chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday; her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "unknown" and all described as "her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive.  Additional information: Description of complaint: Agent reported caller had also said that her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday. There was a Product Complaint. DSU: E-submitting duplicate AE report for caller (69 years old) and her husband (74 years old).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has received from a healthcare worker (Certified Medical Assistant) referring to a patient of unknown age and gender. On 09-MAR-2015 the patient was received an expired dose of M-M-R II (rHA, batch# H018948, lot # 1646AA, expiration ate: 18-OCT-2014, 0.5 ml, subcutaneous). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
2 mins after pt. rec'd shot, got nauseated. Then 5 min pt. passed out. 8 mins after pt. passed out. 15 min after pt. passed out. 20 mins after pt. still feeling like he was going to pass out. 911 called. BP 90/62. Pt. pale. 30 min after EMS. Pt. still dizzy when standing.
injection site pain  tiredness ? headache ? muscle pain ? chills 13 hrs post injection ? joint pain same as above ? fever same as above ? nausea, vomiting, temperature 103.1 same as above ? feeling unwell same as above
11/23 ED for dyspnea, onset 1 week, worsening. Went to urgent care and tested positive for covid.   Reports progressive dyspnea, fatigue and weakness. unable to eat for 3 days.  11/24 On ceftriaxone/zmax, remdesivir, decadron 11/25 Dx Pneumonia secondary to COVID-19, patient is on azithromycin as well as Rocephin and Decadron, DVT prophylaxis, on Lovenox 40 mg twice a day 11/26 Discharged
On Oct. 29 I came down with COVID-19: sore throat, sinus congestion, fever, aches, dry cough. After 8 days of illness, by 11/5/22, fever was gone and worst symptoms had subsided.
Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.; Right arm is hurting; Shoulder is cracking; Uncontrolled spasm in her right arm; Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.), PAIN IN EXTREMITY (Right arm is hurting), MUSCULOSKELETAL DISCOMFORT (Shoulder is cracking), MUSCLE SPASTICITY (Uncontrolled spasm in her right arm) and FEELING ABNORMAL (Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066021A) for COVID-19 vaccination.     Concurrent medical conditions included Mental disability and Physical disability.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR HAEMORRHAGE (Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.), PAIN IN EXTREMITY (Right arm is hurting), MUSCULOSKELETAL DISCOMFORT (Shoulder is cracking), MUSCLE SPASTICITY (Uncontrolled spasm in her right arm) and FEELING ABNORMAL (Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed). At the time of the report, EAR HAEMORRHAGE (Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.), PAIN IN EXTREMITY (Right arm is hurting), MUSCULOSKELETAL DISCOMFORT (Shoulder is cracking), MUSCLE SPASTICITY (Uncontrolled spasm in her right arm) and FEELING ABNORMAL (Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter has reported that patient went to ER No concomitant medication was given by reporter. No treatment medication was given by reporter.
Large area of swelling, burning, stinging, and redness with heat in the area. Injected on June 11 and, as of today, 7/1/15, still have a red mark, with a bump in it, at injection site.
Mild pain in upper right arm approximately 24 hours after injection that lasted about 2 days
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as shingles. The patient was prescribed  acyclovir and NORCO for management of her painful symptoms and chronic pain. On or about 09-NOV-2016, the patient sought subsequent treatment for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed triamcinolone cream for management of her painful symptoms and chronic pain. As a direct and proximate result of the 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.
Extreme difficulty falling asleep, screaming for hours on end, complete drop in appetite and thirst for a total of 8 days and then fully recovered. Exam on day 7 was normal except irritability.
