chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling dizzy; cannot got to work and about to get laid off; This is a spontaneous report from a contactable consumer (patient) reported for himself. This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient received the Pfizer Covid vaccine on 31Mar2021 since the patient had been feeling dizzy and cannot got to work and about to get laid off. Patient asked who would responsible for getting his life back. The outcome of events was unknown. This report was assessed by the reporting consumer is non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pfizer COVID 19 vaccine 2nd dose given on 07/03/21.  On 07/06/21 patient complained of chest pain to his mother.  The patient was taken to peditrician.  Examination was normal.   07/13/21 patient's chest pain worsen.  Patient's mother took patient to emergency room.  Patient admitted on 07/13/21 to Hospital.  Found to have myocarditis.   Patient released from hospital on 07/17/21.
Member felt dizzy and light headed after receiving approximately 10 minutes after receiving 2nd vaccine.  Remained A/O x's 4
had an illness/ illness after having the covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "had an illness/ illness after having the covid 19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm; Some tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Some tiredness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Some tiredness). The patient was treated with METHOTREXATE for Rheumatoid arthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Some tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on blood thinner and also taking methotrexate for AR but he clarified with HCP and deferred the treatment in order to taken vaccine.
This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M026317 (expiration date 11-JAN-2018), (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated that he received a headache. He went to sleep but was awaken due to cramps and nausea. The cramps was located in the stomach. Patient stated that he threw up yellow bile. Patient stated that he has had a headache and nausea since the day of teh vaccine. Patient is taking Motrin and Tylenol but nothing is helping.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (Expired vaccine used).    This case was created for 119th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
received one dose of the Shingles vaccine several years ago; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received 1st dose on an unknown date several years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information were provided as follow: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient stated that it was recommended that to get 2 doses of Shingles 2 to 6 months apart. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The patient enquired if he/she should only get one more dose or start over and get 2 doses. The follow-up would not possible as no contact details were available.
Chills, fever, headache, nausea, diarrhea, extreme lethargy for 56 hours. Some lethargy and upset stomach ongoing.
ARM VERY SORE BY EVENING AND NEXT EVENING. MUSCLE ACHES LIKE THE FLU. THE MUSCLE ACHES GO WORSE EACH DAY AND THEN 2 NITHTS I WOKE UP SHIVERING BADLY. NEVER HAVE HAD A REACTION LIKE THIS.
started wetting the bed on the night; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 26 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENURESIS (non-serious), outcome "unknown", described as "started wetting the bed on the night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately eight hours after receiving the vaccine I started feeling chills and body aches. I then went to bed. I was awoke shaking from being in such significant chills my body hurt all over through the bones something I have an experienced in a long time. I continue to try to sleep and rest the best I could but I stood up in the morning I felt tunnel vision and thought I was going to pass out I laid on the ground at a safety and collected myself over the course of five minutes. When I stood up I am mediately thought I was going to vomit Splash cold water on my face I force myself to eat and drink and take Tylenol and symptoms lessened but remained over the entire course of the following day another 24 hours. I?m about to go to bed and I will not know how I feel in the morning but this is definitely something I did not expect. My entire doctors office received vaccination on the same day out of a group of 15 people two of us had severe reaction similar to what I described and the other female that felt sick like me had worse symptoms and high fevers with the stores as well she has remained out of work as a result of her symptoms. We are both nurse practitioners so it?s not easy to cancel our schedule. I ended up tapping out today despite my leftover post vaccine side effects.
Within 5 minutes of receiving vaccine developed itchy, tightening throat, constant need to clear throat, cough, hoarseness, back redness. Received 25 mg IV Benadryl with relief of symptoms
I began to experience mild numbness and pain from my L gluteus medius, extending inferiorly approximately 6 inches into my gracilis; I began to experience mild numbness and pain from my L gluteus medius, extending inferiorly approximately 6 inches into my gracilis; nerve pain in this area,; This is a spontaneous report from a contactable Other HCP. This 25-year-old female Other HCP reported for self that the 25-year-old female patient who received second dose of bnt162b2 (BNT162B2) via unknown route of administration on unknown date at a single dose for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Pfizer, Lot#: EK5730) via Intramuscular on 12Dec2020 09:00 PM on Right arm at a single dose  for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. Medical history included Known allergies: Lamictal and Unresolved dystonic reaction secondary to taking Lamictal as of 2016. Not fully resolved, currently being treated with baclofen and gabapentin. Concomitant medications included Gabapentin for Unresolved dystonic reaction, methylphenidate hydrochloride (CONCERTA), Clonidine, vilazodone hydrochloride (VIIBRYD), ondansetron (ZOFRAN [ONDANSETRON]), Doxycycline, Baclofen for Unresolved dystonic reaction. The patient experienced numbness, tingling, and shooting pain in her left trapezius one day after her first injection, and this lasted two weeks. While the numbness and tingling have resolved, she sometimes still experience nerve pain in this area, mostly on the L medial trap next to her spine. After her second injection, the patient  began to experience mild numbness and pain from her L gluteus medius, extending inferiorly approximately 6 inches into my gracilis. This has not resolved. Ae resulted in: [Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Treatment was unknown. No covid prior vaccination. Covid tested post vaccination included Nasal Swab, on 02Jan2021 with Covid test result:Negative.  Information about lot/batch number has been requested.
