chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like supply decreased (breast milk); Experienced a half dollar sized hive at the injection sit; arm became itchy; generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back); Random patches of hives in the same areas; Skin reactions; Pruritus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Skin reactions), PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)), URTICARIA (Random patches of hives in the same areas), SUPPRESSED LACTATION (felt like supply decreased (breast milk)) and VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Seasonal allergy.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Dec-2020, the patient experienced SKIN REACTION (Skin reactions) and PRURITUS (Pruritus ). On 01-Jan-2021, the patient experienced PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)) and URTICARIA (Random patches of hives in the same areas). On 09-Jan-2021, the patient experienced SUPPRESSED LACTATION (felt like supply decreased (breast milk)), VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) and VACCINATION SITE PRURITUS (arm became itchy). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 02-Jan-2021, URTICARIA (Random patches of hives in the same areas) had resolved. On 09-Jan-2021, VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) had resolved. At the time of the report, SKIN REACTION (Skin reactions), PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)), SUPPRESSED LACTATION (felt like supply decreased (breast milk)), VACCINATION SITE PRURITUS (arm became itchy) and PRURITUS (Pruritus ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started getting rising numbers of [his] glucose / glucose levels around "130, 140, and 150"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 04Mar2021, outcome "unknown", described as "Started getting rising numbers of [his] glucose / glucose levels around "130, 140, and 150"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: The patient got the first dose of the Pfizer-BioNTech COVID-19 vaccine "on the 4th, and on the 7th" he "started getting rising numbers of [his] glucose in the morning". He mentioned his glucose levels are usually between "95-105", but now they have been around "130, 140, and 150".  He explained his "old internist" mentioned to add "half a pill" when his glucose level rise, therefore instead of taking 2000 mg of Metformin/2 pills he has been taking 2500 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Area of inject site swelled and became feverish and a large red ring surrounded the injection site; pt reported event today and showed the injection site which is still inflamed and red.
symptoms very similar to covid; headache; chest pain; cough; general malaise; nauseate; stomach upset; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (symptoms very similar to covid), HEADACHE (headache), CHEST PAIN (chest pain), COUGH (cough) and MALAISE (general malaise) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and PROPRANOLOL for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SUSPECTED COVID-19 (symptoms very similar to covid), HEADACHE (headache), CHEST PAIN (chest pain), COUGH (cough), MALAISE (general malaise), NAUSEA (nauseate) and ABDOMINAL DISCOMFORT (stomach upset). At the time of the report, SUSPECTED COVID-19 (symptoms very similar to covid), HEADACHE (headache), CHEST PAIN (chest pain), COUGH (cough), MALAISE (general malaise), NAUSEA (nauseate) and ABDOMINAL DISCOMFORT (stomach upset) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Aside from the chills, fatigue, headache, and feeling feverish the not so normal and quiet severe reaction I am still having is swelling and major redness at the injection site on my right arm. It also has moderate to severe  itching . Was given steroids and an antibiotic but have seen no changes due to just starting the medications. Is it common and/or something to worry about?
dizziness; increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included rituximab (Rituxan Infusion).   On 18th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, couple of days after receiving Shingrix, the patient experienced dizziness and heart rate increased. On an unknown date, the outcome of the dizziness and heart rate increased were recovering/resolving.   It was unknown if the reporter considered the dizziness and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of patient. The patient gets Rituxan twice year for rheumatoid arthritis, and had last dose in June 2019 and had steroid injection into wrist for arthritis on 15th October 2019. Few days after the Shingrix dose, the patient experienced extreme dizziness and elevated heart rate.  The reporter took the patient to emergency room to be evaluated and that patient was sent home without being admitted.   The issues were getting better but had not completely resolved yet. The reporter consented to follow up.
Above child received a flu vaccine injection on 10/23/02. On PM 10/24/2002 had sharp pain in left arm and noticed swelling and left arm became discolored from shoulder to elbow. Was seen by MD on 10/25/02 and 10/26/02.
12/16/21 presents to EC ED for "pain all over". PMHx of "C diff, HTN, osteomyelitis, dementia, PE, DVT, COPD, CHF, DM, CKD, chronic abdominal pain, colostomy"
After receiving flu shot developed a fever that was on and off for a week. Used Tylenol and motrin with no effect. He completly changed after that. Would not respond to name no eye contact. We took him to get hearing test done, no problems. Took him to specialist... AUTISM SPECTRUM DISORDER.  9/29/2008 PCP office notes received beginning with 9 mon WCC 11/10/06. PE WNL. Frequent UR sx throughout early 2007. 15 mon WCC 5/1/07 with no expressive words or pointing to body parts. 1 word vocab at 18 months. Delayed speech noted 7/20/07 as well as food aversions. Neuro referral-3/2008. 12/4/08 MR received from neuro dated 6/23/08 with DX: Autistic Spectrum Disorder. 1/26/2010 Autism-Encephalopathy.
