chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 16-JUL-2016, the patient was vaccinated with the first dose and on 18-AUG-2016, with the second dose of GARDASIL 9 for prophylaxis. On 18-AUG-2016, 1 month 3 days after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Approx. 12 hours after receiving a second Covid shot my wife experienced difficulty swallowing, the sensation that her throat was closing and a very rapid heartbeat.
Elevated blood pressure, resting heart rate over 90-110, increased anxiety and stress, subtle body trembling, palpitations.
3 1/2" diameter red swollen area on lt arm 48hr p/vax;no streaking observed grandma will make Md appointment for f/u;
Initial arm soreness resolved by 1/2/21 and there was no redness. On afternoon of 1/6/21 injection site and outward about  2?radius  from site my right upper arm rapidly turned very red, painful and hot and also dizziness and extreme fatigue.  I had a virtual visit with my doctor and he diagnosed cellulitis.  Treatment of 5 day medrol dose pack and 10 day course if Bactrim DS 800-160.  Symptoms are improving.   Rapid test for COVID-19 on 1/7/21 (due to fatigue/dizziness) with negative result.
She didn't feel good, which is not unusual for her when she gets a Covid shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL3248) at the age of 73 years, in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6202), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FC3184) for covid-19 immunisation; rivaroxaban (XARELTO), at 40 mg 1x/day (440 mg, 1x/day (mouth once a day)), oral for anticoagulant therapy. The patient's relevant medical history included: "Blood thinner" (unspecified if ongoing), notes: Manufacturer unknown to Caller. , Therapy start: Caller states about 3 years ago. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered with sequelae", described as "She didn't feel good, which is not unusual for her when she gets a Covid shot". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for rivaroxaban was dosage not changed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200573621 Same patient and drug, different event separated in time
pt recv vax 23OCT97 & about 3hr p/vax pt exp malaise & myalgia described as just not feeling right & a little achy;
Administered booster dose of Moderna (blue top).  Person should have received Moderna Bivalent booster (blue top).   No adverse event.
Achy all over; Hard right at the site and around it; Itchy - at injection site; Sore arm - hurt to move my arm; lymph system was affected, my breast and even my nipples I could not; Redness - injection site arm was red - injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not), VACCINATION SITE INDURATION (Hard right at the site and around it), INJECTION SITE PRURITUS (Itchy - at injection site) and MYALGIA (Achy all over) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy, Allergy to antibiotic, Drug allergy and Oil allergy. Concomitant products included CLONAZEPAM (KLONOPIN), GABAPENTIN, LEVOTHYROXINE, ESTRADIOL (CLIMARA [ESTRADIOL]), MIRTAZAPINE and VITAMINS NOS for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not) and VACCINATION SITE ERYTHEMA (Redness - injection site arm was red - injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard right at the site and around it) and INJECTION SITE PRURITUS (Itchy - at injection site). On an unknown date, the patient experienced MYALGIA (Achy all over). On 01-Feb-2021, PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not) and VACCINATION SITE ERYTHEMA (Redness - injection site arm was red - injection site) had resolved. At the time of the report, VACCINATION SITE INDURATION (Hard right at the site and around it), INJECTION SITE PRURITUS (Itchy - at injection site) and MYALGIA (Achy all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient 's doctor recommended to not receive 2nd vaccine .  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up information was received and an additional event  was added.
Induration around site: 24 hours after shot Bruising around site 48 hours after shot Vomiting and chills 48 hours after shot
An hour after the vaccine, my lower lip started swelling and feeling puffy. It got worse and the inside of my mouth started feeling more puffy and full. I called my doctor. He directed to go to the Emergency Department right away. Since I'm allergic to Benadryl, my doctor wanted to make sure I'd be OK. I was treated with 40 mg of oral Prednisone and given a prescription to continue taking 20 mg daily for the next 3 days. The Emergency Department doctor recommended that I do not take the 2nd dose, but I wondered if I was on Prednisone the day of the next shot if I'd be safer? The ER doctor thinks the next reaction of a swelling lip/mouth could be more intense after the 2nd dose. I will follow up with my internist. I've had a mild swelling of my lip a few times in my life after eating something with artificial preservatives.
