chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient complained of dry mouth with no other signs of swelling or trouble breathing hours after her 15 minute observation time. I advised her to take diphenhydramine and seek medical attention if the condition did not improve. She ended up going to the hospital. Since then division 1 has been checking in with her
Swollen lymph nodes under arms; Swollen breasts from time of shot until start of menstrual cycle; Menstrual period only lasted 3 days which is not typical for me.
pt recv vax approx 10yr ago, & devel redness, swelling, & pain @ the inj site;pt also exp immobilization of shoulder;
striking headache since receiving the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK9231), via an unspecified route of administration on the right upper arm on 07Jan2021 12:45 at SINGLE DOSE for COVID-19 immunization.  Medical history reported as none. Concomitant medication included unspecified allergy medication. It was reported that the patient got the COVID-19 Vaccine this morning (07Jan2021 at 12:45 PM). He said he waited 15 minutes after receiving the COVID-19 Vaccine, until 1:00 pm, and everything seemed to be okay and he had no major problems. On the same day of 07Jan2021, he said he was now having an annoying, striking headache. He described the pain like someone was stabbing him in the head, and then the headache pain goes away.  He said the headache was not constant and only lasts 3-4 seconds. He said the headache has been hitting him every 10-15 minutes. He also mentioned that he takes allergy medication, so it was not unusual for him to have a headache. As treatment, the patient took a loratadine (CLARITIN 24 Hour), and naproxen sodium (ALEVE Liqui-Gel). He said the headache was not getting any worse. He said the headache started slow and was really painful, and then the headache pain lessens up. Outcome of the event was recovering.
About 2Am I could not sleep it did not feel like anxiety or insomnia. I was awake then I started to get very cold then my body was shaking uncontrollably. My teeth were chattering this was not a chill it was 3-4 hours of intense fear. This stopped and my body turned rather red and was very hot to the touch this was about 3 hours. I could not get in the shower to warm up when I was cold I was too weak. Then about 11-1 the next day it all stopped. It was really frightening and kind of like a PTSD moment for me that caused increased anxiety.
horrible cough; sore throat; sore arm; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (horrible cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 24-Dec-2021, the patient experienced COUGH (horrible cough) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, COUGH (horrible cough) and OROPHARYNGEAL PAIN (sore throat) had not resolved and PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-428510 (Patient Link).
No adverse symptoms were reported; administered a dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant (also reported as a nurse) and refers to a 15-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown.   On 13-JUL-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, injection, lot # S022917 and expiration date 19-JAN-2021 (strength, exact dose and route of administration were not reported) for prophylaxis (product storage error). A properly stored sterile diluent was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No adverse symptoms were reported. The temperature excursion was reported as 9 degrees Celsius to 25 degrees Celsius (18.5 degrees Celsius) for 20 minutes. There was no previous temperature excursion. There was a data logger involved in capturing the event.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA008679:
Arm soreness; Low grade fever; Headache; Body fatigue; Weakness; Dizziness; Chills; This is a spontaneous report from a non-contactable physician, the patient. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient did not receive any concomitant medications within two weeks prior to the second dose of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 23Feb2021 at 14:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021 at 05:00, the patient experienced weakness, dizziness, arm soreness, low grade fever, headache, body fatigue and chills. The patient did not receive any treatment for the events. The clinical outcome of the events weakness, dizziness, pain in arm, low grade fever, headache, fatigue and chills were recovering.  Information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 14JUL95 & 13SEP95 pt devel a macular, papular rash;the rash was not vesicular, but more mosquito-bite like;approx 5 lesions occurred on pts' arms & shoulders w/new lesions occurring for 1 wk;
The pt developed redness, heat and swelling on left arm. Mother took the child to MD on 05/20/2002. Diagnosed with cellulitis vx staph infection. Treated with Keflex.
Vomiting; Nausea; This non-serious case was reported by a consumer via sales rep and described the occurrence of vomiting in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, 4 hrs after receiving Bexsero, the patient experienced vomiting (Verbatim: Vomiting) and nausea (Verbatim: Nausea). The outcome of the vomiting and nausea were unknown.   It was unknown if the reporter considered the vomiting and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the vomiting and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 This report involves reporter's sister's friend's daughter, so very little information was available. The patient received her Bexsero injection (dose unknown) and experienced nausea and vomiting a few hours after the injection and then again experienced nausea and vomiting about one week after the vaccination. The reporter did not consent to follow-up.
Gave Expired vaccine to 8 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine to 8 patients) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine to 8 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine to 8 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Right arm is red, no swelling noted, arm is warm, but so is other, painful to touch.  Patient was advised to put ice on arm and alternate with warm compresses.
