chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms which included chills, fever, body aches.; swelling and pain in my left armpit all the way into my left pectoral muscle region; swelling and pain in my left armpit all the way into my left pectoral muscle region; tightness in my chest; wheezing while breathing and raw feeling in my lungs.; wheezing while breathing and raw feeling in my lungs.; The swelling and tenderness lasted for over two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 09:00 (Lot number: EL9267) at the age of 45 years as dose 2, single and administered in arm right, administration date 29Jan2021 09:00 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 16Feb2021 23:00, outcome "not recovered", described as "flu like symptoms which included chills, fever, body aches."; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 16Feb2021 23:00, outcome "not recovered" and all described as "swelling and pain in my left armpit all the way into my left pectoral muscle region"; CHEST DISCOMFORT (non-serious) with onset 16Feb2021 23:00, outcome "not recovered", described as "tightness in my chest"; WHEEZING (non-serious), PULMONARY PAIN (non-serious) all with onset 16Feb2021 23:00, outcome "not recovered" and all described as "wheezing while breathing and raw feeling in my lungs."; TENDERNESS (non-serious) with onset 16Feb2021 23:00, outcome "not recovered", described as "The swelling and tenderness lasted for over two weeks". Therapeutic measures were not taken as a result of influenza like illness, axillary pain, swelling, chest discomfort, wheezing, pulmonary pain, tenderness. Additional Information: The night of the second shot, on 16Feb2021, the patient experienced flu like symptoms which included chills, fever, body aches. A couple days after the shot experienced swelling and pain in my left armpit all the way into my left pectoral muscle region. The swelling and tenderness lasted for over two weeks. Along with the swelling and tenderness, he experienced tightness in my chest, wheezing while breathing and raw feeling in my lungs. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not received any other medications within 2 weeks of vaccination. Patient was reported that most symptoms were temporary, except for the continuous tightness in chest like raw feeling in lungs with occasional wheezing or congested sound while breathing. Patient was not diagnosed with Covid prior to vaccination. patient was not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding medical history, concurrent conditions, drug reactions or allergies were reported. On 19-APR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (with the lot # L029480 and expiration date of 16-MAR-2016 (dose, dose number, route and anatomical location were not provided. Concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
at 13.5 minute mark after the injection, my face started to have an extreme tingle, I was unable to swallow, chest was tight, then my arms also started to tingle. My heart rate was also fluctuating from 70-110 bpm while sitting down. The worst of it went away after 1 minutes, had mild symptoms for the rest of the day.
This case was reported by a consumer and described the occurrence of erythema of extremities in a female patient who received SHINGRIX (batch number ZJ4P2, expiry date unknown) for prophylaxis.  On 15th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the erythema of extremities, pain in arm and skin warm were unknown. It was unknown if the reporter considered the erythema of extremities, pain in arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was curious that a side effect that was normal. On Monday morning, the patient received SHINGRIX on left deltoid. The patient experienced redness, soreness and heat from the injection site to the elbow. The redness, heat and soreness had moved her arm approximately from Tuesday evening to the evening of the reporting date. The reporter will provide pictures if they wish to see them.
46 y/o female who received seasonal flu vaccine on 22 JAN 2013, around 0900. She usually receives annual flu vaccines, but reports receiving the nasal mist over the past 4 years, and denies any adverse events. This year, she delayed getting the FLUMIST because several times since OCT 2012, when she thought about getting the vaccine, she had the "sniffles". She decided to get the vaccine on Tuesday, 22 JAN, as she felt well and was coming off a long weekend. The FLUMIST was not in stock, so she received the IM injection. She denies anything unusual related to vaccination technique or placement of the vaccination. She noted a significant amount of pain during the injection, but no unusual bleeding, bruising or streaking. Later on the day of vaccine receipt, patient reported the onset of a migraine, which started at the back of her head and progressed forward, It was accompanied by nausea, light and sound sensitivity, so by 1300 (4 hours post-vaccine receipt) she went home. She took a MIDRIN and rested, but did not get complete headache relief. She denies any visual changes or mental status changes. She noted some vaccination site soreness that prevented her from lying on her left side (the side she usually sleeps on). She also reports alternating sweats and chills through the night. She was not able to sleep due to her migraine, as well as other symptoms, so she stayed home from work on WED. She rested and increased her fluids. Her intense migraine was gone, but she reports having a dull headache and increased sensitivity of her scalp. After she took a shower that afternoon, she noted that her vaccination site looked red and swollen and was tender to touch. On THUR, she teleworked from home; her vaccination site was still tender and swollen, and her neck was sore due to not sleeping on her usual side. She applied cool compresses to her left upper arm throughout the day and took some ALEVE, which was not effective in relieving her arm pain and swelling. She denies any numbness, tingling or weakness of her left upper extremity. No increased warmth at her vaccination site. She did not experience any dyspnea, wheezing, nasal symptoms, difficulty swallowing, angioedema or swelling of her tongue, itching or tightness of her throat, flushing or hives. She did note her vaccination site and eyes were itchy on Thursday (48 hours post-vaccination). Today, she reports her vaccination site is still tender, red and itchy, but the swelling has decreased a little. Patient denies any other known exposures on day of vaccine receipt or since. Of note, within the past couple of months, she has noted after she ate shrimp, her lips and tongue become "itchy". She is allergic to TCN ' rash, nausea and vomiting, and she experiences allergy symptoms, usually in the spring. She denies any allergic reactions to insect stings or latex. No prior vaccine reactions.
