chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse Practitioner in Emergency Dept. Exposed to household member with possible sxms, but no confirmed dx. Developed personal sxms of ST and congestion on 02 Jan 2021. NP swab PCR performed 02 Jan 2021 was positive for COVID-19. Being followed as outpatient.
Directly after the injection my chest got heavy, I had shortness of breath, dizziness, I could not move my arms then I lost consciousness.  I woke up on the floor with people over me.  They tried to get me back up and I lost consciousness again.  The ambulance was called.  Emergency ambulance assessed that my heart rate was extremely low in the 40's. My blood sugar was also low.   I was kept for observation for 2 hours.   The next 3 days I had left arm soreness, nausia, diarrhea, severe crushing headache, stiff neck, & sharp pain in my achilles tendon of my foot which i could not bear weight on easily or flex the foot.
Patient presented to the pharmacy a couple days later with swelling, itchiness, redness, and warm to the touch. Said she had taken benadryl and it has gotten better. The rash was about 8 inches. Patient is doing better, told her to continue with what she was doing.
This spontaneous report was received from a 71 years old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies, who on 26-MAY-2008, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant therapies included unspecified medication for plaque psoriasis. The consumer reported that in June 2012, she had shingles. Unspecified treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient had shingles was unknown for ZOSTAVAX. Additional information has been requested.
After receiving his vaccinations patient was extremely fussing, screaming for hours on end and had a high fever. I was told this was normal and to give TYLENOL. With each passing day he seemed to not be himself. Over the course of several months he lost speech and he stopped hitting milestone according to his age (for example social skills, fine motor skills, speech, etc). He also developed severe food aversions as well as many other "sensory issues". We did have patient on a delayed vaccine schedule and so a month after his MMR and Hep A, he did receive two more vaccinations with a similar reaction as described above (DTaP and HIB). I was again told this was all normal and to continue vaccinating. Also on January 12, 2016, he had his second Hep A vaccine and after that round he lost all eye contact, began banging his head and rocking himself. He was evaluated at the autism center at Hospital where he was given the diagnosis of encephalopathy, apraxia, and global developmental delay. Patient is in speech therapy, occupational therapy, and feeding therapy. We did have his measles titers tested and according to the physician they are some of the highest levels she had ever seen and felt like it was indicative of an over reaction to his MMR vaccine.
Patient describes reaction as increased temp of 103F, Red hot swollen right arm, body aches and nausea. Patient was seen at ED and recieved Benadryl, Ibuprofen, Phenergan and Dilaudid as well as a prescription for Oxycontin.
Vaccine that administered beyond use date after the thaw process; 2nd dose received 0.25ml instead of 0.5ml; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (2nd dose received 0.25ml instead of 0.5ml) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (2nd dose received 0.25ml instead of 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (2nd dose received 0.25ml instead of 0.5ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19.  Patient reported no adverse reactions after the administration of vaccine. Vaccine number 1 NDC code was reported as 80777-0273-99 COVID-19 Prophylaxis
1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, body aches, Nausea, T 100.2 F.  1/16/21 0200 took Tylenol 500mg nausea, chills HA T 100.8  at 0410 symptoms continue and I i still had insomnia (that is not uncommon for me) symptoms were a bit milder.  0420 took 500mg Tylenol, 1030 500 mg tylenol HA nausea dizzy T 100.8F.  2345 bad again.  took 1000 mg Tylenol and a 3mg tab of Lunesta.  body aches HA nausea chill dizzy T 100.7.  Overnight I had a bout of terrible night sweat and the bed and pillow and night clothes were soaked (not menapausal related)  1/17/21 0830 T 97.8 feel a bit better.  as the day goes on I notice when I move around, especially quickly I have a horrible pain in my head and dizziness. at 1700 T99.9 nausea, dizzy HA.
Sore Arm; Tiredness; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, tiredness, headache and chills. On an unknown date, the outcome of the pain in arm, tiredness, headache and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, headache and chills to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR088885   Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: This case was self reported by patient. The reporter reported that she received the first dose of Shingrix vaccine and experienced chills, headache, tiredness, and a sore arm. AE (adverse event) filed. The reporter was given medical disclaimer. Referred to HCP (Health care professional). Spoke per PI (package insert) and content. Offered after call.  The reporter consented to follow up. Additional supportive information: For the tolerance of 2nd dose, refer linked case US2022AMR088885.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR088885:same report
Got a red spot with a lump under the skin.  It is hot to the touch.  Drew a mark around the site.  It started to expand from the marks, so went to urgent care 1/8/21.  The doctor stated that I was having a local allergic reaction, also that they gave me the vaccination in the wrong spot on my arm.  I was told to keep watch on the red hot bump, take Benadryl if not improved then go back in the the doctor.  He took a picture to put in my chart to watch it. Did another line around the site to watch it 1/9/21 since it got bigger from when I went to the doctor.  It kept getting bigger so went back to the doctor today 1/10/21.  This doctor also stated that I was given the vaccination in the wrong spot on my arm.  Now I'm on an antibiotic and a steroid.  I'm to still watch it and if it doesn't improve I need to go back in.  She also took another pic to put into my chart to see the size difference.
