chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 69 year old male with hypertension, coronary artery disease, osteoarthritis, gastrooesophageal reflux disease, hypothyroidism and allergies to NIASPAN, NEURONTIN, statins, nitrates, cortisone who on 09-JUL-2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 18-OCT-2006 at 15:40, the patient was vaccinated IM into the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot#651399/0486F). Concomitant therapy included atenolol, SYNTHROID, ranitidine, NITROQUICK, NEURONTIN and ECOTRIN. On 23-OCT-2006 at 10:36, the patient developed a scattered rash. The patient's scattered rash persisted. According to a letter received from the patient's wife, on 19-OCT-2006 the next day, the patient developed a rash and itch that appeared at the site of the injection and on both arms and torso. On 20-OCT-2006, the consumer contacted the doctor because the rash was much worse. The nurse  told them that it was a reaction from the shot and to take BENADRYL and call back if it was not better. On 23-OCT-2006, the patient called the doctor's office and told the nurse that the rash was much worse and has spread. The nurse advised the patient to see a dermatologist. That day an appointment was scheduled with the dermatologist. The patient was miserable and uncomfortable with the rash and itch. The patient was treated with a shot of cortisone, a topical cream. After 7 to 8 days the rash improved, but then it flared up again. On 08-DEC-2006, the patient had a biopsy and was given a new prescription. On 19-DEC-2006, the patient contacted the dermatologist and she stated that the patient should see an allergist. On 11-JAN-2007, the patient saw an allergist and was recommended for laboratory tests, to change laundry detergent, face and body soap. On 25-JAN-2007, all laboratory tests came back negative and was told to continue medications and also received new medications. On 15-FEB-2007, the patient had an allergist appointment. Some medications were changed and more blood tests were ordered. The allergist also advised the patient to go to a teaching hospital as soon as possible for test that she could not do. On 21-FEB-2007, the patient had a CAT scan of his torso. On 20-MAR-2007 and 21-MAR-2007, the patient had tests done as well as a biopsy. At the time of this report, the patient had not recovered. Additional information has been requested.
Information has been received from a registered pharmacist concerning her husband who on 08-AUG-2011, was vaccinated with ZOSTAVAX (Merck) (Lot#, expiration date, dose and route not reported). The Pharmacist reported that on 08-AUG-2011, she gave ZOSTAVAX (Merck) to her husband and at 03:00 am on 09-AUG-2011, he was having severe abdominal pain and was vomiting. Patient did not seek medical attention. At the time of reporting the patient had not recovered. Follow up information has been received from the registered pharmacist who reported that on an unspecified date, her husband underwent a surgery and was found to have a "crimped intestine" due to scar tissue from a previous injury. The registered pharmacist reported that at the time of the report, her husband was recovered. Upon internal review, underwent a surgery and was found to have a "crimped intestine" due to scar tissue from a previous injury were determined to be an other important medical events. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 67 year old female patient who on 26-SEP-2007, was vaccinated with mL dose in the right deltoid of varicella virus vaccine live (Oka/Merck) (lot # 654696/1056F) instead of zoster vaccine live (Oka/Merck). No adverse events or current patient status were reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
pt recvd vax & pt devel a fever & 10 pox on face, neck, abd & arm; pt recovered;
injection site swelled 4x normal size, nausea, vomiting, abdominal swelling
she woke up her hands and feet were very cold; her hands and feet started feeling cold clammy and sweaty; hands and her feet have been sweating; feeling jittery; has not been able to sleep; feeling very nervous and anxious; feeling very nervous and anxious; she can feel cold air through her skin easier now/ under hot water her fingers and feet feel more sensitive to hot water; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on 11Jan2021 17:30 at a single dose on left arm for COVID-19 immunization (COVID-19 vaccination). The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 23Dec2020 at a single dose for COVID-19 immunization. The patient said that she got the second shot on Monday 11Jan2021 about 17:30 in the evening. On Tuesday 12Jan2021, when she woke up, her hands and feet were very cold. Her hands and her feet have been sweating. Her hands and feet started feeling cold clammy and sweaty the next day on Tuesday 12Jan2021 while she was working from home. She is also feeling jittery and she has not been able to sleep and she is feeling very nervous and anxious (onset date for feeling very nervous and anxious also reported as 13Jan2021, pending clarification). She said that she can feel cold air through her skin easier now it feels like, and also said that even under hot water her fingers and feet feel more sensitive to hot water than they did before. She has never had these symptoms (feel nervous and anxious) before. It made her nervous thinking that maybe the shot caused her hands and feet to feel cold and sweaty. The outcome of the events was not recovered.
