chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she feels foggy; diarrhea; sore arm; dizziness; weakness; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Excessive (inconsolable) crying over 3 hours in next 24 hrs with fever to 103.
was administrated with an early second dose / dose was administrated 21 days after the first dose; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received first dose of Bexsero and 21 days after was administered second dose, which led to drug dose administration interval too short. No adverse event was reported. The vaccine administration facility is the same as primary reporter. No patient's identifiers was provided, no lot number and expiration date was provided, no vaccination date provided. The reporter did not consented to follow up.
Headache, Myalgia, Arthralgia, Nausea Vomiting, Fatigue  Narrative:
The patient reported large, red spot on her arm the size of a golf ball at the injection site. She reports it being itchy and uncomfortable.
About 2 days after each shot, I experienced an increase in frequency and severity of hot flashes/night sweats. After the first two shots the side effects lasted 4-10 weeks and they seemed to subside. After the booster (third shot) the hot flashes and Nightsweats have not subsided. They have continually gotten worse. I experience nausea, shortness of breath, difficulty breathing and weakness. Sometimes feeling so weak it is necessary to stop, sit down and focus on breathing until the hot flash goes away. It can take one to five minutes to recover. At night the night sweats are so bad they wake me up at least 5 to 6 times a night. For a couple of hours, they seem to run in a cycle going up and down but not really stopping. They calm down but then increase and then calm down and then increase.  It severely impacts my sleep.
Same day after 4-6 hours I started having severe headache. I took TYLENOL, it didn't really help. I had thyroid problem related to vaccine. I kept having headache 3- 4 times a week. Parathyroid gland were very high. I did not have any symptoms, but after Moderna vaccine I had problems. I had higher blood pressure.
Patient had febrile seizure shaking movement whole body lasting around 10 min - took to ER.
still have a rash on my shoulder; still have soreness on my shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (still have a rash on my shoulder) and VACCINATION SITE PAIN (still have soreness on my shoulder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (still have a rash on my shoulder) and VACCINATION SITE PAIN (still have soreness on my shoulder). At the time of the report, VACCINATION SITE RASH (still have a rash on my shoulder) and VACCINATION SITE PAIN (still have soreness on my shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Pt. received ENGERIX-B 20 mg/u on 11/11/14 at 8:20 pm, Next day she complain about body burning, nausea, mild chest pain. SOB (mild), sweating, went to ER gave IV BENADRYL.
Immediately became syncopal at time of injection. No c/o SOB, itching only state faint feeling. Became diaphoretic, nauseated, BP 90/0, pale. Amonia cap helped relieved symp. Layed client flat BP up 145/84, cool cloth applied, rested, BP 126/78 after 10 minutes.
First day after shot I became extremely tired, lump was present on arm, very itchy. Next day, 4/2/21, I woke up and my arm from shoulder to finger tips were swollen tight, bright red and hot, by evening the swelling went into my shoulder blade and my neck circling around to the front. Itchiness experience on day one continued, except now whole arm was itchy. On 4/3/21 I began to experience chills and vomiting,diarrhea. Other symptoms listed for first and second day continued. On 4/4/21 swelling in arm had decreased and I was finally able to move it again, chills, exhaustion and nausea, diarrhea persisted. now on 4/5/21 swelling in arm almost gone, still painful, no nausea yet, still diarrhea, less itchy.
Patient described redness, swelling of left arm down to elbow, same evening of vaccine.  Went to emergency room, was given KEFLEX for possible infection. Symptoms resolved over next 4 days.
This case was reported by a healthcare professional and described the occurrence of crying in a 4-month-old male subject who was vaccinated with Dtap (manufacturer unspecified).  On an unspecified date the subject received a dose of Dtap (unknown manufacturer).  At an unspecified time after vaccination with Dtap, the subject experienced crying.  The reporter was not sure if the vaccine given was INFANRIX or another manufacturer's Dtap.  At the time of reporting the outcome of the event was not known.
My arms felt it was going to fall off; Felt really bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: Felt really bad) and pain in arm (Verbatim: My arms felt it was going to fall off). The outcome of the feeling bad was recovered/resolved (duration 1 week) and the outcome of the pain in arm was not reported.   It was not reported if the reporter considered the feeling bad and pain in arm to be related to Shingles vaccine.     It was not reported if the company considered the feeling bad and pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR036596   Additional Information: GSK Receipt Date: 28-Feb-2023 The patient had the two shots.  The patient's arms felt it was going to fall off and felt really bad for a week.; Sender's Comments:  US-GSK-US2023AMR036596:Same patient (split case)
I woke up feeling a lot of coughing and that coughing got heavier and more intense and lasted for over month. I went to see my PCP for help and steroids were issued and a chest x-ray was done. After medicine I went back because nothing was better. So I went to an ENT specialist because nothing was better. I had a terrible cough that produced nothing. The ENT said I was taking all the wrong medicines for the hoarseness. The ENT put me on nasal administered medicine, FLONASE. He detected resurgence at night. Famotidine. I will see my ENT again on 05APR20233 and 15MAY2023.
