chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red/burning/itching patches on skin; Red/burning/itching patches on skin; Red/burning/itching patches on skin; Red/burning/itching patches on skin; Swelling joints in hands; Acid reflux; This is a spontaneous report from a Pfizer-sponsored Program (reported for himself). A contactable consumer, other health care professional and a physician reported that a 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. Patient received another suspect drug tofacitinib citrate (XELJANZ 5mg daily formulation: tablet) via oral on Apr2021 to an unspecified date in 2021 and on 04May2021 and ongoing as 5 mg daily for Rheumatoid arthritis. Patient decision to hold XELJANZ for two weeks and on 04May2021 restarted 5mg daily. Patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) COVID-19 immunization. Patient reported acid reflux while taking xeljanz 5mg twice daily, his decision to hold xeljanz for two weeks, restarted 5mg daily 04May2021 acid reflux improved. Patient reported with red/burning/itching patches on skin on an unspecified date in 2021, second dose COVID-19 vaccine few days prior to rash-visited urgent care 03May2021- anti-histamine prescribed. held xeljanz for first vaccine, did not stop xeljanz for second due to swelling joints in hands. Physician was unaware. Encouraged to discuss with physician. Outcome of event (Acid reflux) was recovering and unknown for other events.  Information about batch/ lot number has been requested.
pt recv flu vax & pneumococcal vax combined & given in one inj & exp cellulitis to elbow, fever, pain, site warm;
Less than 24 hours extreme reaction. Right side numbness in head, extremely high temperature, couldn't get out of bed.
I am having a shingles reoccurrence in addition to many aches in joints and muscles.
TINNITUS; EAR FULLNESS/DISCOMFORT/PRESSURE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced tinnitus, and ear fullness/discomfort/pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus and ear fullness/discomfort/pressure was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755980 and 20210758691.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist  this week there is still blood in my urine. The amount of blood has decreased, but still showing up.
Reports feeling elevated heart rate post vaccination;  Medical monitoring x 30 minutes; Vitals assessed BP 120/60 HR 96  02 sat 98%. rest "Feels better" after rest. Released to home, advised to f/up as needed with PMD.
Information has been received from a nurse concerning a female who was vaccinated with GARDASIL. Concomitant therapy included hepatitis A virus vaccine (manufactured unspecified) and MENACTRA. The registered nurse reported that the patient did not pass out, because the patient was squeezing her hand, but the mother thought that the patient passed out. This is one of the reports from the same source additional information has been requested.
Fever on and off x 2 weeks, body aches on and off x 2 weeks, headache on and off x 2 weeks, painful arm (whole arm, not just injection site) x 2 weeks.
RED SCAR THAT IS WARM TO THE TOUCH, AND SORE AT INJECTION SITE. ALSO PATIENT REPORTED A BUMP AT SITE.
fatigue; brain fog; tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 27Mar2021 (Lot number: ER8734) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; WARFARIN. Past drug history included: Known allergies: vancomyacin, reaction(s): "Allergy", notes: known allergies: vancomyacin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 12Apr2021, outcome "recovered with sequelae", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 12Apr2021, outcome "recovered with sequelae", described as "brain fog"; TINNITUS (non-serious) with onset 12Apr2021, outcome "recovered with sequelae", described as "tinnitus". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, feeling abnormal, tinnitus.  Additional information: No other vaccine in four weeks. Other medications in two weeks: antacid. Event treatment included medication. No covid prior to vaccination. Patient was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
diarrhea, headache,chills,sweats,nausea welt the size of a small orange that is red and hot with a rash
TOOK COURSE OF UNREFRIGERATED VIVOTIF; A spontaneous case report was received from a consumer on 02-Dec-2019.  Based on the information obtained from the consumer two individual case safety report PVX201912-000916 (PVX2019-2938) and PVX201912-000917 (PVX2019-2939) were created and cross-linked in the database.  This case (PVX2019-2938) described a female consumer who "took course of unrefrigerated Vivotif" (PT: Product storage error). She received Vivotif for typhoid prophylaxis.  Case report: The consumer left Vivotif doses out of refrigerator for at least a week and then took all doses. It was reported that it had occurred about a month ago.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer left Vivotif out of the refrigerator for at least a week and then took the entire course of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer left Vivotif out of the refrigerator for at least a week and then took the entire course of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. US-PaxVax Berna GmbH-PVX201912-000917:
Information has been received from a physician concerning a 20 year old female with no pertinent medical history who on 17-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (658222/0927U).  There was no concomitant medication.  On 17-AUG-2007 the patient developed shortness of breath, coughing, and wheezing and contacted a physician.  There were no laboratory or diagnostic testes performed.  At the time of the report the patient had not recovered.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 20 year old female with no pertinent medical history who on 17-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (658222/0927U). There was no concomitant medication. On 20-AUG-2007 in the evening the patient developed shortness of breath, coughing, and wheezing that persisted over the weekend. She contacted a physician. There were no laboratory or diagnostic tests performed. At the time of the report the patient had not recovered. Additional information has been requested.
