chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt returned to clinic approx 30 min after injections with rash on neck & rt shoulder. Denies SOB, facial/tongue swelling, chest pain, etc. Pt. was in no acute distress; O2 sat, 98% chest clear on auscultation: No inflam at injection site. Pt observed x 10-15 min; Recommended to take OTC BENADRYL when she got home, called pt - 4 hrs later. She denied any sympt. at this time, including rash. Did not take BENADRYL.
Left upper arm cellulitis (Rule out), rule out myositis.  Complained of left upper arm pain, erythema, edema; and range of motion.  Three days after receiving Td booster. Seen by MD-started on Keflex for 2 weeks. Flexeril 10mg twice daily (neck/shoulders/spasm).
Arm swelling and tenderness from wednesday until friday After, could feel hardness and it was itchy from saturday through thursday Still feels hard but no longer itchy Day after felt throat and ear pain but went away within a day.
After 8 hrs of administering the covishield vaccine I had developed some  muscle ache, feverish & uncomfort  After  10 hrs of the vaccine administration, I was dizzy feeling hot from inside the body- feeling of hot flashes, body muscle aches , hallucinations weakness and acute and severe muscle aches.  I lost the sensation of temperature on my body - my skin became dry and I have drank 4 litres of water to quench my thirst. Still my throat and buckle cavity was all dry no saliva   - temporarily for few hours (say 3/4 hrs) after all this symptoms started I was hallucinated and was seeing all fire and hot molten lawa type   My skin lost sensation for the feel of temperature- my palms of both hand and legs went dry my lips went dry during the entire episode.  Seems lost slept or went into dreaming or hallucinations   After 9hrs of this reaction I took paracetamol 659mg
Tested negative after treatment then tested positive about 6 days after treatment; Tested negative after treatment then tested positive about 6 days after treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "Latex" (unspecified if ongoing). There were no concomitant medications.The patient had no other medications in two weeks and no other vaccine in four weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "recovering" and all described as "Tested negative after treatment then tested positive about 6 days after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (02May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
3-5 minutes after injection: experienced profound and sudden dizziness followed by numbness and tingling throughout body. After 1-2 minutes experienced a sudden forceful beating of heart lasting 1-2 minutes. All of the previous symptoms subsided after several minutes. After previous symptoms subsided, I became shaky and with body aches. I was brought to the emergency room for observation. Temperature was normal, HR 80?s, BP 144/98 (but I was shaking). I only felt short of breath when my heart was racing. Episodes of profound dizziness and tachycardia (Heart rate=138-144) occurred again while in the ER approximately 30 minutes after first reaction and subsided in less than a minute. I felt achy again but within 1.5 hours after injection returned to feeling normal with the exception of feeling slightly lightheaded. I did not experience any other symptoms except for a mild sore arm since then.
Pt c/o dizziness.  BP 121/69, HR 68, RR 18 -- > 103/68, 67, 18.  Pt reports that she did not drink much water today.  Pt given water and juice, laid down/rest.  Pt reports feeling much better after laying down.  Pt stable and released from the vaccination site.
MIS-ADMINISTRATION; INTRANASAL H1N1 WAS ADMINISTERED TO A PT WHO WAS OLDER THAN THE AGE RANGE. PT AGE 50 YRS.
This spontaneous report as received from a Medical Assistant referring to an unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL 9 Lot #M042853 with an expiration date on 17-JUL-2019 for prophylaxis, that had been improperly stored. No adverse effects were reported. The vaccines were stored at 48°F during 2 hours and 58 minutes and no previous temperature excursions were reported. The call was because of a data logger. This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1708USA002974:
pregnancy registry; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy registry) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy registry). At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy registry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
tinglining from knee to ankles; Foot cramps; Sore arm; Uncontrolled shaking; Roots of her hair were sore to touch; Severe chills; elevated pulse rate; Leg cramps; exhaustion; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion) and HEADACHE (severe headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion), HEADACHE (severe headache), MUSCLE SPASMS (Foot cramps), PAIN IN EXTREMITY (Sore arm), TREMOR (Uncontrolled shaking) and PAIN (Roots of her hair were sore to touch). On an unknown date, the patient experienced PARAESTHESIA (tinglining from knee to ankles). At the time of the report, CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion), HEADACHE (severe headache), MUSCLE SPASMS (Foot cramps), PAIN IN EXTREMITY (Sore arm), TREMOR (Uncontrolled shaking) and PAIN (Roots of her hair were sore to touch) outcome was unknown.
