chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing in his ear sounding like a cricket, at times very low occasionally; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in his ear sounding like a cricket, at times very low occasionally) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation.     Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (SYNTHROID) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in his ear sounding like a cricket, at times very low occasionally). At the time of the report, TINNITUS (ringing in his ear sounding like a cricket, at times very low occasionally) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   As per patient, a week or 10 days after the shot was given, he heard a ringing in his ears, sounded like cricket at night. The ringing was times very low occasionally. The patient did not have any other reactions aside from this. No treatment information was provided.
Swelling of nipples; Swelling of breast; Tenderness of breast; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NIPPLE SWELLING (Swelling of nipples), BREAST SWELLING (Swelling of breast) and BREAST TENDERNESS (Tenderness of breast) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced NIPPLE SWELLING (Swelling of nipples), BREAST SWELLING (Swelling of breast) and BREAST TENDERNESS (Tenderness of breast). At the time of the report, NIPPLE SWELLING (Swelling of nipples), BREAST SWELLING (Swelling of breast) and BREAST TENDERNESS (Tenderness of breast) had not resolved. Not Provided          The patient reported taking unspecified concomitant medications.  No treatment was reported for the events.
A non-serious spontaneous report of inadvertent administration of second dose was received from a health professional concerning a seven-year-old male. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received the first dose of FLUMIST on 11-Oct-2011 and was again inadvertently administered the second dose of FLUMIST on 18-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved.
About 8 hours after receiving the vaccine, I developed a bad headache that worsened over time. I also had a sharp shooting pain in my upper left thigh that happened randomly several times each hour. This was concerning as I was unable to find any other reports online of this symptom. Approximately 16 hours after receiving the vaccine, I developed severe nausea/vomiting and diarrhea that lasted for about 4-5 hours. 23 hours post vaccine, the nausea has mostly subsided and I now only have a bad headache and normal pain at the injection site. If the vomiting, diarrhea, and/or leg pain return, I will call my primary care doctor today.
Developed Tinnitus (Severe ringing in the ears)after 2nd  Pfizer booster
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient took ibuprofen before the 2nd dose and still experienced mild headache. The reporter did not have additional information. The reporter did not consent to follow up.
Began crying inconsolably around 1pm same day as shot and it continued for almost three hours.  After a short nap the crying began again for another 3 hours. Days later a noticeable regression  in level of engagement with parents and loved ones. Stopped babbling and smiling. A week later a significant head lag was present during routine ?pull to sit? milestone test after not being present at 4 month ped appointment.  Resulted in recommendation from pediatrician and muscular therapist to get an early intervention evaluation done.
Client was inadvertently administered Pfizer COVID 19 vaccine , instead of Moderna  COVID 19 vaccine for his second dose.   Client initially received Moderna vaccine for his first dose.  Client completed the Pfizer consent form today and initially check he had received a dose of Pfizer before he scratched it out on the form.  His mother was present with him.
Body ache; Headache; Fatigue; This spontaneous case was reported by a paramedic (subsequently medically confirmed) and describes the occurrence of   in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (and was hospitalized for over 2 weeks.) in October 2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 relevant concomitant medications were reported. No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow up #1 received with no new information which does not change company causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Agency; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow up #1 received with no new information which does not change company causality assessment.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneous injection, (lot # M003435, expiry date 19-JUL-2017), with a temperature excursion of 40 degrees F for 25 hours. No adverse effects were reported. Additional information has been requested.
Pain at the injection site; Pain at the injection site; Redness at the injection site; Swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included fibromyalgia. Concomitant products included Herpes zoster (Shingrix).   On 13th May 2019 16:00, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Influenza vaccine at an unknown dose. On 13th May 2019, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine.  Additional case details were reported as follows: On 1st March 2019, the patient received the 1st dose of Shingrix.  The patient had more pain at the injection site because of fibromyalgia when she got the flu vaccine every year, compared to most people.  The patient did not have a specific brand of flu vaccine that she had received in mind.  Till the reporting time, the patient had all those redness, swelling and pain injection site symptoms.  The reporter did not consent to follow up.
fever 103-104 x 4 days starting 24 hrs p/vax w/red swollen inject site 4 inches;
Patient presented to the ED and was subsequently hospitalized for spinal fusion within 6 weeks of receiving COVID vaccination.
swollen leg, rash, fever, crying wouldn't eat then went unconscious;couldn't wake pt up;irritable;pt was so sick;
Mild erythema of left upper arm with swelling. Local warm compress and Motrin PRN.
Patient admitted 2/15/22 for chest pain and treated for myositis presumed to be related to COVID vaccination.
COVID-like symptoms; A terrible reaction to it; Fever; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (COVID-like symptoms), VACCINATION COMPLICATION (A terrible reaction to it) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 041l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SUSPECTED COVID-19 (COVID-like symptoms), VACCINATION COMPLICATION (A terrible reaction to it) and PYREXIA (Fever). In February 2021, SUSPECTED COVID-19 (COVID-like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION COMPLICATION (A terrible reaction to it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received over the counter concomitant medication.  Following vaccination with the 2nd dose patient experienced within 24hours, COVID-like symptoms, fever but the next day it was gone.  No treatment drug details was reported.  Company Comment: This case concerns a 30-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of Suspected COVID-19 and non serious events of Vaccination complication and Pyrexia which occurred on the same day after the second dose of mRNA-1273 vaccine. Its reported following vaccination with the 2nd dose patient experienced within 24hours, COVID-like symptoms, fever but the next day it was gone. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-525710, MOD-2022-525739 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up received contains no new information to add.; Sender's Comments: This case concerns a 30-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of Suspected COVID-19 and non serious events of Vaccination complication and Pyrexia which occurred on the same day after the second dose of mRNA-1273 vaccine. Its reported following vaccination with the 2nd dose patient experienced within 24hours, COVID-like symptoms, fever but the next day it was gone. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Reddened and swollen legs (lower right and left) at 17:05. Iced reddened areas and given 3/4 tsp of Benadryl.
