chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2-3 cm wheal on left lateral thigh, temp of 103 - pink, flat to slightly raised confluent macular rash to forehead, chest and back - treated with TYLENOL/MOTRIN, BENADRYL and cold compress.
After receiving my vaccination, I immediately had pain in my neck. I was taking a steroid pill so I had to be careful taking anything but I would take Aleve about 12 hours after taking the steroid pill. The combination of the vaccine and my blood pressure medication did something to my body. I had been taking the blood pressure medication for years and never had a problem. When I stopped taking the blood pressure medication, my neck starting feeling better. I was recently diagnosed as pre-diabetic due to taking the steroid.
Fever of 102.8, chills, body aches, nausea, horrendous headache and feel like I?ve been run over with a bulldozer.  This has been occurring since 9:30 pm. Last night and all day today.   Never had a reaction before to any vaccine other than a sore arm.
Screaming; He was so  scared of when he would go to doctor for the second shot, it would  going to finish him off/kill him off; Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse; swollen arm; red arm; arm really painful; weakness; lymph nodes in arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), FEAR OF DEATH (He was so  scared of when he would go to doctor for the second shot, it would  going to finish him off/kill him off) and PAIN IN EXTREMITY (arm really painful) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cervical spinal stenosis (He routinely takes narcotics for cervical stenosis). Concomitant products included MORPHINE SULFATE (MORPHINE SULPHATE) and OXYCODONE for Spinal stenosis cervical, Symbitotic colostrom powder (COLOSTRUM) from 11-Aug-2021 to an unknown date for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (arm really painful), ASTHENIA (weakness) and LYMPHADENOPATHY (lymph nodes in arm swollen). On 10-Aug-2021, the patient experienced PAIN (Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse). On 11-Aug-2021, the patient experienced FEAR OF DEATH (He was so  scared of when he would go to doctor for the second shot, it would  going to finish him off/kill him off). On an unknown date, the patient experienced SCREAMING (Screaming). At the time of the report, PAIN (Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse) had not resolved and PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), FEAR OF DEATH (He was so  scared of when he would go to doctor for the second shot, it would  going to finish him off/kill him off), PAIN IN EXTREMITY (arm really painful), ASTHENIA (weakness), SCREAMING (Screaming) and LYMPHADENOPATHY (lymph nodes in arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Extreme itching Throughout the body. Treated with Vistaril 25Mg PO, Solumedrol Pack at 4:25PM.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 30-year-old female patient who received ENGERIX B adult (batch number 54RS5, expiry date 11th October 2016). This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number 995J5, expiry date 6th February 2017) and ENGERIX B adult (batch number 24JP3, expiry date 10th July 2017).  On 3rd November 2014, the patient received the 1st dose of ENGERIX B adult. On 4th December 2014, the patient received the 2nd dose of ENGERIX B adult. On 1st June 2015, the patient received the 3rd dose of ENGERIX B adult. On 1st June 2015, not applicable after receiving ENGERIX B adult and ENGERIX B adult, not applicable after receiving ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On 21st August 2015, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possible related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was previously reported to manufacturer. This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B titres following vaccination with ENGERIX B (see cases US2015GSK136757, US2015GSK136758, US2015GSK136759, US2015GSK136760, US2015GSK136761 and US2015GSK136763). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titres. All of the seven patients were new hires at the company and so the reporter was following them. This case concerned to the 7th patient. On 4th December 2015, the patient received the 2nd dose of ENGERIX B adult. On 1st June 2015, the patient received the 3rd dose, which led to lengthening of the vaccination schedule. On 21st August 2015, 291 days after receiving 1st dose of ENGERIX B adult, 260 days after receiving 2nd dose of ENGERIX B adult and 81 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for Hepatitis B antibodies and it was found to be negative (0.3), causing the patient to be a non-responder to the therapy.
I began having menstrual bleeding 2 days after receiving my vaccine.  This was several days before my regular cycle would have normally began.  Since that time I have had bleeding and spotting every single day.  It is now more than 3 weeks post vaccine and this is still occuring.
