chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in arms; she couldn't move her arm; severe pain; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's mother). The consumer reported similar events for three patients. This is the second of three reports. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's mother is calling on behalf of her daughter (patient) that had the first dose of the COVID 19 vaccine and her daughter (patient) is experiencing pain in arms. The mother stated her daughter (patient) got the COVID 19 vaccine yesterday and she is in pain. The mother stated she too had the vaccine and had pain but her daughter (patient) is complaining and the mother does not want to do anything wrong and wanted to see if her daughter (patient) could take Ibuprofen or any other pain reliever. The mother says her daughter (patient) is in severe pain. The mother stated she has three daughters and two received the COVID 19 Vaccine and both are the same. The mother stated her daughter (patient) yesterday had no pain, only at night she was complaining about having pain and then woke up this morning and her daughter (patient) said she couldn't move her arm she was in severe pain. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC Same reporter/drug, different patients, similar AEs;US-PFIZER INC Same reporter/drug, different patients, similar AEs.
Arm that received injection went numb and was unable to use the arm for 8 hours. Chest pain was also a symptom.
redness at distal to the injection site; Tenderness to the injection site itself.; swelling to injection site; A spontaneous report was received from other health professional concerning a 28-year-old, female patient who experienced swelling to injection site and redness at distal to the injection site and Tenderness to the injection site itself.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included lithium, zolpidem tartrate, lorazepam, esomeprazole magnesium, and norethisterone acetate.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number 039K20A) intramuscularly in the Left Deltoid arm for prophylaxis of COVID-19 infection.   The reporter stated that the patient had swelling to injection site (start 01-JAN-2021) and redness at distal to the injection site and down the arm (start 02-JAN-2021) as well as tenderness to the injection site (start 02-JAN-2021). Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported  The outcome of the events, swelling to injection site and down the arm and tenderness to injection site were unknown.; Reporter's Comments: This case concerns a 28-year-old female who experienced NS expected events of injection site pain, injection site swelling, injection site erythema.  Event onset occurred 9 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 22LG2, expiry date 26th November 2021) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2019, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and and 2 days after the patient developed Shingles. The Patient went to see a doctor and was diagnosed with shingles. The reported batch number corresponds to Shingrix adjuvant. The patient took medication to treat the shingles and the shingles resolved. The patient received the 2nd dose of Shingrix on 20th December 2019 with no issues.
Patient was administered a booster Pfizer vaccine and a FluHD both in right arm due to a mastectomy on her left breast. The doses were administered 1 inch apart in her right deltoid muscle. The patient was fine initially but when she was out sitting for her 15 minute interval she began having low back spasms, was having difficulty breathing and was feeling flush. 911 was called as well as Code White. I sat with the patient and got her a bottle of water. By the time paramedics arrived her breathing had returned to normal and the flushing in her face went down and the back spasms subsided. The paramedics took her blood pressure and oxygen level. The patient did not want to go to the hospital and left the store on her own.
Twenty four hours after receiving the injection, patient presented with red skin at injection site. Patient only stated the area was red and denied fever, pain, or heat at the injection site.  After three days, patient reported that the redness spread and was hurting her, but still denied a fever. Patient saw MD who diagnosed her with cellulitis.
fatigue, body aches, headache, nausea, decreased appetite, night sweats, swollen lymph node to axillary area on side of injection
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt came in for 10am appointment for moderna bivalent dose no.5. Vaccine administred as per procedure. Pt was instructed to sit in waiting area for the recommended 15 minutes. Pharmacist administered vaccine to next patient who happened to be pts husband. Pharmacist left vaccination area to come go to the pharmacists to update covid vaccine cards and retrieve immunization coupons. While in the pharmacy pharmacist heard pts husband calling her name. Pharmacy to find pt staring straight and
On an unspecified date, the pt received an unspecified dose of Lymerix.  Subsequently, she experienced induration the size of a golf ball, swelling, redness and tenderness at the injection site.  The most recent information, received on 1/7/00, reports the condition of the pt is unknown.
12 hours to 3 days post vaccine: fever 99.8, painful arm, strong fatigue, headache 7 days later: concerning tinnitus
Woke up that night feeling achy and run down.  Had a low grade fever, headache, nausea for most of the next day after the injection.  Two days later developed swelling and lymphadenopathy on same side for several days treated with NSAID's to help with inflammatory response.  It is better now but some minor swelling still present but mostly resolved.
9/24/21 at about 330PM patient had a sudden onset of chest pain and dyspnea. Presented to ER and diagnosed with AMI with elevated troponin level.
