chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/19/2003 5:10 a.m.- c/o chest pain, nausea and palpitations X 2 weeks with increased intensity and frequency since the previous evening.  History of elevated LDH and Transaminase in March 2003. History of Diabetes diagnosed early 2003 [on Actos and Glucophage, hyperlipidemia, and moderate obesity.  Saw MD in ED.  CPK 80 and Troponin 1.4.  At 6:10, transferred to another hospital for higher level cardiac care.  Diagnosed with non-Q wave infarct.  (See lab results under #12) On 8/22/02 a triple coronary bypass was performed.  At present the pt. is still hospitalized.  60-day follow up on 12/02/2003: "Vaccine recipient has recovered from the adverse events that were reported for this vaccination."
slight dizziness, Nausea and Headache the night after injection soreness in the injection site (arm)
Febrile seizure, turned blue, so called 911 and ambulance took patient to hospital.
Vaccine given 09/26/2001. Pt presents 10/11/2001 with 1 day history of localized swelling and erythema to right triceps. Multiple small resicular lesions to arms, buttock, ear, neck from day 13 PV. Triceps very warm, red and pruritic.
first dose in 2019, not received other 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 49-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th June 2019, intramuscularly).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. After receiving 1st dose of Twinrix, the patient did not realize that there was a 2nd and 3rd dose in the series.  Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete vaccination schedule. Reporter could not provide lot number, expiration date, or route of administration. The patient gave consent to contact healthcare professional but could not provide healthcare professional demographics. The reporter consented to follow up.
passed out about 10 minutes after receiving first dose-came to immediately after; pale; nauseous; vomited once; BP 99/51. gave water, had her rest.
1st dose 2018, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose around 2018).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2023018227, reported by same reporter for different patient. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix yet, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023018227:Same reporter.
Patient presented to the ED and was subsequently hospitalized for acute dyspnea, hypoxemia, severe sepsis within 6 weeks of receiving covid vaccination.
Son had red splotchiness by the injection site on his arm, and  it was itchy so he scratched in the evening the day after the injection. He woke parents up after midnight that night complaining of hives which were all over his body, especially located around mid section of torso. Hives were raised and bubble like and extremely uncomfortable. No fever accompanied hives. Father took him to the ER where he received steroids. Hives disappeared over the following week but reappeared sporatically on and off for 2 weeks. He has an appointment for skin testing on January 25th, 2023.
This case was reported by a healthcare professional and described the occurrence of possible hepatitis A in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date in 2010 the subject received 1st dose of TWINRIX (unknown). On an unknown date, approximately two weeks after vaccination with TWINRIX, the subject experienced nausea and vomiting. Approximately one month after vaccination with TWINRIX, the subject experienced hepatitis A virus IgM antibody positive, possible hepatitis A IgM increased. The subject went abroad two days after TWINRIX was administered and approximately two weeks later developed nausea and vomiting. After the subject returned from abroad, approximately one month after TWINRIX was administered, Hepatitis A titer was drawn and the subject was positive for Hepatitis A IgM. The reporter was concerned about Hepatitis A disease versus IgM elevations from vaccine itself. The reporter did not have additional information. At the time of reporting the outcome of the possible hepatitis A, IgM increased, hepatitis A virus IgM antibody positive, nausea and vomiting were unspecified. Follow-up information was received on 21 December 2010 from healthcare professional via Merck. The healthcare professional notified Merck on 07 December 2010 that the subject received TWINRIX on 29 October 2010 and then traveled to a foreign country. While overseas the subject became extremely ill [unwell], and had to return early from the trip. The onset date was reported as 29 November 2010. The subject experienced diarrhea, fevers, abdominal pain, increased liver function tests and weight loss. Antibody titers to Hepatitis A and Hepatitis B were taken, which showed an antibody titers to hepatitis B and increased reactive antibodies to Hepatitis A (IgM reactive). The subject sought medical attention. At the time of the report no further information was available. The outcome of the events were unspecified.
Patient given MMRV and Varicella vaccines, patient monitored for after vaccines with no symptoms.
