chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNABLE TO WALK; NUMBNESS UP THE BACK OF SPINE AND AROUND HEAD; This spontaneous report received from a patient via a company representative via J and J concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis.  The patient experienced stomach issues and diarrhea for months anti diarrhea medications for months and was exhausted following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced numbness up the back of spine and around head, unable to walk crawled to the purse and took several fast acting allergy pills and had to take them for months plus anti diarrhea pills for months again (Dose number in series 2).  As per the reporter, "My first COVID shot left me with stomach issues and diarrhea for months anti diarrhea meds for months and exhausted. Second forced shot I felt numbness up the back of my spine and around my head unable to walk crawled to my purse and took several fast acting allergy pills and had to take them for months plus anti diarrhea pills for months again" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness up the back of spine and around head and unable to walk was not reported. This report was non-serious. This case, involving the same patient is linked.
stiffness in lower back; warm tingling, sensation down her leg on the left side down toward her foot area; left side of her body was completely sore; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 13Jan2021 12:27 at single dose on the left upper arm for COVID-19 immunization. Medical history included ongoing asthma and ongoing sinus issues. The patient's concomitant medications were not reported. The patient had no history of all previous immunization and no additional vaccines administered on same date of the Pfizer suspect. The caller reported that she took the Pfizer COVID vaccine and had some things going on afterward but she wasn't sure if the symptoms were side effects. She works in a doctor's office, this is how she was able to get the shot. The caller explained she stayed for the 15 minutes and immediately she started feeling stiffness in lower back on 13Jan2021. A couple days later (in Jan2021) she started having a tingling, warm tingling, sensation down her leg on the left side down toward her foot area. She got the shot on the left upper arm and so everything happening was on her left side. Her left side of her body was completely sore. She reported stiffness in the buttocks area, everything was sore on the left side. She had been using a heating pad on lower back and hip area and things are getting better. The tingling was still there but gotten better. The events did not require a visit to emergency room or physician office. No relevant tests were done. The outcome of the events was recovering.
felt fatigued after her second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued after her second dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt fatigued after her second dose). At the time of the report, FATIGUE (felt fatigued after her second dose) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   The patient received the vaccine in her right arm shoulder deltoid muscle.   This case was linked to MOD-2021-409608 (Patient Link).
SORENESS AT THE INJECTION SITE; SORE ARMS, LEGS AND BACK; FEELING TIRED; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) for prophylactic vaccination. No adverse events were experienced. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2)(suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, 1 total administered on 26-OCT-2021 01:30 to Right Arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included influenza vaccine administered on 26-OCT-2021 to right arm for prophylactic vaccination. On 27-OCT-2021,the caller reported that he was given booster dose on 26-OCT-2021 (dose number in series 2) at 1:30 pm and Flu shot in the other arm at the same appointment. He also mentioned that he usually does not take the Flu shot but his doctor advised him that he needs to get it this year. The patient was okay until the next day (27-OCT-2021), around 10 am he experienced sore arms, legs and back, feeling tired (all events dose number in series 2). He was inquiring if it was due to Janssen COVID 19 Vaccine or the Flu shot or due to the fact that he had blood drawn on the morning 26-OCT-2021. On an unspecified date, the patient experienced soreness at the injection site. The patient was taking two pills of Tylenol every once in a while and took two pills yesterday and two this morning and probably take two more around bedtime tonight. He felt better and believed that there was something to do with time not the Tylenol. He received his Primary dose of the Janssen COVID 19 Vaccine in March 2021 and also mentioned that he did not experienced any of this symptoms after the initial dose. Caller refused to answer any further questions or provide any additional information. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling tired, and sore arms, legs and back, and the outcome of soreness at the injection site was not reported. This report was non-serious.
Injection site hard bump, then solid lesion about the diameter of a softball; Injection site hard bump, then solid lesion about the diameter of a softball; Injection site itchy; Injection site soreness, described as being a little tender; Injection site swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE NODULE (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE MASS (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site soreness, described as being a little tender) and VACCINATION SITE SWELLING (Injection site swollen) 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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE MASS (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site soreness, described as being a little tender) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE NODULE (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE MASS (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site soreness, described as being a little tender) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        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.   Concomitant medication list was not provided. Treatment information was not provided.
Noticed gradual ringing in left ear,  a few weeks after vaccine, got louder over time. Now in both ears.  Varies in loudness day to day. Saw doctor, Had MRI and hearing test, normal MRI, borderline normal hearing.
Soreness to injection site next day along with body and stomach ache,  Missed one day of work.
Fever, muscle aches, stomach cramps, chills, swollen lymph nodes in Jaw, Neck, and armpit.
Headache, Fever, inj arm red/tender, headache, body aches, fever Narrative:  Day 1 - headache, body aches; Day 2 - fever took tylenol for relief; Day 4 - site near inj site tender and red;
Swelling kept growing and growing and right now it is a size of 5 inch; Redness at the injection site; Pain at the injection site; "severe swelling started by 1 inch" at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING ("severe swelling started by 1 inch" at the injection site) and VACCINATION SITE SWELLING (Swelling kept growing and growing and right now it is a size of 5 inch) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING ("severe swelling started by 1 inch" at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling kept growing and growing and right now it is a size of 5 inch). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling kept growing and growing and right now it is a size of 5 inch) outcome was unknown and VACCINATION SITE SWELLING ("severe swelling started by 1 inch" at the injection site) had not 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.
