chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; J&J,moderna and Pfizer / BioNTech; J&J,moderna and Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant), outcome "unknown" and all described as "J&J,moderna and Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: after day 8 of negative result, positive result; (15Aug2022) Negative, notes: after day 8 of negative result; (19Aug2022) Positive, notes: Rapid antigen tests showed positives on Day 12 and Day 16; (23Aug2022) Positive, notes: Rapid antigen tests showed positives on Day 12 and Day 16. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 08Aug2022 to 14Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case meets criteria for vaccine breakthrough review. SxS include generalized weakness, fatigue, SOB, dizziness.
soreness; fatigue; slight heaviness; This is a spontaneous report from a contactable other health professional. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, on 13Jan2021 17:15 at SINGLE DOSE for COVID-19 immunization.  Medical history included Acid reflux. Patient received the first doe of BNT162B2 on 23Dec2021 for COVID-19 immunization There were no concomitant medications. On an unspecified date, the patient experienced soreness, fatigue and slight heaviness but still feel off today (16Jan2021). The outcome of events was recovering. Patient did not receive any treatment due to events.  Information about lot/batch number has been requested.
Dizziness, SORE ARM AT INJECTION SITE AND DIZZY ON FIRST DAY. BODY ACHE, FATIGUE, HEADACHE SORE ARM 2ND -4TH DAY AFTER INJECTION Narrative:
This case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 246764). A 31-year-old female patient received an intramuscular injection of Fluzone sv 2005-2006 (lot number V1910AC) on 03 November 2005. Approximately three hours post-vaccination, she complained of her throat feeling completely shut. She could not swallow, and had slight wheezing. She drank some juice and some warm tea, but the symptoms persisted and she began to feel tired, so she went to bed. She also complained of feeling hot, with chills and teeth chattering. When she awoke several hours later, she noted that her eyes were puffy, swollen, and red, with phlegm in the corners. The patient subsequently recovered.
24 hours s/p receiving  a vaccination in the R deltoid, the patient noted R distal ulnar redness, swelling and discomfort. The next morning the swelling got worse and she also noted similar swelling around her Left Hallux Longus (similar to a pseudogout reaction). No intraoral swelling. Speaking clearly in full sentences.  She has never had similar reactions such as this nor has a h/o pseudogout or polyarthritis.
I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
On the morning of 2/11/2023, I developed fatigue, cough, fever, and diarrhea. I got a PCR test on the afternoon of 2/11/2023 and 2/12/2023, and they both yielded positive results. I began taking PAXLOVID on 2/11/2023. I was doing better the next day and was afebrile on the third day. I took a home antigen test on 2/8/2023, 2/10/2023, 2/11/2023, 2/12/2023, and 2/14/2023, and the results on all of them were negative. During the first week, I had fatigue and had to take naps. During the second week, I felt better. At the time of this writing, I'm okay, though I have a residual cough with a little bit of catarrh. I don't know if it's the result of the COVID-19 or my chronic sinusitis, but I suspect the prior.
This spontaneous report was received from an unspecified health care worker via company representative referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II(strength, dose, lot # and expiration date were not provided) subcutaneously into the abdomen for prophylaxis. On an unknown date, the patient experienced a "severe reaction". At the reporting time the outcome of a "severe reaction" was unknown. The relationship between the event and M-M-R II was not reported. No product quality complaint was involved. Additional information has been requested.
No adverse effects were reported; The physician reports that on 5/31/2019, one dose of improperly stored PROQUAD) was administered; This spontaneous report was received from a physician concerning unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 31-MAY-2019, the patient was vaccinated with one dose of improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) for prophylaxis (lot number R021098 with expiration date on 23-JUL-2020, route of administration, strength and frequency were not reported). Other suspect therapy included sterile diluent for prophylaxis (lot number N032755 with expiration date on 04-AUG-2020, route of administration, strength and frequency were not reported).  Administered doses of vaccine experienced temperature excursion between 15 degrees Fahrenheit up to 46 degrees Fahrenheit (36 Fahrenheit) for 8 hours and temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14 Fahrenheit) for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000968: US-009507513-1906USA001160:
The night of getting the vaccine I was the sickest; fatigue, malaise, body aches, hot and cold sweats, weakness, loss of appetite, dizziness.  The day after I had to call into work due to these symptoms. Since then I?ve continued to feel fatigue, throat swelling / scratchiness, dry cough,  malaise. Also arm soreness.
