chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives in different part of body; itching in armpit; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in different part of body) and PRURITUS (itching in armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives in different part of body) and PRURITUS (itching in armpit). At the time of the report, URTICARIA (hives in different part of body) and PRURITUS (itching in armpit) had not resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.  Reporter describes hives in back area which crawl back to chin area   This case was linked to MOD-2022-439506, MOD-2022-439651 (Patient Link).
Difficulty Breathing, Hoarseness, wheezing, fast heart beat and dizziness.
JOINTS HURTING MORE THAN NORMAL; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose and frequency were not reported from MAY-2021 for hidradenitis suppurativa. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced joints hurting more than normal. The action taken with covid-19 vaccine was not applicable. The outcome of joints hurting more than normal was not reported. This report was non-serious.
OFF-LABEL USE; VACCINE ADMINISTERED TO PATIENT AGED 12 YEARS; This spontaneous report received from a health care professional concerned a 12 year old of unspecified 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-SEP-2021, the patient experienced off-label use. On 27-SEP-2021, the patient experienced vaccine administered to patient aged 12 years. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and vaccine administered to patient aged 12 years was not reported. This report was non-serious.
Sore arm, body aches that are as bad as when I  had covid, chills, stomach ache.
Red raised area where vaccine was administered; no pain or itching. Patient didn't even know it was there. Her daughter noticed the spot.
VACCINE KEPT IN THE FREEZER THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 61 year old male. 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 (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced the vaccine kept in the freezer thawed overnight and kept in the fridge till vaccination. On 01-JUN-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine kept in the freezer thawed overnight and kept in the fridge till vaccination and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605104, 20210605120 and 20210605009.
Patient received an extra dose of Moderna bivalent vaccine, as he thought he had received this last year and didn't have his card on him. Patient has been alerted of this extra dose and has noticed no adverse effects thus far.
Ongoing cough; could and flu Like symptoms; excessive fatigue; loss of appetite; irritability; loss of energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2021 15:00 (Lot number: FK5618) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk5618, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 02Dec2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "Ongoing cough"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "could and flu Like symptoms"; FATIGUE (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "excessive fatigue"; DECREASED APPETITE (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "loss of appetite"; IRRITABILITY (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "irritability"; ASTHENIA (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "loss of energy". The events "ongoing cough", "could and flu like symptoms", "excessive fatigue", "loss of appetite", "irritability" and "loss of energy" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, influenza like illness, fatigue, decreased appetite, irritability, asthenia.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Reported Event: Ongoing cough, could and flu Like symptoms, excessive fatigue, loss of appetite, irritability, loss of energy. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Significant redness and swelling at injection site. Large area of the back of the arm was red, tender to the touch and inflamed - approximately 1-2 inches in diameter.
Lethargy, achy, chills, all subsiding after 24 hours. Itching at injection site 2 days after 2nd dose injection. No symptoms with first dose.
This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number 23MJ7, expiry date 22nd October 2015). On 15th September 2014, the patient received KINRIX (intramuscular). On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional details: KINRIX was accidentally administered. No AEs reported as a result of maladministration. This was 1 of the 2 reports received from the same reporter.
Flushing and feeling warm after vaccine received on 10/30/14. Around 9 pm that evening, pt c/o eyes swelling. She took BENADRYL with relief.
