chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. No information regarding the patient's medical history and concomitant therapy was provided. The patient's concurrent condition included arthritis which began prior to receiving the vaccine. On 17-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On the same day, the patient was having some joint pain. Therefore she came to the office to receive a dose of cortisone (dose and route of administration unspecified) in one of her knees. The outcome of joint pain was not reported. Causality assessment was not provided. Additional information has been requested.
Toxic, chemical smelling diapers that lasted for 2 months.  Upset digestive system for 3 months. Behavioral changes: biting her arms, walking on tip toes, waving arms, legs buckling/unsteady, spinning in circles.
I had a headache before getting the vaccine at 10am.  Worsened over time.; By 10pm I was vomiting for 6 hours until 4:30 in the morning.  I must have vomited over 12 times.; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 10:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included headaches that started prior to the vaccination. The patient was drug allergic to codeine. Concomitant medications included vitamin d nos (VIT D), probiotics and multivitamins. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Prior to the 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 vaccination. On 05Apr2021 at 22:00 the patient had a headache before getting the vaccine at 10:00 which worsened over time. By 22:00 she had vomited for 6 hours until 04:30 in the morning. The patient must have had vomited over 12 times. She also had sweats and chills, dizziness and fatigue. The vomiting seemed excessive by any account. The patient also reports that it took a few days to recuperate. Therapeutic measures were taken as a result of a worsened headache, vomited, sweats, chills, dizziness, fatigue included treatment with acetaminophen (TYLENOL). The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. The clinical outcome of the event vomiting for 6 hours until 4:30 in the morning and must have vomited over 12 times was recovered on 06Apr2021 at 04:30, after the duration of 6.5 hours. The clinical outcome of the events worsened headache, also had sweats and chills, dizziness and fatigue were all recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Patient became dizzy after leaving vaccination room, sat down, and fainted in a chair. Patient was unconscious for 20-30 seconds, had very brief convulsive activity, then came to. Patient was lightheaded, cold, clammy, pale (intermittently), profusely sweaty, and mildly nauseous for about 30-40 minutes afterward. The patient was driven home by the spouse who was present (ambulance denied). Patient reported to be back to normal after a 2 hour follow-up.
rt leg immed erythema & induration @ site of inject; induration dec & almost disappeared w/in the hr;
Pt received Hepatitis A & Human Papilloma Virus & flu. Remained seated for 10 min after receiving shots. Then went to bathroom fell & fractured chin & sustained a laceration to chin as well.
pt devel unconsolable cryng 4 1/2 hrs p/shot given w/o redness swelling & heat or tenderness of leg; crying stopped w/in 30 mins of APAP;
PER PATIENT 4/18/19 ARM PAIN AND LEG WEAKNESS WOKE HER UP IN THE MIDDLE OF NIGHT;  4/19/19 LOW GRADE FEVER AND LOCAL ARM SWELLING.
Red and sore ear on the same side as the injection (2 days), swollen lymph nodes in armpit on the same side as the injection (2 days), sore arm and shoulder on the same side as the injection (2 days), neck pain on the same side as the injection (2 days) stomach pain (5 days), sore throat (3 days), congestion (4 days), body aches (4 days), fever (2 days), fatigue (5 days), chills (5 days)
pt was given vax & noted 5 days p/vax devel rash over entire body;states nothing has been changed in her life other than receiving vax; called MD placed on DPH
Patient said he had his 2nd COVID booster dose on 5/24/2022.   On 5/28/2022 he tested positive for COVID. Only symptoms he has was a mild cough and runny nose.  He did not go the hospital or emergency room.   He will follow up with his doctor on 6/8/2022
Vaccination dates in 2021: 02/05  - started feeling weak, fatigued, muscle wasting; liver issues - clinical NASH/cirrhosis? 03/01; 03/05; 04/01; 08/35.
