chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Six months after 3rd dose vaccine, May 15th, 2022, I started with a sore throat. I noticed a cough, chest tightness, fatigue, body aches and chills on 5-16-2022, no fever. I had a telehealth visit on 5-16-2022 with Dr's office, no medication prescribed. They ordered a Covid test and I took it at a drive thru site on May 17th, and I also started having nasal congestion on this day. I found out later that day that I was positive. The doctor then prescribed tessalon pearls as needed. I took a home Covid test on 5-21 (positive) and 5-24 (negative),  On 5-24, the doctor also ordered albuterol inhaler as needed. The cough is still there but its getting better. I am reporting a breakthrough case of Covid.
Devel of profound asymmetric muscle weakness R>L, LE>UE, w/loss of deep tendon reflexes all w/in 4 weeks p/recving 1st DTP/OPV; has had improvement in weakness, but still w/residual permanent muscle weakness R>L, LE>>UE;
administering a vaccine into a very muscular arm and the needle and syringe come apart and the majority of the vaccine come out and splashed in her eye; She does have some eye irritation; This is a spontaneous case received from a contactable physician. A female nurse (patient) of unspecified age was exposed to BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the nurse (patient) was administering BNT162B2  into a very muscular arm and the needle and syringe came apart. The majority of the vaccine came out and splashed into her eye. She did have some eye irritation. The events were reported as non-serious. The outcomes of splashed into her eye and eye irritation were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
A lot of pain; Cannot move arm very well; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain and mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were unknown.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be elderly. After receiving 1st dose of Shingrix, the patient did not experienced any event but after 2nd shot experienced lot of pain and could not move arm. The reporter consented for follow up.
Time of the shot: right arm I received the shot & it burned so bad , then I waited the required 15 mins then started to leave when I was getting into my car 4:38pm it felt like someone was sitting on my chest it was hard to breathe, & my heart was racing but I figured it was normal so I went on home & got into bed within a few hours around 6:30-7:30  I couldn?t even Lift my arm it felt as if it was broken , also I had a severe sore throat, headache,& slight fever! The next day 530-2021 around 7:00 am I woke up with some of these: headache, fever, severe sore throat, body aches & these was all day then on Monday5-31-2021 woke up with some sore arm, headache, & sore throat!
On 08/01/2022 at about 6 hours after her vaccine, she started to feel very tired but no fever, she had low grade temperature. She also felt cold at times and had a lot vomiting and nausea. It was like she had flu like symptoms and also diarrhea. I took her to the clinic to see her pediatrician and they gave her Ondansetron for the nausea to take for few days. This Monday 08-22-2022 she also received her second dose. She still continues today with vomiting and nausea.  I gave her a COVID-19 test on 08/25/2022 at 07:00am which resulted negative. She also has right leg weakness and pain when walking she has trouble. She also has no pain to her right arm where vaccine was given.  I gave her Tylenol for her pain.   I took her to the ER 08-01-2022 on 08-14-2022 due to her  secondary effects of her vaccine.  At the ER they told me she ha no infection and her ganglions were inflamed, she lasted one day at the ER for a routine check up.
Information has been received from a health professional concerning a 24 year old female who on 13-AUG-2007 was vaccinated with her first dose of GARDASIL. On or about 19-Feb-2008 the patient was intramuscularly vaccinated with her third dose of GARDASIL (Lot # 658556/1060U). Concomitant therapy included hormonal contraceptives (unspecified). On 19-FEB-2008 the patient experienced nausea, vomiting, diarrhea, and fever. The patient went to the emergency room and was given IV fluids and was sent home. The patient was diagnosed with a stomach virus. No adverse reactions were reported on the first or second doses of vaccine. Subsequently, the patient recovered from nausea, vomiting, diarrhea, and fever. Additional information has been requested. Follow up information indicated there was no further information available.
This spontaneous report was received from a medical assistant and refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored PROQUAD injection (lot # N010247 with expiration date on 25-SEP-2018, dose, anatomical location and route not reported) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000870: US-009507513-1709USA001401: US-009507513-1710USA009267: US-009507513-1710USA009268: US-009507513-1710USA009269.
