chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not feeling well; could not open mouth; jaw soreness; swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (could not open mouth), PAIN IN JAW (jaw soreness), FEELING ABNORMAL (not feeling well) and LYMPHADENOPATHY (swollen lymph node) in a 60-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN JAW (jaw soreness) and LYMPHADENOPATHY (swollen lymph node). On 30-Mar-2021, the patient experienced ORAL DISCOMFORT (could not open mouth). On an unknown date, the patient experienced FEELING ABNORMAL (not feeling well). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and BENZYLPENICILLIN SODIUM (PENICILLIN [BENZYLPENICILLIN SODIUM]) at an unspecified dose and frequency. At the time of the report, ORAL DISCOMFORT (could not open mouth), PAIN IN JAW (jaw soreness), FEELING ABNORMAL (not feeling well) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown. Not Provided      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 treatment information included Corticosteroids. Concomitant medications were not provided.
Starting about 12 hours after getting second dose of vaccine, I experienced chills, muscle aches, headache and fatigue. It last about 24 hours.   Starting 48 hours after getting the second dose, I experienced redness, pain and swelling on my arm.
caught covid; caught covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no other vaccine in four weeks and had no Covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 24Jan2022, outcome "recovering" and all described as "caught covid". The patient was tested for Covid post vaccination: SARS-COV-2 test: (24Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt dizzy after injection. Patient sit down. He then sat on the floor. Started to  lose consciousness hit his head on the back of padded chair  for 1-2 minutes We called 911 monitored his breathing and looked for any signs of anaphylactic shock. Patient regained consciousness.  Mention he did not eat today. He  drank some water. We advised him not to drink anything. Paramedics came patient left with them. Spoke to patient today. He feels it was do to lack of food.  He started to feel the same way when paramedics went to start an IV . He feels fine today
Patient here with complaints that right arm spasms are getting worse.  It started after she got her flu shot and at the injection site and it lasted two days and then it moved to her right shoulder blade area.  Now she can feel it it in her feet, legs, thumb, knee, arms and back occasionally.  It is not painful, just bizarre.    Area around flu shot was pulsing/fluttering; lasted about two days. Moved towards her back, around the shoulder blade. In the beginning, it was almost constant, but now it is more like one time and then stops. It can be in the hands, fingers, legs, flank (right along the rib cage). Happens most in the legs, some in the feet and thumbs.
tested with an in-house COVID test and came out strongly positive; tested with an in-house COVID test and came out strongly positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested with an in-house COVID test and came out strongly positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested with an in-house COVID test and came out strongly positive; Positive, notes: also positive on a second test. Clinical course: A caller said that a family member received a Pfizer COVID vaccine on Wednesday and was not feeling really well afterward, but it was a typical vaccine response. It persisted into the next day and was then tested with an in-house COVID test and came out strongly positive, and it persisted into this morning, also positive on a second test. His question is, can that person take Paxlovid or will that interfere with the vaccine. The caller said he is an HCP who is calling on behalf of a retired HCP.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in an unspecified number of the adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, several hours after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The Director of Operations for a large physician group reports that the physicians state that most recipients of Shingrix report injection site pain a few hours after vaccination that lasts several days. This case has been linked with case US2018147861, reported by same reporter.
swollen lymph node; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Medical Information Team. The reporter is the patient.  A male patient (reported as patient's age: 74; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous case, initially received from other non-health professional on 08-Feb-2018, concerning a 09-year-old, child, male patient. On 06-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, expiry date: not reported). On 07-Feb-2018, after 1 day vaccination, the patient had soreness of arm and leg (pain in extremities). The outcome of the event was not reported. The reporter assessed the event as non-serious. The case was considered as lost to follow-up since, the patient's mother requested not to be contacted for follow up.
High Fever, left arm very red, swollen, hot above elbow and very painful. Seen by urgent care doctor who ordered blood test and diagnosed cellulitis, prescribed antibiotic Omnicef. Follow up by family doctor, currently under doctors care. Nurse who administered vaccines was distracted by the small daughter of another worker. Child picked up vials of vaccine.
Iching red rash from head to waist. Lips and ear lobes swollen.
Injection given left upper arm 8/6/10. Next day had reaction of tenderness and red area size of softball redness lasted approx 1 week. After 6 months pain and tenderness remain. Pain when arm raised above head to groom hair etc. If arm used too much pain radiates down to forearm. TYLENOL taken for discomfort at times.
This spontaneous report as received from a pharmacist refers to a patient of unknown age with pre-existing allergy. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number and expiry date was not reported). No concomitant medication was reported. As reported, now (unknown date) patient needed steroid shot for a pre-existing allergy (medically significant). The outcome of the event was unknown. Upon internal review the event allergy was considered medically significant. Additional information has been requested.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (unspecified drug).    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported. . On 01-Jun-2022, patient experienced Covid rebound.   The Covid rebound occurred five days after ending Paxlovid treatment.  Device Date- 03Jun2022. COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with medical history of Drug allergy, Concomitant products included PAXLOVID from 24-May-2022 to 28-May-2022 for COVID-19 treatment who experienced the unexpected  event of COVID-19 (AESI) 251 days after  3rd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with medical history of Drug allergy, Concomitant products included PAXLOVID from 24-May-2022 to 28-May-2022 for COVID-19 treatment who experienced the unexpected  event of COVID-19 (AESI) 251 days after  3rd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Erythema and warmth spreading down left arm, nausea and fever, chills. Vaccine given 8/14/06, pain, nausea fever worsening erythema 8/17/06.