9 days after vaccination, varicella-like rash and low-grade fever (about 100 axillary.)
Discharge summary "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented from home with multiple weeks of fever. CT imaging showed pneumonia. Despite adequate treatment fever failed to resolve. ID was consulted and later Pulmonology. Bronchoscopy was unremarkable however one sample from bronch later showed + COVID, 3 days prior was negative. It is unclear if she had this prior to hospitalization or acquired during. She received treatment with decadron/remdesivir and defervesced within 24 hours of starting this therapy. Early in stay she was on cefepme/vancomycin and changed to levaquin monotherapy on which she completed 14 days total course.    Again, her fever is unclear if from infection that ran its course or perhaps drug fever from vancomycin. Compliment levels were normal so lupus flare seemed less likely.     Referral sent for chronic sinusitis though this was not felt to be playing a role in her hospital stay."
Approx 3-4 hrs after influenza vaccine, both eyes noted to be "red - otherwise eyes asymptomatic. Later that evening, had "tightness," difficulty breathing.
Patient experienced chest pain, dizziness, light-headed on October 18, 2021 at 10:30 am. Patient called his primary care provider and was directed to go to the ER. Patient headed to Hospital and admitted around 11:40 am. Patient was released on October 21, 2021 at 10:00 am.
Hypertensive event: 11:30 p.m. 12/31/2020 blood pressure spiked to 175/110.  Normal BP range is 130-145/80-90.  Heart Rate: 110 bpm. Normal range is 60-85 bpm.   TREATMENTS: Initial: rest; OTC ginger, turmeric, CoQ 10, garlic supplements  -- Outcome: BP lowered to 165/110, HR: 110 bpm 01/01/2021: continued treatment -- Outcome BP lowered to 155/100, HR: 100-110 bpm 01/02/2021: added in Pamabrom 50 mg (2 doses 6 hours apart) -- Outcome BP lowered to 145/90, HR: 90-110 bpm Continued treatment 01/03/2021-01/10/2021 with BP results ranging from 120-145/95-110, HR: 80-110 bpm As of 01/10/2021 BP still not returned to baseline and treatment continued with Dr appt pending
p/vax pt noticed large, red, swollen area @ inj site; warm to the touch; lasting 6days
arm pain; didn't feel well; flushing hot; Exhaustion; severe nausea; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 Lot number: EN6207),administration date 18Mar2021 as dose 1 single for covid-19 immunization.The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 18Mar2021, outcome "unknown", described as "flushing hot"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Exhaustion"; NAUSEA (non-serious) with onset 18Mar2021, outcome "unknown", described as "severe nausea"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; MALAISE (non-serious), outcome "unknown", described as "didn't feel well".The patient received her 2nd dose of bnt162b2 on 15Apr2021, lot EW0161.   No Follow-up attempts are needed. No further information expected.
very small nodule; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 via unspecified route of administration in the arm right on 13Mar2021 10:30 (lot number: EN6208), at the age of 45-years-old, at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism, cutaneous lupus erythematosus and allergy to sulfa (rashes, heated). Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) for hypothyroidism and hydroxychloroquine for cutaneous lupus erythematosus; both ongoing. On unspecified date in 2021, patient developed very small nodule; patient thought something was wrong with her lymph nodes in neck area or thyroid but went for ultrasound, found very small nodule. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered medical assistant referring to a 7 patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M049122 with expiration date of 13-JUN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). It was also reported that the administered doses experienced a temperature excursion during 1 hour and 20 minutes at a temperature of 24.7 degrees Celsius on unspecified dates. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported. Sender's Comments: US-009507513-1708USA003540.
patient reports changes in her menstrual cycle; heavier cycle, intense cramps and nauseated feelings; cycle was 10 days late.
Patient showed signs of limping with his right leg. Appears to not be able to bend the leg at the knee. No significant pain seems to be present. No swelling, no redness or bruises. Shots were administered on both arms. Two on left arm and 1 on right arm. I was only able to see the "limping" after he woke up late the following day after the shots. He also slept more then usual. Did not show signs of fever or the such.  As per doctor, I applied cold compresses on the knee area and muscle ointment to see if any improvement would occur with in the following 24 hrs. A day and a half after seeing the effects there is little improvement, still limping, no bending of knee when walking. He is able to fold/bend knee when sitting down and does not complain of pain.
