chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No complications with injections. 5-10 minutes later pt complained of upset stomach. Then started vomiting several times. Then pt started complaining of itching hands. His palms were red/blotchy and swollen.  I checked pt's feet. The bottoms are the same. Pt's doctor was notified. Pt was given Benadryl and checked over by MD, then released.  08/06/04 @ 16:05: I spoke with mother; pt is doing fine today. No rash and has discharged Benadryl.
Pain; Upon receipt of follow-up information on (16Apr2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 11:45 (Lot number: EN6202) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain". Therapeutic measures were taken as a result of pain.  Additional information: It was reported that she just had a visit with her orthopedic surgeon and was given a corticosteroid shot in her left arm. She didn't even think until today to ask about whether it would effect the vaccine. Now it did not seem like she had an option to hold off the second vaccine, so she would like to know if there would be an issue with efficacy. She should be 80% vaccinated from the first shot. Vaccine was not Administered at Military Facility. No prior vaccinations. The patient was administered with Second dose on 10Apr2021 at 11:15 via intramuscular route of administration in right arm with batch and lot number was EN6200. Corticosteroid injection stated as a treatment for Pain on 01Apr2021. Relevant test reported as none.   No follow-up attempts are possible. No further information is expected.  Follow-up (16Apr2021): New information received from a contactable consumer. A 64-years-old female (patient) reported in response to consumer letter sent via follow-up letter which included that: case considered as valid, updated information: age at vaccination, event added, suspect vaccine information, relevant medical history, treatment.    Follow-up attempts are completed. No further information is expected.
w/in 1/2 hrs of vax pt exp achiness in joints,flu-like sx,painful eye movements;seen in ER;no tx given;sx subsided w/in 48hrs;
First dose (administered 4/16/2021) resulted in an extremely sore arm at the injection site. Soreness lasted for about 4 days.  Second dose (administered 5/7/2021) resulted in an extremely sore arm at the injection site. Soreness lasted about 7 days. Within about 24-26 hours after the injection I felt very sick. I had chills, body aches, and a headache. Symptoms lasted about 24 hours. My menstrual cycle has also been delayed. I have always had very regular cycles for 25 years, but at the time of this submission I'm about 4 days later than usual and my cycle has not started yet. (My husband had a vasectomy approximately 3.5 years ago, so pregnancy is unlikely.)
Lipoatrophy at the injection site.  Still have a 1 1/2 darkened area at injection site.
Severe pain, aches, feeling cold, extreme thirst, tachypnea, nasal congestion
Suspect Vaccine Start Date:24Jul2019 / given a split adult Havrix dose of 0.5 ml on 07Apr2021; pediatric female patient was given a split adult Havrix dose of 0.5 ml; Adult product administered to child; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 13-year-old female patient who received HAV (Havrix adult) (batch number X9A9B, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Havrix (1st dose received on 24th July 2019).   On 7th April 2021, the patient received the 2nd dose of Havrix adult. On 7th April 2021, unknown after receiving Havrix adult, the patient experienced drug dose administration interval too long, wrong technique in product usage process and adult product administered to child. On an unknown date, the outcome of the drug dose administration interval too long, wrong technique in product usage process and adult product administered to child were unknown.  Additional details were provided as follows: The reporter stated that, the patient received split adult Havrix dose of 0.5 ml, which led to wrong technique in product usage process and adult product administered to child. The patient received 2nd dose of Havrix late than the recommended interval, which led to lengthening of vaccination schedule. No symptoms were reported. The reporter consented to follow up.
This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. The nurse reported that between 08-MAY-2017 and 24-MAY-2017, the patients were vaccinated with a single improperly stored dose of PNEUMOVAX23, intramuscularly (lot # N000508, expiration date 19-OCT-2017, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 49 Fahrenheit degrees, for 2 hours (supported). There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. This is one of 3 reports from the same reporter. Additional information is not expected, as there was no consent to follow up.; Sender's Comments: US-009507513-1706USA004263: US-009507513-1706USA004264:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Paxlovid start date 01Jun2023 to 06Jun2023. Case was reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fast heart beat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Sep-2021 and was forwarded to Moderna on 28-Sep-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (fast heart beat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21) for COVID-19 vaccination.     Concurrent medical conditions included Tetanus allergy. Concomitant products included CLONIDINE, CARVEDILOL and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced HEART RATE INCREASED (fast heart beat). At the time of the report, HEART RATE INCREASED (fast heart beat) 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.   No treatment medication was reported.
