chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 15th November 2022, the patient received Havrix. On 15th November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: Nurse manager reported a patient was administered an expired dose of Havrix. The reporter consented to follow up via email. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient was administered with expired dose, which led to expired dose administered.
Injection site paint and soreness for 3 days; Fever and flu-like symptoms for 36 -48 hours; Possibly unrelated -- onset of vertigo within 2 weeks of injection.
Ringing in both ears, not extremely loud, aggravating.; This is a spontaneous report from a contactable consumer. A 71-year-old female non-pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/Batch No.EN5318) via the left arm on 18Feb2021 at 1200 as a single dose for COVID-19 immunisation. The patients medical history includes hypertension, cholesterol. concomitant medications included biotin, vitamin B 12, D3 for an unknown indication and allergies to medications, food, or other products include bactum. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/Batch No.EN5318) via the left arm on 28Jan2021 at 1200 as a single dose for COVID-19 immunisation.. The patient was not diagnosed with  COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. The adverse event was treated with B12.  On 18Feb2021 at 0600, the patient experienced ringing in both ears, not extremely loud, aggravating. The clinical outcome of the reaction was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 17-year-old male patient who received BEXSERO. Concurrent medical conditions included latex allergy. On 10th AUGUST 2016, the patient received the 1st dose of BEXSERO. On 10th AUGUST 2016, an unknown time after receiving BEXSERO, the patient experienced labeled drug-disease interaction medication error. In AUGUST 2016, the patient experienced facial swelling, rash and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the facial swelling, rash, hives and labeled drug-disease interaction medication error were unknown. It was unknown if the reporter considered the facial swelling, rash and hives to be related to BEXSERO. Additional details were provided as follows: The patient was having an allergy to latex and received 1st dose of BEXSERO, which led to a labeled drug-disease interaction/medication error. The patient experienced facial swelling, rash and hives on his face. The patient's mother gave him BENADRYL which took down the facial swelling and hives. No further information was provided.
Neither relevant medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 28-Nov-2008, intranasal for Flu vaccination. Approximately twelve hours following administration, on 29-Nov-2008 the patient vomited twice and experienced muscle aches. The patient recovered from the episode of vomiting on 29-Nov-2008 and recovered from the muscle aches on 30-Nov-2008. The patient's physician told the parent she did not think the events were related to FLUMIST.
-Twitching mostly in my legs and stomach and ribs especially during the first week.  It substantially subsided during the second week but still occasionally happens in my leg and sometimes in my temple area beside my left eye. -On the first or second day after vaccination, my pulse was beating profusely (fast and furious) between my left thumb and index finger mid-way toward my wrist of my right hand.  I am not sure what that was, since I had never seen that happen before and it was not happening on my left hand.  I am scheduled to take my second vaccine on 3/15/2021 so I am trying to find out if you would recommend that I take the second vaccine or not take it. I am scheduled to tak
Hives, swollen throat, tongue  hives  all over body started around my neck within 30 min of the vaccine . Took allergy meds and Benadryl along with cortizone. Still getting hi es snd need to take an allergy pill daily., apply cortizone on hives.
Headache, Fever, NauseaVomiting, gas, loss of appetite, chills, fatigue, arm soreness Narrative:  Headache, fever, nausea, gas, loss of appetite, chills, fatigue, arm soreness. taking aspirin.
Myalgia, Fever, NauseaVomiting, injection site pain Narrative:  Employee reports fever (103 F), chills, sweating, body aches, nausea, and injection site pain/discomfort. Reports taking Tylenol and ibuprofen for symptoms.
Chills; Sore arm; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced chills, pain in arm and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the chills, pain in arm and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had reaction to 2 nd shot of Shingles that night had chills, sore arm & headache.  It lasted into the following day. For the chills, the patient sat next to fireplace with a glass of wine. For sore arm and the patient just didn't sleep on that side.  Two Tylenol's for headache.
expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 30-AUG-2023, the patient received Engerix B. On 30-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient).The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter called to report that an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used. The patient´s initials were asked to reporter but information was declined. The reporter consented to follow up via email.
Left arm-swollen, pink, warm to touch, "feels like a baseball". Mother states it is itchy and painful. Domeboro-topical liquid prn.
"covid arm" - inflammation 1.5 weeks after injection. Itching, swelling, warm to touch. Lasted 3 days, applied hydrocortisone topically.
pt fainted about 5 minutes after receiving the 2 shots. She was sitting down in the waiting area and passed out for  a very short period of time (seconds) . We called 911.  Asked Pt to lie down afterwards with her legs elevated.  EMS told us via phone to place her on her left side . EMS took pt with them.
