chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller experienced arthritis after the 2nd dose; This is a spontaneous report from a Pfizer-sponsored progra via a contactable consumer (patient).  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date after receiving second dose of vaccination, patient experienced arthritis. Patient wants to know what kind of Tylenol she could take. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Malaise, STA, hives beginning at the site red raised pustules 1/2 to 2 mm in diameter, Temp 99, Itching pain . Next day progressesd through the rest of body.
Felt a little bit of confusion; Had some mild fatigue for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Felt a little bit of confusion) and FATIGUE (Had some mild fatigue for 24 hrs) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (Had some mild fatigue for 24 hrs). On 06-Feb-2021, the patient experienced CONFUSIONAL STATE (Felt a little bit of confusion). On 06-Feb-2021, FATIGUE (Had some mild fatigue for 24 hrs) had resolved. At the time of the report, CONFUSIONAL STATE (Felt a little bit of confusion) outcome was unknown.            No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-343870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow-up received on 8-Oct-2021,contains non-significant information.
Periods started 2 weeks early; Low grade fever; Body chills; Body ache; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6204) via an unspecified route of administration in the left arm on 11Mar2021 at 15:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not tested for COVID-19. On 02Apr2021 (10 hours after vaccination), the patient experienced low grade fever, body chills and body ache and lasted for a day. On 03Apr2021, the patient experienced periods started 2 weeks early on third day of vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment taken for the reported events. The clinical outcome of the events low grade fever, body chills and body ache resolved on an unknown date in Apr2021. The clinical outcome of periods started 2 weeks early was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash on stomach no fever or other symptoms leading to rash as illness thus believing its a reaction to the MMR.
Pain in right shoulder and felt pressure during vaccination. Next day, unable to lift arm. Seen by provider in occupational health 10/06/16 Rx. ibuprofen, restrictions for (R) arm. Seen in OH 10/31/16 and discharged from care.
Patient presented to pharmacy feeling anxious, drank energy drink prior to vaccine, and had not slept the night before.  He said he had a lot going on at home.  After the vaccine he felt dizzy.  Patient stayed in pharmacy admin area and then in the waiting area for over 20 minutes to see how he felt.  he felt much better after waiting some time.  We provided a gatorade to keep him hydrated.
Narrative: Patient tested positive for Covid-19 and was hospitalized despite full vaccination (received Pfizer dose 1 and 2, no booster). Pfizer #2 dose received on 02/24/2021
At about 20 minutes after the shot, I started to feel about to faint (this lasted for a few seconds). I asked my husband who was driving to park aside.  After resting for a few minutes I recovered without treatment. Since then I have not observed any other reactions nor side effects.
Information has been received from a physician concerning an approximately 10 year old female who on 08-SEP-2009 was vaccinated in the left deltoid with the second 0.5 mL dose of GARDASIL and developed swollen lymph nodes that were very painful. The patient had recovered on an unspecified date. The patient sought unspecified medical attention. No further information is available.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six-month old male patient who was vaccinated with a 0.5 ml dose of PENTACEL (Batch number: C5543AA, expiration date: 08-Sep-2019, route: intramuscular and site of administration: left thigh) on 30-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that the Hib component of PENTACEL was reconstituted in sterile water and DTaP-IPV was not given. It was reported that the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient stated that a few days ago the top of his mouth started feeling smooth like he was losing feeling. On 8/12/2021 he stated that it was hard for him to open his mouth. On 8/13/2021 his eyes were swollen and hard to open. He also could not feel the left side of his mouth. He said he could feel the muscle on his right side but not the left. He thought he was having a stroke. He went to the hospital, and they did a CT SCAN. The doctor diagnosed him with a ceria paisley.
Pt had pink eye without discharge on 3/10/00, fever of 104 on 3/10/00, and pinpoint rash on 3/11/00 through 3/12/00.
30 minutes post vax, the pt experienced severe fatigue and muscle aches. 24 hours post vax, the pt developed a diffuse macular papular rash with vesicles.