Received Pediarix, Hib, Prevnar on 12/11/06 acting strangely after vaccine not interacting with parents normally per parents seems less engaged.
Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates improperly stored doses of GARDASIL 9 lot # L037554, expiry date 25-DEC-2017 (dose unknown) were administered to the patients intramuscularly for prophylaxis. The administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 240 hours. No data logger was involved. No product quality complaint (PQC) involved. This is one of two reports received from the same reporter. Information received on 08-AUG-2017 indicated that all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1707USA001383.
Information has been received from a physician concerning a 14 year old female patient who on 15-OCT-2009 was vaccinated with a first dose of GARDASIL (route and lot # unknown). Concomitant therapy included influenza virus vaccine (unspecified). On 15-OCT-2009 the patient began sweating in the main lobby of the office about 15 minutes after receiving GARDASIL. She fainted a short time later and was carried back to the examination room when she was given oxygen. On the same day, she recovered shortly after the oxygen was administered. Follow up information has been received from a physician concerning the female patient with no illness at time of vaccination and no known drug allergies, who on 15-OCT-2009 was vaccinated with a first dose of GARDASIL, intramuscularly into her right upper extremity, (lot # 663454/0672Y) at 4:45 pm. On the same day a first dose of FLUMIST was administered by nasal route (lot #500695P) at 04:44 pm. It was reported that the patient received the vaccine and then left the exam room and was standing at their checkout desk talking with a physician for approximately 3-4 minutes when she lost consciousness falling toward striking her left cheek on the floor. It was reported that the patient was carried back to exam room and placed on O2 via nasal canula and monitored until fully recovered on 15-OCT-2009. This is one of several reports from the same source. No further information is available.
itchy rash; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and RASH PRURITIC (itchy rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included PROBIOTICS NOS, IBUPROFEN, FISH OIL, TADALAFIL (CIALIS), VITAMIN D3, MULTIVITAMINS [VITAMINS NOS] and CYANOCOBALAMIN (VIT B12) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (pain). On 03-Mar-2021, the patient experienced RASH PRURITIC (itchy rash). On 27-Feb-2021, PAIN (pain) had resolved. At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information for the event included Steroid cream that didn't work and Benadryl lotion that seemed to helped.
This spontaneous prospective pregnancy report as received from a registered nurse (patient's aunt) refers to a 28 year old female patient. On an unknown date, the patient became pregnant. The LMP and EDD were not known. On 06-NOV-2013, at "6 months of gestation" the patient was inadvertently vaccinated with GARDASIL (dose, route and lot number were not provided) instead of the intended unspecified pertussis vaccine. No concomitant medications were reported. No adverse effects reported. The patient called the nurse. The pregnancy outcome was pending. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-MAR-2009, the patient was vaccinated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 29-NOV-2016, the patient was treated by a physician for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. She has also been diagnosed with post-herpetic neuralgia, a chronic condition of residual pain and damage secondary to shingles infections. The patient has been prescribed valacylovir, hydrocodone nortriptyline HCl, gabapentin, and lidocaine for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt. came into the clinic for her 2nd covid vaccine. She accompanied by her husband. The both received the vaccine from me. Patient was injected at 09:50 AM. She came to me at 10:05 am and told me her face (the left side) "feels numb" says, "it feels like licodaine was released into her face. Dr. and CNP came in and examined her face. Returned her to medical clinic Her vitals were taken afterwards. Vitals were given to us by CNP. Pt. walked out of the clinic with her husbman Vitals B/P- 131/87 oxy: 49 and pulse 95. A report was called to hospital by CNP.
It started as soon as I got the vaccine. I had a feeling of heat travelling down my arm followed by a pins and needles sensation. I stayed for 30 minutes and I could feel a strange feeling of pins and needles seemed to be travelling up my neck and into my face. When I saw that my arm was swollen. My arm started to itch and I was taken into the observation area and checked out. I went home and four hours later I felt like I couldn't take a deep breath and I started to get a headache, chills and fatigue. The next day my arm  and face were still little numb and I was still having a little trouble breathing. On day four I still felt like I couldn't take a deep breath and my heart rate was erratic. On the fifth day I went to an Urgent Care clinic. My blood pressure and heartrate were a little high. I went to the doctor the next day because they had found some hardening of my heart. After five weeks I still have a little feeling of pins and needles in my left arm and in the left side of my face.
Sneezing and cold like symptoms (runny nose, watery eyes); cold; runny nose; watery eyes; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported for her self. A 68-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on 13Feb2021 14:00 as dose 1, single (age at vaccination: 68 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination and did not tested COVID post vaccination. On 13Feb2021 18:30, the patient experienced sneezing and cold like symptoms runny nose, watery eyes. No treatment was received. The clinical outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Fever 100.4F. Hives. Started 30-60 min after administration of vaccine.
