chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 1 hour after first dose on 1/20/2021, I had metallic taste in my mouth and itchy lips; resolved within 2 hours.  Approximately 5 hours after injection, I had typical "Covid arm" large (3" diameter) red, raised, itchy welt at injection site, which lasted approximately a week then decreased until redness and swelling were gone around the 3 week mark post-injection.  Also developed extreme fatigue, headache, fever of 101, body aches, and chills approximately 5 hours after infection and lasted 2-3 days.  After second dose, approximately 1 hour after injection I developed metallic taste in mouth and tingling lips; resolved within 6 hours, I think.  Approximately 4 hours after injection, I developed a very large (5" diameter) red, raised itchy welt at injection site.  Developed fatigue, lethargy, headache, body aches, general malaise; no fever.  Lethargy, fatigue, headache, body aches, malaise resolved in approximately 48 hours after developing.  Approximately 48 hours after injection, I developed intense itchy over entire body.  Took standard adult-dose of Benadryl, which provided no help.  Scratching would produce hives. Doctor prescribed double the standard dose of OTC Zyrtec, plus a prescription antihistamine, which provided relief.  Both arms now have slightly indented area at injection site.  Before booster dose on 10/26/2021, took double adult-dose of Benadryl and only had the metallic taste and tingling lips, which developed within the first 30 minutes, but did not last past 24 hours.
slight headache; light headed; heart raced; throat felt a bit constricted; diarrhea; a ringing in my left ear; My Tinnitus seems to have increased as well in both ears; Lymph nodes under arms are so big they are cutting off circulation to my arms. As big as baseballs; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch no./Lot number and Expiration date was not reported), via an unspecified route of administration in Arm Left on 18Apr2021 at 15:00 (at the age of 62-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Chronic lymphocytic leukaemia, Known allergies: Pneumonia vaccine all from unknown date unknown if ongoing. The patient concomitant medications included Atorvastatin, fenofibrate, carvedilol, losartan all taken for unspecified indication start and stop date were not reported. patient did not received any other vaccine within four week prior to the vaccination. patient did not diagnosis covid prior and post to the vaccination. On 18Apr2021, at 15:15, 15 min after first dose, patient experienced light headed, heart raced, throat felt a bit constricted. on 18Apr2021, patient experienced a ringing in his left ear, diarrhea, his Tinnitus seems to have increased as well in both ears, Lymph nodes under arms are so big they are cutting off circulation to my arms. As big as baseballs. on 18Apr2021, 1 hr 15 min after first dose patient experienced slight headache. Adverse events resulted in Doctor or other healthcare professional office/clinic visit it was reported. patient did not received any treatment for events. it was reported that on 18Apr21 at 3:05 at (specialty pharmacy name) in left upper arm his Arm never got sore at 3:15 he had got light headed heart raced, throat felt a bit constricted, at 4:15 developed slight headache. Continued for 6 days he had diarrhea for 4 days he also have had a ringing in his left ear that was not there. his tinnitis seems to have increased as well in both ears. Lymph nodes under arms are so big they are cutting off circulation to his arms. As big as baseballs. Both arms. The outcome of events a ringing in his left ear was recovered on unspecified date in Apr2021, outcome of event his Tinnitus seems to have increased as well in both ears, Lymph nodes under arms are so big they are cutting off circulation to my arms. As big as baseballs was unknown, outcome of event slight headache recovered on 25Apr2021, outcome of event diarrhea recovered on 22Apr2021, while outcome of other events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Patient received 0.5 ml of Moderna 6 mo-5 yrs vaccine instead of 0.25 ml No side effects reported
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE STABLE ANGINA ANGINA, UNSPECIFIED
Twenty minutes after receiving the vaccine I suddenly felt a tight squeezing under my breastbone. It was a lot of pressure and felt like someone was standing on my chest. This lasted about an hour and was about a six on the pain scale. In the three days that have followed since then, I have continued to have chest pressure that comes every 2-3 hours and lasts about an hour. The pain is less than the original episode.
I woke up with coughing, fatigue, upper respiratory, fever of 101, and body aches.  My wife and I tested positive for COVID-19. I called the nurses hotline and they told me to go to the ER. The ER gave me fluid and pain medicine through an IV.  They also did an chest X-ray and prescribed me Paxlovid. I still have trouble breathing, fatigue, and respiratory issues.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received many years before the time of reporting). On 21st May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, 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 patient did not experience any reaction other than minimal pain at the site of injection after receiving SHINGRIX. For further tolerance, refer case US2018190956.
