chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after the shot pt felt tired, weak, nausea, back muscle pain. Severe arm pain at inj site. Third day worse nausea, diarrhea early evening and throughout the night.  No desire to eat. Pt lives alone and has problem getting her drinks. Symptoms continues to worsen and on day 7 pt went to ER due to inability to stand without dizziness and weakness and was at that time having breathing difficulties with chest pain. ER physician ordered lab tests and chest X-ray with chest CT scan. All came back "ok". Pt received one unit of IV therapy and sent home with RX for Potassium and told to continue nausea med which her PCP had ordered. By this time pt had only eaten Ritz crackers and drank Sprite and Coke since illness began.
One week following injection I notice a raised red area - about 2 inches X 2 inches, a little warm to the touch, starting to feel a little itchy.  Had not noticed this before.  At time of shot my arm was a tiny bit sore for a couple of days but I really did not think about it much at all.
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; The patient received vaccine after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter.
5/12/07 Approximately 9am, child was felt warm and was given Ibuprofen. 9PM child developed urticaria and was taken to ER medical center where she was treated with steroid and antihistamine.
Patient was very frustrated; felt sick; nausea; little vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FRUSTRATION TOLERANCE DECREASED (Patient was very frustrated), ILLNESS (felt sick), NAUSEA (nausea) and VOMITING (little vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced FRUSTRATION TOLERANCE DECREASED (Patient was very frustrated), ILLNESS (felt sick), NAUSEA (nausea) and VOMITING (little vomiting). At the time of the report, FRUSTRATION TOLERANCE DECREASED (Patient was very frustrated), ILLNESS (felt sick), NAUSEA (nausea) and VOMITING (little vomiting) outcome was unknown.            The patient started to feel sick  on 04-Dec-2021 (today )at 9:30.The patient had nausea and a little vomiting. The patient was very frustrated and was not interested in answering anything.
6-inch round, red, hard swelling at injection site that started Monday, Nov. 15 at noon and has continued through Wednesday, Nov. 17. Extremely painful. Treating with ice and ibuprofen.
Nausea; headache; slight temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (headache), PYREXIA (slight temperature) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced NAUSEA (Nausea), HEADACHE (headache), PYREXIA (slight temperature) and CHILLS (chills). On 03-Mar-2021, NAUSEA (Nausea), HEADACHE (headache), PYREXIA (slight temperature) and CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
This spontaneous report was received from a office manager refers to unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ lot # M044397, expiration date: 20-JUN-2018, (route unspecified) for prophylaxis. Temperature: 32 ° F to 35 ° F, time frame: 37 hours. There was no previous temperature excursion. No adverse effects reported. Call was because of a data logger. No product quality complaint was involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA011647.
MIS-C symptoms: Abdominal pain, Vomiting,  Diarrhea, Elevated liver enzymes, Headache,  Syncope/near syncope,  Elevated D-dimers, Elevated troponin and BNP, Acute kidney injury, Shortness of breath, Chest pain/tightness, Thrombocytopenia treatment: norepinephrine,  enoxaparin, First IVIG, Steroids Hospital ICU admission date 08/23/2021, discharged 08/26/2021
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with PNEUMOVAX 23. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that PNEUMOVAX 23 had been exposed to multiple (unsupported by stability data) 24-48 hours excursions to 55 degrees Fahrenheit and were likely administered to multiple unspecified patients on unspecified dates. No adverse effects reported. At the time of reporting the patient's status was unknown. This is one of two reports from the same source. Additional information has been requested.
The evening of 1/11/21 - pain at the injection site and feeling of fatigue - went to bed very early.  Arm pain a bit less next day - felt a little tired all day. Back to "normal" on the 13th.   I am not sure if the following symptoms are related to the vaccine but I feel like I should report them if there may be a link.  1/17/21 -Awoke in the morning with severe neck pain - muscles "locked up."  Called the doctor - he prescribed Tramadol and Cyclobenzaprine - I took these for two days before my neck calmed back down and I could function "normally" again.  1/28/21 - Started feeling "under the weather" and tired late in the day while still at work.  Went home and went to bed early.  1/29/21 - Felt same as last PM upon waking up.  Felt much better by mid-morning.  Started feeling bad again later in the day.  Felt cold - but no fever.  Skin sensitive all over my body.  1/30/21 - Felt bad all day.  Felt cold - no fever.  Skin sensitive all over my body.  AM - felt anxious, worried, confused.  Built a fire in the fireplace and heat made me feel better. Felt hot-cold-hot-cold- all day.  My neck ached all day.  Sensitive to sounds. Took a single cyclobenzaprine late in the day - seemed to help. Went to bed early.  1/31/21 - Woke up with very sore deltoid muscle at the site of COVID-19 injection. Very hard to lift arm above head.  Hips, back, and neck muscles ache.  Calf muscles feel almost like they are about to cramp.  Mental state better than yesterday. Still sound sensitive. Not as cold feeling as in days prior.  Yoga seems to help.
