chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pressure all in her head and all over her body; pressure all in her head and all over her body; Feeling flushed; Nausea; feel her heart beating; legs feet and hands would feel tingly; She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total.; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: Unknown, Batch/lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 22Jan2021 at 0.3 mL, single for she did not got COVID. Medical history included continuing A-fib, takes medication for this everyday. Diagnosed at least 10 years ago. The patient's concomitant medications were not reported. Last night (25Jan2021) her symptoms started. She was unsure if it was from the vaccine or not but she was thinking it was, she had not had it before. Around 11 pm last night (25Jan2021) she got a pressure all in her head and all over her body. She felt flushed. She had nausea. She could feel her heart beating. She could really feel it. It was not abnormal. She did have A-fib, but this was normal, not like A-fib. Her took her blood pressure which was normal. She took her pulse which was normal. She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total. Sometimes her legs feet and hands would feel tingly. And the flushing continue- it feels like her body was hot, but it was not hot to the touch. She had felt better this morning when she got up, but she did have one bout when she was just sitting here. She had improved overall. Caller stated she already spoke to the safety department but did not have any reference number to provide. The outcome of event 'Feeling flushed' and 'Sometimes her legs feet and hands would feel tingly' was recovered on 26Jan2021, of the other events was recovering.
10 minutes after dose the patient started having dyspnea, lightheadedness, chest pain, weakness, and headache. Epinephrine 0.3 mg IM was administered prior to transport to the ED. Ipratropium-albuterol 0.5-2.5 mg/3 mL nebulizer solution, dexamethasone 10 mg IV and Diphenhydramine 50 mg IV were administered in ED. Patient was discharged after resolution of symptoms (2.5 hours after administration of vaccine).
CHEST PAIN, SHORTNESS OF BREATH. STARTED 1 DAY AFTER VACCINE, WORSENED TODAY 9/1 PAIN IS SUBSTERNAL, NON RADIATING, FEELS LIKE PRESSURE/SOMEONE SITTING ON CHEST. STATES PAIN IS DIFFERENT FROM PREVIOUS CHEST PAINS FROM FIBROMYALGIA
Pt exp generalized tonic clonic sz lasting approx 1 min approx 24hrs p/receiving DTP/HIB; Hospitalized 1.5 days & EEG & LP, CBC, SMA-6, CA++, Phosphorus-normal; Discharged on no meds;
A covid vaccine vial was reconstituted twice, this patient received a diluted dose of the vaccine, the patient was contacted about the issue, and the patient refused to come into to be revaccinated at this location.
low grade fever; swollen lymph node on collar bone; pain in arm; tingling in lips and tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in lips and tongue), PAIN IN EXTREMITY (pain in arm), PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node on collar bone) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips and tongue). On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 11-Jan-2021, the patient experienced PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node on collar bone). On 07-Jan-2021, PARAESTHESIA ORAL (tingling in lips and tongue) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown and PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node on collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
2nd SHINGRIX shot, upset stomach, shivers, headache, very tired. Had no reaction to first shot
I began to menstruate for a period length of 6 days/post menopausal bleeding; This is spontaneous report from a contactable consumer (patient) via . This non-pregnant 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 14:30 (at 58-years of age) as a single dose for COVID-19 immunisation. Medical history included asthma, coronary artery disease, gastroesophageal reflux disease (GERD), and chronic hypertension, all from unknown dates and unknown if ongoing; and menopause from an unknown date reported as almost 2 years. The patient received unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EN6200) in the left arm on 22Feb2021 at 16:30 (at 58-years-old) for COVID-19 immunisation; and lisinopril (ZESTRIL) from an unknown date for an unknown indication and experienced allergies. On 19Mar2021 at 13:00 the patient began to menstruate for a period length of 6 days; she reported this was unusual as she had been considered by medical definition as in menopause for almost 2 years. The patient reported this was treated by her gynecologist as post-menopausal bleeding and required an endometrial biopsy which was negative for cancer. Treatment was received for the event and the patient underwent pelvic ultrasound, the results of which were not reported. The events required a physician office visit. The clinical outcome of the event was recovered on 25Mar2021. Since vaccination the patient had not been tested for COVID-19.