Information has been received from a nurse practitioner student concerning her 61 year old father who in July 2008, while hospitalized for another condition (unspecified) was vaccinated with PNEUMOVAX vaccine (lot # not reported). "The same day the vaccination was given" the patient had severe swelling and pain in the arm and injection site where the vaccine was given. "1 week later" the patient recovered. No further information was available. Additional information has been requested.
loss of consciousness Narrative:  Presents to the emergency department from vaccination clinic for complaint of feeling lightheaded and felt like he was going to pass about 10 minutes after the vaccine Patient states she was sitting down in the waiting room after his vaccination and felt very lightheaded and his vision became blurred and he thought he was given pass out. Patient had no nausea or vomiting, patient states he had some neck pain and tightness in his muscles in the back of his head but that resolved. Patient was sitting up in the room in no acute distress. Patient denied any chest pain, no shortness of breath, no stridor, no drooling, no hives, no conversational dyspnea, no hypoxia, no chest tightness, no joint swelling. Orthostatics were negative. Lyong BP 136/79, pulse 62, standing BP 141/83,pulse 70. Patient was completely asymptomatic. Accu-Chek was 80mg/dL, he was given apple juice and some graham crackers and drink the juice. At 12:30 PM. The patient states h/e feels much better, ambulatory in the room and in no acute distress. Discharged home. Patient received 2nd vaccine 4/8/21 without issue.
Paternal reports son as having head ache, nausea, vomitting, diarrhea, fatigue, loss of appetite starting 2 days post 2nd hepatitis a vaccination. As of Aug 2nd patient is still nauseated, having diarrhea (non cramping) and fatigue. Patient has just left for a 2 year mission and under the care of clinic.
Heart palpitations; This case was reported by a consumer via call center representative and described the occurrence of palpitation in an unspecified number of an adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The reporter said that the physician told her that he had several patients that experienced heart palpitations after receiving the Shingrix vaccine. This case has been linked with the case US2019089966, reported by the same reporter.
pt recv vax;seen in er,weak,lethargic,confused,emesis;fever 105,erythematous area;8cm diam on upper lt arm,dx as cellulitis;Hosp 5 days;on Rocephin IV;nl;Urinalysis,blood work,chest x-ray(small haziness,poss infiltrate);mental confusion;
Headache, weakness, tachycardia (140), hypertensive (165/110)
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II, lot # L027432, expiration date: 22-JUL-2017, (dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 49 degrees Fahrenheit for 6.5 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
SUFFERING AFTER RECEIVING SHOT AND IT HAD BEEN A YEAR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suffering after receiving shot and it had been a year. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffering after receiving shot and it had been a year. This report was non-serious.
Nausea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0169) via an unspecified route of administration in the left arm on 19Apr2021 at 10:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the left arm on 29Mar2021 at 10:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 23:45, the patient experienced nausea and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events nausea and vomiting was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
lt arm swollen from shoulder to elbow hot to touch, t100.6 w/APAP; 48 hrs p/vax; parents reported clear fluid seeping from inject site; dx w/allergic reaction treated w/DPH;
received infanrix instead of Boostrix; adult patient received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 23rd November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse practitioner reported that, an adult patient received Infanrix instead of Boostrix by mistake which led to wrong vaccine administered and inappropriate age at vaccine administration. The health care professional had not available patient demographics neither lot number and expiration date. The health care professional offered to collect the information and follow up with safety. The reporter consented to follow up.
Rapid heartbeat; Inappropriate schedule of vaccine administered to Dose 1: 02Apr2021; Dose 2: 16Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphedema on an unknown date and unknown if ongoing. The patient was allergic to penicillin (PCN), non-steroidal anti-inflammatory drugs (NSAIDS) and acetyl salicylic acid (ASA). The patient previously took acetylsalicylic acid (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient received unspecified medication(s) within two weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 11:15, the patient experienced rapid heartbeat. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with diphenhydramine hydrochloride (BENADRYL) on 16Apr2021. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rapid heartbeat was recovered on 16Apr2021.   No follow-up attempts are needed. No further information is expected.
pt states  awoke this AM to lt tricep 7 1/2 to 3 1/2cm redness, itchiness, warm to touch;pt rt tricep 3x2cm, 2x2cm raised area, warm to touch;pt states inc malaise since 1st anthrax vax;
Left arm cellulitis seen on 4/23/18 and prescribed a 10 day course of Cephalexin.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 8 year old patient. On 10-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Joint inflammation, can't grip objects and hold at my side over 5 lbs without pain. Within days of injection. No recent injuries or any other cause for this pain in left arm, same arm as injection site.
Eyes became red & sore, face red, breast sore (L). Wheezing, tightness in chest, pain inside & upper back. 2 hours after receiving flu vaccine. Pt took Tylenol, 9/8 went to ER & left without being seen. Called clinic 9/9 @ 9:00am.