chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-FEB-2018, the patients were vaccinated with dose of improperly stored PROQUAD injection (strength, dose, frequency and route of administration were not reported) (lot # N021726, expiration date 06-FEB-2019) for prophylaxis. On 16-FEB-2018, the patients were vaccinated with dose of improperly stored VARIVAX (strength, dose, frequency and route of administration were not reported) (lot # N020014, expiration date 17-JUL-2019) for prophylaxis (product storage error). The vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M034582, expiration date 27-APR-2019). The vaccines were stored in between -14 degrees of Celsius to -10 degrees of Celsius for 2 hours 25 minutes. The previous temperature excursion was between -14 degrees of Celsius to -10 degrees of Celsius for 18 hours 25 minutes and from -9 degrees of Celsius to 8 degrees of Celsius for 1 hour 25 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.
After I received my first dose around 8PM the pain in my right arm started. I could not move my arm, the pain was unbearable, like someone had hit me several times with a baseball bat or something similar. I couldn't sleep due to the pain. It lasted for about 2 days.  No other symptoms other than the awful excruciating pain.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 20-MAY-2013 the patient was administered ZOSTAVAX, (lot# and route unknown), by a healthcare provider. On or about 08-FEB-2016, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The patient claimed damages as a result of: injury to himself and economic losses. Additional information has been requested.
I started 4 hours after the second vaccine I had a fever as high as 103. It lasted 12 hours I did take a Tylenol. I was also tired from not sleeping. About 2 weeks after the vaccine, I started to get cold sores. I called my doctor after having 3 cold sores. I did have shingles after I had COVID. I was having cold sores for a few months. My doctor did prescribe Valtrex for the cold sores. I haven't had any I a few months.
Congestion(sneezing, dry cough, fatigued):  lasted about 8 days.  No fever ever.  Intestinal issues, loose stool, and some nausea with slight vertigo/dizziness(three days).
pt presented to ER  0230 3-17-21 pt c/o right sided weakness and numbness, tried to get out of bed and use bathroom and couldn't bear weight or move his right leg. NIH stroke scale score-2, Glasgow coma score =15 183/105, HR 103, RR 18, 02 saturation 95% RA 98.7 oral temp 0/10 pain. clonidine po tablet 0.1mg. EKG=tachycardia 106 normal P waves, normal PRI, normal QRS complex, normal ST and T waves. labs=SARSCoV2 RNA negative, CT head WO=no acute intracranial abnormality by CT criteria. UA=negative, glucose 359
This case was reported by a healthcare professional and described the occurrence of swollen thigh (injection site) in a 5-year-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccinations given on 20 August 2008 included the 2nd dose of MMR II, (Merck); and the 2nd dose of VARICELLA Virus vaccine; Merck.  On 20 August 2008, the subject received a dose of PEDIARIX (.5 ml, unknown, left thigh), as his 5th dose of a DTAP vaccine.  This was considered to be a drug maladministration, as PEDIARIX is not indicated for use as a booster dose following a three dose primary series of the vaccine.  On 21 August 2008, one day after vaccination with PEDIARIX, the subject experienced a swollen thigh (injection site) and injection site redness.  The reporting nurse stated that the subject presented to the emergency room (date unspecified), and was also seen in the physician's office (date unspecified) with entire thigh swelling and redness.  A product complaint was lodged for this report, as the nurse inquired if GSK had changed the formulation or if there were "hot" lots with the company's DTAP vaccines.  At the time of reporting the events were resolved.  The healthcare professional considered the events were probably related to vaccination with PEDIARIX.  Follow-up information received on 21 October 2008 indicated that the events began on 21 August 2008.  The events resolved and were considered by the reporter to be possibly related to treatment with PEDIARIX.  It was clarified that the subject did not go to the emergency room, but was seen in the physician's office on 21 August 2008.  PEDIARIX had been administered intramuscularly on 20 August 2008 and this was the 5th dose.  Additionally, MMR II vaccine injection and VARICELLA vaccine injection were given intramuscularly on 20 August 2008.  Vaccines administered previously included INFANRIX (31 July 2003), PEDIARIX (03 October 2003), INFANRIX (22 December 2003) and INFANRIX (21 June 2005).
GASTROPARESIS; HUNG HERSELF WITH BATHROBE BELT(SUICIDE); This spontaneous report received from a consumer via a company representative via media concerned an 81 years old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced gastroparesis (which had blown up in her and suffered from the same for 5 months). On 18-AUG-2021, the patient had hung herself with bathrobe belt (suicide) and died from the same. It was unspecified if an autopsy was performed. It was reported by consumer that, "My 81 year old mom committed suicide on August 18th after suffering a blowup of incurable gastroparesis after her poison shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of hung herself with bathrobe belt(suicide) on 18-AUG-2021, and the outcome of gastroparesis was not reported. This report was serious (Death, and Other Medically Important Condition). This case is a duplicate of 20220527077. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126708, 20220126582, 20220130063 and 20220528171.  Additional information was received from consumer on 12-MAY-2022. It was determined that Manufacturer Case Number 20220527077 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220126211. The following information was updated and incorporated into the case narrative: Added reporter (company representative).  Upon review following information was amended: The case was made valid, batch number statement updated in narrative and social media captured in source.; Sender's Comments: V1:Follow up information in this version updated  It was determined that Manufacturer Case Number 20220527077 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220126211. The following information was updated: reporter. Upon review following information was amended: The case was made valid, batch number statement updated in narrative and social media captured in source.The follow up information does not change the causality of the previous reported event.   20220126211-Covid-19 vaccine ad26.CoV-2.s. Hung herself with bathrobe belt (suicide), Gastroparesis.  This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUICIDE
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications in 2 weeks. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with  Paxlovid from 12Feb2023 to 16Feb2023. Clinical course: After finishing Paxlovid and feeling better, COVID symptoms returned after 3 days and started testing positive again.