Patient called today to inform us that she experienced fever, nausea, vomiting, headache, and local injection site pain after receiving Adacel on Monday, June 13, 2022. Patient stated that they had overcome the adverse reactions, but that they had gotten sick at work. Patient stated taking ibuprofen to overcome adverse reactions. No further treatment was sought or is necessary at this time. Patient was instructed that if they had any further site pain or fever, ibuprofen could help and a cold pack could help with local site pain. Patient expressed understanding and resolution was achieved at the store level.
No additional AE reported; HCP reported that PROQUAD got administered to a 24 years old patient instead of MMR II; This spontaneous report was received from a registered nurse and refers to a 24-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W002783, expiration date: 24-JUL-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong vaccine administered). No additional adverse event (AE) reported. No further information was provided.
Fever - vomiting, "a lot" every 1/2 hour - not eating
I had some flu like symptoms the night of the third dose of the vaccine. The following night I had some itching. I put some Benadryl on the area I was prescribed a strong antihistamine. I had little lines of hives on the front of my body. The back of my body even on my legs had huge hand size patches of hives. The medication helped. On the night of the third day I broke out in hives again and then I was prescribed Steroids. The hives have improved now and it has been a week.
This spontaneous report was received from a pharmacist, via a company representative, referring to a currently 76 year old non pregnant female patient. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot# L011529, expiration date unknown) 0.65 ml, subcutaneous (route of administration were not reported). Concomitant medication was not reported. Within 24 to 48 hours after receiving ZOSTAVAX the patient experienced severe pain in her ears, which radiated up to her head. The patient was treated at an unspecified Emergency Room with unspecified medications. Ten days later, the patient was treated with unspecified medications for additional pain. The outcome and causality of the events was unknown. Additional information has been requested.
Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium); body aches, major headache. Couldn't get warm despite spouse providing me with multiple blankets that night. Took tylenol to help with headache through the night. Woke up the next day with major body aches throughout my body. Continued headache and fatigue like symptoms along with the pain. Used tylenol PM the second night to combat continued headache but no chills the second night. Started to feel better today, April 3rd, which is 48 hours since my 2nd Pfizer vaccination.
1 1/2 hrs p/vax given pt screamed approx 3 hrs, fever 104 ax; pt taken to ER;
Muscle soreness and aching in left shoulder / neck / head slightly more than usual.  If other intramuscular shots have been a pain level of 2, this was a 4.  Symptoms lessened to a 1 after 400 mg of ibruprofen.  The headache has remained a 3.  Minimal fatigue for 24 hours.
Infant very irritable, with shrill cry around 4:45pm. At approximately 6pm, infant began vomiting excessively. Infant continued to vomit every 5-10 minutes. Infant became pale, lethargic, cool, clammy and limp. Eyes began to roll back into head. Infant taken to hospital. Abdominal ultrasound benign, ZOFRAN given for nausea. Infant stopped vomiting around 9pm and was able to breastfeed without vomiting.
Hair loss and hair thinning at the top of her head; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported, NDC/UPC number: Unknown, Expiry date: Unknown) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 (Batch/Lot number was not reported) (at the age of 64-year-old) as single dose for Covid-19 immunisation. The patient stated that, she was experiencing hair loss. Her hairdresser was noticing those who had the Pfizer vaccines had on top of the head hair loss. The patient received both doses of the Pfizer covid vaccine. It was her hairdresser who mentioned it to me. Patient was losing a lot of hair it was thinning. It was shedding while shampooing. In order not to go bald on top; the patient was thinning on the top she need to see a hair loss specialist. This was the major hair loss. She also reported that her hairdresser told her that others who received the Pfizer vaccine she had noticed that her other clients had hair loss as well, hair loss and hair thinning at the top of her head on 12May2021.The patient stated regarding the LOT number Moderna COVID 19 Vaccine vial then it was LOT 048A21A that was one LOT. Consumer stated regarding the expiration date was no. The patient saw was the LOT and she had the date they were administered. The patient stated that, "Moderna COVID 19 that was what she saw, were Moderna. So, Moderna was a different company. Oh, patient was told she was getting the Pfizer vaccine, she thought it was Pfizer Moderna. They told her it was a Pfizer Vaccine, they told me she was getting a Pfizer Vaccine. It says Moderna COVID 19. Pfizer and Moderna that was a one vaccine she thought Pfizer/Moderna. Patient stated, Ok, first she was trying to determine if Pfizer Moderna, it was a Pfizer and Moderna vaccine. Consumer was informed if this was the Moderna vaccine then you had to reach out to Modena for the concern. When paraphrased the concern, consumer stated, she took both (first dose and second dose) and her hairdresser said that she was seeing that the patient that took Covid vaccine (Covid-19 Vaccine) that they had a hair loss on the top of their head. She would like whether it was that a reported side effect. Outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Pt is 12 month old female seen 10/12/15 - d/+ worsening blister that scabbed 11 days s/p varicella immun (L) thigh- pt. had systemic reaction : V x 8 12 days after immunizatoin. Irritability and clumziness. Pt temp to 97.5. (L) thigh Redness, torso papules
FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female.  The patient's weight was not reported and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced feeling warm and cold. On 25-MAR-2021, the subject experienced severe chills (extreme cold). On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscles pain. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm and cold, severe chills(extreme cold), fever, muscles pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210663913.
