chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymphadenopathy onset within less than 7 days from dose 2 mRNA seen by her primary care provider, then later an ED visit detected elevated LFTs and low potassium associated with a 1 week history of viral syndrome symptoms (several headache/pressure episodes with a "hot" quality, 1 emesis episode, 2  dizziness episodes, feeling unwell, episodic chest pressure)
arms and legs affected with severe purpura; This case was reported by a consumer via call center representative and described the occurrence of purpura in a 84-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced purpura. On an unknown date, the outcome of the purpura was recovered/resolved.   It was unknown if the reporter considered the purpura to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced severe purpura after receiving 2nd dose of Shingrix. The purpura was fully recovered but arms and legs affected with severe purpura for almost two months. No further information was provided.
GENERAL ACHINESS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAR-2021, the subject experienced general achiness. On 03-MAR-2021, the subject experienced fever. On 03-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and general achiness. This report was non-serious.
vaccine administered from a punctured vial that stayed in the refrigerator for 14hs; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered from a punctured vial that stayed in the refrigerator for 14hs) and INJECTION SITE PAIN (injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered from a punctured vial that stayed in the refrigerator for 14hs) and INJECTION SITE PAIN (injection site pain). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered from a punctured vial that stayed in the refrigerator for 14hs) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product was reported   No treatment information was reported   Reporter did not allow further contact
when i touched I felt a strong stinging sensation on my breast.; inflammation of the breast; Nodules in the breast/hard nodule/lump; it gave me a strong pain next to the breast.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jun2021 (Lot number: EW0181) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot no: EW0168, Route of administration: Left arm, Dose no: 1, NDC: Unknown , Expiration: Unknown), administration date: 12May2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "COVID-19 immunization". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "when i touched I felt a strong stinging sensation on my breast."; BREAST INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "inflammation of the breast"; BREAST MASS (non-serious) with onset 2021, outcome "unknown", described as "Nodules in the breast/hard nodule/lump"; BREAST PAIN (non-serious) with onset 2021, outcome "unknown", described as "it gave me a strong pain next to the breast.".  Additional information: Patient (49 year, female)received the Pfizer COVID-19 Pfizer vaccine and after the 2nd and 3rd doses presented pain, inflammation and the presence of nodules (lumps) on left breast after 2nd dose patient noticed a hard nodule/lump, it gave me a strong pain next to the breast. Patient didn't realize when they appeared when she touched she felt a strong stinging sensation on breast.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax & reported exp a high sensation where felt a rush of energy w/in 1-2hr p/vax lasted 2hr
Fever, seizure 6 days after vaccines given. ER in ambulance. Given VERSED and monitored. Discharged from ER - no other findings.
Approx 10 mins after vaccinating pt, he was diaphoretic and pale.  He stated that he was well hydrated, but was extremely anxious about the vaccine.  He stated that he 'had anxiety all week'.  The pt's vitals were stable BP - 101/92, HR 58, 02 @ 98%.  The pt was given water and an ice pack that he applied to the back of his neck.  The pt was given water and crackers.  Vital recheck was BP-110/91.  The pt stayed in observation for 40 mins.  When the pt left the clinic, he stated that he felt back to normal.
Took a dose of unrefrigerated Vivotif; Spontaneous report received on 16DEC2019.   Based on the information obtained from caregiver (consumer's mother) two individual case safety report 19000468SP (PVX2019-3095-first child) and 19000469SP (PVX2019-3096-second child).  This case (PVX2019-3096) was for a 10-year-old consumer of unknown gender who "took a dose of unrefrigerated Vivotif" (PT: Product storage error), while being oral Vivotif (lot number: 3003279) for typhoid fever prophylaxis. On 15DEC2019, the consumer took the first dose of Vivotif, which was left unrefrigerated since 26NOV2019. Action taken with Vivotif with respect to reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Product storage error). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer took a dose of unrefrigerated Vivotif (Product storage error). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Patient had immediate localized reaction at injection site and bleeding. Cold pack was applied for about 10 minutes and swelling subsided. Bruise remained at injection site with redness.
Maternal exposure during pregnancy; This spontaneous pregnancy report received from a patient concerned a 35 year old female. 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: 1808982 and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of maternal exposure during pregnancy was not reported. This report was non-serious.
