chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of scratch at injection site in a 4 month old female subject who was vaccinated with Pediarix for prophylaxis. The reporter is the subject's grandmother. A physician or other health care professional has not verified this report. The subjects medical history included eczema. Concurrent medications included Eczema medication. 01/19/06 the subject received 2nd dose of Pediarix in the thigh. The consumer reported that, at the time of the vaccination (with Pediarix), the baby kicked, the liquid from the vaccine squirted out and there is a scratch on the baby's leg. The reporter is concerned that the baby may have received an incomplete dose of Pediarix. On 01/19/06, the subject also received an unspecified vaccine (vaccine name not provided) and HIB (manufacturer unknown). At the time of initial reporting, 01/19/06, the scratch at the injection site was ongoing.
No adverse effects; an improperly stored dose of ROTATEQ was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 01-NOV-2019, an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, with lot # R033255 and expiation date on 26-JUN-2020,  for prophylaxis (dose and dose number were not reported) was administered to a patient (product storage error).  It was reported that on an unknown date, the vaccine was exposed to a temperature excursion of 50 degrees Fahrenheit (F)  for 2 hours an 20 minutes. There was previous temperature excursion of 50 degrees F for 30 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Headache; Swallon ankle; Feeling tired; Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (Swallon ankle), VACCINATION SITE PAIN (Arm pain), FATIGUE (Feeling tired) and HEADACHE (Headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS and FISH OIL for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm pain). On 07-Apr-2021, the patient experienced FATIGUE (Feeling tired). On 23-Apr-2021, the patient experienced JOINT SWELLING (Swallon ankle). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 08-Apr-2021, VACCINATION SITE PAIN (Arm pain) had resolved. At the time of the report, JOINT SWELLING (Swallon ankle) and HEADACHE (Headache) outcome was unknown and FATIGUE (Feeling tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    This case was linked to MOD-2021-122530 (Patient Link).
COVID-19 Diagnosis; WEAKNESS; COUGH; FEELING TIRED; FEVER; CHILLS; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 Diagnosis), ASTHENIA (WEAKNESS), COUGH (COUGH), FATIGUE (FEELING TIRED) and PYREXIA (FEVER) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Diagnosis), ASTHENIA (WEAKNESS), COUGH (COUGH), FATIGUE (FEELING TIRED), PYREXIA (FEVER) and CHILLS (CHILLS). At the time of the report, COVID-19 (COVID-19 Diagnosis), ASTHENIA (WEAKNESS), COUGH (COUGH), FATIGUE (FEELING TIRED), PYREXIA (FEVER) and CHILLS (CHILLS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Non-significant follow-up received.
almost blind in left eye; I am obviously getting shingles; massive lesions on right and left buttocks/ mild lesions on left shoulder; Back is bothering me; Back discomfort; developed itching; muscles aches night after / vaccine; This case was reported by a nurse via call center representative and described the occurrence of blind in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of hospitalisation (received 1st dose in 2019 and was hospitalized, refer case- US2021AMR155494), Valtrex with an associated reaction of neutropenia (received doses on an unknown date and experienced neutropenia, refer case- US2021AMR155432) and Covid vaccine (received both doses on an unknown date and did well). Concomitant products included lidocaine.   On 10th July 2021, the patient received Shingrix. On 10th July 2021, less than a day after receiving Shingrix, the patient experienced pruritus and muscle pain. On 16th July 2021, the patient experienced blind (serious criteria GSK medically significant), shingles, skin lesion, back pain and back discomfort. On 16th July 2021, the outcome of the blind, shingles, pruritus, muscle pain, skin lesion, back pain and back discomfort were recovered/resolved.   It was unknown if the reporter considered the blind, shingles, pruritus, muscle pain, skin lesion, back pain and back discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by nurse for herself. The patient did not give any specifics around the hospitalization in 2019, left eye blindness (if this was a new occurrence).  