chrisvoncsefalvay/vaers-outcomes huggingface dataset:
freezing shaking every bone in body ache today I feel like crap; freezing shaking every bone in body ache today I feel like crap; Initial information was received on 06-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer (under reference number: US-SA-SAC20211011000731).  This case involves an adult patient with an unknown gender who experienced non serious events "freezing shaking every bone in body ache today I feel like crap" (tremor) and "freezing shaking every bone in body ache today I feel like crap" (bone pain) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   The patient had no concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious events "freezing shaking every bone in body ache today I feel like crap" (tremor) (unknown latency) and "freezing shaking every bone in body ache today I feel like crap" (bone pain) following the administration of INFLUENZA VACCINE.  It was reported "Got my shot yesterday and boy did it hit me last nite freezing shaking every bone in body ache today I feel like crap. This has never happened to me."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome of events was reported as unknown.  There will be no information on lot number for this case.
Information has been received from a pharmacist concerning a 65 year old male who on 05-Jan-2009 was vaccinated with ZOSTAVAX, subcutaneously, lot number was not specified. On 10-Jan-2009 the patient experienced red, raised rash on his left chest and it extended to the neck and left upper arm. It was reported that the patient experienced an aching discomfort involving the neck both shoulders and left wrist. His scalp and area of the left forearm were sensitive to touch. Patient not recovered. Additional information has been requested.
This spontaneous report as received from a pharmacist via a field employee refers to a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, frequency and route not reported). On the same date, the patient was vaccinated with unspecified Flu vaccination. On an unknown date, the patient experienced local itching. The pharmacist reported that the local itching lasted for 1 week. It was unspecified if the patient received any treatment or if any lab diagnostics tests were performed. The causality assessment was not provided. No product quality complaint (PQC) was reported. Additional information has been requested.
3-4 days after the vaccine was administered the child c/o abd pain, h/a and pain at injection site.  Her left arm was swollen and sore from the shoulder down to the wrist. After a call to the oncall MD, Tylenol was used. At day 10 had int red splotches, c/o sharp shooting pain from left arm accross chest. She began c/o joint pain in knee and ankle and could not use the left arm. She became very emotional by about 2 weeks and would cry easily.  She conts to have pain and has learned to use the right arm and hand to write and prefers not use the left arm.  She conts to be emotional.  The pediatrician saw her at about 2-3 weeks postinjection and has since followed up with a referral to a neurologist.  She will see the neurologist on 11-9-07.
Drowsiness; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date not reported), via an unspecified route of administration, administered on the left arm on 11Mar2021 12:00 (at the age of 44-years-old), as first dose, single dose for COVID-19 immunisation. There were no pertinent medical history and concomitant medications. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced drowsiness on 11Mar2021 14:00. No treatment was received as a result of the event. Event did not result to physician office visit or urgent care. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Acute allergic reaction with skin rash all over the body, intense itching, mildly swollen upper lip.  Treated c Solu-Medrol 125 mg IM, went home c Prednisone (20mg) 2 tabs PO qd,, and Benadryl (25mg) 1 tab PO tid; F/U with PCP.
pt recvd vax & w/in 20mins post vax exp dizziness which lasted 1hr 40mins;
Pediatric patient received Varicella vaccine on, 10/03/16, after Provider reviewed the registry. It was later discovered patient received 2 doses of Varicella vaccines previously and did not need this current dose.
Horrible crucial body pain; Felt like dying; Weakness; Squeezing muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Horrible crucial body pain), FEELING ABNORMAL (Felt like dying), ASTHENIA (Weakness), MYALGIA (Squeezing muscle pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017A21A and 030A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Horrible crucial body pain), FEELING ABNORMAL (Felt like dying), ASTHENIA (Weakness), MYALGIA (Squeezing muscle pain) and HEADACHE (Headache). On 08-Apr-2021, PAIN (Horrible crucial body pain) and FEELING ABNORMAL (Felt like dying) had resolved. At the time of the report, ASTHENIA (Weakness), MYALGIA (Squeezing muscle pain) and HEADACHE (Headache) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-071330 (E2B Linked Report).; Sender's Comments:  MOD-2021-071330:First  dose case
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hib (Hiberix) (batch number 242A7) for prophylaxis.   On 24-JAN-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Left arm red, swollen, warm to touch. Applied ice to arm. No movement on 06/17/2004. Mother took child to ER. Advised to treat with amoxicillin and Tylenol. Today 06/21/2004. Swelling decreased and full range of motion.
