chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had persistent headaches since the vaccination date. I developed a headache (HA) within 30 minutes of receiving the dose, and for 14 days straight I was so fatigued and had a persistent HA, it was hard to go to work. Ever since then, I have headaches almost daily. About half of them turn into migraines and the other half are just general HAs, and I continue to feel somewhat more fatigues than I did prior to vaccination. I have not felt ?right? since vaccination. I don?t remember a day where I did not have a headache- even if I wake up feeling well the HA develops within a few hours. It cannot be attributed to medication overuse because I rarely take medications to treat them for fear of causing medication-overuse-headaches.  I am a healthcare provider.
A patient who received her first dose in 2018 and was now looking to continue the series.; No Additional AE details are available.; This spontaneous report was received from a Registered Nurse, referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  In 2018, the patient was vaccinated with her first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis, and was now looking to continue the series. No additional adverse event details are available.
This is a spontaneous report from a contactable pharmacist. A 90-year-old female patient received PREVNAR 13 (Lot Number: N17827, Expiry date: Nov2017), intramuscular in the left deltoid on 06Dec2016 at single dose for immunisation and AFLURIA (Lot Number: 13849221A, Expiry date: 30Jun2017), via an unspecified route of administration on 06Dec2016 at unspecified dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced ongoing pain in her shoulder almost from 9 months on 06Dec2016. The outcome of the event was not recovered. The pharmacist considered that the event was possibly related to the suspect drugs.
Case number PHEH2015US019021, is an initial spontaneous report from a nurse received on 24 Sep 2015. This report refers to a 24 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN, (batch number: 1515401) in the butt (gluteal region) on 24 Sep 2015. No adverse event was reported.
At first it felt like I received a Tetanus shot. It was stiff and painful. I have been icing it and using a heating pad and taking medication for the pain. There is pain, swelling, redness around the injection site. It is hot to the touch.
left facial decreased sensation, difficulty smiling on left side. Dx Bell's Palsy. prednisone 60 mg daily x 7 days.
Information has been received from a physician concerning an 8 year old Caucasian male who on 5/10/00 was vaccinated IM with a 5th dose of Hep-B in the left deltoid. Subsequently, the pt developed a local reaction at the injection site on the left shoulder which involved a rash 7-9cm large with mild erythema, swelling but no tenderness or fever. The pt sought unspecified medical attention and was treated with Benadryl. On an unspecified date, the pt recovered. It was noted that the pt did not experience a reaction after the 1st dose. No further information is expected.
NOSE BLEEDS; NORMAL BODY ACHING; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced nose bleeds. On OCT-2021, the patient experienced normal body aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nose bleeds and normal body aching was not reported. This report was non-serious.
Received vaccine at work on 12/23/20 at 1600. No problems receiving it. No pain at site or afterwards. about 12 hours later (04am) on 12/24/20, I woke up with body aches and was especially across my shoulder blade area. Had headache. Up that morning. Spiked T-102.5 orally with horrible headache. Temp did break on 12/24/20, but did come back later that day T-101. Continued with horrible headache, body aches, became very sore at injection site. Lethargic. No appetite. Diarrhea.
approximately 5 min post administration - pt complained of tingling sensation in her throat, administered 25mg oral benadryl, called EMS, she left with them once they arrived
Extreme increase in anxiety.  Was going through perimenopause for 9 months and then I had different period than I normally have had.  One day of bleeding, with severe cramps for multiple days.
Some slight heart discomfort - trouble raising left arm fully. Perhaps some form of pericarditis?
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: Patient lost consciousness and hit her forehead during the 15 min wait time. Pharmacist aided and helped patient control her movements. Gave her ice pack to apply on forehead. Offered to call 911 for emergency but patient declined. Monitored patient until she regain strength and was able to answer questions about her name, date, where she is, what her plans were. Called patient 30 min later to follow-up to make sure she was okay at her hair appointment.
long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that; once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average; she has no sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that), HYPERSOMNIA (once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average) and AGEUSIA (she has no sense of taste) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-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 POST-ACUTE COVID-19 SYNDROME (long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that), HYPERSOMNIA (once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average) and AGEUSIA (she has no sense of taste). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that), HYPERSOMNIA (once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average) and AGEUSIA (she has no sense of taste) outcome was unknown.            Patient did not eat or drink and lost weight.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company Comment: This is a Spontaneous case concerning a 72-year-old female patient, with medical history of COVID-19, who experienced the unexpected, nonserious, and AESI events of Hypersomnia and Ageusia. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. 5-6 months after second dose, patient was diagnosed as a long hauler. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 72-year-old female patient, with medical history of COVID-19, who experienced the unexpected, nonserious, and AESI events of Hypersomnia and Ageusia. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. 5-6 months after second dose, patient was diagnosed as a long hauler. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
7:48 Flu shot given.  7:49 Patient passed out / potential seizing??  7:50 administered EPIPEN.  Patient began coming back to awareness very shortly after EPIPEN.  Patient refused to go with ambulance crew.
