chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 st Booster of Moderna Bivalent given to patient on 4/28/2023 at 9:15 am. The vaccine given was at room temperature for 24 hrs. and 15 minutes which passed the room temperature range recommended from Manufacturer which is 12 hours.  MA realized error later during the day  and reported to supervisor.  It is unknown to us if patient is experiencing  any symptoms, we have not been able to reach  despite our effort to reach him.  Manufacturer  Safety team has been reached too for advise.
Information has been received from a registered nurse concerning a female patient at an elementary school of kindergarten to fourth grade, who on 10/25/96 was vaccinated with a dose of varicella virus vaccine live (lot #616997/1656B). Between 03/01/04 and 4/05/04, the patient developed breakthrough varicella. The patient had less than fifty pox and was afebrile. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned other cases of breakthrough varicella at the same elementary school (WAES040401117 and 0404USA01259 through 0404USA01264). Additional information is not available.
Fatigue: 5pm on 3/13/21- current Extreme muscle pain throughout body: 5pm on 3/13/21- current Uncontrollable shivering: 8pm on 3/13/21- 12am on 3/14/21 Swollen lymph nodes on left side of neck: 5pm on 3/13/21-current Nausea  caused by pain and shivering: 8pm on 3/13/21- 12am 3/14/21 Chest pain and arrhythmia: 8pm on 3/13/21- 12am 3/14/21 (mother is an RN and checked this with stethoscope)  I took Tylenol around the clock, did not make any changes to my symptoms. Called the ER and was transferred to a pre-recorded line. Called PCP and was instructed to increase fluid intake, rest, and take vitamins C and D.
Taken to hospital when custodial great grandmother observed tonic-clonic movements. Baby was in crib. Immunizations were given 11 hours before seizure-like movements.
Rash on back. Vesicles on erythematous base x 15-20 scattered all over body.
tachycardia; left side severe pain radiating up on the left arm; left shoulder; left neck; left chest; left side of the face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (left side severe pain radiating up on the left arm), ARTHRALGIA (left shoulder), NECK PAIN (left neck), CHEST PAIN (left chest) and FACIAL PAIN (left side of the face) in a 73-year-old female patient 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.     No medical history was provided by the reporter.  Concurrent medical conditions included Atrial fibrillation, High cholesterol and Hypertension. Concomitant products included APIXABAN for Anticoagulant therapy, FLECAINIDE for Atrial fibrillation, ATORVASTATIN for Cholesterol, SPIRONOLACTONE and OLMESARTAN for Hypertension.    On 26-Feb-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (left side severe pain radiating up on the left arm), ARTHRALGIA (left shoulder), NECK PAIN (left neck), CHEST PAIN (left chest) and FACIAL PAIN (left side of the face). On 05-Mar-2021, the patient experienced TACHYCARDIA (tachycardia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (left side severe pain radiating up on the left arm), ARTHRALGIA (left shoulder), NECK PAIN (left neck), CHEST PAIN (left chest), FACIAL PAIN (left side of the face) and TACHYCARDIA (tachycardia) outcome was unknown.            Concomitant medications Flecainide, Eloquis, Spirinolactone, Atorvastatin, Olmesartan. Treatment details include Tylenol, cool pads. Hospital: Hydration and series of dx tests.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 75 years old female patient who experienced issue with breathing as well. She finds she is very easily SOB with conversations, pain in left shoulder, unsteady on feet with HA, pain down left arm and neck pain, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, concomitant medication and family history were not provided. It was reported that on an unknown date, one month ago, the patient received a 0.5ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious issue with breathing as well. She finds she is very easily SOB with conversations with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious pain in left shoulder with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious unsteady on feet with HA with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious pain down left arm with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious neck pain with unknown latency following the administration of INFLUENZA VACCINE. The patient had no chest pain, does not hurt to take deep breath. Lab data was not provided. Final diagnosis was neck pain, pain down left arm, unsteady on feet with HA, pain in left shoulder and issue with breathing as well. She finds she is very easily SOB with conversations. The patient was treated with PREDNISONE taper. The patient outcome is reported as Recovering / Resolving for pain in left shoulder, as Recovering / Resolving for pain down left arm, as Recovering / Resolving for unsteady on feet with HA, as Recovering / Resolving for issue with breathing as well. She finds she is very easily SOB with conversations and as Recovering / Resolving for neck pain. Reported about 80 percent improvement in symptoms. List of documents held by sender- none.
