chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives between his neck and waist, mostly around his upper chest area; Rash; Red; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives between his neck and waist, mostly around his upper chest area), RASH (Rash) and ERYTHEMA (Red) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced URTICARIA (Hives between his neck and waist, mostly around his upper chest area), RASH (Rash) and ERYTHEMA (Red). In January 2021, URTICARIA (Hives between his neck and waist, mostly around his upper chest area), RASH (Rash) and ERYTHEMA (Red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
From telephone contact received at manufacturer on 08/22/2002, it was reported by the pt, a 51-year-old female, that she had been vaccinated with Imovax Rabies. After the last dose, the pt experienced body aches, muscle aches and muscle spasms.
Severe chills with fever are the main complaint that made her decide to visit Emergency Room. She also said her deltoid and shoulder are very sore.
No adverse event; Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry).    Concomitant drugs were not reported.  It was reported that 7 monovalent doses were administered after expiry. The vaccine had been frozen with no known temperature excursion before being thawed for administration. The vial was initially stored in refrigerator on 27-Feb-2023. It was reported that the vial did not underwent any temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713030, US-MODERNATX, INC.-MOD-2023-713149, US-MODERNATX, INC.-MOD-2023-713031, US-MODERNATX, INC.-MOD-2023-713031, US-MODERNATX, INC.-MOD-2023-713012, US-MODERNATX, INC.-MOD-2023-712974, US-MODERNATX, INC.-MOD-2023-710742 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713030:Same reporter US-MODERNATX, INC.-MOD-2023-713149:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter US-MODERNATX, INC.-MOD-2023-713012:Same reporter US-MODERNATX, INC.-MOD-2023-712974:Same reporter US-MODERNATX, INC.-MOD-2023-710742:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter
Acute on chronic respiratory failure with hypoxia COVID-19 pneumonia only Sepsis present on admission due to above Patient from SNF.  Family stated patient was positive on 1/4, however unable to verify.  Swabbed on 1/8 and was positive for COVID-19.  Patient is febrile, tachycardic, has leukocytosis. Discussed goals of care at length with family yesterday and will continue to keep the patient comfortable.  Patient will be discharged home with hospice likely tomorrow.   Continue comfort measures for now Tylenol for fever Initially required 4 L O2 on admission.  Titrate supplemental O2 for comfort 4L.  Comfort measures in place including muscle relaxants, anxiety medication, pain medication.   Elevated BNP, chronic BNP 2797, previously 28550   Hyponatremia, mild Due to dehydration Refrain from IVF resuscitation due to DNR cc   Anemia, stable Hb 10.5, baseline Hb 9.1-9.9   BPH Continue flomax and proscar   GERD Continue protonix   Cachexia POA   Debility Dementia Frequent falls Pressure sores buttock stage I POA Sacral pressure ulcer stage I POA Follow-up with hospice care.
t105 for 3 days following vax; inconsolable crying for several hrs evening of immunization;
Abdominal cramping; Nausea; Vomiting; Generalized rash; Dizziness; Headache; This is a spontaneous report from a non-contactable nurse, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Sep2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included trigeminal neuralgia and ulcerative colitis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included pregabalin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Sep2021 at 16:30, the patient experienced abdominal cramping, nausea, vomiting, generalized rash, dizziness, headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events abdominal cramping, nausea, vomiting, generalized rash, dizziness, headache was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
12/20 Chills, Fatigue, myalgias, and nausea. Tx: ZOFRAN.
patient received the 2nd dose of Shingrix 30 days after receiving the 1st one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received the 2nd dose of Shingrix 30 days after receiving the 1st one). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date-31-OCT-2023 The pharmacist reported that the patient received the 2nd dose of Shingrix 30 days after receiving the 1st dose, which led to shortening of vaccine schedule. The pharmacist consented to follow up.
The patient developed numbness in her left leg then shortly later numbness in her right arm affecting her balance and ability to walk accompanied by generalized weakness.
Patient informed staff he had itching after receiving each COVID-19 vaccine in his primary Moderna series. Patient received Moderna booster at 15:08, and complained of mild itching in both arms at 15:25. Vitals taken at 13:28, and he was examined for hives. No hives present on body. Vital signs at 13:28: BP 140/70, HR 70 and SpO2 99%. At 15:30, Benadryl 25mg administered PO. No shortness of breath, wheezing or trouble breathing evident.  At 15:40, vital signs repeated BP 138/85, R18, SpO2 99% and HR 65. Patient stated he felt better. Very mild itching present and no hives. Patient released at 15:43.
Patient developed hives overnight. Initially on neck and back but spread during the course of the day. Injection site swollen. By 7PM, patient called after hours, complaining of difficulty breathing, abdominal pain and feeling weak. Referred to emergency room at Hospital for treatment of severe allergic reaction/ possible anaphylaxis.
On an unspecified date, the child received injections of Infanrix, Prevnar and IPOL. It was not known if the child had received previous injections of these vaccines. An unspecified time post-immunization, the child experienced a seizure. No further information was provided.
Headache, head pain, had to have a different rabies vaccine.  Pt had the final rabies series at 1500 on 08/30/2002. Following each rabies vaccine she had a headache x 3 days in the back of her head. The rabies vaccine she had before that was 08/16/2002 that pain in the head lasted 5 days. Rabarvert rabies vaccine given left arm. lot # 305011 exp 07/05
Muscle weakness/deterioration over entire body with eventual paralysis, ventilator and trach dependent due to weakness and respiratory arrest and assisted recovery pending 10/23/00. Dx: polymyositis. On 11/20/00, update, 6 months follow-up, recovering, off trach and walking. Diagnosis includes rhabdomyolitis, dehydration and increased liver enzymes.
