chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 19-MAY-2015 the patient was vaccinated with one dose of improperly stored VAQTA vial 25/0.5, (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same reporter. Additional informatino has been requested.
Coughing, shortness of breath edema of eyelids, erythema, tachycardia.
Patient states she had abdominal cramping, vomiting, diarrhea, cold sweats, body aches, headache, and a very sore arm the night of and day after vaccinations were received.
This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th October 2018, 56 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with famciclovir (Famvir). On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient's initials were not reported. The patient received SHINGRIX on left deltoid. The patient developed mild case of Shingles. The patient (nurse practitioner) visited her doctor and was treated with antiviral (Famvir 500mg TID for 7 days) and was already doing better at the reporting time. The pharmacist had consented to follow up.
28APR99 12MN fever of 105 w/croupy cough devel fever approx 13hr p/vax;seen by MD 1045AM on 28APR99;dx w/fever/croup & ?early rt om urine cult;
A phone call was made to the patient a couple days after his second vaccination and he reported that he had experienced feeling hot, nausea and fatigue starting the night of his vaccination.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two male patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 22-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received from the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Conjunctivitis, congestion, maculopapular rash, temp of 102.9F, treated with Augmentin
Swelling of knot at injection site to almost baseball size, rash extending out and down along arm. Treatment: ice, Tylenol for pain, antibiotics (keflex) for cellulitis.
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 40 years old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ052AB and expiry date: 09-Jun-2019) (dose in series and route was not reported) in the right deltoid instead of age appropriate annual influenza vaccine (Flu Vaccine) on 27-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to inappropriate age at vaccine administration, overdose and wrong vaccine administered. No adverse event was reported. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
pt recvd 3JUL95 & 3JUL95 parents stated pt slept through noc-(unusal for pt);w/in 24hrs had gagging episode seemed well following day;4JUL95 pt limp & pale & lethargy & resp irregularitis during this period;
Subsequent to receiving first and second doses of Lymerix, the pt experienced joint pain and soreness. Pts pain seemed to be located differently at times; in his neck, groin, knees and ankles. Recently his hands have hurt and he had difficulty grasping things, opening jars, etc. Most recently pt has had mild headaches at times, groin pain and could not stand on his feet for long periods. Physician prescribed doxycycline 100mg bid for 21 days. The most recent information reports the outcome of the event as unknown.
For the first vaccine, I started to develop 10 days later a red rash around the site of the shot, that lasted about a week, gradually began to fade away. For the second vaccine, I noticed 90 minutes after the vaccination, the base of my tongue started to feel sore, and it slowly began to get worse, started to notice swelling, no trouble breathing or swallowing, I then called my allergist, and he stated that it did not qualify as anaphylaxis. I took Allegra, and in 20-30 minutes I began to feel normal. A week after, I began to get a red rash again on the new site and it lasted about 24 hours.  Resting heart rate began to be elevated, and then went back to normal after a month.
Pt vaccinated with HIB developed 4x4 CM area of reddness at injection site.
Nausea.  Tiredness. Chills.    For 7 days now
Admitted to ER 3 days after vaccination of influenza and pneumoccal (PPV 23) on 2/7/08 for swollen arm.  Diagnosed with left arm cellulitis.
Arm pain. Cannot sleep on it for two days, limited range of motion, pain radiating  to elbow  on second day. Swelling the size of a golf ball at injection site.
Approximately one week after the injection, patient was still experiencing soreness around the injection site as well as numbness in the left thumb and tingling reaching up to the elbow. The patient called us and told us she would follow up with her physician if the symptoms persisted. She says that she is feeling fine at this point.
hospitalized from 9/17-10/20 for acute anoxic encephalopathy after unknown total downtime / cardiac arrest, respiratory failure, pneumonia, found to have MRI brain on 9/18 showing diffuse global anoxic injury, off all sedation since 9/21. On hospice, then transferred on 10/25 for aggressive medical treatment.
Pt had severe local reaction: marked tenderness, 8 cm diameter erythema, 6 cm diameter thick induration, + itching.
Red and swollen injection site for 2-3 days, chills, temperature over 100, muscle aches, diarrhea.
This spontaneous report was received from a office manager refers to a 9 year old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 04-OCT-2017 the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, units, route and frequency not reported) (lot # N013276 and expiration date: not reported) at a temperature of 29 Fahrenheit for 2 hours. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. Additional information has been requested.
Initial report received on 04 November 2008 from a consumer who was the patient's spouse. A healthy 27-year-old male patient, with no concurrent illnesses or past medical history, had received a intramuscular left deltoid injection of FLUZONE SV 2008-2009 on 29 October 2008. Four days later (02 November 2008), the patient began itching his scalp, face and axillary area and noticed red, raised bumps in that area. The rash (also referred to as hives) persisted and became widespread over the whole body. The patient self medicated with BENADRYL. The hives would come and go, but did not completely subside. The patient was evaluated by a physician (date not provided) who prescribed prednisone (route not provided). No relevant diagnostic tests or laboratory data were performed or collected. At the time of this report, the patient had not recovered, as the hives were still present and widespread over the whole body. Documents held by sender: none.