Case number PHEH2013YS020535 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow-up received on 25 FEB 2014. This report refers to a 39-year-old female patient. On 27 SEP 2013, she was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) into her deltoid at 10:00 AM. It was reported that before vaccination. FLUVIRIN ws placed in the shipping container at room temperature for 72 hours and later administered to the patient. No adverse event was reported following this medication error (incorrect storage of vaccine).   Follow-up received from a nurse on 25 FEB 2014: Site and time of vaccination updated.
Throat swelling, throat itching, chronic fatigue, trouble breathing, wheezing on 9/9/2021   cough, mucus coughing, dizzy spells, fatigue, coughing fits. 9/9/2021- current date of 9/13/2021
Headache, Myalgia, NauseaVomiting, dizzy, fatigue Narrative:
This case was reported by a consumer via call center representative and described the occurrence of fever in a 45-year-old female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine (intramuscular). On an unknown date, unknown after receiving dTpa vaccine, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown. It was unknown if the reporter considered the fever and muscle pain to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that her mother had a Tdap (unknown date, unknown manufacturer) and experienced the side effects.
Bursitis, resting, Aleve, still symptomatic after 3 days.
immunocompromised; This is a spontaneous report from a contactable consumer (patient's parent) via the Pfizer-sponsored program. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 22Feb2021 (Lot number was not reported) as single dose (at the age 38-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Lot number was not reported) as single dose (at the age 38-years-old) for COVID-19 immunization. The patient experienced "immunocompromised" on Jun2021. The reporter was calling on behalf of her son who is 38 years old. The patient received his first dose 28Jan2021 and second dose 22Feb2021 and in June of this year he was started on a biologic agent Entyvio which is an infusion because he is immunocompromised. When he got the first and second dose he wasn't on the biologic, he started on it in June. Therapeutic measures were taken as a result of "immunocompromised" which included Entyvio. The outcome of the event was unknown. The event was considered as serious (medically significant).  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up.
Breakthrough case admission after 4 vaccines  Pfizer 1/16/21 Lot# EL1283;  Pfizer 2/4/21 lot# EN9581;  Pfizer 8/18/21 lot# FA7484;  Pfizer 2/14/22 lot# FM0698
sore injection site Narrative:  Chief Complaint related to Urgent care visit: Dizziness,body aches, headache, sore injection site after COVID shot.
Patient experience bleeding at the time of injection and when he removed the bandage two days later, he saw the bandage was full of blood. Patient also experience severe pain. He said it almost felt like he had an allergic reaction to the medication similar to the reaction he had with levofloxacin in a prior incident. The pain lasted over several days.
Yellow fever vaccination given 02/07/05. Patient called on 02/21/05 stating she had developed a maculo-papular rash, no other symptoms. Viral URI resolved the week before vaccine was given. Follow up call on 02/23/05 indicates rash resolving.
taken Ibuprofen and done everything, she is ready to do something that call handler was not able to clarify, and  fight, and it is now cramping up; arm is really numb; arm is painful; This is a spontaneous report from a non-contactable consumer or other non-Health-care professional (Patient herself).   A female patient of an unspecified age received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.  The patient medical history was not reported.  The patients concomitant medications includes ibuprofen for Pain in arm on an unspecified date. Patient says she got the Pfizer shot on the 29th, and her arm is numb, it was really painful, she has taken Ibuprofen and done everything, she was ready to do something that call handler was not able to clarify, and fight, and it is now cramping up, so she was seeking recommendations on an unspecified date in Mar2021. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Abdominal pain/cramping that went to a 7 in intensity mid-day on April 17 and eventually weened down to a 3. On April 18 the pain remained around a 2-3. On April 19 there was no pain. On April 23 there was mild pain again that went up to a 5. On April 24 the pain ranged from 2-4.