Sore arm; Upset stomach; Diarrhea; Red  burning eyes; Red painful swollen eye lid; Painful swollen eye lid; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), OCULAR HYPERAEMIA (Red  burning eyes) and SWELLING OF EYELID (Red painful swollen eye lid) in a 58-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.    Co-suspect products included non-company products TASIMELTEON (HETLIOZ) capsule for Circadian rhythm sleep disorder and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma.    The patient's past medical history included Victim of child abuse and Developmental disturbance (Patient missed social steps). Previously administered products included for Product used for unknown indication: Depakote, Biaxin, Dynapen, Codeine, Erythromycin, Abilify and Keflex. Past adverse reactions to the above products included Drug allergy with Abilify, Biaxin, Codeine, Depakote, Dynapen, Erythromycin and Keflex. Concurrent medical conditions included Attention deficit hyperactivity disorder (Patient stated the condition as predominantly inattentive type), Major depressive disorder (Patient stated the condition as recurrent, moderate), Post-traumatic stress disorder, Anxiety and Asthma. Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC), BECLOMETASONE DIPROPIONATE (QNASL), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ESZOPICLONE (LUNESTA) for an unknown indication.   In 2015, the patient started TASIMELTEON (HETLIOZ) (Oral) 20 milligram once a day. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). 14-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), OCULAR HYPERAEMIA (Red  burning eyes), SWELLING OF EYELID (Red painful swollen eye lid) and EYELID PAIN (Painful swollen eye lid). At the time of the report, PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Upset stomach), OCULAR HYPERAEMIA (Red  burning eyes), SWELLING OF EYELID (Red painful swollen eye lid) and EYELID PAIN (Painful swollen eye lid) had not resolved and DIARRHOEA (Diarrhea) 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.   Patient reported that she took treatment medication along with Hetlioz. Patient also reported that episodes of not sleeping well after taking Hetlioz resulted in waking with burning eyes.
Vesicular rash; Itching; Sore arm; Fatigue; Poison ivy rash; Cannot sleep; This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th August 2019, 2 days after receiving Shingrix, the patient experienced vesicular rash. In August 2019, the patient experienced pruritus, pain in arm, fatigue, poison ivy rash and sleeplessness. On an unknown date, the outcome of the vesicular rash, pruritus, pain in arm, fatigue and poison ivy rash were not recovered/not resolved and the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the vesicular rash, pruritus, pain in arm, fatigue, poison ivy rash and sleeplessness to be related to Shingrix.  Additional case details were reported as follows: The vaccine lot number and expiry date was unknown. The patient recived vaccine in right arm. All information was provided through an interpreter. The patient experienced a vesicular rash which does not resemble shingles. It was bilateral, scattered, and not in a linear fashion. It looked almost like poison ivy and was itching. The patient denied pulling weeds, but did drive on his tractor and cut grass.  The patient could not sleep due to the itching. The patient also reported a sore arm and fatigue.  There was no local reaction at the injection site. It was unknown when the sore arm and fatigue started. The start date for itching not provided. The reporter consented to follow up. In the document outcome of other events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Approximately 1 week after the injection, noticed heaviness in chest and sore throat only. New type of discomfort that I'd never felt before. These symptoms improved in about a week, only to return after an extremely painful visit to the ER for stabbing chest pain on 6/2. I had felt the sore throat and heaviness in my chest 1 week after the vaccine, but though nothing of it until after the ER visit. When they gave me anti-inflamatory medicine, the pain subsided, to reveal the exact same chest heaviness sensation and further bouts of peri-carditis, chronic chest pain since 6/2. Random incidents of entire body vibrating, and electrical jolts in the left side of my chest with no known cause, as these sensations are occuring at rest.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild.
Information has been received from a RN concerning a 12 month old male with no medical history and no allergies who on 13Feb2004 was vaccinated with varicella virus vaccine live. On 25Feb2004 the pt presented to the doctors office with chickenpox. The pt had about 14 small vesicles on lips, arms, groin, no fever. There was no treatment required. There was no product quality complaint involved. Additional information has been requested.
Lymph node under left arm swollen/painful beginning Thu 4/7. Back itch began and 1 bump noticed on Sat 4/9.  Upper abdominal pain on 4/11 could be felt when walking (i.e., every time I stepped, I could feel internal pain). Shingles in 3 patches on left torso confirmed via visual inspection by NP on Mon 4/11 (clinic).  Headache from 4/11 through 4/13; also during same time, felt like I had fever, however thermometer reported that temperature was always in range.  4/11 Prescribed valacyclovir; use Tylenol as needed. 4/14 pain & itch of shingles has dramatically decreased; very manageable, bearable. 4/17 occasional burn in only 1 patch but bearable
shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported.   In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions.   Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue sufferring 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 shingles was considered to be not recovered and causal relationship was assessed as related.
