chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient confirmed she is not immunocompromised; 0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient confirmed she is not immunocompromised) and ACCIDENTAL OVERDOSE (0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02IF21A, 01FB21A and 030I21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 23-Oct-2021, the patient experienced OFF LABEL USE (Patient confirmed she is not immunocompromised) and ACCIDENTAL OVERDOSE (0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's). On 23-Oct-2021, OFF LABEL USE (Patient confirmed she is not immunocompromised) and ACCIDENTAL OVERDOSE (0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's) had resolved.            Concomitant medications were not provided.  Patient called to report that she was given 0.5ml for her booster dose instead of only 0.25ml. Patient was aware of the difference between the third dose and the booster dose.   Treatment information was not provided.   This case was linked to MOD-2021-361840 (Patient Link).
This is an instance of breakthrough disease after which death occurred.   The individual was vaccinated on 01/16/2021 and 02/13/2021. Lot numbers, route, and site are not available to me.   The invidudual became symptomatic for COVID-19 disease on 08/21/2021 and tested positive for COVID-19 disease on 08/24/2021. They visited an emergency department on 08/24/2021  (primary concern was extremely high blood sugar)  and was admitted to hospital on 08/24/2021. They remained hospitalized until their death on 08/30/2021.
This spontaneous report as received from a pharmacist refers to an approximately 71 year old male patient. Concurrent conditions, medical history and concomitant medications were not reported. On 26-MAR-2015, the patient was vaccinated with expired dose of ZOSTAVAX, 19,400 plaque-forming units (PFU) vial, lot # J014812, expiry date 20-FEB-2015, (dose, frequency, route of administration and indication were not provided). On 26-MAR-2015, immediately following the injection, patient experienced itching at injection site. No treatment was given. Patient sought medical attention by informing pharmacist. On an unknown date in 2015, the outcome of itching at injection site was resolved. The outcome of expired product administered was unknown. Causality was not provided. No product quality complaint (PQC) was involved. No additional information was reported. This is one of the two reports that received from the same reporter (linked with MARRS# 1504USA000966). Additional information has been requested.
Patient admitted to Medical Center on 02/01/2022 for a recently diagnosed Covid infection and hypoxia.  Chest Xray impression:  ill defined basilar infiltrates, PNA, and/or edema.  Patient was given Remdesivir and Dexamethasone.  He had progressive respiratory failure requiring high flow 100% vapotherm.  Patient and family decided DNR was best.  Patient expired on 02/14/2022.
Heartburn; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included LEVOTHYROXINE, BUPROPION HCL and LIOTHYRONINE SODIUM (LIOTHYRONINE [LIOTHYRONINE SODIUM]) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPEPSIA (Heartburn). The patient was treated with ESOMEPRAZOLE MAGNESIUM at a dose of 40 milligram once a day; PANTOPRAZOLE at a dose of 40 milligram once a day and OMEPRAZOLE at a dose of 20 milligram twice a day. At the time of the report, DYSPEPSIA (Heartburn) outcome was unknown.            Patient suffered with an events that includes an upper GI and after 2 nd shot had heartburn but cannot find reason. Safety to follow-up with patient and health care provider provided and contacted with the patient through mail.  Company Comment : 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.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon internal review on 08-Dec-2022 non-significant correction performed to update "case received from  field" to blank.; Sender's Comments: 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.
Two hours after shot #2 of the two-part series, I experienced stomach cramping and diarrhea, which continued the following day also. I had malaise, body aches and pains (similar to flu), and a low-grade fever. I had chills and felt hot and cold intermittently.
Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-19 vaccination.  Started first on the lips and then spread to left side of face and continued for 45 minutes to an hour after vaccination.
