chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt states that the next day after the vax she woke up w/ body aches and had them all weekend. The body aches subsided after 5 days but the neck pain that starts at the base of her skull and extends across her shoulders and down her spinal column still exist.  She has taken Aleve for pain.  Pt has called a left a message for her PCP to give her a CB regarding her symptoms.
This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient had some issues with back spasms in lower back, and he felt pain, it was a short pain in lower back where the kidneys are on an unspecified date. Patient used a heating pad, vibrating heating pad that helped by bringing heating pad up so that he could get the muscles back, kept from spasm but after that he was fine. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid from 04Jan2023 to 09Jan2023 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Post vax, the pt was seen in the ER for angioedema of the face.
This spontaneous report as received from a medical assistant refers to a 60 year old male patient. No information about medical history, drug reactions and allergies was specified. On 11-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of several reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005585, 1410USA005586 and 1410USA005587. Additional information has been requested.
Patient received first dose on 24Apr2021 and second dose on 22Jul2021.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 24Apr2021 and second dose on 22Jul2021.) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included Tinnitus, Cancer (cancer twice) and Shoulder arthritis. Concurrent medical conditions included Type 2 diabetes mellitus and Asthma (taking medication/ inhalers for the asthma.).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 24Apr2021 and second dose on 22Jul2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 24Apr2021 and second dose on 22Jul2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that patient took medication and inhaler for asthma.  No treatment medication were provided.   This case was linked to MOD-2022-651284, MOD-2022-651253 (Patient Link).
Vaccines administered approx. at 10AM. Mother noticed rash and irritability at 2:30pm (red rash to forehead) called office advised to return to clinic. (mother had given TYLENOL at 9:45am and again at 1:45pm). Child arrived at 4:46 at office. Irritable with multiform rash to face, head. T99 no stridor - no facial or arm swelling - today color good, good strong cry. TYLENOL 160/5ml 1.25ml given at around 5pm. Child observed (Approx 45 min) examined by Nurse Practitioner. Instructions given to mother what to do, observe for if needed to go to ER and return to office in the AM. 5/18/18 at 8:30 child seen, doing well, slight redness to forehead. Normal vital signs, temp 99.3. According to mother child did well after leaving office. Slept and ate well, did administer TYLENOL at 8:45pm just in case.
there was an excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  There was an excursion of vial from their freezer on 01-Oct-2021. The vial was frozen at the time of excursion. The vial size was 7.5 ml. The maximum temperature reached was 5.7 degree Fahrenheit and the minimum temperature reached was 4.2 degree Fahrenheit. The duration of excursion was 6 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up contains updated patient initials, gender, date of birth and age
1/19/22 Developed calf pain. Diagnosed with DVT in left distal superficial femoral and popliteal vein on 1/20/22
The pt experienced probable cellulitis, was warm, red, tender around injection site on arm. Treated with Cephalexin.
Notes in record state Shingrix given 5/4/21 left arm SQ.  This is an employee so I was able to talk with her face to face on 6/14/21.  Patient showed me the injection site which was on the lateral aspect of the left upper arm between the bicep and the tricep, well below the deltoid: typically where subcutaneous injections are given.  Patient complained of pain, redness and swelling that lasted a couple of weeks.  She drew a circle on her arm with her finger illustrating the area of redness, which was approximately 5 inches in diameter.  She is concerned about what she calls a ?shadow? circle about 1.5 inches in diameter that is still lingering and wonders if it will ever go away.  I noticed a faint circular discoloration when she pointed it out and suggested she discuss with her provider. She also reported feeling sick all over from the shot.  I told patient that it looks like the shot might have been given subcutaneous.  I asked if this was her first shot for shingles, and she said it was the first, and she is really reluctant to get the second after this reaction.  She asked if it might be less severe this time, and I told her I could not say for sure, but it would be a good idea to discuss this with her doctor and get all her questions answered so she could make an informed decision about the 2nd shot.  She agreed that would be a good idea.
rash on the left side of arm where I received the injection for 9 days with itching throughout body.  However there was no rash elsewhere only in the upper arm.   tingling and numbing throughout different parts face that come and go, not always in the same spot.  It ranges from lips, chin, cheekbones, eyelids, forehead, ears,  arms, and thighs.  these symptoms continue  Migraine 3 days after vaccine that lasted overnight  Felt like glands were swollen on my neck pain off and on.  Swollen with pain mainly on the left side. Seemed to subside during 3 week after vaccine.   Existing lump in left armpit got bigger with pain.  Seemed to get smaller and no longer painful.
