chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin reaction, which never had before; It first looked like a rash, then skin started peeling; It first looked like a rash, then skin started peeling; Headache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 27Aug2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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 patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 06Aug2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021, the day after the second dose, the patient experienced headache. On 02Sep2021 at 14:00, a week after the second dose, the patient experienced skin reaction, that the patient had never before. The reaction first looked like a rash, then the patient's skin started peeling. The patient thought it would go away in no time but it was then on the belly, breasts, back, and arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events skin reaction, rash, and skin peeling which included treatment with petroleum jelly but did not know what action to be taken. The clinical outcome of the events skin reaction, which never had before, it first looked like a rash, then skin started peeling and headache were not recovered at the time of this report.
Localized itching, redness at first that progressed each day. Approximately one week after administration, hives developed. Itching persisted on and off for one week after administration. Patient self treated with Benadryl Gel. Pharmacist also recommended hydrocortisone.
Information has been received from a physician concerning a patient ( age and gender unknown) who on 30-JUL-2007 was inadvertently vaccinated with vaccinated with a dose of ZOSTAVAX (lot# reported 02904), instead of varicella virus vaccine live. No adverse effects were reported. Additional information has been requested.
Swollen, reddened area around left thigh. Also, fever and diarrhea
stomach upset; her whole system is dry"/Skin; hair; eyes; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), DRY SKIN (her whole system is dry"/Skin), HAIR TEXTURE ABNORMAL (hair) and ABNORMAL SENSATION IN EYE (eyes) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Patient had Right eye surgery.). Concurrent medical conditions included Drug allergy (Allergies include sensitivity to certain medications (unsure which).). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), DRY SKIN (her whole system is dry"/Skin), HAIR TEXTURE ABNORMAL (hair) and ABNORMAL SENSATION IN EYE (eyes). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), DRY SKIN (her whole system is dry"/Skin), HAIR TEXTURE ABNORMAL (hair) and ABNORMAL SENSATION IN EYE (eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included drops for eyes   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11 May  2021 contain information: Reporter contact details updated.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns an 84-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Swelling, itching  lips, upper back and scalp. History of anaphylactic reaction to medications. Patient was given one dose of epinephrine, responded well and was transported to the ED for further observation.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
They found a heart murmur. I also diagnosed with SVT. I went to the ER. They did blood work, EKG, Echo cardiogram, and a stress test.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M042853 and N009173 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002734: US-009507513-1708USA002735: US-009507513-1708USA002736: US-009507513-1708USA002737:
Arm soreness at injection site; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiration date: not reported) via an unspecified route of administration, administered in arm left on 22Feb2021 at 15:45 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization at workplace clinic. Medical history was not reported. Patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive other medications within 2 weeks of vaccination. On 23Feb2021, patient experienced arm soreness at injection site. Patient did not receive any treatment for the adverse event. The outcome of the event was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Rash covering both arms, pain, axillary lymphadenopathy treated with MEDROL dose pack with good resolution of symptoms.