Pain similar to being "frogged" at the injection site. Constant ache that is always there.  Intensifies when lift arm up or pressing on the site.  Also hurts when lying on the arm.  Only subsides with medication NAPROXEN 500 mg twice a day.  This pain is very similar today as it was on the afternoon of the injection.
Developed tingling in his right arm mostly the end and then he developed tingling in his right leg; Chest pain; This is a spontaneous report from a contactable physician. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unspecified route of administration, administered in left arm on an unspecified date (at the age of 18 years old) at first dose, single dose for COVID-19 immunization at the pharmacy. There were no medical history and concomitant medications. On an unspecified date on the same day of vaccination, the reporter stated that the patient developed tingling in his right arm mostly the end and then he developed tingling in his right leg. The patient then developed chest pain; because of chest pain, the patient was brought to the emergency room on an unspecified date. The patient underwent electrocardiogram (EKG) that was reportedly normal. The physician brought up the concern that the patient's mother needed guidance as far as her son should get the second shot or not. The physician stated that patient had extensive treatment for chest pain which is that patient was brought to the emergency room and had an EKG. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives starting on 11/18/21.  They come and go and occur on all parts of my body other than my face.    Doctor prescribed prednisone and zyrtec, which help, but as of 11/29, I still have ongoing hives.
Red arm down to elbow; Swollen arm down to elbow; Burning down to elbow; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Red arm down to elbow), swelling arm (Verbatim: Swollen arm down to elbow) and burning sensation of upper limb (Verbatim: Burning down to elbow). The outcome of the erythema of extremities, swelling arm and burning sensation of upper limb were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and burning sensation of upper limb to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, swelling arm and burning sensation of upper limb to be related to Shingrix.   Additional Information: GSK Receipt Date:14-June-2023 The patient self-reported this case.
At 2:30pm, I became very fatigued and had a headache.  By 4:30pm, I began having abdominal cramps on my upper left abdomen and had tingling in my extremities as well as my stomache.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imitrex, reaction(s): "known allergies: Imitrex"; Azithromycin, reaction(s): "known allergies: azithromycin"; Levofloxacin, reaction(s): "known allergies: levofloxacin". Vaccination history included: Covid-19 vaccine (DOSE 4, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for Covid-19 treatment from 09Oct2023 to 13Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
16yo F patient came to our Moderna clinic on 4/23/21, inadvertently received COVID-19 vaccine Moderna lot 007C21A ext. 10/12/21. FDA EUA for Moderna is for age over 18. Patient was notified on the incident. Our ID physician was notified and consulted for feedback. Patient reported no side effects after 1st dose. Clinic leadership immediately convened meetings for process improvement with on-going audit to prevent future incident. The case was discussed with physician over her vaccination. Their recommendation was to offer Pfizer vaccine. Legal guardian consented to 2nd dose Pfizer, lot EW0167, which was given on 5/25/21. Patient reported no side effect after the dose.
