chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore mouth; Rash; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Sore mouth), RASH, and FATIGUE 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 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Sore mouth), RASH, and FATIGUE. At the time of the report, ORAL PAIN (Sore mouth), RASH, and FATIGUE had resolved.            No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.    This case was linked to MOD-2021-030620, MOD-2021-030620.   Reporter did not allow further contact.
The patient said they felt disoriented. They continued to wait and still felt disoriented so an EMT was called and they checked vitals.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of  "adverse reaction"  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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.     On an unknown date, the patient experienced Adverse reaction (adverse reaction).   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. No treatment information was provided.
voice issues; This is a spontaneous report received from a contactable pharmacist. A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as booster dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: DYSPHONIA (non-serious) with onset 2022, outcome "not recovered", described as "voice issues".  Additional information: Patient received a booster of the covid 19 vaccine and experienced adverse events, he did not describe them, only to share that he had voice issues that still remain.   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.
On Feb. 7,21 in the evening I started to get  a rash all over my legs , arms & chest. It started out in lines.   Very itchy , red and raised . continued for a week until it wasn't getting any better , so I got a perscription for Medrol dose pack & topical cortisone cream. After week of these meds. it went mostly away. I still have time that i itch on arms, legs . Also I would get an itchy  foliculitis  , like when you get goose bumps & your hairs stand up. I still on occasions get bouts of itchiness now (3/10/21).
Older vaccination site (childhood vaccination area) is inflamed; Older vaccination site (childhood vaccination area) is soreness; Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness; Fatigue; Slight headache; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Older vaccination site (childhood vaccination area) is inflamed), VACCINATION SITE PAIN (Older vaccination site (childhood vaccination area) is soreness), VACCINATION SITE ERYTHEMA (Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness), FATIGUE (Fatigue) and HEADACHE (Slight headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). On 04-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Older vaccination site (childhood vaccination area) is inflamed), VACCINATION SITE PAIN (Older vaccination site (childhood vaccination area) is soreness), VACCINATION SITE ERYTHEMA (Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness), FATIGUE (Fatigue) and HEADACHE (Slight headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INFLAMMATION (Older vaccination site (childhood vaccination area) is inflamed), VACCINATION SITE PAIN (Older vaccination site (childhood vaccination area) is soreness), VACCINATION SITE ERYTHEMA (Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness), FATIGUE (Fatigue) and HEADACHE (Slight headache) outcome was unknown and FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was vaccinated 1 inch above the site where she was vaccinated as a child. No concomitant medications were reported.
Headache, nausea, dizziness, super tiredness, EXTREMELY painful left arm
feeling nauseated; warm; This is an initial spontaneous report from a contactable consumer(patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) first dose via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. The patient medical history stated she had COVID-19 back in October. The patient concomitant medications were not reported. Patient wanted to know if the reaction happens right away when they ask us to wait for 15 mins. Patient wanted to know if vaccine have the virus in it. Patient wanted to know what if she does not take the second dose. On Apr 2021 patient stated that she received the Pfizer COVID vaccine on 07Apr and feeling nauseated, warm, patient has celiac sprue and wanted to know about the ingredient/ gluten in it. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Presented to the ED with c/o headache, chest pain, shortness of breath, cough, fever, chills and diarrhea. Patient was diagnosed with COVID 19 days ago. patient was admitted to the hospital. patient was given remdisvir and convalescent plasma.   Patient was discharged home on 08/21/2021
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (during first trimester Incarcerated Uterus - It was fixed) and Alcohol use (Once a week) in 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 26-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.            No treatment information was reported.  On Unknown dates, Ultrasound and chromosomal Abnormalities test were performed on patient with normal results  The patient's date of positive pregnancy test was 06-DEC-2020.  The patient previously had live birth with no complications on 27-MAR-2018 The patient previously had a miscarriage on JUL-2020
Patient called me Saturday morning when the pharmacy opened. She stated she could not raise her right arm without significant pain. She came in to the store to show me. Her bicep area was very swollen, warm to the touch and she was holding her shoulder close to her body due to pain. I instructed TYLENOL/ice and rest until Mon which  she experienced breathing difficulties to go to ER.
pt recvd vax 18JUN93 & starting running a fever p/whining most of day; temp 103 R; APAP given; ws not coming down so was given sponge bath; started turning blue, apneic & jerking; taken to ER;
fever, vomiting, eyes rolling to back of head, twitching for 1 hour, patient went to ER and then was seen folling day.
