chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; LOW FEVER; FATIGUE; This is a spontaneous report received from a contactable consumer (Patient). A 37-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via unspecified route of administration in left arm on 23Mar2021 at 10:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient medical history was none and had no allergies to medications, food, or other products. The patient neither received any concomitant medications in two weeks nor any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had not tested for COVID-19 since having the vaccine. On 23Mar2021 at 12:00, the patient experienced headache, low fever and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events headache, fever and fatigue was recovering at the time of this report.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
a little bit of shortness of breath; extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DYSPNOEA (a little bit of shortness of breath) and FATIGUE (extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Tiredness. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced DYSPNOEA (a little bit of shortness of breath) and FATIGUE (extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and DYSPNOEA (a little bit of shortness of breath) and FATIGUE (extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included muscle relaxant due to arthritis.  Description: The patient had a sore arm that went well, but 3 or 4 days ago (31 Mar 2021) she noticed that she had a little bit of shortness of breath and she was extremely tired. The patient reported  that she already felt tired after taking her medications but it worsened after receiving the vaccine.  No treatment information was provided.
He received vaccines on 1.8.19 started to get a slight fever on 1.9.19 and passed away the night of 1.9.19 or early morning of 1.10.19  he was not breathing when I went into his room to get him in the morning.
Stiff neck (painful to turn head to the left, muscle pain and stiffness in the neck and shoulder. Patient said she first noticed symptoms the morning after receiving the vaccine and said they were improving at time adverse event reported.
According to the first pharmacist, the person administering the Flu shot did not hit the muscle, instead a nerve. A large brownish/yellow bruise is evident. Warm to the touch at injection site.
This infant had Advil, went to the ER at 10:30 PM, had a temperature of 104, HR > 200 bpm. He was placed on a monitor, given Tylenol. Fussiness and temp began 1 hour post-vaccination and continued for 48 hours.
CC: left upper arm/shoulder pain - onset of Tdap was administered on left arm. Pt reports the following: Iced; TYLENOL - with some mild improvement; Not improving - now with low grade fever; Spreading redness, warmth; Chills (feels cold).
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female patient who was vaccinated with GARDASIL when she was on her first trimester gave birth to a healthy baby but the baby was born without arms and legs. Lot # is not available. The patient had sought physician for medical attention. No further information provided at the time of reporting. Additional information has been requested.
Nausea, dizziness, pulse rate 100, low grade fever, sore arm w/hot to touch + tired.  These symptoms started about 12  hrs after vaccine was given and she felt the worst 36-48 hrs later.  She still feels tired + a little dizzy.
The very next morning I was feeling body aches which and extreme pain and stiffness in my hands. I could not fold my fingers nor close my hand. The soles of my feet would hurt too. I assumed these were normal side effects from the vaccine and figured they would go away. Three months later, my pain has intensified to the point that I am losing strength in my hands, I wake up without being able to close my hands or bend my fingers, I lost my strong grip, I need help opening items, it hurts to carry a grocery bag and I used to lift weights and now have problems with gripping them.
Fever of 99.6, swelling/pain site of vaccination, chills, malaise, fatigue for 24 hours then gone.
On 10/20/00 at 08:00, had numbness to left side of face and jaw. At 11:00, had numbness to left lower lip. "MD" stated it was a local reaction.
Narrative:  COVID infection following COVID vaccine series 12/17/2020, Pfizer, dose #1 01/07/2021, Pfizer, dose #2 10/06/2021 Pfizer, dose #2 09/08 COVID swab, result: detected 08/30 pt cc: cognitively impaired exposure: unknown 08/30 DDIMER 1.71 08/31 PROCALCITONIN <0.05 08/31 PT/INR 12.2/ 1.09 08/31 APTT 35.5 08/31 DDIMER 1.73 08/31 ESR 35 08/31 LACTIC ACID 1.05 08/31 CTA PE impression: 1. No acute pulmonary embolus is identified, as clinically queried. 2. Atelectasis within the posterior medial lower lobes bilaterally with more patchy opacities in the superior segment of the left lower lobe which may alternatively represent a focus of infection/inflammation. 3. Severe airway malacia with scattered retained mucus. 4. Additional ancillary findings, as above 09/01 ESR 47 09/01 FIBRINOGEN: 391 09/01 DDIMER: 1.60 09/02 ESR 51 09/02 FIBRINOGEN: 384 09/02 DDIMER: 1.83 09/03 ESR 45 09/03 FIBRINOGEN: 384 09/03 DDIMER: 1.56 09/08 CRP 3.109 09/08 COVID swab, result: detected 09/08 LACTIC ACID 0.79 09/08 CXR impression: Left lower lobe consolidation or atelectasis. 09/09 CTA PE impression: 1. No evidence for pulmonary embolism. 2. Bibasilar atelectasis and/or consolidation with plugging of the lower lobe bronchi. 3. Debris in the distal trachea, suggesting aspiration. 4. Tracheomalacia. 5. Background of moderate to severe emphysema. 09/09 SARS-COV-2 Variant Sequencing RESULTS: PENDING 09/09 FIBRINOGEN: 459 09/09 DDIMER: 1.44 09/10 ESR 35 09/10 FIBRINOGEN: 541 09/10 DDIMER: 1.17 09/11 FIBRINOGEN: 555 09/11 DDIMER: 1.38 09/12 ESR 72 09/12 FIBRINOGEN:459 09/12DDIMER: 1.56 09/12 antibodies to SARS-CoV-2 (COVID-19) results: >2500.00
noticed 99F Fever started at about 5pm day of dose (day 1); fever rose to 103F by 7pm,  101F with 500mg acetaminophen lasting until next morning (day 1-2); chills started at about 1pm and went away with fever (day 1,2); pain during injection (day 1); injection site soreness day of and on (day 1+); headache (pain moving eyes, pain during coughing/sneezing) started a few hours after vaccine, worsened with fever (day 1-3); next day slight raised tender bump at injection site (day 2);  quarter-sized raised bump with hardness and tenderness surrounding the raised bump at injection site, minimal redness if at all, slightly warm to touch (day 3,7)* bump is half-dollar size and itchy (day 4-6); pain moving eyes side-to-side and background headache that is obvious when moving quickly (day 1-8); slight dizziness (day 1-4) afterimages (day 3-4)  *the pharmacist administering the vaccine was not wearing gloves and did not clean my arm with alcohol prior to vaccination.