I had lots of sleep; HA fevers; Severe underarm pain 8/10; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (I had lots of sleep), PYREXIA (HA fevers), AXILLARY PAIN (Severe underarm pain 8/10) and FATIGUE (Extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021 at 3:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (HA fevers), AXILLARY PAIN (Severe underarm pain 8/10) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced HYPERSOMNIA (I had lots of sleep). At the time of the report, HYPERSOMNIA (I had lots of sleep), PYREXIA (HA fevers), AXILLARY PAIN (Severe underarm pain 8/10) and FATIGUE (Extreme fatigue) outcome was unknown.            Patient did not take any medications and missed work due to symptoms but did not need to seek care.  No relevant concomitant product were reported.  Company comment:This case concerns a female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of Hypersomnia.  The event occurred on an unknown date after third dose of mRNA-1273 vaccine. The rechallenge was not applicable,  as event date was not reported and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of Hypersomnia.  The event occurred on an unknown date after third dose of mRNA-1273 vaccine. The rechallenge was not applicable,  as event date was not reported and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I had a first episode of vertigo on 3/10/21, about 18 days after 1st shot. Unknown whether it could be related to the vaccine.  Second shot received 3/13/21. Experienced continued dizziness until present day, 6/25/21, although symptoms are decreasing
Lesion formed on arm opposite injection site 12-24 hours after first moderna covid vaccination.
patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided. This case was reported for patient 10  out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
After third day of first Pfizer vaccine the patient states she ended in bed for three days with cough, fever, chills, body aches, no taste or smell, SOB, brain fog and very tired.
This spontaneous report as received from a healthcare worker also reported as nurse assistant refers to group of patients of unknown demographics. Information about patients' medical histories was not provided. On 07-JAN-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, indication and lot # were not reported) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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 ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   No concomitant medications were reported.  No treatment drugs were reported.
Pt had a seizure about 5 minutes after vaccine administration, seizure lasted less than 30 seconds. EMS was called and took pt away to be checked out. Pt was responsive and aware of surrounding when she left.
8/25 high fever 102.6, exhausted, slept for 24 hrs. Dehydrated. 9/1 red areas on back and chest.
cold symptoms; Extra dose administered; This spontaneous report was received from  a pharmacist who is also the male patient of unspecified age. The patient's medical history included 2 previous doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient's concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2023, the patient was vaccinated with a third dose (extra dose administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 01-JUL-2023, the patient experienced cold symptoms. At the time of reporting, the outcome of cold symptoms was not known.   The reporter considered cold symptoms to be not related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Patient's parent's schedule patient to receive an annual influenza vaccine along with sibling. At the visit Patients name and DOB were checked but verification of actually being 6 months was not. Patient received flu vaccine 14 days before being eligible at 6 months. This incident was not found out until patient came back for second flu vaccine. Patient had no adverse reaction or issues with the injection. Office spoke with GSK pharmacist who had no studies or documentation on patient receiving flu vaccine before age of 6 months.  Patient was 5 months and 16 days or 24 weeks and 1 days.  Writer also spoke with CDC to discuss information.  CDC states generally believes that this would not be harmful to patient. Often these doses should be ignored.
Red itchy rash at injection site; Red itchy rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8727), via an unspecified route of administration in left arm on 22Mar2021 at 15:00 (at the age of 48 years) as a single dose for COVID-19 immunisation. Medical history included cerebral palsy, seizures, oral pharyngeal dysphagia, depression, anxiety, sleep apnea and sulfonamide allergy. The patient reported allergies to PPD skin test, ampicillin (MANUFACTURER UNKNOWN), amoxicillin and clavulanic acid (AUGMENTIN) and high-protein medical nutritional supplement with fiber (JEVITY). Concomitant medications included loratadine (CLARITIN), buspirone (MANUFACTURER UNKNOWN), carbamazepine (TEGRETOL), medroxyprogesterone acetate (DEPOPROVERA), Ibuprofen (IBUPRO). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021, after the vaccination, the patient experienced red itchy rash at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for the adverse events. The clinical outcome of vaccination site rash and vaccination site pruritus was not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Fingertips on both hands became inflamed then formed hard calluses, then peeled off in chunky layers of dead skin over the course of several days.  This happened around February 19th, 2021 and again around April 1st, than again in May.  Nothing more after that 3rd episode.
On day 8 after the injection the injection area again became red , feverish, and sore.  On day 10 the redness, feverish and sore area have spread larger, toward the underside of my bicep.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. The nurse reported that an expired dose of MMR II (route of administration, dose, lot number and expiration date were not reported) may have been given to an unspecified patient on an unspecified date. No adverse effects were reported. Additional information has been requested.