I started feeling achy  when I went to bed, which was 12 hours after my vaccine shot.  I woke up around 1:00 am and felt awful.  My body hurt so badly that I couldn't get up to go the bathroom or get pain reliever.  I also had the chills with chattering teeth and was freeing cold.  This lasted for about 6 hours.  The next day, I had mild body aches and some fatigue.  All of the symptoms were gone 48 hours after the vaccine.
By next morning, very sore, area indurated, itchy, hurting. Redness spreading below site. On 10/16 site still painful, itchy, and spreading.
Patient c/o shortness of breathe, right cheek numbness and right leg pain, with foot numbness. Blood pressure was very high 220/110.  10ml of Benadryl given and after 10 minutes of observation the ambulance was called due to her sx not improving.
Patient presented with a cough, and diarrhea. Patient's husband was positive for COVID. Patient resulted positive for COVID-19 yet was fully vaccinated.
DTaP given in left deltoid on 04/19/06.  Mom noticed redness of 13cm x 7cm around injection site and a "slight rash" in left arm pit the next evening.  Rash faded by 04/21/06.  Child taken to Nurse Practioner and diagnosed with cellulitis.  Child was given Duricef due to PCN allergy and is to return on 04/22/06 for status check.  No other signs or symptoms noted.
unconsolable high pitch crying; local react redness, tenderness, edema; 4-5 cm diameter;
This spontaneous report as received from registered nurse via company representative refers to multiple patients older than 50 year old with immunization. Patient's had no previous history of shingles and other medical histories. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml (lot# and expiry date unknown) subcutaneously. No concomitant medications were administered. Nurse reported that on an unknown date, unspecified numbers of patients have reported injection site reactions with ZOSTAVAX. She reported that the patients are experiencing swelling at injection site, and described them as big lumps with major discomfort and redness at injection site more often than not. She reports that the nurse stated that she received two calls from patients just today reporting injection site reactions. The nurse stated that no rashes are occurring. Nurse stated that some of the patients has been seen in the office in relation to the injection site reactions, that no patients have been diagnosed with cellulitis, and they have been managing symptoms with hot compresses and ibuprofen (manufacture unknown). No laboratory test was performed. The outcome of injection site reaction, redness at injection site and swelling at injection site was unknown. Additional information has been requested.
This was her 2nd dose.  1st  day, she had bad chills and alot of body ache all over.  2nd day N&V and bad HA  and all over body aches.  Was able to eat something the 2nd evening.  She is back to work, but still has a lingering mild HA, foggy head feeling and  occasional chills.
Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program  from a contactable physician.   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the first dose, was diagnosed for COVID-19. Clinical outcome was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: A possible contributory role of the suspect BNT162B2 cannot be excluded for the reported diagnosed for COVID-19.  However, more information, such as Vaccine administration date, clinical course, underlying medical conditions is required for the Company to make a more meaningful causality assessments.
On 19Mar91 4hrs /p immun started /w T 102 AX,irritable,swollen arm,cried a lot.Spoke /w MD 19Mar pm who stated to cont APAP & ice to swollen arm. Mom noted twitching during noc, cont crying all noc. Seen by MD who noted T & crying. Admitted
Pt recvd vax 17SEP90 & devel sl high blood sugar @ the end of pregnancy; 27MAY91 delivered a full-term 10lb 1 oz male; apgars were 2 at 1 min & 9 @ five mins; infant exp hyperbilirubinemia & meconium staining;
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling, nausea Narrative:
This spontaneous report was received from a pharmacist referring to a 22 year old female patient. the patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent (MERCK). On 02-NOV-2017, the 22 year old patient was vaccinated with a dose ZOSTAVAX 19400 PFU, subcutaneously, lot # N020852 with expiration date: 31-JUL-2018 (anatomical location was not reported) for prophylaxis. No adverse effect reported.
Terrible burning pain on left arm (couldn't lift arm past waist-high) - then noticed significant swelling and redness (like sunburn) on upper left arm from the site of where injection of Pneumovax was administered to below elbow.  Tremendous pain prevented left elbow from bending.
Pt received 2nd dose on March 10 Tested COVID+ on 6/29/21 Received Regeneron on 7/1/21
Constant smell of smoke all day every day. Some nights the smell will actually wake me from sleep. This started 2 days after the 1st shot a month ago.