Pt received 2 vaccinations d/t pt moving during administration of 1st attempt and knocking the needle out of arm and lack of confirmation to be fully vaccinated/.  2nd attempt successful.
Patient reports that her right arm was sore and stiff the 1-2 days following the shot. More that when she gets flu shots, but not as bad as Shingrix shot, in her words. Then she began to notice more swelling, rash, and itching from shoulder blade, shoulder, arm down to right about elbow. She has not treated it, but at the time of reporting she said it was going down/getting better. Date she reported it was 8/24/23- 1 week after the vaccination. Pharmacist recommended contacting the Dr if the rash did not continue to get better or got worse again.
rash over body;lower abd pain, pt pale & sl diaphoretic, 02, DPH;
Chills; Body aches; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 20Sep2021 between 16:00 and 17:00 (Lot Number: FF2588) as 1st single dose for COVID-19 immunisation. Medical history included ongoing asthma since she was a child and ongoing bad headaches, like migraines, for which she had not consulted any physician. There was no relevant medical family history. The patient's concomitant medications were not reported. There were no vaccinations within four weeks prior to the first administration of BNT162b2. The patient stated that on 21Sep2021 her body was in so much pain, having chills, whole body aches, she had no fever but felt like it. She specified that she could not stay still because her body hurt so bad, and it had gotten worse throughout the day. The patient was tearful while reporting the above side effects. There was no need for an emergency room visit not physician office visit. The patient had not recovered from the above described events.   Follow-up attempts are completed. No further information is expected.
Patient had tonic-clonic seizure on evening of 10/3/21, post-ictal for 2 hours.  Evaluation in ER was negative for blood work and head CT
Information has been received from a physician concerning his approximately 20 year old daughter whose mother was vaccinated on an unspecified date with a dose of varicella zoster virus vaccine live. Two weeks after her mother was vaccinated, the patient had an outbreak of chickenpox. The daughter has no lesions presently. Additional information has been requested. It was also reported that the patient's mother had an outbreak of itchy unilateral lesions after vaccination with varicella zoster virus vaccine live (WAES0611USA07521). This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a physician concerning his 25 year old daughter whose mother was vaccinated on 19-OCT-2006 at 10:00 AM with a SC second dose of ZOSTAVAX (Merck). Two weeks after her mother was vaccinated, on approximately 01-NOV-2006, the patient had an outbreak chickenpox. It was also described as a wide spread puritic rash of chickenpox. It was noted that the daughter lives with the mother. The daughter has no lesions presently. Additional information has been requested. It was also reported that the patient's mother had an outbreak of itchy unilateral lesions after vaccination with ZOSTAVAX (Merck) (WAES # 0611USA07521).
My left armpit really hurts and it seems like the lymph nodes are swollen. Very painful to the touch.
Patient complained of tingling sensation in lips.  She took Benadryl and sensation went away.  Patient is fine now.
CLIENT CALLED TO REPORT A SKIN REACTION AFTER 2ND SHINGRIX RECEIVED ON 10/26/22.  STATED SHE HAD NO REACTION WITH THE 1ST, BUT SHE WAS NOT RECEIVING CHEMO AT THAT TIME.  LAST CHEMO TREATMENT 3 WEEKS PRIOR TO 2ND SHINGRIX VACCINATION.  COMPLAINS OF SKIN REACTION STARTED 10/27/22 TO BILATERAL ARMS, INTO ARMPIT, AND DOWN DOWN BACK. STATES IT IS SCALY, WELTS, PIMPLE LIKE.  SAW HER PCP WHO STATED IT WAS A REACTION TO THE VACCINE AND PRESCRIBED MEDICATION TO TREAT THE RASH.  CLIENT WILL FOLLOW UP WITH HER CANCER CARE PROVIDER AS WELL. NO OTHER REACTION NOTED.
