chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not terribly itchy; Rash on her arm 5 inches in length and 2 inches wide; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash on her arm 5 inches in length and 2 inches wide) and PRURITUS (Not terribly itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced RASH (Rash on her arm 5 inches in length and 2 inches wide) and PRURITUS (Not terribly itchy). On 12-Feb-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, RASH (Rash on her arm 5 inches in length and 2 inches wide) and PRURITUS (Not terribly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot), VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm) and PERIPHERAL SWELLING (bump is swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Flu: Flu shot. Past adverse reactions to the above products included Allergic reaction with Flu shot. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot). In February 2021, the patient experienced VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm), PERIPHERAL SWELLING (bump is swollen) and PRURITUS (bump is so itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 10-Feb-2021 to 12-Feb-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot) outcome was unknown and VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm), PERIPHERAL SWELLING (bump is swollen) and PRURITUS (bump is so itchy) had not resolved. Concomitant medication was not reported. The patient also applied ice on her arm. It was reported that the pain on her arm with second dose was not as bad as the first shot. The red bumps were in splotches and not streaks. It was not gone away on Friday. The patient felt really good except the arm. This case was linked to MOD-2021-033333.
Patient is under the age of 18 and received the vaccine. Patient denies any s/s, adverse affects and is aware of the situation.
Moderna COVID-19 Vaccine EUA   Mild rash on both fore arms very itchy just using anti itch lotion which relives the itch temporally
Extensive DVT requiring surgery. Received second Moderna vaccine approximately one week prior to admission, presented with acute onset of left leg swelling and pain.  Left lower extremity ultrasound demonstrated an extensive deep venous thrombosis extending from the common femoral vein into the peritoneal and posterior tibial vein with a patent IVC.  He was given a treatment dose of enoxaparin and admitted to the hospitalist service.  Overnight he developed diminished sensation in his toes and vascular surgery was consulted.  On 3/31/2021 he underwent mechanical thrombectomy of the left superficial femoral and common femoral veins as well as stenting of the left common iliac vein stent.  Of note he was noted to have May Thurner physiology with compression of the left common iliac vein by the external iliac artery on the right.  Post procedurally the patient's swelling and edema was significantly improved.  He did not have any significant pain or difficulty ambulating.  On postoperative day #1 he was evaluated and found to be hemodynamically stable with improvement of his symptoms and stable for discharge home.  Prior to discharge it was discussed with the patient that he will need to be on a loading dose of Eliquis for 7 days, followed by a maintenance dose of 5 mg twice daily. No h/o COVID.
anaphylactic reaction; anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of ANAPHYLACTIC REACTION (anaphylactic reaction) and the second episode of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, ALBUTEROL SULFATE for Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced the second episode of ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 11-Apr-2021, last episode of ANAPHYLACTIC REACTION (anaphylactic reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced an anaphylactic reaction of constricted throat, face and neck turning red, tingling and numbness in her face and throat, red bumps on her face and throat, and her face felt like it was burning. She used her EpiPen and it wasn't enough (didn't improve the reaction), so she went to the emergency room. They gave 2 prednisone tabs and prescribed prednisone and gave her IV saline and antihistamine. They released her 2 hours later. Her doctor advised her against getting the second dose. After the patient recovered from initial anaphylactic reaction on 12Mar2021, she had 2 episodes of anaphylactic reaction on 09APR2021, requiring the use of two EpiPens, Benadryl, Prednisone, and albuterol. On 10APR2021 at 0100 another anaphylactic reaction requiring EpiPen, Benadryl, Prednisone, and Albuterol. And at 4pm another anaphylactic reaction requiring Benadryl, EpiPen, and albuterol. Currently she has recovered.  Company comment: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. However, patient's medical history of asthma and allergy may have been contributory.; 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. However, patient's medical history of asthma and allergy may have been contributory.
Information has been received from a health professional referring to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # L025204, expiration date 07-JAN-2016, dose, route and lot number not provided). Temperature was minus 9.2 C and there was previous temperature excursion then call was placed because if a "data logger". No adverse events were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Swelling to right thigh= R leg hard and tender to the touch. PR RX for Atarax syrup 1 tsp TID, Hydrocortisone cream 2.5% BID and cool compresses.