Dose 1-3: BNT162B2, Dose 4: Moderna, Dose 5: BNT162B2; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: gh9693) at the age of 48 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: er8732), in left arm, on 16Apr2021 as dose 2, single (Lot number: ew0161), in left arm and on 17Oct2021 as dose 3 (booster), single (Lot number: fe3590), in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 059m21a), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Pre-hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1-3: BNT162B2, Dose 4: Moderna, Dose 5: BNT162B2". Therapeutic measures were taken (PAXLOVID from 24Dec2022 to 29Dec2022) as a result of vaccination failure, COVID-19.
Information has been received from a nurse concerning a 26 year old female, with no pertinent medical history and no known drug reactions/allergies, who on 08-MAY-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (Lot # 0152X).  There was no concomitant medication.  About one week later, approximately 15-MAY-2008, the patient developed an itchy rash and hives all over her body.  The patient was treated with steroids (unspecified) and the symptoms have since resolved on an unknown date.  The patient sought unspecified medical attention.  No product quality complaint was involved.  Additional information has been requested.
Grand mal seizure. 11/18/09 DC summary and medical records received from dates 11/8/09 to 11/13/09. DX: new onset seizures, end stage renal disease, hyponatremia, hyperglycemia, tachycardia. Presented with c/o fall out of bed with pt. stating a gran mal seizure. Pt. had 3 more clonic tonic episodes in ER. Pt admitted.
I started feeling random sharp "nerve stabs." I was walking and felt a bit odd just because I almost immediately tasted a metal taste in my mouth and commented on it and something seemed "off." As I kept walking it off, the pharmacist came to check up on me but I was still trying to figure out what was wrong. Over the next 15 minutes, I had a "heavy knee" feeling under both knee caps at the same time, tingling on the bottom of both feet at the same time like they were placed against a jet and both jaws tightened in one location...not at the TMJ but lower....like where my jaws misaligned from the accident. And then heavy eye brows would hit. And they wouldn't stay like this. It would come and go. Come and go. Not in seconds but 10 minute intervals or something? But I definitely was starting to feel more "nervy." Not prickly. Not pain. Just random sharp here and there or feeling like I could feel a nerve "wake up" here and there. Also, my hips/pelvis. On both sides at the same time they would not ache but get tight or say HI in a weird way but more towards the glute/pelvis region; it was an odd location. Also. My lower back was tight. It got really tight. That was the most annoying thing. It stayed tight. Also, my right shoulder/neck that had been locked up and inflammed from a flare-up...the pain disappeared just like my head pain. (The nerve issues sometimes felt like when I took rizaptriptan the first few times and I could feel the nerve then too.   Due to being used to weird nerve issues since the accident, I was concerned but not enough to go to the hospital and just wanted to wait it out. I had plans of going home and working out and doing my therapy and stretches.   I got home and within 45 minutes of the vaccine my face was starting to feel cold. I was feeling nervy all over. And then my spinal cord lit up, just once, like electrifying....not painful....but like electricity....like nerve. A large section of it just lit up and then that was it. I didn't have any odd movements with it. It just lit up.   Also, my head. There was a spot on the top of my head near the "soft spot" that I kept feeling a nerve burst. Like, as if I could feel the tendrils of the end of a nerve. It would just light up once and stop. Then light up and stop. It had stopped by the time I went to bed.   I worked out and had no issues. I haven't had any more spinal cord issues. I went to my scheduled accupuncture appointment today and it settled some of what was still in my hands. I worked all day as well in retail with no issues. I haven't had any more issues with the "heavy feeling" and my lumbar region was fine by bedtime. My feet are fine now. I am having nerve issues now but it's hard to say if it's my normal issues or still aggravated by the vaccine.   I'm having zero flu symptoms or anything from the vaccine they reported I may have. My arm at the injection site has no welt, redness, I can't find it, and is sore but it's like being hit by a softball. On the pain scale I'm used to: it's a 1/10.   I really do live with horrid chronic pain now.
Pt vaccinated with Meruvax II developed arthralgia in multiple joints, expecially in hands. Lab evaluation revealed ANA 1:60 w/ a speckled pattern.