pt recv vax & approx 30min post vax pt devel h/a;MD indicated that 8 other pt had similar exp (WAES97100694,97100696 through 97100100, 97100102 & 97100103);
Difficulty breathing caused by a myasthenia exacerbation (has never happened before after over 40 yrs of having myasthenia).  Hospitalized after 2 weeks, when oral meds didn't work.  Received IVIG treatment in the hospital x5 consecutive days.  Received IVIG treatment at home every 2 weeks for 3 months.  Out of work for 2 and 1/2 months, transitioned back to 1 day/ week x 1/2 month, then 2 days/ week x 1 month, then 3 days/ week x1 month, and just began 4 days/ week this month.  Also experiencing ongoing fatigue.
pt recvd vax & developed a limp which progressed to ataxia over 3-4 hrs & weakness proximal & distal;
Returned home from receiving vaccine with back pain, burning pain, H/A, uncontrollable shivering, covered with blankets, improving, unsure if fever, will take temp and give ibuprofen.
fever; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (Aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (fever) and MYALGIA (Aches). At the time of the report, PYREXIA (fever) and MYALGIA (Aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 (High) 104 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.         Reporter did not allow further contact; Sender's Comments:
Initially started with chest pain at 1400 on 10/23/2021 lasted for 2 hours and resolved. Then at 0500 on 10/24/2021 started with chest and left arm pain, rapid irregular heart beat up to 140's when walking to room to be placed on monitor felt heart flip and slow down to low 110's.  Sudden onset of violent vomiting  for about 5 mins.  Then developed left arm numbness, heaviness, left facial numbness, left leg numbness, confusion, expressive aphasia, blurred vision. Labs, ekg, Mri, MRA, carotid us CTA of chest, IV fluids, Krider, zofran, hydromorphone, ativan discharged home.  Returned on 10/25/2021 to er with drooling facial numbness, left arm numbness and heaviness, pain in bil legs, extreme muscle pain. neurology consult, lab, mri brain,  ketoralac, nubain given  discharge home
This spontaneous report as received from a 73 year old female patient with no pertinent medical history or drug allergies refers to herself. On an unknown date ("a few years ago") the patient was vaccinated with ZOSTAVAX (lot# unspecified). Concomitant therapies included famciclovir. The patient was now suffering with shingles. She felt a soreness on her lower back, the tenderness spread down her leg across her rib going to her abdominal area, 4 days later she got a rash, now she had full blown shingles and did has blister on her right side of the buttocks to her lower back. The event onset date was reported as 30-JAN-2014. Unspecified treatment was given. No lab tests were performed. The patient had sought unspecified medical attention. The outcome of the events was unknown. Additional information is not expected.
urticaria trunk; no respiratory complaints. Rx diphenhydramine and prednisone.
Approx. 10 min after, began having trouble seeing, breathing, heart racing, very hot, bad head and neck pain, inability to hold head up. Chest pain. Muscle weakness, heart fluttering. Some symptoms subsided, some symptoms stayed and would come and go. Lasted over several weeks. Passed out a couple times. Had to go to ER. Had CT scans, heart testing, blood work. Nothing else found to cause. Other than the vaccine.
Patient admin. influenza virus vaccination (L) deltoid on 11/14/14. Arm felt "achey" on 11/16 during the day. At 9 p.m. that eve. s/p brushing her teeth developed abrupt onset "searing pain" "on fire" from shoulder to finger tips, (L) arm. Denies rash, swelling erythema at inj. site or generalized (-) fever. Visual inspect of site on ofc on 11/18/14. (-) erythema/red/heat at site of LA. Swelling (-) decreased grip strength. No tx by RN.
Vaccines given Friday 10/21/11 at 1300 - pt developed fever, sore throat, muscle aches, redness and swelling at injection site on (L) arm. Both vials (PNEUMOVAX & flu) were new bottles.
Erythema, induration, warmth, tenderness at injection site.  10cm x 9cm.
Sore throat.; Feels as though very dehydrated, even after drinking 64 oz of water.; Sore in tonsils and above uvula; Feels similar to strep throat; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 08Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient had not been 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 four weeks prior to the vaccination. On 09Jun2021, the patient experienced sore throat, felt as though very dehydrated, even after drinking 64 ounce of water, sore in tonsils and above uvula, felt similar to streptococcus throat, but it did not really affect the ability to speak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat, felt dehydrated, sore in tonsils and above uvula and felt similar to streptococcus throat were not resolved at this time of report.  No follow-up attempts are possible. No further information is expected.
sever body aches, chills (no fever), extreme fatigue, malaise, brain fog
Case number PHEH2012US004949, is an initial spontaneous report received from a physician via Novartis representative on 02 Mar 2012: This case refers to unknown age and gender patient. This patient was vaccinated with MENVEO (batch number: M10031) on unspecified date. On unspecified date, the patient experienced severe swelling, redness and heat at the injection site. The outcome and causality of the events were not reported.