Received Td right deltoid on 09/09/2003.  States that on 09/15/2003, noticed small round swelling at site of injection on 09/17/2003 in late afternoon it had grown was hot, raised, red, itchy.  Today 09/18/2003, erythematous area measuring 100 mm diameter and radiates down arm, upper arm only.  No fever reported.  Referred to community health center.
Vaccine 03/02/21. Felt fine without side effects until awakening late on 03/04/21 with very severe abdominal pain. This pain persisted for at least 2 weeks. I did not sleep except in 5-10 minute intervals, and I would reawaken due to severe pain. The pain was worse than the pain I experienced after a bowel obstruction and ileostomy surgery, and I'd never felt pain like it previously. I also did my normal IVIg infusion as scheduled around 03/06/21 or 03/07/21. I got the second dose of the vaccine 3 weeks after the first and again had bad side effects. Prior to March, my weight had been stable (and at a lifetime high for me) at 125 pounds and 5'7." I have subsequently lost almost 20% of my body weight, and the cause is still unclear at this time. Possibly some kind of new malabsorption. I also had two transient ischemic attacks (lost use of dominant arm and facial drooping); one at the end of March and again in April. Since March, I have also experienced recurrent episodes of diffuse bruising, especially on my legs.   Now uncertain if booster would cause more harm and if being on IVIg contributed, but have not yet gotten a booster.
This is a spontaneous report from a contactable nurse who reported the same event for eight different patients. This is the 1st of eight reports. A patient (baby) of unspecified age, ethnicity and gender received PREVNAR 13 (Lot # N16560, Expiry Date 30Sep2017, NDC number  0005-1971-02, UPC number 30051971022), via an unspecified route of administration at 0.5 ml, single on an unspecified date in Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The maximum temperature was 49 degree Fahrenheit and in response to minimum temperature, nurse stated that it did not go outside of the range negatively, it was only too warm. Nurse provided the duration of temperature excursion as 52 minutes. In Oct2016, the patient received the vaccine after temperature excursion with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016474382 Same reporter/drug/event, different patient.;US-PFIZER INC-2016474285 same reporter/drug/event, different patient.;US-PFIZER INC-2016474390 Same reporter/drug/event, different patient.;US-PFIZER INC-2016474345 same reporter/drug/event, different patient;US-PFIZER INC-2016474367 same reporter/drug/event, different patient;US-PFIZER INC-2016474369 same reporter/drug/event, diff patients;US-PFIZER INC-2016474374 Same reporter/product/event, different patient
Case number PHEH2044Us003643 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with follow-up received on 25 MAR 2014. This case refers to a 13 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 009031SA and expiry date: JUN 2014) at dose of 0.5 ml intramuscularly on 04 NOV 2013 at 7:30 PM.  No adverse event was reported following this administration error.  Follow-up received from a pharmacist on 25 MAR 2014. Time of vaccinated was updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information receive don 25 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed form listed to unlisted and added second indication as "drug used in unapproved population".
Nausea; severe stomach cramping with vomiting and dry heaving. Cramping lasted several hours,; severe stomach cramping with vomiting and dry heaving.; severe stomach cramping with vomiting and dry heaving.; DOSE 1: 29Mar2021; DOSE 2: 12Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Apr2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The medical history included hypothyroidism, IBS (irritable bowel syndrome) and gluten sensitive. 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 vaccination. The concomitant medications included levothyroxine sodium (SYNTHROID), epidium meyenii root (MACA ROOT), withania somnifera (ASHWAGANDHA) and chaseberry(unspecified); all taken for unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 07:00, the patient experienced nausea and severe stomach cramping with vomiting and dry heaving. It was reported that cramping lasted several hours. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, severe stomach cramping with vomiting and dry heaving was recovering at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
itching 48hr p/vax lt arm started bruising which extended to the elbow;MD called & said became jaundiced;MD felt bruising probably not from vax;poss bile obstruction;
patient had chills, extreme fatigue unable to get out of bed for 13 days, dizziness/lightheadedness, brain fog
Pt had fever, headache, tightness with breathing, asthma like symptoms. Pt spoke to MD office, used albuterol inhaler and nebulizer, prednisone ordered. No hospitalization required but telephone calls, multiple time office visit.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP via a other company. This case involves an adult female patient (age was not reported) who experienced allergies, while she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported. On an unknown date the patient developed a non-serious allergies (hypersensitivity) following the administration of TETANUS TOXOID. No lab data reported. Final diagnosis was allergies. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergies.