Severe weakness 10 hours after the shot. Then severe dizziness for 48-72 hours after the shot which is today. Chest pressure 72 hours after the shot, making it difficult to go up and down the stairs.
Was immediate sick, very dizzy, nausea, abdominal pain headaches and joint pain that lasted 2 weeks.
Profound "tinnitus", but really was more than that.  In addition to the overbearing sound of rushing of water and non-pulsatile static, there was/is loss of hearing unilaterally in the low decibel range.  The sound/static was not constant. Seen by ENT, had hearing eval and exam.
This spontaneous case reported by a consumer, describes the occurrence of illness (sick), swelling (armpit), neck pain/soreness, cold sweat and lymphadenopathy (lymph nodes are swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (sick), swelling (armpit), neck pain/soreness, cold sweat, lymphadenopathy (lymph nodes are swollen) and nausea. At the time of the report, illness (sick): not resolved; and swelling (armpit), neck pain/soreness, cold sweat, lymphadenopathy (lymph nodes are swollen) and nausea outcome: unknown. Concomitant medication and treatment information not reported. This case linked to MOD-2021-301413 (patient link). Reporter did not allow further contact.
VS: BP 89/52, HR132, RR40, T99.5, O2 88% - decreased orientation. Resident sent to hospital.
Pt got FLUZONE and ZOSTAVAX shot 9/10/09 @ 11:30-11:32 am.  Came back to pharmacy 9/29/09 stating she got a rash on stomach 5 days after shot; it disappeared then re-appeared next day with pustules also experienced tongue swelling on one side of tongue for 12 hours.
The pt developed 1-2mm wheal at the Varicella injection site. Approx. 10-15 mins. after immunization. Elix Benadryl 2.5 ml was taken at the period of onset at 10:45am. Was advised to continue watching and call if necessary.
Mother reported that child's entire left thigh was reddened, swollen, and warm to touch within 25 hours of receipt of vaccines. Mom gave motrin and benadryl for 2 days at which time the condition resolved. Child was not irritable, feverish, or limited in activity level.
dizzy buzzing in ears and lightheaded. Allowed to rest in EMS room and discharged in stable condition home.
pain in her breast and shoulder; pain in her breast and shoulder; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 (at the age of 78 year) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypothyroidism, breast cancer (breast cancer 18 months ago), breast conserving surgery, chemotherapy, surgery, radiotherapy, lymphadenopathy. Concomitant medication(s) included ongoing levothyroxine sodium (SYNTHROID) taken for hypothyroidism and ongoing anastrozole (ANASTROZOLE) taken for breast cancer from Nov2020. Consumer reported that his wife went through with the COVID vaccine. Consumer stated that his wife had breast cancer 18 months ago, and she had chemo, and surgery and radiation, she had a partial mastectomy. Consumer stated that on an unspecified date in Feb2021 she experienced pain in her breast and shoulder. Consumer stated that when his wife had a partial mastectomy, they also removed 9 lymph nodes. Caller states that the pain his wife was having, was in the areas where she had her surgery. Consumer stated that his wife was between 5'6.5" and 5'7". Consumer provided that the patient could not say that the pain was constant, although it was constant in her left arm, but it was not constant in her breast. The patient didn't get the shot in her left arm, because that was the side that she had lymph nodes removed. The patient reports that the pain was in her left shoulder and where the lymph nodes were taken out, she had 9 removed, and that pain started a few days after she got the shot. The patient asked the woman giving the shot if the shot would affect her breast or other arm, and the patient was told that it should not affect those, but the patient did have pain in both arms, but especially in the left breast, where she had the cancer. Caller stated that just yesterday evening, she started taking Tylenol for the pain. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch cannot be obtained.
Patient was given  12 and up pfizer bivalent booster instead of 5-11.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received original shingles vaccine and experienced shingles). On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd August 2018, 113 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced influenza-like symptoms, injection site lump, feeling unwell and injection site swelling. On 17th September 2018, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms, injection site lump, feeling unwell and injection site swelling were recovered/resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, injection site lump, feeling unwell and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. In August, the patient got shingles which lasted for several weeks but was gone by 17th September 2018. The patient also said when she had the original vaccination, less than a year after receiving SHINGRIX, the patient experienced a golf ball (lump/swelling) at the site and she felt ill for 3 days. All symptoms were resolved.