This literature market report was received from an author. Abstract: Studies assessing the economic burden of a mumps outbreak in a highly vaccinated population are limited. A mumps investigation was conducted in an affected village with a highly vaccinated population. To understand the epidemiology, standardized mumps case definition and active surveillance were used to identify mumps cases. In addition, an economic assessment of a combined outbreak investigation and third dose MMR vaccine intervention was performed; estimated by retrospectively evaluating public health response-related activities including use of a third dose of MMR vaccine. From 24-SEP-2009 through 15-JUN-2010, 790 mumps cases were reported-64% were male and highest attack rate was among 11-17 year age group (99.1 cases per 1000 individuals). Of the 658 cases with known vaccination history, 83.6% had documentation of 2 doses of mumps containing vaccine. No deaths were reported. The 2 major exposure settings were schools (71.8%) and households (22.5%). Mumps cases were classified according to the 2008 mumps definition of the Epidemiologists. A clinical case was defined as an illness with acute onset of the parotitis, lasting at least 2 days, and without apparent cause. Clinically compatible illness was defined as that which may present as aseptic meningitis, encephalitis, hearing loss, orchitis, oophoritis, parotitis, or other salivary gland swelling, mastitis or pancreatitis. Laboratory confirmation included isolation of mumps virus from clinical specimen, or detection of mumps nucleic acid, or detection of mumps IgM antibody, or demonstration of a 4-fold increase in mumps IgG antibody titer. Mumps cases were then classified epidemiologically. A probable case was defined as that which meets the clinical case definition without laboratory confirmation and was epidemiologically linked to a clinically compatible case. A confirmed case was defined as a case that met the clinical case definition or had clinically compatible illness, and was either laboratory confirmed or was epidemiologically linked to a confirmed case. This report refers to the 156 case-patients with documented 2 doses of MMR (manufacturer unknown) vaccine, 27 (15%) and who on an unknown date the patients developed parotitis. The outcome of event was unknown. The reporter considered events to be related to MMR (manufacturer unknown). This is one of the several reports with literature linked. Additional information has been requested.
She will have an emergency patient surgery, she is "losing a nerve from the back" on 28Apr2021; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 05Apr2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She will have an emergency patient surgery, she is "losing a nerve from the back" on 28apr2021 (medically significant) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
scalp tenderness; Rashes are really very itchy; Rashes are red; rashes on face, neck and it spread/ rashes are travelling all over her body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (scalp tenderness), RASH PRURITIC (Rashes are really very itchy), RASH ERYTHEMATOUS (Rashes are red) and RASH (rashes on face, neck and it spread/ rashes are travelling all over her body) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M214 or 013MZ14 and 041L208) for COVID-19 vaccination.     The patient's past medical history included Shingles (The patient said that she already had shingles before.). Concomitant products included AMLODIPINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PAIN OF SKIN (scalp tenderness), RASH PRURITIC (Rashes are really very itchy), RASH ERYTHEMATOUS (Rashes are red) and RASH (rashes on face, neck and it spread/ rashes are travelling all over her body). The patient was treated with CETIRIZINE for Adverse event, at a dose of UNK dosage form; PREDNISONE for Adverse event, at a dose of UNK dosage form and HYDROXYZINE HCL for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN OF SKIN (scalp tenderness), RASH PRURITIC (Rashes are really very itchy), RASH ERYTHEMATOUS (Rashes are red) and RASH (rashes on face, neck and it spread/ rashes are travelling all over her body) had not resolved.            On 01-Mar-2021, the patient went to see her primary care physician and the physician diagnosed her symptoms as shingles. But the patient reported that she already had shingles before and went to see another doctor who stated that it was not shingles and could be reactions from vaccine. The physician prescribed the patient with allergy medications.
Crying/inconsolable/fussy for past 2 nights (3 days after vaccination), (+) nasal congestion and dry cough started 3 days after vaccinations. (+) diarrhea x 3 one day after vaccination.
Incapacitating and prolonged shoulder pain due to incorrect placement of injection too high in the shoulder requiring rest and physical therapy, still not recovered almost 4 months later
Presented to clinic on 04/20 with intermittent temperature for which he was given Tylenol. Isolated papular rash over torso, no vesicles, 3 mm papules on exam. Twin bother with similar symptoms. Dx post exam: Viral exanthem vs varicella reaction.
Inflammation of BCG scar; This non-serious case was reported by a consumer and described the occurrence of bcg scar inflammation in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number Xx33P) for prophylaxis.   On 21-AUG-2023, the patient received Bexsero. On 22-AUG-2023, 1 days after receiving Bexsero, the patient experienced bcg scar inflammation (Verbatim: Inflammation of BCG scar).The outcome of the bcg scar inflammation was resolving.   It was unknown if the reporter considered the bcg scar inflammation to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   It was unknown if the company considered the bcg scar inflammation to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 25-AUG-2023 This report was submitted via the online direct entry reporting system.  The reporter was caregiver. The patient experienced inflammation of BCG scar.
