chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 03-Sep-2022, 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 20-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022) 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 EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022).    No concomitant medications were reported.  The patient and the Nurse Practitioner did not wish to report any additional information. Patient did not even want to report the Adverse Event at all.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717576:
Patient received the Pfizer-BioNTech vaccine at around 1:30pm on 12/29/20. After about 15 minutes, she complaints of headache, lightheadedness, weakness, shivering , shaking. and want to lie down. she was taken into a room where she lay down and then had seizures which lasted about 20 seconds.   After she was stabilized and received supplemental oxygen, she was transfered to the ER by the EMT at approximately around 2:05pm
No treatment.  I had a cardiac ablation in the fall because of chronic atrial fibrillation. It appeared to have worked. One day after receiving the vaccination I took a walk with some hills and had what I believe was a mild episode of atrial fibrillation. I verified as best I could, using a pulse oximeter.  I feel fine for the most part, but a little bit tired and dizzy. I do not plan to call the doctor unless things get worse.
Got Hepatitis A vaccine yesterday, fever began last night. Started 100.4, continues to rise today to 103.7. Breathes with mouth open like a dog. No other symptoms of note. Use cold damp towels with concerned. No NSAIDs needed.
Information has been received from a licensed practical nurse concerning a 13 month old white male with no allergies and a history of pertussis before 2 months of age on 02/11/2004 who on 01/24/2005 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  Concomitant vaccination on the same day included an intramuscular third dose in the right (site not specified) of pneumococcal conj vaccine (Prevnar).  Illness at the time of vaccination included a cough and runny nose, the symptoms of which lasted 4 to 5 days.  No fever was noted.  On 02/11/2005, the patient presented to a physician's office with rash/lesions all over the body, but no fever.  There were less than 50 lesions at the time of the report.  Treatment consisted of comfort measures as needed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the licensed practical nurse who indicated that the mother brought the patient into the office stating that the child broke out in a rash the week prior, but that on 02/10/2005, he developed a different type of rash that was spread out in lesions.  There were approximately 30 to 40 macro-vesicular lesions.  The diagnosis was varicella variant and the onset dated was noted to be 02/10/2005.  It was indicated that the event was reported by the office to the state health clinic.  On 02/14/2005, the lesions had scabbed over and the patient was considered recovered.  On 02/25/2005, the mother stated that the child had less than 100 lesions when done.  The patient had no adverse events following prior vaccination.  No further information is expected.
I had an outbreak of Hidradenitis. I was prescribed some medications, but I didn't take them because they irritated my skin. I have to have surgery now because this won't go away.
Shipment of FLUBLOK that took too long in route to the facility so it was found not suitable, They state this FLUBLOK was then administered to two patients by mistake, with no reported AE; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Media Information (under the reference 00839503).  This case involves two patients (unknown demographics) whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] was administered by mistake and also involves temperature excursion due to shipment of flublok that took too long in route to the facility so it was found not suitable (product storage error).  The patients medical history, medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect FLUBLOK QIV (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual case of incorrect product storage (unknown latency).  No adverse event reported.  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 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.  There would be no information on the batch number for this case.
experiencing / episode of herpes in her eye after the injection; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of herpes ophthalmic in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes ophthalmic.   On 3rd July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and sickness. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the herpes ophthalmic and sickness were recovering/resolving.   It was unknown if the reporter considered the herpes ophthalmic and sickness to be related to Shingrix.  Additional information was provided as follows: The patient experienced an episode of herpes in her eye after the injection. Patient also reported feeling sick so she took a motrin and took a three hour nap, she then felt fine after the nap. The reporter consented to follow up. Pharmacist did not have access to the Shingrix Lot at time of the call. Provided pharmacist MI for additional information.