Dizzy and disoriented five mornings in a row. Vomiting on three occasions.
This pharmacist reports giving the patient the MMR II vaccine which was reconstituted with expired diluent; Route: Subdermic; This spontaneous report was received from a pharmacist and refers to a 59 year old male patient. The patient's past medical history, concurrent conditions and concomitant medications were unknown. On 30-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot # M044952 (expiration date not reported), subdermally for prophylaxis. The vaccine was reconstituted with an expired sterile diluent.  Lot numberM044952 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Child was given Flu Mist accidentally. CDC Hotline called-no need to revaccinate child.
Patient was given a vaccine from vial that was punctured for more than 6 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a vaccine from vial that was punctured for more than 6 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Patient was given a vaccine from vial that was punctured for more than 6 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given a vaccine from vial that was punctured for more than 6 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Not Provided)  with no associated AEs.
18 h after having Flu vaccine on left arm, pt developed erythema, swelling, induration at the area where she had vaccine, approx 11 x 9 cm; and some itching bearing to the area. Pt was treated with Benadryl 12.5 g/5 5ml even 6 h and Orapred PO daily x 3 days.
On 10/8/12, patient's tongue started feeling strange like she had been to the dentist. A few days later she woke up with the left side of her face droopy.  This lasted for 2 1/2 weeks.  She saw a physician at the local emergency room and was referred to a neurologist.  She followed up with her PCP. She was diagnosed with Bell's Palsy.
It was identified as an error following the office visit.  There were no symptoms reported following the vaccination.
shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.      On an unspecified date in 2012, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provider at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).         Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.    The outcome of herpes zoster was reported as not recovered.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Headache, Myalgia, Fatigue, Chills, Injection site soreness  Narrative:  Other Relevant History:
3 to 4 drops leaked; 3 to 4 drops leaked out of syringe; A spontaneous report was received from a consumer who was also a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event 3 to 4 drops leaked out of syringe.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On Feb 2021, the patient observed that about 3 to 4 drops leaked out of the vaccination syringe. No adverse event was reported by the patient after being given the vaccine. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.   The outcomes of the events were considered recovered on 26 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
A couple days after injection I started experiencing Heart Palpatations, It seems tobe getting worse.This is a month and a half after injection. I have not been to dr reguarding this
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 10-MAY-2018, the patient was vaccinated with an expired dose of VAQTA intramuscularly(lot # M032492, expiration date: 03-MAR-2018, dose, strength were not provided) for prophylaxis. The nurse reports that VAQTA was properly stored. The patient did not experienced any adverse event.
Patient received COVID-19 vaccine on 1/28 and 1/6/2021.  On 4/25 patient developed cough, back pain, and weakness/fatigue.   Tested positive for COVID.   Treated with monoclonal antibodies.
Presented to ED with body aches, chills and fatigue. Temp: 37.6, Pulse: 106 Resp: 22  123/77 Oxygen sat 100% IV fluids given (1000ml), Tylenol and Ketorolac. Discharged to home and self care.
Problems breathing. I had to be prescribe medications to get my lungs working normally. Still having issues with lungs and breathing.
Donor became pale and lighthead 15 min after vaccination.  Donor assisted to bed and placed supine.  Diaphoretic.  No LOC.  Vitals taken.  No nausea.  Donor felt better after 27 min. and was released.
metallic chalky and bitter smell through his nose; nose has also been stuffy; headache; been nauseated; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old male patient had a metallic chalky and bitter smell through his nose (parosmia), nose has also been stuffy (nasal congestion), headache (headache) and had been nauseated (nausea), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Hepatitis C and Liver disorder. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient also takes a pain killer (name unknown).  On 11-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right shoulder.  On an unknown date, the patient had a metallic chalky and bitter smell through his nose (parosmia), nose has also been stuffy (nasal congestion), headache and had been nauseated (nausea) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.  Final diagnosis was parosmia, nasal congestion, headache and nausea.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.  Information on the batch number was requested.
