chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 8 year old white male patient, who was adopted from Romania at two years of age, with no drug allergies and no known past medical history who on 22-Sep-1997 was vaccinated subcutaneously in the left arm with a first 0.5 ml dose of varicella virus vaccine live (Lot #622852/0540E). There was no concomitant medication. On 09-Oct-2003, the patient developed shingle. The reporter noted that since the patient was adopted from Russia, it was unknown if he had a previous infection with chickenpox. The patient was seen by a physician and was treated with acyclovir (Zovirax) and acetaminophen (+) hydrocodone bitartrate (LORTAB). A VZV analysis was not requested. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Patient developed redness and swelling in the area around the site of administration after the vaccination which progressively got worse. She went and saw a provider at the urgent care on 04/29/2023 and was diagnosed with Cellulitis of the right upper arm. She was prescribed antibiotic Doxycycline by the provider for a 7 day course.
Pt states that a 2 inch diameter, circular rash has appeared around injection site that is hot, raised about 5 mm.
pt presents with dizziness, shaking, & elevated heart rate, pulse 122, o2 sat 98%, pt states HR normal range is 88, also anxious r/t vaccine. within 5  mins s/s subsiding, HR 99, 02 97%, will continue to monitor. injection site warm to touch, instructed to place cold compress @ home.  30  mins post vaccination pt s/s resolved & pt return to baseline. HR 98 , 02 98%, released to home with coworkers.
Severe headache immediately and ongoing, progressively getting more painful. Severe earache beginning after 10 hours. Full body pain/soreness. Pain at the injection site immediately and progressively getting worse. Slight fever beginning at hour 20. In so much pain I can?t sleep or move.
On Thursday, 3/25/21, I woke up feeling tenderness, warmth and a little redness at the site of the injection.  On Friday, 3/26/21, redness grew to 2 inches in diameter and tenderness cleared.  On Saturday, 3/27, redness was still there but got itchy.  Same through Sunday, 3/28/21.  As of Monday, 3/29/21, redness and itchiness was gone.
Patient called about 9:00 AM on 10-28-09 and informed me his arm that he received the PNEUMONIA vaccine in was very swollen and painful.  He stated "my whole arm is swollen".  I encouraged his to see his PCP ASAP.  I called him on 10-29-09 to follow-up.  He said he went to the ER, and they though it was an allergic reaction.  ER prescribed BENADRYL, steroids, LORTAB; and an antibiotic in case it was an infection per patient.  He also clarified that his arm was swollen only down to his elbow and from his shoulder down his chest some.  He stated the pain and swelling has improved.  He told the RN when he got the PNEUMONIA vaccine that he didn't think he had one before.  However, when he called me about the reaction, he told me he was in the hospital about a month ago and he got a flu shot but he didn't think he got a PNEUMONIA shot, but he wasn't sure.  I called the hospital and found out he did receive a flu and PNEUMONIA immunization on 9-20-09.
OBSTRUCTIVE SLEEP APNEA ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Syringe leaked during administration; Syringe leaked during administration; Syringe leaked during administration; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received HAB (Twinrix adult) (batch number h3sg9, expiry date 03-JAN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced accidental underdose (Verbatim: Syringe leaked during administration), syringe leak (Verbatim: Syringe leaked during administration) and pharmaceutical product complaint (Verbatim: Syringe leaked during administration). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 The GlaxoSmithKline representative called to reported product quality complaint with Twinrix syringes on behalf of healthcare professional.  The syringes leaked while administering to patient.  Three patient was affected related adverse event underdose.  The reporter contacted healthcare professional medical assistant for more information regarding product quality complaint.  The defect was discovered after partial use of the box. The healthcare professional stated that two doses administered prior did not have any issues. The reporter confirmed that Luer Lok needles were used. All syringes leaked between the Luer Lok device and the syringe barrel. The syringe was not pre-assembled with needle some time before administration syringes were assembled immediately before administration 20 gauge 1 in needle was used.  The blister and/or carton was not damaged. The Luer lok was not damaged.  The needles which were used was not available for return. There was no damage/breakage on the syringe barrel.  The healthcare professional did not have suspect product to return all 3 syringes were disposed of.  The GlaxoSmithKline had to issue a credit for 3 doses of Twinrix to GSK direct account.  The reporter did not have any demographics for the 3 patients.  The reporter consented to follow up. Additional supportive information:  This was 1 of 3 cases, reported by the same reporter. The syringes leaked while administering to patient and the patient dose was affected, which had led to accidental underdose, Syringe leak and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2023034605:Same reporter US-GSK-US2023AMR035219:Same reporter
Blood pressure went up to 201; Strange feeling in the tongue; Not having appetite; Diarrhea; Chest pain; Temperature 98.2; Chills; Nausea; Little soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea) and CHEST PAIN (Chest pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Little soreness). On 07-Feb-2021, the patient experienced HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea). On 04-Feb-2021, PAIN (Little soreness) had resolved. At the time of the report, HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Blood pressure measurement: 201 High. On 07-Feb-2021, Body temperature: 98.2 Inconclusive.     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 relevant concomitant medications were reported. No treatment information was provided.
