chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Moderna vial best use date 10/17/22. Administered on 10/22/22. Contacted moderna and was advice repeated dose is not necessary, because its within 30 days window. Family was contacted and notified, and no adverse effect was noted.
Sunday my arm was red and hot but that happens every time I get the booster and that went away and Sunday night I had a low grade fever and on Monday I was playing golf and tennis and developed a cough but started developing a temp of 100. Tuesday morning I was doing my V-Safe and started coughing a lot and knew this was not one of the side effects and I had COVID-19 test home and took one and was positive. I called my doctor Wednesday morning and they started me on PAXLOVID. I was having coughing, fever, and head cold symptoms. I have just a bad head cold and my sinuses are full but I have no fever today.
Acute hypoxic respiratory failure: likely related to diastolic heart failure and copd. Improved. Discharged on one liter of oxygen. Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 (Lot numbe: 663888/0627Y or 662599/1076X). The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 ranging form fevers to 102F to 103F and cellulitis". Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 was given". At the time of the report the patient's outcome were not reported. The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital. The other patients sought medical attention at the physician's office. Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 that caused patient reactions in the office. Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 in the past but had never had reactions such as this in their office". Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot number not specified). On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23. This is one of several reports received from the same source.
Patient suffered from muscle fatigue on 1 side of her lower extremities 2 weeks post administration of GARDASIL 9; This spontaneous report was received from a physician concerning a 13-year-old female patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date in 2021 (reported as two years ago), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dose, route of administration, lot#, expiry date, and anatomical location not provided) (that was only vaccine she received that day).   On an unknown date in 2021 (reported as 2 years ago), the patient suffered from muscle fatigue on 1 side of her lower extremities 2 weeks post administration of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The physician was consultant with another physician at their practice regarding this effect, the other physician response was that she had seen 1 other similar case with similar effect with this vaccine (2308USA007430). No additional adverse event (AE) was reported. The outcome of muscle fatigue was not provided. The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not applicable.  The causal relationship between muscle fatigue and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA007430:
This spontaneous report as received from a registered nurse via Medical Record refers to a currently 15 months old male patient with no known drug allergies (NKDA). On 04-MAR-2013, the patient was vaccinated with the first dose of PEDIARIX for DTP/aP; First dose of ACTHIB for Hib; First dose of PREVNAR 13 for PCV; First dose of ROTATEQ for Rotavirus. On 13-MAY-2013, the patient was vaccinated with the second dose of PEDIARIX for DTP/aP; Second dose of ACTHIB for Hib; Second dose of PREVNAR 13 for PCV; Second dose of ROTARIX for Rotavirus. On 12-JUL-2013, the patient was vaccinated with the third dose of PEDIARIX for DTP/aP; Third dose of ACTHIB for Hib; Third dose of PREVNAR 13 for PCV; Third dose of ROTARIX for Rotavirus. On 13-MAR-2014 at 12:04 pm the patient was vaccinated with the first dose of PROQUAD (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the First dose of HAVRIX for HepA; Fourth dose of ACTHIB for Hib; Fourth dose of PREVNAR 13 for PCV and dose of VARIVAX (Merck) for Varicella (dose and lot# unspecified). This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request. Additional information is not expected.
Case number PHEH2015US026500 is an initial spontaneous report received from a health care professional on 14 Dec 2015. This report refers to a 59 year female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 518001) multi dose vial (MDV) intramuscularly in the arm on 07 Dec 2015. On the same day, the patient experienced soreness in the arm of injection site as well as a white bump where the needle was inserted. The events outcome was reported as condition unchanged. The seriousness and causality of the events were not reported.
Patient was scheduled to get a Menveo injection and was given Trumenba in error.  No adverse reaction to vaccine.
