chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash 9 days after arms, legs and trunk; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash 9 days after arms, legs and trunk) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 01-Nov-2023, the patient experienced RASH (Rash 9 days after arms, legs and trunk). At the time of the report, RASH (Rash 9 days after arms, legs and trunk) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It is unknown if the patient experienced any additional symptoms/events. No treatment information was provided by the reporter.
Intense fever, headache, diarrhea, hallucinations, and vomiting for 4 days.
passed the 42 days window; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (passed the 42 days window) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (passed the 42 days window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (passed the 42 days window) 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.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information was added.
Breakthrough case admission after 3 vaccines Moderna 3/6/21 lot# 029A21A;  Moderna 4/7/21 lot# 028A21A;  Moderna 11/16/21 lot# 058F21A
This spontaneous report was received from the patient's wife, concerning a 59 year-old male patient. He did not have any medical history; however, his concurrent conditions included back pain and he presented a codeine reaction/allergy on an unspecified date. His concomitant medications included glyburide, metformin, tramadol, ZOCOR, ZYRTEC, tamsolusin hydrochloride and ibuprofen. On 31-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, frequency, lot # and expiration date were not reported) for prevention of pneumococcal disease. On 01-APR-2017 (reported as "a day after being vaccinated"), he developed "bad neck pain, chills, pain and fever on the injection site"; he did not seek medical attention and no treatment was given for the adverse events. Additionally, no laboratory diagnostics studies were performed. On an unspecified date in 2017, he presented fever. On an unspecified date, the patient got physical therapy on his back. After going to bed on 05-APR-2017, the patient recovered from the neck pain on 06-APR-2017. On an unspecified date in 2017, the patient had "stiffness in his neck". At the time of the report, the patient's chills, pyrexia and musculoskeletal stiffness had not recovered. Also, the outcome of the patient's injection site pain and injection site warmth was unknown. The causality between the injection site pain, injection site warmth and the musculoskeletal stiffness and PNEUMOVAX 23 was unknown. The causality between the neck pain, chills and pyrexia and PNEUMOVAX 23 was considered as related due to they were mentioned as result of the vaccination. Additional information has been requested.
Within 24-48 hours of receiving the injection in my left arm, I could not move my entire left arm and the pain was extreme and constant.  I believe that the vaccine administrator injected the vaccine into my bursar sac in my shoulder instead of injecting into my deltoid muscle.  I believe this resulted in SIRVA (Shoulder injury related to vaccine administration). Over the counter pain relievers did not alleviate the pain.
Less than 12 after taking the pills, she had uncontrolled vomiting, extreme diarrhea - like water. She woke up with it running down her legs at 3 in the morning.  She had a 103 fever.  She discontinued the pills but the symptoms did not decrease in severity for about 12 hours.  Patient had diarrhea and a 102 fever that took another 36 hours after before going away.   She was unable to go to work for two days as she could not leave the restroom!  When she was not vomiting or having diarrhea, all she could do was sleep and it was difficult to rouse her.
4 days p/vax still w/hard red area size of baseball; no fever, drainage;
Severe series of hives (Urticaria) covering body starting 24 hours after second dose of second COVID-19 vaccination injection. Incredibly itchy and irritating. Antihistamines did nothing to help reduce swelling or irritation, neither did prednisone. Tried Xolair injections monthly for 3 months starting in June and it seemingly help. Still getting hives more than usual but less severe.
2in by 3in oval patch of itchy red inflammation, Left Upper Arm , 1/2 in below injection site
1st Injection-Lot# EL3247 given 19Jan2021  2nd Injection: Lot# EL9269 given 09Feb2021/tested positive for COVID on  01Jul2021; 1st Injection-Lot# EL3247 given 19Jan2021  2nd Injection: Lot# EL9269 given 09Feb2021/tested positive for COVID on  01Jul2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EL9269) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no clinical trial. On on 01Jul2021, the patient experienced '1st injection-lot# el3247 given 19Jan2021 2nd injection: lot# el9269 given 09Feb2021/tested positive for covid on 01Jul2021'. Patient stated that she got COVID after having the vaccine. She would like to know if there are any trials going for people who got COVID after being vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Jul2021.
Information has been received from a health professional concerning a 5 yr old male with asthma who on 14Dec00 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot635661/1155K). There was no illness at the time of vaccination. On 09May05 the nurse reported that the pt now has 40 to 50 lesions covering their body. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that on 04May05 the pt had <50 lesions on the base of face, ears, trunk, hairline, arms and legs. The pt was seen for a doctor's visit. Recovery was not provided. Additional information has been requested.
Felt weak. Then about 12 hours later I fainted and smashed my head on the floor. Now I have a concussion. Since then my heart problems that were slowly improving have worsened. My heart rate is always over 100, I can?t even drive or walk for long distances. My dizzy spells are back and there's a ton of chest pressure. I coughed up blood tinged spit. Very short of breath. Hard to concentrate.
