chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-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). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 53.37.  Concomitant medication information was not provided by the reporter.  Product moved to clinic on 13-Jan-2021. Vial was moved to fridge on 09-Feb-2021. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit from 09:00 AM. Beyond use date for the vial was reported as 10-Mar-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 Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Received smallpox on 11/3/07 and received flumist on 11/18/07
Inspection: erythema, swelling, and warmth on both anterior thighs; 4 cm x 2.5 cm induration L thigh and 1 cm x 0.7 cm R thigh. Swelling and erythema from Immunization site 3 days after vaccines.
I was very sick; I could not eat all day after the shot; Diarrhea; I couldn't stop urinating; The urine just kept flowing; I was really in pain I was confused; I was really in pain I was confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0182) at the age of 69 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Verbatim: Hay fever" (unspecified if ongoing), notes: Verbatim: Hay fever; "Chronic obstructive pulmonary disease" (unspecified if ongoing), notes: Verbatim: COPD. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; ONDANSETRAN; COUMADIN; ERGOCALCIFEROL; BREO ELLIPTA; CALCIUM CARBONATE; FLONASE [FLUTICASONE PROPIONATE]; FAMOTIDINE; MELATONIN; ONDANSETRON taken for nausea. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was very sick"; EATING DISORDER (non-serious), outcome "unknown", described as "I could not eat all day after the shot"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "I couldn't stop urinating; The urine just kept flowing"; PAIN (non-serious), CONFUSIONAL STATE (non-serious), outcome "unknown" and all described as "I was really in pain I was confused".  Additional information: The patient was also the reporter. Reporter seriousness for the events was unspecified. Covid-19 Vaccine manufacturer: Unspecified, NDC number of Covid-19 Vaccine: Unknown, UPC number of Covid-19 Vaccine: Unknown, Expiry Date of Covid-19 Vaccine: Unknown. Dates for Concomitant Products: (Start: Unspecified Stop: Unspecified). Patient History of Asthma, Hay fever, COPD. Investigation Assessment: No. Vaccine name: Pfizer Covid 19 vaccine. Consumer stated, she had the shot yesterday and was very sick last night. She could not eat all day after the shot and she had not eaten before either but she had the diarrhea and she couldn't stop urinating. The urine just kept flowing and she was not living with her children. Last night she was screaming for her daughter because she is a nurse and she kept yelling for her and she didn't know what to do. Consumer was informed about Pfizer Medical information department and was provided with the number. Consumer was informed about the role of Pfizer drug safety. Consumer stated she felt like this close, everything was a mess, its mountain here she did not know what to do. She was living in a facility. She never check. She knew that's strange. The patient did not give information on ethnicity. Consumer stated she was not aware what was going on. She was home, she thought of her daughter she kept calling for her. But she didn't know that she (Incomplete sentence), she was really in pain she was confused.  No follow-up attempts are possible. No further information is expected.
couldn't get out of bed for 3 days; nasty headache; fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date the patient couldn't get out of bed for 3 days and he had a nasty headache and a fever for 3 days. The outcome of the events was recovered.   The lot number for the vaccine, [Pfizer BNT162B2], was not provided and will be requested during follow up.
Swelling, itching at the site of injection.  Also, generally feeling poorly, tired, low grade fever.
Second COVID shot canceled due to the weather/missed the second dose scheduled on 15Feb2021; He doesn't remember where he got the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (father-in-law) that. A male patient of an unspecified age received (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced second covid shot cancelled due to the weather/missed the second dose scheduled on 15feb2021 on an unspecified date and he does not remember where he got the vaccine on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
4/2/2021 patient felt fatigue, worsened on 4/3, evening of 4/4 patient got fever, chills, shaking. Symptoms 4/4-4/12 continued including fever, chills, shakes, muscle pain, headache, upset stomach and fatigue. Fever went up to 104.1, but was usually 101 - 102.9.  Taking Tynenol  4/4-4/6, then alternated with Advil, 4/7 - 12.  There was brief break in fever 4/7 of a few hours.  Symptoms became less intense after 9  days. Patient took Vitamin C, D, Zinc and Niacin supplements per doctor recommendation.
