chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, swollen lymph node two days after vaccination.  All but lymph node had recovered by the end of the month. Lymph node ceased swelling shortly after. Patient fully recovered.
Received vaccine 3/12/16. On 3/13/16 patient had swelling in face and lips/itching on face and under neck. Recommended she take BENADRYL and keep a check on herself.
VARIVAX was accidently diluted with Gardasil instead of sterile diluent. No adverse reaction is expected.
5"x3" rectangular red, warm to touch reaction on left upper thigh. Treated with Benadryl, ice pack applied. Follow up appointment Monday 8/29/05.
Site pain with upper arm redness and swelling.  Fever, chills, night sweats, fatigue.
Dizziness; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Extreme fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), PROBIOTIC 10, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Extreme fatigue). On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reporte   This case was linked to MOD-2021-109542 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received and Patient stated that she was experiencing Dizziness since February; Sender's Comments:  MOD-2021-109542:First Dose Case
WITHIN AN HOUR AND ONE HALF, I HAD ITCHING  ON MY NECK WITH A RED RASH. IT IS HIVES, I HAD A NURSE LOOK AT IT. I WILL TAKE BENEDRYL  AND CALL MY DR. TOMORROW.
Pt recvd vax 30JUL92 pt c/o burning @ site upon inject; pt states 1AUG92 late PM joints @ knees & hips were hurting bad; pain cont through 4AUG92; pain greater in PM;  5AGU92 c/o pain around heart x 45 min; also facial swelling on 5AGU92;
Pt was vaccinated and then became dizzy. Pt rested on cot for a while and the symptoms resolved.
Nine days after my first injection, the Injection site and surrounding muscle tissue/joint became sore again.  Sore to touch and eventually sore to move my arm.
big bruise appeared below the injection site; This is a spontaneous report from a contactable other health professional (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 29Jan2021 (Batch/lot number: EL8982), at age 62 years old, as dose 2, single, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. Relevant medical history included high cholesterol (above 200) and known allergies to earlier generations of penicillins both from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to the vaccination. There were no concomitant medications in two weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, on 04Jan2021 (Batch/lot number: Ek92310), at age 62 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 05Feb2021 (also reported as 7-8 days after the second dose), a big bruise appeared below the injection site. The patient did not feel any pain. She just noticed it on her arm. The patient did not receive treatment for the event. The patient was tested for COVID-19 post vaccination thru PCR nasal swab on 25Feb2021 and was negative. The patient recovered from the events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
pt recvd vax 4OCT95 & devel urticarial rash on rt upper extremity & felt gen itching all over;given DPH; pt also exp SOB & chest pain;
This spontaneous report as received from a physician via a company representative refers to two patients of unknown age and gender. No information regarding the patients medical history was provided. On unknown dates the patients were vaccinated with ZOSTAVAX. No concomitant medication was reported. On unknown dates the patients experienced shingles even though they received vaccination. No outcome was reported. No causality assessment was provided. Additional information has been requested.
Pt was in observation after receiving H1N1 injection, when she said she felt dizzy. She was seated on a floor mat, and said she felt better. Her color was good and skin warm and dry. After 10 min more, she walked to clinic with school nurse.
9/13/19 onset sleeplessness, waking up crying, cold symptoms, diarrhea, fever 9/17/19 called public health for advice, advised to seek MD care, MD treated child for ear infection with antibiotics 9/18/19 bilateral hearing loss persists, mom states her concern VIS states MMR can result in deafness
Hand swelling, Headache, Myalgias- Parasthesias, chest pain - abdominal pain sharp, and was in chest - Allover body aches tachycardia.
Patient is experiencing spots/rash on both arms and on right leg 10 days after vaccine.  In addition, patient is experiencing headaches which in not normal.
fever for 48hrs not resolved with tylenol or ibprofen, chills 48 hrs, body aches 72 hrs, headache ongoing
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 22Jan2021, outcome "not recovered", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 5 minutes of shot, experienced extreme tiredness and flushing of face, tightening of the throat, chest pain, heart pounding, numbness of neck and collarbone, rapid pulse, and dizziness.  Staff provided a juice box and said to remain seated.    Most symptoms subside but numbness spread and got worse. It spread to rest of head and back.   When told about continued numbness after 30 minute, staff said patient could go and if it continues, benadryl should be taken and 911 called.    Numbness spread to back and patient took 10 mg of liquid benadryl which took effect within 10 minutes.
Pain at site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2021, the patient received the 2nd dose of Shingrix (unknown). On 14th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th January 2021, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the 2nd dose of Shingrix and less than a day after the vaccination patient had injection site pain. Patient used warm compress to manage pain and stated it felt fantastic after the heat and patient could go to sleep with no issue unlike the first dose. The reporter consented to follow up.
No other adverse events reported; Caller reports that a husband and wife was administered expired doses of MMR II.; This spontaneous report was received from a registered nurse concerning a female patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (lot #T016197, has been verified to be valid, expiration date: 11-MAY-2022), administered for prophylaxis (strength, and route of administration were not provided). No further information was provided, and no other adverse events were reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2205USA003749:
pain in left arm started one week after vaccine and ongoing; blistering on right arm within 4 days of the vaccine which lasted 3 days, mild pain ongoing
Right nostril blistered and closed/ hard to breathe; Right nostril blistered and closed/ hard to breathe; Swelling legs/itching; Swelling legs/itching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling legs/itching), PRURITUS (Swelling legs/itching), DYSPNOEA (Right nostril blistered and closed/ hard to breathe) and NASAL CONGESTION (Right nostril blistered and closed/ hard to breathe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced SWELLING (Swelling legs/itching) and PRURITUS (Swelling legs/itching). On 21-Feb-2021, the patient experienced DYSPNOEA (Right nostril blistered and closed/ hard to breathe) and NASAL CONGESTION (Right nostril blistered and closed/ hard to breathe). On 20-Feb-2021, SWELLING (Swelling legs/itching) and PRURITUS (Swelling legs/itching) had resolved. On 21-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 23-Feb-2021, DYSPNOEA (Right nostril blistered and closed/ hard to breathe) and NASAL CONGESTION (Right nostril blistered and closed/ hard to breathe) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was not reported by the reporter.
