chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ASTHENIA (Weak). At the time of the report, ASTHENIA (Weak) outcome was unknown. Not Provided          Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-077956 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077956:1st dose event
Started feeling very cold. Then had a severe headache and extremely nauseous. Arm of injection site was very sore. Started vomiting the second day. Was still nauseous, had very bad headache, slight fever and arm pain. On day three symptoms got better but then large red arm rash on the arm where injection was given. Arm got hot, very itchy and slightly swollen and tender. Rash got to be about 5 inches in diameter. Rash has continued for 11 days but has lessened in size and intensity.
PFIZER COVID VACCINE #3 GIVEN 12/21/21, LOT #FE3594; 6/16/22 pt presented to hospital after receiving radiation; pt experiencing vomiting and AMS; received Decadron; 6/19/22 pt tested positive for COVID; experienced hypotension and O2 saturation not picking up on NRB; transferred to ICU; DNI; increased hypoxia and hypotension; suffered cardiopulmonary arrest; CPR performed, Epinephrine given; ROSC achieved; transitioned to comfort measures; pt passed away in the hospital
Afebrile, fussy, area of injection (Rt) thigh warm, purplish, redden, knot - 25 cent size.
Case number PHEH2014US002610 is an initial spontaneous report received from a physician on 04 Feb 2014. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN, (batch number: not reported) on an unknown date. On an unspecified date, his blood pressure dropped (results were not reported). The event outcome, seriousness and causality were not reported.
Fever, vomiting, diarrhea, severe abdominal cramping, dehydration, elevated AST and ALT levels.
Information has been received from a physician concerning a 42 month old white male with no medical history who on 22NOV1999 was vaccinated in the left thigh with a first 0.5ml dose of varicella virus vaccine live (lot 631077/0705J). There was no illness at the time of vaccination. On 21FEB2002 the patient developed shingles on his right medial thigh. There was no history of chickenpox or recent exposure or herpes zoster. Subsequently the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
Starting morning after immunization, left arm began feeling hard, red, swollen, "feels like there's a baseball under my skin".  Patient has been taking acetaminophen, ibuprofen, aspirin around the clock, thus is unaware if she has a fever.  Patient states she thinks she has cellulitis.  Symptoms continue to worsen.  Patient will seek medical care tomorrow (2/5/21).
No additional AEs; RMA calling to report that patient pulled away during injection of GARDASIL 9 vaccine and full dose was not administered on 2/14/2023. Caller states this was 2nd dose in series to 14 year old patient. No additional AEs, no PQCs reported.; This spontaneous report has been received from a health care professional concerning a 14-years-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On an unknown date, the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided). Later, on 14-FEB-2023, the patient received a second dose of the vaccine at a dose of 0.5 milliliters (ml) once intramuscularly as prophylaxis (lot number U028825, has been verified to be valid; expiration date reported as 02-JAN-2023 but upon internal validation established as 02-NOV-2023), however during the injection the patient pulled away and a full dose was not administered (incorrect dose administered). No other adverse events were reported.
Pt recvd 2nd dose of vax 24 to 48 hrs later exp severe h/a & flu-like sx in neck & shoulders; No further details were provided;
Post vaccine pt had trouble breathing through his nose. Pt transferred to med obs1 via wheelchair accompanied by parent. pt reports immediately feeling better after sitting down in hospital bed. vitals obtained and monitored. pt released at approximately 1600.  1554 Sitting HR 83 BP 148/92 O2 99 1400 Standing HR 75 BP 131/76 O2 99
I started getting symptoms of a sore throat, tiredness, and congestion like a cold. I took a COVID-19 test that were negative and the third test was positive. I went to my doctor and received a positive rapid and PCR test. I was prescribed prednisone. The tiredness was my worse symptoms. My symptoms lasted for 3 weeks.
Intense pain at injection sight. Almost felt like it was burning at some points. Received the vaccine at 7:30am. ~9:30pm I started running a fever and had a mild fever all night. The fever has gone; Burning at some point; Fever; Headach; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 07:30 (at the age of 27years), (Batch/Lot Number: EN 5318) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021, (Batch/Lot Number: EN 5318) as DOSE 1, SINGLE for covid-19 immunisation. Patient stated, on 16Feb2021 9:30PM experienced, Intense pain at injection sight. Almost felt like it was burning at some points. Received the vaccine at 7:30am., 9:30pm started running a fever and had a mild fever all night. The fever has gone away, but now he was left with a headache. The patient did not receive any treatment for the events. The clinical outcome of the event fever was recovered in 2021 and all other events were recovering at the time of report.  Follow-up attempts completed. No further information expected.
about 3 hrs p/vax started having pain in both joints of shoulders; next day had rash on chest, neck & arms; lt shoulder pain stopped in 2-3 days;
large red rash-like area (hot to touch) appeared 9 days after 1st dose of vaccine
Hi! I got Covid19 during  the fist week of February 21.   I felt like crap for 4 days to the point where going to the bathroom was a tough expedition; I had to stop 2 times and rest(sleep)  for 10-15 minutes at the time. On the 5th day I was at 75% recovered ( just like that).  On 04/23/21 I got my first shot. I felt sicky for 5 hours then back to normal. On 05/21/21 I got my second shot. My shoulder was sore for 6 weeks +. I felt sick for a day and that was it. at around 6PM on the same day I got my shot  I started loosing taste,  things were tasting differently often for the worst and my smell was way off.  to this day nothing as improved.