The patient also reported being on lidocaine, not identified as a new medication therapy.  The patient developed itching and muscles aches night after Shingrix vaccine.  On 16th July 2021, 6 day after receiving Shingrix, the patient developed massive lesions on right and left buttocks, mild lesions on left shoulder and almost blind in left eye.  The patient stated that, 6 day after receiving Shingrix, she was obviously getting shingles and back was bothering her.  The patient stated she was definitely reporting a side effect on Shingrix. The reporter consented to follow up. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR155432:Same reporter US-GLAXOSMITHKLINE-US2021AMR155494:Same reporter
Headache before getting the second dose of vaccine; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 25Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache before getting the second dose of vaccine". Therapeutic measures were taken as a result of headache.  Additional Information: The patient had headache before the getting the second dose so he took 2 paracetamol (TYLENOL) 500s about 10 minutes after the vaccine and wanted to know will this affect the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started having a strange feeling in her stomach after the vaccine, she complained of feeling cold all over. Upon checking her BP, it was 190/97. She mentioned she did not take her morning dose of BP and anti anxiety med, also she had not eaten any breakfast. At this point she took her anti anxiety and BP meds. Checked her BP again in 5 mins, it was 161/89, but she was feeling "bad" felt like vomiting. She laid down but did not feel better.  At this point ambulance was called. By the time fire rescue arrived her BP was 130/82 and she refused to go to the hospital
Admitted  to hospital10/8/2021 diagnosed and treated for acute pancreatitis, likely secondary to alcohol.  Also received COVID-19 and influenza vaccine 10/7/2021.
At 10am on April 29th, approximately 22 hours after receiving my second dose of the Moderna vaccine, I started experiencing symptoms of fatigue and headache.  By 1pm I added body aches and chills. I just started work and initially thought it was just overworked. At 6pm my digital thermometer confirmed a temperature of 100.3°. I had dinner and took three 200mg tablets of Ibuprofen.  At 9pm, my fever was down to 99.9°. I took 3 more Ibuprofen and went to sleep. Slept for 11 hours and woke to temperature of 98.3°. Have some light fatigue and left arm still sore at injection site, but otherwise ok.
Swelling accompanying rash, fever 102 degrees F brought down by ALEVE. Advised pt. to apply BENADRYL to the spot (upper left arm) admin. site of PNEUMOVAX shot.
Child inadvertently given improperly prepared Pfizer vaccine.  Adult Pfizer vial was mixed as Ped Pfizer (using 1.3 ml diluent) and 0.2 ml dose administered to child age 5-11 year old.  Error discovered after child left clinic.  Steps taken immediately to correct the proglem and prevent it from happening again.  Parent notified of error and to watch for side effects.
A healthcare representative reported that a 17 month old female received her 1st dose of Prevnar as part of a post-marketing surveillance study on 8/21/00. Approx. 90 minutes, post vax, she developed hives on her face, chest, axilla and buttock. This was initially thought to be heat rash, but then she developed slight breathing difficulty then wheezing. She was treated with diphenhydramine and hospitalized for observation. She recovered within 8 hours and was discharged. The investigator feels that the anaphylactic reaction (not expected) was "probably related to any 3 vaccinations given". The medical monitor feels that this event was "possibly related".
4/10/15 1030 patient received Hep B #2, she stated that night she was having joint pain to both hands, moderate swollen fingers and face, fatigue and no appetite, sign and symptoms peak on Saturday. Stated by Sunday sign and symptoms went away. She denied chest pain, shortness of breath nor fever.
I was 7 weeks pregnant and started to cramp/bleed the next day and was dignosed with a miscarriage on Friday evening at the hospital.  Rec'd H1N1 inactivated shot. 12/30/09 ER records received for date 11/21/09. DX: threatened miscarriage. CC: vaginal spotting, pelvic pain. Labs same as prev. abstract and MR.
