chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got Dizzy; running nose; sore arm "like someone beat the shit out of me"; felt sick/ like she was coming down with the flu; hacking cough; she did vomit; headache, pressure is felt on forehead; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she got Dizzy), RHINORRHOEA (running nose), PAIN IN EXTREMITY (sore arm "like someone beat the shit out of me"), MALAISE (felt sick/ like she was coming down with the flu) and COUGH (hacking cough) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0042C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL SUCCINATE for Hypertension, NITROGLYCERIN, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL and ATORVASTATIN for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DIZZINESS (she got Dizzy), RHINORRHOEA (running nose), PAIN IN EXTREMITY (sore arm "like someone beat the shit out of me"), MALAISE (felt sick/ like she was coming down with the flu), COUGH (hacking cough), VOMITING (she did vomit) and HEADACHE (headache, pressure is felt on forehead). At the time of the report, DIZZINESS (she got Dizzy), RHINORRHOEA (running nose), PAIN IN EXTREMITY (sore arm "like someone beat the shit out of me"), MALAISE (felt sick/ like she was coming down with the flu), COUGH (hacking cough), VOMITING (she did vomit) and HEADACHE (headache, pressure is felt on forehead) outcome was unknown.            No treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021,  in which declined consent for safety follow-up. with physician.
severe headache starting same day  of vaccination and continuing for 3 days weakness and fatigue 2 days  nausea 1 day
Edema; Swelling; Rash; Hives; This spontaneous case was received on 18-Oct-2021 from a pharmacist via regulatory authority (reference number: SEQW21-04084) and concerned a 94-year-old, male patient.  The patient's concurrent conditions included allergy to amlodipine and pantoprazole. The patient's concomitant medications were not reported.  On 27-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular (IM) and anatomical location: deltoid) as an influenza prophylaxis. The batch number was not reported.  On 02-Oct-2021, five days after receiving Fluad Quadrivalent, the patient experienced rash, swelling, edema and hives treated with prednisone and Benadryl (diphenhydramine hydrochloride).  On an unspecified date in Oct-2021, the patient recovered from the events. As reported, the patient was fine.  The reporter assessed all events to be related to Fluad Quadrivalent. As reported, the patient showed late-onset reactions to Fluad Quadrivalent.  The reporter assessed the case as non-serious.  Company comment: A 94-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. Five days after vaccination the patient experienced rash, swelling, oedema and hives. Information regarding the concomitant medications has not been provided. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: As reported, a patient showed late-onset reactions to Fluad Quadrivalent experiencing rash, swelling, edema and hives.; Sender's Comments: A 94-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. Five days after vaccination the patient experienced rash, swelling, oedema and hives. Information regarding the concomitant medications has not been provided. Based on plausible time relationship, causality is assessed as possibly related.
Fever 101 F; muscle & joint pain; Muscle & joint pain; Fatigue; Arm pain; Nausea; Headache; Chills; Booster; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 28Sep2021 at 14:30 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included biotin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) both via an unspecified route of administration on an unknown date for covid-19 immunisation and had no adverse reactions. On 28Sep2021 at 18:30, the patient experienced arm pain, nausea, headache, chills, fever (101 F), muscle & joint pain and fatigue. The symptoms began about 4-12 hours after shot. The patient reported that first and second shots had no adverse reactions. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, nausea, headache, chills, fever (101 F), muscle & joint pain, fatigue was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Left arm at injection site became raised, swollen, itchy and warm to touch about 5 days after vaccination.
influenza A; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had influenza a while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer,with unknown dose,lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient had a serious influenza a (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza A).  At time of reporting, the outcome was Unknown for the event influenza a.; Sender's Comments: Sanofi company comment dated 01-Mar-2022: This case involves a patient with unknown demographics who had influenza a while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications,findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Pytariasis rosea, generalized red splotches around trunk, starting to spread down limbs and neck. Not itchy,  it painful,
About 7 hours after administration of vaccine patient started experiencing flu like symptoms body aches fatigue mild fever chills headache as well as reported a very sore arm at injection site that has lasted into the next day he feels he can barely lift his arm and it is very painful. He has taken tylenol and ibuprofen and tried to apply ice to the injection site. Will follow up when symptoms resolve.
