chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report received from a Plasma Center employee on 23-Oct-2008.  A 21 year-old female received AFLURIA (CSL Influenza vaccine) via IM injection to the right deltoid (lot 03549111A) on 20-Oct-2008 at 20:30 hours.  The patient had no pre-existing diagnosed allergies or medical conditions.  She was not ill at the time of vaccination. On 20-Oct-2008 at 21:00 hours, patient had general/localized pain in the area of right deltoid.  The pain spread from shoulder to elbow.  Patient stated that her fingers started tingling at approximately 1:00am on 21-Oct-2008.  When she awoke at 6:00am on 21-Oct-2008, her arm was numb.  There was no redness, swelling, or bruising noted to the area.  Temperature was 98.4 F.  Patient had not been running a fever, but the patient felt like she did have a fever the morning post the injection (21-Oct-2008).  Additional information has been requested.  No serious criteria mentioned.  The company considered these events as possibly related to the administration of AFLURIA.  Follow-up information received from a nurse on 06-Nov-2008 from Plasma Center.  Per the reporter, patient has recovered and did receive treatment at the regional occupation care center where she was given (?) PREDNISONE.  No further information is expected.  Information derived from this AE report does not change the current safety profile of the AFLURIA (CSL Influenza vaccine).  Results of CSL Quality Assurance batch review for 03549111A received 18-NOV-2008.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
flu; Initial information received on 05-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of an unknown age and gender who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Nov-2022, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Dec-2022 the patient developed a non-serious event of flu (influenza) (latency: 22 days) following the administration of influenza vaccine.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
After vaccination, a recent blood test revealed the presence of anti JO-1 antibodies.  I do not have a baseline by which to compare this finding.  I have always had a high positive ANA but learned of the anti-Jo-1 antibody only after vaccination.  This is the first specific antibody to be found in bloodwork, and I've had dozens of tests throughout the years to track the meaning of the high ANA (so SSA, SSB, Scl, etc. all negative).  I did have a vaccine reaction at age 23 to a tetanus booster, so I have avoided vaccines.  The risk/benefit profile of the COVID-19 vaccination caused me to opt-in on this one, after consulting with a rheumatologist.   The Janssen COVID-19 vaccine is the first vaccine I've received since having the positive ANA and other health issues around the time of the tetanus vaccination.   I am definitely concerned about the potential decision for additional doses or boosters.
I'm not feeling well"; "Last night I felt with chills"; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ("Last night I felt with chills") and MALAISE (I'm not feeling well") 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced CHILLS ("Last night I felt with chills"). On an unknown date, the patient experienced MALAISE (I'm not feeling well"). At the time of the report, CHILLS ("Last night I felt with chills") and MALAISE (I'm not feeling well") outcome was unknown. Not Provided
positive ANA titer; This spontaneous case was reported by a consumer and describes the occurrence of ANTINUCLEAR ANTIBODY POSITIVE (positive ANA titer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ANTINUCLEAR ANTIBODY POSITIVE (positive ANA titer). At the time of the report, ANTINUCLEAR ANTIBODY POSITIVE (positive ANA titer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: Prior to the shot - ANA positive 1 in 320 dilution. One month after the first shot - ANA positive 1 in 640 dilution..         Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lingering through the next day.
Excessive thirst night of vaccine. I?d had no period since 9/20 and 3 weeks after 2nd dose I got a period with exaggerated pms symptoms.
arm became sore at the injection site.; headache; sweating; nausea; feeling cold; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th January 2021) for prophylaxis.   On 16th April 2020 16:30, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2020, 11 hrs after receiving Shingrix, the patient experienced headache, sweating, nausea, feeling cold and fever. On 16th April 2020, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, headache, sweating, nausea and fever were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, sweating, nausea, feeling cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and described that a couple of hours later, her left arm became sore at the injection site.   It was still sore at the same location. On 17th April 2020 at around 4.30pm, the patient woke up and was experiencing body aches, fever of 100.6, headache, sweating, nausea, and feeling cold.  The sweating and fever have resolved and the nausea is a little less.   However, she still has the other symptoms. The reporter consented to follow up.
I started with achiness, headache, runny nose, and coughing. I did a home test that was positive on July 03rd. I went to urgent care at 11:30am and retested with a COVID-19 PCR Test and was positive. I was prescribed Paxlovid. I started the medication on the same day and started to have improvement in symptoms at about a rate of 10% per day. I am still experiencing low energy with a mild cough. I also have mild to moderate achiness. I have not recovered as I still have symptoms but I am improving.
