chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Moderona / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206) and on 30Mar2021 as dose 2, single (Lot number: ER8733) at the age of 74 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 as dose 3 (booster), single (Lot number: 939903) and on 31Mar2021 as dose 4 (booster), single (Lot number: 066R21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOSARTAN, start date: May2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 4:Moderna / Dose Number: 3:Moderona / Dose Number: 2:Pfizer / Dose Number 1:Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2weeks. Patient received COVID 19 Treatment, Paxlovid, start date: 02Oct2022, stop date: 07Oct2022, Indication: Treatment of COVID-19. Adverse event: Rebound Covid infection. First new symptom on 13Oct2022; tested postive for Covid on 15Oct2022.
About one hour post injections I started developing chest pain and pressure. It worsened throughout the day and because I was worried about a cardiac event, I went to the emergency room.
Caller reported that she gave VAXELIS and HIBIRIX to a patient on the same day (patient received 2 Hib doses) to catch up, instead of VAXELIS and PCV; Wrong vaccine administered; This non-serious spontaneous safety report, with reference number 2023SA057617/ Inquiry# 01495467 was received by a partner on 16-FEB-2023 and forwarded on 20-FEB-2023 from a physician.   Due to the nature of the event, the causality between the events "Caller reported that she gave VAXELIS and HIBIRIX to a patient on the same day (patient received 2 Hib doses) to catch up, instead of VAXELIS and PCV" and Vaxelis was not applicable.  Further information is expected.
BLOOD CLOTS IN LEGS; BLOOD CLOTS IN LUNG; This solicited report received from a patient via PPSCVM000808: Janssen for XARELTO concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots in legs, and blood clots in lung. Patient also mentioned the doctor advised he had blood clots way too often. Patient took off of Xarelto for 3 days frequently to donate blood. On first occasion of donating blood patient was still actively taken Xarelto and once needle was placed in arm, blood shot everywhere. The action taken with covid-19 vaccine ad26.cov2.s, and rivaroxaban was not applicable. The outcome of the blood clots in legs and blood clots in lung was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots in legs, and blood clots in lung was not related; and between rivaroxaban, and blood clots in legs, and blood clots in lung was not related.  This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220534253.; Sender's Comments: V0-20220530488-covid-19 vaccine ad26.cov2.s-Blood clots in legs, Blood clots in lung. The event(s) has an unknown/unclear 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 not related.  20220530488-Rivaroxaban-Blood clots in legs, Blood clots in lung. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event(s) is considered not related.
blisters on both arms, both legs, and trunk of body; pustules and blisters on both arms, both legs, and trunk of body; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3F3FP, expiry date 30th April 2022) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 5 days after receiving Shingrix, the patient experienced blister, pustular rash and rash. On an unknown date, the outcome of the blister, pustular rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the blister, pustular rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix vaccine in the left arm. The pharmacist reported that 5 days after receiving the vaccine the patient had a rash, pustules and blisters on both arms, both legs, and trunk of the body and this was still ongoing till the time of reporting. The reporter did not consent to follow up. The patient did not give consent to follow up with health care provider. This is 1 of the 5 link cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201575:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020AMR202100:same reporter
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: patient passed out and hit the wall, but was breathing and responsive while laying on floor, NP relocated Pt to minute clinic to wait for medical response team-Mild, Systemic: Weakness-Mild, Additional Details: Pt was stable and taken by private transport to urgent/emergent care
My skin is blistering. I have a 103.3 fever and a lot of pain.
Pt vaccinated w/DPT/OPV developed crying for several hrs, limpness, lethargy, couldn't keep eyes open or head up. Temp 103. All sx's resolved 24 hrs later. No treatment needed.
Patient started to shake all body; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Patient started to shake all body) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045JUT) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced TREMOR (Patient started to shake all body). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 04-Dec-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Patient started to shake all body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, Heart rate: 100 (High) 100 heartbeats per minute.         Concomitant medications were not provided.  Patient took Tylenol 10 minutes after booster dose.
Complained of sore and stiff lung and pressure on left side lung; hx of emphysema from smoking 2 packs a day. Called on 11/25/02; doing fine. Case closed. The discharge summary states COPD, and alcohol withdrawal.
COVID(+) WITH SYMPTOMS BODY ACHES, HEADACHES, DRY COUGH Narrative:
~5 minutes (near immediately) after receiving vaccination, I felt tingly in my extremities--mostly arms but a bit in the legs. While sitting in the waiting area, tingling continued,  had brief sense of doom, waves of nausea, a metallic taste in my mouth, light-headedness, and the type of field-of-vision narrowing that occurs before one faints--but I did NOT faint. Companion stated my eyes were dilated and my skin slightly pale/green. Her voice and that of the pharmacist sounded far, muffled.  Upon pharmacist recommendation, applied cool compress to forehead and slowly drank a soda for sugar+liquid. Within another 20-30 min, symptoms resolved.