The pt. said she felt fine at first after getting the vaccine. On days 8 and 9 she started having stomach issues with severe diarrhea. As of day 10, her diarrhea is better, but she awoke with a quarter-sized whelp with blisters at the injection site. She says it is hot to the touch and there is a lot of redness. I advised her to follow up with her doctor.
Fever 102, cough, vomiting. Onset about 96 h after administration of LAIV H1N1.
Client received first dose of Moderna at 0848. Per vaccinator who gave injection - client was tearful and reported anxiety about receiving injection. Per client she reports that her arm immediately felt "heavy and tingly".  She did not tell anyone and proceded to post-vaccine monitoring area with her spouse. She reports that she started feeling "more tingly" at 0903. By 0908 she reported difficulty breathing and PHN responded.  She was making occasional gasping sounds and crying. She was able to speak and HR was  ~72 BPM per her wearable device. Respirations were shallow and frequent.  Spouse was supportive and stated that she was having a panic attack because she hadn't had a shot since her childhood and was very anxious about the vaccine. He also reported that they hadn't slept or eaten anything due to attending to elderly dog  and that "this is what her panic attacks look like". PHN attempted to have client take deeper, slower breaths while continuing to assess. Client's breathing improved. Meanwhile 3 other PHNs responded and then client began to have difficulty breathing again. One PHN called 911. She then reported she was feeling  "tingly everywhere"  and her "eyes felt like they were sweating" Then her hands began to cramp and her face was pale. 0.5 mL epinephrine injected in RA at 0910 by another PHN. Vitals taken at 0910 were 120/85, 73bmp. She reported that her symptoms were beginning to alleviate.  EMS arrived at 0915 followed by paramedics at 0918. Vitals at 0918 were 110/68, 60 bmp, 100% SpO2. Vitals at 0922 were 131/98 and 62 BPM.  Paramedics discussed possibility of it being a panic attack but recommended going to hospital to be monitored - discussed spouse driving vs paramedic transport. At this point client shared that her HR at approx 0905 was 45 bpm per her wearable device. EMS discussed how this is another indicator of anaphylaxis and recommended ambulance transport. Client agreed and she was transported at 0930.
Contracted COVID after having received both doses of Pfizer Covid Vaccine; Contracted COVID after having received both doses of Pfizer Covid Vaccine; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program COVAX US Support. The reporter reported same events for two patients, this is the second of two reports. A female patient of an unspecified age received BNT162B2, dose 1 on an unspecified date, dose 2 on 14Apr2021, both via an unspecified route of administration as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced contracted covid after having received both doses of pfizer covid vaccine on an unspecified date of Jul2021. The outcome of events was unknown.  Information about lot and batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021887180 Same reporter/drug/event, different patient
Local reactions, mild erythema, redness, and warm. Dr a pt here advised to apply cold compress, take some Tylenol PRN for pain and to seek medical provider. Pt not a pt here. Was provided only for immunization update.
4 mon. infant given DTP 6Feb86- no problems until 9FEB86 awoke w/ fever 103F seen by MD normal exam. 18 hrs later generalized tonic-clonic seizure thought to be febrile, 2nd seizure 17Mar86, 3rd 3Apr86, child has developmental delay.
itchy rash at the vaccination site; red rash at vaccination site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 01Apr2021 at 18:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and ocular myasthenia. The patient was allergic to iodinated contrast dye. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN); both from an unknown date, for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208) via an unspecified route of administration in the left arm on 11Mar2021 at 18:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 the patient experienced itchy red rash after 48hours of vaccination at the vaccination site. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient received antihistamines as a treatment for the adverse events. The clinical outcome of the event itchy red rash at the vaccination site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
TDAP, MCV4, VARICELLA ADMINISTERED 5-12-11 AT 10:10 AM. ABOUT 10:12 AM CHILD WAS SEATED AND FELL OVER TO LEFT SIDE INTO SOMEONE'S LAP, LOWERED TO FLOOR, LOST BLADDER CONTROL. WOKE UP IMMEDIATELY ANXIOUS. BP 153/98 10:15, 131/89, BP 129/79 10:20, BP 115/76 10:30. CHILD OBSERVED FOR 45 MIN. MOTHER CALLED. CHILD SENT BACK TO CLASS PER MOTHER/CHILD'S CHOICE. AT 1:10 PM RUNNING IN ATHLETICS AND HAD SIT DOWN AND AGAIN SYNCOPAL EPISODE. MOM CALLED SENT HOME WITH GRANDPARENTS. FOLLOW UP CALL 5-12-11 6:50, DOING WELL MOM STATES.
