chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel asleep on the couch, I had a bug bite that I had scratched and my dog cleaned up the blood; Sore Arm; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that 10 days (04Apr2021) into her first vaccine shot, she fell asleep on the couch and had a bug bite that she had scratched which her dog cleaned up the blood. The reporter inquired if the dog was at risk from anything from the vaccine. The patient was referred to her Vet since there is no information on effects on dogs. She stated that she had a sore arm for a few days (2021). She added that she had scratched her arm while she was napping and she woke up to her dog licking her arm that was bleeding. She inquired if there will be any harm to the dog by licking her blood from her arm after getting the vaccine 2 weeks ago (also reported as 10 days into her first vaccine shot). The outcome of the events was unknown.  Information related to lot/batch number has been requested.
2 dyas after the injection developed redness and pain at injection site of Tdap (Adacel)
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment information reported.   This case was linked to MOD-2021-395985.
5 mins after receiving H1N1 injectable vaccine, student passed out. Was sitting at cafeteria table eating snack. Student hit head on floor, left forehead reddened. Also has 1/4 "scratch to left side of chin. Bleeding noted on inside of bottom lip. Denied nausea diaphoretic, pale. Alert & oriented x 3. PERL, denied HA, dizziness, blurred vision. Able to walk without assistance. Student lethargic for approximately 10 minutes. Was left in supine position with feet elevated & ice pack to forehead until able to sit up. Family arrived and took student home. Recovered.
OBSTRUCTIVE SLEEP APNEA ACUTE HYPERCAPNIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
The day following flu shot developed a mild headache which has persisted to this date. Stated it is not debilitating just there.
"I came down with shingles after I  took my COVID-19 vaccine."; This is a spontaneous report received from contactable consumer (patient) via Pfizer sponsored program. A 78-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient had received tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient came down with shingles after she took Covid-19 vaccine. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was unknown.  Information about batch/lot number has been requested.
resembled cellulitis; arm drained a little bit at the injection site; Some bruising; hot to touch; arm soreness/Arm sore later in the day; arm swollen; they believed subq injection instead of muscle/Dose was not in the muscle, more like subcutaneous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (resembled cellulitis), PAIN IN EXTREMITY (arm soreness/Arm sore later in the day), PERIPHERAL SWELLING (arm swollen), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (they believed subq injection instead of muscle/Dose was not in the muscle, more like subcutaneous) and FEELING HOT (hot to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. WM6628 and WM6638) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm soreness/Arm sore later in the day), PERIPHERAL SWELLING (arm swollen) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (they believed subq injection instead of muscle/Dose was not in the muscle, more like subcutaneous). On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (resembled cellulitis), FEELING HOT (hot to touch), VACCINATION SITE DISCHARGE (arm drained a little bit at the injection site) and CONTUSION (Some bruising). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swollen arm, at a dose of 1 UNK and PARACETAMOL (TYLENOL) for Swollen arm, at a dose of 1 UNK. On 12-Jun-2021, PAIN IN EXTREMITY (arm soreness/Arm sore later in the day) had resolved. At the time of the report, VACCINATION SITE CELLULITIS (resembled cellulitis), PERIPHERAL SWELLING (arm swollen), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (they believed subq injection instead of muscle/Dose was not in the muscle, more like subcutaneous), FEELING HOT (hot to touch), VACCINATION SITE DISCHARGE (arm drained a little bit at the injection site) and CONTUSION (Some bruising) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient also took baking soda + water paste to their arm to alleviate the symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains no new information On 04-Aug-2021: Fallow up received and reporter address were added.
Case number PHEH2014US021414 is an initial spontaneous report received from a consumer on 21 Oct 2014. This report refers to a 63 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 17 Oct 2014. It was reported that 24 hours after vaccination, she experienced lower back pain and muscle ache. The event outcome of back pain was reported as condition improving and that of muscle ache was not reported. The seriousness and causality were not reported.
