chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tired) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (tired) and HEADACHE (headache). On 28-Jan-2021, DIZZINESS (dizziness) and HEADACHE (headache) had resolved. At the time of the report, FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Declined to provide information
Dizziness, nausea, vomiting at around 12 hrs post-vaccination
Grandiose visions and thoughts; trouble breathing; shot altered his DNA; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt). At the time of the report, DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: weight gain.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported.  It was reported that the patient had trouble breathing and weight gain after receiving his Primary Series of the Moderna Covid 19 booster dose. The patient received his first Moderna Covid in the winter of 2021. Patient did not had his Immunization card. Patient did not had lot numbers, dates of administration or expiration dates. The patient took his Primary Series of the Moderna Covid -19 shots because he moved and he felt that he had to take the shot. The patient had a lot of Grandiose visions and thoughts. He thought that the shot might had been given to him to kill him. The patient was concerned that the shot altered his DNA. The patient received his second Moderna Covid-19 vaccine in the winter of 2021 about 30 days later. Patient said that his injection site hurt. Patient breathing was not the same.  No treatment products reported.   Reporter did not allow further contact
Parent called to report chicken pox rash that started on 9-8-08. Started on hands and in mouth. Later in the day rash was all over her body, some with blisters; low grade fever, itching. Full body coverage - breakthrough
10/03/07 Client return to Clinic 10 at aproximately 11:20 am. She reports that she developed redness, swelling and pain to her arm about 4 hours after she was vaccinated with the influenza and pneumococcal vaccines.She states that she had pain and swelling to arm and had applied ice pack for most of the night with minimal relief. Client presented with redness, swelling and complain of pain, arm warm to touch with noted induration to left upper arm where she received the pneumococcal vaccine 0.5mL dose subcutaneously. Treatment pending, referred to physician.
A non-serious labeled spontaneous report of vomiting has been received from a registered nurse concerning a 4-year-old female, subsequent to receiving FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 month of age for FLUMIST.  No medical history or concomitant medication information was provided.  The patient received her first dose of FLUMIST on 25-Nov-2008.  On 25-Nov-2008, one hour after receiving FLUMIST the patient experienced two vomiting episodes, each episode was one hour apart.   No other problems were reported.  The vomiting resolved and the patient was doing fine the day after the event.
Started throwing up at 11pm every hour until 10am.  Was contemplating if I needed to go to ER
ACHY ALL OVER; ARM REALLY SORE; HEADACHE; TIRED; NAUSEOUS; MILD LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced achy all over. On 05-MAR-2021, the subject experienced arm really sore. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced tired. On 05-MAR-2021, the subject experienced nauseous. On 05-MAR-2021, the subject experienced mild low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild low grade fever on 08-MAR-2021, and had not recovered from headache, tired, arm really sore, achy all over, and nauseous. This report was non-serious.
5/22/2021 - Day after vaccine I experienced the following: Sore arm at injection site. Extreme fatigue. Moderate body aches. Headache. Chills. Nausea. Fever.  5/23/2021 - 2nd day after vaccine I experienced the following: Moderate Fatigue. Weakness. Mild body aches. Mild breathing difficulty. 5/24/2021 - Had to take the day off from work as weakness/fatigue and overall residual malaise from the prior 2 days took its toll.
NO FEVER. NO HEADACHE, FINE RASH FROM NECK DOWN TO THE KNEE.
7/27/22 reported diarrhea, body aches, and headache 7/28/22 Positive (+) for COVID-19
This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the pertinent medical history, drug allergies or reaction and concomitant therapies was reported. On 21-OCT-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L035882, expiration date 19-APR-2017 (exact dose and route of administration were not reported). The vaccine was stored 24 hours in 1 degree C. The previous temperature excursion was 24 hours at highest temperature 22 degrees C. Data logger was not involved. No adverse effect was reported. Additional information has been requested.
she hardly sleeps; can't urinate; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (she hardly sleeps) and DYSURIA (can't urinate) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (she hardly sleeps) and DYSURIA (can't urinate). At the time of the report, INSOMNIA (she hardly sleeps) and DYSURIA (can't urinate) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was not a participant of clinical trial.  No treatment information was provided.
Erythema, edema, warmth, itching, tenderness at injection site. Onset 7 days post-vaccination, evaluated on day 8. No systemic symptoms.