ACUTE PULMONARY EMBOLISM 4/25/2023 HX OF PULMONARY EMBOLUS
Patient at daycare, took nap at 12 Noon still sleeping at 2pm; found blue and unresponsive at 3pm.
Chronic pericarditis, I was told it was heartburn, for years I thought I had heartburn, until 900mL of fluid build up and I almost died. There are 4 more.
tested positive for covid; did quarantine have no symptoms; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer reported similar events for 2 patients. This is second of two reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive for covid and did quarantine have no symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382885 Same reporter/product/Event, Different patient
Palpitations with heart rate up to 150 on 1/10/21 at 2pm accompanied by dizziness, nausea, headache and shortness of breath. Required IV fluids, EKG, labs, telehealth visit, cardiology referral and placed on Metoprolol for suspected POTS. Currently still having orthostatic tachycardia 7 days after onset of symptoms and pending cardiology referral.
Information has been received from a registered nurse concerning a 66 yr old male who was vaccinated with his first dose of pneumococcal vaccine 23 polyvalent. Subsequently, within two days  of receiving the vaccine, the pt experienced paresthesia in his hands and developed unspecified swelling. The nurse reported that this was the first time that the pt had ever received a pneumococcal vaccine. The nurse also reported that she was from the health dept and that the pt did not ever receive his vaccine at the health dept. Unspecified medical information was sought. No further information is available.
Sore arm - started at injection site, traveled down to hand and eventually into lymph node of armpit.  Sore for 4 days   Low grade fever and chills start about 7 hours after injection and continued for 30 hours off and on.   Skin sensitivity all over my body  Fatigue, aches, tiredness. Persistent headache into day 5.
underneath her arm swollen "gland" big as a baseball; spread to chest; redness and swelling still spreading; injection site red down to elbow; injection site swollen down to elbow; body aches; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches), INJECTION SITE ERYTHEMA (injection site red down to elbow) and VACCINATION SITE SWELLING (injection site swollen down to elbow) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 04-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches). On 05-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red down to elbow) and VACCINATION SITE SWELLING (injection site swollen down to elbow). On an unknown date, the patient experienced LYMPHADENOPATHY (underneath her arm swollen "gland" big as a baseball), ERYTHEMA (spread to chest) and ERYTHEMA (redness and swelling still spreading). The patient was treated with LEVOTHYROXINE SODIUM (SYNTHYROID) ongoing since an unknown date at an unspecified dose and frequency; BUPROPION at an unspecified dose and frequency and ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches), INJECTION SITE ERYTHEMA (injection site red down to elbow), VACCINATION SITE SWELLING (injection site swollen down to elbow), LYMPHADENOPATHY (underneath her arm swollen "gland" big as a baseball), ERYTHEMA (spread to chest) and ERYTHEMA (redness and swelling still spreading) 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.   no concomitant medications reported.
he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus; he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In 2021, the patient was diagnosed with COVID-19 infection three weeks after receiving his first dose of the Pfizer BioNTech Covid-19 Vaccine. The COVID kept him down for about three and a half weeks with high fevers coming and going. He contracted the COVID virus and was sick for a month. The outcome of the events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Chills, exhaustion, hot flashes, body aches, headache, nausea, muscle pain at site of injection.
patient came i for a Covid Pfizer Bi-Valent vaccination and received a Covid Pfizer Mono-Valent vaccine by mistake. It was discovered recently and brought to the patient's attention. She was very pleasant and did not get upset. She was told to come back in 2 months from the vaccination date to get the Bi-Valent Covid vaccination on or after 11/12/2022 with no complications
Systemic: Dizziness / Lightheadness-Medium, Systemic: Stomach aches-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt started feeling lightheaded 1-2 minutes post-vaccination at 2:50PM and fell down on her backpack. Pt was conscious and mouth showed mild bleeding. RPh on duty had pt lie down on floor with both legs raised on chair and continuously monitored pt's BP and pulse. Pt's BPM was 109/73 and pulse was 88 at 3PM. Of note, pt reported PMH of vertigo x7 years and attributed her lightheadedness to anxiety. At 3:20PM, pt recovered and was able to stand and walk on her own.