Pt found down on 5/7 for unknown period of time. Prodromal dizziness reported, but no additional history or witnesses until pt found down. At ER presentation, noted CHI with subdural hematoma and intracranial hemorrhage. Also noted left cortical vein thrombosis. Follow-up imaging after 24 hours demonstrated persistence of above findings. Pt had concomitant humerus fracture and medical instability after being found down. Now stable but below baseline in rehab facility.
At 1130 on 2 Mar 04 pt presented with reaction on left arm at injection site. Plus redness, plus swelling, plus mild soreness. Redness measured 13 cm x 11 cm. At 1400 swelling & redness had increased to 15 cm x 13 cm. Pt to see provider with recommendation.
Pt experienced swollen, left thigh with redness, rash, and cellulitis.
This spontaneous retrospective pregnancy report was received from  a currently 28 year old female patient who was also a pharmacy technician regarding herself on an online article. Concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in December 2006, the patient was vaccinated with dose 1 of GARDASIL. On an unknown date in January 2007,the patient experienced Postural Orthostatic Tachycardia Syndrome (POTS)(MARRS# 1609USA004199). On an unknown date in February 2007, the patient received the second dose of GARDASIL. On an unknown date the patient became pregnant with her first child(MARRS# 1609USA004199). Subsequently on an unknown date the patient became pregnant with her second child. EDD and LMP was unknown. On an unknown date the patient delivered a male infant. The child was now facing many health issues(MARRS# 1609USA005978). Additional information is not expected as no contact details were provided.
Shot arount 4pm. Couple hours later, a little bit of coughing. Around 8pm, more cough from chest. Close to midnite, wheezing and more cough. Took Xyzal and benadryil. Today (20 hours after the shot), lot of coughing, and weird feeling in chest.  May need to goto urgent care today , lets see.
Patient's mom called and said that the patient has had a reaction to the vaccine that was given in the right leg 2 days ago at visit. Patient's mom describes it as red and warm, bigger than a golf ball but smaller than tennis ball. Looked up vaccine and it was the varicella. Spoke with Dr. about this and she said that it seems as a site reaction. Patient can try TYLENOL and cool compresses. Advised mom to circle the redden area so we can track if the redness gets bigger or smaller. Also advise mom to watch for any systemic reactions and if any are noted to bring patient in.
Influenza Vaccine Quad Split GlaxoSmithKline contact primary care physician for exact vaccine. One was selected so the form could be completed, but unknown if it was a prefilled syringe or not.  Lipoatrophy resulted in area several months after the injection without weakness to the limb.
Migraine afternoon of 1/25/2021.  She then experienced feelings of nausea, mouth-watering, feeling overheated.  While resting during the onset of these symptoms she then felt like she couldn't breath, experiencing pain in the sides of her chest.  The next symptoms that occurred were angioedema to the face, she described her eyes getting so puffy she couldn't see.  She also described her skin getting reddened and itching all over.  She took Benadryl at home and started to feel better in about 1 hour.
pt recv vax 29MAR96 & 22APR97 pt devel a rash;pt was seen by MD who dx rash as bug bites;tx was required;
Patient received COVID vaccine first dose on 1/14/21.  On 1/24 began having myalgia, low-grade fever. Positive COVID test on 1/26/21. Nonproductive cough progressed to significant dyspnea on 1/29/21 and pt brought to ED by EMS with low O2 sats. Admitted to ICU on noninvasive ventilation. Receiving dexamethasone, remdesivir. Alternating optiflow and bipap, O2 sats in 90s, remains with significant SOA.
Got my second SHINGRIX shot 6/28/2018, just after noon. 12 hours later really bad flu-like symptoms - chills, bad body aches, light headed, headache...I had a similar reaction to the first shot 2 months ago.
Severe weakness, unable to stand and walk, mild dehydration, diarreah, nausea.
Waking up with severe tinnitus in both ears and echo sounding in L ear. Head sounds like inside a bucket or down at bottom of a pool. Sometimes there is a repeat echo from inside the L ear. Extreme loss of hearing this morning. The first time this happened it cleared up after an hour or so last Sunday but this morning it is not getting better. I have had tinnitus for many years but never this bad or severe sounding where hard to hear everything and this horrible echo sound.