1. Soreness at injection side immediately after administration, duration around 6 hours 2. Significant headache presented in front and sides of head (near temples), beginning day 1 after injection, with duration of 4 days. 3. Fatigue presented on day 1 after injection, duration of 4 days. 4. Mental health symptoms after day 1, with duration of 5 days, presenting as feelings of sadness and depressive ideation.   The last symptom (#4) is difficult for me to correlate specifically to the vaccination, as I am a 60 year-old and in my first year in a rigorous doctoral program at a hospital. The negative physical symptoms experienced by the injection could have added an extra layer to the sadness that I reported from the daily app check-ins. I already operate (since fall 2020) in an overwhelmed state (while beginning a difficult academic program via Zoom). Could the physical fatigue and headaches from the vaccine lead to the feelings of sadness? Or were the feelings of sadness a third symptom of the vaccine? I cannot answer, and therefore cannot provide this correlation link with any reliability.  I did speak to my therapist via Zoom, and reached out via email to my general physician (who recommended OTC meds.
I developed Chronic Urticaria one week following the vaccine.  I also developed short-term angioedema. The urticaria continues 8 months later despite several rounds of prednisone and continuous antihistamine use.  Also, Raynaud's Phenomenon has increased in frequency and severity.
Dizziness. Pt came to emergency care unit with these symptoms. Swelling in legs.  Tachycardia: chronic, patient at baseline and no charge to EKG today. LE edema; no crackles, able to lie completely flat without SOB suspect  Exp.  6/30/2004. Reported by phone
patient states left arm is still sore over 3 months after receiving vaccine @ injection site. patient also had red, hot injection site rash that lasted 2 weeks
Flu shot given to pt at 10:25 am (10/25/05) = 0.25 ml IM left leg after 15 min at 10:40 am had allergic reaction, redness on left leg and lower back. Notified doctor and check pt.
Pt vaccinated with DTP/OPV injection given 29OCT90; Father reports area of reddness & heat to rt thigh 5x4 wide, temp 101F oral.
titers for measles and varicella that were "too low."; This spontaneous report was received from a nurse and refers to a currently 23 years old patient. Information regarding the patient's concurrent conditions and medical history was not provided.   The reporter informed that the patient received 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) on an unknown date in the past and afterwards showed titers for measles and varicella that were "too low" (antibody test abnormal). The patient then received a dose of measles (+) mumps (+) rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for a "booster dose" in May 2023. No additional adverse events reported.  The causal relationship between he event and suspect therapies was unknown.
had shingles, after I got the shot\ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles three times, once after got the Shingles shot. The patient stated that it was not fun. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Following vaccination, pt. developed a 2 inch red, warm, severely itchy spot at the site of administration that worsened over 24 hours. Hard nodule was also noted.
Headache, Fever, ARM PAIN, FATIGUE SWOLLEN LYMPH NODES Narrative:  Other Relevant History:
Got chills, very fatigue had a fever of 100.0, sneezing, headache and coughing also experiencing weakness and muscle pains
Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body aches, nausea, and very tired.  Slept all day, got up for dinner, then went back to bed.  Woke up the next day and felt 100% good.  I. Other words, had the 2nd dose on Monday morning, Tuesday felt awful, Wednesday felt perfectly fine.
It is making me itch all over but no hives, and it is messing with my asthma.
28OCT pt exp spasms in both knees;awoke 29OCT w/both knees swollen, had fever & a scattering of rash over neck & chest x 2 days; to MD who felt sx was presenting was a result of vax;tingling in hands;circulation impaired;stiffness;
babbling nonsense; hearing things; elevated liver enzymes; hit her head; abdominal pain; vomiting; diarrhea; shaking; shivering; heart racing; fever; This non-serious case was reported by a nurse via call center representative and described the occurrence of abdominal pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 2tl27, expiry date 23-AUG-2025) for prophylaxis.   On 25-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). In SEP-2023, 24 hrs after receiving Shingrix, the patient experienced abdominal pain (Verbatim: abdominal pain), vomiting (Verbatim: vomiting), diarrhea (Verbatim: diarrhea), tremor (Verbatim: shaking), shivering (Verbatim: shivering), heart racing (Verbatim: heart racing) and fever (Verbatim: fever). On an unknown date, the patient experienced speech disorder (Verbatim: babbling nonsense), hearing impaired (Verbatim: hearing things), elevated liver enzymes (Verbatim: elevated liver enzymes) and head injury (Verbatim: hit her head).  The outcome of the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury were resolving.   It was unknown if the reporter considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.     It was unknown if the company considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 Nurse called on behalf of a patient.  A patient received her second dose of Shingrix and within 24 hours of the dose, the patient experienced abdominal pain, vomiting, diarrhea, shaking, shivering, heart racing, and fever.  According to patient's husband, the patient was also babbling nonsense and hearing things.  A recent visit to the office showed that she also had elevated liver enzymes.  The patient hit her head on something while she was vomiting and went to the emergency room.  Per the health care professional, the patient's symptoms were improving. The reporter consented to follow up.