chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her 1st COVID Pfizer vaccine at 1658 pm.  She developed hives around the vaccine site L deltoid and forearm approximately 5 min post injection. She was given po Benadryl 25 mg po x 1. No report of SOB initially. VS at 1710: 169/104 HR 86 Pulse ox : 96 %. Sipping water without difficulty.  1715: VS: 153/104 HR: 87  Pulse ox 96% room air. States feeling like she is short of breath. Benadryl 25 mg IM x 1 at 1715.  1720: States no improvement, c/o difficulty breathing and feels like her throat is closing up and difficulty swallowing water. Epi Autojet 0.3 mg IM given L thigh x 1. 911 called for transport for eval of acute allergic reaction with no prior history. NO HX of any acute reactions to anything in the past, she does not carry an epi pen. Only HX of environmental allergies to dust and mold. She does not take any regular meds.   She felt jittery after the epi but began to improve greatly.  1730: VS: 178/94 HR: 102 RR: 20, states breathing is greatly improved, itching less and hives much less. EMS here, report to EMS. 1745 Patient released in care of EMS to go to Hospital. Feeling much better. VS: 162/68 HR 93 Pulse ox 97%. Does not feel SOB any more, she is breathing easier, able to drink water. Hives gone.
1st dose on 2018 not received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of the Shingrix vaccine in 2018 in an unknown arm intramuscularly ).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: Add GSK Receipt Date: 10-May-2022 Reporter's Comments: The reporter was patient's husband. The reporter reported that his wife received his first Shingrix vaccine and she did not receive his second Shingrix vaccine. The patient did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received which led to incomplete course of vaccination. The case has been linked with the case US2022076274 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076274:Same Reporter
This spontaneous report was received from a pharmacist, as part of a marketing research program, referring to a more than 65 year old female patient. The patient's medical history with no current conditions, was not reported. On an unknown date, the patient was vaccinated with one dose of ZOSTAVAX subcutaneous in the arm, (dose, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced an injection site reaction that was encompassing the entire inner arm (from the elbow up essentially). The outcome of the injection site reaction was reported as recovered. The reporter considered the injection site reaction to be serious and related to ZOSTAVAX. No diagnostic test were performed. Additional information is not expected as the reporter did not wish additional contact and refused to provide personal details.
Information has been received from a consumer concerning his son who was vaccinated with ATTENUVAX (lot # not reported). Subsequently the patient experienced fever and seizure after getting ATTENUVAX.  The outcome of the patient was unknown the patient sought unspecified medical attention.  Upon internal review, seizure was determined to be an other important medical event.  No further information is available.
Hives on his face - both cheeks and eyelids Congestion Bloodshot eye
a vomiting; Underdose; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number Y7352, expiry date 15th September 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation. On an unknown date, 5 min after receiving Rotarix lyophilized formulation, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting and accidental underdose were unknown.   It was unknown if the reporter considered the vomiting and accidental underdose to be related to Rotarix lyophilized formulation.  Additional details were provided as follows:  The age at vaccination was not reported. The patient was given 1st dose of Rotarix and 5 minutes later the patient vomited about 2 to 3 ounces of vomit. The vaccine might had been lasted, which led to accidental underdose.
On Saturday patient began to feel fatigued. Laid down at 3 pm on 1/30/2021 and woke up Sunday morning at 730. He was feeling tired a little. Within a split second he fell back on the couch, he couldn't speak or move. He was dizzy. He was taken to the ER where he was admitted. He was noted to be in atrial fibrillation in the ambulance. His oxygen levels were below normal and temperature was elevated. He was admitted to the hospital for two weeks and was released in February.
Patient called the pharmacy about 5 hours after the shot and said arm was huge like a baseball and red, going down his arm. I suggested he be seen, was having a reaction, he restated that he had not had reaction before but had been a few years since getting a flu shot. I reiterated that he probably needed to be seen at hospital, as Benadryl oral may take too long and I didn't want it to get any worse. wife in background of call , said she would make sure he went . I asked if he had any trouble breathing or swallowing and he said no.
Severe headache that lasted continuously for a month & a half. I tried to treat it with acetaminophen, ibuprofen, and migraine medications. None seemed to help. The headache improved gradually over time until it finally went away.