I felt very sick with temperature and a deep pain in my upper arms, bones, (included the elbows) and couldn't separate my arms from my trunk (it hurt). I was weak and I only wanted to lay down. I couldn't cook or nothing, not to help my children and I was in pain and when I lifted something, it hurt, I didn't want to eat (lost appetite). My symptoms lasted for 3 or 4 days, but from that day, I feel the pain return once in a while again for 1 or 2 days and then is gone. In different parts of my bones (upper arms, elbows, legs mainly) since then my fingers hurt and I don't remember it being like that before. Until now, I prefer to ignore the pains, it's not like it stopped me to do my things. It is sufferable but it put me in a bad mood because I have to do a lot and with that latent pain, it is harder. It called my attention, especially because the pain was in both arms, not just the one with the vaccine. By the way, the area where I received the shot was swollen, hard to the touch and red, like when a bee stings you. The redness was about the size of the palm of my hand and made me nervous to look at it because it was like all that area was above the surface of the rest of the skin and the skin was hot in that red area. But some days, I'm perfectly ok, with no pain at all.
Right upper arm at injection site, member noticed a quarter-size red area that was warm to the touch, but did not think much of it.  By 12:00 PM on 3 Oct 11, redness grew to 5 cm in diameter, still warm to the touch.  Member describes an "irritation" feeling, but not truly "itchy".  No other signs/symptoms reported at this time.
Developed hives on the upper bilateral cheeks and bilateral face, temple area, forehead.  Had red, raised blotchy spots.
Vaccine administration not in accordance with VFC recommended childhood and Adolescent immunization schedule 2005, Administration of vaccine not licensed for adolescents.
Patient is fully vaccinated.  COVID + 12/25/2021.  ED visit 1/6/2022.  Chief complaint dehydration. Positive for congestion, cough, fatigue, headaches, weakness, myalgias, nausea.  BP 108/58  | Pulse 73  | Temp 98.9 °F (37.2 °C) (Oral)  | Resp 18  | Ht 157.5 cm (5' 2")  | Wt 45.4 kg (100 lb)  | SpO2 100%  | BMI 18.29 kg/m² Extensive workup otherwise unremarkable - given fluid rehydration, decadron, benadryl and stable for discharge.
Blood clot in leg; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 04Oct2021 at age of 36-year-old at single dose, unknown dose number for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had blood clot in leg (also reported as allowed to clock in leg) on 06Oct2021. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided. Information on the lot/batch number has been requested.
THE PATIENT FELT PALPITATIONS, A PAIN IN HIS RIGHT TEMPLE, SOME NUMBNESS IN HIS TONGUE
Patient had previously received first dose Moderna under the name in the immunization registry. Patient unable to get second dose Moderna and received Janssen instead.
had vaccination 3/30 in L arm. On 3/31 had headache and on 4/1 developed increased sensitivity in R arm. Started development of herpes zoster in R arm on 4/2/2021.
Took injection at 8am on 12/29/2020 & started showing symptoms about 11pm on 12/29/2020. I have experienced a temperature of 101.9 (being my greatest) and 99.7 (being my lowest). I have continually had a fever since last night (12/29/2020) and all day today (12/30/2020). I have pain, swelling, redness, tenderness at the injection site and the injection site is also hot to the touch. I have experienced nausea with no vomiting, chills, and body aches as well.
Blistery Rash; Blister; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 43S97, expiry date 26th November 2021) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th August 2019, 3 days after receiving Shingrix, the patient experienced blistery rash and rash. On an unknown date, the outcome of the blistery rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the blistery rash and rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting that the patient experiencing a blistery rash after receiving Shingrix.There were more blisters present than rash, it was to the patient's rib cage and a little between her breast.  The reporter consented to follow up.
