chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reddened area at site of DTaP noticed by mother 9-5-02. Patient came to clinic 9-6-02. 5cm in diameter, red, dense area noted. Patient treated for cellulitis with Dicioxacillin 62.5mL, 1.5 tsp po qid for 10 days, cold compresses.
declared Covid+; declared Covid+; This is a spontaneous report from a non-contactable consumer (patient), from Pfizer-sponsored program.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Sep2021,the patient's PCR result declared Covid positive, felt sick moderately. The patient thought it's not a huge problem thanks to vaccination of 2 BioNTech. The patient always wear mask and throw/change daily. Even if tested positive somehow. The patient had big headache and little nose ache and was quarantined now at home. The patient underwent lab tests which included SARS-Cov-2 test: Covid+ on 03Sep2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 Immunization.  The following information was reported: CARDIAC ARREST (medically significant), outcome "unknown".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Dose given on day 31 of the vial being removed from the freezer to the fridge, instead of day 30 or sooner. Per Moderna, the dose maintained the activity necessary to protect against COVID-19.
Patient reported rash/swelling about the size of a bandaid at injection site on 9/11/15.
Middle of the back, left hand side, feels like an inflammation or something in there causing sharp pain upon movement.
Burning and numbness of the hands and swelling of the face. No erythema at sites. Slight increased warmth. Neurologic exam is intake. Minimal swelling of the face. Slight erythematous macular rash of the arms. No wheezing. Treated with Atarax.
11 year old patient was administered MENACTRA which expired 4 days ago with no reported adverse event; Initial information received on 13-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 11 year old  male patient was administered meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] which expired 4 days ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 13-Jun-2022, the patient received a  dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (lot number not reported and expiry date: 09-Jun-2022) via intramuscular route in unknown administration site.  On 13-JUN-2022 the patient was administered menactra which expired 4 days ago with no reported adverse event (expired product administered).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event 11 year old patient was administered menactra which expired 4 days ago with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included Aneurysm (It was found that the size had increased to 4.2 cm.). Concomitant products included AMLODIPINE, ASPIRIN, and VITAMIN C for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANEURYSM (3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm). At the time of the report, ANEURYSM (3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal 4.2 cm Size.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Vitamin once a day. Treatment information was not provided.
feels really bad; sick to the stomach; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels really bad), ABDOMINAL DISCOMFORT (sick to the stomach), CHILLS (chills) and FATIGUE (fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21C, 010M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feels really bad), ABDOMINAL DISCOMFORT (sick to the stomach), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feels really bad), ABDOMINAL DISCOMFORT (sick to the stomach), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications present, yet not disclosed.
Dizziness; A fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:00 (Lot Number: EN6202) as single dose (at age of 71-year-old) for covid-19 immunisation. Medical history included diabetes type II, asthma. Concomitant medications were not reported. The patient previously took lisinopril and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 04:00 patient experienced dizziness and a fast heartbeat a couple hours duration. The patient underwent laboratory tests and procedures which included heart rate: fast on 09Mar2021. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient recovered on unknown date from the events.  No follow-up attempts are possible. No further information is expected.
Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. (Moderna).  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; ZIPRASIDONE; LORAZEPAM; GABAPENTIN; LETROZOLE; VIT C; VIT E [TOCOPHEROL]; VIT D [COLECALCIFEROL]; CALCIUM; BUPROPION. Past drug history included: Cipro, reaction(s): "Allergic to Cipro antibiotic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Bactrim, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Azithromycin, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Zantac, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Nexium, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Omeprazole, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Protonix, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Tizanidine, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Antihistamine, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine. The following information was reported: FATIGUE (non-serious), outcome "recovered" (08Apr2022). Therapeutic measures were taken as a result of fatigue. No follow-up attempts are possible. No further information is expected.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 11-OCT-2011, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration unknown) as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JUN-2013, the patient was treated by a physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant, medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Additional information has been requested.
"Bad headache, sneezing, itchy rash over face, arms, back, and stomach.  Also c/o feeling Hot and cold on and off. Benadryl 25 mg given to employee to take.  She was concerned that it would make her too tired, so she only took one 12.5 mg tab while at work- said helped some.  Stated she will take other 12.5 mg tab when she gets home.  Pt plans to buy Benadryl and Caladryl clear.
Swellling of face, eyes, itchy face, redness in face, swelling in extremities especially ankles and feet which last or approximately 5 days.
she has a suspected exposure to a COVID19 patient/develops symptoms is unable to get the 2nd dose in time; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient herself). A female patient of an unspecified ag received bnt162b2 (BNT162B2 also reported as PFIZER COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. The patient's medical history was not reported.  There were no concomitant medications. The patient was asking if she can get her second shot if she had a suspected exposure to a COVID19 patient and if she developed symptoms and was unable to get the 2nd dose in time, when will the new schedule be. The outcome of event was unknown.   Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Suspected COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
pt recv vax 7 19hr post vax pt had 2" x 2" raised indurated hot erythematous area @ inj site, acutely painful to palpation;48hr post inj lesion changed to discrete red macules 1cm diameter over 4.5" x 3" oval @ site;
Covid monitoring documentation. PT admitted 1/4/21 documented to have positive covid. PT received Pfizer 1/13/21 Lot EL0140 for dose 1. Dose 2 was Pfizer given on 2/3/21 Lot EL3302.
