chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 2B55B, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that the patient had an allergic reaction to FLULAVAL. The physician stated he did not want a follow up.
Pt received FLUZONE HD on Mon 10/10/11 -> about 5 hours later patient experienced rapid heart rate and dizziness. On Tuesday, pt's arm was red and swollen. By Wed most swelling was dissipated.
1 hour post immunizations pt developed temp of 104 F with shaking, chills. 48 hours after immuninzataion pt developed swelling of R deltoid ( site of inject)  4cm x 8cm
From the time the shot was given, I felt pain.  Not from the stick itself, but the feeling of the medication going in my arm.  It has been sore (hurt) ever since.  I have had pain in my are from doing simple daily things like; lifting my arm to remove my shirt, turning over to pull cover over my body.  The simplest movement may cause me to use my other hand to help move my arm.  Sometimes I will feel a tingle or numbness that goes through my arm, down to my hand.  The only thing I have done to help sooth the pain, is running warm/hot water over my arm in the shower, and rubbing alcohol on my arm.  Neither of these remedies help.
Nausea; brief but intense depression and despair; Acutely Heightened sense of smell; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea), DEPRESSION (brief but intense depression and despair), FATIGUE (fatigue) and PAROSMIA (Acutely Heightened sense of smell) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Mar-2021, the patient experienced FATIGUE (fatigue). On 25-Mar-2021, the patient experienced NAUSEA (Nausea), DEPRESSION (brief but intense depression and despair) and PAROSMIA (Acutely Heightened sense of smell). On 26-Mar-2021, NAUSEA (Nausea), DEPRESSION (brief but intense depression and despair) and FATIGUE (fatigue) had resolved. At the time of the report, PAROSMIA (Acutely Heightened sense of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol. Concomitant medications included Diabetic medication and statin.
p/vax lt arm swollen, red & painful, hot to touch;antihistamine x 6 days;
has not received the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose in October 2020) and Engerix B (received 2nd dose in December 2020).   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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: Age at vaccination was not applicable to this report. Pharmacist reported that the patient had not receive the third dose yet, which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021157383:possible same patient
Pain; Tenderness; Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), TENDERNESS (Tenderness), ERYTHEMA (Redness) and PRURITUS (Itchiness) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (Pain), TENDERNESS (Tenderness), ERYTHEMA (Redness) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), TENDERNESS (Tenderness), ERYTHEMA (Redness) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
103 degree fever (while taking fever reducing medication) for 2-3 days, extremely swollen and tender lymph nodes on the side of the injection site, nausea/inappetence, severe headache that did not respond to painkillers, high heart rate at rest
Pt suffer very severe local Rxn at site of pneumococcal vaccine. Two days later suffered urinary retention and ARF. Vaccine was listed as one of many possible causes. Other agents reported to MedWatch.   MR received for DOS 12/182008-1/09/2009 with D/C DX: Paroxysmal Atrial Fibrillation with rapid Atrioventricular conduction.  Ventricular Pre-excitation.  Hx of Bacterial endocarditis.  S/P Aortic Valve replacement (2002). Chronic and acute renal failure.  Massive allergic reaction to Pneumovax vaccine.  Pt already in hospital 12/18-19/2008 for Electrocardioversion which pt tolerated well.  Received Flu and Pneumovax prior to d/c. Pt developed substantila allergic reaction resulting in massive swelling of the L upper extremity with concerns for necrotizing fasciitis. Tx-abx.  Developed acute urinary retention and acute renal failure which improved by d/c w/ some residual renal failure. Required hemodialysis.
Case number PHEH2013US020171 is an initial spontaneous report received from the nurse on 23 Sep 2013 with a follow-up received from the physician on 20 Nov 2013. This report refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in her left deltoid on 19 Sep 2013. On the same date after vaccination, she experienced frozen shoulder. She had a heavy arm which was painful and she was unable to move the arm. She felt very heavy and painful when she lifted the arm/shoulder. She kept ice on the affected shoulder and she was taking ibuprofen around the clock without relief. It was reported that the pain has worsened over the weekend and she did not take any medical care. The seriousness of the events were not reported. The physician commented that in their opinion this was not a reaction from the vaccine. No additional information was available. Follow-up received from the physician on 20 Nov 2013: Updated causality.
Information has been received from a nurse concerning a 24 year old female with allergies to amoxicillin, penicillin, clarithromycin (BIAXIN) and IMITREX, who on 14-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 655154/1210U; site not reported).  There was no concomitant medication.  On 15-FEB-2008 (also reported as 13 hours post vaccination) the patient experienced fever of 102F, swelling of face and swelling of neck.  The symptoms lasted for 2 days, and the patient recovered from the fever of 102F, swelling of face and swelling of neck.  The patient sought unspecified medical attention in the ER.  No further information is available.  Additional information has been requested.