Full body rash two days later; Headache and metallic taste on tongue within the hour.; Metallic taste on tongue within the hour.; Left arm swollen and soreness through the next two days.; Left arm swollen and soreness through the next two days.; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 30Aug2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 30Aug2021, the patient experienced headache and metallic taste on tongue within the hour, left arm swollen and soreness through the next two days. On 01Sep2021, the patient experienced full body rash two days later. The clinical outcome of the events headache and metallic taste on tongue within the hour, left arm swollen and soreness, full body rash was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a nurse referring to a 49 year old female pt who on 4/9/99, received her 1st treatment with Lymerix, with no untoward affects. On 6/11/99, she received the 2nd dose and 6 to 12 hours later, she experienced flu-like symptoms and chills. No treatment was given. The most recent information received on 8/9/99, reports the symptoms resolved after 2 weeks.
Soreness at injection site that went away after 3 days and returned 4 months later.
Injection 5/31/06 fatigue started 6/2/06 stiff neck on Sunday symptoms persisted that week saw physician on 6/9/06 examined thoroughly, to take Aleve.
Immediately following injection: localized pain, reduced sensation/strength in left hand 2 hours later: fatigue 13 hours post injection: 101.5 degree fever, chills (teeth chattering, uncontrollable), muscle/joint pain and stiffness (mostly back, legs, and neck) which made sleeping through the night impossible--one blanket moved and I would freeze; if I moved movement and anything touching me would cause 8/10 pain. No relief with Excedrin. Fever broke 1/28 around 7AM All day today (1/28) I have alternated between chills and sweating. Aches are now mostly in my upper left back and hips/thighs. I have a large rash covering my left deltoid, where I received the injection.
3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.
I experienced extreme teeth and jaw bone pain for a couple days after the vaccination, until I started taking antibiotics. It might be unrealted.
Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as if my upper lid gets stuck, lasting only a few seconds, not painful and doesn't affect my vision). It occurs intermittently throughout the day and began approx. 2 hours after receiving the injection.
02/10/2021 approx 7 min post vaccination client had an 'odd sensation' in her neck, tender, has never experienced this before. Left after 30" not worsening of s/s, 3PM still feeling odd neck sensation. Took Benadryl, called her PCP-, at 5PM called MD again, felt some tingling 'felt weird', neck sensation still there, went into office to see MD. Pt stated she still has neck sensations at this time. Pt was notified her daughter and family all tested positive for COVID, s/s started on 2/8, Pt last had 'not so close' contact w/ her daughter on 2/7, within the 48' infectious window period. Pt had negative vault test done on 2/11, approx 4 days post exposure. Instruct Pt to retest tomorrow. Pt states she kept Additional information for Item 18: kept wondering if maybe her neck sensations were related to the virus. Pt referred back to PCP re getting the 2nd vaccine dose, due 3/10. Staff told Pt if recommended to get the 2nd dose that we would want her to have it done at the hospital in case she has same/worse reaction.
Suspected vaccination failure; have them now; I still hurt; Cried; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In January 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles, pain and crying. On an unknown date, the outcome of the vaccination failure and crying were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles, pain and crying to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient had two shingles vaccinations and had shingles at the time of reporting. The patient had them for 2 weeks now and they were still so bad, under doctors care and everything. The patient stated it still hurt like the dickens and had even cried. The patient stated he/she wouldn't want his/her worst enemy to have them. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous during March 2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-OCT-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ADDERALL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Treatment with anti-viral Paxlovid from 22Oct2022.   Follow-up attempts are completed. No further information is expected.
I woke that day and felt off. Middle of the day, I got a sharp pain in my left upper back that went up to my neck. I couldn't turn my head to the right. It kinda got better with some sleep. I did go in the next week and was seen.
Bivalent booster doses given instead of Monovalent doses for Primary Series.  No injury noted.
several hr p/vax pt devel an inj site rxn characterized by a quarter sized area of induration, swelling, redness & tenderness;tx w/DPH;
with head aches since 2nd dose for the last 2+ weeks.  parietal, pounding.
Redness, heat, swelling and pain in right arm, cellulitis in right arm.  Treated with 1 gram ROCEPHIN to right buttock intramuscular, treated for KEFLEX 500 mg four times a day for 10 days.
Large local reaction measuring several inches (7x5). Post Influenza vaccinations lasting 3-4 days.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a physician concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958784, 20210958534 and 20210958570.
Pt recvd pneumococcal vax & 2 days p/vax pt devel red raised, hard area on the arm & @ the inject site; No further details were provided;