Capillaries behind knees broke, and both legs, knees and feet became swollen. Her provider feels that it is vaccine related. He still wants pt to get second dose but moved that dose to 4/1/21
pt recvd vax; devel blister like red rash around inject site;4aug95 cluster of blisters w/ redness & swelling of skin tissue of face, neck, arms & legs; dx w/ allergic rash;
Patient fainted shortly after receiving Pfizer vaccination. She drank water, ate simple carbohydrates and recovered quickly. After sitting in waiting area for a period, she went home with parent.
kidney pain; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30 (Batch/Lot number was not reported) as SINGLE DOSE and dose 2 via an unspecified route of administration on an unknown date as Single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included calcium carbonate (CALCIUM AL); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); melatonin; ascorbic acid, biotin, calcium pantothenate, cellulose microcrystalline, copper sulfate, folic acid, magnesium stearate, nicotinamide, pyridoxine hydrochloride, riboflavin, silicon dioxide, thiamine disulfide, vitamin b12 nos, vitamin e nos, zinc oxide (CENTRUM B). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced kidney pain on 01Apr2021 05:00. Reported as: Seems to be kidney pain. I never had any kidney problems. The pain started on the second day and continued for 5 days.The same happened after the second dose. I never looked for a doctor, but took pain medicine and got better on day 6 after the medicine,The same is happening after the second dose. The event was reported as serious with seriousness criteria Congenital anomaly. Since the vaccination, the patient has not been tested for COVID-19. No treatment received (pending clarification). The outcome of the event was recovered.  Follow-ups are needed. Information about Lot/Batch number is requested.
RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGERS LASTING ABOUT FORTY FIVE MINUTES. SEVERE VERTIGO LASTING AROUND ONE MINUTE PER EPISODE EXPERIENCING FIVE EPISODES SO FAR OCCURRED AFTER FIRST WEEK OF VACCINATION 1ST DOSE.
chills/ experienced chills both times day after receiving shot; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional; patient's wife).  An 88-year-old male patient received the second dose of bnt162b2 (BNT162B2) via an unspecified route of administration, administered in the right arm on 20Feb2021 03:00 (batch/lot number: EN6203) at the age of 88 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient had no medical history (including any illness at time of vaccination). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, administered in the left arm on 30Jan2021 04:00 (batch/lot number EL9262 and expiration date unknown) at 88 years old, as DOSE 1, SINGLE, when the patient was 88 years old, for COVID-19 immunization; reactions: "he started feeling weak and chills." The following information was reported: CHILLS (non-serious) with onset 21Feb2021, outcome "unknown" described as "chills/ experienced chills both times day after receiving shot." The event did require a visit to Emergency Room and Physician office and did not require hospitalization.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112171 Same reporter/ patient/ drug;  different dose/ different events
painful at the site of injection; stiffness; weakness motion; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 15th August 2020, the patient received the 1st dose of Shingrix. On 16th August 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, stiffness and mobility decreased. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain, stiffness and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, stiffness and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported the patient experienced painful at the site of injection, stiffness and weakness motion after receiving the first dose of Shingrix. The symptoms started the following day. The reporter was not sure if the patient recovered. The patient had not received the second dose yet. The reporter consented to follow up.
Developed a spontaneous right side black eye or periorbital ecchymosis near the right tear duct and extending across the lower part of the right eye.  There was no pain or tenderness noted.  The ecchymosis was not present upon waking in the morning. No trauma causation.