COVID-19 antigen test positive; COVID-19 antigen test positive; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 21Sep2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 045L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: Other medical history= Osteoporosis. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Aug2022, outcome "not recovered" and all described as "COVID-19 antigen test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: having had 2 negative antigen tests; (unspecified date) Negative, notes: having had 2 negative antigen tests; (10Aug2022) Positive, notes: positive antigen test 7 days after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
I had emulated heart rate.  I also had a low-grade fever.  I went to the ER (Pukka Hospital).  I was diagnosed with Tachycardia.  They did urine test, lab, CT scan, and a Echocardiogram.  They also did a Covid-19 test, positive result.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided)(lot #M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
T+4hr: Tenderness at injection site T+12hr: Tiredness, Ibuprofen 200mg T+24hr: Dizziness, confusion, drowsiness, fever (37.5C), Ibuprofen 200mg T+36hr: Neck stiffness
Patient received booster dose of 0.25ml instead of 0.5ml for second dose.
The patient went from a sitting position to a lying position , sweating, eyes closed, dizzy. The patient was given an ice pack for the back of his neck and emergency services was notified. The paramedics arrived and took vitals. The patients vitals were within range and the patient was asked if he wanted to be transported to the hospital which he refused. The patient was given orange juice to drink due to his reponse to the pharmacist stating he had not eaten yet today. The patient then left the store after stating he felt fine.
Patient had just completed a hospitalization from 11/21/2021-11/23/2021 for acute stroke. This is a lacunar appearing infarct due to hypertension ischemia and MRI was done. She will have a Holter monitor 10 days set up, due to 1 episode of atrial fibrillation to make sure there is not any further. She had monitoring, both first hospitalization and this hospitalization, and no atrial fibrillation. Hypertension up titrated to Norvasc 10 mg total daily. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient fully vaccinated and has had his booster for coronavirus.  Positive COVID test 11/19/2021. Admission dx:  shortness of breath, COPD, hypoxemia requiring supplemental oxgen, COVID 19 infection.He developed Cova 19 pneumonia.  He progressively worsened.  He developed acute hypoxic respiratory failure.  He was treated medically and had slow clinical improvement. Treatment:  decadron, remdesivir, supplemental oxygen.   He qualified for 3 L on discharge.  He is discharged to home.  He will be staying with his daughter who will help with his recovery.
WHOLE BODY HURTS; FEVER; LYMPH NODES FEEL LIKE THEY ARE ON FIRE; BURNING TONGUE; LUMPS IN ARM PITS ONE ON THE RIGHT IS THE SIZE OF A GOLF BALL AND LEFT ONE IS NICKLE SIZE; BURNING THROAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-SEP-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-SEP-2021, the patient experienced burning tongue. On 20-SEP-2021, the patient experienced lumps in arm pits one on the right is the size of a golf ball and left one is nickle size. On 20-SEP-2021, the patient experienced burning throat. On 20-SEP-2021, the patient experienced lymph nodes feel like they are on fire. On 21-SEP-2021, the patient experienced whole body hurts. On 21-SEP-2021, the patient experienced fever. On 21-SEP-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 102.4 (units unspecified). On 21-SEP-2021 05:20, Laboratory data included: Body temperature (NR: not provided) 102.4 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lumps in arm pits one on the right is the size of a golf ball and left one is nickle size, whole body hurts, fever, and lymph nodes feel like they are on fire, and the outcome of burning throat and burning tongue was not reported. This report was non-serious.
Lightheaded first. Arm soreness,  Late evening tired, headache, chills, fever up to 100.6, slight blood pressure increase, pulse to 99 (normally 65), chest pain. Woke up 2/17 feeling better. Fever down to 98.8, pulse down to 74
Vaccine given 10/3 -> to ED 10/6 with aches, N/V, cough, malaise for 2 days. Site swollen & tender. Received IV antibiotics for cellulitis as well as ongoing CF therapy. D/C home with home health 10/10 with PO clindamycin.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: growing red hard bump about 2 inches
Fatigue - on morning after second vaccination injection (03/05/2021) - napped from 11:30 am - 1:15 pm MST - fatigue resolved.