Inadvertently administered 0.5ml IM to right deltoid today that expired August 10 2021, notified patient of incident and educated her that vaccination would be ineffective that she would need to return to pharmacy to repeat dose as soon as possible.  Patient reported no adverse event
Started with runny nose and cough, then by 12/4 had diarrhea and vomiting, on the evening of 12/5 started having seizures, non breather, CPR administered, 911 called ambulance transported to Hospital. Continued to seize again and non breathe again .  12/14/09 DC summary and hospital records received for DOS 12/05/09-12/07/09 Pt presented to ED with 2 day hx. of cough, fever, diarrhea, emesis. Reports tonic-clonic seizure at home, another immediately before admission and a third seizure upon admission. EMS reported pt. apneic during seizure.  Received vaccine this week. Admitted for neuro evaluation and seizure management. Seizure activity resolved without requiring anti-epiletics and pt. was discharged home. DC DX: febile seizures secondary to an acute GI infection
severe immune thrombocytopenia; ulcers inside the mouth bleeding; bruises on arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (severe immune thrombocytopenia) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (severe immune thrombocytopenia) (seriousness criteria hospitalization and medically significant), MOUTH ULCERATION (ulcers inside the mouth bleeding) and CONTUSION (bruises on arms and legs). The patient was hospitalized on 19-Jan-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (severe immune thrombocytopenia), MOUTH ULCERATION (ulcers inside the mouth bleeding) and CONTUSION (bruises on arms and legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Platelet count: 71000 (Low) Decreased. On an unknown date, Platelet count: 6000 (Low) Decreased and 40000 (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment for the events were not provided.  Company Comment: This spontaneous case concerns a 72-year-old female patient with no relevant medical history who experienced serious unexpected event of thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine .  Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old female patient with no relevant medical history who experienced serious unexpected event of thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine .  Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Extremely sore arm where shot was located, sore joints, tiredness and last night I had a fever that ended up over 104 degrees.  Today woke up with a slight fever and headache, arm still sorr
Received shot around 10:20am on 10/28/2009. Left the room after receiving shot but still in building- c/o felling "hot" about 10-11 min is shot given-week all over-had to sit down and given water to drink.-Did not return to nurse or let nurse know she was feeling ill. Next morning noticed "ink blot" like bruise on arm. Phoned her physician who stated vessel may have been hit and nurse " should have aspirated" and that is why she had the reaction. Also stated she had not had much to eat that day. Still has a slight bruise on her arm but no other c/o.
The patient reported limited movement on her left arm ever since she received the shingrix vaccine on 9/26/20. The patient described local pain for up to 10 days and feeling sick for the initial 3 days. The patient is having a hard time holding item such as cup at certain angle. The patient will have an appointment with her primary care physician about this issue next week.
2 - PREVNAR administered on 4/13/09 instead of 1. Mother called at 11:30 PM on 4/13/09 and stated had fever 102. Instructed to give TYLENOL  and if persisted to call back. Attempted to contact family several times but no answer.
This case was reported by a healthcare professional and described the occurrence of facial rash in a 1-year-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline. Concurrent medical conditions included anemia, ear infection and upper respiratory infection. Concurrent vaccination included PREVNAR, Wyeth and VARIVAX, Merck both given on 16 January 2009. Concurrent medications included Amoxicillin and Poly-Vi-Sol. On 16 January 2009 the subject received 1st dose of HAVRIX at 0.5ml in the right thigh. On 17 January 2009, one day after vaccination with HAVRIX, the subject experienced facial rash and arm rash in the morning and had swelling of face, hand swelling and ankle swelling by evening. The subject was seen in the emergency room and was treated with BENADRYL and steroids. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 24 March 2009 from the reporting nurse. On 19 January 2009, the events resolved. The reporting nurse considered the events were possibly related to vaccination with HAVRIX.
Pt had pneumonia vaccine 11/1/12, had a fever 11/2/12 and redness/swelling at injection site.
the medication squirted out the left side from the base of the pre-filled Influenza syringe; Product Complaint; nurse was not exposed to the liquid, but the patient was; Patient had a 0.5-inch hardened mass; 1.5-inch redness on her left deltoid; pain at the injection site; half of the immunization was still in the syringe / did not appear to be administered into her left deltoid; This case was reported by a nurse via sales rep and described the occurrence of injection site induration in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number TG729, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 2nd March 2020, the patient received FluLaval Tetra 2019-2020 season. On 2nd March 2020, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site induration, injection site erythema, injection site pain and underdose. On an unknown date, the patient experienced syringe leak, pharmaceutical product complaint and accidental exposure to product. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the injection site induration, injection site erythema, injection site pain, underdose, syringe leak, pharmaceutical product complaint and accidental exposure to product were unknown.   It was unknown if the reporter considered the injection site induration, injection site erythema and injection site pain to be related to FluLaval Tetra 2019-2020 season.  Additional information was provided as follows: The medication squirted out the left side from the base of the pre-filled Influenza syringe and half of the immunization was still in the syringe while administering the vaccine to the patient. The reporter did not believe patient received any of the immunization when it squirted from the base of the syringe, which led to underdose. After a short time, the patient's left deltoid was painful. Patient had a 0.5-inch hardened mass with 1.5-inch redness on her left deltoid. The nurse notified Dr. immediately and he recommended heat application to the left deltoid and to call back if she had any further concerns or worsening symptoms. While administrating the vaccine, the nurse was not exposed to the liquid, but the patient did, which led to  accidental exposure to product. QA result received on 10th April 2020: Conclusions of the QA statement were received as follows GlaxoSmithKline considered complaint of the report as unsubstantiated.
pt recvd vax MAR93 & devel a vaginal yeast infect; No further details were provided;
Patient received Pfizer monovalent in error. Patient previously received Moderna Dose #1, Janssen Dose #2  and should have received Bivalent Booster at todays visit. Patient was contacted by phone and notified of error. Pt states she will contact clinic after 2 months if she decides to come back in for Bivalent Booster dose.