Woke up w/generalized hives; some swelling of knees, elbows, ankles; t102.8; seen by MD in office 10APR92 tx Atarax;
On 05/18/19 I received the first Shingrix shot without experiencing side effects.  On 07/17/19 I received the second Shingrix shot at 9:00 a.m. at the same Pharmacy and continued with my usual daily routine. At bed time (about 10:00 p.m.) I suddenly started to shiver uncontrolably and felt ice-cold for several minutes. When the shivers finally subsided, I fell asleep. The next morning (07/18/19) I felt slightly nauseated and very sweaty but forced myself to get up and feed the cat. When I was in the process of setting his bowl on the floor, I lost consciousness and collapsed on the concrete floor. My partner heard the shattering of the food bowl and found me. When I came to he helped me back to bed and called the ER at Hospital. The doctor on duty, urged my partner to bring me to the ER, since I had experienced syncope and collapse. By the time we reached the hospital, I was feeling well again (aside from a couple of bruises from the fall). Because the tests run by the ER staff showed no abnormalities, they concluded that the episode I had experienced was attributable to the Shingrix shot.  It turned out to be a very expensive shot.
RIGHT BELLS PALSY 9/5/2022,  9/27/2022,  1/24/2023  --  RECURRENCE OF SAME SYMPTOMS
Dizziness, Headache, Myalgia, Arthralgia, Fever, CHILLS, WEAKNESS Narrative:  Other Relevant History:
Abdominal pain; Diarrhea; Nose bleeds that took a long time to stop and that were quite heavy; Intense nausea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the left arm on 04Apr2021 at 13:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, functional dyspepsia, anxiety, depression, obsessive-compulsive disorder (OCD) and emetophobia. The patient was allergic to tree nuts. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) on an unknown date and for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 11:30, 24 hours after the vaccination, patient had diarrhea and further experienced multiple nose bleeds that took a long time to stop and were quite heavy, intense nausea and abdominal pain. 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 events. The clinical outcome of events multiple nose bleeds, intense nausea, abdominal pain and diarrhea were resolving at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
had Covid booster #2 at 4:30pm. Went to bed at around 10pm. Awoke at 1:30pm with muscle aches all over, palor, brain fog and could barely lift L arm due to pain. Took 2 Motrin and went back to sleep. Awoke next day with extreme lethargy, continued aches, light headedness, muscle weakness, chills. These symptoms continued with lessening intensity and as of this date 4/19 still feel tired and have minor muscle soreness.
Patient got onset of Shingles with confirmed viral test from MD. Symptoms includes blisters, pain, rash on lower right back. Also had elevated fever
Headache, Sedation, Diarrhea, NauseaVomiting, Metallic taste Narrative:
Got the Jansen COVID vaccine Woke up with uncontrollable shakes freezing along with very high temperature 102. Took Tylenol and fever broke around 3:00 A.M  Couldn?t sleep until around 5 am
Dizzy; Headache; Soreness in his body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness in his body), DIZZINESS (Dizzy) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced PAIN (Soreness in his body) and HEADACHE (Headache). On 15-Feb-2021, the patient experienced DIZZINESS (Dizzy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PAIN (Soreness in his body), DIZZINESS (Dizzy) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient is currently taking medicine for blood pressure, anxiety and depression
Fever started Thursday evening, followed by refusal to drink/eat, inconsolable crying at times, inability to sleep well, dehydration. Continues 3 days later. Currently still not sleeping/drinking/eating much at all. Only urinating 2x per day, being monitored with daily physician's office visits. Carefully monitoring and providing care at home to avoid need for IV fluids. Axillary Temp 103.1 morning of 7/16, 101.5 7/17, afebrile at present.
This spontaneous report as received from a consumer refers to a female patient of unknown age (consumer's sister, no demographics were provided). On an unknown date, the patient received two of the three-dose regimen of GARDASIL (dose, route, lot# and expiration date not reported). The patient (on unspecified date) then received CERVARIX (dosage unspecified, manufacturer also reported as unknown) as the third dose of the three-dose regimen, which was other-than-indicated in the GARDASIL prescribing information. No adverse effects were reported. Additional information is not expected.
This non-valid spontaneous report was received from a nurse referring to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patients were vaccinated with an unknown number of improperly stored dose of ROTATEQ, for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  The administered doses of the vaccine experienced a temperature excursion of above 47 Fahrenheit degrees for 27 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Local reaction: slightly vesiculated surface of central induration, warm. Area of light pink 9cm x 7cm, center with more erythema, indurated area of about 3.5cm diameter.  Area sore, a little itchy.
Tremors, Optic Uveitis, swallowing problems, hard to breathe, speech slurred, very hard to keep my thoughts, itching, numbness, burning in arms, legs, and face, swollen tongue, difficult to walk and drive, felt I was unbalanced, kept on falling, alot of pain, felt like my neck was broken, very weak in muscles, quick to fatigued, couldn't keep warm.