It was reported that a 5 year old male patient received his 5th dose of Tripedia vaccine, lot number U0532DA, on 9/6/01 at 5PM. The next day the child's arm turned a dark red, almost black color around the injection site. Physician prescribed Augmentin, which resolved reaction within a day or two. From additional correspondence received on 9/17/01 it was reported that the patient received an IPOL and a Tripedia vaccination administered in the right arm and a MMR vaccination administered in his left arm on 9/6/01. In the evening of 9/7/01 the patient's mother noted a hot, violaceous, edematous reaction from the right shoulder to elbow, patient had no fever. Child was treated with Augmentin for possible cellulitis. The patient reportly recovered from this experience. This case is closed. Follow up #1 10/21/02: Patient information was updated. The adversee event coding for peripheral edema was changed to injection site edema. The case is closed.
Swollen Lymph Nodes; Red Swelling Injection Site; Red Swelling Injection Site; Fever; Chills; Body Aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a dietician and describes the occurrence of PAIN (Body Aches), LYMPHADENOPATHY (Swollen Lymph Nodes), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE SWELLING (Red Swelling Injection Site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Nodes), VACCINATION SITE SWELLING (Red Swelling Injection Site) and VACCINATION SITE ERYTHEMA (Red Swelling Injection Site). On 30-Dec-2020, PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 10-Jan-2021, VACCINATION SITE SWELLING (Red Swelling Injection Site) and VACCINATION SITE ERYTHEMA (Red Swelling Injection Site) had resolved. On 11-Jan-2021, LYMPHADENOPATHY (Swollen Lymph Nodes) 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 relevant concomitant medications were reported. No treatment information was provided.
headache; fever; severe body aches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2022 08:33, the patient received Shingrix. In July 2022, less than a day after receiving Shingrix, the patient experienced headache, fever and general body pain. On an unknown date, the outcome of the headache, fever and general body pain were unknown.   It was unknown if the reporter considered the headache, fever and general body pain to be related to Shingrix.     Additional Information: GSK receipt date :13 July 2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received shingrix vaccine the day before reporting in the afternoon and had  fever headache and severe body ache .
Patient received Fluzone HD (high dose flu shot). The next day she reported dry heaves, very weak, shaky hands, feverish, and nauseous. Patient could not report to work that day. The next day she said she felt much better. She had never had a bad reaction from a flu shot before, but this was the 1st time receiving the high dose flu shot.
See primary 11/2/09 numbness, tingling and paresthesia to lower legs toes and fingers - headaches and dizziness - seen in ER - 11/7/09 admitted to floor. Transfer ICU 11/8/09.   11/9/09 Hospital records received service dates 11/7/09 - 11/9/09. Assessment: Signs and symptoms consistent with Guillain-Barre syndrome. Patient c/o tingling sensation to hands and feet with difficulty walking, left hand grasp weaker than right. Stiffness, numbness. tingling of upper and lower extremities. Weakness of legs and hands. Not able to walk without becoming weak. Deep tendon reflexes 0/4. Decreased vibration sense lower extremities.   11/20/09 DC summary received for service dates 11/7/09 to 11/12/09. Assessment: Paresthesias, weakness, possible Guillain-Barre. Elevated blood sugars due to steroids. Orbital lesion. Patient presented because of parethesias, weakness of upper and lower extremities. IVIG. Discharged. To have additional orbital surgeon ophthalmology and neurological consultations.
had a toothache on his right upper molar; The doctor was thinking it was an infection of some sort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6203) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: He has been tested for asthma he is called a slight asthmatic.; "chronic cough" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT taken for cough (ongoing). Vaccination history included: Shingles vaccine (a good year or year and a half ago), for Shingles. The following information was reported: TOOTHACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "had a toothache on his right upper molar"; TOOTH INFECTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "The doctor was thinking it was an infection of some sort". The events "had a toothache on his right upper molar" and "the doctor was thinking it was an infection of some sort" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of toothache, tooth infection.  Additional information: Patient stated that it was the right upper molar. It was tooth number 2 to be exact. He went to the dentist thinking it was a dentist problem. That tooth had been root canaled, prior to vaccine, so there was not much left of that tooth. The dentist sent caller to the root canal people. Caller took antibiotics and it went away after 10 days of antibiotic. The doctor was thinking it was an infection of some sort. It resolved.  When he went to the dentist they said nothing except go to the endodontist which is the root canal people.   No follow-up attempts are possible. No further information is expected.
Intense vivid dream resulting in thrashing around, yelling, screaming. Intensity of dream not typical. Woke up entire household