mild case; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR004619  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a mild shingles case between the first and second injection of Shingles vaccine. The patient had the Covid vaccine two weeks after the second Covid shot and had shingles, it was painful, and the nerve pain was unbearable. The patient stated that the shingles vaccine did not prevent. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004619:same reporter
injection site cellulitis; injection site swollen; injection site red, hot; rash at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE CELLULITIS (injection site cellulitis), PAIN IN EXTREMITY (Sore arm), INJECTION SITE MASS (injection site swollen), INJECTION SITE ERYTHEMA (injection site red, hot) and INJECTION SITE RASH (rash at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced INJECTION SITE MASS (injection site swollen), INJECTION SITE ERYTHEMA (injection site red, hot) and INJECTION SITE RASH (rash at injection site). On an unknown date, the patient experienced INJECTION SITE CELLULITIS (injection site cellulitis). At the time of the report, INJECTION SITE CELLULITIS (injection site cellulitis), PAIN IN EXTREMITY (Sore arm), INJECTION SITE MASS (injection site swollen), INJECTION SITE ERYTHEMA (injection site red, hot) and INJECTION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment for the event included Keflex (cefalexin monohydrate) and doxycycline.    This case was linked to US-MODERNATX, INC.-MOD-2021-013959 (E2B Linked Report). This case was linked to MOD-2021-012383 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-013959:same reportrer, different patient
Bad headaches; Chills; Twitching in legs; Upper extremity myopathy/lower extremity myopathy; Paresthesias/funny sensations; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On 24th June 2020, 6 days after receiving Shingrix, the patient experienced headache, chills, myopathy, paresthesia and twitching of limbs. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, chills, myopathy, paresthesia and twitching of limbs were recovered/resolved.   It was unknown if the reporter considered the headache, chills, myopathy, paresthesia and twitching of limbs to be related to Shingrix.  Additional details were provided as follows: The batch number of Shingrix was reported as 28NDD and was updated to 27N2D as per sales data review. The health care professional was having trouble reading the lot number in his notes, he had given his best guess at the lot number. The reporter stated that after receiving the vaccine, the patient had experienced bad headaches, chills, upper extremity myopathy which eventually also included lower extremity myopathy and paresthesias; twitching in legs and funny sensations. The patient did not get any relief after treatment with Advil. CBC was completed and it came back fine. The events bad headaches, chills, upper extremity myopathy resolved after awhile but the lower extremity myopathy and paresthesias continued 12 days later and into almost 3 weeks later. At the time of reporting, the patient could walk safely and all events were resolved. The reporter consented to follow-up.
Initial unsolicited report received from a healthcare professional via other company (Pfizer, Manufacturer report number: 2017016607) on 30 January 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient felt sick ("every time he takes it"). Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Since having had Covid (diagnosed on July 8th),  I have had hot flashes at least once or twice per evening for the last three weeks.  I am post menopause and did not have hot flashes prior to having had Covid.  I did not have them after my 4th Pfizer shot.  I have an appointment on August 18th with my PCP to discuss this issue.  Also, three days after my 4th shot, I had chest pain that lasted a few hours that I found very uncomfortable and caused me not to sleep well.  Thankfully the pain stopped by morning but I did see my PCP on 5/11/2022 about it.
This case was linked with case 2012-10261 (reported by same reporter for FLUZONE). Initial report received from a healthcare professional on 29 October 2012. A female patient with no reported medical history or concomitant medications received a dose of FLUZONE (0.5 ml pre filled syringe) intramuscularly (batch number: UH791AC) in the right deltoid on an unspecified date. 1 day post vaccination, the patient had tense shoulder and neck. There was no redness or swelling at injection site. The patient also complained of muscle spasms. The lab investigations and the patient requested muscle relaxer for spasms. The patient's outcome was not reported. Document held by sender: None. Follow up information received from healthcare professional on 11 February 2013. The patient was vaccinated on 17 October 2012. It was reported that event was not related to influenza vaccine and clinical finding from neurologist related symptoms were related to C6 C7 weakness.
pt recvd vax; exp fever; high screaming; sleeping all the next day; called MD who stated was rxn to DTP shot; will cut dose in half; swelling & thrashing;
Right cerebellum acute to subacute lacunar infarct detected by routine  MRI on 10/22/2022. Admitted to hospital on 10/20 overnight for additional testing. Asymptomatic, continued follow-up with neurologist.
Shingles front and back torso by 11pm. Initially thought just a rash reaction but the pain worsened so had appointment with insurance telemed doc to confirm.