Mon. 10/18-numbness began in my finger tips. Thurs. 10/21-numbness was now above wrists, so I went to my primary care-Dr. He drew labs and all came back normal: -ANA comprehensive panel: Anti-DNA, RNP antibodies, Smith Antibodies, Antiscleroderma, Sjogren's, Antichromatin Antibodies, Anti-Jo-1, Anti-Centromere B Antibodies, iron, B12, Thyroid studies, Sed Rate, Rheumatoid Factor, CBC W/diff. Wed. 10/27-numbness in arms and legs, with shooting, nauseating, toe curling pains in shoulders, and up into hips, went back to Dr., got lab results and my B12 was not low, but (389 with normal range 223-995) he gave me a B12 shot and told me I needed to see a neurologist. His office called late that afternoon and said my apt. was in January. By that evening, the numbness was across my chest, in my back and abdomen. We decided to go on to ER. They immediately did an MRI w/ and w/o contrast and started IV steroids and gave me Lortab. I was admitted. Thurs. 10/28-Neurologist came in and said my MRI was normal and he wanted me to have a NCT/EMG done, but I could go home and come back for that. Sat. 10/30-pain began shooting up into the left side of my head around my eye over night and worsened after getting up. My spine and neck felt so tight, I could not get comfortable. We went back to ER and they did a CT scan and gave me IV Dilauded/Zofran. CT was normal, sent me home with Lortab. They said my potassium was low and they gave me 2 pills. Mon. 11/1-Worst Day- Had to take 10mg Lortab every 4 hours just to stay semi-comfortable. Pain in head was worse, numbenss and tingling all over and shooting pains were bad. Tues. 11/2-Went for EMG/NCT. They were normal. Dr. said he did not know what was wrong and wanted me to see a Rheumatologist. Pain in head was better. Tues. 11/16-Saw Rheumatologist. He said that I checked out perfectly fine as far as he was concerned and his opinion was that my body had had a reaction to something. He mentioned that it could be from the flu vaccine, but it is impossible to tell for sure. It is the only thing I did outside of my normal routine around the time the symptoms started. Pain management is all that can be done now.  PRESENT-11/19/10-I have continued to gradually improve. Most days I still have to take Lortab at least once, but that is still much better than I was the first 2 weeks.
Patient was fine in room after vaccines were given He went to bathroom then went to waiting room. He was sitting on table then fell to floor; he hit his face on the rug and had an abrasion on R cheek. He was walked back to exam room. He vomited into trash barrel and immediately said he was feeling better. He laid down on exam table for 15 minutes. His color improved after taking water & crackers. He was discharged to go home.
lost of smell/can't say it's lost, I am still smelling, but it is not as strong; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported), via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had first dose of Pfizer-BioNTech COVID-19 Vaccine last day (27Mar2021), second dose scheduled for 17Apr2021, and she stated she was experiencing loss of smell, could not say its lost, she was still smelling, but it was not as strong. She had been quarantining for at least 20 days. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, BRONCHITIS (Bronchitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medication included antibiotic and steroids.
I can still feel a sore spot where the injection site was and my arm injection site started aching within the week.  I called Health Department that week and ask if that was normal.  I ask for shot pamphlet to read about pain after the shot and my arm  Is NOT the same.  I read online and I seem to have symptoms of SIRVA.  Fast toward till now and I?m going to a chiropractor who is sending me for an MRI
Pt admitted for surgery and tested positive for covid infection. No information on vaccine including manufacturer, date, location, etc.
Evening of the second shot, swelling to the lips and face and injection site.  No difficulty with breathing
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hyperventilation-Severe, Systemic: Vomiting-Mild, Additional Details: Patient received COVID vaccine.  Suspected anaphylaxis and throat swelling and shortness of breath occurred within 1 minute of injection.  911 was called promptly and epipen was administered.  first responder on 911 called recommended 324mg aspirin, which was also given.  EMTs took patient to hospital and vitals were taken.
patients communicated he is having stiffness on his neck and feeling generally bad. But symptoms started in august he claims that it has to do with the vaccine
Moderna 2/1/21, 2/25/21, 12/30/21. Positive on 8/1/22
Information has been received from a nurse practitioner concerning a 7-month-old male who on 01-MAY-2007 was vaccinated PO with a third 2mL dose of Rotateq. Concomitant therapy that day included a dose of PedvaxHIB, a dose of Pediarix, and a dose of Prevnar. On 28-MAY-2007 the patient developed intussusception and was hospitalized. It was noted that the patient underwent surgery. The reporter indicated that the patient is doing well, and has recovered. No additional information is available. Intussusception was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.
Around 0300, I was awakened abruptly by a sharp pain in my Right TMJ region. This happened 2 times. It felt worse than a dentist shot.  Around 0430, I went to the restroom and notice my right nasolabial fold is less prominent than my left nasolabial fold.
Nausea and lightheadedness on day of the vaccine.   By that night, fever, chills, headache, shaking, body aches and local pain at site of injection.   Nausea gone the next morning.   Fever lasted 36 hrs.   Body aches and headache lasted 48 hrs.   Fatigue lasted 3 days.   Side effects resolved by 4 days.
welts (size of cough cup - 4inches, and two smaller welts above about the size of a dime), itching, waves of weakness then pain.  Will be taking benadryl.
Patient broke out in hives on both feet about seven days following vaccine administration. Hives lasted 5-6 weeks, were very swollen and uncomfortable.
