chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of Bell's palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine and Flu Seasonal QIV Dresden, the subject developed Bell's palsy. Serious criteria included GSK medically significant. The outcome of Bell's palsy was recovered/resolved. The investigator considered the Bell's palsy to be possibly related to Meningococcal ACWY-CRM vaccine and Flu Seasonal QIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of Bell's palsy in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline) and unspecified influenza vaccine (manufacturer unknown). The patient was part of a self-controlled post licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, the risk window was 1-84 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO and unspecified influenza vaccination (administration route and site unknown; dosages unknown; batch number not provided for both) at a participating medical centre. On an unspecified date, between 1 and 84 days post index vaccination, the patient had upper respiratory tract infection/ cough. Subsequently, the patient was diagnosed with Bell's palsy. In this study, cases in the risk window occurred primarily between 5 and 10 weeks after vaccination. Treatment was unknown. The event resolved completely. The authors considered the event of Bell's palsy to be temporally associated to MENVEO and unspecified influenza vaccine. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50,000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (0.5 ml) (lot number, injection site were not reported) intramuscular in July 2011. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient was "in office today to receive second dose of GARDASIL". There was no adverse event reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Information has been received from a company representative concerning a 1 year old twin patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient broke out in a mild case of chickenpox. This was one of several reports from the same source. No further information is available.
feeling feverish fever reached 101F; Chills; Tested positive for Covid-19/tested positive after 6 months; tested positive after 6 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19/tested positive after 6 months), DRUG INEFFECTIVE (tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19/tested positive after 6 months) and DRUG INEFFECTIVE (tested positive after 6 months). On an unknown date, the patient experienced PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills). At the time of the report, COVID-19 (Tested positive for Covid-19/tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) had resolved and DRUG INEFFECTIVE (tested positive after 6 months) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.         Treatment medication was not provided.  Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Live Follow up received on 13-Aug-2021, event information updated
Information has been received from a health professional concerning a 13 year old female with an upper respiratory tract infection and a history of seasonal allergies who on 07-APR-2008 was IM vaccinated with her second dose of GARDASIL (lot number reported as 654490/0133X). Concomitant therapy included TYLENOL, VICKS DAYQUIL (OLD FORMULA) and VICKS NYQUIL (OLD FORMULA). On 07-APR-2008 the patient fainted. Initially she was dizzy, then collapsed. Additionally she had a urticaria rash on her left amber blood pressure at that time was 142/80 and pulse rate was 47. Fifteen minutes later her blood pressure was 122/68 and pulse rate was 85. There was no sign of anaphylactic shock. The patient had and upper respiratory infection for the past 3 days with some symptoms that include coughing and mucous. The MA also reported that then patient fainted with Dose #1 but did not have any other details. The patient has recovered from the fainting but it is unspecified if her rash has also resolved. The patient sought unspecified medical treatment while at the office. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-NOV-2007, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-DEC-2015, the patient was treated by a physician for a the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Severe chills; headache; extreme fatigue with no appetite for 3 days; extreme fatigue with no appetite for 3 days; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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: CHILLS (non-serious), outcome "unknown", described as "Severe chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), DECREASED APPETITE (non-serious), outcome "unknown" and all described as "extreme fatigue with no appetite for 3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was already on menses prior to injection with my regular heavy flow and no cramping. Around 2 hours post injection my flow was increased **substantially** and I continue to have some pretty intense cramping, which is not my normal. I will be contacting my regular family physician when they open to follow up.
When she tried to get up that same night she collapsed; She states that the first night she had fever, chills, dizziness, and body was soaking wet.; chills; dizziness; body was soaking wet; She also reports her arm was red from her shoulder to her elbow, and states that it was bright red; her arm is sore; This spontaneous report was received from a female consumer reporting on herself. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 30-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) second dose, 1 dosage form (route of administration, lot number and expiration date were not provided) to prevent pneumonia.         On an unknown date in 2020, the patient's arm was red from her shoulder to her elbow, and it was bright red and sore (erythema and injection site pain). The patient stated that on 30-OCT-2020 she had fever, chills, dizziness, and her body was soaking wet (pyrexia, syncope, hyperhidrosis, dizziness and chills) that lasted for 5 days.      The outcome of syncope, injection site pain, erythema, hyperhidrosis, dizziness, chills and pyrexia was reported as recovering. The causal relationship between pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and injection site pain was reported as related. The causal relationship between pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and the rest of the events was not provided.  Upon internal review, syncope was considered as medically significant.