Systemic: Visual Changes/Disturbances-Severe, Additional Details: patients wife called to say that around 1 week after vaccine pt experienced vision issues.  dr say he had a blood clot in eye which lead to partial blindess in one eye.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included FLUZONE QUADRIVALENT. On 16th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria hospitalization), injection site erythema (serious criteria hospitalization), injection site warmth (serious criteria hospitalization) and heart rate increased (serious criteria hospitalization). In January 2018, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and heart rate increased were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm and FLUZONE on right arm. The healthcare professional (HCP) reported that, the patient developed a localized reaction of a red, swollen area about 4 by 5 inches in diameter, which was hot or warm to the touch, after receiving SHINGRIX. The patient also developed increased heart rate which resulted in hospitalization for one day and the patient received treatment to lower the heart rate. No further information was reported regarding the event.
Mother reported that on 9/11/04 child had reddened, raised "hive" and c/o "itching".  Saw FNP on 9/13/04. Was told possible allergic reaction to immunizations or could have had allergic reaction to something else he had came in contact with.  Child had three days of itching.  Hives diminished over ten day period.  Child followed up with primary care physician on 9/22/04.  He agreed it was allergic reaction to something and could have possibly been an immunization.
RED RAISED AREA LEFT DELTOID,  ROUND 12CM AREA , TENDER TO TOUCH, MYALGIA .
This morning patient woke up with redness and swelling of right upper arm.  Arm felt hard and warm to the touch and covered area of approximately 5 x 4 inches.
Menactra and Gardasil 9 were given in left arm, patient saw the blood that appeared after needle was removed and grimaced.  I turned the fan on him and asked if he was ok, he asked for a minute before giving the Bexsero, once he stated that he was ok, and mom was in agreement, the last shot was given.  He immediately started leaning over in the chair and passed out.  Mom and I lowered him to the ground, he did not fall nor hit his head.  I called for the secretary to get a cool rag, he then started having seizure activity for approximately 45 seconds to 1 minute.   His pulse and breathing were monitored.  His breathing became very shallow and I was getting the medical equipment for resuscitation out when he came to and took a deep breath.  During this time, the ambulance was called.  He was alert and oriented x3.  I checked his BP, which was 80/40, his feet were elevated and we kept him comfortable until the ambulance arrived.   Mom wanted him evaluated at local ER.  Report given to Paramedic.  Immunization record faxed to the ER.  Mom did say that he had a seizure in April 2018 but nothing was diagnosed nor is he on any medication.  He was released from ER to home and to follow up with PCP.  ER MD made assessment of Vasovagal response post immunization.  I left a message for mom to call me back to check on patients status but she never returned my phone call.
My Upper Respiratory Infection started on 12/16/2022 in the morning around 08:00AM.  I had a sore throat,  cough and sinus drainage. I lost  my voice .  I had Sinus pressure on my check and forehead. I had a regular check up with my doctor for Diabetes on  12/27/2022 so I didn't call when I was experiencing the Upper Respiratory Infection. When I went to the doctor's appointment on the day of my appointment she prescribed me Doxycycline for  14 days.  I took over counter medication for cough. I took Mucinex at first which didn't help then I switched it to Pseudoephedrine Hydrochloride that didn't help. So, I took Robitussin  every 4 hours/ as per needed for cough . As of today I am recovering. I still have a little cough.
The moderna shot was administered in the very top of my right shoulder above the deltoid muscle near the bone, almost immediately following the vaccine I experienced extreme pain in my arm and shoulder that worsened by the day causing me to be unable to lift or move my right arm.
Information has been received from a grandmother concerning her 18 year old granddaughter with a history of painful menstruation who in approximately August 2007, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). In approximately August 2007, the grandmother had problems after her first vaccination of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient reported the vaccination was very painful. In approximately September 2007 the patient experienced a very painful menstrual period. On 15-OCT-2007 the patient experienced chest pain for which she saw two physicians (no further specified) The patient's very painful menstrual period and vaccination and chest pain persisted. Additional information has been requested.
