chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Taste metallic; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste metallic) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DYSGEUSIA (Taste metallic). At the time of the report, DYSGEUSIA (Taste metallic) outcome was unknown.            No concomitant medications were reported. Patient had metallic taste in mouth with Humira. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment information was reported.
Received flu shot at 0910. At 0915 she c/o tingling of arms, chest tightness- epinephrine 0.5ml given, 911 activated, became SOB & very pale, after 5 minutes c/o difficulty swallowing- epinephrine again 0.3ml at 0926. EMS arrived & transported to the hospital-0930.
Pt had high dose flu vaccine at health department and subsequently experienced shaking, chills, malaise, tachycardia with HR increased to 130s - taken to local ER where he was evaluated and released as symptoms began to resolve
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old child patient of unknown gender. On 24-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. Thi sis one of several reports received from the same reporter. Additional information is not expected.
leg had a deep infection in it; I broke out in the really bad all over my body rash. I mean it was on my legs, my chest my, stomach my face and all over me; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old (also the age at time of vaccination) male patient received bnt162b2 (BNT162B2), via an unspecified route of administration administered in Arm Left on 25Mar2021 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for COVID-19 immunization.  The patient had blood pressure abnormal (reported as blood pressure) and he took medication to keep it under control. Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) taken for an unspecified indication and therapy dates and unspecified medication for blood pressure. Three to four days after he received the first dose (Mar2021), he broke out that was really bad all over his body rash. It was on his legs, chest, stomach, face and all over him.  He did not got his second vaccination as nobody can really tell him what caused this. He was afraid as he was not sure what's crazy thing will go again on him. It was also reported that he had to go to the hospital for a night and it was noted that he had a deep infection in his leg. He was on antibiotics and was discharged instantly. He was also on different kind of creams as he went to the dermatologist. Outcome of deep infection in his leg while recovering from the remaining event.   Follow-up attempts are completed. No further information is expected.
The pharmacist drew up the vaccine for Pediatric Moderna instead of the Moderna Bivalent dosing.
Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 59-year-old, White, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history was not reported. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, after vaccine administration, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 59 year old subject with unknown medical history, who experienced a serious unexpected event of Anaphylactoid reaction. The event occurred after first dose of the study medication administration.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Left arm swollen, hot to touch, tender, painful with several blister like sores around site of injection with fever 99.7.  Mother alarmed at measureable edema 13x9cm.
after I gave him the vacc  (5 mins later) he said he is not feeling well and light headed and can not breath . I gave him Epinephrine 0.3 mg in the  thigh and called 911. he feel better and they take him to pekin hospital.
Medical center called this nurse and stated child presented there with rash from head to foot.  Blanching and raised onset was about 3 days ago. Child received 5 immunizations on 01/28/04 at this clinic (see item 13) with no immediate adverse reaction advised parent of potential reaction to MMR.  Nurse follow up on 08/19/04 states: "Viral exanthum."
Very sore in arm where vaccine given, Muscle aches and pains, tired, diarrhea, chills, no appetite, headache approximately 2 - 3 days
Information has been received from a registered nurse concerning a female healthcare worker from a physician's office who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (therapy dose, route and site unknown). About 3 days later her body was covered with chickenpox lesions. The patient was afebrile and had not experienced body aches. At the time of this report, the patient had not recovered. On 20-JAN-2010 a follow up call was placed. The reporting nurse verified that they received the VZVIP packet and explained that the patient was in the office on 19-JAN-2010 with a fine rash. The patient did not have any vesicles, lesions, scabs or anything that they could un-roof to send a specimen. Since the rash was not vesicular the physician did not think that it was related to the vaccine. Additional information has been requested.
This initial spontaneous report was received from a physician referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 15-DEC-2015, the patient was inadvertently administered an expired dose of VAQTA injection (lot # J005081 with expiration date 22-OCT-2015; dose and route were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Massive sinus issues; the muscle in arm of injection hurts; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Massive sinus issues) and MYALGIA (the muscle in arm of injection hurts) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (the muscle in arm of injection hurts). On an unknown date, the patient experienced SINUSITIS (Massive sinus issues). At the time of the report, SINUSITIS (Massive sinus issues) and MYALGIA (the muscle in arm of injection hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Since the weather changed, she has been having a massive sinus issues and allergies. She has sinus infection but she does not think any of her sinus issue is related to the vaccine. She is taking over the counter sinus medication for her sinus issues.