Weeks of fatigue, sore joints, lack of motivation, headache.  Where they injected the vaccine stayed sore for well over a week.  Still feeling the effects of the vaccine.  Patient information said to expect two or three days of reactions but, it has been a month and the reactions are still strong.  It makes me hesitant to followup with the booster that is recommended within six months.  I had shingles when I was 35 years old and don't know if that made the side effects of the vaccine stronger.
her arm is a bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm is a bit swollen) 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 06-Apr-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 an unknown date, the patient experienced PERIPHERAL SWELLING (her arm is a bit swollen). At the time of the report, PERIPHERAL SWELLING (her arm is a bit swollen) outcome was unknown. Not Provided          Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Received Td booster left deltoid 0.5ml IM on 5/11/05 at about 10:30 AM. Awoke about 08:00 on 5/12/05 with generalized aches and fatigue. By 10:30 AM, had headache (bilateral temples) throbbing. Fever 100.8 after one Tylenol taken. On 5/13/05 only symptoms are body ache and fatigue. 5/14/05 back to normal.
All over body itching and skin withering. Also known as dermatographia. Antihistamines stop the itching, but any scratch still causes skin withering. Ongoing for 2 months, 2 weeks and 2 days as of today.
Extreme chills, fever, trembling, muscle ache for 3 hours, followed by 2 days of less severe symptoms.
Pt returned to clinic about 5 hours after Flu vaccination complaining of dizziness, fainting, chest tightness. No itchy throat, rash, hives, throat horsing, or itching. HR = 100, T = 98.3, RR = 20, BP + 100/62. Pt history of asthma.
Pt stated she developed an injection site reaction to the vaccine approximately one week after receiving her shot. She had redness and swelling the size  of an egg where she received the vaccine.
Child was unresponsive, stopped breathing. For 3 minutes. Child turned blue and was gray. 911 was called and was evaluated and taken into emergency room where tests were done child was gray and lethargic . Child had a fever of 99.2. Child behave more responsive two hours after the ordeal.
This spontaneous report as received from a physician refers to an adult female patient in her 50's. The concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 in the left deltoid (route and dose unspecified). The concomitant medications were not reported. On an unknown date the patient experienced severe pain in the left deltoid after the injection. The outcome of the event and the causality was unknown. Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown gender and age, but possibly a newborn. The patient's medical history and past drug history were unknown. On either 05-MAY-2016 or 06-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # L039660 with expiration date 04-FEB-2018), via injection (dose and exact route not reported), which had previously undergone a supported temperature excursion (incorrect product storage). Concomitant medication was not reported. As 0f 06-MAY-2016, it was unknown if the patient continued to take RECOMBIVAX HB. This is one of several reports from the same reporter. Additional information has been requested.
L arm inj pain, lethargy, chils for !.5 days Narrative:
Nausea; Hypotension; Visual Impairment; Chills; aches; Fever; Right foot swelling; limbs numb; feeling of rapid heart rate; sweating; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (aches), PYREXIA (Fever), PERIPHERAL SWELLING (Right foot swelling) and HYPOAESTHESIA (limbs numb) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 19B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure low.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHILLS (Chills), PAIN (aches), PYREXIA (Fever), PERIPHERAL SWELLING (Right foot swelling), HYPOAESTHESIA (limbs numb), HEART RATE INCREASED (feeling of rapid heart rate) and HYPERHIDROSIS (sweating). On an unknown date, the patient experienced NAUSEA (Nausea), HYPOTENSION (Hypotension) and VISUAL IMPAIRMENT (Visual Impairment). At the time of the report, CHILLS (Chills), PAIN (aches), PYREXIA (Fever), PERIPHERAL SWELLING (Right foot swelling), HYPOAESTHESIA (limbs numb), HEART RATE INCREASED (feeling of rapid heart rate), HYPERHIDROSIS (sweating), NAUSEA (Nausea), HYPOTENSION (Hypotension) and VISUAL IMPAIRMENT (Visual Impairment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Allergy medication, Anxiety, Adderall No treatment information were provided
Patient had a painful, red, warm to touch reaction on her right arm right below the injection site that extened to her elbow.