She received influenza vaccine at pharmacy (outside our medical system) in RUE today and no reaction in the RUE.  She had reaction of redness and swelling in LUE where she received Prevnar vaccine.
felt very tired with first dose; headache with first dose; bruised sore in the musculature; bruised sore in the musculature; musculature from the shoulder to almost elbow was very sore; nausea/a little bit of nausea with the first dose; low level fever up to 100/low grade fever after first dose; sore/achy; arm extremely sore after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 24Feb2021 around 3-4 PM (at the time of vaccination 69-years-old), as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included Allergies, and physical injury that happened 3 years ago. The patient's concomitant medications were not reported. Historical vaccine included Flu Shot on an unspecified date in Oct 2020 and patient previously took tetracycline and she experienced allergy to tetracyclin (hasn't taken in 25 years). On 24Feb2021, the patient experienced sore/achy and arm extremely sore after first dose, on 25Feb2021 low level fever up to 100/low grade fever after first dose, on 26Feb2021 nausea/a little bit of nausea with the first dose, on an unspecified date felt very tired with first dose, headache with first dose, bruised sore in the musculature, and musculature from the shoulder to almost elbow was very sore. Patient states she took Tylenol and aspirin for low level fever up to 100/low grade fever after first dose. The seriousness of the events was reported as non serious. The outcome of an events sore/achy, arm extremely sore after first dose resolved on 10Mar2021, low level fever up to 100/low grade fever after first dose resolved on 04Mar2021, nausea/a little bit of nausea with the first dose resolved on 01Mar2021 and other events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
at 13:15 patient in observation area presented with dizziness and blurred vision. Patient walked unassisted about 100ft to observation medical tent for evaluation. Pt presented with hypertension and denied headache, chest pain or difficulty breathing. due to HTN with blurred vision recommended transport via ambulance. Transported via medic to hospital.  13:21 209/114 p56 r16 13:21 204/108 p57 r16 13:26 211/128 p62 r16 13:32 229/130 p65 r16
A few days after injection armed turned black and blue below injection site.  Then it turned red with a lump under the skin.  The Lump  went away after a couple days.  The red continued to grow for a couple of days then slowly started to decrease in size. It has been 6 days and it is still present.  It does itch.
Dosage of YF vaccine was not verified by administration 5 dose vial was dilated with 0.6 ml's sodium chloride and administered to the patient. Patient was taken to the Hosp for evaluation and released.
Agency Nursing staff called to report uncontrollable vomiting started about 2 hours after the injection
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vial was initially stored in the refrigerator on 20 Apr 2021. The vial did not undergo any temperature excursions.HCP mentioned that there were 14 patients instead of 18 because of some duplicates.   This case was linked to MOD-2021-369020, MOD-2021-369330 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: HCP confirmed number of patients
Information has been received from a female consumer concerning her 76 year old husband with hypertension and hypercholesterolaemia and a history of convulsion and lennox-gastaut syndrome, and no known drug allergies, who on 31-AUG-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck). Concomitant therapy included propafenone HCl, carbamazepine, clonazepam, simvastatin (manufacturer unknown) and atenolol. On 04-SEP-2007 the patient developed a rash on his thighs. The rash consisted of about 5 to 6 "very tiny red blotches with a blister in the center" between his knees to his groin. Medical attention was not sought. No lab studies were performed. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
C/O dizziness (monitored pulse 83 resp 17) x1 hour symptoms did not improve 911 called sent to ER.
Patient complaint on Monday 04/12/2021 of swelling on arm, redness, and swollen.
High fever, body aches, cough, chest pressure, dizziness, lack of energy, lack of sleep, headache
sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (left arm) on 02Feb2021 11:45 AM at a single dose for COVID-19 immunisation. Medical history included known allergies to codeine. No concomitant medications. No other medications in two weeks. No other vaccine in four weeks. No COVID prior to vaccination. The patient experienced sore arm at injection site on Feb2021. No treatment received for the event. No COVID test post vaccination. The patient recovered from the event on Feb2021.   Information of batch and lot number has been requested.
pt recv vax & felt fine but when stood up c/o dizzy spell & face was pale white;p/a few minutes of lying down felt much better;
Painful headache on right side of head that radiated to neck, lasting 3 days. Extreme malaise for 2 days - patient reported sleeping most of the day for the 2 days following the vaccine (would not have been able to work; had trouble doing regular house hold chores - cooking dinner, etc.). Imbalance/dizziness for 2 days (patient reports of feeling her equilibrium was "off"). Painful hard spot at location of vaccine.
Cough 1 day, extreme chills, bed shaking 2 hours extreme weakness, couldn't hardly get to bathroom and back to bed, this lasted 8-9 hours, pain in back of legs, left very weak for 2-3 after the onset.
Dizziness, lethargy, couldn't hold up his head.  The next morning a rash was noted all over his body which was itchy.  Reported to his HCP. Mother reports the dx was "allergic reaction" and further flu vaccine contraindicated.  No dyspnea. Started on antihistamines.  10/29 had increased rash, some difficulty breathing and pain in the neck and spine.  Returned to Urgent Care. Prednisone started and epi pen ordered. Mother states it took another 7 dfays for pt to return to complete recovery.