Symptoms ? EE reports around 10:00 PM on 1/13 pain and achiness to R arm and tired.  EE reports woke up Thursday am with fever (Tmax 103) and chills.  EE reports temp 99 at time of call. ?  Last day of work and shift ? Friday (1/8/21) Home remedies? -   Tylenol and motrin q4h, rest Any improvement? ? mild improvement Recommendation? EE encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive and to apply a cold compress to injection site.  EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns.  EE reports she called out of work today.  EE educated to manage her RTW according to the Workplace policy.  EE said she had a secondary exposure and requested to be tested through hospital but was told by EH unable to test so got COVID tested on Monday 1/11 at pharmacy  and reports negative result.  EE requesting RN to send her manager and email documenting call.  EE notified RN will not be sending her manager an email but if manager needs proof of call, to contact EH.  EE verbalized back understanding and denied further questions at this time.
10/06/04 - Received flu vaccine at work at ~9AM.  Arm was sore by end of day. 10/07/04 - Developed fatigue by 4:30PM.  Explosive diarrhea at 8PM.  Minor sneezing and tingling sensation throughout body by 10PM.  Entire nasal passage blocked with congestion by 11PM.  Difficulty sleeping throughout evening. Body sensitive to blankets at times, and seem painful to the touch.  10/08/04 - Severe headache by 7AM.  Ingested 800mg of ibuprofen at 7AM and able to sleep until 12PM the same day.  Explosive diarrhea at 3:15PM. Increase in sneezing and mucous production and collected temperature with 97.5 degrees Fahrenheit.  Watery diarrhea episodes throughout evening.
On 8/30/2021 Patient presented to store for encounter for immunization for hepatitis B vaccine 2/3. She received Recombivax peds/adol on 7/29/21 at a different Store. Store did not have Recombivax in stock, so it was decided to administer Energix-B. The patient, age 19, was given the adult dose of Energix-B, 1 mL, lot # N4GA4. She was advised to receive her third dose of the series at the end of January. Today, 1/29/2022, she presented to store for her third dose of the hepatitis vaccine, but it was realized that she was given the adult dose in 08/2021 instead of the pediatric dose of Energix-B. Hep B antibody titers were drawn today and no vaccine was administered. Patient reported no adverse reactions or side effects of the adult dose of Energix-B after administration in 08/2021. Clinic manager and Clinic Practice Coordinator were notified.
pt recv vax 28NOV95 & 20OCT96 pt devel chickenpox;22OCT96 pt presented to MD w/chickenpox on trunk & extremities;dx w/a mild case of varicella;
HCP reporting a patient who received ZOSTAVAX on 31MAY2012 developed an anaphylactoid reaction./Patient experienced an itchy throat; This spontaneous report was received from a registered pharmacist and refers to a currently 71-year-old male patient. The patient's medical history and concomitant therapies were not provided. The patient's concurrent conditions included egg protein allergy.   On 31-MAY-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered as injection (dose, strength, exact route of administration, anatomical location, lot #, and expiration date were not provided) for prophylaxis.  On an unknown date, the patient developed an anaphylactoid reaction, patient experienced an itchy throat. The patient sought medical attention and received diphenhydramine (BENDARYL) as a treatment for the event. On an unknown date, the patient recovered from the event. The product was not available for agency retrieval.  The relatedness between the event and the suspect therapy was not provided.  Upon internal review, the event of anaphylactoid reaction was determined to be medically significant.
Mild macula papular rash on back of neck & back of chest, abdomen & spreading to shoulders & anterior chest. No other symptoms or signs. Baby remained alert while temp 100.5 F. Tx'd with Tylenol & told if worsens go to ER.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # K024552, expiration date 22-OCT-2016; dose and route were unknown). The vaccines were exposed to temperature excursion of 1 degree centigrade for 12 hours and 1 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Flu-like symptoms yesterday. Feeling slightly better by today. Large red welt on arm at site of injection.
shingles; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 21Feb2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose last 21Feb2021 but missed the scheduled 2nd dose because he had shingles. Her husband just received the 2nd dose yesterday, 25Mar2021 and she would like to know if that is okay. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Pt noticed a rash all over back & down left side that itches. Raised, but no oozing.  No fever. Dr. said to used Benadryl tablets and Gold Bond anti-itch cream.
Mild pain at injection site, 5 days after injection, I developed herpes sores on my lip.
Breakthrough case admission after 3 vaccines MOderna 3/18/21 Lot# 031L20A;  Moderna 4/15/21 Lot# 007B21A;  Moderna 12/11/21 Lot# 031H21A
Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration, administered in Arm Left on 11May2021 at 13:39 (at the age of 67 years old) as single dose for COVID-19 immunisation. Medical history included ongoing high cholesterol. She does not take it more than that because it causes her back pain and sciatic pain. Her doctor told her she had to take it because her cholesterol is 225. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) twice a week taken for high blood cholesterol. Historical vaccine includes flu vaccine and had a reaction, her throat started closing. That was years ago, it had to be 2014. Before she got the Covid 19 vaccine she checked to make sure she didn't have the Covid 19 virus. No other vaccines were administered on same date with the Pfizer vaccine nor four weeks prior to the vaccination. On an unspecified date, with the first Covid 19 vaccine the patient experienced a sore arm. Adverse event did not require visit to emergency room nor physician office. The lab tests and procedures included blood cholesterol was 225 on an unspecified date. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Severe dizziness, site pain and redness, nausea, vomiting. Numbness, weakness and pain in all extremeties and face (cheeks, lips, tongue). Chronic sleepiness (have slept 60 out of 72 hours over the past three days). My arms are so weak that it feels as if there are no bones in my arms. Headache, ear ache and deep chest cough.