I had very mild flu like symptoms. I never had a fever. I tested for COVID-19 at home and was positive. I went to the urgent care and they tested me as well and they came back positive. Then, they directed me to my PCP  who prescribed me Paxlovid. I had little to no symptoms these lasted 8 days.
I started getting symptoms of headache, scratchy throat. No fever. Then my symptoms progressed the next day to a runny nose. I started taking TYLENOL. Then I was getting fatigued. Two days later, I had  build mucous up. My oxygen lever was 97. I went to a pharmacy and got a COVID-19 test and received a positive result and a negative flu test. I had a telehealth visit with my doctor and was PAXLOVID for 5 days. So far I have took one dose.
Extreme dizziness/Light headedness; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; shakiness; Face completely swollen; Nausea; lump under arm pit, swollen lymph node; Low grade Fever; Chills; Night sweats; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0182, expiration date: 31Aug2021), via an unspecified route of administration in the left arm on 18May2021 at 14:15 (at the age of 35-year-old), at a 0.3 ml single dose for COVID-19 immunisation in hospital. The patient had no medical history and concomitant medications were not reported. The patient did not receive any vaccination within 4 weeks. Patient had no family history, but her husband got the vaccine and has not had any reactions. Everyone was fine. On 23May2021, the patient experienced lump under arm pit, swollen lymph nodes. She went to her general practitioner's office to check the lump and said it was normal from the vaccine and was swollen lymph nodes. On the same day overnight, she had fever/ low grade fever, chills, night sweats. On 24May2021, when she woke up, her face was completely swollen. She doesn't know if it was from the low grade fever. On the same day, she experienced nausea. On 25May2021, she experienced light headedness/extreme dizziness, muscle weakness/ can't walk on her own, was extremely weak and was shakiness. The patient was admitted to the emergency room for the events, and she was treated with Tylenol and anti-nausea medicines. They did a bunch of bloodwork and everything was in normal range and chest X-ray which was clear, then the patient was discharged, and patient was not admitted to the hospital (reported that probably best for her to rest at home and told her to come back if it got worse). She was also seen by the hospital neurologist and musculoskeletal neurologist. They initially thought she had Guillain-Barre syndrome but were able to rule that out. She was home today and was still experiencing light headedness and dizziness. She can't really walk on her own and need to hold on to something to walk as her legs are weak. She has a follow up with a neurologist on 10Jun2021. The outcome of the events lump under arm pit, swollen lymph node, muscle weakness/ can't walk on her own and is extremely weak was not recovered, shakiness was recovered and the rest of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
pt recv vax 7SEP95 & lab eval revealed an equivocal antibody result;
Began with prickly feeling in upper body that went to scalp, progressed to headache, muscle and joint pain, dizziness, thirst, extreme fatigue and weakness.
Rash to neck area- Benadryl 25mg IM X1 administered as ordered. Rash resolved.
Patient reports developing itchy rash two weeks post vaccination administration, rash developed into "pimple like blisters" which also became painful.  Over the next 2 weeks pain continued to spread, patient reports pain started underneath her breast, down her abdomen, and down her legs.  The pain she described as sharp burning pain when she touched her skin.  Pain symptoms improved, although patient still has dull pain.  January 5th, patient attended church at which time she noticied she was unable to hear music or speakers, which time she thought was "bad speakers or sound system"  However symptoms continues as her hearing seams to be coming in and out and sound is like it is being produced by a speaker which is cutting in and out.
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. It was reported that the patient was administration the expired FLUMIST QUADRIVALENT. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
swelling in ankle; Swelling in wrist; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist). At the time of the report, JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
have some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have some side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have some side effects). At the time of the report, VACCINATION COMPLICATION (have some side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were reported.