This is a spontaneous report from a contactable consumer (patient's father). A 17-year-old female patient received TRUMENBA lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization and an unspecified vaccine with unspecified route of administration, therapy dates, drug posology and indication. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine and been experiencing body aches, low grade fever, fatigue, soreness around lymph nodes and had symptoms of mononucleosis virus since unspecified dates. It was mentioned that her doctor thought it was mono and the test was performed on an unspecified date and came back negative. The patient was going back to be tested again because the doctor said it could take some time for the mono test to be positive. It was stated that patient also received other vaccines on the same day and was trying to get an understanding of what the drug companies know about their vaccines. Outcome of the adverse events was unknown. Information on batch number has been requested.
Severe Headache; muscle pain (neck and left shoulder); muscle pain (neck and left shoulder); joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration in the left arm on 30Dec2020 12:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes, hypothyroidism, hypercholesterolemia, and obesity. Concomitant medication included metformin hydrochloride (GLUCOPHAGE), metformin, semaglutide (OZEMPIC), fluoxetine hydrochloride (PROZAC), levothyroxine sodium (SYNTHROID). The patient previously took varenicline tartrate (CHANTIX) and experienced nightmare and allergies to varenicline tartrate. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 13:30, the patient experienced severe headache, muscle pain (neck and left shoulder), and joint pain. No treatment was received for the adverse event. Outcome of the event was recovered on Dec2020. The events were considered non-serious.  The following information on the batch number has been requested.
Fever, fatigue, nausea, chills, tiredness, joint pain, body aches, numbness distal to injection site, rapid heart rate, difficulty breathing, abnormal heart rate, pain in injection site, soreness at injection sight.
The following day after the shot , 3/23/21, I woke up  at 7:00 am, itchy all over my body, had fatigue, &. Chills.  Took 2 Benadryl tablets every 4-5 hours , a total of  8 pill. Then took 2 more in the night time. Continued doing the same the following 2 days. My husband noticed red spots like hives on my back , stomach, and. arms. On the 3 rd day I woke up with itching on the ears and eyes, as well as the body.  Called Dr, and she advised me to be evaluated at the urgent care immediately.  Went immediately and was examined by a PA. where she gave me a prescription for Prednisone, 5 mg. Take 1 tablet by mouth once daily for 7 days then take 1/2 tab once daily for 7 days.  She also advised if no more itching after 5 pills I could stop.
Has not received dose two; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, over 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
Patient had upset stomach and nausea.  Patient vomited. Patient's appetite decreased. Patient has had upset stomach and shaking of hand every since symptoms started.  Two weeks after initial symptoms started, patient vomited again because of nausea and stomach pains.  Patient complained of lower backache and headache.
Patient reported a week later with myalgia in the left arm, has been back twice to report condition is not improving and progressing. Wakes up with pain in left arm, limiting rotation. Has seen PCP about this.
16 year old received vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine) had resolved.        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.   No concomitant medications were reported. No treatment medications were reported.
1st vaccine only sore arm. 2nd vaccine on 02/23/2021  fever, aches, chills, headache *  headache lasted 3 weeks
02/11/21:  Fever 100.1  @ 8:00 a.m. ; mild headache; extreme fatigue 02/12/21:  Fever 101.5 @ 8:00 a.m.; headache worse; extreme fatigue                           Fever  101.9 @ noon ; headache same; extreme fatigue 02/13/21:  Fever 100.9  @ 8:00 a.m.; mild headache; mild fatigue 02/14/21:  temp normal; no headache; mild fatigue
Sore arm, warm to touch, redness and itching in a 4 in diameter of the injection site.  Also a smaller 1/2in-1in circle developed just to the side of the 4 in red circle.  No treatment, redness went away after 5-7 days.  Doctor believes a local reaction to the vaccine at injection site.
Patient requested Janssen vaccine but was inadvertently given Moderna. Patient was given the correct dose of Moderna, monitored for 15 minutes and ambulated from the facility in stable condition. Once the error was discovered, an immediate (unsuccessful) attempt was made to notify the patient. This FNP contacted the patient today (8/30/21), to see how he was feeling and advise that a 2nd dose is needed in order for him to be fully vaccinated. Patient verbalized understanding; reported feeling great and appreciated the call.
Seizure lasting 2 minutes. Child stopped breathing and turned blue. Called 911. Was sleepy and unresponsive for the next 20 minutes. Taken in ambulance to emergency hospital where by then all vitals were normal. Discharged after a couple of hours. Waiting to see a neurologist for follow-up.
Information has been received from a pharmacist concerning a female patient of unknown age, with no pertinent medical history, no allergies, and no concomitant medication. On an unknown date "about 20 years ago," the patient was vaccinated with 3 doses of RECOMBIVAX HB (lot numbers, dosages, and routes of administration not provided). A blood test was performed (exact results and date not reported). The pharmacist stated that the patient subsequently has low titers for hepatitis B (onset not provided). No treatment was given. The outcome of the event is unknown. No further information was provided.       Additional information has been requested.
Patient developed inject site rxn of redness and swelling.  This is 1 of 8 employees of this facility to develop and inject site rxn following vax with lot #4978139.