Later on the day of the vaccine she had a burning itch which intensified. She believes the vaccine triggered the dizziness of her vertigo. A little shakiness in the hands.
About 2 hrs after second dose shortness of breath and throat starting to swell for around 15 min then went away on its own. Next morning 1/28 very sore leg muscles, hot flashes, headache. As day went on my limbs were tingling and had some numbness.  Increasingly getting fatigue and wasn't able to keep my head up for more than 30sec with out it falling. By 5p I could not move left arm at all and called PCP office and went to ER. Over 5 hours I got  feeling back in left arm and left ER at 10:30p. CT was done to rule out stroke or other injury. Next day around 2p my right arm started to get more numb and I wasn't able to move it much. SOB and throat tightening came back briefly. Later that day lumbar puncture done to rule out guillain barre syndrome. Numbness is not as severe now 2/3 and each day since 1/28 it gets increasingly less
Headache, Diarrhea, NauseaVomiting, Chills, Swollen arm, Narrative:
pain, swelling, itching in injection site Narrative: With PMD appt. 1/4/21 at 5PM. was advised to take meds.
canker sore left underside of tongue. symptoms were extreme oral  and left ear pain, fatigue, weakness, difficulty swallowing and speaking. Symptoms started to improved after 7 days.
Three breakthrough cases of COVID; Three breakthrough cases of COVID; Heart is in bad shape; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 40-year-old female patient 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 "Three breakthrough cases of COVID"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart is in bad shape". Clinical course: The caller is reporting that he and several members of his family had breakthrough cases of COVID after being vaccinated. The caller reports specifically that his daughter's "heart is in bad shape" and has had three breakthrough cases of COVID. The caller said her doctor recommends a total blood cleanse with blood from a person who hasn't had the COVID vaccine. The caller said they got the Pfizer vaccine. The caller is asking if there is an antidote in the works for the Pfizer COVID-19 vaccine? The caller asked to "tell your people that there are a lot of people are hurting" that the "misinformation came from Pfizer and CDC", Pfizer has "got to find an antidote'', and that Pfizer has a "got a storm come their way you got to find something for us the vaccine is a disaster for them". Caller wanted to know if there is an antidote for the vaccine because he stated that it is really hurting him and his daughter and that they are in a really bad shape.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300092240 same reporter/patient, different drug/event;US-PFIZER INC-202300092558 same reporter/drug, different patient/event;
Started at 3:00 AM on Sunday,  2/7/2021. With chills, low grade fever, 99.1 - 100.5, muscle aches, fatigue. Lasting approximately 18 hours.
This spontaneous report was received from a nurse and a healthcare worker and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was seated for two minutes after the injection and fainted for several seconds. EMTs were called at the request of the mother. She had low blood pressure when they arrived but quickly recovered after laying with her feet elevated. The patient remained seated at the pharmacy for an additional 45 minutes before leaving under her own power.
PATIENT WAS GIVEN A COVID MODERNA VACCINE SHOULD HAVE RECEIVED PFIZER
Diagnosis: shingles. Treatment : acyclovir 800 mg  every 8 hours for 10 days  Symptoms: multiple lesions on trunk
24 hrs after getting Flu vaccine in (L) arm he developed redness, swelling, pain, tenderness and some local warmth. Symptoms subsided after BENADRYL in 24 hrs.
About 2 minutes after administration of the vaccine the pt noted to have upward rolling of eyeballs with the generalized tonic, clonic seizures lasting for less than 15 seconds with post-ictal drowsiness without urinary or fecal incontinence.