Admitted with diarrhea/sob; hypoxia; Covid +; No steroids as pt remained stable with oxygenation; no remdesivir due to ESRD; D-dimer 1.07 CRP 5.06; Ferritin 1035; O2 @ 2 LPM during hospitalization; No specific tx for covid; No home O2 at d/c
Approximately 2 minutes after both vaccines were administered, patient turned pale with blue lips and said he couldn't see anything.  He completely passed out, awaking about 30 seconds later and began vomiting.  This all happened in the office.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a physician's medical office for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Dx: Acute DVT of the left posterior tibial vein (distal to popliteal) shown on US, opted for repeat CBC next AM to confirm platelet count stability and US in 1 week to assess DVT progression vs stability Symptoms: Headache, nausea, myalgia, shortness of breath, forgetfulness, leg pain starting from bilateral feet cramping
Extreme fatigue upon waking up the morning after the shot (Saturday, Dec. 8) I had no energy.  All I wanted to do was sit on the sofa and close my eyes. I also experienced chills throughout that first day and had no appetite the first day. The second morning (Sunday, Dec. 9) I felt a little less fatigued, did not have any chills, and ate meals. The third day after the shot, Monday, Dec. 10 I felt back to normal. I have never had a reaction to any vaccination I have received in the past.
Sore arm; This is a spontaneous report from a contactable consumer reporting for herself.   A 63-years-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 15Dec2020 at 16:30 at single dose for COVID-19 immunization. Medical history included chronic angioedema and hops allergy. Concomitant medication included simvastatin (SIMVASTATIN), losartan (LOSARTAN). The patient experienced sore arm on an unspecified date with outcome of recovered. The patient was not treated for the event. Prior to vaccination the patient was not diagnosed with COVID-19. The patient underwent sars-cov-1 test (nasal swab) with unknown results on unspecified date and negative on 16Dec2020.    Information on lot/batch number has been requested.
12 hours after injection I woke up with 102 fever.  Left arm so painful I couldn't move it. Migraine headache.  And all the muscles and joints in my body hurt (especially my neck and shoulders)
Patient was given 1 day expired Moderna vaccine.  Patient waited 20 min, after the shot and felt fine. Went back to work with no issue.
Mother said child had temp elevated earlier in week up to yesterday. No elevated temp today. Mother took child home. Mother called child vomited lites were worse got rash, passed out. Encouraged mother to take child to ER on to MD. Called mother on second occasion unable to reach her. Still unable to reach 10/12/09.
About 3 days after the 2nd dose, I started having fever and chills with blotchy skin. I was having difficulty breathing s well. I would have fever and chills for 3-4 hours. Then extreme heat for 3-4 hours. The same cycle as the 1st dose. This lasted 8 days. Then, it pretty much cleared up except for the difficulty breathing. I also had a COVID test done which was negative. I had a pulmonary function test regarding the difficulty breathing. This came back normal. It was about the same as the first dose, but it cleared up a lot quicker. I still have a cough, runny nose, pain in my back, and difficulty breathing.
w/in 24hr of vax pt devel an inj site rxn characterized by swelling, redness, warmth & a blister like swelling below the inj site;tx w/cold compresses & recovered;
Systemic: Anaphylaxis-Severe, Systemic: Other- shortness of breath
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. Reportedly, pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit and all the vaccines were viable. No treatment medications were reported.