Fever, vomiting, diarrhea, aches, sore eyes. weakness.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 10th December 2018, the patient received SHINGRIX (subcutaneous). On 10th December 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In December 2018, the patient experienced injection site swelling, injection site erythema and discomfort. On an unknown date, the outcome of the injection site swelling, injection site erythema and discomfort were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient inadvertently received SHINGRIX subcutaneously, which led to wrong route of vaccine administration. Less than a week after receiving SHINGRIX, the patient experienced redness and swelling at the injection site. The patient felt very uncomfortable. The pharmacist did not know when the events started and consented to follow up. This case has been linked with case US2018226104, reported by the same reporter.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Medium
Fever on and off 4/7-4/22 (date seen). 4/11/17 head/neck angio edema (ED-steroid, EPI and anti hist.). Vesicular rash 4/21-4/22. Itchy, on trunk/face total approx 10.
Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves patient (with unknown demographic) who experienced allergy to tetanus toxoid, while received vaccine Tetanus Toxoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Tetanus Toxoid (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus toxoid (allergy to vaccine) following the administration of Tetanus Toxoid. Other relevant tests not reported. Final diagnosis was allergy to tetanus toxoid. It was not reported if the patient received a corrective treatment. The patient outcome was reported as unknown for allergy to tetanus toxoid. List of documents held by sender: none.
Flu symptoms the next day- 6/22/16. About 5 weeks later three toes went numb and had pain off and on. Revisited doctor on 6/22/2016 and told them I suspected a adverse reaction to vaccine.  I was told the numb/pain in toes was not related. Patient was given her 2nd dose. About 12 hours later she experienced pain in her left side (arm, leg) head hurt on left side, jaw. I brought her to the doctor and was told to bring her to the ER. She received a CT scan and was released. On 6/27/16 returned to ER because she was not able to move her left side at all and was experiencing severe shooting pain in arm and leg. Head on left side severe hurt. This lasted for 10 hours. 6/29/16 terrible headache and neck and spine. Patient was screaming and crying for 4 hours. We were almost to ER again when she felt a bit better so we went home. (we live 90 minutes from the hospital). Patient has had headaches on and off but no more ER visits so far. I hope and pray she continues to improve. We were referred to a Neurologist and have an EEG apt scheduled.
Initial report received from a patient in the USA on 18 December 2006. A 59 year old, male patient (with a history of allergies to PCN and Keflex, mild hypertension and type II diabetes) complained of severe headache, fever (103-104F) for 8 days and chills, in the evening after he received an injection of Decavac (lot number U1704BA, route of administration not reported) in the left deltoid on 08 December 2006. He also developed loss of appetite and complained of metallic taste in mouth, severe pain in knees "or" ankles and a rash from head to toe. He received a previous dose of Decavac in 1989. At the time of the report, the fever resolved and the patient reported that he has not recovered. Follow-up information received on 22 January 2007. The patient received the decavac vaccination at 11:00 am on 08 December 2006, and the onset of the adverse events began at 10:00 pm on 08 December 2006. The recovery status of the patient was not reported.
This initial spontaneous case, was received from other health professional (nurse) on 09-Nov-2017, concerning a 59-year-old adult male patient. The patient's medical history included BPH (benign prostatic hyperplasia), high blood pressure and diabetes mellitus (since an unspecified dates). The patient's concomitant medications included amlodipine, atenolol and FARXIGA for an unknown indication. On 01-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF31407, expiry date: 30-Jun-2018). The patient received the vaccine, which underwent at least one temperature excursion and he did not experience any adverse event after the administration of the vaccine. The reporter assessed the events as non-serious.
One week after the flumist, she began to have simple movements of mouth and fingers -- aka tics.  Eventually hospitalized to evaluate as tics became more complex involving arms/legs.  MRI, EEG, blood tests all normal.  Followed by neurology and undergoing workup.  Also had recent stress and fungal infection at the same time.  Previous history of hospitalization due to dehydration and cramping after flu-like virus. 12/10/08-records received for DOS 11/9/08- DC DX: Complex Tics. Vaginal yeast infection. Presented with recent onset of abnormal facial, shoulder, hand and feet movements. C/O itching of genital area. Observed complex movements involving hands and feet and some lip smacking.