Patient reported tachycardia (just under 100 BPM sustained) that started several hours after the vaccine was administered and continued for approximately 2 weeks. Patient reported this to me today at the time patient was to receive the 2nd dose of COVID-19 vaccine.  He said it was disturbing to him but it did not worsen so he did not report it to, or visit his physician.  Patient was advised to talk with his physician before receiving the 2nd dose of the vaccine.
Arm Pain; Body Aches for 10 hour; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), PAIN (Body Aches for 10 hour), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain), PAIN (Body Aches for 10 hour), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm Pain), PAIN (Body Aches for 10 hour), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
got sick both times after taking them; Initial information was received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media .  This case involves a patient with an unknown demography details who got sick both times after taking them (illness), while being received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown), after starting the suspect vaccine therapy, the patient got sick both times after taking them (illness).   It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Fever, body aches, chills, weakness, and nausea for 2 days.
She received the Pfizer COVID vaccine and became infected by COVID a few weeks later; She received the Pfizer COVID vaccine and became infected by COVID a few weeks later; Head cold; This is spontaneous report from a contactable consumer. A contactable Female reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number, expiration date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. on an unspecified date patient received the COVID vaccine and infected by COVID a few weeks later. On 30Mar2021, patient also had consistent symptoms with a head cold. The outcome for the events was unknown.  Information about lot/batch number is requested.
Morning 8 days after injection, emergence of rash above injection site and redness and swelling at injection site. Morning 9 days after injection rash became a larger hive and doubled regular Zyrtec dosage. Morning 10 days after injection symptoms gone.
He developed POTS (Postural Orthostatic Tachycardia Syndrome); This spontaneous case was reported by a pharmacist and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (He developed POTS (Postural Orthostatic Tachycardia Syndrome)) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (He developed POTS (Postural Orthostatic Tachycardia Syndrome)). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (He developed POTS (Postural Orthostatic Tachycardia Syndrome)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was not known after which shot the patient developed POTS. Patient was diagnosed by a cardiologist in the hospital. No treatment medication was provided. Company comment This spontaneous case concerns a 28-year-old male patient with no medical history reported, who experienced the non-serious, unexpected AESI of Postural orthostatic tachycardia syndrome (POTS). The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. The patient received the 2 primary doses of mRNA-1273. It was not known after which shot the patient developed POTS. Patient was diagnosed by a cardiologist in the hospital. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.
problem with her knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: EW0164) as dose 2, single and administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "rheumatoid" (unspecified if ongoing); "Lupus" (unspecified if ongoing), notes: SLE Lupus (not clarified). The patient's concomitant medications were not reported. The following information was reported: ARTHROPATHY (non-serious) with onset 2021, outcome "unknown", described as "problem with her knees".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 01-DEC-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
The day after the 2nd dose fever, face swelling and was beet red, muscle aches.   Sat 11/13/21 severe itching of neck, and ears started then followed by swelling and pain of the ears, hive rash of ears, neck, cheeks, chest, belly button  and back.    Called PCP on 11/23/21  The office brushed us off stating they didn't have any appointments availability.   We opted to our location is not that great with an expensive copay.  Self medicated with Benadryl and hydrocortisone cream.  No outcome to report yet as we just started the treatment (11/23/21).  If it persists medical treatment will be sought out.
Contracted covid 2 days later; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received the 2nd dose of Shingrix and 2 days later patient contacted covid and was put on pavlova. The reporter wanted to know was did the pavlova interfere with his/her second shot of Shingrix. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a pharmacist via a employee and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-DEC-2016, the patient was vaccinated with ZOSTAVAX vial 19400 PFU, 1 injection (route, lot number and expiration date were not reported) for prophylaxis (reported as "vaccine").  On 06-DEC-2016, the patient "had an outbreak of cold sores" lasting for an unknown duration of time. After the outbreak of cold sores, the patient began therapy with valacyclovir(VALTREX). At the time of reporting, the patient was "fully recovered". No product quality complain was reported. The causal relationship between the event and the suspect therapy was not provided. Additional information has been requested.
Patient started with Left lower leg pain and redness on 4.1.21.  Went to Emergency dept on 4.4.21 and diagnosis of Left leg cellulitis and prescribed Doxycycline.  Patient came to PCP office on 4.6.21 with worsening left lower leg pain and swelling.  Order L lower leg doppler.  Diagnosis of L lower leg deep vein thrombosis of tibial vein on 4.7.21 and prescribed Apixaban 5mg 2 BID x 7 days on 4.7.21