Fever, Fisrt symptom severe pain at injection site and under axilla around 12 midnight; fever later that night Narrative:
Patient presented for second vaccine -- vaccine card indicated he received Moderna for his first dose (on 4/27/21) however administering clinician documented in COLOR system he received Pfizer vaccine (for first dose).  Staff on site at second visit (5/27) did some review and initially concluded that Moderna was not administered that day. and subsequently decided to administer Pfizer second dose based on COLOR system documentation.  However, further review revealed that SLE had administered 7 doses of Moderna (brought by as left over from mobile vaccine unit) and likely this patient was one of the receipients of the Moderna vaccine (high likelihood considering the administering clinician was the one selected to administer both Moderna and Pfizer--safe system put in place however, it's likely he failed to select the drop down feature in Color system and change from Pfizer to moderna from a documentation perspective.  Employee no longer works at facility thus unable to review event with him.  Patient contacted today and informed of the likelihood that he received both Moderna and Pfizer vaccines.  COLOR system contacted to change the documentation to reflect he received Moderna 1st dose--new card made and sent to patient reflecting this.
On Feb 5th 2021,  after receiving my first Moderna Covid Vaccine on Jan 28, 2021 , my left arm and shot sight started to itch terribly, The next day, I broke out in hives over 85% of my body. I started on Benadryl, taken orally and used Benadryl cream and Hydrocortizone Cream - over the counter. As of today, 2/9/21, the hives have stayed the same.  The spots on my body are hard and look like blisters. The itch and burn almost continually. I went to a walk-in clinic today, 2/9/21, and they gave me Hydroxyzine 25 mg to take 4 times a day. So far tonight it doesn't seem to be helping.
The day after patient received the PREVNAR 13 her arm became red and swollen. Over the next few days it turned purple and she developed fever and generalized weakness. She presented the hospital on 11/2 with a temp of 100.8 and was admitted. Pt's symptoms improved and was discharged 11/6/15. She presented to our clinic on 11/19/15. Her arm was healed. She still was weak, but improving.
dizziness; This is a spontaneous report from a contactable consumer (patient). This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, on 18Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting the first dose of the Pfizer-BioNtech Covid vaccine on 18Mar2021 he experienced a little dizziness on an unspecified date. The dizziness dissipated after a few hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
IMMEDIATE FACIAL AND EAR FLUSHING. NO URTICARIA. NO FUSSINESS OR ITCHING. NO COUGH OR WHEEZE, NO VOMITING. REDNESS LASTED LONGER THAN 15 MIN.
History of racing heart since getting vaccine 2/20/07. Short of breath-sent to cardiologist ECG doppler normal. Back again 3/16/07 missed 5 days of school. Coughing waking at night, night sweats, nausea.
Vaccines were kept frozen until they are ready for administration; Vaccine administered beyond use date or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
Broke out on hives, ran a mild fever, had a headache, right arm joint pain. Dr treated with Prednisone and BENADRYL.
Pt returned to office after returning home from clinic because the Rt eye swelled shut and pt was rubbing it, no cough or wheeze. Given 5 ml prednisone - mom to cont. BENADRYL q 4-6 hrs & give 1 more dose of prednisolone next day.
feeling shortness of breath; headache; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient was feeling shortness of breath, headache and runny nose. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
I had congestion in my sinuses.  My face swelled up.  I had trouble swallowing.  These lasted about from July to October.  I went to the doctor about this.  They did an ultrasound of the soft tissue.  They diagnosed me with Salivary Gland Infection.
Numbness lips and tongue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness lips and tongue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness lips and tongue). On 23-Mar-2021, HYPOAESTHESIA ORAL (Numbness lips and tongue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Not treatment was reported.
