chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; sweating; couldn't sleep; felt so miserable all night with her shoulder; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating), SLEEP DISORDER (couldn't sleep) and ARTHRALGIA (felt so miserable all night with her shoulder) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Mar-2021, the patient experienced HEADACHE (headache), HYPERHIDROSIS (sweating), SLEEP DISORDER (couldn't sleep) and ARTHRALGIA (felt so miserable all night with her shoulder). The patient was treated with PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL SINUS MEDICATION) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating), SLEEP DISORDER (couldn't sleep) and ARTHRALGIA (felt so miserable all night with her shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
mild headache; some nasal congestion; Unfortunately, I became infected last weekend, testing positive on 16Aug; I received both of my Pfizer vaccine shots in April. Unfortunately, I became infected last weekend; This is spontaneous report from a contactable consumer(patient). An unknown age and gender patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number were not reported) dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient past drug history included bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number were not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient received both of my Pfizer vaccine shots in April. Unfortunately, patient became infected last weekend, testing positive on 16Aug2021. patient symptoms, which were a mild headache and some nasal congestion, would have likely been severe if not for your vaccine. The patient underwent lab tests and procedures which included Covid-19 virus test was positive on 16Aug2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
I started getting left sided parotitis swelling and pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUAD QUADRIVALENT taken for immunisation, in Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAROTITIS (non-serious) with onset 05Oct2023 at 10:30, outcome "recovering", described as "I started getting left sided parotitis swelling and pain". Therapeutic measures were taken as a result of parotitis.  Additional information: Reported as, Consumer (Physician) stated, he was a Physician and he got his Pfizer Booster (Captured as Unspecified Booster Vaccine) yesterday at Withheld and today about 10:30 he started getting left sided parotitis swelling and pain. The parotitis was acute was not too bad, there was excessive swelling but and that was coming under control. He had taken Flu vaccine (Fluad Quadrivalent Vaccine) 10 days prior. There is no Investigations. He had taken Ibuprofen 800 milligram and it was helping the swelling and pain was going down. Causality: patient mentioned the unspecified Booster vaccine caused the event (parotitis), (Further not clarified).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
About an hour after the second dose, I had the feeling of pins and needles in my left thumb. It was most severe that day and has improved a little but I have had it now for five days.     I also had this same reaction (but didn't realize it was related to vaccine) after the first shot. I believe it only last two days then.
Pt had a reaction to vaccine.  Specifically, she fainted and had seizure.  It happened within seconds after the immunization delivery.  Pt had upper body seizure waist up in the chair.  This lasted about 30 seconds at a time.  This occurred roughly 3 or 4 times.  Emergency services were called.  EMTs responded to scene.  Pt was well enough not to go to the hospital.  Eventually, left with boyfriend feeling better.
Pt reports temp 101, nausea, dry heaves, shakes, dizziness after receiving vaccine - approx 12 hours after immunization.
Information has been received from a mother who is a RN concerning her four year old (also reported as 5 year old) white son who has not significant medical history or allergies, who on 19Jun2003 at approx. 11:30AM was vaccinated SC in the arm with a first dose of varicella virus vaccine live. Additional therapy administered SC in the arm on the same day, 19Jun2003, at approx. 11:30AM included a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The pt's mother reported that a few days before 10Jul2003, her son complained if dizziness on and off. On 10Jul2003, he developed vomiting and fever and on 07Aug2003 he again had a high fever, and he also had a febrile seizure. On 22Aug2003 the pt again had a febrile seizure and was taken to the ER where a computed axial tomograph (CAT) scan and blood work  were done. On 26Aug2003 the pt's had his last recorded fever. Since approx. 26Aug2003 (reported as last Tuesday), The pt's mother indicated her son has been "feeling better", which she described as, "he does not lay his head down everywhere anymore". The pt's mother also stated that the pt had also been "very restless throughout this time falling asleep only by 1AM or so". The mother reported that three other siblings had no untoward reactions to varicella virus vaccine live. The mother reported that she also suspects that the events are related to varicella virus vaccine live. It was reported that the adverse event abated, and prescription medication was required. The mother also reported that the pt had no rashes or other symptoms. There was no product quality complaint reported.   Follow up information was received from the office manager via a telephone conversation, and indicated the pt was not sick at the time he received the vaccinations. The office manager reported that the route of the vaccine administration  was "the normal way", and indicated she had a hard time reading the physician's handwriting. The office manager indicated that at the time of the telephone conversation the physician was out of the office but that he may be able to provide more details. Additional information received from the physician on 23Sep2003 reported that the pt's fever and headache onset was 10Jul2003 through 12Jul2003. The physician also reported that on 07Aug2003 the pt had a temp of 103 and experienced a brief febrile seizure, again on 22Aug2003 the pt had a temp reported as 102.5 and he had another brief febrile seizure. It was noted that from "mid July to Sept" the pt complained of dizziness and slept poorly. The pt's outcome is reported recovered on approx. 01Sep2003. Additional information was received from the physician, who reported that "as of today" 07Oct 2003 the pt is no longer restless and no more vomiting. The physician reported the pt is completely recovered. Unspecified medical attention was sought. Upon internal review, febrile seizure was determined to be an other important medical event.(OMIC)No further information is expected.