Patient received COVID-19 Pfizer vaccine today. She has a hx of allergies and was being monitored for 30 minutes. She alerted staff after approx 25 min that she was feeling unwell.    Reported that she developed generalized headache, ear fullness and tingling in the upper lip soon after receiving vaccine. Denied symptoms of anaphylaxis.   She was brought into the triage area. She appeared well, in no distress, no evidence of angioedema or hives. VS were taken: BP 114/70, HR 87 bpm, SpO2 97%.    She was given zyrtec 10 mg PO once. After approx 10 minutes she reported that she was experiencing new mild itching in the roof of her mouth and back of throat. She was then given benadryl 25 mg PO once.    VS taken again: BP 112/74, HR 86 BPM, SpO2 98%. Continued to appear well. There was no observed difficulty breathing. No hives or evidence of angioedema.   After approx 10-15 minutes she reported significant improvement of symptoms. She reported resolution of headache, ear fullness, tingling of the upper lip, and 90% resolution of itching of roof of mouth and back of throat. She denied feelings of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness.    She was monitored for an additional 30 minutes after reporting feeling improved. During that time she reported resolution of symptoms. She continued to appear well.   Prior to leaving she was counseled that should she develop any recurrent tingling in the lip, itching in the throat/mouth, feeling of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness she should seek urgent medical attention.   Her daughter is waiting outside and will escort her home. Encouraged her to call with questions or concerns. She verbalized understanding of and agreement with plan
Stiff arm, shoulder and neck. Sore arm, shoulder and neck. Severe chills. Couldn?t turn my head to the left and couldn?t raise my arm. Had both shots in the left arm. Still have slight pain in those areas.
Myalgia, Arthralgia, Fever, CHILLS AND PAIN AT INJECTION SITE Narrative:  SHE HAD COVID VIRUS PREVIOUSLY. THESE WERE SAME SYMPTOMS SHE HAD WITH THE VIRUS EXCEPT SHE DID NOT HAVE THE COUGH WITH THE INJECTION. LASTED 24 HOURS
1st dose of post exposure Rabavert  on 14JUL2020 but has missed the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 37-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert) and immunoglobulins nos (Immunoglobulin).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert and an unknown time after receiving RabAvert, the patient experienced incomplete course of vaccination. The action taken with RabAvert was unknown. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient received dose of post exposure Rabavert and the immunoglobulin on 14th July 2020, but has missed the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Rabavert, which led to incomplete course of vaccination.
Mom noticed some "bumps" on chest. Then patient complained of itching from "mosquito bites" this morning. Mom indicates that the rash is all over his body & kind of blotchy. It does not appear to her to be from poison ivy or mosquito bites.
This initial spontaneous report was received from the wife of a 75 year old male patient. The daughter (who is a naturopath) also participated in the call. Medical history/concurrent conditions included "no major health problems, just high blood pressure". The wife declined to provide concomitant medications. On 22-OCT-2012, the patient was vaccinated with ZOSTAVAX at a pharmacy for the indication of "by recommendation of a physician" (dose, route, and lot # were unknown by the reporter). He also received diluent for the vaccine (lot # of this was also unknown by the reporter). On an unknown date after receiving ZOSTAVAX, the patient began having problems controlling his blood pressure that he never had before. On 11-JUN-2015, he experienced a "massive brain bleed stroke and almost died." The patient was hospitalized for months and was in intensive care "for months and months and months" and then he was in rehabilitation. It was almost a year before he came home. The wife did not know if there was any relevant laboratory data. The wife reported that the patient was now paralyzed (considered result of the stroke) and used a motorized wheelchair. Since the stroke, he had difficulty seeing on his left side (considered result of the stroke). Also, he had not learned to control the motorized wheelchair well and he crashed it into walls, eventually leading them to move to a home with wider hallways. Since moving to the new home, the patient still crashed the wheelchair into walls, but not as much as he did before. The wife further reported that the patient had to be dressed, could not go to the bathroom by himself and had to be kept in diapers, and that someone had to bathe him (these were all considered result of the stroke and were ongoing). The wife was currently paying for a caretaker to assist with these tasks. The patient was closely followed by a team of physicians. As of 08-MAY-2018, it was unknown if the patient would receive more ZOSTAVAX. The outcomes of the events were not recovered/not resolved. Causality assessment was not provided. Upon internal review, hemorrhagic stroke was considered medically significant. Hemorrhagic stroke was considered disabling and life threatening. Additional information has been requested.
10/29 Localized reaction red and swollen at injection site. Decadron IM and Motrin PRN. 10/30 Site swollen and red 10cm/12cm, warm to touch. Claritin PO QD and Medrol dose pak. 10/30 Possible cellulitis; Linocin CC IM and Augmentin 1000mg qd. 10/31 Spoke to patient today; improving.
