chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given at 1455.  Patient started experiencing anxiety once sitting down to get the vaccine.  When she sat down in the observation area after vaccine, she started have what she describes as a "flowery" taste in her mouth and tingling on the outside of both ears.   Patient stated that the tingling moved to the side of face, bilaterally (states common for her).  No c/o SOB.  These symptoms increased her anxiety.  Symptoms began approximately 2 minutes after receiving her vaccine.  Patient laid down on the floor and her blood pressure was taken every 5 minutes or so.  First BP=166/102 P 90, 166/102, 150/94 P 80, 150/96 P 68, 150/96 P 66, 160/98 P 74, 162/96 P 66, 142/100 P 64.  Patient has a history of hypertension and is currently on medication.  She stated that even on meds, her BP runs high (140/85).  Patient also stated that d/t an anxiety disorder, the final BP taken was probably not going to go down any further.  After approximately 45 minutes, patient moved to a sitting position and eventually into a chair.  Patient reported tingling and "flowery" taste in mouth was gone and patient felt fine to leave observation after approximately 90 minutes.  Patient left with her partner.  Patient stated that beside the taste in her mouth, her other symptoms were very common for her when she has anxiety events.  Patient followed up with her physician on 12/29 and states her physician agreed that this event was an "anxiety" event and not d/t vaccine.  Patient cleared to receive 2nd dose when due but will take something, prescribed her physician to help her relax.
Wrong diluent was used . did not use sodium chloride supplied with vaccine but used sodium chloride bacteriostatic.
employee had fever, backache post vaccine but then also had a episode of fibrillation occur the next day that lasted 1 1/2 hours.  Had not had episode for over 2 year when had stent placed.
Pt recv vax on 10/13/98; on 10/15/98 pt exp red/ hot/ swollen vax site
I started my period early (13 days since the start of my last period). I know it could be stress but 13 days is too short of a cycle. I'm not sure yet if it was heavy spotting for the one day or if it's going to keep going. It seemed like day one of my cycle last night but it's light again this morning. I don't normally have spotting at all.
Burst blood vessel in left eye; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 49-years-old via an unspecified route of administration, administered in arm right on 01Apr2021 15:30 (Batch/Lot Number: Fp6955) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included canagliflozin (INVOKANA), metformin and rosuvastatin; taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 (lot number: En6199) at the age of 49-years-old administered on the right arm for covid-19 immunisation. The patient experienced burst blood vessel in left eye on 12Apr2021. No treatment was received for the event. The patient was recovering from the event.
Information has been received from a physician concerning a 7 year old male who was vaccinated with the second dose of VARIVAX (Merck). One year after the second dose of VARIVAX (Merck), the patient developed full blown chicken pox, characterized by 500 lesions. The patient did received two doses of vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from the physician reported that there was no need to report the event since there was no adverse reaction. Additional information is not expected.
Minor was pregnant at the time of vaccination. Estimated delivery date is 05/21/2023.
she had a rash on her abs. At first it was not that red and it was on left side and a little on the right. Now it is red.; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiration date: Jun2021), via an unspecified route of administration in left arm at the age of 81-years, on 07Feb2021 at a single dose for doesn't want to get the virus. The patient's medical history included heart attack in Feb2018, and cholesterol. Concomitant medications included eicosapentaenoic acid ethyl ester (VASCEPA) for cholesterol, ciclosporin (RESTASIS) for eyes, losartan for heart, acetylsalicylic acid (BABY ASPIRIN), biotin, and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took an injectable cholesterol medication alirocumab (PRALUENT) at a dose of 75 mg, every 2 weeks (injecting it into the thigh) and experienced reaction. Prior Vaccinations (within 4 weeks) was reported as none. The patient reported that she noticed the rash on her abs when she woke up at 7:30 AM on 08Feb2021. At first it was not that red, and it was on left side and a little on the right. Now it is red. She is using bacitracin, neomycin, and polymyxin (NEOSPORIN). The rash burns. She thought today it was a little better. It is still bright red. She is using Neosporin twice a day. Started Neosporin today, 09Feb2021. The outcome of the event was recovering.
