chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age nd gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 9 of 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860695A, A0860697A - A0860702A for other reports).
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 23-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot# was reported as L035881, expiration date 26-JUN-2017, dose and route were unknown). No adverse events were reported. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE VACCINE for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and FLUZONE VACCINE (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain. On 30th August 2018, the patient experienced muscle pain and feeling hot and cold. SHINGRIX was continued with no change. On an unknown date, the outcome of the muscle pain and feeling hot and cold were not recovered/not resolved and the outcome of the injection site muscle pain was unknown. It was unknown if the reporter considered the muscle pain, feeling hot and cold and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient received FLUZONE on left arm. Less than a day after receiving, SHINGRIX, the patient experienced muscle soreness and it was all over her body and at the injection sites. The patient planned to follow-up with her physician or pharmacist on an unknown date. It was unknown if the reporter considered the muscle pain, feeling hot and cold and injection site muscle pain to be related to FLUZONE as well.
Left shoulder pain starting 2-3 days after injection. Pain has persisted and worsening. Intermittent radiation up into trapezius and halfway down upper arm. Subjective weakness. No numbness/tingling. Started PT. Taking naproxen.
Severely swollen lymph nodes on left clavicle. Very painful to touch. Painful to even have clothes on top of. Painful to turn neck, or use left arm. Nodes are visibly swollen and are round and hard.
As soon as the shot started going into my arm I felt it go straight down into my hand. Pinkie finger and finger next to it went numb. Tingling and burning down my arm. Arm felt heavy and in my forearm felt like a cut burning terribly and like something was pulling there. Also in the bend of my arm near arm pit, burning as if cut and that goes into my chest area over left breast. Behind shoulder in bend of arm set in soon after and feels cut also. Burning and as if something?s pulling there when I move arm as well. Tingling at random areas of arm but the worst part is forearm, arm pit next to breast and behind shoulder in bend of arm.
Pt recvd Hep B vax & subsequently devel a petechial rash;
46-year-old male in the ED between 1 and 2 hours after receiving a COVID-19 vaccine, Pfizer, in the left deltoid with concerns for an allergic reaction.  His vital signs notable only for mildly elevated blood pressure but the remainder of his vitals were in the normal range.  At the time of his evaluation his symptoms had fully resolved and he had no ongoing complaints.  I do not think this is an allergic reaction, no evidence of angioedema or anaphylaxis.  Likely vaccine side effect perhaps with some anxiety.  He was offered Benadryl, and further monitoring in the emergency department however his concern is low at the time of his evaluation and he does not feel he needs any treatment or monitoring at this time.  Given his overall reassuring appearance, benign exam, and resolution of his symptoms I agree.  We will have him go home, take 25 mg of Benadryl and closely monitor symptoms.  If he gets any return of his symptoms get back in to the ED for evaluation.  I recommend that he notify the clinic where he received the vaccine about this side effect so that it can be documented.  I do not see any true contraindication to receiving his second vaccine.  He could premedicate with Benadryl prior to his next vaccine.  An alternative option would be to request the Moderna vaccine in place of the Pfizer brand vaccine. 46-year-old male in the ED with concerns about a reaction to a COVID-19 vaccine.  He presents with his wife today.  He is generally healthy without any ongoing chronic health problems.  He was in his normal state of health until that 1415, received a Pfizer COVID-19 vaccine in the left deltoid.  About an hour after receiving the vaccine he started feeling poorly.  Somewhat rapid onset of symptoms with dizziness, numbness and tingling in his arms and his legs which remained in the distal portions and was not associated with any weakness.  He felt nauseous but without any vomiting.  Developed chills which lasted for a few minutes and then resolved.  He felt like his tongue was swollen but when his wife looked at it it appeared normal for her.  There was no periorbital swelling, lip swelling, facial swelling otherwise.  He did not develop a rash.  His breathing was normal and he did not have any wheezing, shortness of breath.  There is no chest pain or palpitations though he tells me he felt anxious.  He called the on-call nurse line who instructed her to come to the ED.  He has been in the emergency department for about an hour at the time of his evaluation and reports full resolution of symptoms at this time.  The numbness and tingling has fully resolved.  He no longer feels nauseous.  He is without any complaints at this time and tells me he feels silly for coming in at this point.  He is never previously had a reaction to vaccines.  No previous history of anaphylaxis or angioedema.  Differential diagnosis: Differential diagnosis to include vaccine side effect, allergic reaction, anxiety.
