chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have not been able to sleep; I have been awake the complete night; it has caused me complete insomnia and a total sleepless night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 23Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years. The patient's relevant medical history included: "Hypertension" (ongoing); "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The following information was reported: INSOMNIA (non-serious) with onset 23Mar2023, outcome "unknown", described as "I have not been able to sleep; I have been awake the complete night; it has caused me complete insomnia and a total sleepless night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of insomnia.  Additional information: The patient took Zolpidem for the sleep and it has not saved her. The patient took that at 11 o'clock."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
SWELLING OF INJECTION SITE (~6 INCHES DIAMETER) & TEMPERATURE 106F SORENESS (MODERATE) MUSCLE ACHES THROUGHOUT BODY & JOINT ACHES FATIGUE FEVER (99 - 100.6F   (BEGINNING ON DAY 2 AFTER SHOT @ 5:00 A.M.).
Pt reports within an hour of receiving the vaccine she noticed tightness, tenderness and a knot developing in the muscle. Reports just "felt bad", restless all night and couldn't sleep. On 10/28/14, she noticed a large knot, redness, itching and tenderness at injection site. By 10/31/14 knot is smaller with occasional itching.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored M-M-R II (lot #M015931, expiration date 30-MAR-2018, lot # L028273, expiration date 28-JUL-2017 and lot # L039551, expiration date 07-OCT-2017) (dose and route not reported). The administered dose experienced a temperature excursion of 29 Fahrenheit for 2 hours and had previous temperature excursion of 1.5 degrees for 2 hours 50 minutes on 20-JUL-2016. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
I got my vaccine on Monday 12/21/20, On Tuesday I notice a quarter size red mark it the injection site. On Wednesday I notice the red mark a little bigger. On Thursday I notice the red mark move up to my shoulder and  half way down the arm  to the elbow. The arm is warm to the touch.  Took benadryl and resolved thereafter
1 AM on 04/27/21 I woke up to get a glass of water and at that time I blacked out and fell on my face and broke my nose. I went to the ER and had a test and they suspected I had a broken nose. A month later I had surgery to have my nose reset. I wasn't recovered until early June after the surgery. No issues since.
Small bouts of diarrhea; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33 year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Eh6705) via an unknown route of administration in the left arm on 11Mar2021(at an age of 33 year-old) at 12:15 as a single dose for COVID-19 immunisation.  Medical history of the patient was not reported. The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), daily multivitamin (MANUFACTURER UNKNOWN) all for unknown indication. The patient did not receive any other vaccine within 4 weeks, prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Mar2021, the patient experienced diarrhea and on an unknown date in Mar2021 the patient experienced tinnitus. The patient reported mid tinnitus was not constant; which came and went. The patient did not receive any treatment for the events. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of mild tinnitus  resolved with sequelae on an unknown date in Mar2021 while the clinical outcome of the event diarrhoea was resolved with sequelae on 12Mar2021 .    No follow-up attempts are needed. No further information is expected.
Facial paralysis on left side as well as left side weakness and inability to feel left side (arm, leg, foot).   Balance and falling due to left side weekness, confusion, severe headache.  Possible Guillain Syndrome per neurologist.
Severe swelling under arm not at site - Pain in elbow 3 wks. 6-23 yeast infection doctor visit.
Actually two doses were taken (Code #208). In the case of Item #4, issues like unusual cramping (possible parasite but no test taken) on June 1, 2021 at 5 a.m. resulting in hospital viist and check with doctor. There was also an issue with sensation of "freezing" in legs. The stomach cramp issue has continued from time to time. After the second Pfizer dose, received on June 23, Lot EY0579, I noticed some exacerbation of issues like athletes foot infection so I made an emergency visit on August 24 and was referred to my doctor's clinic.  On August 25 at 1:00 a.m. I noticed unusual itching in my left hand (enough to keep me awake).  Last night I had overall body itching (everywhere) during the night that kept me awake
Headache; Diarrhea; My headache and my eyes are killing me; Chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 22Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient stated that, got the Pfizer shot then patient had the side effects and got it on Thursday. Patient believe it was 22nd. Patient got headache, diarrhea, little bit of chills. Headache and eyes are killing patient. So, sounds like all the symptoms here, the side effects since Thursday. Patient want to report it. Patient asked that, do need to go to a doctor. Consumer was unwilling to complete the report. Hence limited information available over the call. The outcome of the events were unknown.  Information about lot/batch number has been requested.
