walk. After 3-4 days, I called Dr. He put me on steroids and a prescription of Hydrocodone and Meloxicam. The pain moved down into my back and into my right leg. My doctor put me back on steroids. It was about 7 weeks that I experienced this intense pain. All of the steroids gave me a UTI. I called my doctor again. He gave me 3 pills of Cipro. About 8 hours after taking the antibiotic the pain started to lighten. On day 3, the pain just completely went away. I started experiencing a low grade fever. It ranged from 99 to 101.6 degrees. I had some blood work completed. They came back that something was wrong, but the doctors could not pinpoint what was wrong. Out of nowhere, a few months later, my fever just went away.
Swelling and redness x4 days in the injection area which initially resolved and then recurred 4 days later,  improved with Benadryl
At approximately 1617 it was brought to the charge nurse's attention that an employee receiving their COVID-19 Pfizer booster received a second dose and not the flu vaccine. When asked how the incident occurred, the LVN stated when the employee sat down and handed over her Clinic Events sheet both flu and COVID were circled which indicates the employee is there for both vaccines. She stated she asked the employee if she was getting flu and the COVID vaccine and the employee stated yes. The LVN proceeded with the COVID questionnaire/consent. The employee signed the consent and the COVID vaccination was administered. After the administration the LVN told the employee she would then be receiving the flu vaccine. It was at this point that the employee stated they had just received COVID vaccine a few minutes earlier. The employee stated she did not dispute the question about receiving the flu and COVID vaccine because she was in the vaccine clinic to receive the vaccine and she didn't notice the questions were the same as the COVID questionnaire/consent she had just reviewed and signed. She was asked to wait for 30 minutes for monitoring and stated she was unable to stay. When she left the vaccination clinic, she was not experiencing any adverse side effects.
Patient is fully vaccinated and was hospitalized due to Covid. According to patient's wife, nurse said he had a mild case and along with his COPD, he was still having some issues with breathing. She stated that both herself and her husband both had the vaccine back at the first of the year and he was the only one so far to get COVID.
Pt received injection on 10-8-12 on 10-9-12 pt woke with area red, warm, and pruritic and painful.
her eyes are watery; She has a Sore nose; she had a bout of sneezing; some coughing; She also felt a slight ache in the center of her chest; She has Drainage; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), COUGH (some coughing), CHEST PAIN (She also felt a slight ache in the center of her chest) and LACRIMATION INCREASED (her eyes are watery) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided. and concomitant drugs are provided.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), XYLOMETAZOLINE HYDROCHLORIDE (XYZOLINE), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT), CARVEDILOL, Low dose aspirin, SPIRONOLACTONE and Labetolol as needed for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RHINORRHOEA (She has Drainage). On 12-Feb-2021, the patient experienced SNEEZING (she had a bout of sneezing), COUGH (some coughing) and CHEST PAIN (She also felt a slight ache in the center of her chest). On an unknown date, the patient experienced LACRIMATION INCREASED (her eyes are watery). On 12-Feb-2021, COUGH (some coughing) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), CHEST PAIN (She also felt a slight ache in the center of her chest) and RHINORRHOEA (She has Drainage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-033759 (E2B Linked Report).
Per pt., e-mailed about 11 pm that night (L) side began to get sore - (L) lymph nodes very tender and pain went down through the (L) side of ribs to pelvis. The site was hot, red, inflamed, and tender, could barely move (L) side was so sore and painful. Stayed in bed entire day - Sat., site still red, hot and sore. Sunday, getting back to normal.
Within 12 hrs of receiving the vaccine patient felt lightheaded, started vomiting, turned "green", and nose was "dripping/running". Arm was sore as well. No fever reported. Patient is now doing better.
Change in sense of smell; Change in sense of taste; This spontaneous case was reported by a patient and describes the occurrence of PAROSMIA (Change in sense of smell) and TASTE DISORDER (Change in sense of taste) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 PAROSMIA (Change in sense of smell) and TASTE DISORDER (Change in sense of taste). At the time of the report, PAROSMIA (Change in sense of smell) and TASTE DISORDER (Change in sense of taste) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications details were reported.  Patient received Moderna Covid-19 vaccine and since then the sense of smell and taste had changed. Patient did not provide additional information and said she would call Moderna back to providemore information. Patient did  not had vaccination card with herself when asked.   No treatment medications details were reported.
Pt devel warmth, erythema, & edema @ the inject site p/recvd DT (ped)/OPV/TB tine test;
Received vaccine 1/13/21. 1/19/21 discovered bright red, hot to touch, slightly raised, itchy rash below the injection site. The site is approximately the size of a post it note.  Reported rash to nurse the morning of 1/20/21. Per my employer I was sent to urgent care for further evaluation and treatment. Given a 5 day course of prednisone.
pt stated started feeling weak in legs and her throat got tight after vaccination. no problems breathing but tongue did swell slightly.
Loss of balance; Dissiness; Nausea; Charlie horse in legs; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via an unspecified route of administration in the left arm on 15Nov2021 at 18:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart disease and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included alfuzosin hydrochloride (XATRAL) and metformin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if on going. On 15Nov2021, the patient experienced loss of balance, dizziness, nausea and charlie hoarse in legs. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events loss of balance, dizziness, nausea and charlie hoarse in legs was not recovered at the time of report.
12 hr p/shot high fever 102,chills alternating,all over muscle aches for 16hr;tx w/APAP,Ibuprofen;pt feel asleep&awoke w/t100.5&no body aches
Received the Covid-19 vaccine on Jan 2. She reports symptoms starting the morning of 1/3 with body aches, migraine, chills, throbbing arm pain, and fatigue. Was unable to work on 1/4.