Significant pain in the upper arm surrounding the injection site beginning about 3 hours after injection. The morning after the vaccination, I also had fever, chills, headache, joint pain, muscle aches, and fatigue. The fever was relieved somewhat by an ibuprofen, and went away entirely about 24 hours after the injection. Other symptoms subsided more slowly. The second day after the vaccination, I still had a mild headache and some joint and muscle discomfort, and my right arm was still painful, though somewhat improved by evening. The third day after the vaccine (Monday 3/15), I had no symptoms except occasional joint pain and a slight soreness of the vaccination site.
Woke up Saturday sept the 11th 7 am with soreness in my chest while breathing in deep and the pain throbs with each heart beat I have not experienced this with dose 1 or dose 2
Information has been received from an LPN concerning a 26 year old female who was vaccinated with varicella virus vaccine live and subsequently, about 1 hour post vax, the pt experienced "her heart racing, tongue and throat swelling, dizziness and numbness in hands". The pt was treated with Zyrtec and the symptoms have subsided. Upon internal review, heart racing, tongue and throat swelling and dizziness were determined to be "Other Medical Events". Additional information has been requested.
In the evening of the 8th day,1/23/2021 my upper left arm felt hot , tender and pruritic. I took off my shirt and an erythematous, slightly raised circle 14cm in length and 10cm wide had developed over upper arm around where my vaccine injection had occurred. I was not alarmed because 2 other colleagues had had the exact same reaction between Day 7-9 after injection.  No fever, no lymphadenopathy. The pruritis and redness are gradually fading and today 1/27/21 visible only at edges. I took a picture as did my two friends for documentation. My concern is that it was missed by v-safe because I was past my first week check in so I wrote to v-safe and was told to report.  I am a physician. My question/concerns are:
Had right ear and neck pain on 5/19/21. Woke up on 5/20/21 with ear pain still present, noticed loss of taste. Had facial paralysis on right side of my mouth. Right eye won't close, excessive watering. Diagnosed with Bell's Palsy 5/20/21.
trouble swallowing; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHAGIA (non-serious), outcome "unknown", described as "trouble swallowing"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
for 7 days after shot had extreme fatigue and body aches.  Took ibuprofen every 5 hours and it didn't do anything for the body aches.  My  knuckles in hands had extreme pain and aching.
This spontaneous report as received from a physician refers to a 2 month old (at the time of second vaccination) and currently 21 year old non-pregnant female patient. On 10-MAY-1992 the patient was vaccinated with the first dose of RECOMBIVAX injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 10-JUL-1992 and the third dose was administered on 08-JAN-1993. The reported stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was give for adverse event. The outcome of hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
My daughter has been itching on both thighs, she got vaccines on both, this started few months after the vaccine mentioned above. There are large lumps under the skin which get smaller and then they return especially when she has some type of infection like a cold etc. These lumps get warm when they get bigger. There are no symptoms on the skin, no eczema, no rash, skin looks clear, you can feel the lumps when you touch it. She scratches both thighs every day usually after waking up. I have made my own research and learned that there were studies done and there are kids with exact same symptoms, the condition is called vaccine granuloma. According to the research, it is possible that my daughter has a reaction to the aluminum from vaccines, I worry that her body didn't get rid of this neurotoxin as it should have and now it is trapped in these lumps under the skin. There hasn't been enough research done to know what effects on the whole body it has so why are we still adding aluminum to vaccines?
When pt noticed the reaction starting, she treated it by applying ice packs, then later moist heat (wash rags/warm water). She went to bed and the next morning the swelling/erythema had increased and spread down her arm - she called her PC clinic, who advised her to report to Emergency Department, where she was admitted for the above and pain, with suspicion of possible cellulitis. Vancomycin 1000 mg BID, diphenhydramine 12.5 mg TID, methylprednisolone 40 mg TID.
About 12 hours after vaccine, patient experiencing blurred vison, shortness of breath, fever, chills, dizziness, body shaking, hands shaking uncontrollably. difficulty breathing, weakness.  Patient called about 3pm the following day still having these symptoms.
Moderna COVID-19 Vaccine EUA Tender, swollen and sore for two days after injection. Rash developed at injection site 1 week after. Itchy and red.  About 2" diameter.
Patient has had edema, skin erythema, tenderness and itching for 2 days.
Concentrated dose administered to patient. Dilution of Pfizer COVID vaccine was done incorrectly.  Patient had no adverse reaction while waiting 15 minutes in the office.
Pt recvd 1st dose of Hep B in OCT91 w/no adverse rxn; On 27NOV91 pt recvd 2nd dose of vax & on 28NOV91 pt had eight repetitive grand mal sz & subsequently hospitalized;
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates, the patients were administered improperly stored dose of PNEUMOVAX 23 (lot # K020215, exp. 15-MAY-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Feeling a little light-headed; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling a little light-headed) and VACCINATION SITE PAIN (Sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced DIZZINESS (Feeling a little light-headed) and VACCINATION SITE PAIN (Sore arm). On 09-Jan-2021, DIZZINESS (Feeling a little light-headed) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      On 29-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles (date unspecified), was treated and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include 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 preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt had cold symptoms with elevated temperature of 1 hour, starting on 4/11/01. Cold symptoms continued until 5/22/01 but temperature ended on 4/11/01. Used acetaminophen for elevated temperature from 4/11/01 to 4/11/01. Used ? for cold symptoms from 5/15/01 to 6/10/01.