Approx 1.5 hrs immun, child developed a high pitched scream & persistent crying/screaming that lasted 6 hrs 12PM to 6PM; child was afebrile-inject site was OK-no erythema or swelling;
left armpit lymph nodes are swollen and painful, visibily swollen under armpit.  sever headache after vaccine 24 hours standing
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # K026532, expiration date 07-AUG-2017) (Lot # L006546, expiration date 27-NOV-2017), (route, dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
After several days of pain in left shoulder, on the morning of 4/11/21 a harsh rash was noted on the back next to the shoulder blade as well as a similar bright red rash on the thorax front.  A visit to a Now Care facility on that Sunday morning confirmed a diagnosis of shingles, and Valacyclovir was prescribed, 1 gm. tablet every 8 hours for 7 days.  In the following 4 days, as the medication was taken, the rash gradually spread around the side of the thorax from front to back and under the left arm.  The pain remains as of 4/22/21.
STROKE; This spontaneous report received from a patient via social media via a company representative 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 (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-MAY-2021, reporter stated that "Same here....vaccine on May 6 stroke on May 25. " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211258275-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt had syncopal episode; upon waking: BP 102/88, P 64, EKG unremarkable.  Had a 2nd syncopal episode, about 12 seconds with right leg extended and arms jerking briefly  Then awoke fully alert without complaints of dyspnea headache, uricaria etc  4:15 97/56, HR 66 PM 4:26 PM 111/71 Encouraged to go to ER due to possible seizure activity but signed consent refusing EMS care
total fatigued, chills and ache. I slept and i slept. lasted all day and about 3:00 the next afternoon i started feeling human again and by the 3rd day i was over it.
thoracic myelopathy; neural impingement; Neuropathy; pain in her back and legs; weakness in her legs; Transverse Myelitis; paralyzed in her left leg; This case was reported by a lawyer and described the occurrence of myelitis transverse in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received Shingrix (intramuscular). On 6th September 2019, 1 days after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant), paralysis (serious criteria GSK medically significant), pain and lower extremities weakness of. On 23rd October 2019, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the patient experienced thoracic myelopathy (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse, paralysis, neuropathy, thoracic myelopathy, pain and lower extremities weakness of were unknown.   It was unknown if the reporter considered the myelitis transverse, paralysis, neuropathy, thoracic myelopathy, pain and lower extremities weakness of to be related to Shingrix.  Additional information: On 05 September 2019, a pharmacist telephonically prescribed a Shingrix vaccination to be administered to the patient by an unsupervised intern. As a direct and proximate consequence, she suffered from Transverse Myelitis, was permanently paralyzed in her left leg, and forced to take medication for severe and chronic pain that interferes with sleep. On awakening the morning of 06 September 2019, she had sharp pain in her back and legs. She went to doctors and was prescribed a muscle relaxant. Over the next few weeks, the condition worsened into weakness in her legs. She did not connect the condition to the vaccination she had received the day earlier. On 23 October 2019, she had a nerve conduction study done. The study showed severe peripheral neuropathy. She consulted with her acupuncturist determined that the cause of the problem was most likely the Shingrix vaccination. As per records dated 21 September 2020, she had shingles and/or been previously vaccinated with Zostavax. She received a Zostavax vaccination in October 2017, only two years prior to being vaccinated with Shingrix.
Arm is still swollen; Headaches; Achy body; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is still swollen"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PAIN (non-serious), outcome "unknown", described as "achy body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Severe headache/migraine; Chills; Nausea; Diarrhea; This is a spontaneous report from a contactable other health care professional , the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route in the left arm on 12Mar2021 at 18:00 PM (at the age of 39-year-old) as a single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included Prilosec 40 mg taken within two weeks of vaccination for unknown indication. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced severe headache/migraine, chills, nausea and diarrhea on 12Mar2021.The patient did not receive treatment for the reported event. The clinical outcome of the migraine headache, chills, nausea, and diarrhea was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Parent spoke to one of our clinic nurses after work that evening and sent her pictures showing the right leg and right side of patient's face red and swelling.   Patient's MD was called and she advised her to go to the after hours clinic since it was 7:00 on a friday evening.  Cold compresses were already being applied.      We have not received an after hours report at this time.
Onset 5pm aching muscle pain from injection site to elbow (R) arm, weakness, nausea, next day vomiting x 1. Treatment: ER visit PERCOCET 5/325 mg tab po q 4hrs/PRN.