chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms/fever/ headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Prostatic specific antigen: 3.73 (normal) Result: 3.73. On 11-May-2022, Prostatic specific antigen: 4.43 (High) Elevated to 4.43. On 10-Jun-2022, Prostatic specific antigen: 4.64 (High) measured at 4.64.         Concomitant medications details were not reported by the reporter.  Reportedly, the symptoms occurred the same day as the injection, but much later in the day around 8-9 PM. It was stated that these symptoms that had experienced were typical to what he had reading on all the websites.   Additionally, Patient had been going to receive PSA tests for his prostate for the past 10 years and over the past 2-3 years he had been going to receive these tests more often and was scheduled to had this test at the beginning of MAY. Patient had discussed these findings with his urologist who recommended to received an MRI of his prostate and also had been following the research of another urologist online who had been seeing similar trends in patients after vaccination.   Patient had not taken any medications or treatments for any of his symptoms.   This case was linked to MOD-2022-588193, MOD-2022-588203, MOD-2022-588204 (Patient Link).
pt recvd vax 2FEB93 that PM pt had fever of 103.6, rash all over body, swelling of neck, jerking of arms & legs, & difficulty breathing; mom did not take pt anywhere; gave APAP cool bath;
Upper right arm where  treatment was injected very sore and painful; in back lower left lung and left side pain full; upper left arm painful. Usually my termperature runs around 96.3 to 97.6; but around 6:30 became very hot and took my temperature and it was 99.2. By 7:30 it was 101.8. I was very warm all evening and thru out the night which I had to lay on my back because both sides were in pain that I could not lay on them. In the morning the fever had subsided; but I was in pain though. I was feeling much better by this morning (3-19-19).
Patient received vaccine and was seated for 5 minutes in vaccination room and was moving to the waiting area and fainted once she got up. Patient was given oral glucose gel and felt better. Paramedics were called and checked vitals and she was fine and mother refused going to the hospital
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. 0n 03-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 19-FEB-2007 was vaccinated with Gardasil (lot # 655618/0186U). There was no concomitant medication. On 19-FEB-2007, "about 2 hours after vaccination" the patient experienced a severe headache and nausea. The patient stayed home from work and took Tylenol. The patient subsequently recovered from the severe headache and nausea on 20-FEB-2007. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/07, Pfizer, dose #1 01/29, Pfizer, dose #2 08/18 pt cc: cough, diarrhea, fatigue, fever, headache, myalgias rhinorrhea, sore throat exposure: unknown 08/19 - 08/29 pt symptoms continue 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Sequencing result: pending 08/30 clinically resolved
has not received his second Shingrix vaccine. (late dose); approximately 6 hours after he received his Shingrix vaccine his heart felt strange; defibrillator/pacemaker placed in February 2020 / no events recorded / 2 days before / first Shingrix vaccine / one event recorded / 2 hours later his defibrillator began recording events that totaled 8 events in 12 hours; This case was reported by a consumer via call center representative and described the occurrence of chest discomfort in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included artificial cardiac pacemaker user (placed in February 2020). Concurrent medical conditions included defibrillator/pacemaker insertion.   On 23rd November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 23rd November 2020, 6 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chest discomfort and condition aggravated. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with amiodarone. On an unknown date, the outcome of the chest discomfort was recovered/resolved and the outcome of the condition aggravated and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the chest discomfort and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was reported for 1st dose and it was not applicable for 2nd dose. 6 hours after receiving 1st dose of Shingrix, patient experienced chest discomfort and 2 hours after receiving Shingrix his defibrillator began to recode events that totally recorded 8 events in 12 hours.  The patient had a defibrillator/pacemaker placed in February 2020 with no events recorded initially. Two days before patient received his first Shingrix vaccine he had one event recorded on the defibrillator. The patient had reported  his Health care professional and put him on Amiodarone that he was still taking. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Shortly after (3-5 minutes) vaccine was given pt began to feel tightness in his throat and right arm. According to staff present symptoms lasted approximately 5 minutes total. Anaphylaxis.
soreness; headache; allergies; This is a spontaneous report received from a contactable male consumer (Patient) via Pfizer sponsored program. A male patient of unspecified age received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after his 1st dose he experienced soreness and headache (from allergies), so patient wants to ask if he can take Aspirin and Antihistamines prior to his 2nd dose. The patient also mentioned that he did not take any of the drugs yet because he wants to make sure that there are no contraindications. Outcome of events was not reported.  Information on lot/batch number has been requested.