itching began and fine bumpy rash areas on arms and 1 leg-itching on top of scalp and now on face.  This is how her other alleric reactions began.
Information has been received from a woman at the department of health concerning a 6 year old white male who on 21-MAR-2001 was vaccinated with Varivax (lot # 006BK). On 03-FEB-2006 the patient experienced a rash. It was noted that the school nurse observed the patient today and that the mother reported that the sister "had disease." No further information was provided. Additional information has been requested.
Moderna COVID-19 Vaccine EUA"  Rash at the injection site the size of 2 half dollars 10 days after receiving vaccination .
Extreme Body aches, pins and  needles all over body, headache, and exhaustion. Lasted about 36 hours .
10 days after 2nd dose of vaccine developed leg weakness that has progressed with ataxia.  Saw neurologist who diagnosed as Miller Fisher syndrome
10/24/99 to 10/28/99, felt tired, with hives on upper chest, deltoids, front of shins & behind knees; itchy w/flaking skin. Symptoms started to go away about 11/1/99; used vitiman-E oil & lotion on effected areas. Also, had pain in deltoids
Patient fainted from sitting position and hit forehead.  Had symptoms of nausea, HA, and laid down for 15 minutes.  Drank OJ, ate chips upon sitting and laid back down due to dizziness.  Patient sat up, vomited, and continued symptoms of headache.   Stayed in observation for an hour and felt better enough to go home with friend.  Recommended patient visit medical provider if no improvement or worsening of symptoms.
Patient began feeling dizzy immediately after administration.  She said she could not open her eyes/ see.  She became extremely sweating  and pale.  She never lost consciousness but could not regain her strength/ color.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Sore Arm) had resolved. Not Provided Event Stop date: ??-???-2021      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported. patient doesn't want to go for second shot ,he wants to know how effective is a single dose of moderna vaccine.
fatigue; Headache; Muscle Pain; Joint Pain; Nausea; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-074471 (Patient Link).   Reporter did not allow further contact
pt recv vax 7SEP95 & 15SEP95 pt devel a febrile sz & was hosp for tx;@ time of the report results from an EEG were pending & the CBC results were listed as viral;d/c from hosp 16SEP95;18SEP95 pt devel rash consistent w/measles rash;
Pt recvd vax & exp an inject site reaction; pt vaxed 27FEB92 & 2MAR reported erythema the size of a quarter w/warmth & swelling @ inject site;
The next morning experienced "weird" muscular and neurological reactions; The next morning experienced "weird" muscular and neurological reactions; This is a spontaneous report from a contactable consumer.   A 53-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot/Batch number, not reported), via on an unspecified route of administration on 11Jul2021 (age at vaccination was 53-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Jul2021, the next morning of vaccination, the patient experienced weird muscular and neurological reactions. These side effects lasted 36 hours. Reporter stated that she sought medical care from her PCP yesterday and they could not recommend whether she should get the second dose of the vaccination series on Saturday or not, therefore patient seeking this information from Pfizer. At the time of this report event outcome was recovered on an unknown date in Jul2021.   Follow-up attempts completed. No further information is expected.