This is a spontaneous report from a contactable consumer or other non-HCP. A (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date in Mar 2021, single dose, for COVID-19 immunization. It was unknown prior to vaccination, if the patient diagnosed with COVID-19 or not. The patient's medical history and concomitant medications not reported. Reason why batch/lot is unknown: it was not available/provided to reporter at the time of report completion. Facility where the most recent COVID-19 vaccine was administered: unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever and chills on an unspecified date in Mar 2021. It was unknown if treatment was received for the adverse events. It was unknown if since the vaccination, the patient tested for COVID-19. The outcome of the events: resolved on an unspecified date in 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD, lot number M031568, expiration date 24-DEC-2017, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The vaccines experienced a temperature excursion between 6 to 14 Fahrenheit Degrees ("6 Fahrenheit Degrees was the actual highest temperature of exposure"), during 30 minutes of time frame. No previous temperature excursions and no digital data logger was involved. No adverse effect were reported and no product quality complain was involved. Additionally, there was also reported that only "2 doses administered". No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012141.
Onset severe h/a w/dizziness,"hot flashy" feeling. Came on fast. Light headedness then head just pounded after that.  Went to ER after taking 2 Tylenol. Was tx w/3 Motrin.
coughing; sore throat; nausea; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Diabetic and Liver disorder.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported.  The patient ?reported she was concerned she had COVID-19. No treatment information was provided.
The patient c/o redness around the injection site on her right arm the evening she received the Menveo vaccine. By the next evening she had swelling and redness. Upon inspection she had a large pocket of fluid in her upper arm. Pt taken to pediatric urgent care by mother due to the amount of fluid on her arm She denied pain or tenderness and there were no signs of infection. Cold packs were given and Tylenol recommended. When seen in office 36 hours after administration, a large amount of fluid remained. We have ongoing monitoring.
See above. Reporting break through COVID (per VAERS phone instructions) after 2 vaccines and 2 boosters. Adverse reaction positive COVID test and A-Fib.
Rash on arms, fatigue, nausea, cough,  sporadic  sharp pain in stomach and legs,  body aches, headache.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included psoriasis (Patient had chronically Psoriatic spots on leg for years, the size of the spot was 1 square centimetre). The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date, three weeks after 2nd Pfizer vaccine, the spot disappeared & the skin has healed itself. Intuitively patient think it is dues to the vaccine raising immune system level. The outcome of the event was unknown. No follow-up attempts are needed. Information about Lot/batch number cannot be obtained. No further information is expected.
Pt's Mother states that the day after office visit (03/18/16), child was slightly fussy, with some low grade fever, and sight of injection to left leg was red, raised.  On the afternoon of 03/19/16 Mother became concerned, the sight of injection to the left leg became severely red, and was raised and hot to touch. Mother then took child to the emergency room for evaluation. The afternoon of 03/19/2016.  According to pt's Mother they diagnosed child with a skin infection, and cellulitis.  Child was seen in the office on 03/22/2016 for follow up.  At that time the physician diagnosed with reaction to immunization.
Temporary loss of peripheral vision in right eye. Started in the center of right eye vision as large white spot and slowly moved to the peripheral before disappearing. Lasted approximately 1 hour.
pt states she was in the bed and started shivering so bad she could not move.  She had fatigue and developed a fever.  She also had loose bowels which lasted for about 3 days.   A week later she developed a red rash on her right leg and right buttock.  She applied Neosporin ointment. She still has pain in the right arm at the injection site.
burning at injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). An 11-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection".  Additional Information: The patient experienced burning at injection after receiving covid and flu vaccinations. Event took place after use of product.  Follow-up attempts are completed. No further information is expected.
not yet received the second dose / due to the pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not applicable for this report.  The patient had not yet received the second dose of Shingrix due to the pandemic. He had nothing else to report. The reporter did not consent to follow-up.
Multiple random areas of twitching (like a jerk) a couple of minutes apart, one area at a time,   when resting at night.  This lasted for around 1/2 a year & still continues but with much larger times in between twitches. Now maybe 15 -30 minutes apart.
I had a very strange vision event. It was as if a lace curtain with a shifting pattern of shapes had been placed in front of my eyes. I could barely see and it completely threw off my equilibrium. I had to hold the walls and doorways of my house to walk to my bed. The pattern was still there when I closed my eyes. Thankfully, this morning, it is gone. So far anyway.
red patch at the injection site; arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red patch at the injection site) and VACCINATION SITE PRURITUS (arm itchy) in a 48-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red patch at the injection site) and VACCINATION SITE PRURITUS (arm itchy). At the time of the report, VACCINATION SITE ERYTHEMA (red patch at the injection site) and VACCINATION SITE PRURITUS (arm itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Patient felt flu like symptoms along with a headache for approximately 5 days after receiving the vaccination. She never developed a fever during those days, only body aches, like the flu and headache.