Around 11:30 p.m. father picked her up and she vomited, and then had a seizure. Father video'd this.  She had shaking of her arms and legs, decreased responsiveness, blinking of her eyes, it lasted about 2 minutes. 911 was called, by the time they arrived the seizure had stopped. Temperature was 101°. She was taken initially to Emergency room but they felt they could not treat her so the was then taken to another Hospital. Preliminary discharge summary note reviewed and forwarded to chart. Labs showed normal metabolic profile except for low BUN (3). CBC showed a low red blood cell count (3.70), hemoglobin 10.6, platelet count 385,000, white blood cell differential 66% lymphocytes, 11% monocytes, 22% neutrophils, 1% eosinophils. Admitted and observed overnight, was sleepy for the whole night. No further seizures. Pediatric Neurology was consulted. Father had shown them some other videos he had of patient stiffening her legs when excited in her bouncy chair at home. They prescribed rectal Diastat for home and she has an appointment scheduled later this month for a 2 hour EEG and Neurology follow-up visit at hospital.
Seven days after receiving vaccination I broke out in a rash that increased in severity for three days. It was located around my waist, down my legs and ankles. It started as raised red bumps that itched. By day four the clusters formed a flat mass of red- like blood pooling under my skin. The rash started Saturday night and I consulted with my healthcare provider in. I was in Denver for the week and she encouraged me to be evaluated. On Tuesday April 13 I saw Urgent Care.  He seemed stumped - especially since the onset of rash was seven days after injection. He put me on a six day course of methylprednisolone.  I began the course that day and that stopped the itching  and the daily multiplication of spots and spreading blood like areas.  Today, April 28 I am home in Portland and the spots are fading.  Both health care providers went through list of common irritants and they did not apply. I was traveling with my husband who did not develop any rashes or spots.
Redness, a little swelling, sensitive to touch; BACTRIM, BACTROBAN prescribed, warm compresses - improved with treatment 2 days after it was started.
Bleeding, SkinRash, On 2/12/2021 developed hemorrhagic lesion to top of left 2nd metatarsal "vasculitis like lesions" Narrative:  First dose administered 12/28/2020 and developed hemorrhagic lesion/rash with blister, and pain to right second and third toe (no blister on 3rd toe, hemorrhagic rash only) on 1/15/2021. On 1/22/2021 administered second dose of COVID-19 vaccine and on 2/7/2021 developed hemorrhagic rash to right great toe and fourth toe (painful). Lesions documented by photography. On 2/12/2021 developed hemorrhagic lesion to left 2nd toe, no blister, tender to touch. 1/5/2021 Real time PCR result: NEGATIVE for COVID-19 2/17/2021 Real time PCR result: NEGATIVE for COVID-19. Evaluated by primary care provider and bloodwork ordered 2/10/2021 , CBC, CMP, ESR, CRP, COVID IgG antibodies ordered. All bloodwork results "within normal limits" and COVID IgG antibodies POSITIVE. Primary care provider advised to continue to monitor as patient is clinically stable and able to work.  Other Relevant History:
pt recv vax 27FEB98 & pt was seen 12MAR98 w/ c/o lt Bell's Palsy;c/o facial twitching & pulling; rt side same 9MAR98;
CRITICAL; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, consumer posted about an uncle who was critical and fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of critical was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220231552 and 20220231819. Sender's Comments: V0: 20220232101-COVID-19 VACCINE AD26.COV2.S-Critical. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Information has been received from a consumer concerning her 16 year old daughter with allergy to DPT and pertussis shot, and no pertinent medical history who on 21-JUN-2007 was vaccinated with the first dose of GARDASIL.  On 06-SEP-2007, the patient received the second dose of GARDASIL and within a week later, approximately on 13-SEP-2007, she started to feel like she's not herself and she felt tired all the time.  Patient's mother reported that she feels like she was in a cloud and she has been day dreaming.  Patient was brought to her family doctor and had a cat scan, blood test and sleep study and it was determined that she had seizures activity.  Patient is currently on seizures medication and the symptoms started to improve.  Third dose of GARDASIL was given on 03-JAN-2008.  Lot numbers were not available.  There was no concomitant medication.  Upon internal review, seizures activity was considered to be an other important medical event.  Additional information has been requested.  10/1/08 Reviewed PCP medical records of 12/27/07-8/28/08 which include Neuro consult of 1/21/08 FINAL DX: epilepsy Records reveal patient experienced black out spells often after a nap, pain behind left ear, tingling in head & becomes briefly unaware w/different thinking & forgetfulness when resolves. Referred to Neuro for altered mental status & possible seizures.   Had generalized tonic-clonic seizure & bit tongue 4/2008.  Neuro consult 1/21/08
Husband called to say pt was feeling dizzy, nauseous, and generally not well. Pt also has a headache. This is the day after she received the vaccine, and she has talked to her doctor about her adverse reaction.
