chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incapacitated or in some way was slowed down to where he wasn't responding in day to day functioning educationally as he would prior to getting the vaccine / he was no longer attending college; He had a neurological reaction; This initial informartion was received from a physician, via a company representative, regarding a case in litigation, referring to a currently 20 to 21 years old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The physician reported that he was unable to determine if the patient was administered Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) which were administered as routine preventative (route of administration, frequency, lot # and expiration date were not provided). On an unspecified date in 2015 (reported as about 5 years ago), the patient was administered the first dose of the vaccine. On an unspecified date, the patient was administered the second dose of the vaccine, at which time the patient was a student at the University. The physician stated that, on an unspecified date after the second dose of vaccination, the patient's parents suspected he had a neurological reaction (neurological symptom) to the vaccine. The pt was "incapacitated or in some way was slowed down to where he wasn't responding in day to day functioning educationally as he would prior to getting the vaccine" (mental impairment). The physician reported the patient was no longer attending college potentially as a result of vaccine injury. At the time of reporting, the outcome of the patient was unknown. The reporter considered the events to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).  Upon internal review, the mental impairment was considered medically significant and disabling.
Mar 18 Received second dose of the Pfizer covid vaccine without incident.  Arm slightly sore for a day and a half.   Mar 20 Started the dermatology treatments consisting of Fluorouracil 5% in the morning and one foil packet of Imiquimod 5% in the evening.  The Imiquimod was in individual foil packets of 0.25 grams each.  I applied the medication to my forehead and small area on the left side of my neck.   I noticed a quick response to the treatment; within a week small rd pimples were evident on the application site.   Mar 31 I came down with flu (symptoms): Major:  Chills, diarrhea, spacey feeling Moderate:  Loss of appetite, aching joints, sinus congestion Minor:  Nausea, fever Terminated the skin treatment.  I h Mar 18 Received second dose of the Pfizer covid vaccine without incident.  Arm slightly sore for a day and a half.   Mar 20 Started the dermatology treatments consisting of Fluorouracil 5% min the morning and one foil packet of Imiquimod 5% in the evening.  The Imiquimod was in individual foil packets of 0.25 grams each.  I applied the medication to my forehead and small area on the left side of my neck.   I noticed a quick response to the treatment; within a week small rd pimples were evident on the application site.   Mar 31 I came down with flu (symptoms): Major:  Chills, diarrhea, spacey feeling Moderate:  Loss of appetite, aching joints, sinus congestion Minor:  Nausea, fever Terminated the skin treatment.  I have 13 foil packets remaining  so I applied one per day for 11 days. Noted that flu symptoms are listed as a side effect of at least one of the dermatology treatments.   Apr 1 Flu (symptoms) continued   Apr 2 Since flu symptoms can indicate covid, I went to prompt care for a rapid covid test.  Negative covid. Except for diarrhea, the flu symptoms moderated. Results from the dermatology treatment became more intense and spread well beyond the area treated.      Apr 3 Took Pepto Bismo tablets for diarrhea.  Seems to have worked. Skin reaction has spread well beyond the treated area.   Applying antibiotic cream twice daily   Apr 6
Got the shot on a Wednesday, didn't have any adverse reactions until that sunday night when chest all of a sudden started feeling tight and just a dull constant pain.
Pt complains of mild arm pain that is still present 10 days post-injection.  Also complains of difficulty raising arm above shoulder.
Lethargy in the morning on Thursday, very tired, with a runny nose, sore throat, stiff neck. Tested with an at home COVID-19 test positive. Called doctor who prescribed PAXLOVID. Symptoms gradually improved over 4 days, with symptoms pretty well disappeared on day 5. Dry productive cough lingers as does nasal drainage.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm 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 Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Negative. Therapeutic measures were taken as a result of covid-19.  Additional information: Known allergies was none; Anti-viral details included Product COVID 19 Treatment with Brand Paxlovid which treatment start date was 14Jul2022 & treatment stop date was 18Jul2022 for indication treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Specific product reported Yes, specific product known from information provided.     On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
This child developed a temperature of 104 on 03/04/01, and his sleep was restless. No cough, runny nose or other illness. Today, he's playful, no temp on 03/05/01 at 11:00 AM.