27MAR98 febrile seizure in PM-ER visit;30MAR98 PCP visit-roseola rash;
Sharp shooting burning pain from left deltoid to bottom of neck; Sharp shooting burning pain from left deltoid to bottom of neck; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number P39N2, expiry date 25-SEP-2023) for prophylaxis.   On 19-JAN-2023, the patient received Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sharp shooting burning pain from left deltoid to bottom of neck) and pain burning (Verbatim: Sharp shooting burning pain from left deltoid to bottom of neck). The outcome of the injection site pain and pain burning were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain burning to be related to Shingrix.     It was unknown if the company considered the injection site pain and pain burning to be related to Shingrix.   Additional Information: GSK receipt date: 10-Mar-2023 The nurse practitioner called to inquired that any information available on what patient was experiencing. The reporter reported that a patient received the first dose of Shingrix back and experienced a sharp shooting burning pain from left deltoid to bottom of neck.  The reporter reported another batch number as 752BN and expiry date 20th May 2024. Then the patient came back for the second dose on 19th January 2023 and was still experiencing the adverse events from the first dose that had never gone away. The reporter consented to follow-up.
Patient reports approximately 30 minutes after leaving pharmacy she felt a tingling and numbness in vaccinated arm (left).  During the next several days the paresthesia like tingling went into both arms and both feet.  No pain or itching reported.  No inflammation or heat near injection.
Received PNEUMOVAX Thurs A.M. - Developed redness and pain at injection site. Developed headache and fever. Treated with over counter Ibupro, TYL. No relief in 3 days. Went to E.R. Checked for meningitis. Was treated next day with prednisone by primary (Monday). Redness and fever diminished by Tues.
I can't move my hand; it swelled a lot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I can't move my hand) and PERIPHERAL SWELLING (it swelled a lot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (I can't move my hand) and PERIPHERAL SWELLING (it swelled a lot). At the time of the report, HYPOKINESIA (I can't move my hand) and PERIPHERAL SWELLING (it swelled a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Fever 101 degrees Fahrenheit, Headache, Body Aches, Fatigue.
Patient experienced severe nausea, headaches, body aches and mild fever approximately 3-4 hours after immunization at clinic. Patient reports that with initial Japanese Encephalitis immunization had the body aches and mild fever symptoms but no nausea.
Red circle around injection site the size of a tangerine. Soreness at injection site. Body aches and pains that continued to get worse over the next 2 days, and then proceeded to get better until she came it to report problems.
This spontaneous report as received from a health professional refers to a 4 month old female patient. Medical history and current conditions were not reported. On 16-JUL-2014, the patient was vaccinated with ROTATEQ, oral (lot number and expiration date were not reported). The patient received another dose of rotavirus vaccine on 16-SEP-2014 from another manufacturer. The patient had not received a third dose of ROTATEQ at the time of the report. No adverse effects were reported. Concomitant therapies were not reported. Additional information has been requested.
Patient was seen in office for vaccines, along with other patients due for the same vaccines. After patient was seen, it was found that there had been a vaccine preparation error with a pentacel. A Pentacel vaccine had not been correctly reconstituted with the Hib component   Only the liquid component of the vaccine had been given. Due to the error being found after the fact, our office was not able to pinpoint which of the earlier patients had been affected.
This case was reported by a nurse and described the occurrence of swelling of the arm in a 5 year old female who was vaccinated with DTAP for prophylaxis. On 5/26/05, the subject received the 5th dose of Infanrix (lot AC14A011AA) in the left arm. Concurrently the pt also received IPV, in the right arm and MMRII, in the right arm, SC. At an unspecified time later, on 5/6/05, after vaccination with Infanrix, the nurse reported that the subject experienced, a "local reaction" manifested as swelling, redness and warmth at the injection site. The subject also complained of a stomach ache. The events resolved on an unspecified date in May 2005. The nurse considered the events to be related to vaccination with Infanrix.
1 chickenpox lesion appeared 13 days p/vax;no treatment;no complications;no fever;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 13-SEP-2017, the patient was administered an expired ZOSTAVAX (dose, route of administration and lot # were not reported), with expiration date on 27-JUL-2017, reconstituted with a non-expired sterile water diluent. No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
0patient felt light headed and was unconscious for approximately 20- to 30 seconds. He told us he has not had any breakfast that day. he said he normally feels light headed after a vaccine but not to the extent of passing out. He was given soda and water for fear of low blood sugar. he was partially responsive and communicative but diaphoretic . 911 came in to assess him but since he was getting better he refused to go to the hospital with them