experienced flu-like symptoms; runny nose; fever; joint pain; spring allergy; Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not reported, Expiry date: Not Reported), via an unspecified route of administration on 13Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history included spring (seasonal) allergy and concomitant medications were not reported. The patient reported that 2 weeks after her 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she experienced flu-like symptoms such as runny nose, fever, and joint pain. She said she is unsure if this is from the vaccine or from her spring allergy. She wants to know if it would still be safe for her to receive the 2nd dose. She also wants to know if it is normal that the side effects appeared 2 weeks after the 1st dose, and if it would be worse/stronger after the 2nd dose. Warm transfer the consumer to DSU, but all agents were busy and unavailable. Response: Responded from the attached SRDs, "CONS-what are the risks of the vaccine (v5.0)" and "CONS-who should not get the vaccine (v3.0). They told the consumer that the vaccine is different for everyone so Pfizer cannot tell whether the side effects after the 2nd dose would be stronger or not. They also referred her to her HCP for more guidance. The patient also wants to know how long after the 2nd dose will the Pfizer-BioNTech Covid-19 Vaccine be effective. She also wants to know if she could still be infected with the virus after receiving both doses of the vaccine. Response: Responded from the attached SRDs, "CONS-What is the efficacy after one dose US (v3.0)" and "CONS - post-vaccination precautions - wearing a mask and social distancing after receiving the vaccine (v5.0)." The patient said that her 1st dose was on 13Mar and her 2nd dose is scheduled tomorrow, 31Mar. She wants to know if this is too early. Response: Responded from the attached SRD, "CONS-Pfizer-BioNTech COVID-19 Vaccine - timing of Dose 2 (v1.0)." The patient wanted to know if she should go ahead and receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine if she takes the Covid test and it comes out negative. And if it comes out positive, she wants to know if she should also proceed with the 2nd dose. Response: Responded from the attached SRD, "CONS-Can I Receive the Vaccine with a Prior or Current COVID-19 Diagnosis (US) (v2.0)." The patient was scheduled for her second dose of the vaccine tomorrow. She experienced flu-like symptoms (fever, joint pain, headache, runny nose) over the weekend. She called in to ask if she can take the second dose. She got her first dose on 13Mar2021. With that, she also asked if it is too early because it is not 21 days after the first dose. On an unspecified date, the patient experienced flu-like symptoms, runny nose, fever, joint pain, spring allergy, headache. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This patient developed swelling of his eyes 27 days after his vaccine, followed by fever, arthralgia, and pleural effusion. She was hospitalized from 01/04 - 01/10/01 with uncertain diagnosis 1. Seronegative RA, 2. viral syndrome, 3. Adverse reaction to vaccine. She is improving. Still has joint pain.
Nausea, headache , body aches. Sat nite had shaking chills that lasted at least 30minutes. No treatment. To this day I still get ha,nausea,muscle joint aches. I think I have a cold now- sinuses draining,coughing body aches
3 days after having the booster shot i began to itch and break out in a rash and hives and it has continued to this date, October 28,2021.  I have been taking Benedryl and Prednisone
Mother states pt got 2 shots in his arm and 1 in his thigh. States that he was with his father since that time and when she picked him up today, his right thigh is swollen and red. Exam: right thigh red, inflammed, warm to touch and swollen from groin to knee. Painful to touch. DX; inflammatory reaction to DTAP. Child's MD was called and spoke with nurse about findings. She talked with mother on the phone and directed her to give Benadryl, Motrin and soak leg in a tub and to take child to see MD tomorrow if no improvement. Note that mother states child has not had fever.
pt recv vax 24JUL96 & 5PM was shaking & having diff breathing taken to hosp 11PM;ER md dx poss sz perhaps d/t vax;
The pt presented to office 2 days post vax complaining of swelling and discomfort at injection site. Reaction to the right deltoid measured 3cm x 2 1/2 cm, was warm to the touch with erythema.
Sudden fevers the night after vaccination. Fever kept rising and rising - up to 105 degrees by midnight (even with Tylenol dosage). Whole body shakes/rigors. Vomiting - about 5-6 times between midnight and 2:30am while fever was at its highest temperature. It has now been 3.5 days since vaccine and his temperature is still 101-102 before his doses of Tylenol. Low energy, low appetite.
Muscle soreness, states could hardly raise arm r/t discomfort day 1 after vaccine, soreness/ discomfort has lessened, but remains present 30+ days after vaccination.
