chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2023, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8, notes: Caller says he had a day or a day and a half until he took Paxlovid, he also says that he had a frontal headache, low grade fever 99.8 was the most he ever had, but once he took the Paxlovid everything seemed to normalize; (unspecified date) Low grade; SARS-CoV-2 test: (18Jan2023) Negative; (19Jan2023) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.
patient return for the second dose past the 28 days recommended so patient was advice to start the series over; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2022-455530 (Patient Link).
Due to storm fridge temps went out of range by 4 degrees, was closed 1/17. Vaccines were administered to patient in the morning
Patient started getting pale, almost fainted, and appeared to have a seizure for a few seconds. 911 was called in between, the seizure stopped before the response team came and patient was able to converse. When medical response team arrived, patient was checked for vitals and all was cleared. Patient was responsive, no SOB, able to walk on his own, full recovered. Called later in the afternoon, patient says he's perfectly fine.
ABNORMAL MENSTURAL BLEEDING NONSTOP, CLOTTING, HEADACHES, FEELING TIRED.
The day following administration of flu shot, about 12 hours later, awoke with extreme lower left jaw pain, a muscular event. It prevented me from chewing on that side of the mouth for 3 days. The site of the pain was the lower jaw rear muscle/conjunction towards the back of the skull. After about three days of acute pain it dissipated as quickly as its onset.
No adverse effect reported; an improperly stored dose of GARDASIL 9 was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 28-AUG-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614897, expiration date 20-SEP-2021 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 48.5 degree fahrenheit during 4 hours and 15 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
I had fever, chills, lots of shivering, terrible stomach, pain lasting several hours, clogged sinuses, extremely thirsty, dry mouth, experienced restlessness. Next day felt more like cold symptoms dry mouth, fatigue lethargic, experienced a cough, postnasal drip progressing to dry throat impeding voice, symptoms lasted over a month started dry heaving felt like I was choking on my own saliva all day long. Had to go to an urgent care due to symptoms also had to go to ENT and was the diagnosed laryngopharyngeal reflux. Was given a proton pump and dietary restrictions lessened symptoms somewhat was placed on nerve meds as a diagnosis of neurogenic cough.
I   received the 4th booster vaccine on 4/2/2022 at approx. 11:00 a.m. by 2:00 p.m. I experienced severe pain at the injection site, I began to feel a rapid heartbeat which dissipated after approx. one hour, I then became extremely fatigued and had a headache which was moderate. On April 2nd. I developed a fever of approx. 100 and treated that with 325 mg. of acetaminophen, I felt extremely fatigued and had muscle aches and nausea. On April 3rd. my fever went away, but the nausea continued, and I had trouble concentrating. I went to the Dr. office and advised them of the situation and was told to report the adverse effects to the CDC and to call them back if I was still experiencing side effects on Fri. April 8th. On Tues. April 5th I felt completely better, now today which is April 6th I am again experiencing extreme nausea, fatigue, and trouble focusing.
Over a course of time patient has notice a bald spot appear, after shot is administered.  It was very noticeable when the shot was administered on Nov 08.
Fever of 104.5 w/APAP; vomiting, suboccipital node swelling, restless, no appetite, equilibrium off;
Received shot on 4/26/2000, did fine through 4/26/2000. On 4/27/2000, she had a swollen and reddened thigh. Red area was approximately 50 cents sized. Area was firm, warm and tender to touch. She walked without any difficulty. Saw MD on 4/27/2000 with dx of sterile abscess. On 4/28/2000, mid morning, thigh returned to normal.