On 3/10/2021 at approximately 2035, a female patient notified vaccine observation staff that she was feeling light headed, queasy and anxious. As staff began to assess the patient she began to pass out loosing consciousness. Staff were able to hold patient before any falls and lower her to the floor. The paramedic on scene began her emergency assessment of the patient. Staff paramedic was able to arouse the patient with a sternal rub. The patient was not fully aware of the event that had occurred. The paramedic place the patient on oxygen via nasal cannula. The patient?s level of consciousness began to improve. The patient stated she has a history of syncopal episode after any immunizations. The patient also relayed that she has a history of anxiety and is complaint with her medication. After secondary assessment of the patient, it was noted that the patient had an extended recovery time from the sycopal episode. She was unable to stand on her own and she still felt nauseous after vomiting. The staff at the clinic notified county EMS at 2055 and care of the patient was transferred.
three nights of very vivid nightmares; waking up with Panics with worm head; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 11Jan2021 at 13:15 at a single dose in the hospital for COVID-19 immunization. The first dose was received on 19Dec2020 at 13:15 on the left arm for COVID-19 immunization. The reaction with the first dose was losing taste and smell for two days. Medical history included sulfa allergies. Patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The reaction with the 2nd dose was three nights of very vivid nightmares to the point of waking up with panics with worm head. This is not usual and happened the night of the vaccination (11Jan2021) and subsequent two nights. The patient did not receive treatment for the events. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.  Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Influenza vaccine and the 2nd dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine and not applicable after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, influenza, vaccination failure and influenza were unknown.  It was unknown if the reporter considered the vaccination failure, influenza, vaccination failure and influenza to be related to Influenza vaccine. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient did not trust shots. The patient received flu shot twice and experienced the flu twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for influenza, time to onset for event and laboratory confirmation for influenza were not provided. The patient was not going to take the chance on the whooping cough shot and get the whooping cough. She like the odds of just not getting the shots better that was her opinion and she was sticking to it.
I have had a mild headache most days since getting vaccine - I never have head aches I have had a stiff neck most days since getting vaccine 4 weeks ago
This spontaneous report as received from a registered nurse refers to four patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. On unknown dates, the patients received improperly stored (Oka/Merck) VARIVAX (lot # L006385, expiry date 25-FEB-2017, dose and route not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial unsolicited report received from a physician on 18 September 2015. This case involves a 57-year-old female patient who was vaccinated with second dose of MENACTRA [batch number: U5172AA, expiry date: 14 January 2017, dose and route of administration were not reported] in left deltoid; fourth dose of FLUZONE QIV (Syringe) [batch number: UI439AA, expiry date: 30 June 2016, dose and route of administration were not reported] in right deltoid and second dose of PNEUMOVAX 23 [manufacturer: Merck, batch number: K021881, expiry date, dose and route of administration were not reported] in left deltoid on 15 September 2015. The patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as head and neck twitching with amitriptyline, MS (Multiple sclerosis), tape, splenectomy. She had a history of getting head and neck twitching from the Amitriptyline. Concomitant medications were not reported. On 15 September 2015, few minutes following the vaccination (reported as immediately after vaccination), the patient had developed fever with head and neck twitching (area of twitching was not specified). On 17 September 2015, the patient was taken to intermediate care center with left arm redness, swelling with lymph involvement, hypotensive and failed to respond to fluid bolus. On the same day, the patient's WBC count was 35,000 and was transferred to hospital with a diagnosis of sepsis, septic shock.  Relevant diagnostic tests included full panel of blood work, lumbar puncture was found negative and CT scans of chest and abdomen showed left arm diffuse swelling with lymph involvement suspicious of cellulitis. The patient had received blood pressure support from fluids and a norepinephrine drip as a corrective treatment. The patient had not recovered from the events. List of documents held by sender: none.
Patient presented with a swollen, red area at the subcutaneous site of the Zostavax injection.
Chills; This is a spontaneous report received from a contactable consumer (the patient) via a company representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills after getting the Pfizer COVID-19 vaccine. The outcome of chills was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After patient received vaccine, another patient shouted that he needed help. Came back out of pharmacy to find patient passed out but he came to quickly. He was very pale, sweating and complaining of nausea. Got patient ice packs, water and Gatorade and after about 20 minutes patient was feeling well enough to leave with his father.