large bright red area inj site w/full body rash;red area is swollen & warm to touch;
Administered vaccine to 17 year old patient; A spontaneous report was received from a nurse concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, administered vaccine to 17 year old patient.  The patient's medical history was not provided. Concomitant medications were not reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 220, the nurse reported the 17-year-old vaccinated patient did not have any symptoms that they knew of. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered vaccine to 17 year old patient, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
At injection site, pt developed a skin lesion that appears consistent with erythema multiforme minor.  Skin changes are still present 1 month after vaccine administration.
Vaccine dilution error.  The Pfizer vaccine was diluted with 1.5ml of the diluent NaCl 0.9% instead of the recommended 1.8ml.  The 0.3ml dose was given with this slightly higher concentration of vaccine.  Patient was contacted later in the day on 7/19/21 and did not report any adverse reactions.
7 hours after injection she developed pain and redness at the injection site, nausea, myalgias and fatigue.
FelT like I was dying! AT 12MN awakened from sleep on (L) side unable To move, felt paralyzed could not turn To (R) side To reach for phone or waste basket due To severe nausea, severe shivering, felt like I was on fire buT could noT move To Take my Temp. Lasted from MN until 4am Than sTopped as fast as It sTarTed. STill have off & on Low grade Temp Told by pharmacist ThaT I should geT The second shoT. (aT $163.09) Told by my Dr. absolutely noT geT iT. I have never had a reaction To any vaccine in my life and I have everyone ThaT comes ouT. (Except for Travel shoTs) Thank you for interest in This matter.
7 days after the shot, I developed what is termed ?Covid Arm?. It is a round, itchy, red rash around the injection site. I had another reaction within 24 hours of getting the shot, where the area around the injection site (about 4 inches) became red and swollen. I got my vaccine along with 2 other family members and I was the only one who had the red mark and severe swelling. My soreness also took much longer to go away.  After doing research and speaking with others online who have/had ?Covid Arm?, I believe if you gave them a head?s up that if they experience the redness around the injection site within 24 hours then they can probably expect to see ?Covid Arm? in 5 to 10 days. That seems to be the major sign of expecting that reaction. Although the people I talked to weren?t aware that the red area after injection wasn?t normal. Everyone I know personally that got this vaccine (the only one available to us), did not have the red area, so that definitely seemed to be part of the reaction.
Vomiting; High Fever; Throat is Red; This is a spontaneous report received from contactable reporter (Other HCP).  A 3-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 29Mar2023 at 15:30 as dose 1 (maroon cap), 0.2 ml single (Lot number: FX5095, Expiration Date: 31Jul2023) at the age of 3 years intramuscular, in right leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PHARYNGEAL ERYTHEMA (non-serious) with onset 29Mar2023, outcome "not recovered", described as "Throat is Red"; PYREXIA (non-serious) with onset 29Mar2023 at 18:00, outcome "not recovered", described as "High Fever"; VOMITING (non-serious) with onset 29Mar2023 at 18:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, pyrexia, pharyngeal erythema.  Additional information: Caller was calling about the Pfizer Covid 19 Vaccine Monovalent for Ages 6mo-4years. Caller stated she had a patient who received a Covid Vaccine for the first time and he was 3 years old. The patient was having vomiting and high fever. Prior to coming in for the vaccine, his Mom and Dad said he was completely fine and healthy. The vaccine was administered at 3:30 p.m. on Wednesday (29Mar2023) and by 6:00 p.m. that night he was running a high fever and vomiting. Caller stated she tested him for Covid, Influenza A and B and those were all negative. The patient's throat was red, which she believed was due to vomiting but she also testing him for strep throat, and that was also negative. Caller asking would this be concerning for a 3-year-old to have that reaction within 3 hours and it was now Friday (31Mar2023) and it was still persisting and this happened on Wednesday. Reporter seriousness for events: Not serious. Relatedness of drug to events was assessed as yes by primary source reporter per global introspection. Treatment: Paracetamol (TYLENOL), ibuprofen (MOTRIN), ondansetron (ZOFRAN).
