chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hands turned blue like they were not getting any circulation; hands turned blue like they were not getting any circulation/to the touch, the skin color would change. The left hand was worse, it's where the injection site was; 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: EW0170) via an unspecified route of administration in the arm left on 01May2021 at 09:30 (at the age of 22-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: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 18:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. 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 02May2021 at 03:00, the patient's hands turned blue like they were not getting any circulation but they were getting because when touched, could see that the skin color would change. The left hand was worse, at the injection site. There was no treatment received for the events. The clinical outcome of the events cyanosis and injection site discoloration was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Treatment received updated to No.
arm sore; arm swelling to elbow with rash; could not stay up; minor rash; nauseous; extreme fatigue, could not stay up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash) and NAUSEA (nauseous) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (extreme fatigue, could not stay up). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash), NAUSEA (nauseous) and FATIGUE (extreme fatigue, could not stay up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-096933, MOD-2021-029359 (Patient Link).
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose and route of administration were not provided), Lot # L007559, expiry date 01-JUN-2017; L018499, expiry date 25-FEB-2017; L023936, expiry date 15-MAR-2017; L039659, expiry date 15-MAR-2017; K018181, expiry date 04-JUN-2017; L036300, expiry date; and L015460, expiry date 20-JUL-2017. No adverse effects were reported. No additional information was provided. This is one of six reports received from the same reporter. Additional information has been requested.
Spoke with mother of client.  Client has had many problems after getting Menactra vaccine.  Mother believes all the problems her son has had are due to vaccine.  Son got shot on 8/9/05.  He had a mild HA on Dec 05.  1/1/06 he had another HA x3 days and very severe. He went to ER. 2 weeks later, he stated he felt strange. Like all the blood was rushing to his head and his head was going to explode. Back to ER for IV Toradol.  He had some mild to severe chest pain. Mid to late January.  He then had nodules on his lower inner lip.   Went to ER agian, 2/21/06, had severe chest pain and HA's. About 1 1/2 weeks ago, experienced needle like pins up and down his spine.  He has been to 3 neurologists and all tell parents it is anxiety.  He had had several EEGs, EKG, Stress Test. Cat Scans Blood work. and all come back within normal range.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
She reports after ~8 days she became ill with cough, aches, shortness of breath and fatigue (Her aunt got vaccine on same day and they fell sick around the same time with same symptoms),was hospitalized in critical care and developed DKA around 5/24/21 and spent a week in hospital
Hospitalized for COVID19, hypoxic respiratory failure 1/14/22-1/21/22. Treated with dexamethasone,  zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily.
Fatigue, moderate body aches and chills and low grade fever. All lasted 36-48 hours.
9 days later, at vaccine injection site, she developed a 3x5 inch are of redness, the area is itchy and tender to touch
Patient complains of severe pain, swelling ("a bump"), itchiness, and redness at site of injection, which started a few hours after the shot. Patient reported side effects to the pharmacy 3 days after the injection, saying the pain and swelling has subsided after taking ibuprofen and acetaminophen and topical Benadryl to the site. Three days after injection, her only complaint is slight swelling and itchiness. Instructed her to take Benadryl at bedtime and continue ibuprofen if needed.
Severe burning and pain at the exact moment of the injection in my left shoulder on June 6 2019. Sensation of hot molten lava being poured from shoulder down to elbow. This burning and pain have continued, somewhat less but still very present, since that date. Treated symptomatically by the medical practice with only minimal and temporary relief but not trying to identify and treat the injury itself. To sleep I must take NSAID for relief. Limited mobility in that shoulder. Have return visit scheduled for 7/29/2019.
On February 20, 2022, I had a little bit of congestion, and I was feeling tired and may have been coughing.  I rested in bed.  On the 25th I tested positive for COVID-19.  I was still congested.  I called the doctor's office and then talked to doctor on Monday the 27th.  Since it had been so many days since I had symptoms, I was not given Paxlovid.  I isolated until March 1, 2023.  I tested negative on March 3rd.  I am gradually getting better but still have a slight cough.
