chrisvoncsefalvay/vaers-outcomes huggingface dataset:
below the injection site was red/had doubled in size/50 cent size area/spread further; inch below the injection site was/ swollen/had doubled in size/50 cent size area; tiny welt; It also felt hot.; She felt pain/ it stung like crazy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021 09:00, the patient received the 1st dose of Shingrix. On 24th May 2021 05:00, immediately after receiving Shingrix, the patient experienced injection site pain. On 24th May 2021 17:00, the patient experienced localized erythema, local swelling, welts and skin warm. On an unknown date, the outcome of the injection site pain and local swelling were recovering/resolving and the outcome of the localized erythema and skin warm were not recovered/not resolved and the outcome of the welts was unknown.   It was unknown if the reporter considered the injection site pain, localized erythema, local swelling, welts and skin warm to be related to Shingrix.   Additional details were provided as follows: Case was reported that patient for herself. The patient received Shingrix in left arm. The patient felt pain as the vaccine was administered which she described as it stung like crazy. In the evening at arounf 5 PM, the area an inch below the injection site was red and swollen with tiny welt. It also felt hot. The next day, redness and swelling had doubled in size to a quarter and the day before reporting date, it doubled again to a 50 cent size area. The redness spread further measuring approximately 3 inch vertical by 2.5 inches wide. The patient said swelling and pain was resolving and did not hurt as much but area was still hot to touch, The patient did not consent to follow up .
Local swelling, redness, and pain progressively worsening over 3 day period.
Painful,swollen gland above left clavicle. Went to Patient 1st for evaluation, told it was most likely vaccine related.
minor bronchial constriction, eoisode which is less than Asthmatic Attack; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHOSPASM (minor bronchial constriction, eoisode which is less than Asthmatic Attack) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Psoriatic arthritis. Concomitant products included ATORVASTATIN, TEMAZEPAM and BUPROPION HYDROCHLORIDE for an unknown indication.    On 01-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 experienced BRONCHOSPASM (minor bronchial constriction, eoisode which is less than Asthmatic Attack). At the time of the report, BRONCHOSPASM (minor bronchial constriction, eoisode which is less than Asthmatic Attack) outcome was unknown. Not Provided      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.   No treatment details were provided.
So on the 11th I got the shot in the morning, the injection site was sore but I continued with my daily routine. Around 5:30pm I came home and I was very tired. I woke up around 6:30pm I had a bad headache, my arms were very painful, it felt like I was lifting weights. I went back to sleep. I woke back up around 8pm and my entire body was aching. It felt like I ran a marathon. At that point I had chills and sweats that alternated back and forth. I took Tylenol, I couldn't focus, hearing was sensitive , and I had loss of appetite. My stomach was slightly upset. I was restless during my sleep throughout the night I was up every hour and I also kept getting up to pee. The next morning everything shut down, I could barely move or eat. It was difficult to walk around the house. I did have shortness of breath yesterday and that why I did the check-in, When I took a breath in it felt heavy. I got COVID-19  twice and I had a really bad bout of it so I know the difference of breathing. I was monitoring it. I took all of my inhalers yesterday and the night I came home from vaccination. Yesterday was a wash, all day in bed, nothing improved. The other symptom I had that I thought was weird, was that my skin was very sensitive. I noticed that when I was getting into bed that my panties rubbing against my skin was painful. This morning I woke up and it was better. My left arm is still sore around injection sight. I have a sore throat more located to the right side. I was able to eat a little bit. Today I feel tremendously better. I wasn't feeling sick before I got this. I haven't done anything exhausting so I'm not sure what I can handle yet but I do feel better. The headache and skin sensitivity has gone.
This spontaneous report as received from a Doctor of pharmacy refers to a 71 years old male patient with no drug reactions or allergies. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX on 17-OCT-2012 (Lot # H013018, expiration date 09-OCT-2012) SQ on 17-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 17-OCT-2012, the patient developed four little welts around injection site along with itching about 10-15 minutes after receiving ZOSTAVAX. After the patient was administered, he was in the waiting area just for an observation and patient complained to pharmacist that the injection site was itching and when the pharmacist examined the patient, she noticed four white welts around the injection site. The patient left the pharmacy soon after and when the pharmacist called the patient to follow up, patient's wife reported that welts had gotten little bigger in size but no other symptoms were reported. The patient did not receive treatment for the adverse events. At the time of the report, the patient had not recovered. Additional information has been requested.
Child developed redness, raised blotches on face and (R) leg where 2 of the shots were given, no breathing issues, monitored for 30 minutes, hives went away and child went home with father.
Onset of numbness/tingling in lips was around 4 hours later after receiving shot.  Numbness area expanded around 35 hours later to throat mouth area.  Numbness/swelling continues to irritate throat/lips area persists with feeling of little swelling, but not impacting any breathing.  I continue to monitor and plan on going to a dr if breathing becomes compromised, if symptoms remain the same - I will notify my doctor Monday morning for documentation purposes and advice on if I should receive 2nd shot?