Headache, Myalgia, Rash, Diarrhea & Nausea Vomiting  Narrative: DAY 1-PAIN;DAY2-  PAIN;SWELLING;HA;NAUSEA/BODYACHE;DAY 3-4 UNCHANGED Day 5- Developed a rash along with nausea and severe diarrhea. (These symptoms did  impact my daily routine.) Day 6  Rash expanded, but still mild. Started getting  body aches. However, the nausea and diarrhea were very severe. I did vomit a  few times. The diarrhea was so severe it was worse than when I had done a bowel  prep. (These symptoms did impact my daily routine.) Day 7  Rash mostly gone.  Nausea and diarrhea continued to be severe. Did start to get a little bit better by  late evening. (These symptoms did impact my daily routine.) Day 8  Continued  with mild nausea and diarrhea. DAY 9: DIARRHEA ; DAY 10- RESOLVED
The day after vaccinations he developed chest pain and fever.  EKG showed ST elevation at a local urgent care. He was hospitalized where his labwork, including cardiac enzymes, were normal.  He was discharged home the next day after observation.
Patient reported being sick after receiving the covi-19 booster shot. No further information provided. Patient does not consent to be contacted.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 27-JAN-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient's age was reported as 0 years. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Gave PNEUMOVAX 23 IM (R) deltoid. Customer states area became red, swollen approx. 1 1/2 later (hours). Also had fever. Area became swollen, red and hot to touch. Lump formed. Went to MD office and he prescribed BENADRYL. States this did help.
Ringing in ears keeps coming and going; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears keeps coming and going) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced TINNITUS (Ringing in ears keeps coming and going). At the time of the report, TINNITUS (Ringing in ears keeps coming and going) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
2 doses of Moderna bivalent were administered after expiration date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.
5 mins. after vaccines given, mom reported mild rash to child's face. Child was seen by Peds doctor immediately. Temp 97.6 (aux), alert and active. Benadryl 12.5 mg/5ml ordered q 6 hrs 2.5ml PO for 3 days.
Client received vaccine approx 3:15pm. Reported throat and chest tightness and throat numbness at 3:25. V/S: HR 78, BP 133/76, RR 12. At 3:40pm, client reported diminishing symptoms and no new symptoms reported. At 3:50pm, client left site unassisted and with a steady gait, accompanied by husband. No medication provided
Bright red rash on both upper arm area both sides of my lower back waist area. It was not itchy, blistery, or bothersome. The following morning the rash was fading. My left arm where the vaccine was given is still a little tender.
Received Engerix-B as her Second Dose; Initial Report Received on 02-Nov-2020  A registered nurse reported that a 51-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for her first dose of hepatitis B immunization and received ENGERIX-B as her second dose.   No medical history was reported. Allergic history included aspirin and penicillin. The patient was not pregnant.  No concomitant medications were reported.  On 26-Aug-2020, the patient received the first dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021, NDC # not reported) to her left deltoid. On the same day, the patient also received a flu shot to her right deltoid.  On 30-Oct-2020, the patient received ENGERIX-B (Lot # 2573G, expiration date 28-May-2022) as her second dose (which has a 3-dose series) to her left deltoid.  This was the patient's first time receiving the hepatitis B vaccine.  At the time of report, no adverse reactions to the injections had been noted.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Informed would like to discuss her reaction to the Covid vaccine.  States received the vaccine 12/21 at 10:15 a.m.  Approx 1500 - 1600 , the same day the injection site had "normal soreness, like a flu shot".  On 12/22 woke up around 7 a.m. and couldn't move the affected arm due to pain.  Reports it hurt to move her fingers.  Temp was 99.5, maximum.  The upper arm was swollen.  On 12/23, temp is 97.6.  Feels "normal soreness, like a flu shot
Face and head on left side where vaccine was given went numb.   This has cleared today, however, My left leg and arm (particularly the hand and foot) feel cold and numb.