SIDS Admitted to hospital through ER with sudden cardiac and respiratory arrest with significan periodic of anoxia/cardiac arrest.  Multiorgan system injury and severe anoxic brain injury. COD as per autopsy exam was anoxic encepalopathy due to resuscitated SIDS. Per F/U 8/13/02: Other conditions: Multisystem ischemia. This is a 2 month old white female who was found unresponsive by her babysitter face-down on a water bed. EMT's arrived and the baby was pulseless but subsequently, on transportation to the ER, a pulse was restored. The infant was transferred to another facility for management of complications of anoxia. It appeared to clinicians that the infant had resuscitated SIDS. At the hospital, the infant showed evidence of severe hypoxic ischemic encephalopathy and subsequently, developed multi-organ failure based upon anoxia. The interval between the initial arrest and death was approx. 2 days. Findings on autopsy: Anoxic encephalopathy with brain swelling; reperfusion infarction of the septum of the heart, hemorrhagic and ischemic infarction of the right colon and transverse colon.
On Jan 14th I did a home test and found out I had COVID-19. I went to the ER the next morning to get the anti-body infusion.
This spontaneous report as received from a phlebotomist refers to 3 or 4 unspecified patients of unknown age. Information on pertinent medical history of patients was not reported. On an unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (dose not reported, lot # L034736, expiry 09-DEC-2016). No adverse effects reported. No further information was provided. This case is one of the several reports received from the same source. Additional information has been requested.
A little over two days after my first COVID vaccine, I started experiencing racing thoughts and feelings of heightened anxiety, franticness, panic, agitation and overwhelm. The severity of these symptoms would fluctuate, but they have been present most of the time since then. They made it very difficult to complete my semester at school. A week prior my long-term girlfriend effectively broke up with me, and I had been taking two herbs, Wort and rhodiola, the former for a month and the latter for two weeks at the beginning of symptoms, which I later found out can significantly influence brain chemistry and even induce mania in some individuals. Thus, it seems likely that a combination of these and other factors could have caused the symptoms I am now experiencing, and this is the opinion of the psychiatrist I am currently seeing (listed under doctor to contact). However, given the close timing of my vaccination and subsequent onset of symptoms, I have been worried about whether it could have played a role and wanted to report it. In the past couple weeks the psychiatrist has prescribed me with hydroxizine to help me sleep and GABA to help calm my mind, and they have helped a bit, but I still do not feel like myself.
Info has been received from an RN concerning a healthy 36 month old female pt with no allergies, who on 2/7/05 was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live (lot 646817/1063N). There was no concomitant vaccine administered on 2/7/05. Beginning on 10/10/05, the pt developed a fever and by 10/11/05, she had also developed "spots" which numbered about 30 by 10/12/05. No treatment was recommended. There were no lab studies completed. Additional info has been requested.
My lymph nodes under my arm pit are very swollen and painful (same arm of injection); My lymph nodes under my arm pit are very swollen and painful (same arm of injection); This spontaneous case was reported by a consumer and describes the occurrence of the first episode of LYMPHADENOPATHY (My lymph nodes under my arm pit are very swollen and painful (same arm of injection)) and the second episode of LYMPHADENOPATHY (My lymph nodes under my arm pit are very swollen and painful (same arm of injection)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced the first episode of LYMPHADENOPATHY (My lymph nodes under my arm pit are very swollen and painful (same arm of injection)) and the second episode of LYMPHADENOPATHY (My lymph nodes under my arm pit are very swollen and painful (same arm of injection)). At the time of the report, last episode of LYMPHADENOPATHY (My lymph nodes under my arm pit are very swollen and painful (same arm of injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
3hrs post vax pt started to have startle response like movements but still alert & playful given phenobarb;pt exp jerky movements & rt eye started to droop & head was deviated to rt & eyes to the lt & drooling;
This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unknown age and gender with no pertinent medical history and drug reactions reported. On an unknown dates, the patients were vaccinated with doses of VAQTA (dose, route, lot number and expiration date were not reported) that were improperly stored. No adverse effect was reported. This is one of several cases received from the same source.  Additional information has been requested.
This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored ROTATEQ (strength, lot # and expiration date were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004085: US-009507513-1709USA007306: US-009507513-1709USA007304: US-009507513-1709USA007305.
Arm is still sore to touch, hurts to raise and/or move arm..feels like it's been smashed with a baseball bat.  Continues still, 3.5 weeks out.  Pharmacist stated that they had others also complain that had received vaccine at same clinic.
Breakthrough case admission after 3 vaccines Pfizer 2/25/21 LOt# EN6202;  Pfizer 3/18/21 Lot# EN6202;  Pfizer 10/22/21 Lot# FF2590
Hives on face arms and torso. Lasted until 10/17/2012 am most had cleared up by the morning.