Patient felt  itchiness and throat discomfort. No respiratory distress. Patient stated it felt like throat was tightening. She brought her own Epi Pen (Seafood anaphylaxis) and was instructed to self administer. 911 / EMS took her to nearest hospital
Severe myositis complicated with rhabdomyolysis and non-oliguric acute kidney injury, thrombocytopenia, myocarditis with pulmonary edema, and pulmonary hemorrhage. The patient was treated with five days course of intravenous (IV) methylprednisolone and IV immunoglobulin with a good response. He was hospitalized for sixteen days and discharged home on a tapering dose of oral prednisolone for a total of 6 weeks.
flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 10-Nov-2020. This case involves a patient with unknown demographics who experienced flu (Influenza), when received vaccine INFLUENZA VACCINE (flu shot). Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced flu (Influenza), unknown latency following the administration of INFLUENZA VACCINE. Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 08-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Pain, painful; Hardness at werid spot, hardness has decreased; Red area, diffused and lighten in color; Tender, tenderness still there; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-APR-2023, the patient received the 2nd dose of Shingrix (unknown deltoid). On 02-APR-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain, painful) and injection site induration (Verbatim: Hardness at werid spot, hardness has decreased). In APR-2023, the patient experienced erythema of extremities (Verbatim: Red area, diffused and lighten in color) and tenderness (Verbatim: Tender, tenderness still there). The outcome of the injection site pain and tenderness were not resolved and the outcome of the injection site induration and erythema of extremities were resolving.   It was unknown if the reporter considered the injection site pain, injection site induration, erythema of extremities and tenderness to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site induration, erythema of extremities and tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2023 The reporter was the patient.  The next day of vaccination the patient noticed pain and hardness at a weird spot to where the injection was administered.  The injection site where it was administered was below the red area. The redness was more toward the upper area on top of patient's deltoid area, more toward the front of the arm.  The patient reported that redness had grown and was hard, painful and tender.  The patient stated that it had diffused and lighten in color and also the hardness had decreased but the pain and tenderness was still there.  The reporter consented to follow up with her and healthcare professional.
weakness numbness on right side of face, numbness in tongue, gums, cheek, and eye, mild dropping watering of eye. 2 days after vaccine, increasing over following days. Diagnosis-bell's palsey treatment prednisone
Info has been received from a health prof'l concerning a 20 wk old male w/no past medical history who on 6/27/02 at 9:30 am was inadvertently vax'd with a 2nd dose of Haemophilus B conjugate vax and Haemophilus B conjugate vax (+) Hep B vax recombinant (yeast) (MSD) at the same time. Concomitant therapy that day and time included the 2nd dose of diphtheria toxoid/pertussis vax/tetanus and the 2nd dose of poliovirus vax inactivated. There was no illness at the time of vax. On 6/28/02 in the p.m. the PT developed a temp of 102.7 F axillary. There were no relevant diagnostic or lab tests. The PT sought unspecified medical attention. It was reported that the PT recovered on 6/29/02. No further info. is expected.
Approximately 30 minutes after receiving the vaccine I lost complete hearing in my left ear. I waited until the next morning to see if hearing would return. It did not and I contacted my doctor at the Clinic and was referred for an audiology test on Thursday at 9:30am followed by a appointment with an ENT. My hearing loss was profound and I was started on high dosages of steroids for a 14 day course of action. I also had a head MRI done on Monday February 8 with no significant findings. My hearing has begun to improve but at this point is not back to normal and it may never be the same. My biggest question is whether or not I should take the second vaccine. I also have a significant bruise at the injection sight that I still have 10 days later.
Chills that were like spasms (violent jerks of my body), fever, nausea, headache, exhaustion, shortness of breath. This was the 2nd time I had a reaction to Moderna that was so horrible I could not get out of bed. Following  the first dose on Feb. 28th, I had the same reaction and my temperature got to 102.5. This time, the reaction last longer. I was still short of breath tree days after the shot. Today, April 1, I finally feel close to 100%.