Headaches, constant, starting approximately 5 hours after receiving the shot. Pulsing headaches near forehead and temples.  Went to see doctor on 7 September 2021 (3 weeks, 3 days after shot).  Doctor indicated headaches as side effect of receiving the J&J vaccine; indicated potential encephalitis (brain inflammation) causing headaches. Prescribed gabapentin (neurontin) for treatment.
Trained Pharmacy technician immunizer administered the vaccine per pt's request. As soon as the vaccine was administered, pt started feeling lightheaded and lethargic, stomach pain and headache. She was given water to drink while being monitored for 30 minutes. Pt who is a current employee at the facility and was on the clock said she  wanted to go home. Her manager was notified and she also assisted in monitoring the pt. After 30 minutes, pt was feeling better and asked to call her husband to pick her up. Her manager granted the permission for pt to go back home. Pharmacist told pt to notify a provider about the adverse event and further advice on the second dose. Pt left with her husband at 1:40pm and was told to call and let pharmacist know how she was doing. Pt later called and said she was feeling much better and she was going to take a nap.
Large (90mmx50mm) on Left deltoid consisting of swelling and erythema. Fluzone 0.5cc was given at this site on 01/21/05. The above described problem developed on 1/24/05.
fever, urticaria @ site 1 day p/vax; 4x6 cm
Fatigue; body aches; Low grade fever; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the left arm on 23Dec2020 and second dose, via an unspecified route of administration on 13Jan2021 (lot/batch number and expiration date were unknown); both at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included COVID-19 on an unknown date prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had not tested for Covid post vaccination. On 24Dec2020, the patient experienced fatigue, body aches, and low grade fever. The patient did not receive any treatment for the events. The patient recovered from all the events on an unspecified date.  Information on the lot/batch number has been requested.
Pt had pneumonia shot on 2/15/17 LD. Called 2/16/17 with red, warm, swollen upper arm. Came to clinic seen by Dr given PR med for sleep.
Initial report received on 14 November 2007 from a health care professional.  A 15-year-old female patient, who had a history of depression and attention deficit disorder, had received a sixth dose, left upper arm, intramuscular injection of FLUZONE SV 2007-2008, lot number U2479CA; and a third dose, right upper arm, intramuscular injection of GARDASIL, manufacturer MERCK, lot number 1266U; on 13 November 2007.  The patient subsequently woke up at midnight on the same day as vaccination and felt like bugs were crawling on her skin.  She also had generalized itching.  The next morning, she experienced soreness at of the left upper arm.  Examination in a medical office showed a low grade temperature of 100.3 degrees Fahrenheit with clear skin.  The patient was in no distress.  Treatment provided was not reported.  Concomitant medications included CONCERTA and PROZAC.  At the time of this report, the event was resolving.  A corrective version was treated on 15 November 2007 with the LRD of the previous version 14 November 2007 in order to amend the product described in this narrative to FLUZONE No Preservative 2007-2008 (previously documented as FLUZONE SV 2007-2008).  Follow-up information received on 07 January 2008 from a health care professional.  No laboratory testing was performed.  The patient recovered.
Sore, shaky arm, warm to touch and swelled for 2 days now. No fever reported.
Patient felt nervous and began to sweat, chills, visual disturbances, nausea and shaking.  911 was called and patient was evaluated on site. He began to feel better with no intervention.
Initial report was retrieved from scientific literature on 31 August 2010; with additional information received on 02 September 2010 from online news report. According to the two literature citations previously noted the objective was to report the occurrence and characteristics of Guillain-Barre syndrome (GBS) after administration of H1N1 vaccine in 2009. The method used the data from the Vaccine Adverse Event Reporting System supplemented by additional data from the center for biologics and research under the Freedom of Information Act. All data was reviewed by a neurologist certified in neuromuscular diseases to confirm the diagnosis of GBS. The data excluded GBS cases that occurred within two days after vaccination. The results were as follows: Thirty five cases (mean age 36.6 +/- 22.5 years; 14 were men) of GBS were reported after administration of H1N1 influenza vaccination, with an estimated occurrence of 3.5 per 10 million vaccinations. All cases of GBS except one were reported within six weeks of vaccination, with 23 cases reported within the first two weeks after vaccine administration. Twenty three of the GBS cases (65.7%) were reported in the first two weeks after vaccination with maximum occurrence in the second week. One report of death and one of disability were reported in the 33 patients who were hospitalized. In 2009, 57 patients were diagnosed with GBS after vaccination with the seasonal influenza vaccine with an estimated occurrence of 7.3 per 10 million vaccinations. The time period of occurrence was similar to that reported for GBS cases after H1N1 influenza vaccination. Documents held by sender: None.
This was the second shot. Adverse effects included vomiting, diarrhea, chills, headache, sweating.  Required ER visit for dehydration.  Treatment included IV fluids, and Zofran for vomiting.
Health maintenance not activated, no visible immunizations incorporated. Shots were ordered based on medical record immunizatoin history. Patient previously received MMR/varicella and was given duplicate injection 1 year later. This was discovered after patient left.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-MAR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.