Symptoms started roughly 12 hours after vaccination. (2nd dose of Moderna COVID-19 vaccine)   Extremely sore arm (almost unable to move it) Fever Chills and shakes  Body aches plus odd pain in feet making it painful to walk Severe headache  Extreme tiredness   Symptoms gradually lessened over the next 48 hours, with headache and extreme tiredness persisting the longest   ***I?d also like to note that I am breastfeeding (my daughter was born 2/4/21) and I noticed that she had a harder than normal time the day after I got the vaccination. More crying, more unsettled, trouble sleeping. I?m not sure if the vaccine had residual side effects for her, if that?s possible, but I felt like it was worth reporting.
Firm upper arm circumference increase redness,itches 19cm erythema shoulder to elbow
Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.; Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) and PRODUCT STORAGE ERROR (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056m21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022 at 10:57 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Apr-2022 at 10:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) and PRODUCT STORAGE ERROR (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. Moderna vaccine was administered past the allowed 24 hours of room temperature allowance and past the allowed 12 hours after puncture. The vial was moved from the freezer to the fridge and believes on 15-April. Vial was moved to room temperature for initial use at 10:46 am on 26-April and punctured at that time. The last dose was administered on 27-April at 10:57 am.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Significant Live FU received, Lot no. updated.
Client started breaking out in hives on Saturday AM, 11/6/04, after receiving the flu shot.  No sign of respiratory diffucilties. Hives were primarly on face, around mouth, and at hairline. She was seen by physician on 11/8/04 and received a Cortisone shot. Client was seen again on 11/9/04 for a second injection. Now doing better.
S/p vaccination at 1110 at 1120 c/o dizziness , hx of acute anaphylaxis, able to walk to stretcher with use of cane. Responses verbally . Vitals signs abnormal to patient: @1135 137/68 HR 83 sp02 99%, @1140 BP 137/68 HR 80 sp02 98%, @1145 pt remains c/o dizziness. pt verbalized she was 'anxious' because her doctor wanted her to get the vaccine. BP increased slightly 160/79 HR 85 sp02 99%.  @1149 RRT was called. Vitals taken @ 1150 BP 157/79 HR 81 sp02 99% . RRT arrived at 1155. Pt able to stand but was slightly unbalanced and was safely transferred to wheelchair and was transported to ED by RRT.
may be "some kind" of IBS (Irritable bowel syndrome); "terrible diarrhea"; anything she eats causes an upset stomach; has been losing weight; pain in the rectum; This spontaneous case was reported by a consumer and describes the occurrence of PROCTALGIA (pain in the rectum), DIARRHOEA ("terrible diarrhea"), ABDOMINAL DISCOMFORT (anything she eats causes an upset stomach), WEIGHT DECREASED (has been losing weight) and IRRITABLE BOWEL SYNDROME (may be "some kind" of IBS (Irritable bowel syndrome)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Radiation therapy (Patient stated that she received 15 rounds of radiation treatment and did not received any chemotherapy.) from 20-Feb-2021 to 17-Mar-2021. Concurrent medical conditions included Milk allergy, Hypothyroidism and Breast cancer since November 2020. Concomitant products included LEVOTHYROXINE for Hypothyroidism, ANASTROZOLE from 17-Apr-2021 to an unknown date for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PROCTALGIA (pain in the rectum) and WEIGHT DECREASED (has been losing weight). On 11-Mar-2021, the patient experienced DIARRHOEA ("terrible diarrhea") and ABDOMINAL DISCOMFORT (anything she eats causes an upset stomach). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (may be "some kind" of IBS (Irritable bowel syndrome)). The patient was treated with HYOSCYAMINE for Diarrhea, at an unspecified dose and frequency. At the time of the report, PROCTALGIA (pain in the rectum), DIARRHOEA ("terrible diarrhea"), ABDOMINAL DISCOMFORT (anything she eats causes an upset stomach), WEIGHT DECREASED (has been losing weight) and IRRITABLE BOWEL SYNDROME (may be "some kind" of IBS (Irritable bowel syndrome)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  took Anastrozole (estrogen blocker) one month after the completion of radiation treatment (around 17Apr2021). She stated that she will have to take Anastrozole for 5 years.  The consumer stated that  she had no known drug or food allergies.  No relevant Lab Data was provided.   This case was linked to MOD-2021-242482, MOD-2021-242482 (Patient Link).
