chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe swelling on lymph nodes around left arm/armpit with pain and tenderness to touch; Severe swelling on lymph nodes around left arm/armpit with pain and tenderness to touch; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2022 14:30 (Lot number: FK9894) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Seizure disorder" (unspecified if ongoing), notes: Seizure disorder; "congenital heart defect" (ongoing), notes: congenital heart defect; "hypothyroidism" (unspecified if ongoing); "Covid prior vaccination: Yes" (unspecified if ongoing), notes: Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0170, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 05May2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 25Mar2022 16:45, outcome "not recovered" and all described as "Severe swelling on lymph nodes around left arm/armpit with pain and tenderness to touch". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional Information: Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. If covid prior vaccination was reported as yes. If covid tested post vaccination was reported as no.  No follow-up attempts are possible. No further information is expected.
pt in clinic 1-24-08 for health check.  Last menses 1-1-08.  Was given TDAP, MCV4, Hepatitis A & HPV vaccines 1-24-08.  Client RTC 1-28-08 for pregnancy test.  Test was positive pregnancy.  EDC 10-8-08.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD21-070124 (E2B Linked Report).; Sender's Comments:  MOD21-070124:
exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 34-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 provided as follows: The patient received the vaccine after being exposed to freezing temperatures (-1 C for total amount of time of 25 min), which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter
Nausea, body aches, chills, menstrual cramps. The first 3  only lasted for about 24 hours. I am still currently experiencing severe menstrual cramps now 2 weeks later. I have an IUD (and have had it for almost a year) so I do not normally experience periods or cramping at all.
red arm allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm allergic reaction). At the time of the report, VACCINATION SITE ERYTHEMA (red arm allergic reaction) outcome was unknown.  No concomitant and treatment medications was provided by the reporter.  This case was linked to MOD-2022-567470 (Patient Link).
1st vaccine 1/22/21; 2nd vaccine 2/12/21; developed cough and chest tightness onset 2/25/21 and seen at ICC same day; was COVID tested at ICC negative
A physician reported that within a couple of days post vax, the pt developed diarrhea and irritability. As of Jul 19, 2001, the pts diarrhea persists. No further information was available at the date of the report.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65 ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2015). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 21-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Syringe leaked during administration/The patient was affected/Related AE - underdose; 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/The patient was affected/Related AE - underdose), 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 (GSK) representative called to report PQC (product quality complaint) with Twinrix syringes on behalf of healthcare professional (HCP).  The syringes leaked while administering to patient. Three patient was affected (Related adverse event - underdose). The reporter contacted HCP Medical Assistant (MA) for more information regarding PQC. The defect was discovered after partial use of the box. The healthcare professional stated that 2 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 HCP did not have suspect product to return - all 3 syringes were disposed of. The GlaxoSmithKline (GSK) 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. 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 syringe leak, accidental underdose and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2023034605:Same reporter US-GSK-US2023AMR035220:Same reporter
I started feeling flu-like symptoms around 14 hours after the second vaccine. Each symptom occurred at the same time at 03:37 AM on July 14, 2021. The symptoms included achiness, cold shivering, slightly elevated temperature (100.8 °F), and almost complete muscular tension in arms and legs. It made it difficult to walk. I took a mixture of Tylenol (acetaminophen) and Advil available in one tablet. I took 2x of these, drank plenty of fluids, and went to bed around 05:15 AM on Wednesday, July 14, 2021. I had a heating blanket along with a microwave bean bag to keep myself warm. I woke up at 1:45 PM with most side effects subsiding, besides vaccine injection site still remaining sore.
Cough, pain and swelling at injection site, chills, body shakes, whole body ache, migraine, extreme fatigue, nausea and vomiting, loss of taste and smell.
A caller reported that her daughter experienced fever about 7 days after vaccination with her first dose of MMR II, injection, when the child was 3 and a half years old that lasted about a day and a half.  The patient at 3 months old picked up a "lung virus" after being vaccinated with a couple of vaccines (vaccines unspecified).  No further information provided.  Unspecified medical attention was sought.  Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 10:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 10:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.70.  No concomitant medications were reported.  Batch number 026C21A administered on 24-May-2021 underwent temperature excursion with temperature of 35 degrees Fahrenheit from 8:00 AM to 09:00 AM. This vial was moved to fridge on 18-May-2021 and beyond use date for the vial was reported as 17-Jun-2021. On 24-May-2021, 3 vials were moved to the clinic.   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 traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
persistent headache, ear pressure (left side), eye pain, severe tinnitus resulting in anxiety and lack of sleep
Fever 101, severe body aches, onset of fainting, extreme fatigue, little cough, sore throat.
103° fever very hard to bring down. Twitching. Fussy. Odd, distant behavior. Fever lasted 3 days. Behavior continues to be odd, won't look when called or make eye contact. Tylenol and Advil were used.
Patient is having extremely sensitive skin that seems hot to the touch. She thinks it may be Cellulitis as she has had this in the past and it seems very similar. She starting seeing this Welt 2 days post vaccine. She felt other flu like symptoms prior to this on day of vaccine and all day yesterday. If the swelling gets worse, she is going to go to Urgent Care to rule out Cellulitis.
