chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site left arm turned "kinda pinky/red and a little puffy; her arm turned "kinda pinky/red and puffy."; injection site left arm/tender to the touch; injection site left arm/little heat/warm; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration in the left arm on 19Jan2021 14:20 at a single dose for covid-19 immunisation. Medical history included ongoing obesity from 2018 (onset was around time her husband died in 2018. She thinks she started getting more sedentary and picking up weight about then). The patient's concomitant medications were not reported. The patient had no history of previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the bnt162b2. The patient previously had smallpox vaccine for immunization when she was a child and that of which really worked, but it was not just a neat little thing and she still has the scar on her upper arm; and varicella zoster vaccine rge (cho) (SHINGRIX) on unspecified date in 2019 for immunization. She had quite a reaction to this first dose of SHINGRIX vaccine but cannot remember what the symptoms she had were; she was down for a few days with that. She told her family doctor about the reaction, and that she received the vaccine at (pharmacy name); the family doctor said she should not get the second dose of the SHINGRIX. On 20Jan2021, the patient experienced her injection site left arm turned "kinda pinky/red and a little puffy, with a little heat/warm and tender to the touch." Outcome of the all the events was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 18-JUN-2014 the patient was vaccinated with an expired dose of ZOSTAVAX 19400PFU (lot # H021710, expiration date 07-MAR-2014, dose, route, indication not reported). No adverse effect had been observed or reported. Additional information has been requested.
8/21/2021-  presented to ED with right sided weakness and numbness, right facial droop, unsteady gait  CTA head and neck showed moderate stenosis in the proximal and distal portions of the right M1 segment.  MRI brain showed an infarct in the left upper pons.  Echo was negative for shunting or thrombus, showed septal LVH.
I got the shot on Wednesday and on Friday I was shivering  so bad I thought my chest was going to pop out and so nausea. I called my neighbor and took me to the ER . They ran Blood test and urine test and everything was ok. They told me i was a side effect for the vaccine and sent me home. I went to bed and didn't feel good, the next day I still didn't feel good. I got so chilled again and nausea and went back to the ER and say the same Dr. and took my Blood work again and said my blood work was better than the night before. I also had a fever and they told me to take Tylenol and it was just a side effect.  I feel so weak and sick at my stomach still.
Information has been received from a registered nurse concerning a school aged male child who several years ago was vaccinated with varicella virus vaccine live. The child gets a rash every time he is exposed to chicken pox in the community. It appeared that the child had numerous episodes. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # reported as M000768 expiration date: 05-JAN-2018 or lot # reported as L033589, expiration date: 02-SEP-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 12.6 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
severe headache; body pain/ aches; Chills; temperature; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: May2021), via an unspecified route of administration, in Arm Left on 04Feb2021 around 09:00 AM as SINGLE DOSE for covid-19 immunization. The patient (age was 66-year-old) first dose was LOT: EK4176 with EXP Mar2021 and was injected 14Jan2021, in her left arm around 09:00AM for covid-19 immunization. She says she did have a flu shot in Sep (unspecified year, NDC/LOT/EXP unknown). Medical history included fibromyalgia from 2009, lyme disease and Arthritis from an unknown date; all unknown if ongoing (reported as diagnosis of fibromyalgia/Lyme disease depends on what specialist she sees, but she was diagnosed first with fibromyalgia in 2009. She says that she also has severe osteoarthritis, but not the one that does the bones, just put arthritis, since it is not the type that deteriorates the bones, it does cartilage). There were no concomitant medications. The patient says she has not had any other recent vaccinations or started any new medications. It was reported by the patient, who says she had her second vaccination on 04Feb2021 and had a pretty strong reaction for about 36 hours. She says she had a severe headache, body pain, and a temperature with no chest involvement. She says she has experienced this every 3 hours for days now after, in waves. She says she would like to know if anyone else has reported a similar thing as what is happening to her. She says she goes 3-4 hours with a headache and chills today, and aches, and she didn't know if that was typical or not. She says she has not spoken to her health care provider about this. The patient reported that she got the vaccines from pharmacists that came to the care center where her mother lives. For the treatment the patient says she took Ibuprofen last night, which seemed to give her some relief. She says that the Ibuprofen (EXP Jan2022, LOT: 63650291AA, UPC: 1387402032). She says that the Ibuprofen is 200mg and she just took one dose, one time only, she tried it yesterday. She says when it started and hit again today she thought she should call someone and talk about it. The outcome of the events was unknown.