1st dose Jun2022, did not complete the series; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (on 22nd June 2022 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter reported that the patient did not return for the rest of the series of the Twinrix. The reporter consented to follow up by postal. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination. This case was linked with US2023026720 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023026720:Same reporter.
Rectal bleeding; Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   The patient received the first dose of Moderna COVID-19 vaccine on 25Mar2021(Lot#028A21A) and the second dose on 22Apr2021(Lot#007C21A).  On an unknown date, after receiving the two doses, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and FATIGUE (Extreme tiredness). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) and FATIGUE (Extreme tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.    This case was linked to MOD-2021-211552 (Patient Link).; Sender's Comments: Limited information regarding these events has been provided at this time. Further information has been requested.
Soreness at injection site; Muscle soreness; Tiredness; Headache; This case was reported by a consumer and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 22nd April 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle soreness, tiredness and headache. On an unknown date, the outcome of the injection site pain, muscle soreness, tiredness and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle soreness, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received the 1st dose of Shingrix in arm and experienced soreness at injection site, muscle soreness, tiredness, and a headache. The reporter consent to follow up.
Tingling in lips/face started shortly after vaccine given. The following morning, developed twitching/tingling/numbness in my left arm (arm that received vaccine) and throughout my lower face.
Shingles appeaRed a few day following the vaccinations weRe given. No oRal medication was given - he use acycloviR cReam
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363. 1403USA011380, 1403USA011414, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
Extreme fatigue, fever over 101, nausea, sore throat, muscle aches, headache
2 days after vaccine delivered 8/31/09 AM pt. presented to ER w/ weakness, fatigue, muscle aches, Phosphorus of 0.6 and CKP 1460. Fluid resuscitated, Phosphorus replenished. 24 hr Phos submittal; results not back.  11/12/09 Medical records received for DOS 9/3/09  Final DX: myalgia and myositis, disorder of phosphorous metabolism, nonspecific abnormal results of function study of kidney  C/O chills, joint pain, fatigue, body aches, nausea, light headed. V&M. Same response to vaccine last year.. Phosphate decreased, CK increased. Low phos corrected. Warned re: protein supplement. Improved. D/C good condition.
blurred vision, elevated BP Went to PCP.  Given BP med and advised not to take second dose of vaccine
Patient was sick for three days and slept for those three days. He recieved the vaccination on a thursday and didnt come back around tp normal until that monday. He didnt eat, drink, or move for those three days. All he did was sleep
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a medical center administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider at a hospital (different from the place where he received vaccination) for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 26Jan2021 11:00 at a single dose for Covid-19 immunization, and potassium chloride ER, via an unspecified route of administration from an unspecified date at 10 mg, daily (every day) for low potassium. Medical history included anxiety and was afraid to take her anxiety medicine; hypertension, and iron deficiency; all from an unknown date. Concomitant medications included amlodipine besilate (NORVASC) for hypertension, and colecalciferol (VITAMIN D [COLECALCIFEROL]). It was reported that when the patient got the shot it did not hurt but when she sat down for about a minute (26Jan2021), her heart start palpitating, and racing and then she got kind of warm and then it went away. She didn't pass out, had no shortness of breath. She just wanted to know if it was one of the side effects and that's why she need to report this. The patient was looking at the ingredients that Pfizer have like potassium and stuff. The patient takes potassium every day. She added that maybe she should have not taken her potassium at the same day, would make your heart raise that's why she was wondering. Otherwise the patient felt fine. She just needed to report this. Furthermore, patient stated that maybe because she was nervous, she was scared to take certain anxiety medicines (unspecified medications) she did not know would had it though. The outcome of the events was recovered.
59 y/o female with hx of severe asthma and allergies to sulfa, PCN, Iodine, E-Mycin, Lanolin, silicone experienced headache apx 15 minutes after vaccination, given 25 mg IM Benadryl and water and symptoms improved
11-25-08 HIVE ON KNEES, ARMS & BEHIND KNEES.  MOM INSTRUCTED TO GIVE BENADRYL.  AS OF 12-02-08 STILL HAD A FEW SMALL HIVES BUT NOT AS BAD AND NOT NEEDING BENADRYL BUT TWICE A DAY.
This case was reported by a other health professional via call center representative and described the occurrence of laceration of finger in a 43-year-old female while preparation of SHINGRIX (batch number B37G7, expiry date 23rd May 2021) for prophylaxis. This case was associated with a product complaint. On 15th January 2019, the patient received SHINGRIX. On 15th January 2019, immediately after receiving SHINGRIX, the patient experienced laceration of finger, accidental occupational exposure to product and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, accidental occupational exposure to product, exposure via skin contact and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. It was stated that two SHINGRIX adjuvant vials were broken when they opened the carton. The patient (staff member) at the pharmacy opened the carton and was getting ready to prepare for administration when she noticed the broken vials. The staff member that opened the box, pricked her finger on the glass pieces, which led to accidental occupational exposure to product, exposure via skin contact. The vials were shattered and there were pieces of glass in the carton. The blister tray nor carton were damaged and there was no evidence of leakage or product in the carton. The vials had been discarded so reporter did not have any additional information regarding the appearance of the vials. The package condition was not damaged or open upon receipt. Vials not available for return to GlaxoSmithKline. The reporter requested credit for two doses of SHINGRIX.