No adverse event; A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date) 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 3rd patient out of 4 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713545, US-MODERNATX, INC.-MOD-2023-713548, US-MODERNATX, INC.-MOD-2023-713553 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713545:Patient 1 US-MODERNATX, INC.-MOD-2023-713548:Patient 2 US-MODERNATX, INC.-MOD-2023-713553:Patient 4
The night after the vaccination had flushing during sensation on skin chills headache and a fever of 99-101 for two days and felt tired. Theses symptoms were very similar to what I initially felt when I had COVID in April of 2020. I tested negative for COVID by PCR.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event DRUG INEFFECTIVE cannot be ruled out.    ,Linked Report(s) : US-PFIZER INC-202300159882 Same patient, different drugs and different AE.;
starting morning on 1/21/2021 had symptoms consistent with Bell's Palsy on the right side of my face. spoke with my PCP and described the symptoms.  was started on prednisone and valtrex, advised to keep my right eye lubricated to avoid corneal ulceration.
Prevnar and Hib given 12/13/04 and patient developed periods of irritability , rigidity and inconsolable crying for up to 40 minutes several times a day for 3 days.
The Patient received a dose of ACTHIB that was 4 days expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via medical information (Reference number- 00650269) and transmitted to Sanofi on 21-Jun-2021.  This case involves a one-year-old female patient who received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [total, once, lot number: UJ225ABA, expiry date: 23-APR-2021, other dosing details were not reported] on 27-Apr-2021 for prophylactic vaccination that was 4 days expired (expired product administered).   Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error de to expired vaccine used. At the time of report, reporter was requesting clinical guidance If does it need to be re-administered.   At the time of report, no adverse event was reported.  At the time of reporting, event outcome was unknown for event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
My son was incorrectly dosed with the Pfizer Covid 19 vaccine. I am waiting for guidance on what to do from Pfizer, the CDC Dept of Health (whether that first dose counts or if they have to repeat the first dose).
Child had muscle spasms in arm that would not stop. Taken to ER twice in one day after doctor's office stated they did not have the means to help. First time ER sent child home, but spasms continued so was brought back. When treated with Keppra, spasms stopped. Followed up with neuro and continued Keppra for additional two years after vaccine was received. Charts notate that child was having seizure activity. Child has not received a flu shot since incident.
Pain in arm at injection site. Pain persisted until 2/20/17. Pharmacy was informed of this reaction on 2/20/17. Pharmacy was unaware of this reaction until 2/20/17.
no adverse effects; a 15 weeks old infant was administered their first dose of ROTATEQ; 15 week old infant was administered their first dose of ROTATEQ; This spontaneous report was received from a physician concerning a 15 weeks old infant of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, or concomitants medications were not reported.  On 11-APR-2019, the patient was vaccinated for prophylaxis with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (dosage schedule, lot number and expiration date were not reported) (inappropriate schedule of drug administration and inappropriate age at vaccine administration). No adverse effects at the reporting time.
Pt c/o numbness at injection site. Persisting 2 hours after injection. 3 hrs after injection, Temp increased 99.3 and nausea and vertigo. Pt was sent home with mother.
Fever, chills, body aches, headache from 8:30 p.m. day of shot until 12 noon day after. Headache still current.
Friday morning, October 8th I woke up with a fever over 102° and normal flu symptoms. I had excruciating back pain and assumed it was due to the fever. The fever broke roughly 48hrs later but it has now been three full weeks and my lower back pain (that I have never experienced before) is still excruciating.
chills; sore arm; fevers; extremely tired; headache; sinus headache; muscle cramps; eye migraine; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN IN EXTREMITY (sore arm), PYREXIA (fevers), FATIGUE (extremely tired) and HEADACHE (headache) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DISULFIRAM for an unknown indication.    On 03-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 CHILLS (chills), PAIN IN EXTREMITY (sore arm), PYREXIA (fevers), FATIGUE (extremely tired), HEADACHE (headache), SINUS HEADACHE (sinus headache), MUSCLE SPASMS (muscle cramps), MIGRAINE (eye migraine) and FATIGUE (exhausted). At the time of the report, CHILLS (chills), PAIN IN EXTREMITY (sore arm), PYREXIA (fevers), FATIGUE (extremely tired), HEADACHE (headache), SINUS HEADACHE (sinus headache), MUSCLE SPASMS (muscle cramps), MIGRAINE (eye migraine) and FATIGUE (exhausted) outcome was unknown.            No treatment information was provided.