This case was reported by a physician via call center representative and described the occurrence of local swelling in a 49-year-old female patient who received BOOSTRIX (batch number 3K44J, expiry date unknown). On 28th February 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 2nd March 2018, 2 days after receiving BOOSTRIX, the patient experienced pain in elbow. On 6th March 2018, the patient experienced ear pain, neck pain, shoulder pain, back pain, feeling hot and cold and exhaustion. In March 2018, the patient experienced eyes heavy feeling of. On an unknown date, the patient experienced local swelling and feeling of warmth. On an unknown date, the outcome of the local swelling was recovering/resolving and the outcome of the feeling of warmth, ear pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow were unknown and the outcome of the neck pain was not recovered/not resolved. It was unknown if the reporter considered the local swelling, feeling of warmth, ear pain, neck pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow to be related to BOOSTRIX. Additional information was received as follows: The patient received BOOSTRIX vaccine on left deltoid. The patient reported that the patient came to the office on 5th March 2018, because the patient still had a large lump on arm that was warm to touch. The patient emailed the reporter to report that on 6th March 2018, the day after coming in to the office, the patient's ear, neck, shoulders, and back began to hurt. She started to get hot and cold and felt exhausted all of the time. In the email she also described that two days after the injection, she felt like a cold had settled in her left elbow because it felt achy and sore. Unable to obtain additional information.
Patient noted to have unsteady gait - experienced syncopal episode. Placed in supine position, with BP 82/40 (pulse 46). Blood glucose 112. Given 500 mL normal saline. Sent to Medical center.
Vaccine diluent was administered without antigen. MA did not complete reconstitution with Antigen Powder. Upon monthly logs discovered this. Will need to administer another PENTACEL at 8mo. Notified mother and father of issue on 1/28/19 PENTACEL Administration where training MA under supervision of clinical MA and MD. Failed to reconstitute diluent with Antigen powder for PENTACEL. So inadvertently diluent was administered without Antigen. Pt did not received adequate IPV-Hib-DTaP dose protection as needed. But no adverse effect of the diluent administered. Discussed with mother/father and will administered PENTACEL at 4, 6, 8 months age to give full protection.
Red, swollen arm (left) below injection site and around elbow. Icepacks, BENADRYL, ADVIL.
Information has been received on 24 JUL 2001 from a female registered nurse who was vaccinated with a first and second dose of varicella virus vaccine live (site unknown), within the last 8 years. A titer was drawn a few years after the vaccinations, subsequently the patient failed to seroconvert. The patient did not seek medical attention. Additional information has been requested.
patient was in 3 MenB dose schedule and the 3rd was Bexero; This case was reported by a consumer via call center representative and described the occurrence of interchange of vaccine products in a adolescent male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE for prophylaxis.   Previously administered products included Meningococcal B vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 2nd dose of MENINGOCOCCAL B VACCINE. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 Information: GSK Receipt Date: 14-JUL-2022  Reporter's Comments: The reporter was the mother of the patient. The patient received Bexsero for the third dose of their Meningococcal B vaccine, despite previous two doses being a different brand (did not provide brand of previous doses).  The reporter did not consent to follow up. Additional Supportive Information: The patient received Bexsero for the third dose of their Meningococcal B vaccine, despite previous two doses being a different brand, which led to interchange of vaccine products.
vaccination failure; Thinks she contracted shingles; Itching on her back and it appears as 4 linear dots; burning over that area (back); thought it may be bra rubbing skin; Itching on her back and it appears as 4 linear dots; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number T4952, expiry date unknown) for prophylaxis.   On 6th February 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, the patient received the 2nd dose of Shingrix. On 3rd August 2019, 178 days after receiving Shingrix and 108 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, burning sensation, chafed skin and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, rash, burning sensation, chafed skin and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash, burning sensation, chafed skin and pruritus to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient experienced itching on her back and it appeared as 4 linear dots (2 on top and 2 below). She stated that she has burning over that area. Initially, the patient thought it might be bra rubbing skin but later she thought she contracted Shingles.  The patient worked at a facility and might have contracted Shingles at work.  The reporter consented to follow up.
Seizure (focal) noted the next day. Was admitted to hospital. Had hyponatremia.
Redness, swelling from injection site down to elbow. Described as hot and itchy. Patient took Benadryl