Vaccination site sore; Ache; Itchy, tender to touch "giant circle-oblong" rash on the injection site; Tender to touch "giant circle-oblong" rash on the injection site; Very, very tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE PAIN (Vaccination site sore), HEADACHE (Headache) and FATIGUE (Very, very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polymyalgia rheumatica on 26-Aug-2016, Hay fever and Anaphylaxis. Concurrent medical conditions included Asthma, Penicillin allergy (reaction hives) since 1950, Drug allergy (Aspirin/Ibuprofen) since 1988, Allergy (nonsteroidal anti-inflammatory drug NSAIDS) since 1986 and Drug allergy (ALLERGY TO LIPITOR) in 2019. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ALIROCUMAB for High cholesterol, CELECOXIB (CELEXA [CELECOXIB]) from 12-Sep-2000 to an unknown date and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 13-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). On 11-Feb-2021, the patient experienced FATIGUE (Very, very tired). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site) and VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site sore) and MYALGIA (Ache). On 11-Feb-2021, HEADACHE (Headache) and FATIGUE (Very, very tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE PAIN (Vaccination site sore) and MYALGIA (Ache) outcome was unknown.            No treatment medication was reported by patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Significant Follow-up received on 10-6-201 contains significant information - Height , weigh and race of the patient was updated as white. Medical history and allergies was updated. Concomitant medicine was also  updated.
Severe upper abdominal pain, Recurring episodes upper abdominal pain; Vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) and VOMITING (Vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On 09-Aug-2021, ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Laboratory test: abnormal (abnormal) abnormal revealed some  irregular numbers.     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 product information was provided by the reporter.  No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Extreme body aches, especially in core area of the body. Came on gradually in the evening and woke up at 2 a.m. with the extreme pain. Took a Tylenol Extra Strength and within 15 minutes, pain began to lessen.
SITE ON LEFT ARM BECAME RAISED AND RED WITHIN 24 HOURS.   SITE BECAME LARGER AND WARM IN 48 HOURS.  MOM BROUGHT CHILD IN AT 72 HOURS WITH NO CHANGE.  PATIENT SAW PROVIDER, DIAGNOSED WITH CELLULITIS, AND WAS PRESCRIBED KEFLEX T.I.D.
pt was given a covid bivalent vaccine on 09/13/2023, it is no longer authorized stated on 09/12/2023.
Patient was found by her son, expired.  He states it looked like "she went in her sleep". 10/19/06 Received Death Certificate which states COD as Found Dead, CAD s/p angioplasty, and hypercholesterolemia with contributing factors of HTN, PVD and hypothyroidism.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742
feels the injection is "breaking the bones" in her arm,; hands and feet are cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: Caller was diagnosed with osteoporosis six years ago. The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "feels the injection is "breaking the bones" in her arm,"; PERIPHERAL COLDNESS (non-serious) with onset Dec2021, outcome "unknown", described as "hands and feet are cold".  Additional info: Caller would like to know whether she can take Aleve for pain symptoms following Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began having numbess to face, tingling to hands and legs and dizziness that started  roughly 6 hours after injection; felt dizzy with movement and that her legs were going to give out.
Rash: On 12/26 she developed a red spot near the MMRV injection site, on her proximal, anterior thigh, about 1 x 2 cm, red, slightly raised/bumpy. She also developed scattered red macules and papules on her trunk and extremities. She is not itchy, fussy or febrile; she has no symptoms of URI; she is eating, drinking, and sleeping well.
food sensitivities; loss of 10 lbs; Stomach upset; Heartburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Feb2021 (Lot number: EL9267, Expiration Date: 18Feb2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time: 13:00, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9263), administration date: 28Jan2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 19Feb2021, outcome "recovering", described as "Stomach upset"; DYSPEPSIA (non-serious) with onset 19Feb2021, outcome "recovering", described as "Heartburn"; FOOD ALLERGY (non-serious), outcome "unknown", described as "food sensitivities"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss of 10 lbs". The events "stomach upset" and "heartburn" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal discomfort, dyspepsia.  Additional information: The patient had not received any other vaccine within 4 weeks. As of 10Apr2021 still dealing w/some food sensitivities loss of 10ibs in first 3weeks of onset symptoms.   No follow-up attempts are possible. No further information is expected.