Patient states that >24 hours after receiving vaccine she developed a red, itchy rash at the site of injection.
chills, temperature of 100.3, sweats, extreme headache, overall full body aches, exhaustion, pain at injection site temperature lasted 4 hours.  chills and sweats lasted 5 hours.  headache lasted 24 hours.  pain at injection site lasted 60 hours.  exhaustion lasted 18 hours
Severe numbness in left arm and hand and less severe numbness in right arm and hand starting approximately two weeks after receiving my second dose of Moderna COVID-19 vaccine in May 2021. Both vaccine shots administered in left arm.  Numbness manifests as tingling feeling in both arms and hands; no sensation of hot or cold temperatures in left hand; swelling in both hands with knuckle joint pain; warm, flushed feeling in left arm; weakness in both shoulders and arms.  As of mid-December 2021, numbness still present in both limbs and severity has worsened.  Have seen local doctor on December 16, 2021.
Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves 59-year-old female patient who experienced blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE for 25 years without reaction. The patient's medical treatment, past medical history and family history were not provided. On 11-Jan-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) in the left arm. On 11-Jan-2019, the patient developed a non-serious five fluid-filled blisters in left arm (first 3, then 2 more, then yesterday 1 more), sores (blister), on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 16-Jan-2019, the patient developed a non-serious flu (influenza like illness), 5 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient felt bad and laid around (feeling abnormal), her left arm burst open with infection (localised infection), raw throat (oropharyngeal pain), difficulty breathing intermittently during Sunday night, Monday and Tuesday (dyspnoea), like a big hole in arm (injection site injury), arm in which she received the injection (left) has swollen (peripheral swelling), blisters left arm they hurt and itch (pruritus) and she has been running a fever of 101 (pyrexia), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient also stated that she may end up with scarring on her left arm. The patient went to Emergency room (ER visit) over the weekend due to her left arm infection. It was reported that the patient was seeking compensation for her reaction. Other relevant tests were not reported. Final diagnosis was blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia. Patient received Benadryl, Augmentin (strength: 875 mg) and mupirocin ointment to put on her arm as a corrective treatment. The outcome of the events feeling abnormal and fever was not reported. The patient was not recovered from the other events. Follow-up information was received from a consumer or non-healthcare professional by phone on 17-Jan-2019. Date of birth, patient age, site of administration of suspect vaccine, additional events and corrective treatment was updated and changes made in the field and narrative accordingly. Follow-up information was received from a consumer or non-healthcare professional by phone on 22-Jan-2019. Additional events localised infection and fever added. Event details, emergency room visit and corrective treatment were updated and changes made in the field and narrative accordingly. List of document held by sender: none.
About 8 days after receiving the vaccine the injection site is red, swollen and tender. It was not at all for the first week when I would have expected it. Going on day 3 of the discomfort.
About 24 hours after vaccination, patient noticed a red, sore, firm, warm patch on her arm below the vaccination site, roughly 5" x 6". Advised to try cold pack.
When I had caught covid it started out with pain coming from my neck up into my head on both sides. I was having trouble at night sleeping. It got increasingly worse. I stayed home and was isolated. I got weak and started having a lot of nausea for a long time all the way from August to November of 2021. I was prescribed muscle relaxers, pain meds, and Zofran.
Soreness at injection site, overall achy feeling, listless, feverish. Treated with aspirin during daytime hours and ALEVE at night. Same reactions were experienced with the first dose of SHINGRIX, although I experienced severe chills and severe weakness on that occasion (March 2018) Symptoms continued on and off for a week in that case. Length of symptoms this time not yet known, as I'm still experiencing them as of this report.
Patient stated she couldn't breathe and wanted her Epipen.  She then gave herself a shot in her right thigh.  After this, she started to feel better, then worse.  She said it hurt to breathe and she was very jittery and nauseous.  I called 911 and they came and took her to the hospital.  The gentleman paramedic told me the patient was likely jittery and nauseous due to the epinephrine.