fatigue with weakness; fatigue with weakness; inability to carry out the daily schedule; nausea, and overall felling sick; overall felling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 39-year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 2021, outcome "unknown" and all described as "fatigue with weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "inability to carry out the daily schedule"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea, and overall felling sick"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "overall felling sick".  Additional information: She specified her sick feeling is not the typical body aches talked about. She further said she had to delay her second dose due to her symptoms that are now persisting for 5-6 weeks. She also mentioned she read about an incident at a retirement home where Pfizer-BioNTech COVID-19 vials with a particular lot number had too much vaccine in each vial and thus caused problem to the recipients. She asked if there were similar reports of side effects associated with the lot number of the vaccine she received. She asked if there were similar reports of side effects associated with the lot number of the vaccine she received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Parents describe child as excessively sleepy after receiving Hepatitis B Vaccine.  Woke for feeding, but slept other times, unlike usual behavior. Cranky 12/29-30.  Normal behavior thereafter.
Headache; Severe muscle spasms while the pharmacist was injecting the serum; I couldn't raise my arm at all; Flushed; Nausea; Pain in arm; Muscles in that arm hurt when I move my arm; Muscle throb; This case was reported by a consumer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching. The patient was treated with ibuprofen (Advil) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the headache, muscle spasm, flushing, nausea, muscle pain and muscle twitching were unknown and the outcome of the injected limb mobility decreased and pain in arm were recovering/resolving.   It was unknown if the reporter considered the headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The patient received dose of Shingrix a week ago from the date of reporting. The patient had severe muscle spasms while the pharmacist was injecting the serum. The patient reported her shot took much longer to give than her husband's. Several hours after vaccination, the patient could not raise her arm at all. The patient was flushed. The patient stated she expected to be sore, but an arm that she could not lift up, was a surprise. This pain lasted 5 days. On the sixth day, the patient began to be able to lift her arm higher up, but with pain. That still was where she was on the seventh day. The patient had tried Advil and ice, as directed by a doctor, but she had received little relief. The patient's muscles in that arm hurt when she move her arm, and sometimes they throb without movement. The patient asked if the anyone heard of this happening. The patient asked if she inoculated incorrectly.
Reporter states that pt receiving OPV w/other vax are experiencing loss of appetite & loose stools following vax; reporter states that this does not occur when pts are given IPV along w/other vax
Severe headache-worst headache ever experienced Vomiting Diarrhea ***Headaches that have persisted. More days with headaches now than without.
This spontaneous report as received from a consumer refers to her 16 years old female daughter with tetracycline allergy. The patient had no pertinent medical history. The patient was vaccinated with the first dose of GARDASIL (lot # unspecified) on 27-DEC-2012. No other co-suspects were reported. There were no concomitant medications. On 28-DEC-2012 the patient fainted and was taken to the emergency room of hospital. She was found to be fine and was not admitted. No treatment information was given. Chest X-ray, blood work and electrocardiogram were performed. The outcome of fainted was reported as recovered. Additional information is not expected.
this is my 4th vaccine and i have been sick with ALL of them;  this one was the mildest but felt it needs to be reported 12 hours after injection: - extreme cold and shivering -low fever (100) -cramping, especially in both hands, very painful -upper back muscle spasms on side of injection -vomiting and prolonged nausea -feverish dreams -exhaustion 48 hours after injection -large lump under on torso near armpit on side of injection, the size of my hand -red hard hart itchy lump at injection site -pain in arm of injection site -slightly swollen glands on right non injection site -continued discomfort in upper left torso -exhaustion -slight nausea
Lots of pain in the head, sadness, tiredness, pain/throbbing in the neck, back pain. Patient suffered from (OCD) but had it controlled & after the vax, she started to feel anxious. She is better than the 1st couple of days, but wanted to inform you.
Information was received from a consumer regarding a 6 month old male patient who received Dimetapp Infant Drops Decongestant therapy and experienced difficulty sleeping and upset stomach. Relevant medical history was not provided. Indication for Dimetapp Infant Drops Decongestant was nasal congestion. Therapy began on 9/26/03 and was permanently discontinued on 9/28/03. Dose regimen was 1.2 mL 2 times per day (oral). Additional suspect medication included Prevnar, DPT, Hepatitis B vaccine and Hib-Titer Vaccine. Concomitant medications were not reported. The patient experienced difficulty sleeping and upset stomach on 9/26/03.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
flu like side effects; chills (hot/cold); chills (hot/cold); congestion; watery eyes; scratchy throat; terrible nausea (cannot eat or drink, only ginger ale); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu like side effects"; CHILLS (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset Mar2021, outcome "unknown" and all described as "chills (hot/cold)"; NASAL CONGESTION (non-serious) with onset Mar2021, outcome "unknown", described as "congestion"; LACRIMATION INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "watery eyes"; THROAT IRRITATION (non-serious) with onset Mar2021, outcome "unknown", described as "scratchy throat"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "terrible nausea (cannot eat or drink, only ginger ale)". Additional information: The patient wanted to know what she can do about the side effects and if she could take paracetamol (TYLENOL).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.