chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT CALLED PHARMACY OF 03/08/18 TO REPORT REDNESS AND SWELLING. SHE SAID IT DID NOT BURN OR WAS NOT SORE BUT THE REDNESS AREA WAS ENLARGING SHE THOUGHT. I TOLD  HER TO TAKE A BENADRYL AND GO SEE HER DOCTOR. SHE WENT TO HER DOCTOR WHO VERIFIED IT WAS A REACTION AND INSTRUCTED HER TO TAKE BENADRYL EVERY 8 HOURS UNTIL REDNESS AND SWELLING WENT DOWN. I SAW THE PT THAT DAY AND INJECTION SITE AREA WAS RED AND SWOLLEN AND WARM TO THE TOUCH.
A non-serious spontaneous report of flu like symptoms has been received from a consumer concerning her 49-year-old husband, subsequent to H1N1 vaccine. The patient's medical history and concomitant medication were not reported. On 17-Oct-2009, the patient received H1N1 VACCINE. Within 36-48 hours of taking H1N1 mist, the patient got flu like symptoms (i.e. headache, fever, running nose). The outcome of the event was not reported.
Information has been received from a nurse referring to multiple unspecified patients (age and gender were not reported). On unspecified dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K020214, or lot #K008410, expiration date 25-MAR-2016, (dose, dose #, route and application site were not reported). No adverse effects reported. Additional information has been requested.
extremely ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 1, 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: MALAISE (non-serious), outcome "unknown", described as "extremely ill".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165648 Same patient/event, different dose number;
80x80mm swelling, redness to R deltoid, warmth, minimal tender to touch. No fever.
varicose veins in the left leg; I've had problems with sciatic nerve in my left hip; This spontaneous case was reported by a health care professional and describes the occurrence of SCIATICA (I've had problems with sciatic nerve in my left hip) and VARICOSE VEIN (varicose veins in the left leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SCIATICA (I've had problems with sciatic nerve in my left hip). On an unknown date, the patient experienced VARICOSE VEIN (varicose veins in the left leg). At the time of the report, SCIATICA (I've had problems with sciatic nerve in my left hip) and VARICOSE VEIN (varicose veins in the left leg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included generic of Flonase for sinuses, vitamin C and vitamin D for unknown indications.  Patient reported that she had sciatic nerve in her left hip after second vaccination. But, she stated that normally she had it in her right hip and it was strange to notice it her left hip. She also mentioned that she has Varicose vein in her left leg and had reported about that to her primary care physician. Patient said that she visited another doctor on 16 Mar 2021 for the same, but he had prescribed her with Prednisone but she didn't wanted to take it because she had it before and it had given her insomnia. She also stated that no treatment was taken for Sciatic nerve pain incident.       Reporter did not allow further contact
Difficult breathing 20 minutes after receiving the vaccine; Dizziness 20 minutes after receiving the vaccine; weakness 20 minutes after receiving the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficult breathing 20 minutes after receiving the vaccine), DIZZINESS (Dizziness 20 minutes after receiving the vaccine) and ASTHENIA (weakness 20 minutes after receiving the vaccine.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (Difficult breathing 20 minutes after receiving the vaccine), DIZZINESS (Dizziness 20 minutes after receiving the vaccine) and ASTHENIA (weakness 20 minutes after receiving the vaccine.). At the time of the report, DYSPNOEA (Difficult breathing 20 minutes after receiving the vaccine), DIZZINESS (Dizziness 20 minutes after receiving the vaccine) and ASTHENIA (weakness 20 minutes after receiving the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were not provided. Treatment Medications were not provided.
Headache, Myalgia, Diarrhea,  fatigue, brain fog, swollen lymph node in left armpit Narrative:
Employee complains of feeling dizzy & vomited. Donor laid in office and received no medications.