enlarge heart; would not go through all the symptoms, and she is very disturbed; Reaction to shot; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (batch or lot number was not reported) as dose 2, single dose for covid 19 immunization. Reporter stated that the patient did not receive any vaccination 4 weeks prior to covid 19 vaccine. Reporter stated that patient has always been very healthy. The patient's medical history reported as no and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (batch or lot number was not reported) as dose 1, single dose for covid 19 immunization. On unspecified date in Sep2021, the patient experienced she has an enlarge heart, would not go through all the symptoms, and she is very disturbed, reaction to shot. The patient had the side effects after the second shot and age at the time of reaction reported as 55 years. Reporter stated that calling about her daughter (patient) and stated both had the Pfizer vaccines in March and April. A couple months ago she started having symptoms, could not figure it out and reporter would not go through all the symptoms. But the point the doctor cardiologist, she just visited, gave her possible causes of the symptoms that she is having, one of them is a reaction to shot, she has an enlarge heart now. Reporter did not have the exact date and time of administration of COVID 19 Vaccine, reporter got in March and April and reporter stated maybe patient got hers in April and May but reporter not sure. Reporter was informed about the role of Pfizer drug safety and also informed that Pfizer medical information is the concerned department to answer the question that reporter have. Reporter was requested to probe to file a safety report. Reporter inquired that, do you have some ideas that you can give me about research, what we should look for, is this curably and also inquired to find out if it was, what symptoms were being reported or what she should be doing. Regarding treatment reporter stated that she has visited several doctors to try to find out what is wrong with her. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
32 y/o female developed SOB & chest tightness onset 12 days following receipt SPV, AVA 2, & inactivated influenza vaccines given 9/10/2009.  Pt first noted mild difficulty getting deep breath and tightness in chest on 9/22 which worsened by 9/23 accompanied by feelings of anxiousness due to difficulty breathing; symptoms not related to exertion or position; no coughing; wheezing or actual chest pain.  Pt was well prior to & day of vaccinations; denied antecedent viral illness, exposure to sick contacts, inhalants, recent travel; no cardiac, asthma. psychological smoking history; no prior vaccine-related reactions.  She is instructor with adult students in classroom setting.  PMHx significant for LTBI s/p completion 4 month course RIFAMPIN in early Aug 2009; pt had taken 2 doses of MEFLOQUIN (9/14 & 9/21) malaria prophy in preparation for scheduled deployment planned in early Oct.  She was medically evaluated in military ED 9/23/2009.  PE was reported as tachypneic respiratory exam otherwise benign, BP 147/83, HR 100, Temp 96.9, O2 set 100%; pt was felt to be low risk for pulmonary embolism per XX; phosphorous level noted low & treated with neutrophos; also given ATIVAN 0.5mg for anxiety; symptoms improved prior to d/c; final impression; doubtful deployment.  On 9/24 pt reported symptoms improved but not completely resolved, no new symptoms.  Cardiac panel, ESR, CRP-hs wnl 9//24.  Over phone f/u 9/28, pt says she saw her own private physician that AM with normal baseline spirometry in office and was advised to use inhaler prn symptoms - no opportunity to use thus far. On 9/28/2009 pt also saw MTF OCC Med physician who thought she had possible idiosyncratic reaction to MEFLOQUINE and recommended she remain off medication and use DOXY for malaria prophy.  Diagnosis: dyspnea, hypophosphatemia, idiosyncratic reaction to drug.  Symptoms: dyspnea, chest tightness.
Redness in vaccination area; Blotching in vaccination area/noticed rash on arm, right around vaccination site; Runny nose; Chest tightness; Coughing/persistent cough; Congestion; Diarrhea; Sinus headache/persistent sinus headache; SLIGHT FEVER; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough), NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (ROSUSTATIN), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced RHINORRHOEA (Runny nose), CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), SINUS HEADACHE (Sinus headache/persistent sinus headache) and PYREXIA (SLIGHT FEVER). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in vaccination area) and VACCINATION SITE RASH (Blotching in vaccination area/noticed rash on arm, right around vaccination site). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), PYREXIA (SLIGHT FEVER), VACCINATION SITE ERYTHEMA (Redness in vaccination area) and VACCINATION SITE RASH (Blotching in vaccination area/noticed rash on arm, right around vaccination site) outcome was unknown and CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough) and SINUS HEADACHE (Sinus headache/persistent sinus headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-086580 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Concomitant medication list was updated, event verbatim added, event outcomes updated. On 27-May-2021: Non-Significant follow up appended to MOD-2021-027155; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086580:Case for dose 2
Immediately after receiving the high dose flu the patient flared up directly next to the injection sight.  The sight became red, slightly swollen and itchy.  The patient was given an ice pack which allowed the swelling to go down.  He was sent home with Benadryl about 45min-hour the patient was doing better.  Swelling and itchiness had resolved.
Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung when she received the first dose. She felt it running into her vein.; When she took the band aid off, instead of a spot, there was an area of blood; muscle pain; This is a spontaneous report from a contactable consumer (Patient) self-reported. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date: unknown), Injected via an intramuscularly route of administration in left arm on 06Feb2021 at 16:15, as a single dose for COVID-19 immunization. Patient medical history included high blood pressure, diminished kidney and family history like her mother had a breast cancer and father had massive heart attack. Patient concomitant medications included as amlodipine (5mg) daily for high blood pressure start date and stop date was unspecified. Patient did not take it prior to getting the vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not get the adverse events prior vaccinations. Patient experienced felt like it was stung" when received the first dose. Patient could feel warm fluid running through vein on 06Feb2021, and stinging sensation at vaccination site on 06Feb2021 at 16:15 and arm felt like lead and could not raise it on 06Feb2021 at 18:00. When she took the band aid off, instead of a spot, there was an area of blood in Feb2021. And experienced muscle pain in feb2021. Patient took an extra strength Tylenol. The outcome of the event felt like it stung and felt it running into vein and Arm felt like lead and could not raise it was recovering and outcome of the event Stinging sensation at injection site, band aid off, instead of a spot and muscle pain was unknown.
Red, raised, and itchy rash at the spot of injection about 4 square inches in size.   Continues to grow in size and itchiness over the course of the last 4 days.