Severe body rigors; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Severe body rigors) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025LEOA) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement (replacement of mitral and aortic valves) in 2017 and Aortic valve replacement in 2017. Concurrent medical conditions included Hodgkin's lymphoma (Non Hodgkins Lymphoma in 2002 and is in remission.) since 2002, Cancer and Heart disorder.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced CHILLS (Severe body rigors) (seriousness criterion hospitalization prolonged). At the time of the report, CHILLS (Severe body rigors) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood pressure measurement: low (Low) Low blood pressure. On 01-May-2021, Heart rate: high (High) Fast heart rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CHILLS (Severe body rigors) to be possibly related.    No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: The follow-up document was received on 10 August 2021 and contains no new information.; Sender's Comments: Although patient's medical history is confounding, based on the current available information, a causal relationship cannot be excluded.
FIRST SHOT:  VERY SORE ARM AND HEADACHES FOR 3 DAYS SECOND SHOT:  CHILLS, FEVER 101.7, SEVERE HEADACHE FOR OVER 24 HOURS, ROLLING BOUTS OF NAUSEA, VERY SORE ARM WITH DISCOMFORT IN THE LEFT PALM BELOW MY THUMB.
Suffered Chronic Hives for 2 weeks, required steroid injection and dose pack, including daily benadryl
Pt devel swollen face, eyes, nose, lips, & lt leg; Blotchy spots on hands; fever 101; Dx delayed Hypersensitivity rxn to immun; tx Tavist syrup;
This study case was received from the investigator in a trial on 04 September 2013. A male subject had received the following vaccinations on 20 August 2013: ACAM2000 (lot number, route and site not reported), Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Nine days later, on 29 August 2013, the subject was found to have an elevated Troponin level. From labwork from 29 August 2013, the troponin level was 0.67 ng/ml. The subject also experienced fatigue starting on 21 August 2013 and stopping 29 August 2013. The fatigue was considered possibly related to vaccine. The subject did not take any medications for treatment. The subject had an EKG on 03 September 2013 and it was described by reporter as "normal". On the EKG it noted, "Sinus bradycardia with occasional supraventricular premature complexes, non-specific intraventricular conduction delay, ST elevation consistent with epicardial injury, pericarditis, or early repolarization, abnormal EKG" with a notation written, "artifact." On 29 August 2013, the patient felt good and denied any trouble breathing, chest discomfort, chest pain, pressure, palpitations, shortness of breath, dizziness, and dry cough without cold symptoms. Subject circled "0" on the scale. Subject stated that one month prior to smallpox vaccine he experienced an episode of syncope. No further information was expected to become available except a follow-up redraw. The subject's outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Swelling and pain at the injection site, persisting three days. Low grade fever. Full body aches. EDD: 2/6/18.
A health 23 month-old male patient, had received in error a 0.5 mL intramuscular left outer deltoid adult dose of Fluzone SV 2009-2010, lot number U3189AA on 02 September 2009 instead of 0.25 mL pediatric dose of Fluzone. The patient had also received on the same day a fourth intramuscular right deltoid injection of ActHIB, lot number UF566AA (Sanofi Pasteur SA lot number D0021-1); an intramuscular right deltoid injection of HAVRIX, lot number AHAVB326AA (manufacturer GSK); and an intramuscular left deltoid injection of INFANRIX, lot number AC14B0690. The next day after receiving the vaccinations, the mother reported , and a physician observed a two inch (5cm) pink firm area with no depth at the Fluzone injection site on the left outer deltoid area. The patient had no fever, but was started on antibiotics (not specified) that day. At the time of this report, it was "unknown" if the patient had recovered. Follow-up information was received 06 October 2009 from a health care professional. The patient had received Fluzone, ActHIB, HAVRIX and INFANRIX on 01 September 2009 (previously reported as 02 September 2009) and the event onset was amended to 02 September 2009 (previously reported as 03 September 2009). The patient was prescribed Omnicef 125/5mL for 14 days; however the patient went on a trip with his father and did not complete  the 14 day regimen. The patient's mother was unsure of the stop date for Omnicef. The pink firm area increased from 4 cm x 3 cm to an additional 1 cm by the next day and no further treatments were required. The event began to resolve after the third day, and by on week, the patient fully recovered with no residual effect.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-APR-2011, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
In March 2022, I started getting sick with what was diagnosed as a sinus infection. My lymph nodes have been swollen since that time.