Immediately after I got it I felt different. Fight or flight response kicked in. My heart started racing and chest felt tighter. It felt like I just ran a marathon. My breathing increased and I felt very dizzy and lightheaded. I stayed in the store and walked around hoping symptoms wouldn't get worse for 25 minutes then left. I had my three small children with me and wanted to get them home. I called my husband who is a physician and told him everything I was experiencing. He told me to stay in the store to see how things went. I then drove home to monitor my symptoms. I had post nasal drip and it exacerbated over the next few weeks. I was on two different antibiotics because it felt like I had a bad ear infection. It never went away. I saw an ENT and my tympanaplasty that I had as a child blew. I have a large hole in my ear drum currently and very dizzy. I am getting a CT of my ear this Wednesday and I will have to have surgery in the next few months for another tympanoplasty.
Pt recv vax on 10/10/97; on same day pt exp dizziness, sweating, headache, nausea &vomiting.
One week after the injection my are swelled and bcame very warm to the touch  the doctor prescribed warm soaks and an antibiotic.  It seems to be improving
Bruise/hit a blood vessel.; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise/hit a blood vessel.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, VITAMIN C [ASCORBIC ACID] and MULTIVITAMINS;MINERALS for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced CONTUSION (Bruise/hit a blood vessel.). At the time of the report, CONTUSION (Bruise/hit a blood vessel.) outcome was unknown.            Lab data details and Treatment information were not provided.   This case was linked to MOD-2021-375383, MOD-2021-375417 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up received on 09-Nov-2021: contains No New Information.
Received DTaP 06/25/2003, left deltoid seen 06/26/2003 for swelling and red deltoid started antibiotics and returned 06/27/2003.  High surface area, temperature 100.9F, (+) pain.  Red vesicles noted.
Within 12 hours of vaccine spikes fever of 103.  Within 72 hours of vaccine broke out in diffuse pruritic rash.  Saw Pediatrician on 06/30/2013 and diagnosed with Erythema Multiforme.
My husband has a head cold after all the vaccines he received; This spontaneous case was reported by a non-health professional and describes the occurrence of NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fifth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received). At the time of the report, NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received) had resolved.            Concomitant medications were not reported. Patient had a head cold after all the vaccines he received. That was a typical symptom of the vaccines Reporter confirmed that they only received all six doses of Moderna COVID-19 vaccines. Treatment medications were not reported.   This case was linked to MOD-2023-733140 (Patient Link).
Patient called at 10am on 10/2/2019 stating that this morning when she woke up she had a rash on her lower legs. Rash did not cause any pain or irritation. Just small red bumps. Confirmed no changes in any detergent, soaps or fragrances. Stated only change was Shingrix and flu shot given on 9/30/2019. She knows a rash can occur but was surprised on lower legs. Patient knows if gets worse to see provider.
CANT SLEEP; WOKE UP HURTING RIGHT ARM; WEAK; SPOTTING AND REDNESS AROUND  WHERE HE RECEIVED VACCINE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain, fibromyalgia, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 03-AUG-2021 for prophylactic vaccination. Concomitant medications included for chronic pain. The batch number was not reported and has been requested. On 03-AUG-2021, the patient experienced cant sleep. On 03-AUG-2021, the patient experienced woke up hurting right arm. On 03-AUG-2021, the patient experienced weak. On 03-AUG-2021, the patient experienced spotting and redness around where he received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from woke up hurting right arm, and weak, and the outcome of cant sleep and spotting and redness around where he received vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000188853. The suspected product quality complaint has been confirmed to be voided(did not meet a product quality complaint criteria as reported complaints were adverse events) based on the Agency evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 10:15 as dose 4 (booster), single (Lot number: FE3590) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 at 10:15 as dose 1, single (Lot number: ER8732), in left arm, on 19Apr2021 at 10:45 as dose 2, single (Lot number: EW0164), in left arm and on 26Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a healthcare worker refers to a 2 years old patient of unknown gender. On 20-OCT-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.