Tingling in face and hands, extreme tightness in chest and back Felt like I was having a heart attack
This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 3-year-old male patient who received FLUARIX quadrivalent (batch number 7HZ73, expiry date 30th June 2016). On 20th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 21st October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced injection site redness, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site warmth to be related to FLUARIX quadrivalent. Additional details were received as follows: On 22nd October 2015, the patient was better but the events were not completely resolved.
Onset of severe h/a, w/accompanying nausea; hives/pruritis form the waist up;
now I am losing my voice.; I have a cough filled with mucus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 11:30 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, product = COVID 19,, lot unknown = True,, lot unknown  reason = Unable to locate or read the details, vaccine location = Left arm), for COVID-19 Immunization. The following information was reported: APHONIA (non-serious) with onset 22Apr2021, outcome "not recovered", described as "now I am losing my voice."; PRODUCTIVE COUGH (non-serious) with onset 22Apr2021, outcome "not recovered", described as "I have a cough filled with mucus". The events "now i am losing my voice." and "i have a cough filled with mucus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of aphonia, productive cough.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with Covid 19. No known allergies and Other medical history reported for the patient.  No follow-up attempts are possible. No further information is expected.
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351 with expiration date of 11-AUG-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
BLOOD CLOTS; SEVERE PAIN; This spontaneous report received from a consumer concerned a patient of unspecified sex and age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots and severe pain, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and severe pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a report of a patient, unspecified age, unspecified gender, unknown ethnicity, who was hospitalized for pain and blood clots on an unspecified number of days after receiving the covid-19 vaccine ad26.cov.2.s. The information provided precludes a meaningful medical assessment. Additional information requested.
Pt developed SOB 2 weeks after 2nd vaccine, admitted with saddle PE.  No history of VTE.  Treated with Eliquis and recovering well.
Patient received the vaccine from an already expired vial. Vial was opened in May, 2018 and the vaccine was administered on July 14, 2018.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 20-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
The flu shot was administered on 10/3.  on 10/8 a dose of Shingrix was given  in the same arm.  redness/swelling distal to vaccination sites was first noticed 10/10 in the morning.  per the patient, the swelling and redness was greatly lessened by the time she was here late morning.  Patient does not plan to see a doctor unless redness and swelling worsens again.
This is a spontaneous report obtained form a contactable pediatrician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 2nd of three reports. A 17-years-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, (Batch/Lot #: M37315, expiration date: 01APR2017) at 0.5 ml single at 16:00 and MENACTRA (Manufacturer: Sanofi, Lot # 45272AA) at 1 DF single, both intramuscular in the right arm on 12Apr2016. Medical history and concomitant medications were not reported. The patient had local site reaction described as arm was red and swollen on 12Apr2016 with outcome of recovered. The outcome of the events was unknown. Follow-up (16May2016): New information from the same contactable Physician included: patient age and gender; administration details (lot/batch number, exp date, route site, date); event start date and outcome. Follow-up attempts completed. No further information expected.
Chills; sweats; headache; very tired, could not get out of bed; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported about a 44 year old male patient reported that the patient received the second dose of BNT162B2; Pfizer-BioNTech COVID-19 Vaccine; Lot number: EN6204; expiry date: unknown; Solution for injection);via an unspecified route of administration in the left arm on 28Mar2021 at 11:45 and received the first dose of Pfizer-BioNTech COVID-19 Vaccine; Lot number: EN6206; Solution for Injection) on 07Mar2021. The known allergies were Digestive allergies to Dairy and Gluten. The patient experienced chills, sweats, body aches, headache, very tired and could not get out on 28Mar2021 at 11:30 pm. The patient received Tetanus shot on 3/18, Prozac. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
FLU LIKE SYMPTOMS, CHILLS, HOT FLASHES, ACHES
fever; lymph node swelling under arm; chills; fatigue; off and on headaches; muscle aches / Body ache/ arm soreness; diarrhea; runny nose; dizziness; increased heartbeat; brain fog; eyeballs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling under arm), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (off and on headaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 003B21A) for COVID-19 vaccination.   The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer, Lymphedema, , Mastectomy bilateral, Gallbladder removal and Hysterectomy.  Concurrent medical conditions included Drug allergy (Multiple drug allergies but not listed.).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 08-Mar-2021, the patient experienced PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling under arm), CHILLS (chills), FATIGUE (fatigue), HEADACHE (off and on headaches), MYALGIA (muscle aches / Body ache/ arm soreness), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), DIZZINESS (dizziness), HEART RATE INCREASED (increased heartbeat), FEELING ABNORMAL (brain fog) and EYE PAIN (eyeballs hurt).   On 12-Mar-2021, PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling under arm), CHILLS (chills), FATIGUE (fatigue), HEADACHE (off and on headaches), MYALGIA (muscle aches / Body ache/ arm soreness), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), DIZZINESS (dizziness), HEART RATE INCREASED (increased heartbeat), FEELING ABNORMAL (brain fog) and EYE PAIN (eyeballs hurt) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-079460 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079460:SECOND  Dose Events
shivering, muscle aches, skin sensitivity, mild fever (99.3F), lethargy, pain at injection site. Resolved in 24 hrs.