Tingling in left and leg, shot was given in left arm, then developed fever and numbness in the left hand and headache. Was advised by pediatrics to go to emergency room if numbness developed or if she got a headache.
Rash from hip to ankle on injection leg.  Then spread to arms and torso ending with welts on the face.  Benadryl and Motrin administered.
Two days after vaccine administration, pt. had redness of lower leg (hot over injection site). Knee swollen some pain on inside of L leg. No fever. No trauma. No limp. No hives. No itching. No swelling now. Went to urgent care sat. Given ORAPRED.
Headache; taste was more impacted/ food didn't taste right/ too bitter/taste horrible; very bad migraines; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot/batch number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 07:30AM at single dose for COVID-19 immunization in hospital. Medical history included tested positive for COVID-19 on 09Sep2020. She had loss of taste and smell; next day horrible diarrhea; third day she had a headache for two days; then on day four or five she got a slight fever. The whole time starting on day three her heart was racing and she couldn't sleep. States her rapid heart rate was resolved about two weeks before the vaccine. She is still recovering her sense of taste. Mentions she saw a cardiologist and had an echocardiogram that was normal in 2020. She has continued to experience the episodes of resting tachycardia but not so often now. Maybe once every two weeks. Concomitant medications were none. No vaccines were administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 22Dec2020 at 10:00AM in the left arm for COVID-19 immunization. She had a headache and rapid heart rate that night and was up all night. It seemed like some of her COVID symptoms came back that first night. Added her arm hurt but she felt like that was related to the administration of the shot. Adds that is not how to give a shot. Adds her COVID symptoms had all gone away and then they came back but only for that first night after the first dose. Physical therapist reported that she received part two of the vaccine two weeks ago and ever since then she has had very bad migraines in Jan2021. She felt like she had recovered from the previous vaccine then she noticed her taste was more impacted on 15Jan2021. Her taste and smell was coming back from her COVID infection but after the second dose it seems like food didn't taste right. Mentions she loves Cilantro but now she can't eat it or anything citrus because it seems too bitter and Coke products taste horrible. Now she has a headache that started again on 16Jan2021. Adds normally she doesn't get headaches. She has tried rehydrating, tried drinking water and gatorade but the only thing that is helping is taking ibuprofen or Tylenol. She is rotating taking these products every other day and it is helping. Headaches come back when the medication has worn off. Patient does not require a visit to physician or ER for events. The outcome of events migraines, taste was more impacted was not recovered; unknown for another event.  Information about lot/batch number has been requested.
red area on L DLT with 24 hours of vaccination given in LDT that day went to pediatrician given Benadryl cream area is resolving.
Developed a few scattered hives 01/31/10 in early AM. Over that day they worsened & multiplied. By 02/01/10 at 100 AM they covered body. Pt. called her clinic, on-call nurse Rx'd SUDAFED/BENADRYL/Ibuprofen, which pt. took. Pt. called MD @ 10AM & her nurse reported signs to MD who wanted to see pt. at office. Pt declined eval. Pt. continues to take CLARITIN & BENADRYL. Slowly improving. Thinks hives D/I H1N1 4 days earlier. Counseled pt. to consult w/medical provider for f/u & treatment.
COVID after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID after vaccination) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced COVID-19 (COVID after vaccination). At the time of the report, COVID-19 (COVID after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. Sender's Comments: This case concerns a 34-year-old male patient  with no relevant medical history who experienced non-serious unexpected event of COVID-19. Temporal relationship is unknown since exact date of vaccination was not provided per SD. The rechallenge was unknown as the event occurred after the first dose of the vaccine and no information about second dose was given. Very limited information regarding clinical course of the event has been provided at this time. Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
on  01/08/22. 4 hours after getting booster shot, neck started to itch with rashes and little hives. Went to the hospital and got prescribed epipen and 20mg prednisone pills. on 01/09/22 (the day after getting the booster), whole body cover in rashes and hives. itched all over and felt like fire and was screaming in pain and agony. went to hospital later that night and was given 20mg prednisone and Benadryl. on 01/10/22, went back to hospital for using the epipen. was given ibuprofen for the leg pain and was also given a Benadryl and  a 20mg prednisone. went home and took more prednisone because it started to get worse after leaving the hospital. slept as much as possible and itch as less as possible. finally, today, on 01/19/22, there is no pain, no itching, and no rashes and hives. but the skin all over body is slightly cracked from the dryness and itching that took place. during the whole time of this event, itch creams and recommended rash and hive lotions were used but none worked, they only made them worse and more vulnerable to itching.
