chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 29-JUL-2016 in the form of an initial legal complaint regarding an approximately 17 year old female consumer who was administered a series of three GARDASIL injections from 04-MAR-2010 through 20-JAN-2011. As a result of the three GARDASIL injections the patient experienced serious adverse immunological and other disease reactions beginning approximately in March 2011 and continuing thereafter until this date. Due to the complexity and heterogeneous nature of her disease process the patient's actual disease process remained medically undiagnosed until approximately August 2015, when diagnosed as a postural orthostatic tachycardia syndrome (POTS) with a further diagnosis in February 2016 of an underlying small fiber neuropathy existing within and throughout her body. Prior to February 201, without an adequate medical diagnosis of the patient's underlying disease process, it was not reasonably known, ascertainable or ascertained that there was a causal connection between GARDASIL and the disease process. However based upon the foregoing diagnoses plaintiff believes that the GARDASIL vaccinations were the proximate cause of her underlying disease process. Additional information has been requested.
Starting 05/01/2022, I started getting a rash on my leg. I thought it was an allergic reaction to something outside because I was working outside. It started spreading to the left side of my body and was burning. So, I decided to go to the clinic and they diagnosed me with Shingles. I was given an antiviral, valacyclovir, which I took for 7 days and it subsided. They said it was most likely a stress reaction due to my father passing away. The pain and the rash remained on my left side and never spread to the other side of my body during this event.
Td booster given in left arm on 09/20/2003.  Patient reaction 09/22/2003-said Td site became red, hot, hard and swollen yesterday.  Patient also feels like she has the flu/upset stomach.  Temperature has been ok.  No treatment given for Td site.  Patient on Cefzil for sliver wound through.
SOB CLIENT C/O FEELING LIKE A LUMP IN HER THROAT . BP 145/66 HR79 RR22 SPO2 @ 100% ON ROOM AIR  SHE RECEIVED 1ML OF IM BENADRYL . ASSESSED 30 MIN, CLIENT STATES FEELING MUCH BETTER TEACHING REINFORCED TO CALL 911 IN SYMPTOMS REAPPEAR. CLIENT VERBALIZE UNDERSTANDING OF INSTRUCTIONS.
Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mild, Systemic: Patient felt faint then had an overall body flushing sensation, quickly went away shortly after vaccination-Mild
Injection site pain; Tiredness; Chills; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EB8732), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00(at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ZICAM and calcium supplement (MANUFACTURER UNKNOWN)from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 17:45, the patient experienced injection site pain, tiredness and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the vaccination site pain, tiredness and chills was recovering.   No follow-up attempts are needed. No further information is expected.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 23-NOV-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Extreme fatigue for 36 hours. Injection site tenderness for 2 weeks now.
Broke out in rash & blisters - itched extensively - blisters kept appearing for several weeks. Received shots 9-17-10. Broke out 9/20/10. May have had MMR years previously - have had all 3 diseases MMR.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Had welt on flu shot site with small blisters. Blister and welts cleared up. Doing fine. Case closed. 11/25/2003
Experiencing moderate to severe ulnar nerve neuropathy or cubical tunnel syndrome (aka funny bone) since receiving first shot, worse after 2nd
Diagnosed with COVID; Felt pretty sick; Breathing issues; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID), MALAISE (Felt pretty sick) and DYSPNOEA (Breathing issues) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID), MALAISE (Felt pretty sick) and DYSPNOEA (Breathing issues). At the time of the report, COVID-19 (Diagnosed with COVID), MALAISE (Felt pretty sick) and DYSPNOEA (Breathing issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.    This case was linked to MOD-2021-067968 (Patient Link).
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (oka-merck) PROQUAD (dose, route and lot number were not provided). No adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at this time. On an unknown date unspecified number of patients were vaccinated with (oka-merck) PROQUAD (lot# K000709, expiration date 16-JUL-2015). No further information was available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received Gardasil #1. 10 minutes after receiving shot patient fainted. Regained consciousness within seconds. Dizzy for another 10 minutes. Blood pressure 100/70, pulse steady and regular. Pt recovered and left office 1/2 hour after fainting
severe reaction to it, he is dizzy and he can't stand up; severe reaction to it, he is dizzy and he can't stand up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DIZZINESS (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "severe reaction to it, he is dizzy and he can't stand up".  Additional Information: The reporter was asking if the events was normal or will it go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pins and needles all over my body-- arms, neck, face, back legs, butt, chest, head, etc.  Started on 2/9/21 -- the pins and needles have not stopped (today's date- 2/28/21)
Initial unsolicited report received from other Health Care Professional on 19-Jun-2018. This case involves a five months male patient who were vaccinated with PENTACEL (batch number: C5325BA and expiry date: 14-Nov-2019) and MEASLES VACCINE; MUMPS VACCINE; RUBELLA VACCINE; VARICELLA ZOSTER VACCINE (batch number and expiry date not reported) (dose, dose in series, route and site of administration were not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination patient exhibited a 101 fever at night and when he woke up he presented with a lower grade fever. No Lab data was reported. It was unknown if patient received any corrective treatment. The patient outcome was recovered/resolved on an unknown date for the event. List of documents held by sender: none.
