chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & exp backache, gen aches, & flu-like sx;shakiness has resolved;all the other sx persist as of 11JUN96;
Pain at injection site - consistent severity weeks later and causes waking up in the middle of the night. At injection tingling traveled down the arm and hand, with numbness in hand for 20-40 minutes. Was light headed and nauseous for 30 minutes after dose. Only half the side effects as first dose but shoulder pain is more severe and didn't vanish after 1 hour.
Erythropsia in both eyes - pink/red tinged vision (happens with febrile illnesses) that has been recurrent since May 2013 - one month after Tdap vaccine.
On December 17, 2007, four days after receiving the third Gardasil vaccine patient developed violent tics. She was unable to control the movement of her head and limbs. The tics were proceeded by a low grade temperature, then severe shooting ear pain. The following day she was seen by her pediatrician and a pediatric neurologist. Blood tests and MRI's done. There were no positive findings. She was placed on Klonopin and Tenex. The tics reduced and became more manageable. Due to there being no positive findings she was referred to a psychiatrist who gradually took her off Klonopin (the Tenex has been discontinued) and replaced it with Effexor. The tics were controllable, but not gone. Feb 4, 2008 patient developed a low grade temperature, followed by stabbing ear pain, then the tics resumed. She was seen by her ped and ped neuro. Stress was thought to be the cause. They lasted for four days. Then the tics subsided. The temp, ear pain, and violent tics reappeared on March 10 lasting 9 days. Blood tests were run. There were no positive findings. She was seen by the ped, ped neuro and by an ENT. The ENT believes the ear pain was due to clenching of the jaw. She was placed on a soft food diet for two weeks. On April 7 the tics appeared but not as violently. There was a small temperature but no ear pain.
Client presented to the vaccination site on 11/11/2021. The client notified RN that he she received a single dose of Sputnik COVID vaccine on 06/05/21 and Moderna First dose 08/28/2021. RN submitted a medical consult via phone number to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Moderna second dose. Per CDC guidance, approval to proceed with COVID vaccine Moderna was obtained from medical consult team via phone by Vaccine Operations Lead. Client received COVID vaccine Moderna Lot#066F21A on 11/11/21. The client did not report any symptoms during the 15 minute observation period.  RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site in a steady gait
Fever 101.8, chills, nausea, abdominal pain, muscular and joint pain, increasing throughout day into evening.
1-2 weeks later after 2nd MODERNA vaccine patient developed diffuse painless livedo reticularis throughout her lower extremities has persisted up until October consultation with rheumatologist, Dr. Lab testing for notable for double high positive anti-phospholipid antibodies that increase patient's risk of thrombosis. Placed on aspirin without progression or improvement thus far and we to plan to repeat APL antibody testing in 3 months
Pt complaining of tongue swelling, throat itchy 6 minutes after of getting Moderna Booster vaccine. Benadryl 50 mg po given per Dr order. Pt stated she was also having difficulty swallowing water. Pt remains alert, oriented, denies any sob nor wheezing. !o to 15 minutes after the Benadryl pt able to swallow liquids without difficulty but tongue still feels swollen. Dr came and second dose of Benadryl 50 mg given as ordered. 30 minutes after second dose of Benadryl, pt stated her tongue swelling and all symptoms were resolved. Dr came and examined pt, okay to go home. Pt left in stable condition.
Patient became very pale, clammy and started shaking immediately after vaccination. Patient almost passed out.  The shaking became worse and she was not responding to questions so the paramedics were contacted to attend to the patient.
Monovalent Moderna was administered instead of bivalent Moderna. Wrong bottle of vaccine was pulled from the refrigerator by student intern .
second dose was scheduled for mora than 42 days after the first.; slight discomfort at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was scheduled for mora than 42 days after the first.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (slight discomfort at the injection site). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was scheduled for mora than 42 days after the first.). On 12-Mar-2021, VACCINATION SITE DYSAESTHESIA (slight discomfort at the injection site) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was scheduled for mora than 42 days after the first.) had resolved. Not Provided      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.   It was enquired by the reporter that since more than 42 days has passed, she should start the series again or only receive the second dose No concomitant medication reported   No treatment medication reported  The case is cross linked to MOD21-080188   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: First dose date updated
Invalid dose due to spacing error at office. MMR vaccine was given on 1/24/16 in the office then on 2/2/18 a Varicella dose was given in the same office. No known adverse reaction, school nurse called Local Health Department because office was not understanding that the dose would be invalid and said child didn't need further vaccines as that would be over vaccinating the child.  Local Health Department sent a letter to office that child would need another Varicella vaccine with spacing 3 months from 2/2/18. This will protect child and fulfill school requirements. CDC directed me to report this.