Onset of fever 10 hours after vaccination, resolved by the 24 hour mark. Arm stiffness and lymph node swelling in the left armpit beginning 36 hours after vaccine.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer - patient's husband) from medical information team and product quality group.  A 56-year-old female patient received BNT162B2, administration date 05Mar2021 (Lot number: EN6198) at the age of 55 years as dose 2, single and administration date 2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: ADVIL for Headache. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient has contracted COVID on 23Nov2021, testing positive after receiving both the Pfizer COVID vaccines. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Product Quality Group provided investigational results on 24Nov2021 for BNT162B2: Conclusion of Previously Completed Investigation:The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6198 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
After receiving vax on the way home the pt felt "weird" on way home. Abdominal pain and itching. Returned to CHD with mother. Rash noted on arms, back and legs; face red. No dyspnea. Benadryl was given by IV which relieved the itching and the rash decreased. Mother then took the pt to the ER.
1 of 3 pts who recvd DTP/HIB/OPV exp an acute severe inject site rxn @ DTP site; rxn included erythema, swelling, hot to touch & pain; also had irritability; resolved w/in 24 hrs; tx w/APAP/cold compresses; pt immunized from same vial;
I received the Moderna Booster (my 3rd Moderna shot) on 1/4/22. I woke up in the middle of the night sweating, dizzy, my heart was racing, and I had pressure in the middle of my chest (breast bone area) as if something was pushing on it (chest pain). I was having trouble breathing and I felt as if I was having a heart attack. I laid on the bathroom floor and almost went to the ER. This lasted a few hours at this extreme and got better around 9:30pm the next night (1/5/22). I am continuing to have intermittent chest pain and shortness of breath, but definitely not as strong.
A little bit of a fever; Really bad cold symptoms; Allergy symptoms were not going away; Bad runny nose; Congestion; Sinus pressure/headache; Sinus pressure/headache; Itchy throat; Losing my voice; Temperature today was 100 °F; This is a spontaneous report from a contactable consumer (patient). A 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 02May2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 18 years). Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not received any prior vaccinations within 4 weeks. The patient prior to receiving the vaccine, she was having allergy symptoms, however, she stated that she would take an allergy pill and the symptoms would go away. On Sunday on May2021 after her first dose of the vaccine she noticed that what she thought allergy symptoms were not going away. She reported a bad runny nose, congestion, headache, sinus pressure/headache, itchy throat, losing my voice, and temperature today was 100 degree F. She has been taking medicine and drinking Theraflu but continues to feel worse and not better. She wanted to know if these are normal side effects or if she should see a doctor. Caller questioned that should the patient ask to be tested for COVID-19. Caller went and got shot on Sunday 2May2021 and later that day on 02May2021 she got really bad cold symptoms and they haven't gone away. Caller stated that she has taking medicine. Today she checked to see if she had a fever and she had a little bit of a fever. Caller asked if these are normal side effects or does she need to get checked out. Caller stated her symptoms are not going away. she has had allergies before and she was able to control them with over the counter allergy pills but that night they did not work. Caller stated that she didn't think to check for fever yesterday, but that she checked today on 04May2021 and has a bit of a fever. Yesterday she felt bad but today she got a little better, but today is still bad. The patient received treatment for really bad cold symptoms. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit on May2021. The patient did not visited Emergency Room/Physician Office. The clinical outcome of the event allergy symptoms were not going away, bad runny nose, congestion, sinus pressure/headache, itchy throat, losing my voice, temperature today was 100 degree F was unknown, really bad cold symptoms outcome was recovered on an unspecified date, a little bit of a fever outcome was recovering.     No follow-up attempts are needed. No further information is expected
weak; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and HEADACHE (pounding headache) 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ASTHENIA (weak) and HEADACHE (pounding headache). At the time of the report, ASTHENIA (weak) and HEADACHE (pounding headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments:  MODERNATX, INC.-MOD-2021-032600:
small scratch; less than recommended dose given due to patient moving during administration of initial vaccine; Information has been received from a Medical Assistant reporting on a 9-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 17-AUG-2021, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis (route of administration, lot number and expiration date were not reported). Medical assistant was calling to request information on hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) revaccination, after less than recommended dose given due to patient moving during administration of initial vaccine. The patient moved during vaccination and the needle left a "small scratch" on the patient's thigh. She states the physician was aware. Medical assistant verified the vaccine has been stored at recommended temperature and that the vaccine was not expired. The outcome of scratch was unknown.  The causality assessment was not provided.
Local reaction from vaccine at the vaccination sites (both deltoids) with erythema and induration of 2-3 inches.
Information has been received from the authors in a literature article concerning a 19 year old female with MMR vaccine (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The 19 year old patient with known exposure to measles during travel developed disease despite 3 documented MMR (manufacturer unknown) vaccine doses (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Threw up; Neck stiffness; He has this pain in his neck; he cannot move his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (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: VOMITING (non-serious) with onset 22Nov2021, outcome "unknown", described as "Threw up"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Nov2021, outcome "unknown", described as "Neck stiffness"; NECK PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "He has this pain in his neck"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "he cannot move his neck".  The lot number for bnt162b2 was not provided and will be requested during follow up.