Moderna COVID dose was given to unautherized age group- age 16 No adverse reaction
Persistent Itchy red rash on chest, arms, and legs. Zyrtec and Cortisone cream are not effective.
Customer called 10-18-13 morning complaining of pain on left side of neck. She felt a lump Thursday morning on 10-17-13 and says its painful. Advise cust to contact MD go to the emergency room.
Information has been received from a pharmacist concerning a 64 year old female patient with no pertinent medication history or drug allergy who on 21-MAY-2012 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck). There was no concomitant medication. On 04-JUN-2012 the patient developed tingling and stinging pain on the arm and back after receiving ZOSTAVAX (Merck). Patient sought medical attention by contacting pharmacist. There was no lab diagnostics performed. At the time of report, the patient was not recovered. Follow-up information has been received from the pharmacist, concerning the 64 year old female patient, with no pre-existing allergies and medical conditions, who on 21-MAY-2012 was vaccinated subcutaneously with the first dose of ZOSTAVAX (lot # 672606/1655AA, Exp. 21-JAN-2013) and experienced stinging back pain, stinging pain on arms and legs. Additional information is not expected.
Developed hives that came and went. Given CLARITIN and BENADRYL with little relief. Seen in office 3 times for this and had some body swelling as well. Symptoms completely resolved approximately 5/10/16. Also had been treated with amoxicillin during this time and had several possible environmental triggers.
Ischemic stroke, two clots in left brain. Results: right hand weakness, right side of face sagging, slurred speech.
Pt recv vax on 9/23/98; subsequently pt exp acne type skin condition on upper rt arm & LA.
This spontaneous report as received from a 55 year old female patient regarding herself. Patient's relevant medical history was unknown. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant medication was unknown. On an unknown date in 2012, the patient experienced swelling at injection site, missed work for several days and returned to the doctor. Diagnostic tests carried out were unknown. The outcome of swelling at injection site, missed work for several days was reported as recovering/resolving (also reported as resolved). The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected.
Inactivated Influenza Vaccine 0.5ml administered to patient intramuscularly into left arm using 1" needle. Initially patient appeared fine. His 2 siblings also received their flu vaccines and his sister was seen by physician. About 5 minutes later, the family was leaving the exam room and standing in the hallway when patient appeared dazed and fell to the floor, unresponsive for 5-10 seconds. He initially had 1 twitching movement of his head after falling to the floor but no seizure activity. Regained consciousness in 5-10sec. Responsive and oriented. Appeared pale and felt dizzy. Recovered after ~ 10minutes of rest, intake of water, and candy. Sibling also developed lightheadedness, pallor after seeing patient lose consciousness. Sibling did not lose consciousness, recovered with rest, intake of water.
Fever 102 +, dizziness, "weakness" no concerns of muscle weakness on P.E. <24 hrs of symptoms.
Around 6 PM (after receiving my shot at around 12:30 PM), I started to feel very tired and slightly achy.  By around 9-10 PM, I had a fever of about 100.5 degrees with pretty severe chills, and my arm had started to hurt VERY badly.  For almost the entire rest of the weekend (from Friday night-Sunday), I was very fatigued and achy and could not lay on my left side due to the soreness in my arm.  The fever seemed to pass by mid-day on Saturday, though, and I was able to go back to work on Monday.  It was not pleasant, but it was totally worth it and a million times better than actually being sick with COVID!
Localized swelling, warmth and bruising at injection site, 3 days post-vaccination. Ice as needed.
w/in 2 hrs p/vax of DTP devel incontrollable crying, shakes & fever to 103; given APAP for fever; taken to hosp ER; dx as rxn to DTP & released; pt devel hives;
Had generalized tonic - clonic seizure 8 hrs after vaccines.  CT, labs EEG normal.
vaccinee (CASE #3) rec'd a first dose (lt deltoid) of engerix-B on 26JAN90 (third dose in series of Hepatitis B vax); Testing for titers 28FEB90 indicated did not seroconvert;
Information has been received from a consumer concerning an approximately 5 - 12 year old child who in approximately 1996 - 2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. The patient subsequently recovered. There was no product quality complaint involved.  Additional information has been requested.