Pt presented to emergency dept 3 days after vaccination with acute chest wall pain, acute coronary syndrome ruled out, pericarditis/myocarditis ruled out.  He had a very tender, nonerythematous firm chest wall mass at the right costochondral junction that has been present from 1/3 to date (1/14/22). Ultrasound showed no pericarditis in ED; chest xray was unremarkable. He simultaneously had a rash on his upper shoulders that when I saw him on 1/10  looked like pityriasis (pink-tan macules, ovoid, no scale, nontender, not itchy.   At one point this looked like another clinician like urticaria, but the flat macules that were present on my exam were not itchy and were persistent over days.   He has had no fever or chills, but has had, since the vaccine, episodic and relatively quickly resolving (over 1-2 days) swelling of the elbow, and the nasal bridge.  He does have a single palpable cervical lymph node.   -originally entertained possibility of Tietze's syndrome after case of pityriasis but with extremity joint involvement and nasal bridge swelling find this now less likely -ddx does include relapsing polychondritis but no vestibular/acoustic/otic or ophthalmic involvement; also quite rare.  Appreciate the work of our public health colleagues.
2 days after receiving my first shot of the COVID19 Pfizer vaccine, I got my period significantly earlier than usual (about 2 weeks early). The period flow was heavier than usual.
Breathing feels labored, started Sunday night. Feels the same tonight, slight cough (dry). Have not sought medical heip, not sure if related to vaccination.
Fever soreness at injection site. Rhinorrhea. Narrative: Per nursing report: "took 2nd Moderna vaccine yesterday [1/26]. At work this morning [1/27]. c/o fever 101.4 this morning, throbbing left arm and runny nose. States headed home because not feeling well."
Pt received typhoid immunization in the right arm at about 08:13 hours . About 2 minutes after receiving the immunization the pt had a swelling sensation in the throat.
Received flu shot at flu clinic in AM. Noticed reaction 10 pm 10/27/12 - reddened area 60 x 65 mm noted firm, sore, warm to touch. No other s/s.
This case was reported by a consumer and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) for prophylaxis. On 5th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th March 2018, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain and fever. On 7th March 2018, the outcome of the chills, general body pain and fever were recovered/resolved. The reporter considered the chills, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, achy body and low grade fever. The patient was tested for the flu but was negative.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 12/31/2020 and 01/27/2021. They became symptomatic on 08/18/2021 and tested positive the same day at the nursing home at which they were a resident. They were admitted to hospital 08/22/2021-08/24/2021 and discharged back to the nursing home. The individual was released from COVID-19 isolation on 08/28/2021. It does not seem teh individual was hospitalized again, but they died on 09/16/2021. COVID-19 is listed in part 2 of the death certificate (as is remote fall with possible left inferior pubic ramus fracture; they had a pelvis X-ray on 08/25/2021 which was after hospital discharge).
Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeling a little full; didn't feel tender exactly, just different. Bra felt slightly tighter fitting. Seemed to get better, then right breast tenderness again after second COVID shot, also in right arm on 27 Feb 2021, lot # EN 6202.  Very mild discomfort diffuse through breast; 25 days after second shot (and after mammogram) nipple tender again, breast mild discomfort, including vague sensation of warmth in breast.
Patient presents with generalized swelling/lump left clavicular area which began after receiving second dose of covid vaccine and persistent at 6 weeks post  second dose
Information has been received from a registered nurse regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a recalled dose of GARDASIL (dose and route was  not provided) (lot # J007354, expiration date 20-FEB-2016). On an unknown date, the patient experienced adverse effect. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
On 8/23/00, pt had fever with rapid breathing; child taken to ER at 22:00. Had heart monitored and it was normal. Temperature was 103.7F. Pt discharged home. Rapid breathing and fever continued. On 8/24/00 at about 09:30, child notified by doctor at ER, not to be breathing regular. Taken back to ER and at 20:30, mother refused to be discharged. Dx'd with strep infection.