Became COVID-positive, pneumonia, ARDS, hospitalized for hypoxia 2/21/2021, death 2/25/2021
One week after I had my second covid vaccination, I woke up and was unable to lift my left hand or move any of my fingers on my left hand.  I saw my PCP and she ordered labs which resulted in an elevated ANA and a referral to an RA.  While we were waiting on those results, on May 9th, I woke up in the middle of the night and fainted 3 times and was experiencing excruciating upper abdominal pain on in my ribcage area.  I could not lie down and could barely move, so I went to the ER where they performed a CT scan, followed by an ultrasound and transvaginal ultrasound which showed internal fluid and bleeding but they were unable to determine the source.  I was admitted to the hospital in order to have exploratory surgery in the morning, however, upon awaking the surgeon decided that I had an ruptured ovarian cyst and was kept in the hospital for the next 5 days.  I have been experiencing ongoing pain in my upper right quadrant under my ribcage ever since, that is worse when I sit, lie down or lift.  I have had another CT scan, 3 x-rays, an upper Right quadrant ultrasound, seen an RA, other various doctors and had multiple sets of labs drawn, but everything has been negative/normal, except for the ANA continues to be elevated, and no one knows the cause of the pain.  The RA did think that my hand stopping working was a result of the vaccination and there have been other suggestions that the pain could also be a result of the vaccination.  Thankfully, my hand did return to normal after 7 weeks with a brace.  I am currently managing the pain with OTC meds, acupuncture, and am seeing a pain clinic doctor.
While loading the Data logger I had it away from the Refrigerator too long and the X appeared. None of the vaccines were compromised they never left the refrigerator and the temp did not change.
Client stated she did not feel well & sat down, her head began to fall back and she began to get rigid and tremble.  Lasted only seconds. Client was evaluated by nurse & ARNP & discharged after observation.
Red, swollen arm, little neck pain, diarrhea, headache. Patient used BENADRYL for itchy red swollen arm.
Received shot on Saturday 09/11/21. Sunday 09/12/2021 my under arm of my left arm, which is the arm I recieved the vaccine in, started itching and developing a rash. It continued to get worse. I have a mole on my arm pit and on Wednesday 09/15/2021 I noticed what looked to be pus leaking out from my mole. I also had a lump underneath said mole and when pushed the mole would leak more pus. I went to a urgent care clinic on 09/16/2021 and they did not confirm if it was from the vaccine or not but issue started after vaccine
patient's arm got "really red" and "swelled up two minutes after receiving her second dose of GARDASIL 9"; patient's arm got "really red" and "swelled up two minutes after receiving her second dose of GARDASIL 9"; This spontaneous report as received from a medical assistant via field representative refers to a female patient of unknown age. The concomitant therapies included birth control pill. No information regarding the patient's medical history and concurrent conditions was provided.  On an unknown date, the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot# and expiration date were not reported) for human papillomavirus (HPV) prevention. The patient had no symptoms after the first dose. On 03-FEB-2020, the patient was vaccinated with second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prophylaxis. On the same day, two minutes after vaccination the patient's arm got really red and swelled up. No treatment was given for the adverse events. No lab diagnostics/studies performed. The patient did not seek for medical attention. No product quality complaint (PQC) was involved. The adverse events were not a cancer events and no overdose occurred.  The outcome of the events was unknown. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Within two minutes of receiving the vaccine I experienced tachycardia and dizziness that were severe for approximately five minutes and improved over the subsequent ten minutes. Beginning approximately twenty minutes after receiving the vaccine I experienced another bout of dizziness accompanied by chest tightness. This resolved within approximately ten minutes.
Pt received Tdap per Dr request on 8-8-12 Pt in on 8/13/12 stating (R) upper arm swelling with redness at injection site and towards inside of arm.
At 30 minutes after vaccination patient informs she felt palpitations, blurry vision and headache. The day after she noticed a lump on her left supraclavicular area, no other swelling noted.
Needlestick injury to the healthcare provider, due to incorrect movement of the syringe and needle towards the sharps container.
About 1.5 weeks after my 2nd Moderna injection, I started persistently smelling cigarette smoke
Chest pain, heart palpitations, lightheaded lasted a few hours. Then soreness in the chest, ribs still having palpitations 24  hours later. Now adding body aches and pains and skin tenderness.