melanoma carcinoma on his scalp; melanoma carcinoma on his scalp; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 85 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), MALIGNANT MELANOMA (medically significant), outcome "unknown" and all described as "melanoma carcinoma on his scalp". Therapeutic measures were taken as a result of neoplasm malignant, malignant melanoma.  Clinical information: The reporter stated that the patient within 3 months of receiving the suspect vaccine (purple cap) first dose developed a very rare and strange melanoma carcinoma on his scalp and that they now had to cut-off the melanoma carcinoma and he will have an open wound for a year. The reporter regarding the information on of the suspect vaccine stated that this information does not have the specific information developing a very rare and strange 'melanoma-carcinoma' on the scalp following vaccination with the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). The reporter stated that the people that work at Pfizer had no integrity for being a part of a company that fails to be transparent and called in Feb and Mar but received the same information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
PT WOKE ON 7/1, 2ND DAY AFTER SHOT WITH VERY SORE ARM, PALM-SIZED KNOT, HAND PRINT-SIZED REDNESS, WARM TO THE TOUCH. PT PRESENTED TO PHARMACY 7/2 TO SHOW ME THE REACTION. IT WAS ABOUT 1/2 THE SIZE OF WHAT SHE REPORTED IT WAS ON 7/1. SHE SAID IT WAS IMPROVING. PT REPORTS IT IS ONLY SLIGHTLY DISCOLORED AS OF THE MORNING OF 7/3.
Initial report received from a non-healthcare professional (consumer) on 03 SEPTEMBER 2013. A 64-year-old female patient whose medical history includes acid reflux and hiatal hernia and concomitant medication was not reported, had received a ADACEL (batch number: site of administration and dose number were not reported) intramuscularly on 13 AUGUST 2013. On 14 AUGUST 2013, 24 hours after vaccination the patient experienced symptoms of arm soreness and stiffness. On 17 AUGUST 2013, the patient experienced episodes of flushing and it was hot flash, symptom remains as it on day and night. On unspecified date in next week the patient had episode of frequent flushing which were sporadic and lasted from just a few minutes to hours. Symptoms continue to occur. No laboratory investigations were done and corrective treatments were not reported. At the time of this report, the patient was not recovered. Documents held by sender: none. Follow up received on 03-OCT-2013. No new information was reported.
0843a patient c/o chest flutter, no SOB or any other symptoms. BP 130/78 oxygen 97% HR 100, seen by EMS and at pt's side. No new interventions provided. Monitored patient an additional 15 minutes . At 0905, patient feeling slightly better BP 134/74, HR 101 and down to 94, oxygen level 93 to 94%, . Patient feels ok to go home, released by EMS and assisted to son's car.
fever to 102, aching in lt arm to elbow & up lt shoulder to lateral neck;marked erythema (20x28cm) w/induration;got chills, shakes, sweats;started on erythromycin & DPH;
I came off my immuno suppressant for two weeks after taking the shot to try to build up an immune response. After that, I had swollen lymph nodes in my left breast that lasted for one month and a major cardiac sarcoidosis flare that increased in intensity for eight weeks. I have now started prednisone In addition to Micophenolate 1000 mg twice a day to come the flare. One month prior to the shot, I had had a clean PT scan?no flare.
Pt brought to med obs #1 via wheelchair with staff for c/o racing heartbeat and bilateral hand and lip tingling. Pt denies cardiovascular history. No SOB noted. Denies chest pain. No s/s of distress noted. Pt reported she felt better upon arrival to med obs. VSS. Pt discharged to home after evaluation by MD. Refused wheelchair. Escorted to exit with staff. Ambulatory independently. Gait steady. VS are as follows: 1045: BP 163/81, HR 101, RR 18, O2 sat 100% on RA 1050: BP 151/75, HR 91, RR 18, O2 sat 100% on RA
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment drug was reported.
RASH ON LEFT FOREARM; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced rash on left forearm. Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on left forearm. This report was non-serious.
A COUPLE OF BRIEF DIZZY SPELLS; SWEATING; DIFFICULITY FALLING SLEEP; CHILLS; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy spells, sweating, difficulty falling sleep, chills, and extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, extreme tiredness, difficulty falling sleep, sweating and dizzy spells was not reported. This report was non-serious.
