chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient under 4, received Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient under 4, received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 24-APR-2023 The physician reported a patient under the age of 4 received the Kinrix vaccine. Not able to consent to follow-up due to chat disconnecting. The patient received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This case is linked with US2023059942, reported by same reporter.; Sender's Comments:  US-GSK-US2023059942:Same reporter
Fever; Flu like symptoms; Social problem; This case was reported by a nurse via call center representative and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, influenza-like symptoms and social problem. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported but could be 67 or 68 years. The patient after 1st dose experienced fever and flu like symptoms lasting a day and a half. The patient was told by physician not to get the next dose in Mar due to the Covid virus the patient question was is it safe to get it during this pandemic and can get it later than June.
Lymph node reaction with streaking across chest and neck swelling. Had loss of mobility in left shoulder.
flushed, dizziness, nausea within minutes after vaccines. Patient reminded seated, removed sweater, fanned self. Started to feel better within 5-10 minutes. Waited in store 15-20 minutes to make sure well enough to leave. Felt much better, no longer flushed, dizzy, or nauseated when left. Was going to go home and take it easy/more slowly rest of day and monitor for symptom return and reach out to Dr. if needed or continued
Patient received a dose of Moderna and is only 17 years old. Moderna is not currently approved for patients less than 18 years old.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 30th June 2018, refer linked case US2018GSK209685). On 7th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 8th November 2018, 1 days after receiving SHINGRIX, the patient experienced inability to work. In November 2018, the patient experienced injection site pain, headache, fever, shivering, sleeplessness and nasopharyngitis. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the headache, fever, shivering, sleeplessness, nasopharyngitis and inability to work were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, fever, shivering, sleeplessness, nasopharyngitis and inability to work to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced soreness at the injection site, headache, fever, and shivered all night. The patient said that she slept very little because she was cold and could not get warm. After receiving SHINGRIX, the patient missed work the next day. The patient's arm was still slightly sore however, all other symptoms resolved within 24 hours. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information.
89 year old male experienced two weeks of crippling weakness in  the lower extremities. Inability to get out of bed. Required assistance from family member living outside the home. He reported his symptoms after they had already resolved, approximately 2 weeks after vaccination.
Pt recv vax on 10/12/98; on 10/13/98 pt exp noise in ears, loud hearing & roaring, sensitivity to sounds & dizzy. Dx=tinnitus
My autoimmune disorders were generally in remission. About a day after vaccination, I started experiencing severe joint pain in my hands, feet and sternum, my eczema  on my stomach, chest and face, I began having bloody stools and developed giant papillary conjunctivitis (the last occurred 10 days after vaccination).  Most have calmed down naturally within 2 weeks.
Presented with weakness, generalized, and mild sweating.  per patient " I typically get weak and sweaty when I stand prolonged periods of time."  patient states symptoms pre vaccination and continued after vaccine."   patients symptoms improved after sitting in chair, no other symptoms.
Left Lymph Node swollen 2 days after the shot - this was resolved in about a week Started to develop headaches 3 or 4 days after the shot and they are continuing as of today.  Headaches are usually behind the eye and temple, some times in the back of the head in addition
A report was received from a health care professional on 11/26/03 concerning a 45 year old female vaccinee who was administered Fluvirin vaccine in the buttocks on 10/30/03. On 10/30/03, the vaccinee requested Fluvirin be administered in the buttocks instead of the deltoid. The vaccine had not exhibited any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Pt given HPV vaccine IM injection as well as Varicella SQ injection. Pt had syncope at check out desk and required staff intervention.
~ 10 minutes after receiving the vaccine, patient began feeling dizzy and then felt hotter than normal with facial flushing noted.  Vital signs were taken.  Initially B/P 132/84, pulse 97, O2 sat. 97%.  No loss of conciousness.  Remained awake, alert, responsive and oriented x 3.  Husband in vehicle during entire time.  Staff assisted patient in reclining seat.  Continued to monitor vital signs. B/P 126/82, pulse 74, O2 sat 97% 5 minutes later.  ~ 10 minutes later, vital signs were B/P 120/72, Pulse 70, O2 sat 97%.  Patient felt "back to normal self" about 5 minutes after feeling first signs.  Patient states 120/70 is her baseline.
On April 12, 2021 experienced extreme dizziness at about 1 pm while standing. Immediately sat down and put my head lower than my heart. Extreme dizziness lasted about half hour and continued to be dizzy for another hour or so. Slept about 1.5 hours and felt ok upon wakening. Light Dizziness/fogginess April 13, 14, & 15 mid-day. Lasts off and on for a few hours.
This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency and route were not reported). No adverse events were reported. Additional information has been requested.