Severe itching in hands (tops and palms) that spread to upper back and moved from area to area in the body. The itching lasted 5-6 days before red welts (hives? ? I've never had them, so unsure) appeared with the severe itching.
By minute 5,  I had numbness in the arm, numbness and tingling in the lips and tongue.  By minute 12, I had flushing and passed out.  I came back and all of the sudden my words started not making sense and I couldn't move my arms or legs.  My speech got better but it continued to be slurred, lost use of my legs  3  different times.
patient fully vaccinated in March, +Covid diagnosis 8/5/2021, presented to ER with stroke symptoms/aphasia 8/7/2021
Within about a minute of receiving the injection patient passed out for about 20 seconds, woke up coughing and started to vomit several times. Patient's vitals were obtained. MD evaluated patients' mouth for swelling and listened to lungs.  RN (Myself) and 2 physicians were in the room with patient.  Patient given juice and crackers, additional vitals taken, and provider did a final evaluation. Patient appeared stable and was released to his mother per MD.  Thy were both advises what to watch for in the even any additional symptoms occurred and to go to ER if anything new develops.
Brief Summary of Hospital Stay: 80-year-old female with a history of chronic obstructive pulmonary disease, HTN, T2DM who was admitted for acute hypoxia 2/2 to COVID-19 infection and likely COPD exacerbation. She was given a course of Remdesivir for 2 days, Ceftriaxone, and Prednisone. She was feeling better at time of discharge. She was sent home on 2L of oxygen. She was discharged to finish 2 more days of antibiotics with Cefdinir, and 7 more days of Prednisone. She was found to have soft BP's inpatient and was told to hold HCTZ until she sees PCP. She was discharged on home oxygen.     She needs to follow with PCP for management of care after inpatient stay.
This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date; varicella virus vaccine; manufacturer unspecified; unknown given on an unspecified date. On either 28 March 2011, 29 March 2011, 2 April 2011, 8 April 2011 or 13 April 2011 the subject received unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced injection site inflammation, swelling injection site and inflammation site soreness. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 7 children experienced the same side effects after receiving KINRIX vaccine. The vaccine was administered on 28 March, 29 March, 2 April, 8 April, and 13 April 2011. This is case 1 of 7; see case IDs A0924036A-A0924041A for details of the other reports.
Patient presented to vaccine clinic today for dose #2 of Moderna vaccine.  Two minutes after receiving the vaccine patient had a syncopal event and dropped to the floor from the chair.  He aroused easily, initial blood pressure was 109/56, pulse 45. Patient complained of dizziness and feeling lightheaded. He sustained mild abrasions to the right side of his forehead. He was alert and oriented x 3, pupils equal. Ice applied to forehead.  Patient attempted to stand up, however he was instructed to lay on the floor and his legs were elevated onto a chair to prevent him from another fall.  Blood pressure on the floor with legs up 114/76, 109/58, pulse 65. When patient attempted to set up on the floor he became dizzy again and laid back down with legs up. After approximately 15 minutes, patient was escorted to the cot on the clinic floor via wheelchair as he continued to report not feel well.  Blood pressure retake 98/58, patient provided with water. He reported that he had only had a small amount of fluid intake today, he had eaten lunch two hours prior.  Patient reported this had happened several times before when receiving injections, having blood taken and having stiches taken out.  After 30 minutes of observation patient was still symptomatic upon standing, blood pressure 98/58. Patient assessed by doctor attending the clinic. It was felt patient should go to ED for further evaluation and IV fluids.   EMS summonsed ambulance for further evaluation.  Patient was transferred to the care of EMS staff in stable condition.  Patient was assessed in EMS vehicle and started to improve. Blood pressure 127/86, pulse 65 per per report from EMS staff.  Patient was allowed back into the clinic so he could wait for his ride. He was accompanied by EMS staff on site. He left the facility stable and feeling well.
08 Nov 2009 -  pt states that she "experienced a slight discomfort in her chest after receiving the vaccination." Injection site was itchy & painful to the touch. Developed local rash on face, neck & arms. 09 Nov 2009 - injection site redness & rash > 2cm.
I have no concerns about my reaction and did expect it but wanted to report for your information. I did report to v-safe. I had COVID-19 disease in September, so I was expecting to have a robust response to the vaccine. I received my Moderna vaccine on 12/29. I developed fever, shaking chills, and terrible body aches about 13 hours after the dose. I felt a bit better in the morning, so I went to work as usual but was still sore with body aches. I developed shaking chills, nausea, and worsening aches at lunch time and left work early because the nausea and chills were so significant. I slept the remainder of the day and by the morning of 12/31 felt well again. My symptoms probably lasted around 24-30 hours total. I did miss a half day of work but otherwise had no significant effects.
Dizzy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) 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 DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided
After injection emp went home to sleep afrer shift. Aprox 8:00Pm noticed rash to rt deltoid where injection was given radiated to shoulder and upper back to neck area area was also hot to touch. Reported to Employee Health on 10/30 area noted above slightly raised rash area warm to touch.
The entire anterior and medial and lateral part of right thigh are red. Central swelling around site of shot is more discolored.