Mother phoned in and stated that within an hour of the flu shot, child started to have redness and warmth of the area where shot was given.  Mother stated she did put cool pack to the area.  Mother also reported that child had welts at the site.  Mother gave child some Benadryl and some prednisone that she had.   Stated that child has had prior reactions to the flu shots, but not every time.  Mother had marked "no" on the consent form to the question if child had had a severe reaction to a flu shot before.  Mother states the prednisone did relieve child's symptoms.  Mother also stated she talked to the child's PCP on the phone, and they decided they would treat child prior to the shot and that child would go to the PCP's office for the flu shot from now on.
extreme vertigo; the first dose was probably on 03FEB2021 but I have not received the second one yet; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), via unspecified rout of administration on 03Feb2021 as a dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she got the first Pfizer COVID-19 vaccination on the (place name), and they gave her a card but she lost it, the first dose was probably on 03Feb2021 but she had not received the second one yet because she had a reaction to it; the next morning probably on 04Feb2021 it was about 9 or 10 hours later, she got extreme vertigo and she was in the hospital, the diagnosis was extreme intense vertigo that lasted for 6 weeks, she was terrified because she live alone, she just called # the y took me to the hospital, she learned different positions to alleviate vertigo and she did that over the time one morning it was gone. If she moved the head, if she even tilted my head, that would trigger it." "my doctor said yeah go ahead for second dose" "my girlfriend called (Pfizer Safety) for me, they gave her a number #". She asked "anyway they said they give it at (pharmacy name), do I have to have the card to get 2nd dose. my doctor said I can get another COVID vaccine. The outcome of event was recovered for vertigo and Unknown for the first dose was probably on 03Feb2021 but I have not received the second one yet.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 05Jul2022 to 09Jul2022 via oral for treatment of COVID-19. Clinical Course: No other medication in 2 weeks and no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event vaccination failure and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Vaccine administration error - Janssen administered by RN to patient younger than 18 years.
Right away, my chest felt  heavy, and a little tight.  My throat and  the back of my tongue felt like it was swelling. The middle of my tongue felt peculiar, kind of numb and tingly at the same time. This started 2 to 3 minutes after getting the shot. I had already taken a Benadryl, I have had this kind of reaction before. I did not have any trouble breathing. However, my throat and tongue swelled a little more and then after about 35-40  minutes, it started to subside. I remained in the pharmacy area for about an hour and 10 minutes total, while the pharmacist continued to check on me.
after the 2nd dose, her arm was sore for about a day.; Rash; Lips are swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Lips are swollen), PAIN IN EXTREMITY (after the 2nd dose, her arm was sore for about a day.) and RASH (Rash) 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 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced LIP SWELLING (Lips are swollen) and RASH (Rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (after the 2nd dose, her arm was sore for about a day.). On 12-Mar-2021, RASH (Rash) had resolved. At the time of the report, LIP SWELLING (Lips are swollen) and PAIN IN EXTREMITY (after the 2nd dose, her arm was sore for about a day.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 added new event.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 18-NOV-2015 the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (lot # J013904 with expiration date 30-OCT-2015; strength, dosage and route unspecified). No adverse effects were reported. Additional information has been requested.
Pt. received vaccine waited in room for 15-20 minutes after several hours later began to experience rash & itching. Came into pharmacy, BENADRYL was administered, pt. didn't go to ER. Took BENADRYL went home was OK afternoon.
Patient said he felt "faint" after the flu shot. Pharmacist asked if he'd like some water, and she stepped a few feet away to grab a bottle of water; then she saw the patient pass out/fall out his chair. She grabbed another RPh (me) and we ran back to the patient. She ran to call 911 while I waited with the patient. Within maybe 30 seconds the patient started sitting up. I proceeded to ask him questions (e.g., Are you okay? Do you know what happened to you? Do you have a history of seizures? Do you have diabetes? Do you have any medical conditions? Has this happened to you before? Does your head hurt? Would you like some water? etc...) Meanwhile, the other pharmacist contacted 911 and store management. EMTs were on their way. We gave the patient water and sat with the patient on the floor. We kept asking him questions and asked him to contact anyone that he felt he should contact. (He sent a text to his girlfriend.) We took the patient's temperature and were about to take his BP, when the EMTs arrived. They asked him questions and the patient refused to go to the hospital since this happened several times before (though, he did not recall this happening after a flu shot) and he said he felt fine. He signed a waver for the EMTs. EMTs left. I told him he could sit for as long as he wanted. He sat for a few more minutes and then he said he felt fine and was ready to go.