Moderna COVID-19 Vaccine EUA; developed swelling and redness at injection site with heat noted; "COVID Arm"
12/17/20 1st dose Pfizer vaccine     1/1/21   Developed acute fatigue, malaise, headache, and muscle aches/pains.  Tested negative for Covid that same day.       1/7/21  2nd dose Pfizer vaccine. * Within 2-3 hours I developed cramps/diarrhea, worsening fatigue, aches, pain, and fever. Tested positive for Covid later that day.  Over the next few days I developed muscles aches , pain,headache and fever.    July and August increasingly fatigued and difficulty working as a Physical Therpaist in hospital.   August increasing,y worse muscle pain and stiffness,neck pain and headache.   September/October diagnosed with polymyalgia rheumatica. Unable to work. Early retirement.   I am just wondering if this auto-immune disease PMR was due to the poorly timed vaccine ( got vaccine while unknowingly infected with Covid.  Could this have affected my immune system?
itch and pain at injection site, feeling of numbness around site and into shoulder exacerbated by rubbing/scratching
15 minutes after dose, experience nausea and vomiting. Days after, arm was red and sore. Months after, hard lump inside arm is still present.
Monday following  COVID the vaccination( 2 days later) , patient   noted pain in left axilla and forearm that felt like a  "burning  pain"
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-AUG-2016, the patient was treated at a clinic for the onset of a severe vesicular which was diagnosed as herpes zoster or shingles. On or about 29-AUG-2016, the patient sought subsequent treatment at a clinic from a physician for a vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever of 101, chills, headache, vomiting, body aches, tiredness  Fever, chills and headache onset 7 hours after the injection. Vomiting started shortly after and continued for 24 hours straight. Vomited every 15 - 30 minutes for 24 hours. After 24 hours of bad side effects, started to feel better. Felt like the worst flu I've ever had.  Took tylenol twice during side effects.
About 10 hours after I received the vaccine I felt my heart racing, then I felt dizzy, and I fainted. My friend who was with me stated I stopped breathing. I was gasping for air and I turned blue.  * I am healthy and never had any health issues*
The patient stated that her left arm (site of PNEUMOVAX 23) developed a large, hard, red spot near the injection site and that she woke up with a rash on her left leg the next day. No issues were identified on the right side of her body.
metallic taste in the mouth; tingling sensation; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included covid-19 from Jun2020 to an unknown date. The patient's concomitant medications were not reported. The patient received covid vaccine on 22Dec2020 and noticed around 4 days after (26Dec2020) had a metallic taste in the mouth and tingling sensation (persists until now), which according to her were similar to her symptoms when she had covid back in June. She was wondering if she can get the second dose of the vaccine which would probably be stronger. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Fever; Felt bad all day yesterday/still feeling bad/Does not feel good; Sore arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad all day yesterday/still feeling bad/Does not feel good), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic back pain. Concomitant products included HYDROCODONE for Chronic back pain.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and MYALGIA (Body aches). On 25-May-2021, the patient experienced FEELING ABNORMAL (Felt bad all day yesterday/still feeling bad/Does not feel good). On 26-May-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt bad all day yesterday/still feeling bad/Does not feel good), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: 99.7 (Inconclusive) Fever- 99.7degrees.         Patient reported that he takes monthly injections in the back for the chronic back pain. Action taken with mRNA is not applicable.
Immediate aching in left arm.  Severe shake and chills 8 hours later. Severe vomiting 10 hours later lasting 4 hours with dry heaves. Fever aches and mild chills for 48 hours. Tried on third day.
Fever of 101 plus for 2.5 days.  Arm where injection was given became very painful, swollen, hot to the touch, itchy.  Area was about 10? long by 4-5? wide.  Swollen lymph nodes in neck and arm where injection given.  Swollen arm started within 24 hours.
Severe headache, muscle weakness, fever of 102.4 F for 7 days in total, unable to get out of bed for 3 days after 1 day following shot, but most problematic is a long term and on-going rash and itching with bright red bumps on skin that become painful and cause constant scratching of the affected areas. I still have the itching after 7 months following vaccination.
Pt reports global amnesia. Was brought to the Emergency Room and worked up to rule out a stroke. Was diagnosed with Transient Global Amnesia, which lasted approximately 5 hours.
Patient received a double dose of vaccine. The vial was not diluted. Patient family notified. Parent stated that other than sore arms no other symptoms had occurred
AT THE TIME OF INJECTION, PT BECOME COOL, PALE, STATED HE FELT NAUSEOUS, PT HEART RATE DECREASED WITH A RATE IN THE 50'S, APPEARS TO HAVE HAD A VAGAL RESPONSE. 10 MINUTES POST INJECTION PATIENT'S HEART RATE IN THE 70'S, NO COMPLAINTS, STATED HE FELT FINE.