Post vax, the pt developed a 12 cm area of edema/erythema. Treated with Benadryl.
Employee presents today after receiving his second pfizer covid vaccine. Pt. received 1st vaccine on 4/2/21 and 2nd vaccine on 5/7/21 around 1500 pm  today. Pt. received 2nd vaccine in left arm. Symptoms started twelve minutes in 1522 pm and in cluded: headache, back of shoulders feel "super tight", soreness to the back of neck, and headache is b etween patient's eyes as well as blurry vision. Pt. states that his shoulder pain is 10/10 and headache is an 8/10 Pt. denies shortness of breath, denies chest pain, denies trouble breathing. Pt. denies numbness, d enies tingling. Instructed patient to go to the Urgent care for evaluation.
Bleaching of my skin at the injection site, immediately after the injection.  ( I noticed it when I removed the bandage that night) A white spot or non-pigmented spot that might otherwise look like a scar, no pigmentation, or freckles that are otherwise in that area. The area is about 1 inch tall by 1/2 inch wide directly surrounding the injection point. A pharmacist I saw at store who administered my recent Covid booster shot, one month later, said he had never seen anything like this and that I should report it as an adverse event to the vaccine. Any research I did following the shot did not imply any similar reactions except for redness around the site.
herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a  male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 19-SEP-2016, at age 60, the patient was administered the zoster vaccine live (ZOSTAVAX) by a registered nurse (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, and economic losses. The outcome of the Herpes zoster is unknown.  Additional information has been requested.
After being vaccinated with the second dose, within 1 day, my left ear started ringing.
This spontaneous report was received from a consumer's mother refers to a 14 year old male patient with ADD (Attention deficit/hyperactivity disorder). No medical history was reported. On an unknown date in August 2012, the patient was vaccinated with a dose of GARDASIL. Concomitant therapies included CONCERTA for ADD (Attention deficit/hyperactivity disorder). On an unknown date in August 2012, the patient experienced red at injection site, swelling plus pain. The outcome of red at injection site, swelling plus pain was reported as recovered/resolved with sequelae on an unknown date in August 2012, 4 days post injection. No lab tests were performed. Action taken with GARDASIL was reported as continued. The adverse event diminished after stopping the therapy. The events did not re-appear after restarting therapy. The reporter considered red at injection site, swelling plus pain to be related to GARDASIL. Additional information has been requested.
Information has been received from a physician assistant via a company representative refers to a female patient of unknown age. The patient was vaccinated with three doses of GARDASIL (lot#, expiration date, dose and route were unknown) on unspecified dates. No concomitant therapies were reported. The patient claimed sexually inactive and presented with an atypical squamous cells of undetermined significance (ASCUS) lesion on an unspecified date after vaccination. An human papillomavirus (HPV) DNA test was conducted (on an unspecified date) and showed positive for HPV 16 and 18. The outcome of the events was unknown. Additional information has been requested.
Fatigue; Severe body aches; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in the right arm on 04Jan2021 17:30 at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe body aches and fatigue on 06Jan2021 04:00 (also reported as about 36 hours after injection). Treated at home with rest, increased fluids, and Ibuprofen 800mg. The patient fully recovered at 72 hours post-vaccine. Outcome of the events was recovered in Jan2021. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Rash & UrticariaPruritus Narrative: Reports developing a well circumscribed ~3x2 inch area of redness described as raised/firm and associated with erythema and pruritus under site of injection on day 7 post vaccination. Applied an ice pack and took OTC anti-inflammatory, which resolved the issue by the next day. No other associated side effects including hives.
Patient received 3 doses of pediatric (ages 5-11) Pfizer vaccine. 20 ug each, on 11/19/21, 12/10/21 and 12/13/21. The patient experience no complications at the time of this writing
pt began to feel dizzy and light-headed approximately 5 min after vaccine administration.  directed pt to put head between legs and took her BP which was 56/38.  also, asked the last time she had ate which was in the morning - gave her some OJ to drink.  continued to monitor BP every 5 min until returned to normal about 15 min later.  gave pt some cookies to eat and continued monitoring BP for the next hour until pt mother came to pick her up, pt was sat with by pharmacy tech at all times.  explained the entire event to pt mother, including pt low BP (90/65) even after the event and told her to have primary md contacted with this info.