My arm was sore for several days /  I had body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My arm was sore for several days / I had body aches) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (My arm was sore for several days / I had body aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (My arm was sore for several days / I had body aches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter   This case was linked to MOD-2021-344168 (Patient Link).
Patient received Pfizer first dose on 2/23/21 and Pfizer second dose on 4/20/21.  Client received Moderna for third dose on 9/15/21.  Monitored for 15 minutes and educated patient on side effects after receiving the vaccines.
Headache, fever, aches, chills, dizziness, started about 12 hours after vaccination and began to subside after 24 hours after vaccine.
the right palm of her hand became red and puffed/ it was red and a little bit it looks raised, not super puffy but a little bit fat; right palm of her hand became red and puffed/ it was red and a little bit it looks raised, not super puffy but a little bit fat; underneath her wrists, she said she noticed red veins; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9267; Expiry Date: Unknown), via an unspecified route of administration on 19Feb2021 (at the age of 43-years-old) as dose 1, single for covid-19 immunisation. No relevant medical history and concomitant medications were reported. The patient was calling about the Pfizer-BioNTech COVID-19 Vaccine and she said that she has a little bit of a reaction after receiving the first dose of the vaccine. The patient clarified that within the first few minutes after she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 19Feb2021, the right palm of her hand became red and puffed. Then underneath her wrists, she said she noticed red veins. She said the reactions went away after a little while, but she wants to know if these reactions have been reported before and if it would still be safe for her to receive the 2nd dose of the vaccine. The patient further clarified that the palm was red and a little bit it looks raised, not super puffy but a little bit fat after getting the vaccine. The patient was not received treatment for reactions as the reactions went away pretty quickly. She would say it went away like a couple of minutes might be. The patient stated, she know there was system to report the reactions but het point was to find out whether the reactions that she had was something that has been experienced by others and whether she should continue to get the second vaccine or not. The patient further added, "she want to know to someone who can talk to who has knowledge as to what the reaction are to the Pfizer vaccine and what was safe and what's the reaction that should not take to the second vaccine and what was the reaction was fine to take the second vaccine. The outcome of the events was recovered in Feb2021.  No follow-up attempts are possible. No further information is expected.
I ran a fever the night I got the third vaccine. It subsided by the next day. I also experienced muscle aches and weakness, and my period started the day I received the shot. It came a week early, which is unusual, as I have a regular cycle. I also haven't had an appetite since I received the shot.
dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.            No concomitant medications were reported. It was repoetd that patient had a similar experience, but caller's dizziness was for a minute. No treatment medications were reported  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..
Narrative: Patient received first dose of COVID-19 vaccine (Pfizer) on 8/11/21 around 09:00. Within 30 minute she c/o tingling sensation in mouth, metallic taste, and dizziness after receiving her first dose. She was seen in the ED about 1 hour after vaccine. Son has hx of peanut allergy, no allergies for patient. Given meclizine for vertigo sx and discharged from ED to home.
TC from the mother. She reports that Patient had her vaccines at 1315 on 8-20-19.  At 1445 8-20-19, she was complaining of a severe headache and achenes in her legs and knees. She was crying. The mother gave  her 3 Tylenol and water and encouraged her to sleep. The symptoms were relieved and the client was able to play volleyball in the evening  of 8-20-19. The next day she felt fine. Today 8-22-19, she had a mild headache the mother contributed to not eating.  The mother was informed that the episode would be reported to VAERS.
I woke up shaking at 2am terrible chills, vomiting, no fever and severe pain in all of my joints making me unable to function. Extremely weak and lay in bed for the most part of the next day. Everything hurt it was almost as if I could feel the vaccine attacking my joints . Toes hands back knees were the worst and a headache. I took Tylenol but it didn?t really help much. Feeling much better this morning 3/6/21
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunisation.     No Medical History information was reported.  On 11-Jan-2021 at 3:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 57.54.  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 02 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
got very swollen for a few days; This is a spontaneous report from a contactable Pharmacist via  sales representative. A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. After use of the product, the patient got very swollen for a few days on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
soreness at the injection site (right arm); aching underneath the right arm, and near the outpart of the right breast; aching underneath the right arm, and near the outpart of the right breast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 14:15 (Lot number: FF8841) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "elevated cholesterol" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 05Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 15Jan2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Oct2021 22:00, outcome "not recovered", described as "soreness at the injection site (right arm)"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset 12Oct2021 22:00, outcome "not recovered" and all described as "aching underneath the right arm, and near the outpart of the right breast". Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, breast pain.  Additional Information: The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
@ 1PM pt felt warm-mom went to store for APAP;while there pt had brief episode of eye rolling, drooling & shaking of extremities;went to ER t104-exam done;APAP suppository given;p/exam pt t98.3 (ear) active, alert;
Influenza, PO Typhoid, Tdap given 5/2/06. She developed weakness and shortness of breath that night which continued until 5/3/06. Also mild tachycardia.
Patient stated that 4 or 5 hours after receiving the vaccine she started feeling itchiness in her body. She has spots on her body that look like mosquito bites.  She is still having this reaction.
Injection site pain; Swelling at the injection site; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.