Information has been received from a physician concerning a male with a preexisting history of gastroesophaegeal reflux, who was vaccinated with a first 2ml oral dose of Rotateq (human bovine). Concomitant therapy included ranitidine HCl (Zantac) and metoclopramide hydrochloride (Reglan). "Within the last four months" in 2006, the patient developed gastroesophageal reflux disease. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
pain at injection site, tired, malaise, generalized pain, nausea, runny nose Narrative:
Headache, sore at injection site (which felt like I'd been punched in the shoulder the next day), fatigue, runny nose, sneezing (like the worst of my allergies, before I got them under control years ago)
Red arm; Swollen arm; Swollen lymph nodes at the arm of the injection; Pain at the injection site; Fever; Chills; Headache; Joint pain; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy Aspirin), Drug allergy (Toradol), Drug allergy (Maclodent), Drug allergy (Anaprox), Contrast media allergy (Contrast), Drug allergy (Ensids) and Drug allergy (Retromicin).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) 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 product use was not reported.  Treatment : Steroids   This case was linked to MOD-2021-022482 (Patient Link).   Reporter did not allow further contact
Information has been received from a physician concerning a 6 month old female with pertinent medical and adverse drug reaction history unspecified who on 10-OCT-2007 was vaccinated with a dose of COMVAX (lot #657379/0376U). Concomitant therapy diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal conj vaccine (unspecified) and ROTATEQ (MSD). On 10-OCT-2007, after the patient received the COMVAX, she experienced a 102-103 degree fever which lasted 3 days and had pain in both legs. At the time of reporting, the patient was recovering from the event. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available.
Blood vein in my finger swelled to extremely large size and burst. The blood in my vein was visible through the skin and was an abnormal bright blue color. This has also happened to my mother (1st dose of an mRNA, also in finger) and my husband (2nd dose of an mRNA, blood vessel burst in ankle).
On 10/22/2020 pt presented redness, some swelling and warmth in arm from injection site to just above elbow then went up into armpit. He started noticing the adverse reaction on 10/21/2020. Primary care was notified and was to call and speak with patient later. Phoned pt. 10/23/20 for check up - was doing better but had not received response from provider.
pain all over her body; pain that was hurting her so bad/achiness; cramping in her hands, feet and facehands were completely cramped up; Nausea; This is a spontaneous report from a contactable Nurse. A 27-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 29Aug2021 (at the age of 27-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for achiness. The patient medical history was not reported. There were no concomitant medications. Patient previously took first dose of bnt162b2 on an unspecified date in 2021 for covid-19 immunisation. On 30Aug2021, the patient experienced pain all over her body. Like out of ten she had stated then with pain that was hurting her so bad/achiness, she was hyperventilating so she had cramping in her hands, feet and face. Before they act they drew up and nausea (medically significant). It was reported that afterwards she experienced the little bit of the achiness she took Ibuprofen but it became, It got worse in the morning 30Aug2021. Nurse stated that we gave her treatment in response to adverse events which included steroid, Solu Medrol, gave her Benadryl. Norflox to relax her muscles cause her hands were completely cramped up. Zofran for Nausea. Solu Medrol, steroids, famotidine, fluids and then we gave her, she was given the steroid started taking the next day (on reporting date). The action taken in response to the events for ibuprofen was unknown. Outcome of all events were unknown.    The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pain, Muscle spam, and Nausea and BNT162B2.  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.
R arm was sore 10/5/09, 10/6/09. Noticed redness and warm to touch on 10/7/09. Saw HS clinic-rx CEPHALEXIN 500 mg po QID x 7 days.
1 of 5 pts ranging in age from 4-10 yrs who had inject site rxn (redness & swelling) & fever 102-104 w/in 24 hrs post immun, despite premedication w/APAP; pt had prev rxn to DTP & therefore was immunized w/DT:
20mins post vaccination pt c/o feeling SOB. Vitals: 121/70, 84, 24, 100% -- > 114/66, 85, 24, 100% Color WNL for ethnicity and all VS WNL for age.  Recommended parent take patient to PCP if symptoms do not improve. Pt stable and released from the vaccination site @10:25
This spontaneous report as received from a medical assistant via a company representative refers to a 65 year old female patient with diabetes. On an unknown date, as recommended because she was a diabetic, the patient was vaccinated with her second dose of PNEUMOVAX 23 (lot#, expiry date and dose were not provided) "as indicated" via intramuscular (IM) injection. Since getting her second dose of the vaccination, the patient reported that she had swelling and shoulder pain. The outcome of the events was not provided. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a 73-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell and vomiting. On an unknown date, the outcome of the feeling unwell and vomiting were unknown. It was unknown if the reporter considered the feeling unwell and vomiting to be related to SHINGRIX. Additional details were provided as follows: The physician reported that they had a patient that received the SHINGRIX vaccine and experienced vomiting and they did not feel well for 48 to 72 hours. No additional details were available.