Does not know how much, if any, the patient received; Needle malfunctioned, fell apart, spilled vaccine onto patient's arm; Spilled vaccine onto patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.      Additional Information: GSK Receipt Date:10-Jun-2022 Reporter's Comments: The reporter reported that a dose of Shingrix was reconstituted and when the dose was going to be administered, the needle got malfunctioned and fell apart, spilling the vaccine onto the patient's arm. HCP stated she does not know how much vaccine had been spill.  Warm transferred to medical information for further guidance and provided reference number to agent for adverse event report. Additional Supportive information: Spilling the vaccine onto the patient's arm. HCP stated she does not know how much vaccine had been spilled, which led to incomplete dose administered, accidental exposure to product and exposure via skin contact.
I was achy, felt lethargic, my legs were really achy, my head was stuffy, it felt like the flu, a low-grade fever. I used a home COVID-19, it came back positive. I called my doctor to discuss my symptoms, we decided against my taking the Paxlovid since I had, had the symptoms for a couple of days. In seven days, I was feeling better, by day nine I tested negative.  I do not have any lingering or long term side effects.
Left arm pain started at 8 pm on 4/13. Tylenol taken at 10 pm without relief of pain.  Patient reports she felt as if "fluid went down inside of arm" when vaccine given but no pain until the evening.   Feels pain in left upper arm and down in forearm and hand   Left hand tingles "every once in a while"   Upper extremity feels heavy and "hurts really bad"   Pain is a 9 or 10 on scale of 1-10.   If she touches her left hand, she feels pain in the upper extremity near the shoulder.     No fever or lightheadedness.     No pain to left upper extremity prior to the vaccine.   On exam: tenderness to left upper extremity and limited mobility 2nd to pain; no erythema or edema  Attempted to get US of left shoulder but local facilities could not accommodate  Ordered MRI of left shoulder/upper extremity or arm without contrast to evaluate surrounding structures of deltoid muscle  For pain control, treat with naproxen 500 mg po q 12 hours or ibuprofen 600 mg po q 6 hours.   Return to clinic early next week for recheck.   Will report to VAERS.    Discussed with family ddx.     Addendum: Called family after 5 pm this afternoon. Will need to get prior authorization for MRI and will update family. In the interim, Patient has taken 600 mg of ibuprofen and pain has improved mildly to an 8 out of 10. She is moving her arm a little more with the pain; she was able to extend her arm to the side and then touch her shoulder and raise her arm above her head. Discussed with mom how to check for capillary refill in left hand fingernail(s) and it was brisk per mom's report. Discussed if symptoms worsen, may report to ED for further evaluation. Encouraged her to continue to move the arm to avoid stiffness.  The site of the most pain is in deltoid region.
dizziness; headache; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old patient (gender not reported) who experienced dizziness and headache, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6522AB, expiry date, dose, dose in series and site of administration were not reported) via unknown route.  On an unknown date, the patient developed a non-serious dizziness and headache following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No Lab data was reported.  Final diagnosis was headache and dizziness.   It was not reported if the patient received a corrective treatment.  The outcome of the events were not reported.  Documents held by the sender: none.
Patient is a 13-year-old female with no significant past medical history who presents to the Health Agency-Immunization. Healthcare Office further evaluation and management of an adverse event following immunizations. Patient is accompanied to the clinic by her mother who provides most of the history. Patient was in her normal state of health on 13 October when she received school-mandated meningococcal vaccine. She did well until approximately 2 weeks later (27 Oct 15) when she began to develop a rash. The lesions initially developed on the back of the arms but then spread towards her trunk and then moved to her upper extremities, lower extremities, abdomen, neck, and face and minimally on her lower back. Lesions on her extremities tend to be more densely distributed around the elbows and knees. She denies any pruritus associated with these lesions but has noticed some pain occasionally, though currently denies any. She also endorses feeling fatigued but denies any other symptoms such as arthralgias, myalgias, fevers, chills, night sweats. She denies any mucosal involvement of her mouth, vagina or anus. She denies any other systemic symptoms. Patient denies any other known adverse events following immunizations. Patient denies any medication use recently. Patient denies any previous h/o herpes labialis or cold sores. Patient treated supportively with antihistamines and topical steroids with resolution of all symptoms in about 6 weeks.