Case number PHEH2012US007167 is an initial spontaneous report received from a nurse on 28 Mar 2012: This case refers to multiple patients. These patients were vaccinated with MENVEO (batch number: M10132 and M10133) intramuscularly on 20 Mar 2012. MENVEO reached 34.1 F for up to 3-hours on 20 Mar 2012. No adverse event was reported during this administration error.
My vaccine was given Feb 24th and everything was great until 5:00pm March 5th.  I started to not feel well. Very cold, body aches,, bad headache and my glands hurt.  At 7:00 I headed to bed and noticed a large welt on my arm were I received the shot 11 days ago. In the morning my glands really hurt and I still felt really bad and went to an Urgent care.  They said it was a side effect from the shot.  Take aspirin and Benadryl.  The drew blood.  My WBC was 3.1, LYM% .6, RBC 3.93, Hemoglobin 12.1, Hematocrit 38.2, MCV 97.1 MCH 30.8 RDW 12.3, Platelets 170. Temperture 97.6.  Later that day I felt a little better, but developed a second welt on my arm about 3 inch below the 1st.  That night work up at 4:00am drenched in sweat.  Changed PJ and sheets and actually felt better.  In morning 2nd welt was larger. Later that day an area surround my mouth started to tingle for a minute or so and then had about 30 muscle twitchs in the area of my mouth, same thing happened in 8 inch area of my backside.  Later that night my toes started to tingle.only on my right wide.  Next day toes still tingle 2nd welt is larger.  Went back to urgent care because of my toes, they said there was nothing to do, but I should report my side effects.  As of now 9:44 3/8 still tingling.
Patient noted a rash on throat and torso, that developed post vaccination,  not painful and is subsiding as of 09/26/23 12:45PM
pt recvd vax 11MAY94 & the following day devel a raised hot, red welt 4 inches in diameter;pt recovered;no further details were provided;
Pt came in and asked to get covid vaccine. He said he hasn't received it and also checked "not received" on consent form.  Later on same day, his daughter called and told us Pt received both Pfizer vaccine at different location on Feb 2021. She said his father just don't remember that he received already. She understands that he received 3rd dose of Pfizer and let us know if there is any other concern.
Rash on my legs a week after the vaccine; little reds dots and sometimes it would itch and sometime not. I showed it to my nurse practitioner who I work with; put Zetifil lotion/creme. That didn't really do anything and then it went away and was pretty gone away when I had the second shot 1/7/2021. When I got the second shot it came back.
Patient states she woke up in the middle of the night with tightness in her throat, redness and itching on face and chest. She took an antihistamine and did get some relief after taking that and drinking plenty of water.
Severe swelling at injection site and extending down arm to elbow.  Fever 102-103 for three days.  Headache, severe fatigue, muscle aches.  Given prednisone, clindamycin & lidex to counteract problems.
Tested positive for COVID on 11Jul2023; Tested positive for COVID on 11Jul2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), on 11Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) and 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), COVID-19 (medically significant) all with onset 11Jul2023, outcome "unknown" and all described as "Tested positive for COVID on 11Jul2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2023) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------  HYPOTENSION 11/22/2022 SURGICAL ARTERIOVENOUS FISTULA MALFUNCTION, INIT
Our son vomited for 6 hours and ran a moderate fever after 2nd dose. He also was lethargic, weak,  and had bad body aches and chills.
Metallic taste in mouth. Warm flush feeling.  Metallic taste got better over time and last for 14 hours. Flush felling about 5 minutes after it started.  The 2 symptoms happen at the  same time.  Reaction very similar to a IV flush
Patient fainted after vaccine administration, duration of 8-10 seconds. Patient was placed in supine position with legs elevated for 15 minutes and ice pack placed behind neck area. Patient was able to ambulate without assistant after incident.
This spontaneous report concerning a patient of unknown age and gender, was received from the patient's mother. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9, intramuscularly for prophylaxis (lot # and expiration date were unknown), which was not indicated in the prescribing information (extra dose administered). No adverse events were reported. Additional information is not expected, no contact details were provided.
gave the second dose of Shingrix vaccine a month early (28 days after the first dose of Shingrix); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 95JR5, expiry date 5th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine a month early (28 days after the first dose of Shingrix), which led to shortening of vaccination schedule.  The reporter realized it was too early after giving the patient the Shingrix vaccine. No other information was reported. The reporter consented to follow up.