chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash over abdomen, back and suprapubic region; This is a spontaneous report from a contactable nurse (patient). A 22-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 16:15 (at the age of 22-years-old) (Batch/Lot Number: EL9269) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ethinylestradiol/norgestimate (TRI FEMYNOR), spironolactone, creatine monohydrate for all drug are taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number:EL9261) administered in Arm Right on 21Jan2021 01:00 PM for covid-19 immunisation. The patient experienced rash over abdomen, back and suprapubic region on 12Feb2021 17:00. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 18Feb2021. Patient did not receive any treatment for adverse event. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient has no known allergies. Prior vaccination patient did not tested for covid and post vaccination patient tested for covid. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited required 15 min.  w/o reaction. Pt remained for husband's 15 minute wait. During this time, patient felt dizzy and nauseousl and generally weak at 1150. Nourishments provided without relief. Rapid response called at 1155. Team arrived assessed patient. VS179/81 82 pulse, O2 - 96%. Dr. from Urgent Care came to check patient. Told to observe patient and repeat VS, patient ok per Dr. VS repeated at 1215 - 185/92, pulse 84, O2 sat 98%. Patient with c/o pressure to chest, chills and hives. Patient remained stable, husband present.  911 called. EMS Station 28 B shift arrived at 1225 and assumed care of patient.  1245 Ambulance arrived Unit 217 assumed care of patient.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment information was reported.
Numb finger tips; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb finger tips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 HYPOAESTHESIA (Numb finger tips). At the time of the report, HYPOAESTHESIA (Numb finger tips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.   Reporter did not allow further contact
Erythematous papules developed the next day on bilateral thighs were immunizations were given, not in distribution of bandaid but rather in a 2-3cm area around site of vaccine. Rash worse on right than left. Non-pruritic, non-painful. Seen in clinic 2 days after immunization.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPERSOMNIA W SLEEP APNEA ADULT OBSTRUCTIVE SLEEP APNEA NEUROPATHY ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA 1/26/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
20 minutes after the patient received the second vaccine the patient experienced a mild headache, tightness in chest and tingling in the throat.  The issue resolved without concern.
Nowit is like a bleed; fingers were tingling and this was also very painful; fingers were tingling; now it is more like a bigger bruise; a red circle on the lower inside part of the arm of the injection; it is painful/hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise) and VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise), VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) and VACCINATION SITE PAIN (it is painful/hurts so bad). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise), VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) and VACCINATION SITE PAIN (it is painful/hurts so bad) outcome was unknown.            Other concomitant medications included birth control medication and unknown another medicine. The patient  got the booster from Moderna last Friday and a few hours later developed a red circle on the lower inside part of the arm of the injection, Now it was more like a bigger bruise, like a bleed and it was painful and hurts so bad the patient was crying last night. Also state the patient's fingers were tingling and this was also very painful. It was reported that the first and second doses might had been administered at the patient's place of work early on, might be last winter since the patient is a nursing aid. Reporter was concerned that it might be a blood clot.   This case was linked to MOD-2022-452965 (Patient Link).
Extreme pain in my right thumb/ very sharp pain in the middle and base of my thumb; This is a spontaneous report from a contactable pharmacist reported for himself. A 38-year-old male patient received second dose of bnt162b2 (Lot number: EJ1686), via an unspecified route of administration in left arm on 07Jan2021 09:00 at single dose for covid-19 immunization. Medical history included HTN (hypertension) from an unknown date and unknown if ongoing. Concomitant medication included amlodipine, hctz, amfetamine sulfate (AMPHETAMINE-SALTS). The patient previous received first dose of bnt162b2 (Lot number: EJ1685), via an unspecified route of administration in left arm on 17Dec2020 11:00 AM for covid-19 immunization. The patient experienced extreme pain in his right thumb/ very sharp pain in the middle and base of my thumb on 09Jan2021 05:00. The event was reported as serious per disability. No treatment received for the adverse event. The adverse event result in disability or permanent damage. 36-48 hours after the second dose, the patient started experiencing extreme pain in my right thumb whenever he attempted to use his right hand for something including the simplest of tasks like tying his shoe. When he holds, lift, pull using his right hand he experienced a very sharp pain in the middle and base of his thumb.  At first, he thought maybe he hit it on something, but he did not.  A week later his wife was at work (she was a hair stylist) and was talking with one of her clients.  Her client who is a nurse said recently she had also taken the vaccine (2nd shot) and said the weirdest thing had happened. She told her that she can't hold anything in her right hand, and she has been experiencing unbearable pain in her right thumb when she used it for anything.  The pain has lasted almost two weeks now and was not going away. He still speak with the lady who has pain too and she said the same thing and he know it came after the second shot of the vaccine. The outcome of event was not resolved. Facility where the most recent COVID-19 vaccine was administered: Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "pain in thumb" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021058634 same reporter/product/event, different patient
Pt complained of pain in left arm after injection. On 4-30-14 pt advises that late in the evening on 4-29-14 she began to have a headache: On 4-30-14 she describes the worst HA she has ever had with vomiting, and Aura, muscle fatigue, neck stiffness, eye pain with movement, evaluation by physician, evaluation by neurology, Pt taken to ER CT, spinal tap, Admit to floor, Pt currently receiving IV steroids, IV fluids, IV ABX.