Info regarding Prevnar was received from a healthcare professional regarding a 15 month old female pt who experienced pneumococcal sepsis and respiratory symptoms. At 6 months of age the pt received the third dose on 5/24/05. The pt also received a dose of DTAP and a dose of Hep-B on 5/24/05. Indication for Prevnar was immunization. Product was administered on 5/24/05. Dose regimen was 1 dose 1 time per day. Event Details: A physician reported that the pt developed pneumococcal sepsis (drug ineffective) and was hospitalized on 2/22/06. Respiratory symptoms occurred prior to the sepsis. Serotyping of a sample collected was unavailable at the time of this report. Results from chest films obtained were "clear". Recovery status of pt is unknown.
This patient was listless, irritable, and unlike herself for two weeks following shots. She was unable to walk for 2 days and had trouble walking for the 2 weeks following shots.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 9:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 9:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.22.  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a pharmacist concerning an approximately 13 year old of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2016, the patient was vaccinated with one single dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. In approximately 2017, the patient was in the office for the second dose of GARDASIL 9. No adverse effects reported.
Patient reports she developed pain, swelling and decreased range of motion the day after getting the vaccine. She reports it lasted several days after. She has been taking Tylenol and prescription NSAID daily to ease the pain. The prescription is actually for her knees but she states she has been taking it to relieve the pain in her right shoulder. She reports now (16 days after vaccine) her range of motion has returned but she still has discomfort to pectoral and deltoid area when doing a "rowing" motion.
Patient received IM injection of DTAP using 1 inch sterile needle into left deltoid.  Arm swelled, turned red, hot, painful 24-48 hours after immunization was given.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender with rheumatoid arthritis. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB, 1 ml, intramuscular (lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that the patient had titers drawn at unspecified time which were negative for hepatitis B. The outcome of hepatitis B surface antibody negative was unknown. The causality was not reported. The patient did not seek medical attention. Additional information has been requested.
Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information provided include ibuprofen
Red, swollen, tender arm just above elbow, possible cellulitis, treated with Keflex
Did have a sore arm right away -hour 24 to hour 58;  and then on  day 5 I had  left subiclaviclier lymph node swelling   - - doctor visit the next day and he estimated about 3-4 centimeters in size and it was tender - and he followed up with me about two and a half weeks later on Feb 9 and it was less tender and it was starting to go away.  It was 75% better by the time I had my second vaccine and it didn't re-occur after the vaccine.
For two days after I got my shot, I was really tired.  Then, in the afternoon on the second day, I got up and suddenly my right ear felt like it was clogged, and I worried about wax buildup.  Ear felt like it was stuffed with wool, and hearing capability went down approx. 30-40%.   Tinnitus was detected, but attributed to earwax buildup.  Attempts with cotton swabs and washing with warm water in the shower did not work.  Right lymph node in lower jaw swelled a little bit on the 18th.  Swelling went away on the 19th.  After two days of trying to clean it out traditionally, I got an appointment at Hospital.  Closest appointment I could get was on the 21st.  2 hours before the appointment on the actual day, the doctor canceled, so I had to go to the ER instead.  Left ear was irrigated along with the right.  ER doctor insisted on doing both, despite nothing wrong with the left ear.  Left ear was irrigated 3x.  Right ear was irrigated 4x, but failed and resulted in slight pain.  Debrox ear drops were used for the next 5 days, and while most of the wax appears to have been cleaned out, right ear still feels like it is slightly stuffed with wool, and the Tinnitus is louder now.  Tinnitus is still going on as of this report.   Hearing capability has improved, but still 10-15% less than the left ear.  Mild bouts of vertigo have been occurring on and off since the irrigation.
Received PREVNAR 13 vaccine approximately 36 hours after vaccination had severe headache lasting for approximately 48 hours.
Post vaccination reports feeling lightheaded w/ no additional symptoms or complaints; medical monitoring w/ vital assessment: BP 138/79 P89 O2 sat 98% RA; rest w/ symptom resolve, released home w/ self.