Case number PHEH2015US020987, is an initial spontaneous report from a pharmacist received on 15 Oct 2015. This report refers to a 10-months old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 09 Oct 2015. No adverse event reported following this medication error (inappropriate age at vaccine administration).
Still swollen, taking Benadryl, Tylenol.   Fatigued and achy but feeling  better 48 hours after initial vaccination
Shingrix induced trombocitopenya (ITP secondary to Shingrix); petechiae; lesions in his mouth; wide spread rash; nose bleed; This case was reported by a pharmacist via sales rep and described the occurrence of thrombocytopenia in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number DP2D3, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date).   On 7th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, 5 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant), petechia (serious criteria hospitalization), oral lesion (serious criteria hospitalization), rash (serious criteria hospitalization) and epistaxis (serious criteria hospitalization). The patient was treated with prednisone and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the thrombocytopenia, petechia, oral lesion, rash and epistaxis were unknown.   The reporter considered the thrombocytopenia, petechia, oral lesion, rash and epistaxis to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's Comments: the reporter stated that unclear why patient developed symptoms post 2nd dose by not after the 1st dose. The patient developed petechiae, lesions in his mouth, widespread rash and nosebleed 5 days post 2nd dose of Shingrix.  The patient was prescribed Valtrex and prednisone. The patient was admitted to the hospital 10 days after the 2nd dose of Shingrix.  The patient was then diagnosed with Shingrix induced thrombocytopenia (ITP secondary to Shingrix) by hematologist. Due to no other source for patient presentation, pharmacist believed this could be due to Shingrix.  The reporter consented to follow-up.
My hands went numb, it started in my hands and feet. My nose and lips were getting numb. Throat feeling weird. Hypertension. Next day weak and nauseated. 3 day i got hives and tongue was swollen. Back and neck pain. constipation, I couldn't breathe sitting down. body numbness in face, legs, hands, and feet. I had a cough and mucus in my throat. and very weak.
I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the following morning at 5am. Body aches/mild. Worked the next day but had to leave an hour early due to fatigue and body pain. That evening developed nausea. (2-26).  The 27th I had a terrible headache upon waking with increased nausea. Started vomiting around 10am. Unable to take in any liquid until that evening late. The 28th mild headache, more of a heavy headed feeling. Today, March 1st, nausea without vomiting thus far, weak & drained feeling.
Moderna on 1/29 and 2/24. Positive on 9/12
Woke up at 2.30 am after getting the first dose and felt nauseous, and had fever chills and a headache and slightly disoriented. Was unable to sleep until after 5 am. Woke up around 10.30 am with a bad headache that stayed for several hours. Also tenderness, pain and redness in the arm that received the shot for 2-3 days.
I was a perfectly healthy teenage girl with absolutely no health conditions at all. I was in college and graduating high school and then I got high blood pressure first and then that ended up turning into anxiety, depression, tremors, muscle pain, weak arms, hair loss, really scared of dying, really fast heart rate. I havent been able to drive my car in months and it has depleted most of my vitamins.
4/1 and 4/2  Swelling and redness to injection site, warm to touch - fever 100.00, nausea, diarrhea , swelling size - tangerine sized 4/3 swelling down to golf ball sized, temp 99.6,  diarrhea
rash & low grade fever 10 days p/vax;pt saw MD on 10FEB98 & was told it was rxn to the vax;
Fever, sore throat, swelling at injection site, diffuse maculo papular rash.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Information has been received from a Nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 16 year old female patient with no known drug allergies who on 15-DEC-2008 was vaccinated with a dose of GARDASIL 0.5 ml intramuscularly. Concomitant therapy included MOTRIN. On 15-DEC-2008 the patient was administered GARDASIL intramuscularly and was determined to be pregnant. No adverse effect was reported. Follow up information from a nurse practitioner indicated that the patient hasn't been into the pediatric clinic in a while. She "scrutinized the patient's chart for adverse events following the GARDASIL vaccine". The patient had been seen for sore throat and other minor complaints but there was no mention of pregnancy at any of those visits. She did not have any more information to provide on the patient. This patient was now considered lost to follow-up for the pregnancy registry. No further information is available.
After having received his first dose of COVID vaccine, shortly after pt went to bathroom, and after leaving the bathroom experienced syncopal episode. Pt fell forward and hit his forehead. staff responded immediately, pt regained consciousness quickly and said he felt ok. no other notable injuries. Charge/manager notified, EMS called, vitals taken. pt safely escorted with EMS, cleared to go home.
Patient called office saying she was having difficulty breathing and chest tightness-advised to go straight to nearest ER.
Pt developed stuffy nose and sneezing. These increased in severity and also his eyelids became swollen. Was given Epinepherine. BP 90/50 at discharge O2 Sats-99 and B/P 104/80. Stable