p/ pt recv vax same day devel 2 centimeter wheal around the inject site described as white bump, treated w/benadryl
Stroke; 1st on 29Nov2021 / 2nd on 26Feb2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2022 14:00 (Lot number: FK9895) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fg3527, Location of injection: Arm Left), administration date: 29Nov2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 12Mar2022 13:45, outcome "unknown", described as "Stroke"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Feb2022 14:00, outcome "unknown", described as "1st on 29Nov2021 / 2nd on 26Feb2022". The event "stroke" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative: (12Mar2022) negative. Therapeutic measures were taken as a result of cerebrovascular accident, inappropriate schedule of product administration.  Addition information: The patient was not received other vaccine in four weeks. Stroke 14 days after receiving covid vaccination in otherwise healthy adult without any other medical conditions. Physically active and healthy individual without any medical concerns prior.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event CEREBROVASCULAR ACCIDENT  Cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
mildly pruritic area of discoloration @ inj site;mild swelling & ecchymosis;no systemic sx, no SOB or urticaria;
swelling of bicep area-some swelling on forearm;tx ice & DPH to call if arms become red or swelling persists;
By 4/8/21, my eyes were swelling, and by 4/10, my face was badly swelling as well. After an E.R. visit on 4/11, I was diagnosed with an allergic reaction, and prescribed meds which included Prednisone.  Follow-up visit with my doctor on 4/19, where he said he believed the second Moderna dose was not advisable due to the fact that the allergen that effected me was unknown, the allergic symptoms were still subsiding(see #20), and the fact that I had recently been on Prednisone.
39 yo Female c/c of Nausea post vaccination.  Pt states shortly after getting vaccinated she felt a sudden in onset of nausea with no associated vomiting.  pt denied any sob or difficulty breathing.  no signs of allergic reaction noted.  no complaint of cp.  pt signed ama with medic 71 mercy.
30-45 minutes after flu vaccination pt c/o dizziness and feeling like she was passing out. No loss of consciousness. Taken to ER for evaluation.
Anaphylaxis to flu shot. Dyspnea, audible crackles, diaphoretic, nausea, skin cool to touch, nausea, accessory muscles to breath.
Client to clinic for Moderna Bivalent Booster, Client received Moderna TOT vaccine 0.5ml
Experienced rapid heart rate within 24 hours of vaccination.  Symptoms lasted until next day after ER visit.  Symptoms started around 10pm and gradually increased,  symptoms abated for 4-5 hours for sleep and came on again upon waking.  Called DO and she advised me to go to ER. Tests results came back normal except for dimer test and CT scan and heart X-ray came back normal.
This study case was received from the investigator in the above mentioned trial on 16 March 2011. A 25 year-old male subject with a medical history of pericarditis was found to have an unspecified disease of the pericardium 8 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported) on 29 June 2010. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.10 and a normal Echocardiogram. The subject's ECG, MRI (brain, spinal cord and heart) and lumbar puncture were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Patient came in on 6/19/18 afternoon with concerns of her adverse reactions after the vaccine. Patient stated that she started having pain at injection site the day after the injection, then itchy and warmth remains. On the 4th day she starting having redness and swelling at injection site, as well as upper lip swelling. On the 5th-6th day she started having headache and heaviness of head. The patient did not appears to be in acute stress and was alert and oriented. Although some of the adverse events seemed common as listed per package insert, lip swelling and warmth at injection site were not. I made a follow up phone call on 6/20/18 but was unable to reach the patient.
I am unsure if this started after the first or second shot but it has been a bit of a short progression. I have heard of brain fog filling covid shots but this isn?t exactly that. It is more like a glitch. I find myself replacing words in scentences with words that don?t belong. Like ?I went to the store to get the  *stroller*. (Instead of milk). ? This has never happened before and is recent since the vaccine. Of course it could be coin it it I wanted to report it in case it?s valuable information. This occurs through the day.