Pt recvd vax & 7 days later exp tingling of nose, a runny nose & water & swollen eyes; ASA taken a/react;
After both doses in spring she was no longer immunocompromised.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; hydrocortisone acetate, neomycin sulfate, polymyxin b sulfate (CORTISPORIN) (Batch/Lot number: unknown). Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After both doses in spring she was no longer immunocompromised.". The action taken for hydrocortisone acetate, neomycin sulfate, polymyxin b sulfate was unknown.  Additional information: Talking about booster shot. Has always been considered immunocompromised. Took her and Dr along time to decided if caller should get covid vaccine. After both doses in spring she was no longer immunocompromised. Also had booster shot about week ago or so. Hasn't noticed anything about it in news but would like to know for those getting booster, wondering what level of protection they have after booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Jerky eye movements, head shaking 2 days p/vax episodes x 3; EEG normal; diarrhea; devel intermittent opsoclonus myodionus & developmental delay;
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: pt states she had a bad reaction a few hours later (difficulty breathing and swallow) - she took 3 benadryls which relieved her symptoms
Individual was vaccinated prior to the approval of Pfizer for 12-15 year old's. On April 26, 2021, individual arrived at vaccination site for first dose of COVID-19 Pfizer vaccine and provided birth year of 2004, parent consented. This date of birth would make the individual age 16 and eligible to receive the vaccine. Individual arrived for the second dose of Pfizer COVID-19 vaccine on May 17, 2021 and registrar recognized the minor and questioned the date of birth provided. The minor provided their correct birth year of 2006, with parent consent. On May 17th, Pfizer was approved for 12yrs and older and received his second dose of Pfizer vax. Individual did not have any adverse events during the  observation period.
Swollen to right side under armpit and side of right breast. Numbing to right upper arm (injections site).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated at the medical center for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 80-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medications was provided by the reporter.
My wife and I stay hydrated either before or at least after our second shot so as to help reduce the impact of any side effects; his wife experienced tiredness; discomfort for several days; sore arms; lethargy; she experienced discomfort for both of her buttock; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "My wife and I stay hydrated either before or at least after our second shot so as to help reduce the impact of any side effects"; FATIGUE (non-serious), outcome "unknown", described as "his wife experienced tiredness"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort for several days"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms"; LETHARGY (non-serious), outcome "unknown", described as "lethargy"; PELVIC DISCOMFORT (non-serious), outcome "unknown", described as "she experienced discomfort for both of her buttock".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285186 same reporter/drug/AE, different patients
No additional adverse events.; Nurse reports on 7/16/2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, and previous drug reactions or allergies were not reported.    On 16-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number S036635, which has been verified to be valid, and expiration reported and validated as 14-NOV-2021), as prophylaxis (dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided) (product storage error). The suspect vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not provided). Furthermore, it was reported that varicella virus vaccine live (oka/merck) (VARIVAX) was stored at different temperatures, one between minus 14 degrees Celsius (C) to minus 10 degrees C (minus 11.1 degrees C) for a time frame of 2 hours; another one between minus 9 degrees C to 8 degrees C (2.2 degrees C) for a time frame of 9 hours ad 30 minutes; another one between minus 14 degrees C to minus 10 degrees C (minus 9.8 degrees C) for a time frame of 2 hours and 30 minutes; and other one between minus 9 degrees C to 8 degrees C (0.4 degrees C) for a time frame of 3 hours, as recorded by digital data logger. Also, there was a previous temperature excursion between minus 9 degrees C to 8 degrees C (minus 6.1 degrees C) for a time frame of 8 hours. No additional adverse events were reported.