Patient received HPV #3 vaccine in (L) arm and Hep #2 and DEPO in her (R) arm. Approx. 1 hr later, pt. called office c/o feeling faint and (R) arm numbness. On 05/17/2011 patient was given 150mg DEPO shot in Right arm (IM) I also gave patient Hepatitis A .5mL shot in Right arm (IM) just below and to the right a little of DEPO shot. Patient also received HPV .5mL in Left arm (IM). Patient was kept 15 minutes after receiving shots and was released. Patient felt no problems at that time.
Moderna COVID-19 Vaccine EUA  A week after my first dose, I developed a rash 2 inches around the injection site. It is itchy, raised, and warm to the touch. It did not develop until one week after the injection.
pain at the injection site; This is a spontaneous report from a contactable pharmacist (pharmacy floater) via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) tends to have a higher rate of pain at the injection site on an unknown date than other vaccines. It was clarified that event took place after the use of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The outcome of the event was unknown.  Information on the batch number has been requested.
I am a breastfeeding mother of 23 months old daughter; I am a breastfeeding mother of 23 months old daughter; I am also 11 weeks pregnant when I took first dose of vaccine; muscle pain; This is a spontaneous report received from a contactable consumer (patient).  A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0168) via unspecified route of administration in left arm on 06May2021 at 18:15 PM (age at vaccination 34-year-old) as single dose for COVID-19 immunization. Medical history included asthma (asthma not active currently) and drug hypersensitivity (known allergies: Ibuprofen, paracetamol). She was pregnant at the time of vaccination. Concomitant medication included pre-natal vitamins (medications in two weeks). No other vaccine in four weeks. Reporter states that, I am a breastfeeding mother of 23 months old daughter. I am also 11 weeks pregnant when I took first dose of vaccine on 06May21. I checked with Gyn and Pediatrician before taking vaccine. I had usual muscle pain 08May2021 at 03:00 PM after vaccine and I continued breastfeeding. No treatment was given for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of event myalgia was not recovered, whereas unknown for other events.  Information on Lot/Batch number was available. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021519339 same reporter/drug with different AE/patient
after receiving vaccine patient went to waiting area to wait for 15 minutes  we heard her boy friend asking for help because she passed out pharmacy staff went out to help one of the staff called 911 her boyfriend stated she did not had food all day and was nervous  we gave her orange juice to drink  paramedics came and took her
fever to 104.2 intermittently w/severe tenderness @ site of inject w/crying & moaning for 2 days;
Almost immediate soreness at injection site, as well as tingling in left arm and fingers and palm of left hand. Pain in shoulder and neck developed after a few days, and is still ongoing.  Turning and tilting the head to the left still triggers tingling down the arm into the hand.
Pt started to have a reaction approx 10 minutes after administration. Pt was diaphoretic, short of breath, feeling very faint and nausea.  Healthcare provider was notified and pharmacy immediately provided epi pen.  911 was called and epi injection was applied to L upper thigh.  Pt never lost conciousness and no vomiting noted.  EMS arrived and assessed patient. EMS discussed transport to ED, pt declined.  Pt was alert and oriented and walked to car on own.  Pt was advised by EMS to seek additional care at ED or pcp of thier choice and to call 911 for any additional complications, pt verbalized understanding.
Patient reports sweating, light headed. blood pressure 121/69 heart rate 72 and blood oxygen 99%. brought patient to the clinic, obtained blood pressure and cold water offered. patient was fine after a couple minutes and able to drive him self home.
pt recv vax & exp rt leg immed swelling & redness @ inj site occurred DPH elixir given
Pfizer- 1st dose 3/9/2021 Pfzier- 2nd dose 3/30/2021 8/14/2021- ED and hospital admit- increased SOB, generalized weakness, feeling ill.  Preceded with 9 days of this at home before coming into facility. Covid+ swab while in ED 8/15/201- admit to ICU 8/16/2021- out of ICU now pulmonary unit on oxygen Dx- pneumonia due to Covid