Information has been received from a licensed practical nurse concerning a 14 month old male patient who on 05-JUN-2008 was vaccinated with a dose of VARIVAX (Merck) (lot# 657106/1891U) 0.5 ml subcutaneous in the right leg. Concomitant therapy included PREVENAR and MMR II, both given in the left leg. Immediately post vaccination the patient experienced hives around the injection site of right leg. The patient was monitored with no treatment. Subsequently, the patient recovered from hives around the injection site of right leg. The patient sought medical attention in office. This is one of several reports from the same source. Additional information has been requested.
3 hours after vaccine severe inconsolable crying for hours.  Went to ER where she was said to have a very tender abdomen.  4 episodes of watery stool, large volume. (nonbloody). Spiked a 102 fever
Pt received GARDASIL #1->1/6/10 and received GARDASIL #2 5/11/10. Positive preg test 6/25/10.
approx 12hr p/vax mom was feeding child when became flaccid-eyes rolled back;was rushed to ER;no responsive to mom x7min;hosp overnight for observation;no fever @ any time;
I had my Moderna Booster on 1/6/22 and on 1/16/22 I woke up with a very stiff neck, scratchy & itchy head, a rash on my neck.  The next day I woke up with patches of rash from my neck all the way down my torso and back to my pants area.  The rash looks like welts and lashes like I was whipped.  They pop up and then  disappear within an hour and then new spots pop up.  They seem to be popping up with no rhyme or reason but where my clothes are tighter, it's worse.  They are itchy & red.  I was putting hydrocortisone creme on them & went to Urgent care last night for Prednisone.
This case was reported by a consumer via call center representative and described the occurrence of respiratory tract congestion in a adult female patient who received Influenza vaccine Quadrivalent. Concomitant products included BREO. In October 2017, the patient received Influenza vaccine Quadrivalent. In October 2017, less than a month after receiving Influenza vaccine Quadrivalent, the patient experienced respiratory tract congestion, wheezing, cough, general body pain and sickness. On an unknown date, the outcome of the respiratory tract congestion, wheezing, cough, general body pain and sickness were unknown. It was unknown if the reporter considered the respiratory congestion, wheezing, cough, general body pain and sickness to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The caller wanted to remain anonymous and wanted to disconnect. Limited information was provided. The caller reported that the patient who was her friend, was younger than her, also had a flu shot (unknown manufacture), and got sick from the flu shot and experienced the same issue of congestion, body aches, wheezing and coughing. This case has been linked to case US2017165605 reported by same reporter.
Stabbing pain in uterus immediately after exposure to COVID vaccinated individuals and chronic pain in ovaries since March 2021, which gets worse after exposure to COVID vaccinated individuals
infected one of them (pertaining to her grandsons), he's also vaccinated (with Pfizer covid-19 vaccines); infected one of them (pertaining to her grandsons), he's also vaccinated (with Pfizer covid-19 vaccines); This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 13-year-old male patient received BNT162b2 (BNT162B2 NOS), 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), outcome "unknown" and all described as "infected one of them (pertaining to her grandsons), he's also vaccinated (with Pfizer covid-19 vaccines)". Clinical course: Caller was a retired Registered Nurse. She stated that she had infected one of her grandsons, he was also vaccinated with Pfizer covid-19 vaccines. He did not had a long positive with a fever, missed an important musical piece, 13 years old.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal association between the reported adverse events drug ineffective, Covid-19 and the suspect product BNT162b2.,Linked Report(s) : US-PFIZER INC-202300165347 same reporter/product, different patient/event;
over 42 days, 1st dose 05/28/2021, 2nd dose 09/13/21
Initial misuse report received from a healthcare professional on 06 June 2013. A 15-year-old patient had received a dose of ADACEL in September 2010 and then received again last week. No adverse event was reported. List of documents held by sender: none.
After receiving the vaccination I experienced a severe headaches, stinging , pain and  tingling in my left arm. On day 5 and 6th the tingling was intermittent accompanied by itching,  Very painful left arm.