It started with tingling in my tongue (which I ignored), then it became numbness that spread down my throat I also became short of breath. That's when I notified one of the nurses. They checked my blood pressure. I vaguely remember hearing it was high (189/?). They called 911 and the paramedics came. Shortness of breath became worse and chest pains started. The paramedic gave me Benadryl and then epinephrine since I was increasingly getting worse. I was shaking  and I felt lethargic. I could not control the shaking and I felt cold. I do not remember a lot of details when I got to the Emergency Room. Looking at my record they gave me: LORazepam (ATIVAN), methylPREDNISolone sod suc(PF)(SOLU-MEDROL) and famotidine. I went home that night with the condition that I see my primary care physician. I felt like I have the flu and soreness of arm the next couple days. I went back to work after four days.
Tingling in feet; BP 110-152; 76-82; HR 81; RR 16
Moderna COVID-19 Vaccine EUA  I received my first COVID-19 vaccine (Moderna) on January 31st, 2021. About 2 hours later, I had moderate-extreme pain in my left arm (couldn't raise my arm). About 4-6 hours later, I had side effects such as a red, raised rash near the shot (about, 3-4 inches in diameter), fever (99 degrees), swollen painful lymph nodes under arm pit (left arm) and fatigue. On February 1st, 2021, I continued to have pain in my arm, rash and swollen lymph nodes for about 48 hours. After that, my rash was then no longer visible. No medication was taken for symptoms.  On February 7th, I noticed in the morning that my rash near the shot came back (same location) with no other signs or symptoms. The rash was now red and flat (not raised).  On February 8th, around the 4:00PM my head felt heavy (sort of like a head cold), fatigue, loss of appetite, stuffy nose, fever (100-101 degrees). I took an Advil that night at about 10:00PM (first time taking medication to treat symptoms).  On February 9th, in the morning my symptoms (fever, fatigue, stuffy nose) were gone. My rash mostly went away in the morning (still slightly visible). My appetite in the morning seemed to return but I felt slightly nauseous after eating breakfast. Around noon, my nausea dissipated, I felt fatigued and had a fever of 101.6. I took Motrin at about 5:00PM and my fever dissipated. That night, at about 10:00PM I went to bed and was unable to sleep at all that night (extremely unusual as I don?t have any problems sleeping). I felt my fever came back at about 11:00PM but tried to go without the Motrin until about 3:00AM. I checked my temperature at 3:00AM which was 101.9 degrees. Due to feeling extremely uncomfortable I took the Motrin at that time. My fever dissipated again and I was able to get maybe a couple hours of sleep.   On February 10th, I woke up with no appetite, joint pain in my elbow of my left arm (no history of injury) and a fever of about 100 degrees at 11:00AM. I had a very small breakfast at about 11:00AM. I haven?t felt hungry since 4:00PM today, consistent with a loss of appetite. Currently, I?m checking my temperature about every hour or so and have been going back and forth between 100-101 degrees. My elbow joint pain on my left arm has only started today and it has only flared up in the morning and then the afternoon. I took another Motrin today at 6:00PM and will take another tablet of Motrin before bed to get rest. I am scheduled to do an e-visit with a doctor tomorrow morning.
No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant  male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Red and swollen at injection site hot to touch and hard at site of PNEUMOVAX. Advised pt to take ibuprofen and BENADRYL and put ice on it.
Information has been received from a registered nurse concerning an approximate 8-year-old female who on 11-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Pt noticed local redness and itchiness on right upper arm on Tuesday (9/12/17). By Weds and Thurs, she noticed the redness has spread to most of her right upper arm. She also felt burning sensation. I asked her to go get it checked out by a doctor.