Was not responding/wouldn't open her eyes; Very sick; Her pupils were dilated; Hypoxia; Life support; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes), ILLNESS (Very sick), MYDRIASIS (Her pupils were dilated), HYPOXIA (Hypoxia) and LIFE SUPPORT (Life support) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes) (seriousness criteria hospitalization and medically significant), ILLNESS (Very sick) (seriousness criterion hospitalization), MYDRIASIS (Her pupils were dilated) (seriousness criterion hospitalization), HYPOXIA (Hypoxia) (seriousness criterion hospitalization) and LIFE SUPPORT (Life support) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 09-Apr-2021 to 11-Apr-2021 due to LIFE SUPPORT, then on 09-Apr-2021 due to HYPOXIA, ILLNESS, LOSS OF CONSCIOUSNESS and MYDRIASIS. On 11-Apr-2021, LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes), ILLNESS (Very sick), MYDRIASIS (Her pupils were dilated), HYPOXIA (Hypoxia) and LIFE SUPPORT (Life support) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Oxygen saturation: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on life support.  Very little regarding these events has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.; Sender's Comments: Very little regarding these events has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.
Pt called complaining of itchy hands and puffy eyes. No shortness of breath or temp.
Showing a couple of like mosquito bite on his neck and then on his shoulder it was like raised area; It was on the neck and the shoulder area and little bit on the back area like at top of your back; He was showing some little like I would say almost like when you get Poison ivy or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-years-old male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: E19267) at the age of 67 years as unknown, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: ATORVASTATIN; METFORMIN taken for diabetes mellitus. The following information was reported: BITE (non-serious), outcome "unknown", described as "Showing a couple of like mosquito bite on his neck and then on his shoulder it was like raised area; It was on the neck and the shoulder area and little bit on the back area like at top of your back"; DERMATITIS CONTACT (non-serious), outcome "unknown", described as "He was showing some little like I would say almost like when you get Poison ivy or something".  Additional Information: When probed for the concern, the reporter stated, she was actually calling for her husband (Consumer/Patient), he took the PFIZER COVID-19 vaccine on Monday (01Mar2021) but it looked like he got a little rash, like a mosquito and stuff kind of on his neck and may be on top of his shoulder, so she was trying to see if anything was alarmed about. When probed for weight, she stated, that about 250 pounds." (Further not clarified. Hence, not captured in the tab). About Lot Number: She stated E19267 (not clarified further, hence not captured in tab). About start date of events: She stated, she would say Tuesday (not clarified further). About outcome of events: She stated that it was still persisting (events not paraphrased and clarified further, hence persisting not checked in seriousness criteria). When probed for vaccine expiration date, reporter stated, no expiration date. When probed for any treatment for the problem, she stated that no, not really, he kind of rubbed like alcohol along it but no he did not take any medicine because he did not really knew what he was taking it for.  No follow-up attempts are possible. No further information is expected.
Within minutes - neck pain/injection site pain 1 hr dyspnea/chest tightness. Sent to ED for monitoring
This  spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient received improperly stored VARIVAX dose number 1 on 16-MAY-2012 and dose number 2 on 10-JUL-2012, both from lot # 671861/1907AA with expiry date of 05-DEC-2013 (dose unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Severe stiff neck.  Couldn't look to either side or up.  Couldn't sleep for 2 nights due to pain.  Took extra strength Tylenol .  Saw chiropractor to help with stiff neck on Tues 11/9.  Stiff neck gradually improved daily until Sunday 11/14 - almost back to normal.