Case number PHEH2014US006300 is an initial spontaneous report received from the nurse on 28 mar 2014 and a follow up information was received from a consumer on 25 Apr 2014. This report refers to a 20-year-old male patient. His medical history and concomitant medications were not reported. On 26 Mar 2014 at 14:30 pm, he was vaccinated an intramuscular dose of MENVEO (batch number: M13051) in the arm, where MenA lyophilized conjugated component reconstituted with a sterile diluent (instead of Men CYW-135 liquid component). No adverse event was reported following this administration error (wrong solution used in drug reconstitution). Follow up information was received from a consumer on 25 Apr 2014: Updated vaccination time and site. Reporter information was also updated.
tested COVID-19 positive/had your first Pfizer shot and then week and half later contracted covid; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested COVID-19 positive a week and a half after receiving the 1st dose so his 2nd dose schedule was moved on 20Apr from 13Apr. Consumer (Patient's wife) was asking on behalf of patient if this was okay confirming that patient already recovered from the virus. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received PedVax Hib (third dose) at his 6 mos. WCC visit. This dose should have not been given until his 1 year birthday or after.
A red bumpy rash from the neck down. And as of 4/4/2018 A diagnosis of Croup (after not being exposed to any sick persons).
Pt received PREVNAR 13 on 5/29/15. Developed cellulitis. Received KEFLEX on 6/8/15 for treatment. Pt had redness warm to the touch and line on this arm.
sore arm; This is a spontaneous report from a contactable Nurse. This 64-year-old female Nurse (patient) reported in response to Hcp letter sent in cross reference case which included that.  A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1284), dose 1 intramuscular, administered in Deltoid Left on 29Dec2020 as (At the age of 64-years) dose 1, single for covid-19 immunisation; ibuprofen (ADVIL 12 HOUR), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 1 hour after injection again 12 hours later. for an unspecified indication, paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 1 hour after injection again 12 hours later. for an unspecified indication. Medical history included sideroblastic anaemia from 1997 and ongoing, and haemochromatosis from 1999 and ongoing. Concomitant medication included epoetin alfa 40000 units SQ every other week (PROCRIT) taken for sideroblastic anaemia from 2000 and ongoing; deferasirox 720 mg Po daily (JADENU) taken for haemochromatosis from 2017 and ongoing. The patient experienced sore arm on an unspecified date. The action taken in response to the event(s) for bnt162b2 was not applicable, for ibuprofen was unknown , for paracetamol was unknown. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
6 day long migraine,  Weak, nausea, body chills, stiffness, dizzy, body aches all lasted 6 days. No fever though. After day 3, I went to hospital thinking I had Meningitis because my head hurt so bad and my neck was stiff. They ran an urinalysis and found a pretty bad UTI.  The doctor said that the UTI exacerbated the side effects of shot. I don't know if that's true. I got I. V. Keflex and prescription. Migraine continued for another 3 or so days. I missed 4 days of work. Honestly the symptoms felt like I was doing chemo again. It was awful.
Delayed hypersensitivity reaction occurring 11 days after first dose. Redness, itchiness occurring at the site of injection. Treatment with OTC antihistamines.
Tenderness; Itching; Warm; Pink circle around injection arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Pink circle around injection arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced TENDERNESS (Tenderness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Pink circle around injection arm). On 07-Mar-2021, TENDERNESS (Tenderness) had resolved. At the time of the report, PRURITUS (Itching), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Pink circle around injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient's wife reported the erythema, pruritus, and warmth had resolved on 07MAR2021 and then recurred the following day.  Treatment information was not reported.
DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced death, and blood clots. On an unspecified date, the patient died from unknown cause of death. The reporter stated that "blood clots is what Covid is all about and other stuff. My friend died after taking one of the other. Not Covid". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient died of death on an unspecified date, and the outcome of blood clots was not reported. This report was serious (Death, Other Medically Important Condition).  Version created to amend previously reported information on 13-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  20220232663- covid-19 vaccine ad26.cov2.s-Death, Blood Clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
injection site is itchy; injection site swollen; injection site red; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site is itchy), PYREXIA (Fever), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (Fever). On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red). On 30-Dec-2020, PYREXIA (Fever) had resolved. On 07-Jan-2021, VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included advil to treat her fever the night of the injection.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Extreme fatigue, aching, headache, dizziness, injection site pain,  etc
I had shortness of breath with my normal walking routine. It went on for a couple weeks and then I reported it to my doctor. I finally went to the doctor and had some blood work done. The results were fairly normal, but because I am still having shortness of breath, they contacted me and told me to go to urgent care. I am still undergoing tests to see what is going on.
within a day or 2, patient started to experience pain and swelling left knee. Went to see her primacy care doctors and says "it hasn't been the same since".
Fever as high as 101.7 with Advil, chills, body aches, and a head ache. Itchy rash at injection site that is also painful. It last around 36 hours.
Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. On 29-AUG-2015, the patient received a dose of ZOSTAVAX (lot, expiration, dose, and site not reported) for prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster or any other ailment collectively referred to as "shingles." On or about 12-JUN-2016, the patient was treated by a health care professional for symptoms of a rash on his right anterior and posterior chest wall.  The patient was then diagnosed with an advanced case of herpes zoster, also known as a shingles outbreak. On or about 12-JUN-2016 the patient was prescribed valacyclovir (manufacturer unknown)  and grabapentin for the treatment of shingles and shingles-related nerve pain. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result. the patient has sustained severe and permanent injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant pain and suffering. mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. Herpes zoster and shingles-related nerve pain were considered disabling. Additional information has been requested.
11 am - vaccine administered. 12 pm - dry "barking" cough, throat tickle, felt like "swallowing razor blades". 1 pm - throat "on fire", chills. 4 pm - unable to open eyes (applied warm cloth x 4 and it helped).
Patient received  Moderna Bivalent booster vaccine on 09/16/2022 (lot # AS7147B). Patient inadvertently received another Moderna Bivalent booster dose (Lot #023H22A).
Initially sore arm at injection site, on 2/1/21 continues with drowsiness, sore throat, stuffy nose, productive cough with yellow phlegm, congestion
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 56-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received the 1st dose). On 6th February 2019 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th February 2019 21:00, 5 hrs after receiving SHINGRIX, the patient experienced tiredness. In February 2019, the patient experienced fever, chills, general body pain, muscle pain and bizarre dreams. On an unknown date, the outcome of the tiredness, fever, chills, general body pain, muscle pain and bizarre dreams were recovering/resolving. It was unknown if the reporter considered the tiredness, fever, chills, general body pain, muscle pain and bizarre dreams to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. After vaccination at around 9:00 or 10:00 pm the patient felt very tired. On 7th February 2019, the patient woke up at night at around 1:00 am or 2:00 am, 9 hours after receiving SHINGRIX, the patient experienced fever, chills, body aches, and muscles pains. He could not get warm and experienced weird nightmares. On the day of reporting the patient felt better but was not fully recovered. The reporter had no consent to follow up and would not be providing any additional information.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose, route and indication were not reported). The reporter did not provide if this dose was a first, second or third dose in the GARDASIL series. No adverse symptoms were reported. Additional information has been requested.
Paralysis from chest down 6/9/04. Unable to void or move bowels; headache/vomiting. Diagnosed on 6/12/04 with lesions on brain stem and spinal cord from immunizations: ADEM. Treated with high dose IV Solu-Medrol and physical therapy. Discharge Summary received on 2/16/2005 states knee pain, neck discomfort, numbness and weakness in extremities, tingling in hands, low-grade temperature, mild imbalance, muscle strain, and abnormal gait. Follow up 02/05/05:the report was unable to obtain lot number for vaccine 1, manufacturer and lot number for vaccine 2, manufacturer and lot number for vaccine 3, lot number for vaccine 4, and lot number and manufacturer for vaccine 5. Continues with chronic fatigue, urinary retention and incontinence joint pain (knees, hips, back, neck) balance disturbance chronic constipation, sleep disturbance (o/t pain) short term memory difficulty. My life has completely charged since immunization and I am concerned as the military is still giving the same immunizations knowing they cause these effects. At age 21 I am officially retired from a productive life.  Per the follow up report-Patient is currently experiencing continous pain throughout body, fatigue, sleep interruption, short term memory loss, at time balance is affected. But the worst is that patient has no control of bladder and bowels. Since immunizations patient has no control of bladder. Currently having Botox injections every 6 months. Training bladder to render it. Completely paralyzed. Patient must catherize himself 4-6 times a day. The pain and sleep deprival does not allow patient to work or go to school.
Patient was given a Dtap although she is 10 years old.  She should have received a Td, or in the alternative, a Tdap, due to limited supply of Td.  The patient did not have an adverse reaction, she received the wrong vaccine.
Moderna COVID19 Vaccine EUA  Admitted inpatient 4 days for pyelonephritis, mild dehydration and Acute kidney injury.
Headache 5 days now,  face flushing 1st day, face swelling 2nd day.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Covid vaccine was administered, within 2 minutes patient started passing out.  Paramedics arrived.  Pt was passing in and out a couple of times, was weak and vomited twice.  When paramedics arrived they assessed the patient and within 30 -45 minutes patient was able to leave the store on her own.
hallucinations; short of breath; fever; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. After use of product, patient experienced fever, hallucinations, short of breath, fatigue, headache on an unknown date. Treatment was unknown. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.