Large local reaction at injection site not extending beyond shoulder or elbow joint of left arm with associated erythema
After vaccine administered patient had an episode where she became stiff and very pale gray/white lasting a few seconds. Pt then back to normal consciousness
Pt became fussy, irritable, cried all afternoon, mom took temp 103; ER t102; pt does not want to eat; Pt given APAP;
24 to 36 hours, post vax, mother noticed painless swelling of thigh. Swelling has not subsided in 24 hours.
Approximately 8 hours after the vaccine my temperature starting to increase, and I experienced shivers.  By 12 hours after, I had a temperature of 106.5F and was visibly shivering.  Within 24 hours my temp had returned to normal 97.5 but my body still felt cold.  By the next day I was perfectly normal again.
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
Post nasal drip in throat; This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (Post nasal drip in throat) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post nasal drip in throat). At the time of the report, UPPER-AIRWAY COUGH SYNDROME (Post nasal drip in throat) 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 information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Rash; Headache; Fatigue; General aches for a few days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (General aches for a few days) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH (Rash), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (General aches for a few days). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in 2021 for Rash, Headache, Fatigue and Myalgia, at an unspecified dose and frequency. In 2021, HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (General aches for a few days) had resolved. At the time of the report, RASH (Rash) was resolving.            No concomitant medications were reported. It was reported that her rash had not resolved at the time of the second dose but had improved significantly and she had not experienced any symptoms for the months between her rash resolving and the booster dose of the vaccine. It was reported that there was no product complaint associated. Treatment medication information: she may have taken a Tylenol once or twice for her symptoms.   This case was linked to MOD-2022-483243, MOD-2022-481671 (Patient Link).
c/o rash 13SEP95 w/itching;20DEC95 mom states pt ok now-no further problems;
Initial report received from healthcare professional on 05 June 2014. 10 patients, whose gender, date of birth, age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that on an unspecified date, after receiving FLUZONE ID, the patient experienced redness, soreness at the injection site and an achy arm. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovered. Documents held by sender: none.
Body aches and chills began around this time. Slowly progressed to a severe state by 7:00pm. Fever recorded of 101.2 F at 7:55pm
All PM. Approx 5:30 - extremem fussiness/crying/inconsolable 6:15: head drooping to side. 6:55-7:05: turned pale white and blue, body went limp. 7:05 - 7:15: Blue tint to skin all over, listless, in/out consciousness and eyes rolling back. 7:15 Vomiting. 7:20 limpness subsided. 7:22 vomit. 7:25 color returning to skin. 7:30 normal behavior returning.
So I got the vaccine on January 23rd and the Sunday following I started noticing I was getting very dizzy I went to the ear doctor they said it was not my inner ear so I went to a heart doctor and they did a tilt table test and the tilt table suggested orthostatic hypotension. The heart doctor did alot of heart tests and the heart is good. My vision was blurry with constant headaches went to an eye doctor and I have onset strabismus in my right eye and then I went to a neurologist because the tips of my toes were numb . The heart doctor has me on fludrocortisone and metropolol because my heart rate was very high all the time ever since the vaccine it was stuck at 130 to 150 beats per minute no matter if I was resting or sitting. My pupils oscillate and ever since the adverse reaction started I have had pupillary athetosis or hippus. Horrible brain fog can't think clearly or sleep well insomnia came with all of this as well. I go to the mayoclinic, because dysautonomia is expected.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 62-year-old female patient 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 (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Treatment information was not provided.  Company Comment -This case concerns a 62-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after an unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after an unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Report 2002001269-1 describes a 53-year-old female who did not respond to a 4-injection series of hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. On 03/08/2001, 04/10/2001 and 09/12/2001, the pt received her 1st, 2nd and 3rd injections of Engerix-B (all from lot #ENG3375A4; expiry 04/20/2003) respectively. Antibody titer against hepatitis B surface antigen (HBsAg) was measured on 11/20/2001 and was negative. On 11/30/2001 the pt received her 4th injection of Engerix-B (lot ENG3375A4), expiry 04/20/2003). Anti-HBsAg titer was negative on 01/17/2002.
Narrative:  Pt is a 82y.o. male who died on 05/05/2021 with h/o CKD4, HTN, and DM. Patient received Pfizer Covid-19 on 02/25/2021 at specific location. Location of death was HOSPICE. Unlikely Pfizer Covid-19 vaccination caused/contributed to death.
Still not received the second dose and missed 42 day window; A spontaneous report was received on 02 MAR 2021 from a consumer, who was a 82-year old,  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the second dose and missed the 42-days  window (inappropriate schedule of vaccine administration ).   The patient's medical history was not provided. No concomitant product use was reported.   On 16 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection and did not receive the second dose and missed the 42-day window. No adverse events were reported, and no treatment medications were reported.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, not receive the second dose and missed the 42-days window, was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, no vaccine administered, with no associated AEs.