Information has been received from a certified medical assistant concerning an 11 year old female with azithromycin (Zithromax PAC) allergy (abdominal pain) who on 27-SEP-2007 was vaccinated on left arm with a dose of Zostavax (Oka/Merck) (lot #658212/0887U) instead of a dose of Menactra.  Concomitant therapy on same day included a dose on right arm of Gardasil (MSD).  It was reported as a staff error and not product quality complaint.  The patient was monitored post-vaccination with no apparent side effects during the time of observation.  A product quality complaint was not involved.  Additional information has been received from the certified medical assistant who stated that it was human error.  The staff member just grabbed the wrong package.  The patient was administered a dose of Menactra and no adverse events were noted.  No further information is expected.
Severe stomach pains, small lump just above my left shoulder blade, I put cold water on it,  In the morning the small lump spread to 10 centimeters.  I called my Doctor, She said, I did the right thing and to continue with the cold treatment every 15 min.  from the lump to where I got the shot for the soreness.  I threw up once.  Was tired all day.  Today is Thursday, 4/1/21, The swelling went down.  My shoulder is still sore.
extreme dizziness; extreme diarrhea; tiredness; small rash on right forearm; This is a spontaneous report from a contactable consumer (Patient). This 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL1283) via unspecified route administered in Arm Right on 08Feb2021 11:00 as SINGLE DOSE for covid-19 immunization. Medical history included type 2 diabetic, GERD, high cholesterol, leaky valve, sinus allergy. Concomitant medication included atorvastatin, Allegra D, Fluticasone, Olopatadine. Patient was allergic to vicadine, ciproflaxin, lactose intolerant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No covid tested post vaccination. On 17Feb2021 at 18:00 the patient experienced extreme dizziness and tiredness most in the late evening. I have some tiredness after I eat a meal and on 20Feb2021 extreme diarrhea, a small rash on right forearm. No treatment for event. Patient visited to Emergency room/department or urgent care. The outcome of the event was not recovered.
Minor muscle soreness several hours after vaccination. Tenderness at injection site only when pressure applied (i.e. sleeping on side)
had outbreak of Shingles on both sides of body after the second dose; swab the blister; This case was reported by a physician via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th November 2019).   On 28th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were reported as follows: The patient had outbreak of Shingles on both sides of body after the second dose of shingrix. After transfer from first line specialist, physician stated that she was willing to swab the blister in order to test whether the shingles were caused by the vaccine. She states this can be requested via safety follow up. The reporter did not consent to follow up.
This spontaneous case reported by a consumer, describes the occurrence of headache in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. The patient's past medical history included migraine (prone to migraine). On Jan 28, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; 1 dosage form. On Jan 29, 2021, patient experienced headache. At the time of the report, headache outcome: unknown. No relevant concomitant medications or treatment information reported. Reporter did not allow further contact.
Information has been received from a registered nurse concerning a child who was vaccinated with MMR (second generation). Subsequently the patient developed seizures. Unspecified medical attention was sought. Upon internal review, the convulsions as considered to be an other important medical event (OMIC). The registered nurse also reported that another child developed a seizure and lost cognitive ability. Additional information has been requested.
Rashes started  with only 2 itchy rashes on 2/9. On 2/10, rashes spread to right neck, right and left side of the body including armpits, left upper arm and some on the abdomen and chest. The actual injection site which is the left arm became red and warm to touch. On 2/11, rashes spread to bilateral lower arms. Rashes are red, raised, itchy and in different sizes and shapes.
Patient experienced abdominal discomfort. Patient had several episodes of vomiting.  Facial coloration flushed. Tingling sensation in fingers.  Patient was light headed/disoriented. Low blood pressure.
Lymph node swelling - under right arm for approximately 1 week as well as cold symptoms including fever, sore throat, body aches for  48 hours). Possible weakened immune system - have had several colds and sinus infections since the 3rd dose.
Ended up in the hospital due to a drop in blood pressure; Reaction to the Polysorbate 80; This serious case was reported by a consumer via other manufacturer and described the occurrence of blood pressure decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included CHEMOTHERAPY and Meningitis vaccine (received back in 2018/2019 with no problems). Concurrent medical conditions included asplenia.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blood pressure decreased (Verbatim: Ended up in the hospital due to a drop in blood pressure) (serious criteria hospitalization) and reaction to drug excipient (Verbatim: Reaction to the Polysorbate 80) (serious criteria hospitalization). The outcome of the blood pressure decreased and reaction to drug excipient were not reported.   It was unknown if the reporter considered the blood pressure decreased and reaction to drug excipient to be related to Shingrix.     It was unknown if the company considered the blood pressure decreased and reaction to drug excipient to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The patient did not had a spleen and  had to get the meningitis vaccine periodically.  The last meningitis vaccine she had was the Pfizer Trumenba in 2018 and she believes or 2019. Well she's due again for her booster and had no issues.  The situation was that between 2018 and in 2020 she had the Shringrix vaccine. After the vaccination patient had an adverse reaction, ended up in the hospital due to a drop in blood pressure and all that kind of stuff.  Now she was due again for another Trumenba shot.  The pharmacist here in thought that it might have been a reaction to the Polysorbate 80 in the Shingrix vaccine.
pt recv vax 23SEP98  @ 7PM;24SEP 24hr p/inj arm was hot, red & swollen in deltoid area of lt arm;by 8AM 25SEP arm was much more swollen & tender from mid sternum to mid clavicle good ROM of arm;
severe hives resulting in Pred med x 1mo;superficial saphenous vein clot, poss pulmonary arterial venous malformation;
Blister/fluid pocket near injection site. Site of blister was where the adhesive of the bandage was.