This spontaneous report as received from an 88 year old female consumer reporting on herself. The patient's current conditions or medical history were not reported. On an unknown date at an unspecified time in the past, the patient may have been vaccinated with a dose of tetanus and diphtheria toxoids, adsorbed (Manufacturer unknown) (dose, route, indication, lot and expiration date were not reported). Co suspect therapy included ZOSTAVAX (dose, route, indication, lot and expiration date were not reported) at an unspecified time in the past. On an unknown date, in the recent past, the patient spilled a cup of tea on herself that resulted in burns. On an unknown date the patient was hospitalized for burn care. At the time of the report outcome for burned was unknown. Additional information has been requested.
after about two weeks after the initial body deterioration that is known to happen when receiving this vaccine, I started experiencing heart palpitations so bad that i had constant pain in my chest, trouble breathing, and brain fog. it has now been over 4 months and these symptoms have not gone away. my menstrual cycle has been completely erratic as well.  at the hospital, they did an EKG but could not find the issue. the Doctor said it is most likely swelling around my chest cavity due to the vaccine.
pain in left leg/pain a little bit in her left leg; has difficulty walking; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 11May2021 at 11:00 (Batch/Lot Number: EW0168) as 2nd DOSE, SINGLE for covid-19 immunization. Medical history included knee replacement. The patient's concomitant medications was not reported. The patient experienced pain in left leg/ pain a little bit in her left leg and has difficulty walking on 12May2021 at 09:00. Reporter states she got the Pfizer COVID19 shot yesterday for her 2nd dose and had been feeling fine after the shot and then this morning all of a sudden she was feeling pain in left leg/pain a little bit in her left leg; states she had a knee replacement. States the pain began around 9:00am this morning and she was ok when she first got up and was doing things and all of a sudden she gets up from the couch and there the pain was. States the feeling that occurred this morning was a little bit down her leg and up on her thigh and she has difficulty walking; states this feeling is ongoing and she can't say it is pain but more of not being able to put weight on it and more like something with the nerves and it is affecting something in her leg. States the pain is ok and she can take aspirin and that will take care of it and she has taken Tylenol; states she tried to take Naproxen and not Tylenol and the Naproxen did not do a single thing and she put her foot down and tried to walk and it was very sketchy and she wants to know if there have been any reactions like that reported. Therapeutic measures were taken as a result of pain in left leg/ pain a little bit in her left leg and has difficulty walking. The outcome of the events was unknown. The patient received first dose of BNT162B2 for Covid-19 immunization on 20Apr2021.   No follow-up attempts are needed. No further information is expected.
Pt reports 24 hrs after 1st dose, starting having visual hallucinations that lasted 1.5 hrs.
Immediate pain and cramping from the site running down to the hand. Pain and cramping continued into 01/05/2019 and then mild Shaking of the hand also started. The pain continued, but the shaking stopped by the days end. Pain and stiffness got worse on 01/06/2019 and the hand became significantly weak. Unable to move arm due to severity of pain. Pain and stiffness and weakness  remained 01/07/2019 and has not resolved as of 01/08/2019.
Chills two different times kind of week; fever; This is a spontaneous report from a contactable consumer (Patient brother). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown and Expire Date: unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient had chills two different times kind of week, and fever. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Lymphadenopathy; had fever, Lymphadenopathy; Allergy to Pneumovax; This spontaneous report was received from an unspecified reporter via Pfizer and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis.  On an unspecified date, she experienced allergy to the vaccine, fever and lymphadenopathy. The treatment was reported as an unspecified antihistamine medication. The outcome of the events was not reported.  The aforementioned events were considered related to the suspect vaccine.; Sender's Comments:  US-PFIZER INC-2021192337:
Tire on day one-slept for 18 hours.  Day 2:  Woke up and was mildly achy, not wanting to do anything and red large swelling in my right deltoid. Very tender.  Also, edema starting in my right axilla extending down my lateral chest about 7".  Day 3 to 7:  Achiness is gone.  Edema and swelling continue.  Eventually the red swollen area became itchy.  The edema under my arm (not a lymph node) was tender when my arm was close to my body.  Woke me up during the night frequently.   Very hard to sleep.
Foreign travel overseas. Requested HepB series to begin due to job tasks.  Administered Typhim Vi to Right deltoid, IPV to R arm, HepB#1 to left deltoid and Td to left deltoid.  Complained of "feeling funny" after HepB.  B/P 88/50, pulse 60, clammy skin resolved in 10 minutes.  Bp  110/68, pulse 72, skin dry.