Approximately 10 days after first dose, swelling or inflammation under the tongue .  Appears to be inflammation of papillae of Wharton's duct based upon images observed on-line.  Whether this is related to the vaccine or not, I'm not sure.  I have never had this inflammation before.
Redness, swelling at the injection site.  Large swollen area 6x6 inches.  Advised patient to take Benadryl and apply cold and warm compress.  Telephone call to patient on 8/29/08.  Patient stated swelling and blisters down to elbow.  Advised patient to go to ER or see private doctor.  Patient refused to go.  Telephone call on 9/2/08.  Patient stated "arm is fine now."
pt had febrile seizure lasting approx 10-15 mins w/sudden onset of fever to 105.6; taken to ER dx w/BOM; this febrile seizure was 9 days p/recvd MMR/HIB 48 hrs later; also macular papular rash;
Mother declined 3 set of vaccines today stating child had fever to 102.6 & febrile seizure after last set of vaccines (child also has hx of prior febrile seizure non vaccine related). Mother will reconsider after f/up.
Tingling; Numbness in fingers; This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) for prophylaxis.   On 4th October 2019, the patient received Shingrix (intramuscular) .5 ml. On 4th October 2019, less than a day after receiving Shingrix, the patient experienced tingling of extremity and numbness in fingers. On an unknown date, the outcome of the tingling of extremity and numbness in fingers were unknown.   It was unknown if the reporter considered the tingling of extremity and numbness in fingers to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix about 2 hours ago in left deltoid. The patient started experiencing tingling and numbness in fingers of the left arm and now it was also on the fingers of the right hand. No further details were provided.
Moderna vaccine vial must be discarded 12 hours since first puncture. Although the vial was kept in the refrigerator, patient received a dose from a punctured vials that was first opened past the 12 hour mark.
Patient has a large purple bruising extending from deltoid muscle, across bicep muscle and down to elbow. There was not excess bleeding or pain at administration. The patient reported it was 3 days later when he started to notice a purple pooling/bruise on his arm and continued to enlarge for 2 days. It has since stopped enlarging and has some yellowing in the upper arm. Patient was seen by a prescriber and stated "they ran blood work and said I was fine".
Pt.'s mother states 06/17/2021 4:00pm, really agitated hitting herself, pulling skin off of arm. ER visit (stitches). communicated everything burns, she felt dirty. 06/29/2021 regular Physician appt. Still experiencing symptoms.
