chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 19-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N022728 and expiration date 31-MAY-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
Hives all over body- progressively spreading in the 24 -48 hours following injection.
Injection site was very tender for 4-5 days after the shot. Then noticed my arm was a dark pink around  the site, slightly warmer than the rest of my arm and area was hard. The pink area has gotten bigger and   has started to fade; the muscle is much softer and more natural; the site itches less and less each day.
While receiving the shot, I felt a strong pain down my left arm to my wrist. It felt unusual, and I thought the tech inserted the shot very high in my arm. Normally it is given right in the meaty part of the arm. After an hour of receiving the shot, my left arm was extremely sore. It was not the normal soreness I felt from receiving the shot every year, this felt like a strange pain almost at the shoulder area and joint of my arm. After three days, my arm still felt too sore to lift and while lying down I felt pain. Now it has been two weeks since getting the shot and I am still having trouble with my arm. It hurts to lift it in certain positions. There is a constant achy feeling in the muscles around my shoulder.  It is very sore where the shot was entered into my arm. I am wondering if others have felt this from this specific shot or if the person who gave me the shot did something incorrectly. I have never experienced this before and as a teacher, I get the flu shot every year.
pt recv vax & devel unspecified rxn;no further details known as of the date of this report;this is one of five patients reported from this site;
VACCINE EXPOSED TO TEMP. OUTSIDE OF REC. RANGE FOR STORAGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
pt recvd vax & 3 to 5 mins later exp redness of the face, lightheadness, severe h/a, heavy extremities, became very dizzy; 1 wk later exp rt abdo swelling & stinging in stomach; MD indicated that pt had hepatitis;
At next day of vaccination patient noticed the vaccinated area red, swelled and hot. Went to her doctor and diagnosed cellulitis and prescribed to her CIPRO 750mg tabs.
Nine days after receiving my fourth dose of Moderna, I had routine blood work done and for the first time in my life, my thyroid levels were low. My doctor did indicate that he thought there could be some relation to my recent vaccine. I did not have any symptoms, which I conveyed to the doctor. He stated it could be subclinical hypothyroidism but would need further checking to properly diagnose. After three months, I had more blood work done and a TPO. My levels were high on the TPO, but my THS numbers had gone back to normal. So, at this time, there is no need for further treatment.
Breakthrough COVID infection. Asymptomatic. Tested positive on 5/8/21 after having Moderna vaccine on 3/8/21 and 4/5/21.
Upper rt quad pain 3 days p/HIB booster; Scleras faintly yellow on 25MAR92; skin "tan color" when normally very fair; extreme lethargy beginning 20MAR92 lasting till 30MAR92 (10 days);
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: about 7 minutes after the 2nd dose, pt complained of light headedness and nausea, his feet were elevated and bp was taken(79/53). 9 minutes later, bp was taken and was 95/68. About 5 minutes later pt stated that he felt better, bp was taken and was 113/74. counselled pt to self monitor any symptoms and call 911/ go into the urgent care/er if the symptoms reoccured.
Follow-up information received from the reporter indicated that there were no patient adverse reactions. Information regarding Prevnar was received from a healthcare professional that indicated they were "having a problem getting the last of the air out of the pre-filled syringes" and the "children were reacting as if it is more painful with prefilled syringes". The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medication were not reported. The physician indicated that they were " having a problem getting the last of the air out of the pre-filled syringes" (pharmaceutical product complaint) and the children receiving Prevnar therapy were "reacting as if it is more painful with the prefilled syringe" (injection site pain). Additional notes from the reporter indicated that " there were no patient adverse reactions."
Herpes simplex 1 outbreak 36 hrs after vaccination. First symptoms subsequent to disease onset 15 years ago; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm, via an unspecified route of administration on 23Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included fluconazole allergy, sulfa allergy, herpes simplex 1 (15 years ago). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included naproxen. On 25Jan2021, the patient experienced herpes simplex 1 outbreak 36 hrs after vaccination. First symptoms subsequent to disease onset 15 years ago. Treatment received for the adverse event included Medication for Herpes Simplex Virus (hsv). Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown.
nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
incorrectly gave patient two vaccinations of Spikevax, rather than one and a flu vaccine.