Found out pregnant after taking 1st dose. Due date would be 11/17/21. Day following dose - injection site reaction = red, raised, itchy, tender to touch. Lasted 5 days
t37, vomit x 3, fussy, seen in ER, limp episode;
10 days later, itchy feet and hands, followed by hives and rashes all over body. heart burn, feeling of something stuck in throat. responded to antihistamines. swelling in fingers and thumbs. rashes have continued ever since. flaring up in random places all over body that go away within one-two hours. sometimes they itch, sometimes they are just red. going on 6 weeks now, antihistamines daily but does not completely resolve it.
Pt started having itching and redness on face, neck, axilla, flanks and hands around 11am today, reported symptoms at 1430 because it was getting worse.  Pt was given FluMist at 1100 11/4/06.  Pt denies any shortness of breath, no difficulty breathing, throat swelling.  No Stridor noted. Pt given 50 mg benadryl at 1445 PO.
HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported. ; Sender Comments: US-009507513-2306USA011972:
1.5 hrs after getting flu shot, incision scar approx 9cm from vaccination site noted by pt to be more swollen than usual and bumpy.  MD notes scar tissue at incision site.  Incision is 3 months old and this is her first injection in that arm since.
My neighbor took this/they're getting sick from COVID; My neighbor took this/they're getting sick from COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My neighbor took this/they're getting sick from COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient broke out with what looked like hives all over his body it is now 6 days and there is still a sign of them on his body
Sore arm reported by patient via phone on 6/9/18 at 9am. Sore to the point can't lay on side. TOLD PATIENT SORE ARM IS TYPICAL SIDE EFFECT FOR 3-4 DAYS AND TOLD PATIENT I WOULD CHECK BACK WITH THEM THE NEXT DAY. ON 6/10/18 I LEFT A VOICEMAIL FOR PATIENT AT 11 AM. I HEARD  BACK FROM PATIENT AT 2PM. SHE STATED HER INJECTION SITE REACTION HAD GOTTEN WORSE. IT IS RED AND RAISED AND IS ALSO CAUSING A SPASM-TYPE PAIN WHEN SHE RAISES HER ARM. SHE DESCRIBED IT AS A CHARLIE-HORSE-LIKE PAIN. EARLIER TODAY, SHE CALLED HER PCP AND SPOKE WITH AN ON-CALL NURSE. SHE WAS TOLD BY THE NURSE TO TAKE OVER THE COUNTER IBUPROFEN AND GO TO THE ER IF THE ISSUE WORSENS. I TOLD PATIENT THAT I AGREE WITH THAT AND THAT WE WILL BE REPORTING THIS AD VERSE EVENT TO THE VACCINE ADVERSE EVENT REPORTING SYSTEM. I ALSO TOLD HER WE WOULD CALL HER BACK TOMORROW TO CHECK ON HER AGAIN.
vaccine administered to a sixteen year old; Off label use in unapproved age group; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     Concurrent medical conditions included Hearing reduced since 23-Jun-2021, Obesity since 23-Jun-2021 and Penicillin allergy. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) from 23-Jun-2021 to an unknown date for Contraception.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received a Moderna vaccine that was not age-indicated. Patient did not experience any adverse event at any time. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: added reporter details. added current  conditions. added concomitants. added no adrs after receiving vaccine.
Extremely sore arm, swelling, redness, pain at injection site. 102+ fever for three days, week, achy body, chills, fever, severe headache. Live alone. Was too sick to drive to urgent care or hospital.
Patient called in and stated that approximately two hours after his vaccination he had "blood clots" in his mouth. Patient didn't know what other words to use to describe it. He said he was not coughing it up, but didn't know where it was coming from. I asked if it could possibly be from his gums and he said yes. It was coming from the upper part of his mouth and it was a thick, dark red blood. It was not bright red. He stated that it would congeal together and then become big enough that he would want to spit it out and this had been occuring throughout the day yesterday and into today. He reports no other loss of blood, dizziness or other symptoms. I requested patient reach out to his physician to discuss this matter.