Blood in urine; urge to urinate; she had a sensitivity all over her body; Hardness at injection site; chills; Joint pain; body ache; swollen injection site; warm to touch injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch injection site), BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate), SENSITIVE SKIN (she had a sensitivity all over her body) and VACCINATION SITE INDURATION (Hardness at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth infection (root canal problem (tooth problem)) and Multiple injuries. Family history included Blood disorder (not officially diagnosed). Concomitant products included AMOXICILLIN and METRONIDAZOLE for Tooth disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch injection site), VACCINATION SITE INDURATION (Hardness at injection site), CHILLS (chills), ARTHRALGIA (Joint pain), MYALGIA (body ache) and VACCINATION SITE SWELLING (swollen injection site). On 11-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate) and SENSITIVE SKIN (she had a sensitivity all over her body). The patient was treated with PARACETAMOL (TYLENOL) on 11-Mar-2021 at a dose of 500 mg. At the time of the report, VACCINATION SITE WARMTH (warm to touch injection site), BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate), SENSITIVE SKIN (she had a sensitivity all over her body), VACCINATION SITE INDURATION (Hardness at injection site), CHILLS (chills), ARTHRALGIA (Joint pain), MYALGIA (body ache) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Urine analysis: inconclusive (Inconclusive) inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received vaccine at 9:25AM.  Felt achy around 4PM and two Advil.  Felt better.  12:15AM awoke to fever 101.4, chills, body aches and headache.  Persisted through night into morning.  Switched to 2 Tylenol at 8AM and felt a bit better.
A COUPLE MINUTES AFTER ADMINISTERING VACCINE, PATIENT WAS SITTING IN PHARMACY WAITING AREA FOR THE REQUIRED 15 MINUTE PERIOD. CUSTOMER ALERTED ME THAT HE WAS SLUMPED OVER. WENT OUT AND SAW PATIENT SLUMPED OVER WITH EYES CLOSED. PATIENT UNRESPONSIVE TO TOUCH AND SOUND. HE HAD A PULSE AND COULD VISIBLY SEE STOMACH MOVING SO HE WAS BREATHING. PATIENT SWEATING PROFUSELY AND FAINTED A COUPLE TIMES- EYES WERE ROLLING AROUND IN HEAD. CALLED 911 AND LAID PATIENT ON BACK ON THE FLOOR- STAYED WITH PATIENT UNTIL EMTS ARRIVED. GOT PATIENT A SODA TO DRINK BEFORE LEAVING. PATIENT DID STATE HE ONLY HAD A GRANOLA BAR BEFORE COMING FOR VACCINE AND IS NOT GOOD WITH SHOTS
Joints more achy hands/shoulders/knees and right wrist; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joints more achy hands/shoulders/knees and right wrist), PAIN (Body aches) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced ARTHRALGIA (Joints more achy hands/shoulders/knees and right wrist), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, ARTHRALGIA (Joints more achy hands/shoulders/knees and right wrist) had not resolved and PAIN (Body aches) and FATIGUE (Fatigue) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-631471 (Patient Link).   Reporter did not allow further contact
It started a day after with headache and neck ache. I felt a spasm in my neck area. When I move my head up and down I felt very sharp pain. I took a head ache pill. A week later it started back again. I felt a pain from my head coming towards my heart. I believed I was having a stroke. The next week I went to the ER and they gave me muscle relaxer. On 3/3/2022 I had headache again and today it not really as bad.
MMR and Varicella given on 2/24/15. On AM of 2/25 mom noted patient walking strangely as if legs wobbly - resolved Kw/in 1 1/2 hours. Patient later developed swelling and erythema (L) arm - upper exterior aspect 2" x 3".
Information has been received from a physician assistant concerning a female patient who "experienced a severe headache after her first dose of GARDASIL (lot # not provided).  She recovered by experienced a severe headache again after receiving her second dose of GARDASIL (lot # not provided).  Patient sought unspecified medical attention and dose not plan on receiving a third dose.  At the time of this report patient had recovered.  Additional information has been requested.