I received the vaccine on March 13, 2021. I did not have an immediate reaction, but began breaking out in hives all over my body 24 hours later. I was lethargic, wanted to sleep all the time, and had no energy. This is gradually getting better, but still occurs. I periodically have headaches. After two full months I continue to have regular eruptions of hives on my arms. Prior to taking the vaccine I had no health issues, ran daily,  and worked out regularly. I have just recently started walking, but have not been able to run.
15 to 30 seconds after immunization was administered, patient complained of lightheadedness, where he then lost consciousness and proceeded to have a seizure, where he was shaking uncontrollably for about 45 seconds. Upon regaining consciousness, the patient was able to recall what had occurred before the seizure, but said he did not remember what happened after the vaccine, and that he felt that he had defecated in his pants.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient was pregnant while on the Moderna vaccine) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was pregnant while on the Moderna vaccine). On 10-Mar-2021, EXPOSURE DURING PREGNANCY (Patient was pregnant while on the Moderna vaccine) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported.
Left ulnar neuropathy.  Tingling in fingers and fatigue in arm.  Soreness at injection site.  Has not subsided.
24 yo male seen on 10-26 for smallpox immunization screen. Immunization applied to right arm.  Reaction began about day 7 with redness and swelling at primary site. Fever (did not task temp) and malaise developed by day 9. Seen at 0700 temp 100.5 po, thought to have cellultitis on right arm with localized swelling redness and red streaking toward shoulder. Stared onm Amoxicillin 875 mg po BID, Acetominophen 325 mg po q6h and Naprosyn BID. Swelling in arm has improved over last three days.  Skin symptoms; noted pustular eruption on arms and trunk that began on Monday 11-06 at time of cellulits sick call visit. No change in pattern with Amoxicillin. Tues-WED was last day with emergence of new lesions. Still feelng warm with malaise this week. No shaking chills since 11-05-06   No neck symptoms No stiff neck  °  No previous history of concerns about reproductive health  °  No musculoskeletal symptoms  °  No neurological symptoms  °  No psychological symptoms    Generalized smallpox vaccination reaction (self-limited): Lesions c/w follicular eruption of small pox vaccination. Lesions are not suggestive of generalized vaccinia. This occurs in approximately 2% of patients with the vaccination. pt educated on contact precautions, wound care and follow up.  Pt received small pox vaccine on 26Oct2006.  f/up on rxn to vaccine.  no symptoms today.  reports lesions all dry and initial site improved dramatically  Skin: lesions on torso and upper arms - all are either resolved or dry with no erythema.  lesion of right arm from initial immunizations site now shows 4mm by 4m dry eschar with no erythema or induration. Normal except as noted.
Mild headache; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 26 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache".  Additional information: Caller stated that he received the first dose of the Pfizer covid-19 vaccine on 29Mar2021. He had a mild headache but no fatigue. He wanted to get a second opinion on what to do after the vaccination. Caller stated that he normally liked to work out and wanted to know if he can work out and drink a caffeinated sports drink after the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SYMPTOMS LASTING 2 DAYS: MILD SKIN & MUSCLE SORENESS @ INJECTION SITE.. SEVERE CHILLS AND BODY ACHES. FEVER FLUCTUATING  BETWEEN 99.4 AND 101.2. TOOK IBUPROFEN EVERY 4 HRS AS NEEDED TO REDUCE FEVER.
On January 5,  2023 at 2:30 pm (approx) while driving I started feeling different, then I couldn't blink or close my left eye.  Within minutes my whole left side of the face was numb.  I pulled over to the side of the road and called my doctor and they told me to come in.  I drove to their office and he sent me to the ER to rule out a stroke.  I was diagnosed with Bells Palsey, prescribed Artificial Tears Ophthalmic solution, prednisone 10mg oral tablet, and ValACYclovir 1 g oral tablet..  I am now paralyzed on the left side of my face and tongue, doing all the above medications, unable to work, drink or eat.  Please advise.
little discomfort at the site of the injection; patient received 2 doses on Fluzone Highdose same day; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 66 years old female patient who experienced little discomfort at the site of the injection (vaccination site discomfort), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 19-Sep-2019, the patient received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (injection) lot AG8347 (Expiry date 06-May-2020), twice via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious little discomfort at the site of the injection (vaccination site discomfort), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also a case of actual medication error case due extra dose administered.  Other relevant tests were not reported.  Final diagnosis was little discomfort at the site of the injection.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for little discomfort at the site of the injection.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Left arm erythema 11 cm x 14 cm at site of vaccine decreased with Benadryl.  Also had central area of darker erythema at site injection.