13 days after my first Pfizer covid shot, I had sudden onset of tinnitus and sensation of ear fullness on the left ear only. This lasted 48 hours and spontaneously resolved. I saw ENT physician on day 15 and had normal audiometry. After second Pfizer shot on 1/21/21, that evening I had about 30 seconds of tinnitus which then resolved.   I am pregnant and my due date is 5/27/21. No complications with the pregnancy at this time.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: temperature between 0 and 2 degrees Celsius for 30 minutes and temperature of more than 8 but less than 25 degrees Celsius for 45 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002794: US-009507513-1702USA002795.
second dose administered from a expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second dose administered from a expired vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included CLONIDINE and HYDROCHLOROTHIAZIDE for Blood pressure management, ATORVASTATIN, NIFEDIPINE and METOPROLOL SUCCINATE for an unknown indication.   On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose administered from a expired vaccine). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (second dose administered from a expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP stated that dose was administered after 30-day use by date or after manufacturer date of expiry. Number of doses/vials was 1 vial, 1 dose administered. Vaccine was kept in the freezer till the day it was used. On the day of reporting, it was removed from the freezer. The vial did not undergo any temperature excursions.  No treatment information was provided.
herpes zoster recurrence--typical neuropathic pain in right abdominal region. As I'm a physician who is immunosuppressed and have experienced this previously and had valtrex on hand, I started it immediately and the pain resolved within three days.  No rash developed due to rapid treatment.
Bilateral Flushing/swelling of hands, redness on face, hives on neck and back, ears red, no itching. Gave Benadryl 25mg @4:10 at 4:20 stated she was feeling better and redness had diminished at 4:30 patient described feeling jittery dosed another Benadryl 25mg at 4:35 After no improvement sent her with her husband to the ER
devel fever, lethargy, sz on 19MAY94-hospitalized pt 19MAY-23MAY04; t103.7; prolonged sz 40 mins;
NONE- AGE-APPROPRIATE BIVALENT MODERNA VACCINE WAS ADMINISTERED ONE DAY AFTER FDA WITHDREW AUTHORIZATION
First dose received 28Jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected MRSA) prescribed Doxycycline for 7 days.  Infection reduced (but not completely; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included panic disorder. Concomitant medications included sertraline hydrochloride (ZOLOFT); trazodone; doxycycline (DOXYCYCLINE); sulfamethoxazole, trimethoprim (BACTRIM); all taken for unspecified indications, start and stop dates were not reported.  First dose received 28Jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected MRSA) prescribed Doxycycline for 7 days. Infection reduced (but not completely resolved). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021, sars-cov-2 test: negative on 02Mar2021. Therapeutic measures were taken as a result of first dose received 28jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected mrsa) prescribed doxycycline for 7 days.  infection reduced (but not completely (staphylococcal infection). The outcome of the event was recovering.
14 yr old boy was fine after receiving the flu shot.  Stood up and walked to bench to sit down while I administered to other family memeber.  After about 5 minutes after getting vaccine he stood up to talk to his sister and fainted.  He hit the floor but woke up immediately.   We kept him in the laying down position for 10 minutes then sitting for another 15 minutes and administered ice to his head.  As of today, I do not know if he received follow up care but I have left messages with family to inquire.
I contract Covid after Christmas and took a Covid test after the first of January and was positive. My symptoms were slight chills, slight headache, sore throat, some coughing, my temperature was 99 and never went higher and came and went, fatigue, and congestion. All of the symptoms were relatively mild and I was able to be home and relax but still was able to make myself something to eat and move around. My doctor prescribed PAXLOVID, and about the 3rd and 4th day was feeling better.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 79 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
1/09-  6pm arm heavy and unable to lift 1/10-  4am - can?t sleep major headache feel nauseous and pressure in brain 1pm- Very sleepy still lightheaded.  Between 3pm-8pm-  needing to gag every 30 mins, Can?t keep water or food down for long  8pm- Used bathroom and didn?t have any color in face from not eating or drinking  8pm did albuterol nebulizer from tight chest- felt weaker and felt gaggy again and couldn?t get up.  Got up for 5 mins around 8:30 to get things and drank water, still feeling weak and nauseous but not gagging  9pm- felt tired but all symptoms were gone and no longer felt like gagging or ill, color returned to face and was able to eat and drink normally
This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. Concomitant therapy included DILUENT MRK INJ. On 20-APR-2018 the patient was vaccinated with expired dose of (wistar ra 27-3) M-M-R II therapy type rHA (dose, units and frequency unknown) (lot # M016234 and expiration date 31-MAR-2018). The DILUENT MRK INJ (lot# N007760, expiration 31-MAY-2018), used for reconstitution of (wistar ra 27-3) M-M-R II was properly stored. It was reported the expired (wistar ra 27-3) M-M-R II had no temperature excursions prior to being administered. No adverse effects reported. No product quality complaint was reported.
got so sick; terrible rashes; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and rash. The patient was treated with steroids nos (Steroids) and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the sickness and rash were unknown.   It was unknown if the reporter considered the sickness and rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got so sick after getting the first shot of Shingles vaccine and later got terrible rashes, even a month later the patient had to take steroids and creams. The patient was contemplating not getting the second shot. No further information was reported.
Sharp shooting pains in (L) forearm. Sometimes pain starts in bicep and radiated to lower arm. Describes pain as "achy" at times. Pain is intermittent.