Some adverse event reported; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some adverse event reported) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some adverse event reported). At the time of the report, VACCINATION COMPLICATION (Some adverse event reported) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
This spontaneous report as received from a other health professional refers to a 12 years old female patient. The patient was vaccinated with dose 1 and 2 of GARDASIL (lot # not reported) on 27-JUL-2011 and 27-SEP-2012, respectively. On 13-AUG-2012, the patient was in physician's practice, requesting to received her third dose of GARDASIL (lot # not reported). No adverse effect has been observed or reported. It was unknown if the patient sought medical attention. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty) and NIGHTMARE (nightmares) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Hypothyroidism. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ENALAPRIL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), BUPRENORPHINE HYDROCHLORIDE (SUBUTEX), CLONAZEPAM (KLONOPIN), GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MONTELUKAST SODIUM (SINGULAIR), ALBUTEROL [SALBUTAMOL] and LEVOFLOXACIN (LEVOXIN) for an unknown indication.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), NIGHTMARE (nightmares), MUSCLE TWITCHING (jumping and twitching when they are asleep), MEMORY IMPAIRMENT (are forgetting staff too), DECREASED ACTIVITY (Loss of personal independence in daily activities), MYALGIA (Myalgia) and FATIGUE (fatigue,Tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), NIGHTMARE (nightmares), MUSCLE TWITCHING (jumping and twitching when they are asleep), MEMORY IMPAIRMENT (are forgetting staff too), DECREASED ACTIVITY (Loss of personal independence in daily activities), MYALGIA (Myalgia) and FATIGUE (fatigue,Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Cellulitis; Vaccine Administered at Inappropriate Site; Wrong Route of Administration; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. On 6th June 2019, less than a day after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the outcome of the cellulitis was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   The reporter considered the cellulitis to be related to Shingrix.  Additional details were provided as follows: The patient reported that her 2nd dose of Shingrix was administered subcutaneously in her fatty tissue, which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route.  The patient developed cellulitis and wanted to know if that dose was effective or if she would be needing an additional dose.  It was reported that efficacy of Shingrix was studied with deltoid muscle as the injection site.  Medical Advise disclaimer was given.  The reporter had consented to follow up.
Feeling normal before the vaccine, with exception of slight cough that Dr said was due to allergies. But then a fever, chills and aches the day after vaccine. Two days after, still febrile and feeling worse and experiencing shortness of breath and lightheadedness. Fatigue, fever and lightheadedness continue for three more days. On the 6th day post-vaccine, taken to ER and admitted to hospital with a pneumonia and blood counts dangerously low. Received 3 blood transfusions and is receiving 2 different IV antibiotics to treat pneumonia. Still in hospital and waiting to see how blood counts go. I can?t say the vaccine CAUSED this, but it all happened rapidly, immediately following the vaccine.
An adolescent female patient experienced bright redness at injection site and "extreme" swelling of upper arm where injection was given after she had received an intramuscular injection of Menactra (lot number not provided). The outcome was unknown. A corrective version has been created using the original receipt date. The sole purpose of this version is to amend the event term from "extensive limb swelling" to "extreme swelling of upper arm". No other medically significant information has been added.
Sustained Ear pain on left side, slightly sore throat of left side. Injection site pain for two days
redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient was hesitant to provide demographics. The patient received dose 1 of Shingrix and she experienced redness at the injection site measuring approximately 2 inches by two inches. The reporter did not consent to follow-up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Feb-2021 at 10:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.28.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM , 11 AM, 2 PM, 3 PM temperature was 32, 32, 32, 35, 35  respectively total doses given for the day was 162 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient has swelling in the upper arm that is just below the injection site and goes to just above the elbow. Patient did state that the red area/swelling was higher up on her arm last night. There is a raised area of redness that is fevered and painful to touch. The area does not itch the patient. I have advised the patient to take OTC allergy medication and a OTC anti-inflammatory. I also advised the patient that if there was no improvement or it seemed to be getting worse, to seek care at a walk-in clinic or go to the ER for evaluation.
Lightheadedness, drop in blood pressure (89/50). Patient had not eaten breakfast, so patient was made to lie down with feet elevated, observed, and assessed by a doctor in clinic. Patient's vital signs were monitored, and was given water. Blood pressure was stabilized to 100/60, and was released at 11:49 AM.