Pt recv vax on 2/1/99; on 2/2/99 pt exp red knot on LA vax site, reddish-purple color
woke day p/vax given w/swollen wrists, hands, feet;fine raised red rash on body, more on lt thigh, hands & feet;
Signs and symptoms consistent with erythromelalgia of hands and feet and widespread neuropathy within days of 2nd vaccine
When we asked her to come check out fifteen minutes post vaccination, she asked if she should feel dizzy. I told her no so she sat on the floor until someone came to pick her up around 6pm. I gave her water, chocolate bar and had her smell alcohol pads for the nausea.
Patient reported area of redness and mild pain on the back left arm about 1 inch on 9/21 and increased to redness and swelling with mild pain and warmth along the entire length of the back of the arm.
Had a sore arm; tightness of breathing; nasal congestion; This is a spontaneous report received from a contactable consumer or other non hcp. A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: En6207) dose number unknown via an unspecified route of administration in Arm Left on 12Mar2021 08:15 (age at vaccination 29years old) as single dose for covid-19 immunisation. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. On 12Mar2021 10:00 the patient experienced had a sore arm, tightness of breathing, nasal congestion. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.
pt recvd Typhoid vax & 1630 hrs had chills, t102.4, abd pain & vomiting; about 2 hrs later had cardiac arrest & could not be resuscitated from ventricular fibrillation;
Pt recvd vax 20NOV922 & 23NOV92 pt devel a rash on all four extremities; pt was in India @ time of exp; tx DPH was ineffective;
Woke up on 10/10/2021 with mild rash in axillary regions...blanching rash spread over entire body from knees to head. Warm to touch. Added Benadryl  10/10/21 and 10/11/21 with no improvement. Contacted my primary physicians office for advice. Had a virtual appointment and scripted five days of Prednisone 20mg.
Patient is 5 weeks pregnant and received JEV vaccination. No adverse effects have taken place as of this moment to patient or the pregnancy.
p/vax pt exp a mini-stroke w/mask like appearance & arm tremor;pt hosp;condition of pt is ongoing
A few hrs after vaccination pt noted redness, pain, itching to both arms - spreading. (R) arm area distal and proximal to injection site approximately 3 in diam. (L) arm area distal to injection site approximately 3 1/2 in diam BENADRYL 25-50mg every 4h-6hr PRN - treatment.
It was reported that a pt (13 of 13) received a Fluzone SV 2000-2001 vaccination on 10/17/2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
WARMTH IN THE ARM; ACHINESS AND PAIN IN THE ARM AROUND THE  INJECTION AREA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was not reported and height was 167 centimeters. The patient's concurrent conditions included penicillin allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 13:45 on left arm for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure. On 05-MAR-2021, the subject experienced injection site pain. On 23-MAR-2021, the subject experienced warmth in the arm. On 23-MAR-2021, the subject experienced achiness and pain in the arm around the injection area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from achiness and pain in the arm around the injection area, and warmth in the arm. This report was non-serious.  Additional information was received from patient on 31-MAR-2021.The following information was updated and incorporated into the case: Patient height, medical history (penicillin allergy) added, Concomitant product amlodipine added. Vaccination time added, Expiry date added.
Death 5/12/2021 Causes of death listed on death certificate: 1) Acute Myocardial Infarction  2) Acute Coronary Artery Thrombosis  3) COVID-19  Other: Acute Respiratory Failure
my skin is itchy daily; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced itchy skin (Verbatim: my skin is itchy daily). The patient was treated with dermatologicals nos (Lotion). Shingles vaccine was discontinued. The outcome of the itchy skin was not resolved.   It was unknown if the reporter considered the itchy skin to be related to Shingles vaccine.     It was unknown if the company considered the itchy skin to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient got the first shingles shot and his or her skin was itchy daily.  No rashes and he or she use lotion it was crazy.  The patient was not sure if he or she had a reaction from the first shot.  The patient did not get his or her second shot in fear of what that might do.  The follow-up could not be possible as no contact details were available.
Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose) and DRUG INEFFECTIVE (Lack of efficacy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.            Paxlovid was prescribed. No concomitant treatment information was provided by the reporter.  Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. Patient received 3 doses of mRNA-1273 vaccine. The onset date of the event and the vaccination dates were not reported, hence latency cannot be assessed, and lack of efficacy cannot be concluded in this case. Paxlovid was prescribed. Clinical course was not reported. The outcome of event was unknown. Current COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. Patient received 3 doses of mRNA-1273 vaccine. The onset date of the event and the vaccination dates were not reported, hence latency cannot be assessed, and lack of efficacy cannot be concluded in this case. Paxlovid was prescribed. Clinical course was not reported. The outcome of event was unknown. Current COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information 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 events, a causal relationship cannot be excluded.
A resident of a nursing home inadvertently received Pnu-Imune and Fluzone mixed in the same syringe. Within 24-36 hours, the pt developed an injection site reaction characterized by redness and inflammation. The resident was treated with an unspecified medication.