7/5/13 Seen in clinic for rash/given BENADRYL. 6/25/13 Hospitalized for 2 days with chest pain on (L) side and radiating into (L) arm. Had 2 day Cardiolyte Stress tests - negative. Developed rash. Questioning whether the prodrome to chicken pox was the instigating factor to his left sided chest pain.
After 3 days after the second dose my mom developed dermatographism (we went to her primary dr and a dermatologist) and about 10 days later on April 26th she developed symptoms as: shortness of breath, palpitations, chest pain. I neglected her symptoms thinking it was anxiety (she was going back to visit my sister in a couple of days). Her symptoms persisted and got even worse (she also started spitting blood) and went to see some doctors there and they gave her medication  and suggested it is a reaction to the vaccine (I have the doctors' findings and prescriptions of medication). I do have to mention my mom is a resident and she got the vaccine. I am writing because she does not speak English.  She is coming back  on August 19th, and I will take her to other doctors for further investigation, but I wanted to get this information to you soon.
antibody test 1 week ago, it came back negative/ took a second one it also came back negative/ IgM: Negative, IgG: Negative; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) on 20Jan2021 and her second dose on 10Feb2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of COVID 19 vaccine on 20Jan2021 at a hospital and her second dose on 10Feb2021. They were planning a family vacation at the end of this month so as an added precaution, she took an antibody test 1 week ago (Mar2021), it came back negative, the second one (16Mar2021) was also negative. Both IgM and IgG were negative. The patient was at a loss as to what to do next since as per these results, she has not developed immunity. If possible, she would like to know what she can do next. The outcome of the event was not recovered. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
I'm a 67 year old female. On 11/11/2020 at 2:00 pm I went to the pharmacy for a pneumonia injection. I received (Qty 5 pneumovax 23 INJ 25MCG/0.5ML) in my left arm. I never had a pneumonia shot prior. On Thursday I experienced pain at injection site, by early Friday the pain worsened and was experiencing severe pain. I was not able to move my arm easily. By Saturday I was not able to raise my arm past my torso or move my arm horizontally to my hip without severe pain. I'm not able to move arm laterally to my left without severe pain. My arm feels week. I've taken 400mg or ibuprofen without relief.
Pain , low grade temp and inflammation of L upper arm ,,  about  1/3 of  L upper arm involved,  appears to be cellulitis
Pt has a red, raised lump on the back of right arm that is warm to the touch.
Initial unsolicited report received from a pharmacist on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (same reporter,same vaccine, same lot number). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiry date: 30 June 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 04 Oct 2016 (over the past month). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date (over the past month), following the vaccination, the patient had developed headache (systemic reaction) and red, raised, size of baseball, very hot (local reaction). The patient's laboratory data was not reported. The patient required Emergency room visit. The patient did not take any treatment. The patient was recovered from headache (for 24 hours), and outcome of other events was unknown. List of documents held by sender: none.
Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes after she received the vaccine and also started with a weird iron taste in her mouth, and tingling in her hands. She felt like she was going to pass out but got better after 20 minutes. The tingling in her hands continued though and would start and stop periodically.