Not an adverse reaction, but administration error. Patient came for COVID bivalent updated booster and was administered the original Pfizer COVID formulation instead.
Patient temporarily lost consciousness twice becoming incontinent after the second episode. Patient complained of lightheadedness, dry mouth and was pale throughout. EMT arrived and administered an IV ultimately transporting the patient to the hospital as they remained weak and unable to maintain balance.
Pt sat down and about 1 minute later, lost consciousness.  We called 911, got him on the floor, then he came to and begin to know where he was. Paramedics showed up and took his bp and blood sugar and within 10 minutes he was up and walking around
For: erythema and induration at site of flu shot injection that improved with warm compresses used.
Pt suffered painful, swollen arm which developed a day or two after receiving the PNEUMOVAX and FLUVIRIN shots. She called to explain her symptoms and we told her to see her MD. (She said the area irritated was the back of her arm and not the area where the shots were given) MD determined it was cellulitis and prescribed cefadroxil for her. Pt has high risk of C. difficile and was concerned about having to take antibiotic. Pt very upset about reaction she had.
HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022, no exact dates provided.; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD), dose of 0.5 mL, lot number: W016358, expiration date: 16-NOV-2023(dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error).   On 14-JUL-2022, the administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD) experienced a temperature excursion. It was unknown whether a digital data logger was involved.
This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). Concomitant products included ADVIL, FLONASE, IMITREX, MUCINEX, ALLEGRA, PEPCID and PEPTO BISMOL. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 21st March 2018, the patient experienced extensive swelling of vaccinated limb, injection site itching and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, injection site itching and injection site erythema were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, fever, injection site itching and injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was reported by a technician at the healthcare professional's (HCP) office. At 14:19 hours, the patient received SHINGRIX vaccine in right deltoid. After 1 day of vaccination with SHINGRIX, the patient experienced redness, swelling and itchiness at the injection site. The patient had not visited the office, but had called every day. The injection site reaction was 4 inches, but at the same time of reporting, it was twice as big.
Information has been received from a registered nurse concerning a 25 year old female who on 08-JUN-2009 was vaccinated with a first dose of GARDASIL. The patient fainted after receiving the GARDASIL dose. The patient recovered in the office without treatment. This is one of two reports from the same source. Additional information has been requested.
that's had the flu is the person that got a flu shot; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who had the flu is the person that got a flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that's had the flu is the person that got a flu shot (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (that's had the flu is the person that got a flu shot).  At time of reporting, the outcome was Unknown for the event that's had the flu is the person that got a flu shot.
axillary lymph node swelling; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included COVID (had Covid back in Jan). Concomitant medications were not reported. On an unspecified date, the patient experienced axillary lymph node swelling. The patient wanted to know if axillary lymph node swelling was common coming up on 5 months since her second Pfizer dose. PS she also had Covid back in Jan her provider might be ordering a biopsy of her node if she didn't clear up soon any advice or information would be greatly appreciated. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
No adverse effects reported; the patient was administered improperly stored PROQUAD; This spontaneous report as received from a nurse refers to a 4 year old male patient.  The patient's concurrent conditions and medical history were not provided.   On 18-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T001187 with expiration date of 11-JUL-2021, subcutaneously, for prophylaxis (dose not provided), which was reconstituted with properly stored sterile diluent (DILUENT MRK INJ) (dose, lot# and expiration date were not provided). The vaccine had temperature excursion of 6 °F to 14 °F (10.9 °F) during 2 hours 30 minutes. There was not previous temperature excursion. The report was called because of a data logger. No adverse effects were reported.
Dizziness, Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:
9':55 c/o heart racing, Blood sugar 131 prior getting vaccination.  Apical 108  162/82, 98.5, 98%.  Transported to EMS truck due to rain.  Vital signs 10:05 HR 99, BS 184, B/P 150/88. 10:13 States feeling bette 10:15.  Asst. to car, stated felt much better.  Stated she ate breakfast from fast food vendor (Bagel) prior receiving vaccination.  Blood glucose monitor implant.
Patient was sitting down after receiving the injection. After about 5 minutes he felt dizzy and lost consciousness for about 10 seconds but then regained consciousness. 911 was called and paramedics came to take pulse and blood pressure which were both normal. Patient chose to not go to the ER and his mother came to pick him up.
Breakthrough case admission after 3 vaccines Pfizer 2/10/21 Lot# EL9269;  Pfizer 3/3/21 Lot# En6202;  Pfizer 9/27/21 Lot# FF2587
left arm pain near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm pain near injection site) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (left arm pain near injection site). At the time of the report, VACCINATION SITE PAIN (left arm pain near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt received Anthrax vaccine 02/22/2017 in left arm IM.  Patient had normal soreness after vaccine and claims swelling and redness started occurring the next morning (23 Feb 2017).  Pt claims swelling and redness have remained the same and that is why he came back to see us on 24 Feb 2017.  Provider saw patient and treated with antibiotics for cellulitis.  Pt will be f/u on mon/tues of next week and told if sx become worse over the weekend to go to ER.  Pt agreed and understands plan.