For Dose #1 I had relatively no Side effects. After Dose #2, I was extremely sensitive to the touch for about three weeks.   My current symptoms are I am dizzy, experiencing veritgo, general unsteadiness. This began about September 4th without clear underlying illness. I am seeking treatment and should be seeing an ENT specialist on August 24th 2021.
Next day nausea, tiredness, weakness, loss of sleep/ following day shortness of breath, sneezing-- asthmatic chronic affect treated with use of albuterol inhalant
Patient reported to the clinic because her PCP is here. states she got a second dose of the varicella  Vaccine at pharmacy last night between 4 & 5. This morning she noticed the approximately 3" chickpox like rash at the injections site. the rash itches, red , mild discomfort, no fevers.
I63.9 - CVA (cerebral vascular accident) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism
These are adverse effects that my spouse experienced as a result of my vaccination:  1st period after 2nd dose:   Expected period start date 5/17; Actual start date date 6/5; End date 6/9; experienced quarter sized clots  however normal flow.  2nd period after 2nd dose:  Expected start date 7/6; actual start date 7/8; end date 7/12 Smaller clots; lighter than normal flow;
Patient c/o feeling "sparkly", lightheaded, nausea 5-10 min after receiving flu vaccine. Hives on trunk, neck and lower jaw began 45-60 min. after flu vaccine. Benadryl 25mg  PO given to pt @ 10:00am. Benadryl 25mg PO given @ 10:45am
Chills followed by low grade fever; Chills followed by low grade fever; fatigue with body aches; fatigue with body aches; first dose on 22Dec2020/ second dose on 08Jan2021; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer sales representative. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration; the first dose (lot EH9899) on 22Dec2020 01:00 AM at a single dose in the left arm and the second dose (lot EL0142) on 08Jan2021 13:00 (01:00 PM) at a single dose in the left arm; for COVID vaccine. Medical history and concomitant medications were not reported. The patient experienced chills followed by low grade fever and fatigue with body aches on 08Jan2021 19:00 (07:00 PM). Treatment was not received for chills followed by low grade fever and fatigue with body aches. Facility type vaccine was noted as hospital. It was unknown if other vaccines were received in four weeks. It was unknown if he had COVID prior to vaccination and if he had COVID tested post vaccination. The outcome of chills followed by low grade fever and fatigue with body aches was recovering.   No follow-up attempts are possible. No further information is expected.
Chills, nausea, aches and slight dizziness with some fatigue.  These lasted for approximately 14 hours.
The day after getting the shot i woke up feeling very tired.  By mid day i was very weak every muscle and joint in my body hurt and had a horrible headache.  Today is the next day.  Im feeling better but symptoms are still present.  Still very weak and sore all over and head is still hurting.  Rest is the only thing i can do to help over the counters are useless. Will see the dr if not better by tomorrow.
Tinnitus and loss of hearing in my left ear. After the first shot I lost partial hearing in my left ear: thought it was wax The second shot caused the tinnitus and loss of hearing in the left ear.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 73-year-old female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). On 26th September 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 26 September 2015, less than a day after receiving BOOSTRIX, the patient experienced injection site blisters, diarrhea and headache. On an unknown date, the outcome of the injection site blisters, diarrhea and headache were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, diarrhea and headache to be related to BOOSTRIX.
This spontaneous report as received from a 60 years old female reporting on herself with no allergies, diabetes, high cholesterol and high blood pressure. The patient was vaccinated with dose 1 ZOSTAVAX (dose, route and lot # not reported) on 12-SEP-2012. No other co-suspects were reported. Concomitant medications included: SYNTHROID and LIPITOR. On an unknown date the patient bled after getting the ZOSTAVAX. No treatment information was reported. The outcome of patient bled was unknown. The relatedness for patient bled after getting the ZOSTAVAX was unknown for ZOSTAVAX. Additional information is not expected.