Light headed and passed out/fainted.  Tingly fingers after and  jittery for a while after.
throat closed up; couldn't breathe; This is a spontaneous report received from a contactable consumer (patient) via medical information Team.  A 21-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, Batch/Lot number: Unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown single for immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced throat closed up and she couldn't breathe. She wanted to know if she was eligible for the 1st dose of the Pfizer Covid vaccine with a past reaction to Prevnar. Outcome of the events was unknown.  No follow-up attempts are needed. No further information expected.
Arm pain; pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment:  The reporter stated that most people complain of arm pain right after receiving Shingrix and that it was more (pain) than with any other vaccine they have received. HCP does not have any additional details (patient demographics, lot number, expiry date) as she stated that most of them say it in passing. The reporter gave consent to follow up via postal.
Tiredness; Chills; experiencing little difficulty in breathing; This is a spontaneous report from a contactable consumer (patient). A 95-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported, Expiry Date: unknown) via an unspecified route of administration on 16Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, chills and experiencing little difficulty in breathing. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient found unresponsive sitting in recliner and breathing.  Vitals normal. After 5min sternum rub patient became conscious and stated he could hear being spoken to but could not respond. Felt weak rest of the day.  Although this occurred several days later there were 3 patients at same facility experiencing similar issues on same day
During observation period, patient sitting next to dad/felt faint, passed out in Dad's lap - I ran out to assist patient had come to. Complaint of light headedness and dizziness/Had patient lie down, elevate feet/cold compress/observed patient for additional 15 minutes / had patient sit up. After 5 minutes or so complained of light headedness, had patient sit on chair and put head between knees - once feeling better gave patient water and had him sit for additional 15 minutes. During this time period parents explained patient gets extremely anxious with immunizations and has fainted in past with Flu immunization. Patient was feeling better, left on own with parents. Followed up later that evening and following morning, per patient's father patient was fine, NO other episode just a little bit of a sore arm.
Patient got the vaccine and the next morning had an extremely sore arm and couldn't bear weight on it.  1 week later it was still a little sore and a small red spot at the site of injection.  She will call her md to report it and I asked her to let us know if any further problems.
hepatocellular pattern of liver injury; This is a literature report for:  A 74 year-old female patient received BNT162B2 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Extramedullary hematopoiesis" (ongoing), notes: unknown significance on prior liver biopsy. The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 1779 IU/l; antinuclear antibody: 1:640; blood alkaline phosphatase: 391 IU/l; blood bilirubin: 1.1 mg/dl; international normalised ratio: 1.0; autoimmune serologies: negative; sars-cov-2 test: negative; viral serologies: negative. Therapeutic measures were not taken as a result of liver injury. Timing of pattern presentation of injury was 27 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event LIVER INJURY cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Lt arm pain radiates to hand , bodyaches , headache, cough, chills ,low grade fever, back pain   Took ibuprofen, tylenol  continue with with symptoms
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-352611 (Patient Link).
She is feeling burns in her skin; muscles hurt; her head also hurts; This is a spontaneous report from a. A contactable female consumer (patient herself) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller got the 2nd dose yesterday. She is feeling burns in her skin, her muscles hurt, and her head also hurts. She would like to know if she can take Tylenol or not.The outcome of the events was unknown  information about lot/batch number requested.
At 11:30pm, I came down with fever, and felt shivering cold.  Muscle aches and joint spasms, feeling the need to stretch and move.  All joints hurt, legs arms shoulders back.  Had mild headache and itching at the base of my head/neck.  Majority of symptoms and severity happened for about an hour.  Finally fell asleep after taking 600 mg motrin.  Woke up stiff, spinal pain most noticeable.  I could feel every bone in my spine hurting.  Took 600 mg motrin this morning and symptoms seem to be subsiding.