9 Hours after administration of 4th dose. Headache, eye pain, slight respiratory constriction (wheezing), productive cough, severe muscle and joint aches, hot and cold flushes. Immense fatigue (sleeping 18 hours per day). All lasting four days. Unable to work. No side effects at all with any of three previous  shots.
Left thigh red and swollen start 4/19/05, Progressively worse seen in office 4/2005 12" induration. Treated with Benadryl PO and Elidel topically.
Felt warm near injection site; Rash near the injection site; Red rash near the injection site; Itchy sensation near vaccination site; Mild Arm Pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild Arm Pain - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection site) and VACCINATION SITE WARMTH (Warmth - Near Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild Arm Pain - Near Injection Site). On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash - Near Injection site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection site) and VACCINATION SITE WARMTH (Warmth - Near Injection Site). At the time of the report, VACCINATION SITE PAIN (Mild Arm Pain - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection site) and VACCINATION SITE WARMTH (Warmth - Near Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
I have CLL / SLL cancer; small lymphocytic lymphoma; 1st dose of Shingrix / through a subcutaneous injection; This case was reported by a consumer and described the occurrence of chronic lymphocytic leukemia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2018, the patient received the 1st dose of Shingrix (subcutaneous). In January 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced chronic lymphocytic leukemia (serious criteria GSK medically significant) and lymphocytic lymphoma (serious criteria GSK medically significant). On an unknown date, the outcome of the chronic lymphocytic leukemia, lymphocytic lymphoma and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the chronic lymphocytic leukemia and lymphocytic lymphoma to be related to Shingrix.  Additional information were received as follows: The age at vaccination was not reported. The patient had incorrectly administered the 1st dose of Shingrix to me through a subcutaneous injection. This led to  At the time of reporting, the physician recommended that I not have the 2nd dosage as Chronic lymphocytic leukemia cancer and a determination had not been made at that time as to what the effect would be of that incorrectly administered 1st dosage. Shingrix was now recommended for patients with CLL / SLL and almost 2 years have past since the incorrectly administered 1st dosage.
Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2016, the patient was vaccinated with ZOSTAVAX, (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries. No other suspect or concomitant therapies were reported. On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. On an unknown date in 2016, the patient was treated for shingles. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter determined adverse events as medically significant, disabling and life-threatening events.
pain in left arm; swelling left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (breast cancer removed). Concurrent medical conditions included lymphadenectomy (lymph nodes removed from right arm).   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, immediately after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and shortly after receiving the vaccine, she developed pain and swelling in her left arm. The swelling was recovered, however the pain did not resolved till the time of reporting. The patient stated that every time she lifts her arm, it hurts. The reporter consented to follow up.
Patient received FLUARIX 10/4/17 with no problems immediately following shot. Patient states then when he got home and the following morning/day his left hand began swelling and turning black/blue. The swelling progressed to approximately his wrist and the black/blue discoloration only appeared on the the hand. He had pain traveling up the arm to the elbow. He had no swelling, redness, pain around the injection site, only in the lower part of the arm. He said the black/blue discoloration lasted about a day or two but when he came to the pharmacy to report this his hand was still quite swollen. He said he had not been bitten by anything and there was no trauma to the area. I referred the patient to their doctor and he was going to call today.
Mother noted swelling in L arm. L upper arm was red and hot to the touch. Mother described skin as very tight. Seen at after hours clinic on 7-25. Dx with cellulitis and given Keflex qid. Mother notes significant difference after 1 dose of ATB. Swelling has gone down and redness is almost gone.
Pt recvd vax 6OCT88 & exp 12OCT88 devel itching& 3 days later devel hives & swelling of eyes, face & lips; seen in ER; hospitalized on 3OCT88 due to an inc in facial edema, pruritic rash & the onset swollen joints & sl difficulty in swallow
Patient experience localized irritation at the injection site, followed by tingling and pain in extremities (toes, hand and wrist, tip of tongue) starting a few days after injection.  Patient did not seek out treatment immediately as it was mild.  Pain, tingling, and irritation later progressed to entire extremities (shooting pain in bilateral arms, bilateral legs, and bilateral shoulders) over the course of a few weeks. Patient received cortisone injection and methylprednisolone burst and pain was partially relieved on 9/12/2022
COVID positive on 4/6/21, after completing the vaccination series on 1/26/21.