DID NOT REFRIGERATE AND TOOK ALL FOUR DOSES; TOOK HER FIRST DOSE IN THE CAR AFTER PICKING IT UP BUT NOTED THAT IT WAS NOT COLD/PHARMACY DID NOT TELL HER TO REFRIGERATE IT OR PROVIDED ANY LEAFLETS OR LABELS ABOUT IT; This spontaneous case report (PVX2019-2874) was received from a consumer on 21-Nov-2019. It described a 31-year-old adult female consumer who "took first dose in the car after picking it up but noted that it was not cold/ pharmacy did not tell her to refrigerate it or provided any leaflets or labels about it" (PT: Product dispensing issue), thus she "did not refrigerate and took all four doses" (PT: Product storage error). She was receiving Vivotif for medical missions.  Case report: The consumer picked Vivotif doses from a pharmacy on 14-Nov-2019, but was not informed to refrigerate it and also did not provide any leaflets or labels about it. Then, she took the first dose in the car after picking it up but noted that it was not cold. She finished the last dose on 20-Nov-2019.  Action taken with Vivotif with respect to reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "took first dose in the car after picking it up but noted that it was not cold/ pharmacy did not tell her to refrigerate it or provided any leaflets or labels about it" and "did not refrigerate and took all four doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took first dose in the car after picking it up but noted that it was not cold/ pharmacy did not tell her to refrigerate it or provided any leaflets or labels about it" and "did not refrigerate and took all four doses" was considered as not applicable.
No additional AE reported; VARIVAX that experienced temperature excursion was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-JAN-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W006412, expiration date: 23-FEB-2024, administered for prophylaxis (strength, dose, dose number and route of administration were not provided); and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose, lot #, expiry date, route of administration, and indication were not provided) (Product storage error).  On 16-JAN-2023, administered dose of the vaccine experienced the temperature excursion of -14 up to -10 (-14.4) degrees Celsius for 30 minutes. There was no previous temperature excursion.  No additional adverse event or product quality issue reported.
Loss of taste; Loss of smell; Extreme Fatigue; Constant headache; chills; fever; Her arthritis in her knees and hands hurt worse than usual.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), FATIGUE (Extreme Fatigue) and HEADACHE (Constant headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia from November 2020 to January 2021. Concurrent medical conditions included Drug allergy (sulpha drugs), Penicillin allergy and Arthritis (Arthritis in knees and hands).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), FATIGUE (Extreme Fatigue), HEADACHE (Constant headache), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 28-Feb-2021, PYREXIA (fever) had resolved. On 02-Mar-2021, ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), FATIGUE (Extreme Fatigue), HEADACHE (Constant headache) and CHILLS (chills) outcome was unknown. At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102 (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment of events was not reported.
This case was reported by a healthcare professional and described the occurrence of injection site hives in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to Amoxicillin. On 25 September 2011 at 12:00 the subject received a dose of FLUARIX at 0.5 ml. On 26 September 2011, 1 day after vaccination with FLUARIX, the subject experienced injection site hives and injection site rash which progressed to generalized hives. The subject was treated with over the counter BENADRYL. The events were unresolved as of 27 September 2011.
This initial non-serious spontaneous case was received on 04-Oct-2017, from other health professional, concerning a 29-year-old, adult, patient of unspecified gender. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscular, anatomical location: deltoid). It was reported that, that patient was administered with the vaccine that had expired in the month of April-2017. The patient had not experienced any adverse events after administration. Revaccination with the current season was advised. The reporter assessed the events as non-serious. Follow-up received on 12-Oct-2017: The reporter stated that, the vaccine was administered intramuscularly in the deltoid muscle and confirmed that, the patient had not experienced any adverse event. Narrative amended accordingly.
Patient had hives appear about 4-5 hours after his second Pfizer Covid vaccine was administered on 6/6/21.  He had hives on his arms, legs, stomach, torso, and groin.  He said they were very itchy. No signs of any other issues, so we gave him Benadryl and monitor him. He continued to have hives for about 36 hours. We continue the same course of care and gave him Benadryl during that 36 hour period. The hives eventually went away and he has not had any other issues as of today 06/21/2021.
had a positive covid test; This is a spontaneous report from a contactable consumer.   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 28Mar2021, the patient had a positive covid test and on 05Apr2021, the patient was out of quarantine. 07Apr2021, second dose is scheduled. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Large red rash at injection site appeared 13 days after  getting my first moderna shot. Warm to touch , slightly burning, with upper arm soreness. On the 14th day the rash was there but had grown in size.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On an unknown dates, the patients received doses of VAQTA (lot #, dose, route and site of administration were not reported) that were improperly stored. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
ON 12 DEC 08 PT RECEIVED KINRIX (GSK)& HEP A IN HER LT THIGH; ON 15 DEC 08 PT PRESENTED WITH LOCALIZED REACTION AT SITE OF ADMINISTRATION. PT HAD EDEMA & ERYTHEMA WITH DIAMETER OF 6.5 CM. PT C/O ITCHING, SORENESS & DIFFICULTY WALKING AFTER ADMINISTRATION OF KINRIX.  PT ALSO RECEIVED IPPD IN LT FOREARM AND TYPHOID IN RT THIGH.