Yesterday I started to feel the bottom of my feet each a little, today I woke up coughing, with a little runny nose and by this afternoon I was covered with rash all over my legs and feet
Post vaccination, patient while in observation for the 30 min flag (Previous reactions). Husband approached observation team with concerns of patient developing a rash, redness of body and uticari.  Patient during assessment continued to show increasing signs of reaction to include a sensation of throat swelling without any difficulty breathing.  911 notified for transport, treatment under protocols of the agency due to patient progression on reaction and anxiety due to hives, throat sensation and increasing itch. Treatment on site included 0.3mg of Epinephrine and 25mg IM of Benadryl.    Monitoring maintained to include pulse oximetry
No longer has recurring pain in the shoulder/90% reduction in pain; Fever for 24 hours after vaccination; Chills for 24 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (No longer has recurring pain in the shoulder/90% reduction in pain), PYREXIA (Fever for 24 hours after vaccination) and CHILLS (Chills for 24 hours after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shoulder pain (recurring pain in the shoulder).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (No longer has recurring pain in the shoulder/90% reduction in pain). On an unknown date, the patient experienced PYREXIA (Fever for 24 hours after vaccination) and CHILLS (Chills for 24 hours after vaccination). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (No longer has recurring pain in the shoulder/90% reduction in pain) outcome was unknown and PYREXIA (Fever for 24 hours after vaccination) and CHILLS (Chills for 24 hours after vaccination) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.
She sts that the  rash now involves both arms, elbows and involves abdomen all the way to pelvic area. She reports that she has no rash on her back and minimal if only rash on lower extremities.
Cough, congestion, runny nose, fever, not himself, loss of appetite, irritability, febrile seizure. Returned to pediatrician at onset of symptoms. Prescribed breathing treatments. Gave Motrin. Ambulance to the ER following seizure.
SORENESS; FEELS LIKE AN ITCH; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (SORENESS) and VACCINATION SITE PRURITUS (FEELS LIKE AN ITCH) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (SORENESS) and VACCINATION SITE PRURITUS (FEELS LIKE AN ITCH). At the time of the report, PAIN (SORENESS) and VACCINATION SITE PRURITUS (FEELS LIKE AN ITCH) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.
very bad pain on the side of her neck from ear to shoulder; right in there, both shots were in left arm, that's where the pain is; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 76-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) in left arm for COVID-19 immunization. It was reported that, the patient had problems. The patient had both shots. She had second dose on 05Feb2021, and for last 4 days (on an unspecified date in Feb2021) she had "very bad pain on the side of her neck from ear to shoulder" "right in there, both shots were in left arm, that's where the pain is". The patient reported that it was quite painful. The patient declined to contact recommended doctor as she was contacting her doctor anyway. The patient did not want to proceed with the report, as she did not see where this helps her, as far as her hurting. Investigation assessment was not provided. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
102 fever; Sick for 2 days; This is a spontaneous report from Pfizer-Sponsored Program. This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included illness from an unknown date and unknown if ongoing, reported that the patient as a baby had always got sick when got vaccines. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced 102 fever, and was sick for 2 days. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. The caller stated that her daughter, when the patient got her vaccine, she did not think this had anything to do with it, but her second dose, she had a 102 fever, she was sick for 2 days. The patient recovered from the event sick for 2 days and the outcome for the event 102 fever was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Persistent daily left shoulder pain for 4 weeks with initial onset immediately at time of injection.  Symptoms were moderate for the first week and now remain mild but consistent.
fever 103 called in by mom 28JUL94 which began aobut 3 hrs p/vax;mom took pt to urgent care 30JUL AM instructed to call MD; fever of 104; given ATB inject; dx coincidence infection by MD;
Redness and swelling where I got the shot. Then the next day, I felt tired, had muscle pain, a headache, fever, stomach discomfort
This spontaneous report as received from a pharmacist refers to a 62 years old patient (gender was not reported) who on 01-FEB-2013, was vaccinated with, 0.65 ml ZOSTAVAX subcutaneously in right deltoid (Lot number reported as 0150Z) that expired on 01-APR-2011. No other co-suspects were reported. No concomitant medications were reported. No adverse effect has been observed or reported. Additional information has been requested.
Narrative: Pt reports " extreme swelling: after getting COVID vaccine booster. She tolerated dose 1 and 2 fine.
About an hour after the injection, I had a very sharp pain in my left ear and my left side of my neck got very tight.  I had about 2 more very sharp pain in my ear that evening, and feels like I have something trapped inside my ear.  I still feel as though something is still in my ear and my neck is very tight.  I have  had a headache since the injection, and started getting chills and fevers on April 8 and has continued.  I have been extremely tired since April 9....it is interfering with my work.  My stomach hurts and feel miserable.  I have not yet recovered.
Pt recv vax and may have devel anaphylaxis. Additional info recv 07Nov97, MD stated "no adverse rxn occurred".