Sudden heart rate increase Aprox. 2 hrs. after a FLU VACCINE SINGLE DOSE INJECTION-3YR+(FLUARIX, FLULAVAL, FLUZONE). My Normal rate is in low 60's -- heart rate more than doubled - very suddenly - lasted for Aprox. 1-1/2 - 2 hours. Shakiness, lightheaded, felt like passing out. Heart rate decreased after an hour slightly, then elevated again, then went down and stayed down. I consulted with daughter who is an RN. I put pressure on my Carotid Artery on one side to see if rate would decrease. No change. I proceeded to just sit and relax until it dissipated and if it was not going to, was prepared to seek further medical treatment. The remainder of the day I was extremely tired.
This spontaneous report was received from a Registered Nurse concerning to a 52 year old male patient who was a smoker. Concomitant therapies included LIPITOR. On 12-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N022303, the expiration date: 01-MAR-2019, (dose was not reported) for vaccination. On the same date, at the same site in the deltoid area of the same arm, the patient received a dose of FLUZONE (dose, route, lot# and the expiration date were not provided). On 15-OCT-2017, the patient developed "cellulitis like symptom" from the area below the injection site down to the elbow. The patient sought medical attention, visited the physician and received unspecified treatment for the event. At the time of reporting, the outcome of Cellulitis of upper arm was unknown. The relatedness between the suspect therapies and the Cellulitis of upper arm was not reported. Upon internal review, the Cellulitis of upper arm was determined to be medically significant.
Information has been received from a physician assistant concerning a 66 year old female who on 08 JUN 2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck).  On 09 JUL 2007, the patient came into the doctor's office because she experienced a three by three centimeter rash on her mid-back.  The rash was excoriated from scratching.  There was no signs of vesicles.  The patient experienced itching but no pain.  The rash started off as spots.  The patient was treated with antihistamine and the reporter has not heard back from the patient.  A product quality complaint was not involved.  Additional information has been requested.
flu like side effects; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid with an associated reaction of influenza like illness.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   The reporter considered the influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Jan-2023 and 25-Jan-2023 Reporter's Comments: The patient received the first shot 3 years ago. The patient experienced flu like side effects from the vaccine. She also she stated that she had flu-like symptoms with her first dose in 2020. The patient experienced same side effects from all the Covid shots and boosters. So, the patient kept putting off getting second dose of Shingrix shot. Now, the patient had like to get it, but wonder if it could just get the second dose, or if it could start the series over again and get the 2 shots several months apart. The patient was concerned that the vaccine would not be effective with shots space of 3 years apart. This case had been linked with US2023011253 same reporter.; Sender's Comments:  US-GSK-US2023011253:Same reporter
Already gone through menopause I have started with hot flashes again. Worse than during menopause.
Only diluent administered; Only diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Apr-2023 The reporter consented to follow-up. The patient received only the diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
2 days  after injection, left side neck, throat area had gland swelling and pain.   Extremely tired that night.   I had an appointment with Dr. that afternoon on an unrelated issue but mentioned these symptoms to him.  He suggested taking Zyrtec, along with Tylenol or similar OTC and prescribed an antibiotic.    I still have symptoms 4 days later.
This is a spontaneous report from a contactable nurse via Pfizer-sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA at single dose for immunisation. The medical history and concomitant medications were not reported. Site reaction to meningococcal group b rlp2086 was reported - hives for four days and large lump. They subsided with no further complications. Outcome of the events was recovering.
6/5/19 patient had a fever of 101.4 with swollen, red, warm area on right leg. Grandmother drew circle around area. 6/6/19 area increased in size to about the size of 1/2 dollar bill. Grandmother called pediatrician who in turn referred her to the ER. Evaluated in ER and sent home with instructions for Tylenol and benedryl. When asked what the ER doctor said, the grandmother thinks they told her it was a local reaction to a vaccine that can occur. Called grandmother the next day to check on patient. Left message. no response to phone call.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; Product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 5:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 5:59 PM, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant No Treatment Medications were reported. It was reported that 280 patients received Moderna Covid 19 stored at minus 82 degrees Farenheight.   This case was linked to MOD-2021-402935.