he had Ramsay- Hunt syndrome; internal shingles; internal shingles (with PHN); he had GI pain and pain from his spine to his right ring finger; right arm pain from spine to to ring finger; pain from his spine; This serious case was reported by a consumer via call center representative and described the occurrence of ramsay-hunt syndrome in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On 17-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular). In AUG-2023, 48 hrs after receiving Shingrix, the patient experienced ramsay-hunt syndrome (Verbatim: he had Ramsay- Hunt syndrome) (serious criteria GSK medically significant), shingles (Verbatim: internal shingles), post herpetic neuralgia (Verbatim: internal shingles (with PHN)), gastrointestinal pain (Verbatim: he had GI pain and pain from his spine to his right ring finger), pain in arm (Verbatim: right arm pain from spine to to ring finger) and pain in spine (Verbatim: pain from his spine).  The patient was treated with valaciclovir (Valacyclovir). The outcome of the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine were resolved.   It was unknown if the reporter considered the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine to be related to Shingrix.     It was unknown if the company considered the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine to be related to Shingrix.   Additional Information: GSK Receipt date: 18-SEP-2023 The patient self-reported this case. The patient stated he received Shingrix (dose 1) and within 48 hours he had GI pain and pain from his spine to his right ring finger.  He went to see HCP (healthcare professional) and was diagnosed with internal shingles (with PHN) which he had a history of.  The HCP was given Valacyclovir 2 Gm for 10 days, he then stated he had Ramsay- Hunt syndrome. He stated his symptoms had resolved now.  The reporter consented to follow up.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: ILLNESS (non-serious), outcome "unknown", described as "sick". The reporter wanted to reschedule appointment on 19Mar2021 for second dose as patient is sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within twenty minutes I could feel a fuzziness in my head, by six thirty that night I was very sick.  The symtoms were chills, brain fog, dizziness and my head felt stressed pressured and bloated.  Within a few days I had tinnitus like my body had experinced a shock like when I had fallen off of my bicycle. For the first week afterward I was making mistakes at work as my mind was not clear.  I am a lawyer and this was an issue,  I could not follow a conversation or read a newspaper.  At home I could not get hot enough and kept my home temperature at eighty five degrees. I slept under two covers and a comforter.  The second week I improved a little bit and the third week a little more I was still hot and could not think straight this lasted at least six months.  I know get all kinds of colds and flu like my immune system is all screwed up.  In the Summer of 2021 my whole face was swollen or swelled up.
chest pain, sharp pain on left side; sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (COMIRNATY), administration date 05Oct2021 (Lot number: FC8839) at the age of 19 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 06Oct2021, outcome "unknown", described as "chest pain, sharp pain on left side"; ILLNESS (non-serious) with onset 06Oct2021, outcome "unknown", described as "sick".  Additional information: It was reported that Her son and she has not been vaccinated since the covid pandemic. She has been working and she has been tested constantly and she has not caught the virus. Further clarified that her son was vaccinated yesterday, and her son is sick now, something is going on. He got the vaccine yesterday. He has always been a healthy kid. A day after he received the vaccine, he left work and he is on the floor right now in pain and he is having chest pain, sharp pain and he is pointing towards his left side. The patient was advised to contact hcp or seek medical care.   No follow-up attempts are possible. No further information is expected.
Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of VARIVAX (Merck) which were improperly stored under 8 F for 2 hours were administered to multiple unspecified patients (incorrect product storage). The lot # of the VARIVAX (Merck) included: L032396 with expiration date 26-AUG-2017 and L039093 with expiration date 06-OCT-2017. There was no previous temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 11Sep2021 as dose 2, single (Lot number: FD8448) at the age of 12 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (19Dec2022) positive, notes: tested positive on 19Dec after taking Paxlovid for a previous case on 30Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She had COVID 19 symptoms again & tested positive on 19Dec after taking Paxlovid for a previous case on 30Nov.Known allergies: No, Other medical history: No, Other medication in 2weeks: No.
Flu vaccine was given and a nerve was hit. Pt said arm went numb and sharp pain down arm. Pt sat for 10 mins and arm ok. Pt followed up 3 days later and says he loses feeling in arm every once in a while. Will follow up with pt in a few days.
Returned 9 days after vaccine due to 1.0x1.5 cm area of redness and swelling in (R) thigh where immuns. were given. This is non-tender
Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of Varivax (lot# 654530/1046F). Concomitant therapy included a dose of  influenza virus vaccine (unspecified). Subsequently, the patient experienced a red, swollen arm and a fever. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 029K20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and CALENDULA OFFICINALIS, GINKGO BILOBA, SOLANUM LYCOPERSICUM, VACCINIUM MYRTILLUS (EYE HEALTH) for Supplementation therapy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Cholesterol medication( unspecified). No treatment medication reported.   This case was linked to MOD-2021-403387, MOD-2021-403391 (Patient Link).
Patient reported warm, red, swollen area of right arm that began 5 days after her first SHINGRIX vaccine and had gotten worse overnight. She did not report any pain, but stated the area was very pruritic. Patient reported that this is her first adverse event to any vaccine. I recommended that the patient mark the current area to watch for worsening symptoms and OTC hydrocortisone cream or BENADRYL for the itching. If it continues to worsen, I counseled the patient to see her provider.
Excessive crying x 1 night after immunization; fever of 101-102 x 1 night.
This spontaneous report was received from a licensed practical nurse and refers to a 22 year old male patient. The patient's medical history, concomitant therapies and concurrent conditions were not reported. On 20-JUN-2017, the patient was vaccinated with an expired dose of VAQTA lot # M003025, expiration date: 26-MAY-2017 (dose and route of administration were not provided). There were no adverse effects reported. Additional information has been requested.