This spontaneous prospective pregnancy report was received from a currently 17 year old female patient reporting on herself. The patient had no pertinent medical history, concurrent conditions or drug reactions/allergies. There was no concomitant medication. On 17-JUL-2018, the patient was vaccinated with VARIVAX for prevention of chickenpox, while she was pregnant. The patient became pregnant with last menstrual period of 23-JUN-2018, estimated date of conception of 07-JUL-2018 and estimated delivery date of 30-MAR-2019. The patient was informed she was pregnant by the physician's office after they reviewed her blood work from 17-JUL-2018. The pregnancy outcome was pending. No adverse experiences were reported. No treatment was given.
Started feeling tingling in left arm 3-4 weeks after shot. Tingling was going down to just elbow. Now it is going down to wrist.
2x3 in erythematous raised circular rash, pruritic- lasted 3 days and improved with oral Benadryl not with topical Benadryl, ibuprofen, or tylenol
Pfizer-BioNTech COVID-19 Vaccine EUA:  The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged.   On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged.   While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face.   On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged.   On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
The MMR shot was one of the environmental factors contributing to diagnosis of Autism. Other eczema, chronic constipation are other symptoms.  10/23/2007 MR received for WCC on 2/14/2003 to 3/29/2005.  WCC on 2/14/03 with normal growth & dev however still walking with assistance at age 15 mon.  Child had seen opthomologist for eval of stabismus/pseudostrabismus. 18 mon WCC 5/16/03 shows only saying 4 words otherwise doing well.  Hearing eval 5/03 and myringotomy tubes placed 6/03.  TC with MD 8/27/03 re: autism.  MD advised to watch progression of speech and reassessment of skills now that pt is hearing well 2' to ear tubes.  Speech delay noted at 2yr WCC.  Speaks 3-5 words, no phrases. Receiving speech tx and early intervention. Multiple visits for ear issues-bleeding, drainage, OM. 3 yr check with developmental delay noted.  DX: Autistic Disorder. PDD. Refered to GI for constipation and stool withholding. See also 292954. Per 60 day follow up: Constant eczema, chronic constipation, autistic like characteristics.
Vomiting 3 weeks after each shot. Even the booster had this effect 3 weeks later.
child should have gotten the pediatric dose, but the 12+ formulation was used but diluted and administered with the pediatric guidelines (1.3ml diluent and 0.2ml dose). mom reports child complaining of sore arm and achy joints.
Moderna vaccine was given Tuesday,  April 6. Fever of 99-101 began that evening and lasted till Sunday, April 11.  The injection site was swollen/red/inflamed and started to fade on April 10.  On April 13, a large itchy rash appeared at the injection site and still persists. The area feels warm to the touch and is much larger than the first swollen injection site issue.
Headache sinus congestion ear ache fatigue 1days post vaccine improved then worsened 7 days later, covid test 1/192021 negative Narrative:
Patient was in the office to receive her Moderna booster. Patient received a full dose of 0.5ml instead of the booster dose of 0.25ml of the Moderna vaccine.
Patient reported itching on 2/2/17. On 2/3/17 swelling at injection site and a rash.
Simple febrile seizure lasting approximately 3 minutes at 0210; transient post-ictal period with return to appropriate baseline prior to arrival at hospital. Rectal temperature 103.8 on arrival to ED. Treated with 15mg/kg acetaminophen PR on arrival and 10mg/kg ibuprofen PO 1hr later with appropriate decrease in fever.
Extreme back pain where i have permanent injury to spine; Extreme back pain where i have permanent injury to spine; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in arm left, administration date 04Nov2021 16:00 (Lot number: FF2593) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. The patient took unspecified concomitant medications two weeks prior to vaccination. The patient did not receive other vaccines in four weeks. The vaccine was administered in other facility. The patient was not diagnosed with Covid prior vaccination and was not tested post vaccination.  The following information was reported: BACK PAIN (medically significant), BACK INJURY (medically significant) all with onset 06Nov2021, outcome "not recovered" and all described as "Extreme back pain where i have permanent injury to spine". Therapeutic measures were not taken as a result of back pain, back injury.  No follow-up attempts are possible. No further information is expected.