arm soreness; weird lymph node pain all over her body; weird muscle or nerve pain in her legs; weird muscle or nerve pain in her legs; skin hurts all over; Her groin lymph nodes and lymph nodes in her neck were really painful; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported for her 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on 07Apr2021 as SINGLE DOSE for COVID-19 immunization. The medical history and concomitant medication were not reported. Approximately on unknown date in 2021, about a week in patient had arm soreness and she's been having weird lymph node pain all over her body. Her groin lymph nodes and lymph nodes in her neck were really painful. It started with weird muscle or nerve pain in her legs. She has gone to her doctor and they don't know what to do. On an unknown date in 2021, the patient performed with a blood test and x-ray, but the results are not provided. Her skin hurts all over. We're not sure what it is, but I'm concerned about her getting her 2nd vaccine. Patient mother asking, the skin pain is a symptom of lymphadenopathy. Patient mother asking what the protocol for managing these side effects. Patient mother also enquired about lymphadenopathy would be worse after the second dose. The caller also asked about the efficacy of the first shot. The response included, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-publication-results-landmark.The cumulative incidence of COVID-19 cases over time among placebo and vaccine recipients began to diverge by 12 days after the first dose, and 52.4% vaccine efficacy (95% confidence interval: 29.5, 68.4) was observed between dose 1 and dose 2, indicating the early onset of a partially protective effect of immunization. Two doses of vaccine provide the maximum protection observed. The outcome of the events was unknown. No PQC involved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patients that were given MENQUADFI after they found out that the vaccine is not suitable for use with  no reported adverse event; The excursion happened last 17 March 2023 and was reported 24 March 2023 with no reported adverse event; Initial information was received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 12 patients of unknown age and gender patient who stated the excursion happened last 17 march 2023 and was reported 24 march 2023 and patients that were given menquadfi after they found out that the vaccine is not suitable for use with no reported adverse event after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Mar-2023, the patient received dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U7459AE, expiration date: 03-Nov-2024) (strength, frequency was unknown) via unknown route in unknown administration site for Immunisation.  On 17-Mar-2023 the patient developed a non-serious event of the excursion happened last 17 march 2023 and was reported 24 march 2023 with no reported adverse event (product storage error) same day following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.   On an unknown date (in between 17-Mar-2023 to 24-Mar-2023), patients were given menquadfi after they found out that the vaccine is not suitable for use with no reported adverse event (poor quality product administered) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Waited 30 minutes for observation. Driving back home. Left side of face got tingling and on left arm. Just going away. Tingling is going away. Walking up the stairs, and got long winded and feeling fast heart rates. Tried to get up feeling fatigue. Notified manager. Informed of Vsafe to register there as well  Scheduled to work on Monday 12/28 on site. Last onsite worked day was 12/22/2020 Covid testing last August and was negative Per the algorithm, her recommendations were to monitor and call PCP and 911 if symptoms persists or worsens
Pox on trunk, arms, face in different statges, numerous. Acyclovir 200/5 1 tsp PO Q D x 5 D
Pt developed headache, followed by fever up to 102, then had skin hot to touch, developed reticular rash extending up to neck/shoulder area on right, and a soft lump that is tender on right side of neck/supraclavicular region.  Rash resolving as of 4/2/21 but lump and tenderness remain.
Information has been received from a nurse practitioner concerning a 16 year old female who in August 2007, was vaccinated with her first dose of Gardasil (lot# not provided).  Concomitant therapy included MENACTRA.  As the patient was walking out of the exam room she had a syncopal episode and hit her head really hard.  The patient has since been complaining about headaches.  The nurse practitioner sent the patient for an MRI which was negative for injuries and malignancies.  The patient received the second dose of Gardasil (lot# not provided) in October 2007 without a problem.  The patient's mother called the office on 07-MAR-2008 and reported her daughter still continues to have headaches.  It was not clear whether or not the patient would receive the third dose.  Additional information has been requested.
Very itchy rash developed first on left hand and then on right hand. Washed 3-4 times per day and applied topical hydrocortisone, lasted 3-4 days.
Pt experienced injection site pain aproximately 1 hour after injection. Redness at injection site occured 6 hours after injection. The site also had fever and swelling. Over the next 36 hours the redness subsided at injection side but slowly streaked down to the bicep area covering aproximately 7 inches by 5 inches. Patient will follow up with any new symptoms. Does not appear infected.