Knot and muscle weakness, difficult to move arm, developed about a week after vaccine and hasn't gone away
pt recv vax 9JUN95 & 6JAN97 pt devel a chickenpox rash that covered entire body & consisted of greater than 100 lesions & fever of 101-102 first 2 days of rash;pt recovered from chickenpox rash & fever;
MOM STATES PT CAME IN A WEEK OR SO AGO FOR SHOT ONLY VISIT TO START GETTING HER KINDERGARTEN SHOTS SO THAT WHEN SHE IS TO START SCHOOL NEXT YR SHE WILL BE READY.  PARENTS DO ALTERNATE VACCINE SCHEDULE. MOM REPORTS THAT PT HAS SINCE RECEIVING THE VACCINES (HEP B #2 & VVX #1) ON 8/25/15, DEVELOPED A FACIAL TIC.  MOM'S SISTER NOTICED THIS 1ST AS SHE KEEPS CHILD DURING THE DAY.  SX STARTED LAST WEEK.  MOM DESCRIBES THE SX AS PT'S LOWER JAW JUTS OUT (FORWARD) WHILE HER HEAD JERKS FORWARD.  BOTH OF THESE MOVEMENTS OCCUR SIMULTANEOUSLY & @ LEAST 50x/DAY AS COUNTED BY MOM, DAD, & MOM'S SISTER, PER MOM.  IT'S ALMOST LIKE SOMETHING W/ THE MUSCLES IN HER NECK ACCORDING TO MOM.  THERE HAS NOT BEEN ANY INJURY THAT SHOULD CAUSE THIS TO HAPPEN.  MOM SAYS SHE CANNOT LINK THIS TO ANYTHING ELSE OTHER THAN THE VARIVAX VACCINE B/C PT HAD NEVER HAD IT BEFORE.  MOM ALSO STATES THAT PT DOESN'T EVEN REALIZE THAT SHE IS DOING THESE MOVEMENTS B/C IT'S HAPPENING WHEN SHE IS COLORING, WATCHING T.V., TALKING, etc.
Hives on Arms and Trunk & Swelling around my eyes within a couple of hours of the vaccine. I took Zyrtec/Benedryl to control it and for the most part it did. Within the week I started having more symptoms including: Shortness of breath  Dizziness I could feel my heart beating in my chest. I saw my doctor and took a 3 day steroid. 2 weeks later and I am still having shortness of breath, pain in my back, and sometimes have a tightness in my chest where I can feel my heart beating.
fever; fatigue; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills). At the time of the report, PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was provided.
Rash left arm- red circle around where I got the vaccine, warmth, & a little swelling. No pain. Narrative:
Duration is 1 Day(s). Maximum temperature is 102.5 F. The frequency of the symptom is intermittent. Context includes concurrent URI symptoms and sick contacts at home. Associated symptoms include nasal drainage. Pertinent negatives include cough, diarrhea, rash or vomiting. Additional information: Two days ago, patient received influenza vaccination.
Had severe arm pain; Had severe / swelling at the injection site; Caused her not to be able to play tennis / physical therapy would be needed; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm, injection site swelling and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, injection site swelling and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain in arm, injection site swelling and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. Post vaccination the patient had severe arm pain and swelling at the injection site. The pain and swelling caused the patient not to be able to play tennis.  The patient's mother stated that physical therapy would be needed for the pain and swelling. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061888:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021AMR061883:Same reporter. Patient #1.
FEELING COLD; JOINT PAIN IN GROIN; LEG AND ARM PAIN; HEADACHE; STOMACH PAIN; This spontaneous report received from a patient concerned a 29 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced stomach pain. On 27-APR-2021, the subject experienced feeling cold. On 27-APR-2021, the subject experienced joint pain in groin. On 27-APR-2021, the subject experienced leg and arm pain. On 27-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain in groin, leg and arm pain, feeling cold, headache, and stomach pain. This report was non-serious.
Swelling started within 20 minutes of receiving vaccine. Area is red, itchy, warm for about 3 inches in diameter. C/o sharp, stabbing pains in the area, very tender to touch.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 18Jun2022 to 23Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.