Pt started with a slight red rash and within 24 hrs after the rash, leg swelled. Doctor on call notified and started Benadryl.
approximately 10 days after the second vaccine, I developed  several cold sore blisters on the right side of my lip and ulcers all down the left side of my tongue.
Transverse Myelitis; Over a few days, pt developed complete plegia of legs and sensory level at T2 with bladder and bowel incontinence. This has persisted. Pt also has persistent pain at site of injection. Rash. Able to do self care. Stimulation only was walker in house. Wheelchair when goes out. Tired easily. Transverse myelitis.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 04-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 repots from the same source. Additional information has been requested.
Child was described as fine at one moment and then suddenly began shaking uncontrollably and taken to the ER. Was found to have 102 degree temp. Once fever began to lower the shaking subsided. Was evaluated in the ER and told that sometimes vaccines can cause fever and to just monitor the child for further problems.
5/20/15-"heat rash" on legs for 2 days. 6/4/15-swelling (R) knee x 24 hrs-resolved. 6/5/15-swelling (L) knee-almost fully resolved as on 6/9/15. Has taken ALEVE x 3d.
covid 19/ loss of taste and smell; she could not eat; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ loss of taste and smell) and FEEDING DISORDER (she could not eat) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19/ loss of taste and smell) and FEEDING DISORDER (she could not eat). At the time of the report, COVID-19 (covid 19/ loss of taste and smell) and FEEDING DISORDER (she could not eat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received Moderna COVID-19 bivalent booster shot on 23-Jan-2023. Patient tested positive for COVID about 2 weeks ago. Patient's symptoms lasted for about 5 days, after which she recovered. No treatment information was reported.
Arm red that grew in size and spread to elbow.  Felt like bruise size of softball.  Two days after the injection, got moderate case of chills.  Third day after shot, woke up with moderate itching at site of injection.  This is the fourth day after the injection and it is getting better.  Bruised feeling in smaller in size and itching is now mild.  Appears the reactions will be gone within a week.
Pt took blood pressure & cholesterol meds at 7pm then started to read and felt tired. Started to have problems with breathing. Labored breathing until 4am.
Vertigo/ 2 dose was not quite as bad but still not good 14 days later; This is a spontaneous report received from a contactable reporter The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Lot number: EW0173), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE; MULTIVIT [VITAMINS NOS]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER8731; Anatomical Location: Left arm), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Vertigo". The following information was reported: VERTIGO (non-serious) with onset 21May2021, outcome "recovered", described as "Vertigo/ 2 dose was not quite as bad but still not good 14 days later". The event "vertigo/ 2 dose was not quite as bad but still not good 14 days later" required physician office visit. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient experienced vertigo with all the three doses and afraid to get second booster. The patient had no covid-19 prior to vaccination. Patient had no known allergies.
Pt received Moderna x2.  Pt tested COVID + on 10/11/21 and admitted to hospital for COVID on 10/11/2021. Pt receiving remdesivir and dexamethasone.