looks like an allergic reaction; still does not feel real good; her cheeks gets red; Stomach has a bunch of growling and gassy like; 3 to 4 hours of vomiting; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) in an 85-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.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PAIN (very sore arm). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and VOMITING (3 to 4 hours of vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, VOMITING (3 to 4 hours of vomiting) had resolved. At the time of the report, VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol and Ibuprofen used as a Treatment medication
at 8am on 02/28/2021 I woke up in pain, feeling  tired and sick. All of my skin, back and spine hurt, in the way that your body is sensitive and extra painful when you have a fever but I checked and I haven't had a fever yet. All of the day on 02/28/2021 I experienced skin and back pain, headache, fatigue, and brain fog (difficulty focusing and making decisions) as well as swollen and tender lymph nodes in my left armpit and under the left side of my jaw. On 03/01/2021 I woke up and felt better in the morning, I went for a walk around 3 pm and around 4 pm when I got back and sat down I started to experience headache, severe nausea which turned into chest pain and chest tightness and I still have swollen lymph nodes.
Tiny blood capillaries that burst under the skin on her legs within 4.5 hours of her receiving the Pfizer covid vaccine; petechiae; This is a spontaneous report from a contactable consumer (reported herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included, hereditary blood disorder from an unknown date and unknown if ongoing, she was allergic to penicillin (She was allergic to penicillin/amoxycillin, which she took 25-26 years ago.) from an unknown date and unknown if ongoing. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxycillin and experienced swellon throat, amoxycillin for but her throat and experienced broke out in hives, swelled shut and she was allergic to amoxycillin. She had been on a 5-day treatment of amoxycillin/penicillin and required treatment at the hospital. The patient stated that tiny blood capillaries that burst under the skin on her legs within 4.5 hours of her receiving the pfizer covid vaccine and petechiae on an unspecified date. The patient wanted to know whether petechiae was reported before after receiving the Pfizer covid vaccine. The patient would like to know how long she was protected with one dose of the Pfizer covid vaccine, if she needs to hold off on getting the 2nd dose. The patient lab tests included blood test was normal and platelet count was normal on an unspecified date. The outcome of the events was unknown. The reported did not wish to report  Follow-up attempts are completed. No further information is expected.
Pt recv vax on 3/2/99; on 3/6/99 pt exp two macular patches on lt cheek
Dose administered >12 post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient was administered with dose >12 post puncture. Reportedly, it was patient's first dose.   This case was linked to MOD-2021-347184 (Patient Link).
Client reports that 3 hours after receiving Tdap vaccine the following symptoms presented: "chills, headache, sweating, fatigue, swollen lymph nodes under both arms, injection site warm and swollen, aches all over". Client presented to PCP next day who told her he believes this may be due to the Tdap vaccine.
feel like im going to faint; nauseous; dizziness; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (feel like im going to faint) in a patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (feel like im going to faint) (seriousness criterion medically significant), NAUSEA (nauseous) and DIZZINESS (dizziness). At the time of the report, SYNCOPE (feel like im going to faint), NAUSEA (nauseous) and DIZZINESS (dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had booster and feels nauseous and keep getting dizziness patient felt like patient was going to faint.  No concomitant medication details were provided by reporter.  No treatment medication details were provided by reporter.  This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the events of  syncope, nausea and dizziness. The events and the received third booster dose of mRNA  1273 vaccine was experienced on an unknown date. Syncope was reported as medically significant and at the time of report the outcome of all the events were still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the events of  syncope, nausea and dizziness. The events and the received third booster dose of mRNA  1273 vaccine was experienced on an unknown date. Syncope was reported as medically significant and at the time of report the outcome of all the events were still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 6 patients. This is 5th of 6th reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date. Outcome of the event 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-2021003207 same drug/event and different patients
5 days later, woke up extremely dizzy and nauseated.  Slightly sweaty.  Temp was 97.3.  Nausea left after 5 hours.  Dizziness was reduced but still slightly present.