Approximately 4 months after I got my booster shot (Dose 3) I contracted COVID-19 and had the following symptoms: fever, chills, fatigue, sore throat and it all lasted for 3 days except for the chills and recently I just had an intense cough. I was prescribed with benzonatate and PAXLOVID, as of today 05/23/2022 I still have some lingering cough and have not fully recovered from it.
Patient received 3 doses of Moderna vaccine. March 11, 2021, 4/28/2021, and 6/11/2021.
Right arm extremely painful. Extreme pain in joint and deltoid. No redness or swelling.
In the morning, I started feeling body aches, headaches, nauseated, very tired as well. Due date September 16, 2021
16 hours post vaccination, fever of 102, extreme fatigue, sore joints.  Took Tylenol throughout the day to reduce fever and pains.   Following morning fever was down to 100, fatigue and joint pain were mostly gone, but the injection site is still swollen, red, and very sore.
Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. No relavent medical history . The patient did not have any allergies to medications, food, or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), ramipril (PROVACE) and levothyroxine sodium (SYNTHROID) for unknown indication from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:  EN6205) via an unspecified route of administration in the left arm on 12Mar2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 13:00 the patient experienced Hives all over body. Unknown if the patient received any treatment for the events. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the event Hives all over body was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Pain at injection insertion, administration, and following administration. On 8/14/13, patient noted redness/ swelling left upper forearm 26length x11cm. Decreased range of motion of arm. Tenderness along left trapezius muscle area. (improved range of motion 8/15/13).
pt tested positive on 10/22/21. symptoms started on 10/22/21 also: congestion, body aches, HA, fatigue.
I had rash on my torso/stomach that was itchy. It was a faint rash but more itchy than visible.  There was a few spots on my back. It took a few days for the rash to go away. I used Hydrocortisone cream
Suspected vaccination failure; shingles; painful; frustrating; 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 for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and frustration. On an unknown date, the outcome of the vaccination failure, shingles, pain and frustration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and frustration to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was vaccinated and had shingles for third time at the time of reporting.  The patient stated that, it was so frustrating and painful.  This time the patient had shingles beside eye. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided. Note: From the narrative it was not clear if the patient had shingles three times after taking vaccine or not, hence shingle was coded only once.
Chills began 12 hours after lasted for 3 hours body aches/fatigue/headache began 12 hours after lasting ~24 hours
Moderna Covid-19 vaccine, bivalent received; No Adverse event; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Moderna Covid-19 vaccine, bivalent received) and NO ADVERSE EVENT (No Adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 059S22A and AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Moderna Covid-19 vaccine, bivalent received) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Moderna Covid-19 vaccine, bivalent received) was resolving and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Moderna Covid-19 vaccine, bivalent received).    No relevant concomitant medications were reported.  No treatment information was provided.
Breakthrough case admission after 2 vaccines Pfizer 5/10/21 Lot# Ew0182;  Pfizer 6/4/21 Lot# EW0191
Gasping for Air; Turned Grey; Hives; anaphilactic reaction; Eyelid Angioedema; Lip Swelling; Emesis; This case was reported by a physician via call center representative and described the occurrence of anaphylactic reaction in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 30th September 2012, the patient received Kinrix. On 30th September 2012, less than an hour after receiving Kinrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), eye angioedema (serious criteria GSK medically significant), lip swelling, vomiting, gasping, skin discoloration and hives. On an unknown date, the outcome of the anaphylactic reaction, eye angioedema, lip swelling, vomiting, gasping, skin discoloration and hives were unknown.   It was unknown if the reporter considered the anaphylactic reaction, eye angioedema, lip swelling, vomiting, gasping, skin discoloration and hives to be related to Kinrix.  Additional details were provided as follows: The physician reported that patient had an anaphylactic reaction to Kinrix, when given concomitantly with other vaccines. The events occurred within minutes of administration in September 2012. The physician did not had batch number or expiration date of Kinrix.
The night p/the vax were given, on 13SEP91, mom went into pt room to check on & felt that pt was "not breathing" taken to ER where pt appeared well but had t101.5 R; Hospitalized for 2 days-apnea monitor alarm sounded 3 times during hosp;
pt recv vax 23APR98 & arm became red, pain from inj site to mid arm measurement 4 3/4across & 5 1/2inch long);had been seen in ER;
A non-serious spontaneous report of some of H1N1 went into his eyes was received from a registered nurse concerning a 15-year-old male. The patient's medical history was not reported. On 11-Nov-2009, the patient received H1N1, Intranasal and some of the vaccine went into his eyes when he moved his head during administration. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Swelling/pain in lymph nodes in left armpit.  Symptoms presented 5 days after receiving the injection and persist.