chest pain (feeling of heavy gas build up in chest and needle feeling); Arm sensitivity (feeling of arm on clothes felt off); hand tingling within 15 min; Nausea; headache; Tiredness; fog brain; arm pain within 3 hours; intense night sweats; diarrhea; heavy breathing during movement; dry mouth; dry mouth/ tongue; This is a spontaneous report from a non-contactable consumer. A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Fa7485) via an unspecified route of administration, administered in Arm Right on 30Jul2021 at 12:15 as DOSE 1, SINGLE (at the age of 23-year-old) for covid-19 immunisation. The patient's medical history included drug hypersensitivity (Sulfer based medicine), gastrooesophageal reflux disease, contraception. The patient's concomitant medication(s) included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for gastrooesophageal reflux disease, contraception. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 12:30, patient experienced arm sensitivity (feeling of arm on clothes felt off) and hand tingling within 15 min (tingling was for 2 minutes), nausea and headache within 1 hour, tiredness, fog brain, and arm pain within 3 hours (arm pain only lasted 8 hours) nausea, intense night sweats, chest pain (feeling of heavy gas build up in chest and needle feeling), diarrhea, heavy breathing during movement, 99 temp, dry mouth/ tongue for 3-4 days (chest pains up to 2 weeks-has never happened before). The patient received the treatment for the events. The outcome of the events was recovered in unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
On 1/16/2021 - 1st dose; I experienced BCG spot was red and inflamed, body aches, joint pain, chills, nausea, head ache. On  2/8/2021 - 2nd dose, I experienced all of the above but magnified even more, plus fatigue, head congestion, cough.    Long term effects has been high blood pressure, heavy and painful menses, thyroid nodules of unknown origin.
off and on breathing problem that felt worse last night; lymph nodes swelling on their left arm and a little on the right arm; hard, tender, reddish, inflamed spots on different parts of their body; joints were swelling, specially their elbow, and they feel their knees have stiffen up since last; red patch area of 2 inches long by 1.5 inches wide on their left arm; tenderness in their arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (tenderness in their arm), INFLAMMATION (hard, tender, reddish, inflamed spots on different parts of their body), JOINT SWELLING (joints were swelling, specially their elbow, and they feel their knees have stiffen up since last), ERYTHEMA (red patch area of 2 inches long by 1.5 inches wide on their left arm) and DYSPNOEA (off and on breathing problem that felt worse last night) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PRAVASTATIN for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (tenderness in their arm). On 01-Mar-2021, the patient experienced INFLAMMATION (hard, tender, reddish, inflamed spots on different parts of their body), JOINT SWELLING (joints were swelling, specially their elbow, and they feel their knees have stiffen up since last), ERYTHEMA (red patch area of 2 inches long by 1.5 inches wide on their left arm) and LYMPHADENOPATHY (lymph nodes swelling on their left arm and a little on the right arm). On 03-Mar-2021, the patient experienced DYSPNOEA (off and on breathing problem that felt worse last night). At the time of the report, PAIN IN EXTREMITY (tenderness in their arm), INFLAMMATION (hard, tender, reddish, inflamed spots on different parts of their body), JOINT SWELLING (joints were swelling, specially their elbow, and they feel their knees have stiffen up since last), ERYTHEMA (red patch area of 2 inches long by 1.5 inches wide on their left arm), DYSPNOEA (off and on breathing problem that felt worse last night) and LYMPHADENOPATHY (lymph nodes swelling on their left arm and a little on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Medications: thyroid medication, blood pressure medicine. Claritin is used for treatment.
Began to get muscle pain at the injection site a few days ago (about 5 months ago). It has not gone away since I first noticed.
Sudden onset headache accompanied with nausea and vomiting around noon. ER visit MRI showed grade 1 SAH at basilar artery. Transported to ICU. Angiogram negative, nonaneurysmal unknown cause. No history of high cholesterol or high BP or trauma  to head.
father call w/ c/o high pitched cry;inconsolable crying for 3hr non stop;
Dose given from vial opened/punctured on 09/01/2021. Vial not discarded after the recommended 12 hours after puncture. Dose given on 09/06 from previously punctured vial.  Vial kept in refrigerator at appropriate temperature with no temperature excursions. Reported to Moderna.
No additional AE reported; Caller reports that a four year old patient received the second dose of PROQUAD less than 4 weeks after receiving the first dose of proquad; This spontaneous report was received from nurse referring to 4-year-old patient of unknown gender. There was no information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies.  On 25-JAN-2022, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(recombinant human albumin)) (PROQUAD), 0.5 ml (lot number # was reported as U022722 and expiration date was reported as 16-JAN-2023, route, anatomical location were not reported) and on 18-FEB-2022, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(recombinant human albumin)) (PROQUAD), 0.5 ml less than four weeks after receiving the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Inappropriate schedule of product administration)(lot number # was reported as U024510 and expiration date was reported as 02-FEB-2023, route, anatomical location were not reported) for prophylaxis.         No additional adverse event was reported.