Pfizer on 7/29/21, 8/19/21. Positive on 5/23/22
I felt fatigue, soreness and redness at injection site, and muscle aches the next morning (1/1/21). Noted a red area that was 1.5 inches around. The redness started to improve on  1/5/21. On 1/6/21 the redness came back worse. I felt pain and itching at the site. It began welting. By that afternoon it was 3 inches around, dark red, small blister on top of the welting.  I  called my doctor's office, they had me call the COVID-19 number. The COVID-19 Nurse stated it sounded like a typical reaction. He recommended Benadryl cream and heating pad. Today is 1/8/21. The redness is at 4 plus inches around. Still sore and itchy. I still have some muscle aches and a headache. I haven't been seen by a doctor, but I may go to urgent care for evaluation.
extremely lethargic; had pains that went down my left arm; sick in bed; a bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "a bad headache"; LETHARGY (non-serious), outcome "recovered", described as "extremely lethargic"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "had pains that went down my left arm"; ILLNESS (non-serious), outcome "recovered", described as "sick in bed". Therapeutic measures were taken as a result of headache.  Additional information: After receiving the first shot of Pfizer's COVID vaccine, female consumer had a very mild headache that lasted about 6 hours. "Patient took 2 Tylenol and it went away. Patient had pains that went down to her left arm she had the shot in which were pretty intense but only lasted a second each. Patient was sick in bed the whole next day with a bad headache and was extremely lethargic and she is normally extremely healthy. On the 2nd day, she was back to normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 1:00 am I started having chills and body aches. At 5:00 am I woke up with a headache and cold like symptoms, sore throat, headache, waves of nausea, soreness.
Pt experienced head pains, light headedness, dizzy spells, swelling in hands, constant ringing in ears. Constant joint pains in fingers, wrists elbows and legs. Numbness in hands, arms and legs. The pt experienced right arm and chest pain, shaking from head to toe getting progressively worse, muscle spasms in arms and legs, sleeplessness due to tremors/spasms. Lymph node swelling and pain under arms and leg/torso juncture, periodic memory loss and concentration difficulty, periodic slurs in speech and vision problems, nerve twitches on left side of face (affecting chin, lower lip and eye), mobility problems, joint stiffness, and difficulty grasping and holding objects with hands due to numbness and shakes.
General malaise about three days after vaccination; moderate soreness at left deltoid running down thru left shoulder and mid back.; moderate soreness at left deltoid running down thru left shoulder and mid back.; moderate soreness at left deltoid running down thru left shoulder and mid back.; experienced headaches off and on for about three days; This is a spontaneous report from a contactable pharmacist reporting for himself.  A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot EJ1685, intramuscularly on 21Dec2020 (Dose 1) as a single dose, left arm  (age at vaccination: 51 years)  for COVID-19 immunization.  Medical history was none. There were no known allergies to medications, food, or other products. He was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included multivitamins, krill oil (KRILL OIL).  No other vaccines were received in the 4 weeks prior to COVID vaccination. Starting 21Dec2020 at 18:00 after the first vaccine, the patient experienced headaches off and on for about three days, usually at night especially while trying to sleep. General malaise about three days after vaccination (on 24Dec2020) which lasted about four days. Also had moderate soreness at left deltoid running down thru left shoulder and mid back (onset 21Dec2020 18:00). There was no treatment received or hospitalization for the events. The events were reported as non-serious. The outcome of the event headaches off and on was recovered in Dec2020, for the event general malaise was recovered on 28Dec2020 and for the event moderate soreness at left deltoid running down thru left shoulder and mid back was recovered on an unknown date. The patient was not COVID-tested post-vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018615 same patient/drug, different dose/event
My son suffered five grand mal seizures two of which were in the hospital.  He was prescribed phenobarbital until his first birth day. 6/20/08-records received-for DOS 5/14-5/16/06-DC DX: Seizures. Presented to ED for seizure activity.Had a seizure in ED.
Patient received her 1st COVID Moderna dose on 3/10/21. She received a dose of the Pfizer vaccine on 3/12/21 at a different facility and her 2nd Pfizer dose on 4/2/21 at that same facility. She then returned to our clinic and received the 2nd dose of Moderna on 4/7/21. She received both doses of both COVID mRNA vaccines within a month.