So sick/ I became sick sick sick; feeling cold; feeling tired; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (So sick/ I became sick sick sick), CHILLS (feeling cold), FATIGUE (feeling tired), NAUSEA (nausea) and VOMITING (vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (feeling cold), FATIGUE (feeling tired), NAUSEA (nausea) and VOMITING (vomiting). On an unknown date, the patient experienced ILLNESS (So sick/ I became sick sick sick). At the time of the report, ILLNESS (So sick/ I became sick sick sick), CHILLS (feeling cold), FATIGUE (feeling tired), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.            No concomitant medications were provided.  On follow-up, the patient reported that she was so sick. Her health care provider sent her to urgent care. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 4-AUG-202, Event has been added.  Amended dosage regimen from initial version. On 05-Aug-2021: Follow-up information received email address updated
Arthralgia Pt developed swelling of L knee on 2/22/06. Had received varnax on 1/31/06. No fever, erythema, warmth. No ///// injury.
I developed a case of shingles on the left side of my face and head. My skin doctor prescribed Valtrex to treat the condition.
Continuous facial nerve pain on one side. Including eye, cheek, side of nose and gums. Possible Trigeminal Neuralgia
Since pt had reported allergies to other medications, we asked her to stay 30 mins instead of 15 mins.  At the end of 30 mins, patient asked clinical observer if it was normal to feel tingling lips and swelling at the back of her tongue.  Clinical observer LPN, said no and took pt to triage area.  Pt continued to report tingling different places ie hands, back of her head, and legs. She also stated she felt flushed and hot.  911 was called.  I gave her 25 mg Diphenhydramine po with water. Nurse repeatedly took the pts blood presser the last one was 207/102, HR 92, O2 sats 100%.  Due to pt's high blood pressure and when asked if she had difficulty breathing she said no, I did not administer Epi pen.  PMH and vitals were handed off to ambulance personnel when they arrived.  Pt was still alert, awake, oriented, and no difficulty breathing,
This spontaneous report as received from Registered Nurse concerning a 4 month old patient (gender not specified). On 21JUL2014 the patient was administered a dose of ROTARIX at the age of 2 months. On 24SEP2014, at the age of 4 months old, the patient was vaccinated with ROTATEQ. No adverse event was reported. No additional information was provided. Additional information is expected.
Discharge Provider: MD  Primary Care Provider: MD Admission Date: 2/13/2023 Discharge Date: 02/14/2023   Admitting Diagnoses: Hypokalemia  PRESENTING PROBLEM:  Hypokalemia Hypoxia  COVID    HOSPITAL COURSE: 70-year-old lady with medical history of coronary artery disease status post CABG, chronic obstructive pulmonary disease, bipolar 1 disorder, ischemic cardiomyopathy, gastric ulcer, chronic opioid dependence, paroxysmal AFib on Xarelto presented to ER 2/13 with flu-like symptoms.  According to patient, she started experiencing generalized body weakness/body aches, dizziness, dry heaves, shortness of breath, cough occasionally productive of yellowish-green sputum about 4 days prior to presentation.  No fevers but she endorsed chills at home.  Patient endorsed poor appetite, low water intake at home.  Her symptoms worsened and she presented to ER 2/13.  On presentation vital signs stable.  Labs with sodium 132, potassium 2.5, creatinine 1.45.  Cardiac workup negative, pro BNP normal and troponin 27> 22. Patient tested positive for COVID-19.  Chest x-ray showed cardiomegaly but no acute cardiopulmonary process.  No consolidation.  Patient was given potassium supplements (30 mEq).  She had slight desaturation with ambulation (88% on room air).  Patient has home oxygen but uses it as needed.  When she started noticing difficulty breathing, she will use 2.5 L. Due to COVID infection, AKI, severe hypokalemia she was admitted for further management. Started on dexamethasone 6 mg for COVID 19 infection.  Patient was given potassium supplements, serum potassium improved.  Was given 1 L IV fluid bolus, renal functions also improved.  Serum magnesium low, replaced with IV magnesium sulfate.  Patient also found to have low phosphate (1.5), started daily phosphate tablets. 2/14:  Patient feeling significantly better.  No body aches or chills.  No nausea or vomiting.  Normal appetite.  No difficulty breathing.  No phlegm, very minimal cough.  No fevers. Supplemental oxygen weaned off.  Patient would like to go home today.  Labs showed resolution of AKI (serum creatinine 0.95), improvement in potassium (3.4).  Patient informed to get magnesium, phosphorus, BMP  checked next week. Will be discharged with dexamethasone course.