Pt called with c/o h/a and blurred vision.  States intermittent h/a started1  day after receiving Hep B #3 and Flu vaccines on 3/6.  Reports 1 episode of vomiting and mild fever on 3/7 as well with no further reports of these s/s after 3/7.   States blurred vision started about 1 wk after vaccination.  States she notices the blurred vision when she goes to read and the h/a occurs about q3 days.  States she rests to relieve the h/a and has not had to take any medication.  Advised her to f/u with an Optometrist/Ophthalmologist and if symptoms worsen, advised to present to an Urgent care for further evaluation.  Pt's intermittent h/a and blurred vision appear to be unrelated to immunizations.  Pt verbalized understanding of info provided and has no further questions or concerns at this time.
Shaking chills and temperature up to 100.7 the day following injection. Took TYLENOL and fever/chills subsided within about 5 hours. Five days after injection red circle /warmth noticed at injection site. Redness radiated vertically down arm about 6 inches. Seven days after injection redness present but less so and warmth ceased. Saw primary NP.
Plugged ears; Numbness right side of face; Numbness right lip; Tingling in throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Plugged ears), HYPOAESTHESIA (Numbness right side of face), HYPOAESTHESIA ORAL (Numbness right lip), THROAT IRRITATION (Tingling in throat) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021 at 10:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EAR DISCOMFORT (Plugged ears), HYPOAESTHESIA (Numbness right side of face), HYPOAESTHESIA ORAL (Numbness right lip), THROAT IRRITATION (Tingling in throat) and HEADACHE (Headache). At the time of the report, EAR DISCOMFORT (Plugged ears), HYPOAESTHESIA (Numbness right side of face), HYPOAESTHESIA ORAL (Numbness right lip), THROAT IRRITATION (Tingling in throat) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provider by the reporter.  Treatment information was not provided.
All over body rash that has increased in severity over time, it's about 10 days past the second dose and it's getting worse not better. It's all over trunk, groin, not as much on the extremities, on the neck.
@ appr. 10 min p/Hibtiter & DPT vax, trunk of body developed large reddened blotchy areas; was transported to ER & given Epi & Benadryl;
When injected patients had a large, hard bump with some slight bruising under.  No pain at site of injection and no heat or redness detected. Applied cold compress to patients arm for 15 minutes and gave patient 25 mg of diphenhydramine.  The lump did decrease and did loose hardness.
From 5/2/2021-current I have experienced balance/equilibrium problems, Tingling in my arms and feet, Numbness in my feet, 30lb weight loss, cognitive and memory issues, persistent headaches, muscle weakness, bowel issues, stomach cramps, malaise and fatigue, shortness of breath and chest tightness.
pt reports red, raised bumps that are itching started on 1/18/21 on hands, arms, feet, and elbows.   progressed to more over several days.  Seen by MD in our office on 1/19/21 who referred her to dermatology for skin biopsy.  Biopsy done on on 1/21/21 and path consistent with interstital granuloma annulare.  areas are regressing at this time but still itching and red.   taking Pepcid and Claritin per MD recommendation.
After the booster shot,  a month later I started noticing my left upper arm started to hurt and was not able to move it freely.  When I raise my arm up fully it hurts but when I bring it back down it hurts even more.  I can?t sleep on my left side due to increased amount of pain.
Redness, swelling at injection site, immediate  15 x7 cms , 5days Nausea & light headedness ,sleepiness ,  next day x 36 hours Full recovery by 8th May
Sx onset 7/16/2021 with cough, runny nose, nasal congestion and headache. Tested positive for COVID-19 on 7/18/21