Information has been received from a medical assistant concerning an unknown number of patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies reported. On 21-FEB-2017, the patients were vaccinated with an improperly stored ROTATEQ orally, lot number M022371 with expiration date of 18-FEB-2018;  lot number: M006111 with expiration date of 18-NOV-2017; lot number: M004544 with expiration date of 18-OCT-2017 (strength, dosage schedule and anatomical location were not provided) for prophylaxis, and the administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 5 hours and 43 minutes (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010922:
About a day after being vaccinated, he devoloped SOB.  He continued to worsen and was seen at urgent care on 10/10/22. He was provided medication (unknown) but continued to worsen so saw his PCP on 10/20. Dr. gave Rx Methylprednisilone and Trelegy Ellipta on 10/20. He continued to worsen and went to ER on 10/23/22 where he was diagnosed with ILD. He is currently in ICU and not expected to survive. It had reportedly been mentioned to the family that vaccination could have precipitated this event. He also received influenza vaccine on 9/28 at same pharmacy but family did not have vaccine info
Arm pain; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned that he received the full course of Shingrix and had no issue other than the arm pain. No further information was captured regarding caller, contact ok with follow up regarding brother. This case linked with US2019143875, reported by same reporter.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX HB lot # N002914 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Sender's Comments: US-009507513-1709USA003145: US-009507513-1709USA003455: US-009507513-1709USA003454.
This is a spontaneous report from contactable healthcare professional received via Pfizer Sales Representative. A 16-year-old female patient received TRUMENBA on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. In the night of vaccination the patient experienced pain, nausea, vomiting, headache, fever, lasted 2 days. The final outcome of the events was unknown. Information on the batch number has been requested.
History of anaphylaxis to IV Taxol in her past. She did well after her first dose of the Covid vaccine, Within 10 minutes of receiving her second dose of Covid vaccine she c/o throat tightness, lightheadedness, flushed/warm sensation in her chest, C/O of SOB.   She was injected with Epi, given Benadryl 25mg po, Zyrtec 10mg po.   A CODE Blue was called and she was transported to the ED where she received a second Epi injection.   She was monitored in the ED overnight, was given Benadryl every 6 hours, treated with prednisone and pepcid and Tylenol for headache.  Was discharged from the ED the next morning and given Rx for prednisone, benadryl, pepcid for 5 days and and Epi pen.
Extreme pain in shoulder going down into right hand. Tingly feeling going down arm into hand. Can not move shoulder away from body without sharp pain. Right hand is also weaker.
little bit of soreness in her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Lot number: 331708A) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "for bone density" (ongoing), notes: Additional Information for Other medicines Fosomax: She has been taking this 3 or 4 years.; "Thyroid", start date: 1980 (ongoing), notes: Additional Information for Other medicines Levothyroxine: She has been taking this since the 1980s. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 1980; FOSAMAX taken for bone density abnormal; FISH OIL; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6199), administration date: 02Mar2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number: EK8732 or ER8732), administration date: 20Mar2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "little bit of soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little bit of soreness in her arm".  Additional information: The patient also received Multivitamin. The patient did not receive any other vaccines administered on same date of the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the first administration date of the suspect vaccine and no adverse events following them. The patient did not have any family medical history relevant to AE(s). Relevant laboratory history was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200974944 same reporter/patient/product, different dose/AE;US-PFIZER INC-202200975335 same reporter/patient/product, different dose/AE;
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247,) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Patient colleague got sx 26Dec after exposure 25Dec and tested + covid PCR 28Dec2021". The event "patient colleague got sx 26dec after exposure 25dec and tested + covid pcr 28dec2021" and "patient colleague got sx 26dec after exposure 25dec and tested + covid pcr 28dec2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (28Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Since the vaccination, the patient has been tested for COVID-19. Case reported as non-serious. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events Vaccination failure, COVID -19 and the suspect drug BNT162B2 cannot be excluded.
Deterioration of heart health after taking first two doses of COVID19 vaccine, and increased heart issues and death at home on 4-DEC-2021 about 63 days after COVID19 booster.
Since the day I got the vaccine I have experienced sensitivity to bright light particularly at night. I have never had issues with this before but now when I'm driving it feels like every oncoming car has their high beams on (even when I can tell they don't) and working on the computer at night now becomes painful as my eyes are too sensitive to bright light to work at night under artificial light.
My throat got tight, hard to swallow, some shortness of breath, shaky and shivering, my eyes got puffy. I took Advil and went to bed.