Began elevated temp immediately (same day) p/vax given, ran temp of 102 that day 18DEC91 & was 103 orally 18DEC91 in night 2 days p/immun began vomiting; Seen by MD-tx antibiotics, ill x 6 wks;
Patient described hand pain on the hand opposite the arm that the vaccine was given in.  There were no objective physical exam findings.  Pain persists to date.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included antihistamine for an unknown indication and LAMISIL unknown for an unknown indication. Previously administered products included ZOSTAVAX. Concurrent medical conditions included shingles (mild shingles outbreak). On 2nd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient started antihistamine at an unknown dose and frequency and LAMISIL at an unknown dose and frequency. On an unknown date, less than a year after receiving SHINGRIX and not applicable after starting LAMISIL, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site rash, injection site discoloration, eruption facial, fatigue and drowsiness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth and injection site rash were recovering/resolving and the outcome of the injection site discoloration, fatigue and drowsiness were unknown and the outcome of the eruption facial was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site rash, injection site discoloration, eruption facial, fatigue and drowsiness to be related to SHINGRIX. It was unknown if the reporter considered the fatigue and drowsiness to be related to LAMISIL. Additional details were provided as follows: The caller was a patient. The caller reported that she experienced local reaction at injection site that was raised, pink in color, warm to the touch that started out size of a 50 cent piece and grew to size of palm of her hand. The caller reported that also developed tiny bumps and itchiness around the perimeter of the area. The caller reported that the reaction has improved, still has discoloration at the area but no other issues. The caller reported that she developed two outbreaks on her face of tiny bumps that resolved and she has experienced fatigue and drowsiness since getting the shot. The reporter consented to follow up.
Dizziness and confusion followed by a grand mal seizure. We have no family history of seizures.
I developed diabetic hypokalemia. I am not sure if it was related but it is new. I have to track my sugar now and I feel like I am constantly tired. I saw a doctor on 06/08 and that is when they diagnosed me. I had really low vitamin D also. I went to the ER right after the vaccine because I had dental surgery the day before. After I got my vaccine though I felt terrible. I went in just to make sure nothing was wrong. I had a lot of pain in my mouth. I was not sure if I had developed an infection because I overloaded my immune system. I was sick and vomiting. I had an infection in my stomach and they sent me home with an antibiotic.
The first day I had sore arms, the second day I had nausea and cramps and it lasted about two day. The third to fourth day I started to get the pain and spots in my chest spreading to my back. I did go to a fast care. I had shingles once before, and it felt similar to that experience. I went to the fast care and they gave me a prescription to help with the Valacyclovir HCL 1gram, its one table by mouth. 3x a day for however long the infection. There's 21 tablets. I went to the doctor on 11/06 and started to take the medication on that day. It's getting worse as the days go by. Its spreading from the front to the back. There is pain, its gets worse every day.
Red line From inj site within 3 hours. Patient went to MD who said nothing to worry AbouT. IT is Almost All resolved 10-11-20
fatigue; headache; muscle aches; 100 earlier and 100.2 now; soreness in my left arm again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my left arm again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in my left arm again). On 16-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now). At the time of the report, PAIN IN EXTREMITY (soreness in my left arm again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature (97-99): fever of 102f and 100.2 f. (High) fever of 102F and 100.2 F..         No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Fever 104 with temporal thermometer at home, 101.7 in office, fussy, not eating.
Arm area very sore after shot.  6 days later felt itching in R-upper arm area.  Thought it was from an insect bite.  After 3 days of continued itching and in a larger area, looked at R-arm and saw that it was patchy red and swollen from shoulder down to almost elbow on the outside of R-arm.  Continued for another week, and subsided over a period of 2 weeks.
11/28 was congested and had a productive cough. This caused me to have laryngitis along with the sinus congestion and post nasal drip. After a couple of weeks I decided to call my physician and got a COVID test on 12/9. Got antibiotics (Doxycycline HYC) and steroids (Prednisone) from my doctor after the phone call. After this course I have recovered for the most part.
Case number PHEH2013US022590 is an initial spontaneous report from nurse received on 24 Oct 2013. This case refers to a male patient of an unknown age. The patient was vaccinated with Influenza virus vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Influenza vaccine- unknown INN) on an unknown date. On an unspecified date, after the vaccination, the patient "had a really big problem" and that the injection area was swollen up. The seriousness, outcome and causality of event were not reported.
I received my Covid-19 vaccine on 09/11/2022. On the morning of 11/18/2022 I woke up with a 102 fever, fatigue, headache, sore throat, runny nose, eyes hurt, muscle pain, and cough. I tested positive for Covid-19 on 11/22/2022 after having previous negative results. I went to the doctor and was prescribed PAXLOVID. Took about a month to fully recover.