Client had numbness in jaw and left side of face approximately within 2 hours of Td. By next morning some numbness in jaw only, resolved by the afternoon. That afternoon redness appeared and swelling at site of injection. As of 3-22-04 area still reddened.
within minutes entire body numbness and "hot", followed by full body erythema. Was transported to the ED for treatment.
This spontaneous report as received from a medical assistant refers to an identifiable patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose and frequency were unknown by reporter) from lot N022979 expiry date 23-AUG-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK) (lot/expiry date unknown by reporter). Temperature was reported as 15 degrees Fahrenheit to 46 degrees Fahrenheit (32 degrees Fahrenheit). Time frame was reported as 7 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1803USA012518: US-009507513-1803USA012301.
Asymptomatic, COVID-19 PCR positive beginning on 6/2/21.
fever 3 hrs p/vax 23MAR92 until PM of 25MAR92; t102 23MAR92 until 24MAR92; stayed 99-100 p/that; lt arm noticed to be swollen & red Tuesday; red Wed w/knot in it then this AM black & blue (3cm) area w/sl blanching @ spots;induration (mod)
I had dermatitis reaction. My body was full of itchy and painful rash followed by weakness and body aches. Treatment: Benadryl 1 tablet single dose.
Had vaccine at 6p, dry cough and headache by 9p, chest tight/sore throat,chills, sweating and fever of 102 degrees all night, woke with nasal congestion but by 10a all symptoms subsided.  No reaction at shot location.
Very painful left arm x 2 days after injections. Improved gradually. Past week after "working outside" left arm became very painful at upper arm, radiating down arm and up into neck. Can not lay on that side nor lift things with that arm.
Client begin to experience weakness, dizziness and nausea shortly after receiving the Covid 19 Janssen vaccine.  She was assisted to triage area. EMT was present at facility and assessed client. She remained alert, awake and oriented to self, person, place and time. She was cleared per EMT, educated on vaccine side effects and care by this nurse. Client was able to ambulate out of facility and drive self home.
Wrong Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received HBV (Engerix B pediatric) (batch number FP9TJ, expiry date 24-OCT-2025) for prophylaxis.   On 15-AUG-2023, the patient received Engerix B pediatric. On 15-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced wrong vaccine administered (Verbatim: Wrong Dose Administered).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date 16 Aug 2023: The pharmacist reported a patient received the pediatric dose of Engerix-B inadvertently which led to wrong vaccine administered. The reporter consented to follow up.
Nausea, Fever, Chills, Severe fatigue, severe body aches for 3 days following injection.  **I received my menstrual cycle 9 days early on Aug 17  with extremely heavy flow, body aches, nausea and vomiting ( not typical for me) cycle lasted 8 days. ( double the amount that is usual).  **Rash came up on my legs and arms, vesicular, brown spots that 'popped', fluid drained and left with residual brown spots  for several days then faded. this happened for intermittently for 2 weeks following the injection which has never occurred in my life prior to vaccine.
10/20/06  CALLED TO REPORT THAT INJECTION SITE TENDER, RED, WARM TO TOUCH.
The vaccinator gave the patient her flu shot and before moving on to the COVID Moderna booster noticed she looked "flushed" and her and patient agreed to let boyfriend get his vaccines then go back for the second vaccine.  Before they switched the patient passed out while seated and the pharmacist was alerted and EMS was called. Upon entering the room, The patient was slouched over to the side and her eyes were open but slightly rolled back.  She was not answering to her name or questions but was breathing and coughing/clearing throat.  After about 1 to 2 minutes the patient came around and was confused, sweating, lightheaded, tired.  We sat with the patient and her boyfriend while waiting for EMS.  She said she has never had a reaction to vaccines before but gets lightheaded/queasy with blood draws.  I did take her blood pressure (with poor posture) and was 106/63 HR 71. She was feeling tired and wanted to lie down so we assisted her to the floor until EMS arrived shortly after.  EMS discussed it may be vasovagal reaction and is common but we agreed not to give the COVID moderna booster at that time. They/We waited with her a while longer until EMS assisted them back to their car.