SLIGHT REDNESS AND  SOAR MUCSLE 2 DAYS AFTER SHOT GIVEN.
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-248562 (Patient Link).
Excruciating new onset arthritis in multiple areas of body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Aug2023 as dose 6 (booster), single (Lot number: GK0928) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects". The following information was reported: POLYARTHRITIS (medically significant), outcome "not recovered", described as "Excruciating new onset arthritis in multiple areas of body". Therapeutic measures were taken as a result of polyarthritis. Clinical Course: Patient reported that since the onset of covid 19, as soon as it became available patient was vaccinated 6 times. The first 5 presented No adverse effects, however the 6 administered on 02Aug2023 had basically destroyed the quality of life. With excruciating new onset arthritis in multiple areas of body for over 3 months now with no pain relief in spite of hard narcotics. Patient was asking how to escape from hell. It kept getting worse.
itching at injection site and back; muscle pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site and back) and MYALGIA (muscle pain in right arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at injection site and back) and MYALGIA (muscle pain in right arm). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site and back) and MYALGIA (muscle pain in right arm) outcome was unknown.            No concomitant medication was provided. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Localized reaction of right arm at injection site; Spotting and patient states she is not due for menstrual period for another 2 weeks; Fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Localized reaction of right arm at injection site), VAGINAL HAEMORRHAGE (Spotting and patient states she is not due for menstrual period for another 2 weeks), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE REACTION (Localized reaction of right arm at injection site), VAGINAL HAEMORRHAGE (Spotting and patient states she is not due for menstrual period for another 2 weeks), FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-May-2021, VACCINATION SITE REACTION (Localized reaction of right arm at injection site), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Spotting and patient states she is not due for menstrual period for another 2 weeks) and CHILLS (Chills) had resolved.            Birth control pills were reported as concomitant medication.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Outcome of events provided.
Leaving office after vaccine, became diaphoretic and vomited, had brief nosebleed.
Presented with c/o headache generalized in nature. All VS WNL for age. No other complaints per student. Observed 20 minutes. VS remained normal. Neuro checks normal. Mother called per school nurse to bring Tylenol/ stable to be treated by mom.
4-days after getting the vaccine shot, I was really tired and had extreme fatigue. This lasted a couple of days and then on July 18, I woke up in horrible pain with a migraine. I could barely walk and was slurring my speech. We went to urgent care where I was told to go immediately to the ER for a CT scan and stroke test. For more than 36-hours, I couldn't open my eyes or do anything. It was the most crippling headache I have ever had and I didn't even get out of bed for those two-days. In the five-weeks since, I am  regularly dizzy or lightheaded when walking or standing up - never experienced this before. I also don't have near the energy I had prior to getting the vaccine and some days are extremely fatigued.   The migraine left after 48-hours, mild headaches from time-to-time, the fatigue and dizziness is what I am still experiencing.
2nd dose given before the 6 month interval.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-year-old male patient who received HAV (Havrix) (batch number 4KJ79, expiry date 30th October 2021) for prophylaxis.   Previously administered products included Havrix (received first dose on 20th August 2019 of batch number PA99T and expiry date 7th June 2021.).   On 11th February 2020, the patient received the 2nd dose of Havrix. On 11th February 2020, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 03-JAN-2023 Reporter's comment: The nurse called to ask for information about patient who received the first dose of Havrix.  The second dose was administered 9 days before 6 month interval. The reporter asked if the second dose was valid or if the patient had to receive an extra dose of Havrix. The reporter consented to follow up. Additional supportive information: The patient received the dose of Havrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Information has been received from a licensed practical nurse (LPN) concerning a 25 year old female patient who on 04-Sep-2008 was vaccinated with the first dose of GARDASIL in her left deltoid (lot# 659184/0843X). Concomitant therapy included oral hormonal contraceptives (unspecified). Illness at time of vaccination included dizzy lightheaded and blurred vision. On 04-Sep-2008 the patient did not feel well 20 minutes after getting GARDASIL. On 06-Nov-2008 the patient was vaccinated with the second dose of GARDASIL in her left deltoid (lot#661764/0650X). The patient was observed for 20 minutes and had no reaction. Two hours later the patient reported that she experienced the same symptoms as before. The patient recovered from the adverse events. The patient did not seek medical attention. Additional information is not expected.