On 2/03/2021 13 days after the second vaccine my head started itching  and tingling. The next day 2/04/2021 I developed hives and they have been ongoing. I gave it a week to get better.  On 2/11/2021 I reported to the doctors office; at that time I thought it could be gum or vitamin b12. Theses were the only new things to my daily routine. I was given a steroid shot. The hives became even worse over night so I started a prednisone dose pack on 2/12/2021 and took it until last Friday 2/19/2021. The itching and welting stopped with the Prednisone but the red lines and circles still continued . Sunday night my head start itching and tingling. The next day Monday 2/22/2021 the hives returned. I called my doctors office yesterday and today 2/24/2021 I started another dose pack and have been referred to an allergy clinic. I hope this dose pack works because I cannot be seen until 3/30/2021
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided.  On 15-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I just caught Omicron recently; I just caught Omicron recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  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 included: "Type 2 Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just caught Omicron recently". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Clinical information: Reportedly, "I am just an average person who happens to be Type 2 Diabetic. These past years have been horrible with COVID-19. I wanted to simply contact you to say thank you for all of your work with the vaccines, as well as Paxlovid - as I just caught Omicron recently. I Truly believe your work protected me from severe disease, and for that I am eternally grateful! Thank you to all of you for all you have done, everything you do, and everything you   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 23Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "heart condition" (unspecified if ongoing). There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 08Dec2022 to 14Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
numbness in their limbs after receiving the first Covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported for a friend. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified the patient experienced numbness in their limbs after receiving the first covid 19 vaccine. This report is in reference to the patient that the reporter's friend mentioned in the first report. When the reporter was speaking of her own experience with the Covid 19 vaccine, she mentioned a patient that had a similar experience. One of the reporter's friends is a primary care doctor and the doctor saw the same type of reaction that the reporter had, in another patient. The reporter's friend who is a doctor mentioned someone that had numbness in their limbs after receiving the first Covid 19 vaccine. When this person had the second Covid 19 vaccine they had more numbness in their body and now they are hospitalized in hospital. That person is having a bad reaction. When probing for information regarding the other patient that experienced numbness after receiving the Covid 19 vaccine who is now hospitalized, the reporter reports she does not know anything about that person. Outcome of the event was unknown.  No further information is provided or obtained.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
11-17-09 numbness to right side of body. Woke up with swollen face. Better on 11-18-09. Face  numb, right side.  11/23/09:  Prenatal records received for dates of service 11/18/09 to 11/23/09.  Pregnant pt. c/o feeling numb on right side of body with facial swelling and facial numbness day after receiving H1N1 injection.  By 11/23/09 felt well, normal.
Suspected vaccination failure; Case of breakthrough herpes zoster / was fully vaccinated with Shingrix in the past; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure and herpes zoster were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient was fully vaccinated with Shingrix and during the pandemic, the patient had breakthrough of herpes zoster. The reporter attributed the breakthrough herpes zoster case to the stress of the pandemic. The case had resolved without issue. The reporter could not recall patient's initials, age, date of birth and when they were vaccinated. The health care professional consented to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset  and laboratory confirmation were unknown at the time of reporting. This case has been linked with the case US2021AMR102457, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102457:same reporter ,same suspect(1st patient case)
Patient complained of tingling and numbness in left arm at completion of the 15 minute observation time.  Neuro-Vascular assessment was performed by and was found to be within normal limits. Capillary refill was brisk, skin was dry and warm to touch, no localized reaction was observed at the injection site, bilateral grip was of equal strength and quality.   Observation period was extended for an addition 15 minutes, with no worsening of symptoms.  Patient was offered follow up examination and medical care at the in-house Urgent Care, which the patient denied any further medical treatment at that time.  Patient advised to continue to monitor for neurological changes, loss of mobility or sensation, signs and symptoms of anaphylaxis and if experiencing worsening symptoms,  to seek immediate emergency medical care.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017; lot # L019297, expiration date 18-AUG-2017; lot # K026247, expiration date 29-JAN-2017, dose and route not reported). The doses of vaccine were improperly stored at 34 degree Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
itchiness started around on 4/6/2019 early afternoon on injection site, spread to abdomen, and back. On 4/8/19 Monday, there is a small lump on the injection arm and the opposite arm and on abdomen. Patient said he went to emergency room and the physician told him that might be an allergic reaction to the vaccine. Itchiness relieved by benadryl and prednisone.
pt recv vax 1/27/98 & several wk post vax pt tested positive for preg LMP 1/15/98, EDC 10/22/98;sonogram was performed @ 19wk w/no results reported;24wk into preg pt exp rt renal colic & rt hydronephrosis;
Chills, fever (102), nausea, bed-ridden 36 hrs. Felt bad another 24hrs. Had same reaction in 2014-with the high dose flu shots-2015 No reaction w/regular shot.