This spontaneous report as received from a physician via company representative refers to a currently 3 year old male patient. There were no concomitant medications, concurrent conditions and medical history reported. The patient did not have any drug reactions and allergies. On 22-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K020215 (route and site of administration, dose and expiration date were not reported). On an unknown date in 2015, after receiving PNEUMOVAX 23, the patient had gross redness on arm. The patient was treated with BENADRYL. He sought medical attention via a phone call to physician. The outcome of injection site erythema was reported as recovered/resolved on an unknown date in 2015. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Patient stated there was a persistent soreness that made it hard for her to use her arm. She had to follow up with her physician and is current taking steroids for the pain.
NURSE GAVE TD SHOT IN BACK OF THE LEFT ARM ON WEDNESDAY. LARGE WHEAL AND FLARE, ON THURSDAY EVENING. BENADRYL GIVEN FOR ITCHING. ALSO RECEIVED PPD SAME DAY.
body ache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), CHILLS (chills) and PYREXIA (fever) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced PAIN (body ache). On 03-Apr-2021, PAIN (body ache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            no treatment information provided no concomitant medication provided
t103 subsided evening of 10NOV92; puffy eyes; vomited x 2 evening of 9NOV92; cold chills; red, swollen area 2"-3" @ site of inject x 2 days;
I had a double frozen embryo transfer on February 5th and a positive pregnancy test on February 15th.  On March 4th I had my 6-week ultrasound and one embryo had implanted but did not survive and the 2nd was clearly not strong, smaller than it should have been with a fetal heartbeat only visible, not audible yet.  A week later, on March 11th, the ultrasound showed only empty gestational sacs and I had miscarried both.
Rash after the first dose; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on an unknown date for COVID-19 immunisation. The patient medical history included Polycystic ovarian syndrome (PCOS), irritable bowel syndrome (IBS). Concomitant medications were not reported. It was reported that the patient experienced rash after the first dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pfizer vaccine received on 4/15/21, 5/6/21    #1 Diabetes Mellitus Type 1 With Ketoacidosis Without Coma (HCC)   19 year old type 1 diabetic here with acute, severe DKA along with being COVID positive (on Nov 1).   He became a bit sleepy in the ED and a head CT was performed.  This showed no evidence of acute cerebral edema.  An arterial line was placed due to difficulty with blood draws.  He received a total of 1500 cc's in bolus saline in the ED.  Will follow DKA protocol and consult endocrinology.  Isolation precautions due to previous COVID diagnosis.  CXR done in ED is reassuringly clear.  He is on room air.     I have seen and examined the patient, reviewed events and record, and directed care on multidiscip    #1 Diabetes Mellitus Type 1 With Ketoacidosis Without Coma (HCC)   19 year old type 1 diabetic here with acute, severe DKA along with being COVID positive (on Nov 1).   He became a bit sleepy in the ED and a head CT was performed.  This showed no evidence of acute cerebral edema.  An arterial line was placed due to difficulty with blood draws.  He received a total of 1500 cc's in bolus saline in the ED.  Will follow DKA protocol and consult endocrinology.  Isolation precautions due to previous COVID diagnosis.  CXR done in ED is reassuringly clear.  He is on room air.     I have seen and examined the patient, reviewed events and record, and directed care on multidisciplinary team rounds.  I was involved in all high-complexity critical decision making to assess, manipulate, and support vital system functions to prevent deterioration. This required interpretation of multiple physiologic parameters or application of advanced technology. Removal of current cardiorespiratory support would result in high probability of imminent or life-threatening deterioration of the patient's condition.   This is a supervisory note.  I have seen and examined the patient, reviewed events and record, and have directed care.  I have discussed the findings and plan with the multidisciplinary care team as documented in the resident's electronic note from today.   Additional information for Item 12:  Hospital Diabetes Mellitus Type 1 With Ketoacidosis Without Coma (HCC)    Non-Hospital Diabetes Mellitus Type 1 Hyperglycemia (HCC)  Attention Deficit With Hyperactivity Disorder  Depressed Mood  Eye Examination Normal  Diabetes Mellitus Type 1 (HCC)