Headache, Arthralgia, Fever, NauseaVomiting, chills Narrative:
Numbness down whole left leg hip to feet; Burning down whole left leg hip to feet; Pain in left hip; Cannot stand greater than 10 minutes; Lost sense of smell; Lost sense of taste; Lower back started hurting; Immediately felt pain after "shot" in whole arm going to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Immediately felt pain after "shot" in whole arm going to shoulder), ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), BACK PAIN (Lower back started hurting) and HYPOAESTHESIA (Numbness down whole left leg hip to feet) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-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) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (Immediately felt pain after "shot" in whole arm going to shoulder). On 22-Apr-2021, the patient experienced ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste) and BACK PAIN (Lower back started hurting). On 24-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness down whole left leg hip to feet), SCIATICA (Burning down whole left leg hip to feet), PAIN (Pain in left hip) and DYSSTASIA (Cannot stand greater than 10 minutes). At the time of the report, PAIN (Immediately felt pain after "shot" in whole arm going to shoulder), ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), BACK PAIN (Lower back started hurting), HYPOAESTHESIA (Numbness down whole left leg hip to feet), SCIATICA (Burning down whole left leg hip to feet), PAIN (Pain in left hip) and DYSSTASIA (Cannot stand greater than 10 minutes) outcome was unknown.            Patient gave consent for Safety follow up,Prefers phone call. Tylenol is taken as treatment medication.   This case was linked to MOD-2021-090169 (Parent-Child Link).   See case MOD-2021-090169 for details regarding the child case.
back of my ear has rash and is very red; sometimes a little pain; rash in the back of my right ear; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in the back of my right ear), RASH ERYTHEMATOUS (back of my ear has rash and is very red) and PAIN (sometimes a little pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced RASH (rash in the back of my right ear). On an unknown date, the patient experienced RASH ERYTHEMATOUS (back of my ear has rash and is very red) and PAIN (sometimes a little pain). At the time of the report, RASH (rash in the back of my right ear) had not resolved and RASH ERYTHEMATOUS (back of my ear has rash and is very red) and PAIN (sometimes a little pain) outcome was unknown.            No concomitant medications were reported. No treatment medication were reported.
The same symptoms  as my first and second shot started within 24 to 48 hours of the vaccine.  So, it was a skin reaction where at first my skin just got red on my face, neck, ears, chest itchy swollen, it was very itchy. It progressed to the skin around my right eye was red and swollen and impairing my vision. I went to urgent care again and was given a steroid injection and I still had the Benadryl cream I was given previously from the other breakout. I do not feel as though this is resolved, I only got the vaccine because my work required it. My skin is not right, I now have very sensitive skin to everything, for example Items I have always used cause issues for my skin, I can not use the sun screen I have always used. I have to use sun screen that is completely mineral based. Other products that I have used for a while that I never had a reaction to I now  have had problems. I need to use very basic products that I put on my skin otherwise I break out and get swollen.
A nurse reported that a patient inadvertently received Acel-Immune, instead of Td and the next day following immunization, developed an injection site reaction characterized by swelling and tenderness. This is 1 of 2 patients from this facility to experience this event following receipt of Acel-Immune lot # 462-355. Additional info received from product quality 08/21/00 indicated (from reporter) that the patient is "doing fine".