Low grade fever of 100.2 , chills, muscle aches, runny nose , sore throat, headache, cough, wheezing, shortness of breathe diarrhea and lost taste and smell.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L032181, expiration date 25-AUG-2017, rHA albumin status (strength, dose number and route of administration were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to a temperature of 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs; 07-JUN-2017, to 47°F for 18 hrs; on 09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. It was not reported if the administered vaccines were exposed to all temperature excursions. Adverse effects were not reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA004111: US-009507513-1709USA008834: US-009507513-1709USA008836: US-009507513-1709USA008833.
Sudden onset of premature ventricular contractions (constant and multiple) a few hours after vaccination.  Saw internist the next day and on 9/16.  EKGs both days.  He referred me to a cardiologist, who I saw on 9/17.
Shot administered at about 10am, felt fine until about 2:30. Started to feel tired. By 3:30 I had an increasingly painful headache. I had a sore left arm. I went to lay down and took temp. It was around 99F. I rested the rest of the day and fever increased to about 102F in the night. Severe painful headache, body aches, joint pains, fever and chills, and slight wheezing all night long. I didn't take any meds. In the morning the fever still there but lower 99F. Headache and achy body remained all day, even after taking ibuprofen in the morning. Fever was reduced from meds. That afternoon, 4/11, the fever broke in the late afternoon and I sweated a lot. After the fever broke, the headache and body aches were reduced and I felt a little weak and tired. By morning of 4/12 I felt fine, except a little dizziness when bending over. Only a sore arm remained for one more day.
This 60 year old man was admitted with respiratory failure.  He was intubated in ED.  He was seen by ICU tea,/  He also had hyperglycemic hyperosmolar syndrome with glucose over 1600.  He was treated with ivf and iv insulin.  Course was complicated by septic shock.  He also had nstemi with atrial fibrillation with rapid rate and was seen by cardiology.  Echo showed normal lvef.      He continued on vent and was not able to be weaned.  He also had covid and was treated with remdesivir for this.  He did require bronchoscopy due to atelectasis.     As sedation was weaned he was found to not be moving left side.  CT head showed bilateral CVA.  TEE showed PFO.  MRI showed extensive cva.  Follow up CT showed the strokes with mass effect and edema with mild left cerebellar tonsil herniation.  Discussion had with family and he was terminally extubated and made comfort care.  He expired at 2043
Pt stated she blacked out following injection, c/o headache & dizzy.  Taken to Observation area per w/c.  Eating crackers & water.  BP 122/76 P 64  2:10PM Pt c/o throbbing headache  BP 133/78 P 68  3:36PM Took pt to car via w/c to go home with spouse.
RASH; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (RASH). At the time of the report, RASH (RASH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
irritation & itching @ inj site p/2nd ID inj;area was big & red (later described as quarter sized);also states devel rash 24hr p/2nd inj described as long red lines on rt arm & chest;irritable 24hr p/inj;
15mins after getting vaccine got a tickle in my throat.  By 6pm I had a headache, tickle in my throat, intense fatigue, dizziness, chest pressure/sob, intense joint aches especially where I had fracture a bone in the past, deep muscle aches, nausea, right arm pain where injection went, also wasn't able to move my arm about 15degrees,   By 9pm that evening my side effects increased 10fold.  At that time it had taken some Benadryl and Tylenol to help with.  That evening I don't remember going to be or how I got to bed.  Then the next morning I woke with a terrible headache I, wasn't able to open my eyes, dizziness, nausea, SOB/chest pressure, intense joint pain, intense deep muscle aches, nausea, right arm couldn't move >15degrees, memory fogginess. Lasted all day and took tylenol, benadryl, and rescue inhaler for the SOB.  Sunday AM I woke up feeling pretty good at 0800  Got started doing somethings around the house and it hit me again by 1200.  SOB/Chest discomfort, headache, nausea, body aches, joint aches and lasted the remainder of the day. Then on that Monday I went and was tested x2 for covid and x1 for influenza/
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. On 11-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.