Nausea, vomit, muscle ache, migraine (migraine medicine didn't help and it usually does).
Was very close to passing out; Stumbling in her words; Really bad, extremely bad headache in front of her head; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Was very close to passing out), DYSARTHRIA (Stumbling in her words) and HEADACHE (Really bad, extremely bad headache in front of her head) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PRESYNCOPE (Was very close to passing out), DYSARTHRIA (Stumbling in her words) and HEADACHE (Really bad, extremely bad headache in front of her head). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 15-Jan-2021, PRESYNCOPE (Was very close to passing out), DYSARTHRIA (Stumbling in her words) and HEADACHE (Really bad, extremely bad headache in front of her head) had resolved.            Concomitant product use was not provided by the reporter.
That sucker hurt for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received Shingles vaccine. In MAR-2023, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: That sucker hurt for a few days). In MAR-2023, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-Mar-2023 This case was reported by a patient via interactive digital media. The patient got the shot last week.  He or she suggested to make sure to get the shot in the arm someone would not sleep on.  He or she stated that sucker hurt for a few days but was well worth it. Follow-up was not possible, as no contact details were available.
Tingling and burning sensations for a week in hand and feet and persistent Brain Fog, Derealization, Swollen left armpit lymph node Neck and Back Pain.
warm-hot Injection site; itching Injection site; Redness at Injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-OCT-2023, the patient received Arexvy (intramuscular, right arm). On 19-OCT-2023, 4 days after receiving Arexvy, the patient experienced injection site warmth (Verbatim: warm-hot Injection site), injection site itching (Verbatim: itching Injection site) and injection site erythema (Verbatim: Redness at Injection site). The outcome of the injection site warmth, injection site itching and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site warmth, injection site itching and injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site warmth, injection site itching and injection site erythema to be related to Arexvy.   Additional Information: GSK receipt date: 30-Oct-2023 The patient reported that she received the Arexvy and had a delay reaction 4 days after the vaccine. The patient had redness, itching and warm-hot to touch at injection site. The vaccine was provided at a local pharmacy.   Lot and expiration date were unknown.   The patient wanted to point out that her concern was the delay in the reactions. Patient provided consent to follow up with her through email correspondence.  Not all information was available.  Patient declined to provide full address.  No consent for follow up with HCP was provided. Did not consent to follow-up.
Case number PHEH2014US006575 is an initial spontaneous report received from a pharmacist on 01 Apr 2014. This case refers to a 22-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired MENVEO (batch number: A11032 and expiry date: Mar 2014) intramuscularly on 01 Apr 2014. No adverse event was reporting following this administration error.
24 Y/O M reports "scratchy throat" and onset of cough. Hx of anaphylaxis 2yrs ago. Stated symptoms similar to previous episode. PT given 50mg Benadryl w/out resolution of symptoms. EMS called. Sent to ED.
I had nose and head congestion; and a mild fever lasting 5 days and a cough lasting 3 weeks. I took PAXLOVID.
19 yof received Varivax vaccine on 10/14/08 at place of employment.  On 11/6/08 she developed a headache, sty on eyelid, and scattered vesicular lesions.  Pt. went to walk-in clinic on 11/7/08.  Headache worsened and on 11/8/08 she went to ER.  She was admitted with chickenpox and viral meningitis.  She was discharged on 11/10/08.  11/13/2008 MR received for DOS 11/8-9/2008 with DX: Apparent viral meningitis that is probably vaccine related due to Varicella vaccine.  Pt presented with 2 day hx of intense frontal H/A, worse with cough. PE (+) for vesicular rash on trunk and extremities as well as one on the R eyelid, faint flow murmur. Tx with Acyclovir and Rocephin and d/c home next day.