ACTHIB diluent was expired, and the powder was good (with no reported adverse event); Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to case 2023SA087047.  This case involves a 1 years old male patient and reporter reported Hib (Prp/T) Vaccine [Act-Hib] diluent was expired, and the powder was good (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Immunization.  On 06-Mar-2023, the patient received 0.5 ml Total dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection (lot number: UJ642AA, Expiry date: 27-Mar-2023; Diluent) (lot number: U7247AB, Expiry date: 02-Mar-2023;Powder) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for immunization.  On 06-Mar-2023, the reporter reported Hib (Prp/T) Vaccine diluent was expired, and the powder was good (with no reported adverse event) (expired product administered) (latency: same day).  It was reported, It was given to two patients after the expiration date.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event acthib diluent was expired, and the powder was good (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine was given 5/23, on 5/24 she felt a heaviness in her chest, this persisted to 5/25 when she felt like she could not eat. When she told her mother that's when mom noted the facial droop and took her to ER for evaluation. There she was given steroids and a prescription for eye drops and oral steroids. She has not taken the oral steroids at this time but nearly all of her symptoms have resolved.
Following my first vaccine, I developed some blurry vision in left eye and upper arm weakness. A few days after my second vaccine, blurry and double vision occurred, significant cognitive deficits occurred that included difficulty processing information, memory problems, brain fog, and severe fatigue. This was associated with a headache and dizziness/lightheaded and I lost fine motor control in my upper extremities. Sound sensitivity was very prevalent. Symptoms lasted about 6-8 weeks and were so severe I was unable to drive or work for about 2-3 weeks. I continue to have lingering symptoms but would say they are 90% resolved.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 08-APR-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K016131 with expiration date: 23-SEP-2016, dose: 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Severe hives (raised painful bumps, redness, itching around injection site for the varicella vaccine); severely dry/burning/ cracked fingertips down to the first knuckles on both hands.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended. In or about May 2016, the patient was treated at a hospital and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of 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 suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Aches experienced same day of inoculation. After 3 days of subclinical symptoms, systemic symptoms experienced.  Fever of 99-100 for over 2 days with continual headaches, myalgia, weakness, nasal congestion and inability to concentrate.
I have had on and off serious muscle soreness for 3 weeks now. comes and goes. will last 2-3 days, lessen up for a couple days and come back. hurts and sore to get out of a chair, walk around. hamstrings extremely tight. metabolism in overdrive, have lost 3-4 pounds.  begging to become concerned how long this is going to last. my wife had nothing. best friend nothing. I have had flu shots for 14 years straight and no side effects.         I am scheduled for my second shot in two days on monday 04/05/21     DO I Go ?
My face turned  completely red, inflamed  and itchy and made my eczema flare all over my face. Face was sensitive to sun, makeup and any other product. Only cold water was tolerated. It lasted for years and nothing would make it go away. My face has not been the same since and cannot tolerate anything.
Left lower deltoid began to develop warmth and feel sore below injection site. No systemic sxs or breathing issues, vitals stable, ice applied, monitored pt. 15 min. Offered BENADRYL, etc. Pt. declined all medications.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ACHINESS), NERVOUSNESS (FEELS SHAKY LIKE NERVOUS), ASTHENIA (weak), NAUSEA (nauseas) and FATIGUE (tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (ACHINESS), NERVOUSNESS (FEELS SHAKY LIKE NERVOUS), ASTHENIA (weak), NAUSEA (nauseas) and FATIGUE (tired). At the time of the report, PAIN (ACHINESS), NERVOUSNESS (FEELS SHAKY LIKE NERVOUS), ASTHENIA (weak), NAUSEA (nauseas) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
brain bleeds; did not each much because did not feel hungry; She couldn't move; was throwing up all bile; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (brain bleeds), DECREASED APPETITE (did not each much because did not feel hungry), MOVEMENT DISORDER (She couldn't move) and VOMITING (was throwing up all bile) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain bleeds) (seriousness criteria hospitalization, disability, medically significant and life threatening), DECREASED APPETITE (did not each much because did not feel hungry) (seriousness criteria hospitalization, disability and life threatening), MOVEMENT DISORDER (She couldn't move) (seriousness criteria hospitalization, disability and life threatening) and VOMITING (was throwing up all bile) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, CEREBRAL HAEMORRHAGE (brain bleeds), DECREASED APPETITE (did not each much because did not feel hungry), MOVEMENT DISORDER (She couldn't move) and VOMITING (was throwing up all bile) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.  Company comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and gender. The patient's concomitant medications, height and weight not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number not reported) dose, start therapy date not reported for immunization. The patient never had the flu, never got a cold. The batch/lot number not reported. The company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced stiff muscles 24/7, pain all the time, felt a difference in their body, constantly cold, and muscles always sore. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from muscles always sore, stiff muscles 24/7, pain all the time, and constantly cold. The outcome of felt a difference in their body not reported.