10 minutes after vaccine, patient became unconscious and fell out of chair. Began gasping for air and clenching fists. Epinephrine was administered immediately. Patient began breathing normally after a few minutes. The whole event lasted about 5 minutes. Patient disclosed afterwards she had a fear of needles. This did not look like a panic attack, it appeared to be a true anaphylactic response.
sinus headache; cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUS HEADACHE (sinus headache) and NASOPHARYNGITIS (cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced SINUS HEADACHE (sinus headache) and NASOPHARYNGITIS (cold). At the time of the report, SINUS HEADACHE (sinus headache) and NASOPHARYNGITIS (cold) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information for the events was provided by the reporter as Azithromycin 500mg for ten days. No concomitant medications were provided by reporter.   Reporter did not allow further contact
headache; cough; fever; This is Spontaneous report from a contactable consumer or other non hcp reporting for himself (patient) via Pfizer sponsored program. A contactable male consumer reported that:  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunization. The patient medical history included he was exposed to a person who was positive for the Covid-19. The patient concomitant medications were not reported. The patient experienced headache, cough, fever on an unspecified date. The patient experienced a headache, cough that stopped a little bit and cough a lot of liquid, and fever. He took a cough drop. Prior taking the 1st dose, he was exposed to a person who was positive for the Covid-19 virus. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 70 years with past medical history of Depression, Chronic low back pain, History of Tobacco use, Severe COPD, GERD disease, PTSD, Anxiety, Pain in joint Involving shoulder region, Pleural Plaque. From past few notes patient had few visit to ER for having chief complaint of difficulty breathing and swollen feet. Also patient had severe COPD and taking medication for it. Also getting oxygen support for 3L at rest, and 3.5-4L whilst active. Since past few days patient was also having problem with his neck and back which was getting worst. No cause of death was noted on chart. Patient was deceased on 5.16.2021
3-8-19 My wife and I each received a SHINGRIX 50 Mcg/0.5 ml injection at our local Pharmacy store. 3-9 - 530 AM Woke up, did exercise on treadmill, walked the dog. About 9 AM felt really tired. Very unusual for me. Got the shivers, felt hot. Took my Temp is was 99.8. Laid down about 10 AM and slept for a couple of hours. Very unusual for me. Got up had something to eat. Still the chills, temp the same and a few shivers. 2 Laid down and slept for a couple more hours. Still hot but shivers almost gone Went to bed, slept OK 3-10 A little tired. Temp 98.6, no shivers. Went to church took nap in afternoon. 3-11 Felt good, right arm sore where shot given. Hurt to touch, it was red about 4 inch longs about 2' wide, running up and down my arm.
Local allergic reaction and cellulitis to injection site 2 days after administration. Pt. was given oral steroids, topical steroids and oral antibiotics.
pt recv vax;exp abd cramping & d;swelling of tongue,throat w/ nasal passage ways;states face became extremely flushed;states had edema of lips,upper & lower extremities;
At 8:30 pm, around bedtime on the day of the vaccine, I experienced severe heartburn, followed by debilitating nausea (was not able to even sit up). By the next day, I began to break out in shingles, first on my hands and arms, and eventually on my legs, feet, trunk, and back. These have continued until today (3 weeks later) and still continue.
Information has been received from a physician's assistant concerning a 12 month old patient who in June 2007, was vaccinated with varicella virus vaccine live (Oka/Merck). In June 2007, the patient developed a severe case of varicella, at which time there was also an outbreak of varicella in the patient's community. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Fever, chills, severe muscle pain. Joint pain. Headaches. This lasted for about 10 hours.
Patient did not complete Pfizer series. First dose: 6/17/2021. Received J&J vaccine dose 09/02/2021.  Too early for a booster, wrong booster, incomplete series.
Patient requests to get GARDASIL vaccine, signed immunization consent for GARDASIL-9, stating she is not pregnant. Patient was found to be pregnant after vaccine was administered.
Swelling, redness at injection site on left thigh (MMR vaccine site) at 8 days post vaccination. Mild rash on back at 9 days post vaccination. Systemic rash 10 days post vaccination. Fever 100.1 degrees fahrenheit (rectal) 8 and 9 days post vaccination; stopped at 10 days post vaccination. Temporary pain and stiffness in knee joints and some jerking at 9 days post vaccination
Patient experienced syncope after administration of her first COVID vaccine. Her mother is a physician and was present, providing care for her by fanning, comforting and helping her to lie down on the floor next to the waiting chairs. The patient did not faint. She did experience what appeared to be heavy breathing and light-headedness. We provided an ice pack from the immunization cart. The mother stated that the patient experiences this reaction every time she receives a vaccine due to her fear of needles. After about 30 minutes the patient was up and smiling. The family was thankful for our concern and help.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, lot # L039638, expiry date 23-AUG-2017 (dose was not specified). The administered doses of ROTATEQ underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine 03/25/21 in am. Rash developed on vaccinated arm 03/27/21 in pm.  Rash seemed to almost clear up by 04/02/21. Rash was back by 04/03/21 in am.  Muscle fatigue began in rash area 04/08/21.  Rash cleared up by 04/12/21 but still experience intermittent muscle fatigue where rash was located and sometimes residual minor itchiness.
Patient c/o tingling in her throat about 10min after receiving her 2nd dose of Pfizer vaccine. Patient states that she feels very warm and then 10 min later feels cold. Lungs were clear. O2 was 99% on RA. Pulse was 74. Patient given 2.5 tsp of Children's Benadryl. Observed for 25 min and then she left with boyfriend to go to Hospital for further evaluation.