chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red, itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole.; Large red, itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; Itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; Hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; I didn't feel well, but not sick; Just weak and didn't want to eat.; Just weak and didn't want to eat.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and pseudotumor cerebri. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included furosemide (LASIX), hydrochlorothiazide (HYDRODIURIL), verapamil hydrochloride (CALAN-SR) and malus spp. vinegar extract (APPLE CIDER VINEGAR); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. 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 30Mar2021 at 17:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 18:30, the patient experienced large red, itchy, hot knot on the left arm. The knot was where the injection was, but it was bigger than the injection hole. The patient did not feel well, but not sick, just weak and did not want to eat. The events did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. 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 large red, itchy, hot knot on the left arm, did not feel well, but not sick, just weak and did not want to eat were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
VOMITING; RASH ON FACE; NAUSEA; COLD; CHILLS; FEVER; HURTS INJECTION SITE; TIREDNESS; SLEEP LOSS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:50 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sleep loss. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced hurts injection site. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 22:00, the subject experienced cold. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced rash on face. On 08-APR-2021, the subject experienced nausea.  Laboratory data included: Body temperature (NR: not provided) 102 F, 101.8 F, 99 F.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fever, and nausea, had not recovered from rash on face, hurts injection site, tiredness, and sleep loss, and the outcome of cold was not reported. This report was non-serious.
Extreme overall body pain lasting for about 2 hours. She never complains of overall body pain. She cried very hard during the pain - I've never seen her react to anything like this.
Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that patient had a sore arm for 10 days after receiving Shingrix. The reporter did not had any further information. This case has been linked with US2021252832, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252832:same reporter
I haven't felt right; Very tyred; Brain fog; Shortness of breath upon exertion; weakness; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, tiredness, foggy feeling in head, exertional dyspnea and weakness. On an unknown date, the outcome of the feeling unwell, tiredness, foggy feeling in head, exertional dyspnea and weakness were unknown.   It was unknown if the reporter considered the feeling unwell, tiredness, foggy feeling in head, exertional dyspnea and weakness to be related to Shingrix.     Additional Information: GSK receipt date: 02-OCT-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient reporterd that he/she have not felt right since getting Shingrix second dose 7 days ago. The patient experienced very tired, brain fog, shortness of breath upon exertion, weakness. Additional supportive information: Follow up would not possible, as no contact details were available.
Left arm swollen and red (deltoid area).  The next day 8 X 9 cm diameter with Erythema / edema.
Extreme headache/ body aches/ nausea/ chills - This all came on rather suddenly at around 7:30 pm.  The pain continued through the night and extreme fatigue set in.  The headache was so extreme that ibuprofen did not help, and loss of appetite for the entire day.  At 6:30 on Feb. 25, I was able to take ibuprofen and sleep.  By 6 am the following day, I was light headed but over the sever symptoms.   I had COVID in October, tested positive, quarantined, and I wear a mask.  I know I have antibodies because I donated blood in December.  Why are there no reports out about those of us that have had the illness, have antibodies and end up getting SICK from the vaccine?