This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. The reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by a receptionist from physician's office. The age at vaccination was not reported. The reporter advised that, the physician was out sick with Influenza A and B even though she had received the flu vaccine, inferring the flu vaccine (brand unknown) the patient received was ineffective. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. No other details were available at the time of call. The sales representative did not know the reporter's contact information. This case is 1 of the 3 cases reported by the same reporter.
Within 12 hrs of vaccine patient felt weird like she had no control of her emotions. She had spontaneous crying or laughing and felt like she was being tickled from the inside.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant medication was not reported. Staff gave patients vaccines past the use dates. The use-by date of vaccine was 18-Jun-2023. Patient received vaccine at administration site 2. Treatment medication was not reported.  This case was for the 43rd patient out of 47 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine administration date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Patient presented to pharmacy with a red rash from 1" below shoulder to elbow. Rash was warm to the touch. patient also has chills. Patient came to pharmacy 6/25/16. Noticed rash on 6/25/16. Follow up on 6/28/16 SX improvement but still present.
Redness, firm and swelling on just about the entire upper arm, at injection.  Itches constantly.  1st 2 days muscle aches on my entire right side,  only.  Redness and itching did not go away until 10/23.2020
Fever, arthralgias, myalgias, headache, rash, redness, swelling, heat, tenderness.
After 9 days of receiving the vaccine,I got a swollen red spot in the right arm the size of around 3 inch in diameter around the location where shot was given. The arm muscle also was sore again. Did not take any medications for this and then the spot went away after 2 days.
Terrible itch within 1-1/2 hrs from scalp to fee. (When I realized why) Broke out in bubbly rashes over face- scalp arms chest back leg still dealing w/eruptions here and there only a few. Felt under the weather that early evening. Have allergies. Used medicines and steroids to help w/it hive like rashes.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2014, the patient's healthcare provider at a primary care office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 27-APR-2017, the patient was treated by a physician at the primary care office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Pt received her first dose of the Moderna COVID19 vaccine. While sitting in observation the pt reported feeling lightheaded, clammy, and shakey. Pt was laid down on cot. Pt was evaluated by Trinity EMS. BP: 124/60, 110/64, 110/70.  HR 84, 82. O2 Sat WNL. Pt reported feeling better after eval by EMS. Pt signed refusal for transport to the ED. Pt was advised to follow up with her PCP.
I woke up with slight facial paralysis issues in the left side of my face. It got worse over 24 hours. I went to the emergency room and they confirmed it was a case of bells palsy. They prescribed me prednisone.  Outcome unknown, treatment will be for the next 7 days from September 9th
Immediate pulsating and numbness in the left nostril that migrated to the left eye over the next few days and down the left side of the body. Almost two weeks later and there is still numbness on the left side of the face. Overall weakness on the left side.  Joints cracking every - movement and every joint is effected. Arms, legs, feet, neck, crack even with the slight lest movement. (Never cracked prior to vaccine) This started a week after the vaccination.
Tachypnea, Tachycardia, pt c/o tingle/itch in mouth Narrative: pt given PO Benadryl 25mg and monitored by provider, symptoms resolved. Employee will f/u with PCP
High fever, rash, vomiting, hives on legs, not eating or drinking much.
his spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     The patient's past medical history included Maternal exposure during pregnancy.    On 30-Dec-2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The mother's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The cesarean delivery occurred, which was reported as Full-term. For neonate 1, with an APGAR score of 7 and 7 at (1, 5 minutes). The outcome was reported as Term Birth w Complications. Retained fetal lung fluid.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   The Treatment information was not provided.   This case was linked to MOD-2021-006493, MOD-2020-006493 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: NNI
Mild heart failure; His heart has a fast beat; Shortness of breath/ difficulty breathing; Extremely weak; His heart beat was irregular and a little higher then normal; Coughed a couple of times on the call; Patient said that he has lost his appetite; Very very ill; Walking was very difficult; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Mild heart failure) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CARDIAC FAILURE (Mild heart failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath/ difficulty breathing), MUSCULAR WEAKNESS (Extremely weak), HEART RATE IRREGULAR (His heart beat was irregular and a little higher then normal), COUGH (Coughed a couple of times on the call), DECREASED APPETITE (Patient said that he has lost his appetite), ILLNESS (Very very ill), GAIT INABILITY (Walking was very difficult) and PALPITATIONS (His heart has a fast beat). The patient was hospitalized from 05-Apr-2021 to 07-Apr-2021 due to CARDIAC FAILURE. On 10-Apr-2021, CARDIAC FAILURE (Mild heart failure) had resolved. At the time of the report, DYSPNOEA (Shortness of breath/ difficulty breathing), MUSCULAR WEAKNESS (Extremely weak), HEART RATE IRREGULAR (His heart beat was irregular and a little higher then normal), COUGH (Coughed a couple of times on the call) and DECREASED APPETITE (Patient said that he has lost his appetite) had not resolved and ILLNESS (Very very ill), GAIT INABILITY (Walking was very difficult) and PALPITATIONS (His heart has a fast beat) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Additional information included events were added, hospitalization details was updated, hence case was upgraded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
1 wk p/vax pt devel generalized rash of red,pruritic bumps.Pt seen by MD(allergist) & cause of rash not determined. Pt tx w/unspecified prescribed med. Exp most relief w/Benadryl oral & cream. Rash persisted as of 02/05/98.
patient died 48 hours later with Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (patient died 48 hours later with Moderna) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided by the reporter. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected death, which occurred at an unknown time with regards to vaccination with mRNA-1273. It was reported that the patient died 48 hours after vaccination. No further information was provided. The cause of death is unknown, and it was not disclosed if an autopsy was done. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected death, which occurred at an unknown time with regards to vaccination with mRNA-1273. It was reported that the patient died 48 hours after vaccination. No further information was provided. The cause of death is unknown, and it was not disclosed if an autopsy was done. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
t101-102 extremely fussy & irritable all noc; seen by MD stiffness of neck, fontanel bulging adm to hosp had sp tap-cult of blood-urine all neg; had RSV-pneumonia 1 mo ago; MD felt due to DTP to get DT from now on;
27 hours after the vaccine, patient's left thigh from where the injection was down to her knee only on the front side turned extremely swollen, red, warm, painful, sore, itchy with a rash. Her anus and vulva were also red.
Delayed reaction, itchy at injection site, 5cm area of erythema, induration, soreness.
About 12 hours after the vaccination (9a.m. the morning after the 4 p.m. injection), became incredibly tired and went to bed, but never slept. For about the following five or six hours, had vivid visions of past events in my life?all while lying awake, and not in a hypnagogic state, but prolonged wakefulness. Stayed in this state even when getting up to drink or use the bathroom. The vivid visions were structured: each was showcased in a cube with an initial image of a memory. The image then came to life in three-dimensional color and filmic action and took me over a long, detailed and emotional memory-experience. This recurred several times over about eight hours. When I final got up to eat, I was emotionally distraught, breathing in shallow breaths?anxious. Felt if I thought too much about the experiences, I would have a very powerful?even overwhelming?emotional outpouring. The following two days, some lingering anxiety.
Patient came to mass COVID19 vaccination event in the community.  Johnson and Johnson was being administered.  The patient received the vaccine and then it was determined that she did not meet criteria because she is <18 years of age.
fever; This is a spontaneous report from a Pfizer-sponsored program  Support via contactable consumer or other non hcp (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported that, received her 2nd dose on 15Mar2021 and had a fever (on unspecified date) after the 2nd dose. Asking if it is safe to take Tylenol. The patient underwent lab tests and procedures which included body temperature: fever on unspecified date. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Two Quarter size welts on left deltoid. Welt is red, hard. Treatment: Watched until it was gone Friday 9/4/09.
inadvertently administered a third dose on 05Oct2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number EB4E4) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th March 2023, from batch 29EY3) and Shingrix (2nd dose received on 31st May 2023, from batch 34EC5).   On 05-OCT-2023, the patient received the 3rd dose of Shingrix. On 05-OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: inadvertently administered a third dose on 05Oct2023.).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 Pharmacist reports a patient inadvertently administered a third dose of Shingrix doses, which led to extra dose administered. The vaccine administration facility is the same as primary reporter. The reporter gave permission for follow-up.