Extreme exhaustion started 3/24 while teaching on video  at 4:45 pm - could not stay awake   and  erratic glucose levels  254  fir no reason @ 15 min later 72 -  coaster for 24 hours -  then still through today 3/26  just totally exhausted  sugar levels leveled out this morning ( I hope)
9 days after injection, arm is sore, stiff, swollen and warm at injection shot. Suspect covid arm.
Severe headache; Sore eyeballs; Chills; Body aches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the right arm on 12Feb2021 at 12:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis. The patient had known allergies to penicillin and prochlorperazine edisylate (COMPAZINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VIT D), cod-liver oil (FISH OIL) and calcium (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the right arm on 23Jan2021 at 12:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 at 03:00, the patient experienced severe headache, sore eyeballs, chills, body aches and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, sore eyeballs, chills, body aches and nausea were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Patient has history of seizures under control with medication. After administration of vaccination, patient had seizure episode within 10 minutes. Patient said while waiting during observation period she got very hot and heat can be a trigger for her seizures. Patient's head and body was secure. Patient claims no injuries from seizure. With ice and water patient cooled down. Checked on patient frequently, Patient felt  hot again after 2 hours, however patient was working at this time. Patient again sat and ate some ice and water. Checked patient's blood pressure and heart rate at 2 and half hours after administration. BP was 130s/70s and HR was 64. Patient was recommended to take Tylenol whenever she gets a chance or when she gets warm and was advised to contact her PCP or specialist as soon as possible. Patient felt good enough to continue working according to patient.
This case was reported by a consumer via patient support programs and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX for prophylaxis.  On 19th January 2019, the patient received the 1st dose of SHINGRIX .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated that after receiving a dose of SHINGRIX she had redness, swelling and soreness at the injection site of the upper left arm. The reaction was still present as of 25th January 2019.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021 at 2:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 49.60. No concomitant medications were reported. On 15-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 06-Apr-2021 and beyond use date was 09-May-2021. Product moved to clinic on 15-Apr-2021. Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42and 5 PM : 42. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a registered nurse concerning a 2 month old female who on 16-MAR-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 intramuscularly. The patient had not experienced any known symptoms. Follow up information was received from a RN who stated that a new nurse was confused and gave the infant PNEUMOVAX 23 instead of PREVNAR. It was reported that the patient was doing fine. This was a case of product confusion. Additional information has been requested.
EDC IS 01-09-2020 RECEIVED VACCINES ON 6-24-19  ALSO (7-25-19 HEP B: LOT # CP275, TD LOT # Z116A2) 15 YR OLD TO OUR CLINIC @ 31 WKS. RECEIVED VACCINES DURING KNOWN PREGNANCY. WAS GIVEN PRENATAL VITS ON SAME VISIT AS THE VACCINES IN THE CLINIC.  HAS NOT HAD QUAD SCREEN (AFP) DONE D/T ARRIVAL TO CLINIC.  PT HAS BEEN REFERRED D/T HEART MURMUR. UNKNOWN DEFECTS.
took flu shot in September, got flu on Friday; Initial information was received on 08-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional via Social Media.  This case involves an unknown age and unknown gender patient who took flu shot in september, got flu on friday after receiving  influenza vaccine.  The patient's past medical history included COVID-19 in Jan-2022. The patient's past vaccination(s) included COVID-19 VACCINE with COVID shots and boosters. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing long COVID.  In September 2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza).  On 06-Jan-2023, (latency 3 months approximately) the patient took flu shot in september, got flu on friday (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
One day post vax, pt had macular/papular rash all over arms and legs.
Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00 that night began to have back pain, fever reached up to 102 around 2:00 am and took Tylenol. Felt very weak, headache, difficulty walking and decreased balance. On Jan 5, 2021 still had back ache and headache. On Jan 6, 2021 I felt better and began to have abdominal pain after eating dinner. I assumed it may be because of eating more then I had in past few days and did not attribute to much but the pain gradually increased to a strange burning/pressure across my upper abdomen that night. Very nauseous and ran low grade fever (99.45). Next morning I had less diffuse pain and could localize it to right lower quadrant.