This spontaneous report as received from a other health professional refers to a 16 year old female patient. On 09-OCT-2012, the patient was vaccinated with the first dose of GARDASIL (dose, duration and route were not reported). On 14-DEC-2012, the patient was vaccinated with the second dose of GARDASIL (dose, duration and route were not reported) and on 18-OCT-2013 the patient received the third dose of GARDASIL (dose, duration and route were not reported). The patient had her first seizure two days later on 20-OCT-2013. The patient was under the care of pediatric neurologist. The outcome of seizure disorder after her third dose of GARDASIL was unknown. The family believed GARDASIL triggered the seizure disorder. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA Patient had just received her 1st COVID vaccine and was sitting down monitoring symptoms when she suddenly flipped into a different heart rhythm and felt palpitations like her heart was racing.  Her heart rate was checked and found to be 130 beats per minute. Transferred to the emergency department On arrival to ED, patient is well-appearing in no distress.  Heart rate 134 on arrival.  EKG performed and confirmed atrial fibrillation.  IV was established, fluids and additional IV metoprolol administered.  Labs with mild hypokalemia at 3.2 which was replenished in the ED.   Heart rate flipped to normal sinus rhythm and repeat EKG showed her baseline right bundle-branch block with left axis deviation, T-wave inversions in lead V2, V3, III consistent with previous EKGs.  She reports she has improved symptoms, no increased dyspnea and no chest pain.  Patient discharged home
Joint pain in both knees/ knees hurt; Pain in his right hand; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in both knees/ knees hurt) and PAIN IN EXTREMITY (Pain in his right hand) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21D) 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 an unknown date, the patient experienced ARTHRALGIA (Joint pain in both knees/ knees hurt) and PAIN IN EXTREMITY (Pain in his right hand). At the time of the report, ARTHRALGIA (Joint pain in both knees/ knees hurt) and PAIN IN EXTREMITY (Pain in his right hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
This is a spontaneous report from a contactable nurse. A 4-month old patient received PREVNAR 13 on an unknown date along with suspect vaccine PENTACEL, which was given in the opposite arm. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient developed a dry scaly rash on both arms after receiving "both doses of PREVNAR 13." Outcome was unknown at time of report. No follow-up attempts possible. No further information expected.
small grape sized lump noted to left breast during self-breast exam on 2/24/21. imaging performed next day (2/25/21) revealed abscess of Left breast.  treated with 10 days of antibiotics
Patient felt dizzy after receiving his vaccine upon walking to observation room pt fainted and was guided to the floor by his mother. Patient came to by the time the nursing staff reached him. vitals were assessed and were as follows bp 52/23, hr 58bpm, O2 sat 100% temp 97.2, respirations 16. Patient was given fluids and the site MD was contacted. MD came to see patient and gave more fluids and considered him ok as his BP began to slowly rise. Patient reported that he gets faint like that every time he gets shots or blood draws. Patient also stated that he didn't eat much today (a bite of chicken). Pt has a history of spitting out food and poor eating habits.
Patient appeared to be having a pseudo-seizure according to family report. She was found upright in her wheelchair, and appeared to have difficulty breathing. She was maintaining her airway, and did not have any oral secretions present. She appeared to be unresponsive with verbal communication, in addition to making eye contact. EMS called per family and nursing decision. Bilateral feet were placed on a nearby chair, and the patient remained upright in her wheelchair. Upon EMS arrival, patient was assisted into gurney with nursing assistance. All patient belongings were presented to the paramedics at this time. Family states that a similar event had occurred earlier during the day of receiving her vaccine around 10 am, and reported that she was able to "get through it", and were on their way to obtain assistance for the event. The family suspects the event experienced today was not related to her receiving her second dose of the moderna vaccine today.
General malaise, nausea, hypotension.   11/13/09: Medical record for date of correspondence 11/13/09:  Assessment:  Received H1N1 vaccine 11/6/09 at a dialysis appointment and did not feel well,  c/o nausea and malaise on 11/7 & 11/8/09, according to pt's husband, she continued to feel unwell on 11/10/09.  On the morning of 11/11/09 the patient was found to have died in her sleep.  11/13/09: Hospital discharge summary(hospitalizaton prior to vaccine), hemodialysis clinic records and correspondence of case summary received. On 11/09/09, patient received out-patient dialysis. The patient had gained four pounds since her previous dialysis appointment.  12/21/09 Death Certificate received. DOD 11/11/09. Cause of Death: Hypertensive cardiovascular disease.
It started with nausea when I woke up on Wednesday December 15, 2021. Then I started experiencing head pressure nothing like I have ever had I consulted my doctor had a Covid test on December 16, 2021 before taking any medication. I was advised to take Tylenol that same night it was hard to sleep kept waking up. After 5 days started to loose taste and smell and recovered on January 2, 2022.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 1:27 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 74.60 for dose administered on 27-OCT-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 27-OCT-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 32 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 29-SEP-2021 and 05-OCT-2021 and beyond use date for the vial was reported as 29-OCT-2021 and 04-NOV-2021. Product moved to clinic on 27-OCT-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
MINIMAL TONGUE SWELLING, PT RECEIVED BENADRYL AND MONITORED FOR 60+MINUTES IN PHARMACY AND THEN LEFT W/HUSBAND TO DRIVE HER HOME B/C PRECAUTION W/BENADRYL DROWSINESS.  PT HAS FOLLOW UP WITH THEIR PRIMARY.  TONGUE SWELLING HAS RESOLVED
Narrative: Pt received 1st Moderna vaccine on 2/13/21; received 2nd vaccine on 3/13/21. Wife was diagnosed with COVID around 3/1/21. Patient became symptomatic of covid on 3/14/21, presented to ED on 3/17/21, was admitted, and tested positive for both COVID-19 and adenovirus. Discharged on 3/19/21.