Hives and tingling mouth.  2+ to 3+ diffuse hives head to toe.  As of 5/5/08 pt is still getting hives.  IV steroids in ER on 5/3/08.  Prescribed prednisone x 4 days, zantac, and benadryl.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 25-JUN-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 6706228/0952AA and expiration date 14-JUN-2013). No adverse effect reported. Additional information has been requested.
Smelled something weird; Palpitation; Chills; Fever 100.5F; Fatigue; Bruise 3"X 1"  slightly below Injection site after booster/Raised bruise area below Injection Site; Sore left arm Injection Site; Raised bruise area below Injection Site; Sore under left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise 3"X 1"  slightly below Injection site after booster/Raised bruise area below Injection Site), FEELING ABNORMAL (Smelled something weird), PALPITATIONS (Palpitation), VACCINATION SITE PAIN (Sore left arm Injection Site) and VACCINATION SITE SWELLING (Raised bruise area below Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE BRUISING (Bruise 3"X 1"  slightly below Injection site after booster/Raised bruise area below Injection Site), VACCINATION SITE PAIN (Sore left arm Injection Site), VACCINATION SITE SWELLING (Raised bruise area below Injection Site) and AXILLARY PAIN (Sore under left arm pit). On 09-Dec-2021, the patient experienced FEELING ABNORMAL (Smelled something weird). 09-Dec-2021, the patient experienced PALPITATIONS (Palpitation), CHILLS (Chills), PYREXIA (Fever 100.5F) and FATIGUE (Fatigue). On 10-Dec-2021, FEELING ABNORMAL (Smelled something weird), PALPITATIONS (Palpitation), CHILLS (Chills), PYREXIA (Fever 100.5F) and FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise 3"X 1"  slightly below Injection site after booster/Raised bruise area below Injection Site), VACCINATION SITE PAIN (Sore left arm Injection Site), VACCINATION SITE SWELLING (Raised bruise area below Injection Site) and AXILLARY PAIN (Sore under left arm pit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, Body temperature: 100.5 (High) Fever 100.5F (Usually at 97.6F). On 09-Dec-2021, Heart rate: 84 (High) raised resting Heart Rate 84 BPM (Usually 67 at rest).         Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-408457 (Patient Link).
Information has been received from an 80 year old female consumer who "may be allergic to nickel" and has a history of a hip replacement who on 11-APR-2008 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) on her upper right thigh. There was no concomitant medication. Subsequently, on 12-APR-2008 the patient had a dot, which was the size of an egg, that was hot, red and painful. The patient reported she put an ice pack on her thigh to help with the warmth, but she still had the red, warm egg shaped spot. The patient also reported the spot had spread a little bit and was pink on the edges. Medical attention was sought, the patient called the physician. There were no lab studies performed. At the time of the report the patient had not recovered. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from an 80 year old female concerning herself and follow up information was received from the registered nurse. The patient "may be allergic to nickel" and had a history of a hip replacement, who on the morning of 11-APR-2008 was vaccinated subcutaneously in upper right thigh with a first dose of ZOSTAVAX (Oka/Merck) (LOT# 658604/1088U). There was no concomitant medication. Then patient reported that on 12-APR-2008 she had a dot, which was the size of an egg, that was hot, red and painful. The patient reported that she put an ice pack on her thigh to help with the warmth, but she still had the red, warm egg shaped spot. The patient also reported that the spot had spread a little bit and was pink on the edges. The nurse reported, in conflict, that on the morning of 11-APR-2008, the patient noticed that the injection site was very red and warm, which lasted one week (and recovered). The nurse also reported that there was no pain "so far" and that no other complaints were verbalized by the patient. The final outcome of the pain reported by the patient was not reported. Medical atttention was sought, the patient called the physician. There was no lab studies performed. Additional information is not expected.
The injection site is swollen, very tender, and red. This started around 10 am on Jan 15th. I had a headache all day. Around 3 pm, I started having body aches and felt very tired. Around 8 pm I started having fever (100.6°F). I took ibuprofen and that helped. Today, Jan 16th, I feel good so far, no body aches, no fever. The injection site is still swollen, red, and tender.
nausea; diarrhea; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced nausea and diarrhea. On an unknown date, the outcome of the nausea and diarrhea were unknown.   It was unknown if the reporter considered the nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient reported that after receiving the 1st dose of Shingrix in late August, patient experienced side effects such as nausea, diarrhea. Patient was asking about 2nd dose should be worse or same.
error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. N treatment was provided by the reporter.
Started with pain in neck that radiated down the left side.  By 1:00AM I woke up with severe rigors that lasted appx 4 hours. This then turned into cold sweats and chills. Extreme fatigue throughout the next day keeping me asleep all day. Apx around 5:00am on 2/19/2021 I was able to go to work. Felt extremely weak and unable to list my 5 month old. Experienced headaches daily until  2/25/2021.