Moderna dose #2 given 1 week after dose #1 due to patient rescheduling appointment.  Vaccinator did not verify first dose date.
Plaintiffs allege that as a result of immunization in Feb84 at age 5 months (no mention in litigation of any previous vaccination), infant sustained cerebral palsy, Encephalopathy, & spastic quadriparesis
Pt recv vax on 11/19/98; 2 min post vax pt exp dizziness, tx=rest 1 hr-dizziness persisted
This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got the first dose of COVID-19 vaccine last 12Mar2021 and he will be getting the second dose tomorrow (30Mar2021) and experiencing dizziness and some stomach problems. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling and redness at injection site. Some pain and discomfort in arm and underarm.
swelling of the hands; tremendous headache; ache at the injected arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the hands), HEADACHE (tremendous headache), VACCINATION SITE PAIN (ache at the injected arm) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling of the hands), HEADACHE (tremendous headache), VACCINATION SITE PAIN (ache at the injected arm) and CHILLS (chills). On 27-Feb-2021, PERIPHERAL SWELLING (swelling of the hands), HEADACHE (tremendous headache), VACCINATION SITE PAIN (ache at the injected arm) and CHILLS (chills) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Fax from HCP, requesting patient name, NNI.
Information has been received from a registered nurse concerning a child male patient who on approximately 27-MAY-2009 was vaccinated with the first dose of either ROTATEQ or ROTARIX. On 30-MAY-2009 the patient experienced rotavirus symptoms and was hospitalized. On an unspecified date, the patient had a positive test for rotavirus. In the morning of 01-JUN-2009, the patient had been discharged from the hospital and had recovered. Additional information has been requested.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071154 and 2019SA071155, same reporter. This case involves a 11 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 11 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Golf ball size lump at injection site warm to the touch and sore, joint pain and body ache
Information has been received from a health professional concerning now a five year old female who on 09/19/1996 was vaccinated one dose of varicella vaccine. Subsequently, it was reported that on 05/17/2001, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Headache; body aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported) via an unspecified route of administration on 24Mar2021 (at the age of 43-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: Not reported) as single dose for COVID-19 immunization. On an unspecified date in Mar2021, the patient experienced headache, body aches, chills and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient presented to ER with complaints of erythema, pain, and swelling to smallpox site. Patient was diagnosed with cellulitus and treated with Cephalexin 500mg X 10 days.
Fatigue, heart racing, lightheaded, breathing problems, muscle aches, felt like I had saline injected in me I felt the coldness go across my back and into my arms and feet, tingling,
Immunized on 8/4/2012, 2 weeks later approx the 18th, noticed swelling and an "uncomfortable" feeling in both hands. On the 19th she started having small "bumps" on her hands starting at her knuckles. On the 20th the bumps were progressively worse and had spread to her hands and between her fingers, and eventually up both arms to the extent of the medial bicep region. She was out of the area and had called the clinic to report her symptoms. At that time she stated she was having severe pain in her hands and Public Health Tech had advised that if the pain was that severe she should be seen by a civilian provider and when she returned to the area to report into the clinic for follow-up. On 8/23/12 she was seen by a provider who in turn consulted with an allergist about her symptoms. She was dx with an allergic rxn to smallpox. Prescribed 40 mg Prednisone PO daily x 5 days, Vicodin 1 tab Q 6 hrs PRN pain, Cimetidine and Allegra BID daily, f/u PRN. Returned to f/u on 8/28 with provider who in turn continued her on 20 mg Prednisone PO daily x 4 days, d/c'd Cimetidine, continued with Allegra.  Sx cleared at that time, however on 8/5/2012 member noticed one bump reoccurring on her finger with significant pain.  She reported into the clinic for her Tdap and Anthrax vaccination and upon asking her the screening questions about previous rxn, she reported the above events.  Member referred to provider.
For both the 1st and 2nd vaccination of moderna, an itchy red patch appeared on my right arm measuring approximately 2? x 3.5?.  The red patch after the 1st shot appeared 5 days after the shot and lasted 5 days.  For the 2nd shot on 2/20/21, the red patch appeared the next day.
Employee felt shaky,dizzy, sweaty and nauseated. Employee currently has a headache.