Tuesday Morning started with achiness and soreness with difficulty walking and moving around. when to urgent care that evening and was tested for Covid and the flu. both results came back negative. On Wednesday the Pain level increased to 10, also experience chills, sweats, nausea, and a fever of 101. went to Hospital, they ran a battery of tests which all came back within normal range. was discharged with Ibuprofen, anti-nausea, and acetaminophen. did not resolve the pain level. The pain continued the next day and returned to the hospital. still, not able to function or move without pain.   Sore and achy chest, joint pain in all extremities, difficulty walking and moving around. pain level equals a ten. can not function without assistance. Fever that comes and goes.
pt recvd vax; devel gen rash of 10-15 pox & a sl T;
Deep pain in ribs and back near spine. (Vaccine was given in right arm). Shingles rash developed 09/12/2016. Diagnosed with shingles 09/15/2016.
25Jul91 pt vax 5th Engerix-B; exp dizziness, n, blackouts, dehydration, elevated liver enzymes, & increased bilirubin.  Pt to ER.  Tx w/ fluids & meds.
This is a spontaneous report from a contactable physician. A 66-year-old female patient received the second dose of BNT162B2 at 66-year-old, via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) at single dose, and the first dose via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8730; Expiration Date: 30Jul2021) at single dose for COVID-19 immunisation. Medical history included congestive heart failure, chronic obstructive pulmonary disease (COPD), diabetes, high blood pressure, and chronic kidney disease. Concomitant medications included furosemide, BREO ELLIPTA, carvedilol, insulin, losartan, and metformin. The patient had BNT162B2 and was tested positive COVID on 17Jul2021. Reporter assumed that it was delta variant, but did not know for sure. They did not know for sure, so they were sequencing DNA sample. After COVID, patient was put on dexamethasone treatment. It was 6 mg for 10 days. Patient also had not a BMP but a CMP a week before. So, low potassium, high chloride, low carbon dioxide, and a mildly elevated anion gap, the number was 12, anion gap was 12. Outcome of the events was unknown. Based on the information currently available, The casual association between the reported event Covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 20-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
after getting the vaccines, she is feeling tired and lazy; after getting the vaccines, she is feeling tired and lazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), LAZINESS (non-serious), outcome "unknown" and all described as "after getting the vaccines, she is feeling tired and lazy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller already had the 2 primary vaccines in Jan, she hadn't gotten the booster yet since then as her antibodies were high, they were now in Oct and her antibodies were still high, asking when she could get the booster, after getting the vaccines, she was feeling tired and lazy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 202201262963 same patient, different vaccine dose/AE.;
Spoke with patient. She stated at day 10 post vaccine she developed a raised area around the injection site with warmth and itching. It is now resolving. Injection was March 4th. Reaction accord Approx. March 11. She is currently using cortisone cream. I recommended ice as well and to report any other symptoms or worsening in condition to her provider.
little bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (little bit of soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to excipient (Patient is being allergic to polyethylene glycol.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (little bit of soreness). At the time of the report, DISCOMFORT (little bit of soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Reporter did not allow further contact
Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 54-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 19th January 2023, the patient received the 1st dose of Havrix 720. On 19th January 2023, unknown after receiving Havrix 720, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter reported that the adult patient inadvertently received the pediatric dose of the Havrix vaccine in the right arm. The reporter did consent to follow up. Additional supportive information: The adult patient was administered a pediatric dose of Havrix, which had led to accidental underdose and adult use of a child product.
Patient received second dose of Moderna prior to 28 days, or 24 (with 4 day grace period).
Patient received his first shot of Pfizer COVID-19 and was asked to remain seated in the pharmacy. After several minutes, his mother informed pharmacy staff patient felt faint and was passing out. Pharmacist immediately went to check on the patient, and the mother was slapping his face to keep him awake. Patient was able to open his eyes and said he felt lightheaded. Patient looked pale and his hands felt clammy. Pharmacist called 911 and another pharmacy staff took his blood pressure, it read 127/69 with heart rate of 66. While paramedics were driving to pharmacy, patient had his eyes closed but it is unsure whether he lost consciousness. He was able to talk to his mom several times. When paramedics came, they took his vitals again and it was about 130/70. They also took his blood glucose reading and said it was about normal. After about 20-30 minutes of checking vitals and EKG, patient said he felt better and refused medical attention at ER/urgent care. He was able to stand and walk back to car with his family. Unsure whether patient will follow up with his doctor.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 36 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: Er8729), in left arm, on 02May2021 as dose 2, single (Lot number: Ew0179), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: Fj1611), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT, start date: 03Dec2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures paxlovid from 10Jan2023 were taken as a result of vaccination failure, covid-19.