Typical side effects (headache, nausea, vomiting, muscle aches, chills) from the evening of 4/23 until the evening of 4/24 including some chest heaviness . However, starting on 4/25, and  ongoing ,is a persistent cough and inability to take deep breaths without coughing.
Pt administered TDAP/Menactra/HPV administered IM tolerated well. Pt or Mother denied problems or concerns at present time. While I washed my hands upon completion of administration, the pt stood beside my desk and stated she felt like she was going to vomit. I immediately handed the pt the trash can in case vomiting occurred. Pt gagged twice but did not vomit. I applied a cool wet towel to the patients forehead. Pt then states she felt "numb" and went limp. Possibly experiencing a vasovagal syncope episode. Pt was assisted to sitting position by support of myself and her mother. Pt remained conscious and answered questions appropriately when asked by pt's mother and nurse. Mother denies occurrence happening in the past. Pt assisted to lying position on exam table while in nurse's room. B/P at this time 116/68. Pt no longer had flushed appearance and states she feels better. Mother states they did not eat before coming to the clinic and they planned to eat as soon as they left. Pt issued a bottle of water and animal crackers. Tolerated well. Pt alert and oriented. Denies any problems or concerns, stated she feels much better and she did not know why that happened. Pt reassured and informed that syncopic episodes do occur with needle sticks or injections at times. Verb an understanding. Respirations even and unlabored. Instructed to wait 20 mins for observation. Pt waited with mom and nurse. Pt' skin warm and dry to the touch. Respirations even and unlabored. Ambulating with ease. Skin normal appearance for race. Left with mother after observation period. Denies any problems or concerns at present time.
my heart is fluttering; I had horrible air hunger; a rapid heart rate; I awoke from a nap because it was causing my body to freak out; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 30-year) in Left Arm on 17Aug2021 at 01:15 PM as dose 1, single for COVID-19 immunization. Medical history included Lyme disease, diverticulum, Possible PCOS, all from an unknown date and unknown if ongoing. Concomitant medications included vitamin d3/k/a, app+, bart+, dtc+, tbb+, o.n.e, taken for an unspecified indication, start and stop date were not reported. No known allergies were reported. No COVID prior vaccination was reported. The patient was not tested COVID post vaccination. On 18Aug2021 the patient experienced her heart was fluttering, she had horrible air hunger, a rapid heart rate, she awoke from a nap because it was causing my body to freak out. It was reported by the patient that "she received her shot Tuesday. Wednesday night she had horrible air hunger and a rapid heart rate. That was Friday and after working, during sleep, her heart was fluttering so much so that she awoke from a nap because it was causing her body to freak out. Have had air hunger episodes since Wednesday". No treatment was received for the adverse events. The clinical outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a 6-month-old female patient who received Rotavirus vaccine. Co-suspect products included pneumococcal vaccine (batch number unknown, expiry date 31st December 2016). The patient's past medical history included pneumonia (A week and a half prior vaccination, the patient had pneumonia but she was fine on 10 Feb 2015). On 10th February 2015, the patient received the 3rd dose of Rotavirus vaccine and the 2nd dose of pneumococcal vaccine. On 10th February 2015, 3 hrs after receiving Rotavirus vaccine, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced aspiration (serious criteria GSK medically significant), respiratory syncytial virus infection, cyanosis and extra dose administered. On an unknown date, the outcome of the seizure, aspiration, cyanosis and extra dose administered were unknown and the outcome of the respiratory syncytial virus infection was not recovered/not resolved. On an unknown date, a CT scan showed something in skull bone but the brain matter looked fine. It was unknown if the reporter considered the seizure, aspiration, respiratory syncytial virus infection and cyanosis to be related to Rotavirus vaccine. Additional information: Three hours following administration of vaccines, the patient had a seizure. At that time, the patient's mother called 911. The patient had another seizure prior to her admission at hospital. While admitted at hospital, the patient had another two seizures. Patient was then transferred to another hospital, where she had another seizure. The patient had a total of 5 seizures over three days and also turned purple. The patient was discharged Friday evening (on 13 February 2015). On 10 March 2015, another pneumococcal vaccine was administered to the patient.