Knot in her Right Shoulder Blade; Not Sleeping Well; Pain in the Arm; Being Uncomfortable; Terrible Heartburn; Lightheaded that lasted 20 seconds and it went around; Underlying of a headache that never came out; A spontaneous report was received on 04JAN2021 via the call center from a 56-year-old female patient who reported receiving the Moderna COVID-19 vaccine on 30DEC2020 at Urgent Care. The patient stated she experienced terrible heartburn, lightheadedness, headache, shoulder pain, insomnia, pain in arm and being uncomfortable".  The patient's medical history was not provided. Concomitant medications were not reported.   On 30DEC2020, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The batch or lot number was not provided.  On 04JAN2021, Action taken with mRNA-1273 was provided as treatment by the patient in response to the events as taking 20 Tums for heartburn, one Tylenol as prophylaxis for possible fever, Aleve for arm pain (dose, frequency and end date not provided) and heating pad for right shoulder pain.  The patient agreed to safety follow-up reporting.  The outcome of the events was not reported.; Reporter'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.
No adverse effects; first dose on 15-SEP2-016 (at age 12 years), and second dose on 24-JUL-2019; This spontaneous report as received from a medical assistant to an adolescent patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose, lot # L026602, expiration date 19-OCT-2017 (exact dose, site and route of administration were not provided). On 24-JUL-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose, lot # R025730, expiration date 18-JUN-2021 (exact dose, site and route of administration were not provided). No adverse effects were reported.
Dizziness, headache and mild palpitations lasting for two days.   Took Tylenol and stayed in Bed
She recently had a coronary stent; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY DISEASE (She recently had a coronary stent) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORONARY ARTERY DISEASE (She recently had a coronary stent). At the time of the report, CORONARY ARTERY DISEASE (She recently had a coronary stent) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that patient had all her Moderna shots before and she knew that the new Moderna booster is now available at her State. patient recently had a coronary stent and on antiplatelet medication.   Reporter did not allow further contact  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of coronary artery disease (described as She recently had a coronary stent). The event occurred on an unknown date. Temporal associating with a dose of mRNA-1273 is unclear. As reported, patient received all her Moderna shots before and recently had a coronary stent and is under antiplatelet medication. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Warmth, redness, pain, low grade fever. Started 24 hrs after administration that progressed after 48 hrs. Seen in facility. Treated w/ KEFLEX.
Slight pain when he touched in right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight pain when he touched in right arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025BUN) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Slight pain when he touched in right arm). At the time of the report, VACCINATION SITE PAIN (Slight pain when he touched in right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080086 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080086:dose 1
Redness/rash at injection site/appears as a splotchy red; Redness/rash at injection site/appears as a splotchy red; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number and Expiration date: Unknown), via an unspecified route of administration in left arm on 05Mar2021 at 11:00 (at the age of 36-year-old) as 1st dose, single dose for COVID-19 vaccination. Medical history included Eczema, full thyroidectomy, right neck dissection to remove lymph nodes (Neck dissection), right neck dissection to remove lymph nodes (Lymph node excision) and papillary thyroid cancer from an unknown date in Nov2018 to unknown date and unknown if going. Concomitant medication included levothyroxine sodium (SYNTHROID), Kaitilib (Birth Control Pill), Vitamin. Patient previously took Ceclor drug and experienced allergy. Not received other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021, after 48 hours from vaccination, the patient experienced Redness/rash at injection site. Rash was not itchy or raised and appears as a splotchy red. Patient was treated with antihistamine for events. The outcome of the events was Recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
moderate-severe pain p/vax then about 15-20 mins rt arm @ inject site became red, hout to touch & harden; 4PM took PDH later than evening bruising devel; fever for 3 days;
A sudden drop in Blood Glucose immediately after the shot.  Started feeling clammy after about 15 minutes. BG before shot was 160; after about 20 minutes BG was 120.
description from patient:  1.. On Wed, Apr 28, I got the JnJ vaccine. Other than fatigue the following day no major issues.  2. On Sat, May 1, I had an afib episode in the morning. Reset to sinus rhythm the next morning around 2:30am. I spoke with you during the episode.   3. On Mon, May 3, I had brain fog. I?m usually tired after an afib episode. But this seemed different. I?ve never experienced something like this before. But I chalked it out to the after effects of the afib and moved on. 4. On Fri, May 7, I started having the stiffness in my right calf. I checked in with you that weekend to make sure it wasn?t a clot. After we spoke I think we ruled out a clot.  5. In addition, I?ve developed some added symptoms since then: (i) Sweaty feet. (ii) Pins and needles sensation in feet.  (iii) Tightness in the arch of the right foot. (iv) Feet and hands feel sensitive to cold.  (v) Burning sensation in feet and left hand.  (vi) Mild headache mostly felt in the left temple.  (vii) A pulling feeling on the left side of the face. (viii) A feeling that if I close my eyes, I may faint.