Pt presented to Peds clinic on 11/29/10 complaining that left side of face was droopy since last Wed. She could not blink her eye lids or move mouth.  Pt was diagnosed with Bell's Palsy and treated with prednisone.
I got the J&J vaccine around 2:30pm on a Saturday and by 6 or 7pm I was experiencing a really bad headache. This headache extended down my back and around the back and top of my skull. By 8pm I had began experiencing chills, body aches, and nausea. By 9pm I had a fever and could not stand up without feeling like I was going to vomit. Walking to even get water in the other room gave me motion sickness. I was shaking and sweating with a fever all night, was unable to sleep, and experienced hallucinations due to the high fever. The next morning I still had a fever but could finally sleep. I still had a bad headache, body aches, and nausea. I slept most of the day and my fever went down but was still >100 degrees all day. On Monday, I had a mild fever in the morning which went away by afternoon. I  felt weak all day Monday and still experienced body aches and a headache. By Tuesday, I was only experiencing fatigue and brain fog. This lasted about a week.
After influenza vaccine 0.5 cc AFLURIA. Pt had increased polyneuropathy she attributed polyneuropathy to vaccine Dec 1 2015.
Chills, body aches , headache, fever for 24 hours.  Soaking night sweats x 4 days.  Headache x 3  Severe sore injection pain and arm weakness x3 days   Took Advil and Tylenol.
Woke up with severe Vertigo. (I've never experienced vertigo before). I could barely make it to the bathroom and back to bed for 2 days. Just moving my eyes or my head made the room to spin. I had some nausea, but no vomiting. I called my PCP, and he prescribed Meclizine. I took 2 doses 8 hours apart and it made me sleep for the greater part of these 2 days and drowsy afterward. My husband made me jello and pudding to eat while lying down flat in bed. The Vertigo then became less severe and I was bothered by dizziness for the next week.
Temp of 104; body aches; chills; Diarrhea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2022 10:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Shrimp" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR. The following information was reported: PYREXIA (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "Temp of 104"; PAIN (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, diarrhoea, decreased appetite.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Known allergies: Shrimp. Other medical history: Asthma  The lot number for bnt162b2 was not provided and will be requested during follow up.
Memory loss, family loss, Mother and father are dead. Permanent coma. Delusional thoughts if my brain died. Adopted. Birth certificate. Orange birth certificate. White birth certificate is necessary.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site induration (hard spot), injection site rash (arm rash) and chills in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 008B21A and 026A21A) for COVID-19 immunization. The patient's past medical history included breast cancer. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 4, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced chills. On Apr 7, 2021, patient experienced vaccination site induration (hard spot) and injection site rash (arm rash). On Apr 4, 2021, chills resolved. At the time of the report, vaccination site induration (hard spot) and injection site rash (arm rash) outcome: unknown. This case linked to MOD-2021-072778 (patient link).
On 10/09/09 at 10:00 AM, pt. called and mentioned that pt. have pain in her hand and she can't move it, suggested to use hot compress and spoke with Dr at her MD office and she told that pt. has to go E.R. Dept.
This spontaneous report as received from a registered nurse refers to a 6 years old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a dose of PROQUAD lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Dose 1 (lot no. ER8730) was 03/24/2021 at same pharmacy.  Dose 2 (described above) was 04/21/2021.  I started feeling very sensitive skin when I woke up the morning of 04/28/2021.  On 05/01/2021 red splotches began to appear on my right shoulder, upper chest, and neck.  The skin from the top of my scalp (right side) to my right hand is sensitive.  The condition has been diagnosed as shingles.
contracted Covid-19; contracted Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "contracted Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: they have contracted Covid-19. Caller was a pharmacist inquiring about two kids that were vaccinated with the pediatric formulation orange cap Pfizer BioNTech Covid-19 vaccine 3 weeks ago. Caller stated they have contracted Covid-19 and have now fully recovered. Caller would like to know if the second dose of the pediatric formulation Covid-19 vaccine should be administered on schedule or if the second dose should be delayed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Myalgias, chills, fever to 101+.  Do not remember exact level, but close to 102.  No other symptoms; no URI, cough or other sources of fever.
Information has been received from a physician concerning a 14 year old female who on 20-AUG-2007 was vaccinated intramuscularly with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot number 658490/0802U) There was no concomitant medication. On 22-OCT-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot number 658563/1063U) intramuscularly. On 23-OCT-2007 the patient experienced a fever of 103.1F, headache, chills, nausea and fatigue. The patient sought unspecified medical attention. At the time of the report, 23-Oct-2007, the patient still had not recovered. Additional information has been requested.