This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # J011045; expiration date: 15-MAY-2015 (also reported as 15-MAY-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Night after receiving vaccinations patient came down with a 100 degree F fever. She had fever and chills the next day and fatigue the following day. The third day out she lost her voice for one day.
pt recvd vax & was found to be 5 wks pregnant; during pt's pregnancy exp swelling; AUG93 p/3 hrs of labor delivered a female baby vaginally & exp 4th degree lacerations; baby had no congenital anomalies but was born w/broken clavicle;
pt recv vax 24JUL97 & exp a high fever, pain in joints, muscles, & back;mom took to ER @ hosp;MD say it was a rxn to Td & it should not be given again;pain med given to pt;
On 12/05/2022 I received my Covid-19 vaccine. On 02/01/2023 my heart rate started to increase to 130-182.  I reached out to my cardiologist. I had Holter monitor placed on me for a month.
This case was reported by a physician via sales rep and described the occurrence of headache in a patient who received BEXSERO. Concurrent medical conditions included migraine. Concomitant products included MENACTRA and Unspecified migraine medication. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. The reporter considered the headache to be unrelated to BEXSERO. Additional details were provided as follows: The physician reported to a field representative that a patient had a headache after receiving BEXSERO and MENACTRA. The physician did not believe the headache was related to BEXSERO, as the patient had a history of migraines.
PAINFUL SWOLLEN RED ARM. NOT HOT TO THE TOUCH. BLISTERS/BUMPS AT INJECTION SITE.
Autoimmune hepatitis; This is a literature report.  A 67-year-old female, experienced significantly elevated liver enzymes and bilirubin levels after receiving four doses of the Pfizer COVID-19 vaccine. Liver biopsy revealed Grade 4 Stage 1 with lymphoplasmacytic infiltrate and interface hepatitis, consistent with autoimmune hepatitis and the patient was initiated on Prednisone, tapering down every 10 days. Upon completion of prednisone therapy, she started on Cellcept. She responded well to treatment and has been maintained on immunosuppressants. Chronic liver disease workup ruled out other underlying liver diseases. Conclusion: The incidence of vaccine-induced liver injury is rare, but clinicians should be aware of this potential adverse effect. The benefits of COVID-19 vaccines outweigh the risks of liver injury. It remains unclear if the vaccine triggers an autoimmune response or leads to de novo autoimmune hepatitis. Further research with a greater sample is necessary to understand the underlying mechanism and identify risk factors. Additionally, determining the optimal duration of immunomodulatory treatment is crucial. Despite rare cases, the overall safety and efficacy of COVID-19 vaccines support their continued use in combating the pandemic.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported event 'autoimmune hepatitis' due to a plausible temporal association.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300273746 Same article/event/drug; different patient.;
Had headache, diarrhea and fatigue starting about 8pm 9/17/10. Felt feverish during night. Had vomiting 9/18 and 9/19. Went to ER 9/19 and had IV fluids. Continues to have fatigue 9/21/10.
Fever/temperature of 104.5F; feeling cold; feeling crummy/ like she got hit by a truck; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, feeling cold and feeling bad. On an unknown date, the outcome of the fever, feeling cold and feeling bad were unknown.   It was unknown if the reporter considered the fever, feeling cold and feeling bad to be related to Shingrix.  Additional details were reported as follows: A few months ago at 17.30, the patient received the 2nd dose of Shingrix. After receiving the 2nd dose of Shingrix the patient experienced a fever at 104.5 degree F, feeling cold, and feeling crummy. The health care professional noted all adverse events were began the morning after the vaccine and completely resolved two days after vaccine administration. The reporter consent to follow up. This case is linked to case US2020141508, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141508:same reporter
Patient said injection hurt when administered. Patient developed black and blue mark at injection site the day after. Saw her MD a few days later- was still bruised and sore. Called me 11/10/08 to say she was still feeling sore.
Suspected vaccination failure; breast cancer; outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), breast cancer (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, breast cancer and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, breast cancer and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's daughter. The age at vaccination was not reported.  The patient received shingles shot, possibly Shingrix and experienced outbreak of shingles. The reporter mentioned that, the patient had breast cancer. It was unknown if the breast cancer was prior or post vaccination. This case was considered as suspected vaccination failure as details regarding number of doses, time to onset of target disease and laboratory confirmation was unknown at the time of reporting.
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 70 years old female patient who experienced itching at the site of injection, while she received vaccines B12-VITAMIIN and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient received a dose of suspect B12-VITAMIIN not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious itching at the site of injection (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and B12-VITAMIIN. (Other relevant tests included No lab data). Final diagnosis was itching at the site of injection. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of document held by sender: none.