little itchy bumps in left hand; little itchy bumps in left hand; finger was swollen and itchy; big red itch splotch; injection site is incredibly huge swollen and very red; injection site is incredibly huge swollen and very red; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient 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 13May2021 at 16:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none that the patient knows of. Known allergies were reported as none that the patient knows of. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021, the day after the patient got the shot, the patient started to get little itchy bumps in her left hand. The patient didn't think anything of it. On Saturday (as reported) the patient had to take off her wedding ring because her finger was swollen and itchy. The patient had a big red itch splotch on her ring finger with a few itchy bumps on her left hand and also her injection site was incredibly huge swollen and very red. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events little itchy bumps in left hand, finger was swollen and itchy, big red itch splotch, injection site incredibly huge swollen and very red were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Found lump in breast in April 2021 and saw PCP in May 2021.  Because of scar tissue at that site we both decided it was from that.
Patient contact today 6/7/2018 in pharmacy - patient stated she had a "bad" reaction after the vaccinations last month. She described having pain on the left side of her neck (anterior cervical lymph node area) extending up to her ear. It was "very painful," sharp at times and otherwise continuously "very achy." She thinks it may have been slightly swollen and doesn't remember if it was tender or warm to touch. She doesn't remember having any other side effects besides sore arms. It lasted for 3 days after the shots and she was ready to go to the doctor when it subsided. She is "fine" now.
24 hrs p/vax pt devel red blotches @ lt elbow, proceeding to trunk & back & axillae, then to legs (front & back) to below knees; low grade fever (not measured); took DPH for rash;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cervical spondylosis" (unspecified if ongoing); "HLD" (unspecified if ongoing), notes: HLD; "hypothyroidism" (unspecified if ongoing); "ischemic colitis" (unspecified if ongoing); "ischemic heart disease" (unspecified if ongoing); "macrocytosis" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=11Jul2022, treatment stop date=16Jul2022, Indication=Treatment of COVID-19. 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 , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19  and the suspect drug BNT162b2 .
Patient complained of feeling dizzy a few minutes after receiving the HPV 9 vaccine. He then had a very brief convulsion (lasting a few seconds), his eyes rolled into the back of his head and he lost consciousness (also for a few seconds). When he awoke, he said his stomach hurt and his fingers felt tingly. We observed him in the office for 30 min and symptoms completely resolved.
Tested positive getting Covid near the end of the cruise; Tested positive getting Covid near the end of the cruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: I have had Covid before plus fully vaccinated. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "Tested positive getting Covid near the end of the cruise". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive. The patient received a booster 3.5 weeks before, just before a cruise. She has had Covid before, plus fully vaccinated. On 17Aug2022, she tested positive getting Covid near the end of the cruise. Most likely from an excursion. She was quarantined, but the booster appears to have minimal affect on reducing transmission. The patient was negative and self-quarantining. Boosters may have helped in surviving the first infection. She was stable now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 1-2mins sz, generalized tonic postictal state-30min; low grade fever, lasting 12 hr;
Patient was in office today and asked to receive her 1st COVID booster.  Moderna Bivalent given.  Patient was given vaccine from a vial that was in the refrigerator more than 12 hours.  Vial was opened on 12/10/22 and was stored in the refrigerator and was never stored ambient.  After patient left the office I went in to do COVID inventory and realized that a new vial had not been opened for the day and that the CMA who drew up vaccine had taken it out of the opened vial from 12/10/22.   Call to patient was made to make her aware of the situation.  Gave patient signs and symptoms of what to look for in case of a reaction out of the ordinary and what to do if something did happen.