Approx. 2 weeks after receiving flu vaccine, this patient noticed a rash covering most of his back and the back of his neck. He also is experiencing a burning sensation in both eyes. He stated that the rash or hives are somewhat itchy (but not extremely), it is more bothersome. I recommended that the patient be seen
Within first 24 hours, I experienced: fever, chills, headache, neck ache, body aches, nausea, injection site redness and pain.
headache; chills; diarrhea; Dizzy; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 79-year-old 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 79-year) on 04Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Feb2021 the patient experienced headache, chills, diarrhea, dizzy. It was reported that "caller received the Pfizer-BioNTech COVID-19 Vaccine first dose last Thursday and was wondering if it would be possible to experience headache, chills, and diarrhea after taking the vaccine & asking if this would also occur in the second dose. Stated that she got the shot on Thursday. Stated that on Saturday night that she got a headache, chills, dizzy and diarrhea." The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Per patient, He didn't feel well, flu like symptoms, possible tiredness the next day. He went to work and had a car accident. He says that he doesn't know if tiredness could have caused his car accident He went to ER for car accident
Red, swollen, warm (R) deltoid. Started 7/23/14 knot got worse. Now the size of a golf ball. Called on 7/24/14 advise ibuprofen and BENADRYL and to call if not better. Came into office 7/25/14 knot got bigger. Advise cold compress, Ibu tid and BENADRYL.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with 2 improperly stored doses of PROQUAD lot # M015695, expiration date 26-SEP-2017 (unknown route of administration) reconstituted with sterile diluent, for prophylaxis. There was no adverse effect reported. Administered doses of PROQUAD were exposed to an unspecified temperature excursion due to defrost cycle for an unknown time frame. There were no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA004540.
Rash on left arm in injection sight next day the area looks like it's a big hive. Very itchy.
Fever of 101.3, full body aches,  chills, exhaustion, moodiness started 9pm on 8/24/21. And continued until 8/27/21. When these symptoms stopped I had a vague headache.  Needed tylenol every day and sometimes twice a day and slept with an ice pack on my head every night until 9/7/21
Achy left arm; fingers (left) feel tingly and almost numb; finger almost numb; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PFIZEREP7534); via an unspecified route of administration in the left arm on 15Mar2021 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 07:00, the patient experienced achy left arm very painful to sit, to lay in bed or drive (pain felt like it hit his funny bone). The patient experienced fingers (left) tingly and almost numb. The arm pain started 3 days after the first dose. The adverse event resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. Therapeutic measures were taken as a result of pain in arm, tingling and numbness and included ibuprofen, cyclobenzaprine and naproxen. The clinical outcome of the events pain in arm, tingling and numbness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Bone crushing pain lasting 24 hours requiring opiate medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2593) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: mold" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: mites" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid Prior vaccination: Yes. Concomitant medication(s) included: BUPROPION; GUANFACINE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 18May2021, when the patient was 42-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Apr2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Bone crushing pain lasting 24 hours requiring opiate medication". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Facility type vaccine: Pharmacy or drug store. No other vaccine in four weeks. Other medication in two weeks: Bupropion and guanfacine. Event treatment: Pain medication. Patient was covid tested post vaccination. Covid test post vaccination: Type post vaccination: Nasal swab, name: PCR and result: Negative.
Upon arrival to observation 21 year old female stated she felt nauseous and light headed.  Fire Rescue took vitals and after 10 minutes pt. felt better and refused more treatment and was driven home with instructions to call 911 if symptoms worsen.
Soreness in  both shoulders, eventually arthritis in both shoulder s and multiple other sites of joint pain, weakness, tingling R hand  Arthritis symptoms are ongoing-unclear if related to COvid vaccineSecond dose of Covid vaccine on 3/21/21 Pfizer ER2613
Feel pretty crummy; This case was reported by a consumer and described the occurrence of feeling unwell in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 18th September 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient felt pretty crummy after receiving Shingrix.
26NOV93 bil hip joint pain, shoulder & neck pain, t101.2 intermittent h/a & dizziness; seen by MD 26JAN93; tx w/Ibuprofen & seldane; 29JAN93 heart murmur, e. nodosum, knee pain, iritis; seen in ER:
pt recvd vax & 1 or 2 days old was administered 1st Hep B vax on approx 22JAN93 & 27JAN93 age of 7 days devel cerebral venous thrombosis w/intraventricular hemmorhage; exp prolonged hospitalization;