Tired; Hot; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Jun2021 at 15:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included graves' disease and hyperthyroidism. The patient had known allergies to food, gluten, sugar and diary. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and thiamazole (METHIMAZOLE); both from unknown dates for unspecified indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11Jun2021 at 20:30, the patient reported that she felt tired and hot. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tired and hot was resolving at the time of this report.   The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient was given her final Hep B dose in the series of 3 by Employee Health Nurse (myself). She had no previous reactions to vaccine. The vaccine was given around 11:30 or Noon on 3/26 and by 6 AM on 3/27 she was feeling itching on her hands. The itching increased as the morning went on. Patient tried a OTC steroid cream to calm the itching, but by end of the day she had itching up to her elbows and could feel itching on her knees also. When reporting to work on Wed 3/28, patient's manager noticed her face looked a little puffy. Then noticed a occasional dry cough. Patient's clinic manager contacted me to question next step. Patient's manager drove her to ED and stayed with her until discharge. Patient followed up with Occupational Medicine Department on Fri 3/30 per ED physicians order. Patient had not changed any of her behaviors or the product she uses as she has a family member with allergies and this is the only thing in her routine that changed.
Pt was diagnosed with Varicella symptoms for 2 days. Fever 102 with lesion appearing withint 24 hours.
Pt.'s Daughter In-Law states that after receiving the 2nd dose of Phizer 03/27/2021, started experiencing symptoms 04/02/2021 of vomiting, chills, difficulty communicating, and shortness of breath. 04/03/2021 lost consciousness 911 contacted 11:35am.
Herpes Zoster/Shingles on the right side of her neck; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or around 31-JUL-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered herpes zoster/ shingles on the right side of her neck. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  The event of herpes zoster/shingles on right side of her neck was considered to be disabling.
Gillian Barrett Syndrome; hands and feet intense neuropothy; numbness feet, hands, back, belly;paralysis right side of face; tingling in face and head; tongue numb and no taste; muscle weakness and loss of grip strength;dizziness
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.  No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
got his first Shingrix 14 months ago; This case was reported by a other health professional via media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 14th months ago).   On an unknown date, the patient received 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 details were provided as follows: Age at vaccination was not applicable to this report. The reporter reported that the patient received his 1st dose 14th months ago, which led to incomplete course of vaccination. The reporter asked did he just get his second shot now and the series was complete or did he need to start over again because of the time lapsed.
Patient Recived her Men B vaccine yesterday around 9:30 AM Pt states her arm felt weird immediately and she could feel it travel down her arm. Over the course of the next few hours. She developed a headache, Nausea, upper back Pain - burning sensation & C/O weakness and a lack of strength overall. Pt was able to Participate in soccer practice
Aches, severe headache, fever over 101.1, loss of appetite, overall malaise, injection site swelling and pain for four days
Severe headache, 100.2 fever, some shortness of breath, chest congestion, Tingling in right hand that has not gone away yet. Severe weakness.
9/1/14 8:30 PM - noticed what looked like mosquito bites. 9/3/14 rash started to blister. 9/4/14 took child to Dr. who diagnosed mild case of chickenpox by sight.
SSORE ARM AT 3 HOURS, FEVER BODY ACHES AT 8 HOURS, ACETAMINOPHEN/DIPHENHYDRAMINE AT 9 HOURS, WORSE BODY ACHES AT 12 HOURS,  HEADACHE AND LEFT FLANK PAIN AT 15 HOURS, SYMPTOMS IMPROVING MARKEDLY AFTER  MORNING COFFEE AT 18 HOURS, EXCEPT SORENESS AND INDURATION AT INJECTION SITE.
1ST DOSE PFIZER GIVEN ON 3/17/2021; 2ND DOSE PFIZER GIVEN 12 DAYS EARLY-3/029/2021 LOT# EP6955.
Severe reaction; lost feeling in right hand and foot; pain (sharp) throughout body; flu like symptoms, high fever 7 days quarters 2 days hospitals.
1/4/22 Headache immediately following the injection. Swelling at injection site.  Had flu symptoms throughout the day. Severe chills in the evening that lasted roughly 4 hours. Used a heating pad(on high) and several blankets but could nit warm up. Hips and thighs were very cold. Skin hurt when touched.  1/5/22 No more chills but I feel like I have the flu. Lethargic.
Received first dose 2/27/21 and received second dose 3/20/21 and died 3/26/21.
(1) Fever (T max 103.2) began within 13 hours of receiving the vaccines (Tdap X MENACTRA). (2) R arm sore. No treatment.
Onset of photosensitivity rash on forearms, cheeks, ankles 2 weeks after receiving ZOSTAVAX. Mild pruritus. No treatment received so far. Macular erythema, no vesicles.