Administered Pfizer 2nd dose to patient at 1542 hrs.  After injection was complete, patient's body went limp, and began to exhibit a tonic/clonic seizure for approx. 5 seconds at 1545 hrs.  Patient became limp and I assisted her to the ground safely.  Patient came to, no postictal state, A/Ox3, and does not recall seizing.  EMS activated approx. 1553 hrs, and Engine 16 arrived on scene approx. 1556 hrs.  VS (sitting) @ 1559 hrs: 90/53, 60 bpm, 100% room air.  VS (standing) @ 1605 hrs: 101/60, 64 bpm, 100% room air.  Patient went into M-14 ambulance for additional monitoring.  No medications given.  Patient AMA with M-14 and left with husband with husband driving at approx. 1630 hrs.
My left arm swelled, was red and very sore for 4 days. Upon the redness and swelling subsiding within the 4 days, my left arm began having a sensation of spasms (or twitch) which began in the left arm and then extended to my entire body, which never happened before this flu shot. It is currently still happening over a month later, as of today's date of Oct 25,2017. I reported the reaction to my doctors office via the web portal, they requested I come in for a follow up office visit of which I did on Oct 18, 2017. I reported that the spasms have possibly slowed down but are not completely gone.
Took Paxlovid for 5 days. 4 days after treatment negative covid test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Took Paxlovid for 5 days. 4 days after treatment negative covid test) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Unspecified drug).    In March 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Took Paxlovid for 5 days. 4 days after treatment negative covid test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 23-May-2022, COVID-19 (Took Paxlovid for 5 days. 4 days after treatment negative covid test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative Negative. On 27-May-2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: positive Positive.         Patient Race Native Hawaiian Other Pacific Islander. Patient date of birth was reported.  The patient did not take any other medications or products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.  Company comment: This spontaneous case concerns a 55-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred approximately 2 months after the third dose of mRNA-1273 vaccine. The patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment for 5 days however; 4 days after treatment negative covid test and again positive on 5th day. SARS-CoV-2 test was positive as on 27-May-2022.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 55-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred approximately 2 months after the third dose of mRNA-1273 vaccine. The patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment for 5 days however; 4 days after treatment negative covid test and again positive on 5th day. SARS-CoV-2 test was positive as on 27-May-2022.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Very small rash around vaccine site. Small reaction on right leg. Rash gone by the evening of 11/23/10, reported by family member.
Started from my hand on the top of my hand gets really red,; the heels of my feet has like a red rash and it just feels raw; COVID toes; really red, so raw; have a couple of toes and each foot that are red around the cuticle and then the heels of my feet has like a red rash and it just feels raw; COVID toes; Felt like a raw burning in my hand; This is a spontaneous report from a contactable consumer. A 62 year patient of unspecified gender had received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-EW0179 ) via an unspecified route of administration on 10May2021 (Age at vaccination 62-years-old) into arm left as DOSE  2 SINGLE for COVID-19 immunization.The patient medical history and concomitant were not reported. The patient previously took BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on unspecified date as DOSE1,SINGLE for COVID-19 immunization. On 19May2021 the patient had experienced rash and felt like a raw burning in my hand and now noticing that patient have like red round the couple of toes and a rash on top of foot and heels of feet. They feel raw and looked it up it said COVID toes. Therapeutic measures were taken for the AE and treatment was included with putting Aloe Vera gel on it so to sooth like a little bit. It's not itchy but it is some sort of a rash. Really don't know what. The clinical outcome of the events were unknown.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Information has been received from a registered nurse concerning a female (age not reported) with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 31-OCT-2006, the patient was vaccinated intramuscularly with GARDASIL. There were no concomitant medications reported. Subsequently, the patient experienced a cut which was less than 1/4 inch when the syringe was pulled out from the patient. It was reported that the patient had received the full dose. The patient sought unspecified medical attention. The registered nurse reported that the cut was very minor. At the time of this report, the patient was recovering from the events. Additional information has been requested.
Patient presented to emergency department on 11/21/2021 due to difficulty with urination and bladder spasms. He was found to be COVID-19 positive and had a fever at presentation. He was admitted for further management of his multiple acute conditions. He was treated with dexamethasone, remdesivir and supplemental oxygen. His respiratory status continued to progressively worsen during admission and patient did not want to be intubed or placed on ventilator for worsening condition. He was placed on comfort measures on 12/1/2021 and expired on 12/2/2021.
Began with left lung aching all night.  Next Day had migraine on left side of head. Dizzy, Chills, Nausea, Feeling pulsing throughout body. Tired (no fever)  I have had a migraine for 6 days. It moved to right side of head behind eye mostly for the last 3 days. I believe migraine causing nausea, dizziness, lack of appetite and pulsing of head.  Head feels numb.  Tylenol doesn't help. If it isn't better by today I am going to call Dr. or go to ER.  I can't take another day of this.
Systemic: Fainting / Unresponsive-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient fainted from seated position. Hit left side of head from this distance. Patient regained consciousness within a few moments and legs were elevated while laying on back. Reported vision tunneling occured before fainting (once she came to). Patient was pale but regained color 15+ minutes later. Patient answered all questions 2 paramedic crews had/checked her BP/O2 sats etc. Declined hospital and signed off with father present who was called in. Father drove her home.