Information has been received from a nurse, for the Pregnancy Registry for GARDASIL concerning a 22 year old patient who on 20-SEP-2006 was vaccinated with a first dose of GARDASIL. The patient had LMP 10-Sep-2006. She received her dose on 20-Sep-2006 and delivered a normal healthy baby boy with no congenital anomalies on 05-Jun-2007. Follow-up information was received from a registered nurse in the office concerning the 22 year old female with renal disease and history of 5 previous pregnancies, 4 live births and 1 spontaneous abortion who on 20-SEP-2006 was vaccinated with GARDASIL (lot #: 653735/0688F). On 20-NOV-2006, the patient was vaccinated with a dose of FLUVIREIN (lot # 7135). Medication used during pregnancy included prenatal vitamin, iron. On unspecified dates the patient had a 24 hour urine, sonos and non stress tests due to history of renal disease. On 05-JUN-2007 the patient delivered a normal, healthy male baby weighing 5 pounds 8 ounces, via repeat C-section at 38 weeks 1 day pregnancy done for "size less than dates" (this was the patient's 3rd c-section). Pregnancy complication was reported as intrauterine growth retardation (IUGR). It was reported that the IUGR was not the reason for the c-section, however they "may have" opted to schedule the c-section at 38 weeks and 1 day, due to the IUGR. The apgar score test was performed with result 9/9. According to the reporter the patient was not hospitalized longer than the "normal" length of stay for a c-section. The patient was diagnosed with post-partum anemia (which did not prolong hospitalization and was not considered life threatening) and has since resolved (date not provided). It was reported they "may have" opted to schedule the c-section at 38 weeks and 1 day, due to the IUGR. Therefore upon internal review, IUGR was considered to be an other important medical event. The patient became pregnant after receiving the second dose of GARDASIL (WAES# 0905USA01417). No further information is available.
13 year old was administered adult dose of Engerix B vaccine; 13 year old was administered adult dose of Engerix B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HBV (Engerix B adult) (batch number 475S4, expiry date 04-APR-2025) for prophylaxis.   On 22-JUN-2023, the patient received the 3rd dose of Engerix B adult. On 22-JUN-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 13 year old was administered adult dose of Engerix B vaccine) and inappropriate age at vaccine administration (Verbatim: 13 year old was administered adult dose of Engerix B vaccine). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 03-JUL-2023 The practice manager reported that 13 year old male patient was administered an adult dose of Engerix B vaccine which led to inappropriate age at vaccine administration and overdose. This was the patient's third dose in the series. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The reporter gave permission for follow up
14 hrs after-102.9  temp, sever chills and hot sweatshirt; 14-32 hrs after- between 101.4 and 102.9 temp, severe chills, hot sweats, migraine, body aches; 33-49hrs after- 103.9 temp several times with a low of 102.4.  Severe chills, severe hot sweats,  migraine, dizziness, heaviness in chest swollen lymph nodes at collar, abdominal pains 50-68 hrs after- 101 temp decreasing to 100.4.  Migraine, abdominal pain,  dizziness, lymph nodes at collar and armpits swollen badly, arm at shot site extremely red, hot, swollen, hard and itchy; 69-82 hrs after- temp between 99.7 and 100.1.Migraine, nausea, abdominal pain,  dizziness, lymph nodes at collar and armpits swollen badly, arm at shot site extremely red, hot, swollen, hard and itchy.
about a 3 year-old female patient who received Kinrix; about a 3 year-old female patient who received Kinrix/ extra dose of IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included IPV (last IPV dose was administered in February 2021).   On 07-SEP-2023, the patient received Kinrix. On 07-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: about a 3 year-old female patient who received Kinrix) and extra dose administered (Verbatim: about a 3 year-old female patient who received Kinrix/ extra dose of IPV).The outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter called to ask for information about a 3 year-old female patient who received Kinrix, which led to inappropriate age at vaccine administration. The reporter mentioned that Dtap dose was ok, however, the patient received an extra dose of IPV, which led to extra dose administered. The reporter asked how to proceed with this patient. The reporter consented to follow up.
body aches; weakness; chills; headaches; fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5). At the time of the report, PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache and fever are consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache and fever are consistent with the known safety profile of mRNA-1273.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # N002202, expiration date of 04-NOV-2019 or N006321, expiration date of 08-NOV-2019 or N009802, expiration date of 19-DEC-2019; strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
pt recv vax 21SEP95 & 1APR97 pt devel a possible case of varicella;
09/12/22 admitted to inpatient rehabilitation unit for "aphasia" PMHx of "multiple medical problems including vasculopathy, prior CVA in 2013"
Itching in my left arm- 1st shot lasted abut 2 days after immediate injection - did not think much of it. Itching in my left arm after 2nd shot- got more aggressive, some swelling, itching traveled to my entire forearm, very apparent on 8th - 10th day.  Arm felt warm, no fever though.  Took Allegra on 4/9/21,  itching subsided somewhat, not as severe.  I will take Allegra tomorrow, it is 24 hr tablet.