30MAR94 inc fatigue noted 7PM; 30MAR93 h/a (severe); 31MAR93 h/a, back ache, body ache 6AM;  t103.3, facial flushing, chills w/diaphoresis;
Per patient she was feeling fine with her treatment (said dose was given) till she went home and felt so tired that she couldn't eat the next day (April 13, 2021). So her daughter called ambulance and sent her to the hospital. In the hospital, a lot of tests  and procedures were done  including cardiac cath.  One of the patient's nephrologists stated that patient admitted with possible myocarditis after her second shot of Covid but no significant intervenable disease after the cardiac catherization and it's difficult to attribute it to the shot completely. Patient got discharged from the hospital on April 17, 2021.
Pt given required doses of MENVEO and BEXSERO on 8/14/17. Pt was given another dose of both MENVEO and BEXSERO on 8/29/17.
Red circle around Vaccination site. Hard lump. Sore under arm approximately 6 days after getting vaccine dose 1. Seems to be getting better on day 10-11
Patient was admitted to the hospital approximately 2 days after receiving the Moderna vaccine. She was under Hospice care before receiving the vaccine.
patient received both vaccinations in one sitting at the pharmacy; after injections, patient stated that she felt fine and went to sit with her parents in the post-vaccine waiting area; she started to feel dizzy and began to sway back and forth; she then fell back in her seat and hit her head; her parents turned her on her side making sure she was not having a seizure; she awoke a few seconds later stating she did not remember the fainting spell; EMTs were called
Nausea; Muscle soreness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, muscle soreness and fatigue. On an unknown date, the outcome of the nausea, muscle soreness and fatigue were unknown.   It was unknown if the reporter considered the nausea, muscle soreness and fatigue to be related to Shingrix.  Additional details provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingrix and experienced nausea, muscle soreness and fatigue. The patient reported that there was no allergic reactions after vaccination. The reporter wanted to know if nausea can be a side effect of the vaccine. No further information was provided.
patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received an expired vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received an expired vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. This is a case of Expired Product Administered concerning a 61-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 61-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Local swelling at injection site (R) deltoid erythema with warmth at and below site rash approx 10 x 12 cm no lymphadenopathy, lymphangitis, fever
Patient had headache the evening of vaccination. Then 24 hours after headache, she had diarrhea and 2 days later she developed very itchy rashes that look like chicken pox wrapped around her trunk and buttock and the back of her legs.  The patient went seek medical advice and had a prednisone prescribed. Also went see natural medicine doctor. The rashes lasted about 3 weeks and it gets better now.
Severe local reaction with erythema and induration at injection site. Reaction 15cm x 15cm.
No adverse event; fluid had dripped down her arm from the hub of the syringe; fluid had dripped down her arm from the hub of the syringe; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe), UNDERDOSE (fluid had dripped down her arm from the hub of the syringe) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age 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 28-Sep-2022 at 8:00 AM, 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 28-Sep-2022 at 8:00 AM, the patient experienced DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe) and UNDERDOSE (fluid had dripped down her arm from the hub of the syringe). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe), UNDERDOSE (fluid had dripped down her arm from the hub of the syringe) 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 assessments were provided for DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe) and UNDERDOSE (fluid had dripped down her arm from the hub of the syringe).    No Concomitant medication was reported.  The patient reported that she felt, there was an initial trickle of cool liquid running down her arm during the injection and when she looked over while the nurse was injecting it, she saw the liquid leaking down her arm to the point where it needed to be wiped. The Patient reports it looks like the liquid was leaking out from the area where the needle screws into the syringe. The reporter reports that it was not much that leaked out, only a drop that rolled all the way down her arm. Patient noticed there was more fluid that had dripped down of her arm in two other places. For all 3 spots, in all she thinks it was at least 2 microliters of fluid. Patient was concerned that she did not receive the full dose.  No treatment information was provided.
pt recv vax & mom states on-going crying x 4hr;irritable & crying & handling;2Pm quiet;APAP given q 4hr;
Patient with a generalized tonic clonic seizure while asleep approximately 18 hours after 2nd dose of Moderna COVID vaccination.