Left deltoid erythema with hyperpigmented scaly area & was prescribed Cephalexin (250mg/5ML)
Fever, nausea, malaise, rash on neck - lasted approx 48 hours
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-AUG-2007 the patient was vaccinated with VAQTA dose 2 for prophylaxis. On 22-AUG-2007, 5 months 27 days after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to VAQTA.     {Additional information has been requested.}
Patient experienced loss of consciousness, difficulty breathing, muscle rigidity, nausea and vomiting. 911 was called. Patient declined transport to hospital.
hives; itches so bad; body rash; Her feet hurt so bad; joint pain; This is a spontaneous report from a contactable consumer (patient, reported for herself).  A female patient of unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via unspecified route of administration on 18Mar2021 as a dose 2, single for covid-19 immunization. The patient stated she was allergic to the Pfizer covid vaccine. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: not reported), via unspecified route of administration on unspecified date as a dose 1, single for covid-19 immunization and experienced Few hives, swollen lip, Allergic to the Pfizer covid vaccine. On an unspecified date in 2021 she broke out in hives, with the second dose. Her doctor prescribed her steroids and the hives/rash comes back once she finishes the steroids treatment. The patient stated that it itches so bad, she has body rash, have joint pain, her feet hurt so bad. Patient queried for what she can do about her symptoms. Therapeutic measures were taken as a result of hives, itches so bad, body rash. Outcome of hives, itches so bad and body rash was not recovered and for feet hurt so bad and joint pain was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
fever of 99.8°; felt achy; really bad headache; normal arm sorenes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (normal arm sorenes), HEADACHE (really bad headache), PAIN (felt achy) and PYREXIA (fever of 99.8°) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (normal arm sorenes). On 21-Feb-2021, the patient experienced HEADACHE (really bad headache). On 22-Feb-2021, the patient experienced PAIN (felt achy). On 23-Feb-2021, the patient experienced PYREXIA (fever of 99.8°). On 22-Feb-2021, HEADACHE (really bad headache) had resolved. On 24-Feb-2021, PAIN (felt achy) and PYREXIA (fever of 99.8°) had resolved. At the time of the report, PAIN IN EXTREMITY (normal arm sorenes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Itching, headache, nausea, lump in throat feeling. Treatment 80mg DEPOMEDROL IM, PHENERGAN 25mg IM, BENADRYL 50mg PO, TYLENOL 1000mg PO.
Nausea; muscle cramps; vomiting; muscle rigidity in jaw, neck and tongue; unable to open his jaw; Initial information received on 18-Nov-2009 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 66 years old male patient who experienced nausea, muscle cramps, vomiting, muscle rigidity in jaw, neck and tongue and unable to open his jaw, while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 15-Oct-2019, the patient received a dose  dose of suspect RABIES (HDC) VACCINE lot TIC85 via unknown route in unknown administration site.  The patient developed a non-serious nausea <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious muscle cramps (muscle spasms) <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious vomiting <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious muscle rigidity in jaw, neck and tongue (muscle rigidity) <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious unable to open his jaw (trismus) <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. Final diagnosis was unable to open his jaw, muscle rigidity in jaw, neck and tongue, Severe vomiting, Severe muscle cramps and Severe nausea.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for nausea, as Unknown for muscle cramps, as Unknown for vomiting, as Unknown for muscle rigidity in jaw, neck and tongue and as Unknown for unable to open his jaw.
Fell on day after due to dizziness, compression fracture resulted from fall,  shortness of breath,  delusional, depression, confusion, weak legs
Swelling, redness around injection site. No treatment at home clinic, received compresses, Benadryl. Swelling of left thigh. (presumed to be 2 degrees DTaP).
At a routine lab appt for a CBC, my platelets were lower than normal at 82,000.  I have never had a hx of low platelets prior to this.  This continued for several months and they dropped even lower - to undetectable at one point after I recv'd a series of MMR vaccines.  I was on and off oral steroids and had IV steroids at times as well.  I know this is several years later, but I decided to file this now as I wasn't aware of this system until recently.  Thank you.
On12/17/20 staff member received 1 st dose of Pfizer vaccine / 2nd dose received  1/6/21 staff member  5/17 tested - 5/19 POSITIVE result with no symptoms   *staff member had the virus back in April of 2020
About 9 hrs after vaccination began to have fever, chills, achy bones; vomited x one 11/12/09. No appetite. 11/13/09 now doing fine.
After I received the vaccine,  I went home, then I came back into work that night. Around 1am  when I started experiencing chills along with general malyase. When I got off, it was general fatigue then headache. When I got home, I started having joint pain and muscle aches. I never had a temperature.
It's been a year since first shot; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.