Initial report received from a healthcare provider on 5/9/06. A 16 year old female patient had received a right deltoid injection of Menactra, lot number U1769AA, and a left deltoid injection of Boostrix, lot number ACSB004AB, on 5/8/06. The patient had no period for two months and was referred to an OB.GYN for pregnancy follow up. An estimated date of delivery was not provided. Per the reporter, there was no adverse event. Follow information received on 6/26/06. Per the reporter, the patient was not evaluated in their medical office. Follow up information received on 7/24/06. The date of the patients last menstrual period was in Feb 2006 and her estimated date of delivery was in Nov 2006, She had no history of previous pregnancies. On 5/27/06, 19 days post vaccination, the patient was seen by a physician for bleeding during pregnancy. She was determined to be having a spontaneous abortion (less than 20 weeks gestation). A copy of the surgical pathology reported dated 5/27/06 was provided. Products of conception was submitted for examination and included were portions of blood clot. Chorionic villi were not identified. No changes were present to suggest malignancy. The patient has no known maternal drug exposure. She had no exposure to alcohol, tobacco or recreational drugs during her pregnancy. It was not reported whether the patient recovered from the event. Based upon the new information provided in this follow up report, this case is being upgraded to serious (OMIC).
Wheezing 24 hours after H1N1 vaccine given. No prior history of wheezing.
shortly after the second vaccine she got a UTI; After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.; If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI), DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI), DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol). At the time of the report, URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI) outcome was unknown, DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) had not resolved and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood calcium: High. On an unknown date, Blood test: (abnormal) patient stated that her blood came with high on couple of things and another things. On an unknown date, Protein total: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Antibiotics for UTI, Probiotics (Women's health one and then the digestive one).   This case was linked to MOD-2021-275324 (Patient Link).
Pt recvd vax approx JUL92 & approx 2 to 3 wks later pt exp coughing, congestion, low grade fever, lightheadedness & joint pains; No further details were provided;
Severe dizziness upon rising or getting up, unable to move for moments. This happened the day after the shot. Some improvement yesterday but not right today.
VACCINES EXPOSED TO TEMP. OUTSIDE OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
The night she got the booster, she got up to use the bathroom and passed out. Her husband found her unconscious, laying in a pool of her blood because she split her chin open. Didn't want to go to ER because of Covid. She went to her ENT the next day. They could barely examine her because her eardrum was swollen shut with blood. They were able to drain the blood and was given antibiotic eardrops which she is still using. She was told if she got a headache to go the the ER, as it could be a symptom of a brain bleed. She did develop a headache so she went to the ER and they performed a CT scan of her face and brain. The results were negative. They said she likely had a concussion. She was told that her jaw was pushed up into her ear. Her doctor asked her to stay off her computer for a week. She had also gone to a recommended Plastic Surgeon, and had to have a lot of stitches to repair her chin.
pt found slumped over; EMS called and brought to ED; BS too high to read; pt intubated; BS 700 (serum) in ED; severely acidotic; CT of thorax showed large left lower lobe infiltrate vs loculated infiltrate; possible obstructive lesion in bronchus; bronchoscopy planned; positive for COVID and UTI; given ABX; steroids; supraventricular tachycardia; heart rate in 200s; cardioverted twice and given medications; family transitioned pt to DNR and eventually to comfort measures; pt passed away in the hospital
This spontaneous report was received from other health professional and refers to a 5 year old female patient. The patient's drug allergies included penicillin allergy. The patient's concomitant therapies included IPV, DTAP, VAQTA and M-M-R II. On 03-APR-2017 09:30 hrs, the patient was vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018) dose 2, subcutaneously in the left thigh for prophylaxis (incorrect product storage). No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. This case is cross-referenced with 1704USA006422, 1706USA000217, 1706USA000261 and 1706USA001751 (Same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1704USA006422: US-009507513-1706USA000217: US-009507513-1706USA000261: US-009507513-1706USA001751:
after inject site pain subsided i started to notice full arm numbness/pain starting. no pain has spread to both arms and hands.  some time extremely numbing pain and have no strength in arms and hands.   pain "comes and goes" but has always been present after the last shot and was not present before the shot.  seems to "typical" be worse in mornings and does not fully go away if I take a pain killer.  I have started to notice same type of pain in legs and feet but  only random and not constant.
2 hours following injection patient started to feel itching and discomfort at waist line, he did not see anything then, but later that evening he developed a rash to his trunk and sides and swelling of the right arm, patient is a physician so he took prednisone, woke the next more with rash still present on trunk and now also on his face, he called an infection disease provider that he knows personally and discussed his symptoms to which he was instructed to take another dose of prednisone and that this reaction is not uncommon as of 10/13/2020 all symptoms have resolved and patient is feeling well.