Shot administration: 5/28  Episode of Bells Palsy: 6/10  No previous episodes before shot and none since shot
pain in elbow of right arm; Pain in fingers/knuckles of right arm; Anxiety level increased; Heart rate went to 101; blood pressure skyrocketed to 142/88; Throat started closing; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number UNKNOWN) via an unspecified route of administration in the right arm on 25Mar2021 at 14:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received codeine (MANUFACTURER UNKNOW) for unspecified indication on unknown date and she experienced drug allergy to it. Concomitant medications included ethinylestradiol; norgestimate (SPRINTEX), bifidobacterium bifidum; bifidobacterium lactis; bifidobacterium longum; cactobacillus acidophilus; cactobacillus rhamnosus (PROBIOTIC) and colecalciferol (VITAMIN D3), all were for unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19 on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Mar2021 at 15:15, the patient experienced pain in elbow and fingers/knuckles of right arm. After about 20-25 min throat started closing, anxiety level increased. Heart rate was 101 and blood pressure skyrocketed to 142/88. The patient underwent COVID-19 antigen test on 25Mar2021 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The therapeutic measures included treatment with benadryl for all the event from an unknown date. The clinical outcome of pain in elbow and fingers, anxiety, heart rate increased, blood pressure increased and throat constriction was recovering at the time of report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Information has been received from a consumer concerning a male family member, now 8 years old, who experienced autism after receiving vaccines at age 2. The reporter could not specify which vaccines the child received and who manufactured them. It was unknown if the patients sought medical attention. Follow-up information has been received from a registered nurse who reported that the patient was vaccinated with MMR II before developing autism. Upon internal review, autism was determined to be an other important medical event. No further information is available. This is one of several reports received from the same source.
5 days after getting shot started as redness at site then moved to Right breast - tender and red. Also had diarrhea, headache, body aches. Started having relief 9 days after getting shot.
Syncopal episode occurred while seated almost immediately after having received her last injection - GARDASIL. She was lightheaded and nauseous. She closed her eyes and leaned into her dad at her side she turned very pale and had slight twitching movements of arms; lost consciousness about one minute she was immediately seen by Dr.
I had 102 fever; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL9266), dose 1 via an unspecified route of administration, administered in Arm Right on 15Feb2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included primary biliary cholangitis, hypertension, covid-19. Concomitant medication(s) included ursodiol (URSODIOL); atorvastatin calcium (ATORVASTIN); metoprolol tartrate (METOPROLOL TARTRATE); lisinopril (LISINOPRIL). No other vaccine in four weeks. No Known allergies. On 16Feb2021 07:00 patient experienced i had 102 fever, chills, fatigue, headache. The patient had second dose on Arm Right on 08Mar2021 12:45 PM Lot no. EN62A3 as DOSE 1, SINGLE for covid-19 immunisation. No treatment was received as result of event. Covid tested post vaccination. The patient underwent lab tests which included body temperature: 102 fahrenheit on 16Feb2021, body temperature: 101 fahrenheit on 17Feb2021, sars-cov-2 antibody test: negative on 22Feb2021, sars-cov-2 antibody test: negative on 01Mar2021, sars-cov-2 antibody test: unknown reults on 08Mar2021 RT-PCR test result pending Nasal Swab. The outcome for all events was recovered on an unspecified date in Feb 2021.    No follow-up attempts are possible. No further information is expected.
Approximately 2 weeks after receiving booster I am experiencing what can best be described as dermatographia.  Any pressure or scratching to the skin results in redness and itching.  If itching gets bad enough results in what looks like hives.  Reaction/redness appears 5 minutes after exposure to stimulus and if left alone disappears ~1hr later.  Have been taking OTC cetirizine which seems to help with the itchiness but not necessarily the redness.  Also, when initially occurring, my feet also felt quite painful for ~1.5 days, appearing red and felt swollen, but that (aside from occasional redness) has seemed to resolved.
On Friday became confused, fever (103.4) and a stiff neck. Went to Hospital. In ER was treated with IV fluids and Toradol.
2 episodes of shingles; 1st dose 12Feb2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 52LX4, expiry date 23rd April 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 19-JAN-2023 Reporter comment: The pharmacist reported that, the patient developed 2 episodes of shingles following dose 1 of Shingrix.  The first episode occurred a month or two after the 1st dose and the pharmacist was unaware of when the 2nd episode occurred. Both episodes have cleared up (unknown time frame). The second dose of Shingrix had not been administered. The reporter asked for email address but pharmacist states they did not get external emails. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Tinnitus 3 weeks after vaccination of first dose; constant; still present at this time.