@ 4mos pt recvd vax & t103.8, uncontrollable crying;
That evening I was shaking, chills, and achy. The next day I was still achy and felt tingling in my body.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Patient was being held for monitoring after receiving the COVID-19 vaccine.  Within 1-2 minutes, patient developed facial redness and itching.  She then started to feel as if her throat was itchy and started coughing uncontrollably.  Denied lip or tongue swelling.  Was feeling normal prior to receiving the vaccine.  Was not recently seen/assessed for other medical care.  No similar symptoms previously.  Patient was taken to the Emergency Department.   Ptaient did have a few red splotches on her chest, but these did not appear consistent with urticaria per the ED physician's report.  ED physician felt patient's symptoms may be secondary to anxiety.  However, given history of anaphylaxis and feeling of throat itching it was felt necessary to treat for possible allergic reaction.  Patient was given epinephrine, Benadryl, famotidine, and Solu-Medrol.  She was then monitored in the ED for 4 hours.  During this time, she developed no new symptoms.  She continued to breathe easily with normal and stable vital signs.  She was discharged with instructions  to buy OTC Benadryl 25mg PO to take every 8 hours for 48 hours.  Prednisone 20mg, 3 tablets orally daily for 5 days weas prescribed.  An EpiPen was also prescribed.  Patient advised not to receive second dose of the vaccine and to follow up with her primary care provider.
14AUG92 according to pts mom @ approx 850AM pt began shaking; mom picked up the ashking subsided w/in 5 mins pt becam rigid, eyes rolled back & resp were labored; this episode lasted approx 2-3 mins;
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: itching all over body, lips and tongue were tingling
On 5/10, I developed body aches, chills, nausea, headache, and injection site soreness. I was over those symptoms by 5/11.  On 5/11 I developed armpit soreness and swelling, which I still have today on 5/12.
Flu shot given just below acromian process too high on the left shoulder, immediately felt a shooting pain down to my left arm and into my hand followed by tingling and numbness into my fingers. My shoulder is becoming increasingly more painful and more difficult to move. My deltoid is screaming in pain everytime I try to use it and I'm losing sleep.
Stomach Pain; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD lot # L050910 with expiry date on 14-JUN-2017, lot # M002053 with expiry date on 11-JUL-2017 and lot # M004893 with expiry date on 26-JUL-2017. No adverse event was reported and no product quality complaint was involved. Temperature: 18.5 Fahrenheit degrees. Time Frame: 5 hours. Previous excursions: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
I had a cough hard enough to cause loss of voice and incontinence. Asthma flair ups and migraine flair ups. Buildup of intra cranial pressure and sinus pressure with sinus drainage and swelling. Broke blood vessels in eye and gained new stretch marks on abdomen from coughing. Illness lasted about 2 months as it got better and came back. Fever, headaches, lived on nebulizer. Multiple trips to ER 8-2, 8-13, and 9-2, and one night overnight in hospital due to one pupil being bigger than the other due to coughing on 8/2/22. Prescribed PAXLOVID; Vocal range is diminished on low end.
R upper arm swelling on=2/3rd's area, lateral aspect with redness, warmth=5-6 cm in length, onset=24 hrs after administration. Tx with BENADRYL/Ibuprofen.
pt. recvd 1st dose of hepatitis B vac & exp. loss of peripheral vision,& numbness on the rt side of face & rt arm.
Administered MMRV by accident, should have had Zoster administered instead. Pt is out of age range not indicated for this vaccine. Pt was administered ZOSTAVAX directly after error was caught. No reaction indicated. Pt tolerated well.
Moderna was administered instead of Pfizer by mistake. Patient was given a second dose of Moderna because it was decided best to not mix vaccines. Mother aware, MD aware.
Information has been received from a physician concerning a female patient between the age of 8-12 years old who on unspecified dates was vaccinated with two doses of VARIVAX (Merck) (lot#s not reported).  On an unspecified date in 2004 the patient came down with full blown chickenpox.  Unspecified medical attention was sought.  At the time of this report, the patient had recovered.  This is one of several reports from the same source.  Additional information has been requested.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
Information has been received from a nurse concerning a female patient who was vaccinated "a few months ago" with a dose of Gardasil. The patient experienced pain in the arm from the injection site to the fingers after receiving the dose of Gardasil. Unspecified medical attention was sought. Patient's outcome was unknown. Additional information has been requested.