Received Varivax 8-26-08 to (R) upper thigh.  Started not feeling well approximately 8-30-08.  On 9-3-08 broke out with a Varicella like rash to stomach and back.  Lasted approximately 3-4 days.  (R) upper thigh had a dime sized hard area to thigh with rash.
Information has been received from a Registered Pharmacist/mother concerning an approximated 5 year old female with a mild allergy to egg and peanuts, who in June 2004, was vaccinated with one dose of VARIVAX (Merck). The patient took ZYRTEC as needed. In April 2007, the patient developed a mild case of chicken pox with 30 or less lesions. The patient did not receive a booster dose of VARIVAX (Merck) since she has developed chicken pox in April, 2007. On 12-DEC-2009 her sister was vaccinated with the first dose of VARIVAX (Merck). On 25-DEC-2009 the now 7 year old patient developed a fever and broke out with 3 spots "chicken pox". The patient was evaluated at urgent care at a hospital and diagnosis of chicken pox was confirmed. The sister did not develop any adverse effects. The pharmacist/mother mentioned that she felt that the vaccine virus was transmitted from sister to sister. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Severe headache / migraine for 10 days, muscle cramping and tension in arms, shoulders, neck, legs.
constant buzzing in both ear Right after my regular shower I felt my ears were plugged, just like when going swimming and water gets in though the sensation and sound never went away nor hasn't changed since then. Went to urgent care and was prescribed decongestants even though I wasn't congested. This treatment was unsuccessful. I'm waiting to see an ent doctor. I'm reporting because I am reading others are experiencing the symptom after receiving the Pfizer Covid vaccine. I have three of them and Im worried the buzz would not go away. Thank you
Patient presented to me a red, inflamed area on her left arm 2-3 inches in diameter. She indicated that it neither itched nor was warm to the touch. She indicated that a friend pointed it out to her, so she turned her arm in order to observe it for herself. I recommended acetaminophen or another anti inflammatory if needed. I also recommended an ice pack if it got worse and advised diphenhydramine if it began to itch.
Sever fatigue, mussel and joint pain.   Fever of 102.6 that lasted for 36 hours and only came down to 100 with Tylenol.  I had a bad case of COVID on Dec 14, 2020 that kept me in the bed for 14 days.  I was not hospitalized due to the face that my o2 blood level did not reach the level to be admitted.  I have had lingering effects for several months from the COVID.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB injection (strength, dose, route and site of administration, lot # and expiry date were unspecified). No concomitant medications were reported. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
c/o nausea & vomit beginning 9/15/99 approx 930AM @ work;unable to eat w/o vomiting;to ER 9/16/99 when still unable to keep food down;
No immediate affects noted. Patient lives in residential facility with mother and nursing staff. Together, they will continue to monitor the patient.
Patient reported hives on neck later in the day.  Took zyrtec. Woke the next morning with more hives on neck.
Nausea, diarrhea, muscle aches, large red circle around injection site, warm to touch, itchy, site is swollen/ hard. Aspirin. No difference.
Developed fevers and malaise on 5/19, went on the develop jaundice. Admitted to hospital then quickly transferred to another hospital for liver consult.
At the injection site, there was a / lump; At the injection site, there was a red lump; At the injection site / was itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site lump, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site lump, injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the 1st dose of Shingrix and  experienced the red lump which was itchy at the injection site and it took about 4 weeks to resolve. The reporter consented to follow up.
24 hours after vaccination, began vaginal discharge. This continued daily since that time. Initially tinged pink, but more recently clear.
After 2 weeks from injection, patient developed pain, some relief with OTC Advil, some relief with Medrol dose pak, no heat nor ice, pain continues at week 3 and 4.
Language regression, despondency, development of repetitive and somewhat gradual, self-stimulatory behaviors, culminating with a dx of autism (9/1999). Development arrest and deficiencies in all domains (cognitive, social, adaptive, communication and motor).
Had vaccine at 4:15 pm on 02/05/08. Slept poorly, woke up Wednesday feeling anxious. Went to work felt like my blood pressure was really high (no ongoing history of high blood pressure) heart periodically raced throughout the day. Started getting a headache. Left work at noon. Took blood pressure at home - 120/85. Rested in afternoon. Headache came off and on for the rest of the day. Went to bed early and got up feeling fine on Thursday. Didn't occur to me to read the information sheet to connect symptoms to shot.