Narrative:  Patient received the Pfizer vaccine dose #1 on 1/21/2021 and dose #2 on 2/15/2021. He tested positive for COVID-19 on 10/11/2021. He reported that symptoms began ~9/27/2021. ABG revealed hypoxic respiratory failure (pH 7.41, pCO2 35, pO2 60). CXR revealed reticular opacities in mid-lungs and LLL. CTA was negative for PE but did reveal multifocal bilateral PNA. Patient was deemed to not a be a candidate for casirivimab/imdevimab due to duration of symptoms (~2 weeks) and SpO2 trending to low 90s on room air. Oxygen was placed at 1LPM via nasal cannula. Patient was not given any medications in the ED. He was admitted to ICU as Medical Stepdown status for further care. He received remdesivir and dexamethasone. He was transferred to the Medical COVID Unit on 10/12/2021 and discharged home on 10/13/2021.  Symptoms:  & Hospitalization
Started with pain at the injection site 5 1/2 hrs after immunization, low grade fever 18 hrs after injection; 24 hrs after injection arm painful to touch, swollen from elbow & shoulder red at site; fever persisted for 24 hours despite MOTRIN; BENADRYL X 24 hrs; swelling began resolving to resolve 4/27, only slightly red at site uncomfortable to touch
gradual decrease in food intake after shot, then on 8/7/22 he appeared to be ashen in color, hypotensive, bradycardia noted, increased respirations. over the next few days this continued as well as muscle twitches in arms and legs, oxygen saturation unable to be obtained, he expired on 8/12/22
pt devel high pich uncontrollable crying lasting 3 hrs from approx 4PM-7PM the vening p/vax 10FEB94; mom called MD during episode; instructed in APAP use;
Patient received 2 doses of a manufacturer unknown COVID-19 vaccine. Patient requested a Moderna booster (0.25mL); administered to the patient on 12/7/2021. However, patient was 15 years old (<18 years old) at the time of vaccination, and should not have received a dose of Modera (would have only been eligible for Pfizer vaccine). School nurse was informed of the incident and will inform the patient and his parents.
had both shots Vax and still got them/Suspected vaccination failure; still got them, small area on back n chest; still in pain, extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In September 2021, 3 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had received Shingles shots and still got shingles and 3 months later patient was still in pain, since September 2021. The patient still had Shingles in small area on his back and chest and it was extremely painful. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting.
EXPIRED VACCINE GIVEN PER SLIP RECEIVED WITH VACCINE LOT 201A21A AND EXP 21SEP WHICH LED PHARMACIST TO BELIEVE EXPIRATION WAS 9/30/21 WHEN EXPIRED ON MFR WEBSITE WAS 9/21/21.
Night of the vaccine he had a red rash over his scalp. this resolved in 1-2 days but then developed a fine reticulonodular rash over full back as well as sides and lower abd.
Began with itchiness and redness at vaccination site. Applied ice pack. The next day, there was a 4 cm x 9 cm itchy, red, and raised area. It became very sore. On Sunday 1/12/13 I called nurse hotline and was instructed to take Benadryl and massage the site. It is now over 2 weeks later and after a hot shower I noticed the area turned slightly red, still about 4 cm x 9 cm. Other symptoms seem to have cleared.
Patient states that around 2am (approximately 12 hours after vaccination) he woke up feeling very anxious and restless. He states he was unable to go back to sleep and he just walked all night. He has followed up with his family physician who has prescribed him Xanax and another medication he cannot remember to treat new onset anxiety and depression. He states his doctor advised him to let the health department know about his reaction so that it could be reported.
Health Department nurse gave immunizations around 11:30 am at School. Call to Health Department nurse from School Nurse at 1255 stating that student was in her office with complaints of headache and dizziness. Upon request by this health department nurse, school nurse took vital signs. Temp 100.6, BP 133/73 P 127. No respiratory distress noted, No hives, edema at this time. This health department nurse advised nurse to have student lay down on left side and to call mom for notification with request to call pediatrician for further instruction. Health Department nurse attempted to call mom as well. Left message on voicemail to return call. Follow up call made by Health Department nurse to School Nurse @1326. Patient Temp 100.8, BP 120/76, P118. Patient still c/o headache, dizziness improving, no edema, no respiratory distress, no hives at this time. School Nurse stated that she did get in touch with mom who is coming to pick up student and will call pediatrician's office. 14:18- call from school nurse, mother picked up student and has not heard back from pediatrician. Call to mother from this health department nurse. Mother did call pediatrician who states the patient probably had a vasovagal response. Advised parent to have patient eat and rest. Call if temp >102. Mother states that the patient is feeling better at this time.
p/vax pt exp significant swelling @ inj site, from arm to wrist; pt was seen by MD & is still exp swelling however it has gotten better;
4 hours post vax, the pt developed a 10 cm circumference indurated, tender, warm area at injection site. Pt is febrile, treated with Benadryl and Prednisone.