I had serve headache and fever of 101.5 that lasted about 4 days.  I had body aches, running nose, and congestive for about two week.  I also had a cough that is still ongoing today.  On Jan 12th, I tested positive for Covid-19.
Tinnitus; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number NY749, expiry date 4th December 2021) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On 24th December 2019, 82 days after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient that received the first dose of Shingrix and started to experience Tinnitus two to three weeks ago. The reporter consented to follow up. The batch number for Shingrix was reported as NY747, but it was changed to NY749 as per sales data sheet.
PATIENT REPORTED TO ME ON 2/9/23 THAT A COUPLE DAYS AFTER VACCINATIONS SHE BROKE OUT IN SEVERE HIVES ALL OVER HER BODY. SHE SHOWED ME SOME SPOTS THAT APPEARED TO HAVE SOME SCABBING FROM SEVERE ITCHING. SHE WENT AND SAW A DOCTOR THAT GAVE HER CLOBETASOL CREAM, TRIAMCINOLONE CREAM, KETOCONAZOLE SHAMPOO, NONE OF WHICH RELIEVED THE ITCHING. SHE WAS HERE TODAY TO PICK UP DEXAMETHASONE TABLETS PRESCRIBED BY A DERMATOLOGIST THAT ALSO TOOK A SKIN SAMPLE TO TRY AND FIGURE OUT THE CAUSE OR POSSIBLE SOLUTION FOR PATIENT
Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a pregnant female patient who on an unspecified date in 2009 ("in the last couple weeks") was accidentally vaccinated with a 0.5ml dose of GARDASIL instead of flu vaccines. It was reported that the nurse had reached into her diebold dispenser to retrieve the flu vaccine syringes, but took out GARDASIL filled syringe instead. No adverse effect was reported. Unspecified medical attention was sought. The nurse pointed out that the patient was in her third trimester. This is one of several reports from the same source. No further information is available.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.  The reporter initially reported a potential connection between the vaccine and shingles. Since then the reporter realized that there was no connection between the vaccine and shingles.   Reporter did not allow further contact
Ears and eyes itched, swelled, turned red. That subsided within an hour. Injection site on arm also swelled and turned red, very painful. Was completely swollen, hard, and red through entire upper arm the following morning. Kid looked like a very sad Popeye. Unable to move arm without extreme pain. Benadryl and pain relievers helping at the moment.
Tongue started swelling about 7 hours after injection; swelling worsened after biting it; unable to eat, take medication and have trouble breathing when lying down. Presented to hospital 07/17 with lymphadenopathy and enlarged tongue; VSS. Treatments included epinephrine IM, solu-medrol IV; Benadryl IV; and famotidine IV
Sore arm within two hours.  Some fatigue and slight headache  and slight nausea within the first 24 hours.  All very minimal.  Fever, chills, bad headache, sweats, general discomfort beginning around 24 hours after shot.  Fever subsided 36 hours after shot.  Headache persisted for over 48 hours.  Some nausea between 48 hours and 72 hours after shot. Fatigue and haziness throughout.
pt was vaxed 7JAN92 pt c/o pain intoes 11JAN93; denied any vomiting, fever, diarrhea, & rash; mom called clinic 14JAN93 & reported the event; pt seen by MD 12JAN93; MD could not assoc pain w/vax;
Pruritic macular rash over arms, legs, back and trunk. Treated with Benadryl and cimetidine, then prednisone.
I originally tested positive using a home test on 14Feb2023; I originally tested positive using a home test on 14Feb2023; Vaccine dose number=1/2: vaccine brand=Pfizer/BioNTech; Vaccine dose number=3/4/5: vaccine brand=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 01May2021 as dose 2, single (Lot number: EW0171) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3, single (Lot number: 013F21A), in left arm, on 11May2022 as dose 4, single (Lot number: 056A22A), in left arm and on 21Nov2022 as dose 5, single (Lot number: 017H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinusitis" (ongoing); "high cholesterol" (unspecified if ongoing); "stroke" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "known allergies: NSAIDs" (unspecified if ongoing), notes: known allergies: NSAIDs; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Septra, reaction(s): "known allergies: Septra", notes: known allergies: Septra; Relafen, reaction(s): "known allergies: Relafen", notes: known allergies: Relafen. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2021, outcome "unknown", described as "Vaccine dose number=1/2: vaccine brand=Pfizer/BioNTech; Vaccine dose number=3/4/5: vaccine brand=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Feb2023, outcome "unknown" and all described as "I originally tested positive using a home test on 14Feb2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) positive, notes: using a home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.