chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph node; low grade fever; Severe nausea; Felt dizzy and lightheaded; Sore arm; This is a spontaneous report from a contactable health care professional, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EPT534), via an unspecified route of administration in left arm on 17Mar2021 at 15:15 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. The patients medical history included GERD, 4 knees surgery (reportedly one was in last month) and spring allergies. The patient was allergic to azithromycin, chlorohexidine and tramadol. Concomitant medications included omeprazole(MANUFACTURER UNKNOWN), ibuprofen(MANUFACTURER UNKNOWN), acetaminophen(MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN) for unknown indications since unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 15:15, the patient experienced severe nausea approximately 5 minutes after receiving the vaccine, while she sat down and immediately felt she might puke, dizzy and lightheaded, which only lasted for around 5-10 minutes. On an unknown date in Mar2021, the patient experienced typical sore arm for 3 days and on 20Mar2021, reportedly on the third day  the patient experienced swollen lymph node in her armpit and low-grade fever (99.5)  The patient did not receive any treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea and dizziness lasted for around 5-10 minutes, recovered on 17Mar2021. The clinical outcome of the event sore arm was lasted for 3 days and recovered on an unknown date in Mar2021. The clinical outcome of the events swollen lymph nodes and fever were recovered on unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Flu shot administered on 11/4/10 in (L) deltoid muscle at 9AM. At 10AM (L) arm hurt at injection site which lasted through 11/6/10. Started to feel pain in (L) armpit on 11/5/10 thru 11/6/10. On 11/7/10 pain started in (L) hand palmar side between thumb & index finger. Pain progressively worse and (L) handed weakness is occurring now.
This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 69-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). On 23rd April 2018 13:39, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, several hours after receiving SHINGRIX, the patient experienced vomiting, chills, headache, fever and stomach virus. On an unknown date, the outcome of the vomiting, chills, headache, fever and stomach virus were recovering/resolving. It was unknown if the reporter considered the vomiting, chills, headache, fever and stomach virus to be related to SHINGRIX. Additional information was reported as follow: The healthcare professional reported that, the patient received the SHINGRIX vaccine one day before the day of reporting and on the day of reporting called the pharmacist and stated that they had symptoms that started overnight. The patient vomited 4 times and experienced severe chills, and headache. The patient had body temperature of 101 degree F. The patient called their doctor and was waiting for a call back from the on-call physician since their doctor was away. It didn't seem that the symptoms were improving. The healthcare professional stated she wasn't sure if this was due to the vaccine or if the patient picked up a stomach bug or a virus. The healthcare professional also stated that, the patient was very healthy when she received the vaccine.
Information has been received from a 76 year old male who in November 2006, was vaccinated with a dose of Zostavax (Oka/Merck).  In December 2006, one month after vaccination the patient broke out in a rash on his knees and elbows.  At the time of report the patient had not recovered.  No medical attention was sought by the patient.  No further information is available.
About 5 min after I got the vaccine I was on observation and I started getting a rapid, pounding, heartbeat, they waited about 5 min and it started getting faster and stronger, so they called paramedics to take me to the ER. It seemed it could be a severe reaction, I had fast rate for several hours and also broke up in hives while I was at the ER. They did  a cardiac workup and noticed I had change on my heartrate according to the EKG they had previously done.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
BODY ACHES; CHILLS; 102.3 FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 38 year old White (Not Hispanic/Latino)male. The patient's height, and weight were not reported. The patient's past medical history included stroke, dialysis, and drug abuse or illicit drug, and concurrent conditions included smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug or non drug allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced 102.3 fever. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.3 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 102.3 fever, body aches, headache, and chills. This report was non-serious.
2 weeks following second administration of Covid-19 vaccine, patient began experiencing heart palpitations.  The palpitations have been daily, lasting 1-2 minutes throughout the day.  Medical treatment was sought 4/16/21.  Blood work and EKG performed.  Blood work revealed elevated WBCs.  EKG showed T inversion.  No treatment was initiated and repeat blood work scheduled for 2-3 months.  Pt is still experiencing symptoms.
3/22/2019 1110--Client's mom, called to report that patient had a reaction following immunizations given on Wednesday, 3/20/2019. She states that yesterday in the evening patient complained that her L arm (where DTaP was given) was itchy - she was wearing long sleeves and when mom examined it she said that her L arm had a approx 3 x 3 inch raised area of redness and swelling which was warm to touch and itchy. She described it as looking like a big hive. She states that today it isn't quite as red but it is still pink with swelling and has extended down her arm covering area from shoulder to elbow - it is still itchy but not quite as intensely and is also tender.
I'm a very healthy strong fitness instructor and I ride 3 styles of bikes recreationally on a regular basis.  I am so exhausted after eating, muscles including  my heart feel weak, hard to recover from exercise  and difficult  to work. I have  just been  blood tested and due to talk to my Dr this week. I hate how I feel and it came on suddenly  and very intensely.
I had pain in my upper left arm of the injection site that started about 5 days or so after the vaccine. The pain from it was extremely intermittent I could go for a matter of hours and it wouldn't bother me and then I would notice pain even if I hadn't been doing anything. It went on like that for months. It wasn't really consistent maybe the pain would last 15 minutes if I was just sitting. If I was moving and it would hurt then it would be pain that lasted a minute or so. My doctor sent me for an x-ray showed mild arthritis in my shoulder but that was it. I started also having pain in my left leg which was totally different then the pain in my arm. I would get a burning sensation in one localized area on my leg that exclusively happened with movement, like with a walk. It would start on the latter part of my walk that part was consistent. If I tried to rub the area while I was walking, that would lessen the pain. The intensity of my pain/burning wasn't as consistent. My doctor sent me to physical therapy. I talked to a couple of doctors and my physical therapist and none of them had any idea what was causing the problem. The physical therapy didn't help. I stopped it. Both of these pain issues/symptoms are still occurring to this day. For a time, I thought the pain had gone away in my arm and then it came back just as bad as it had been.
pt recv vax & exp a fleeting rash w/urticaria @ the site of inj (upper rt arm);these sx have disappeared & returned repeatedly for the last two months;
Patient developed itching after second Pfizer vaccine.  She had the same thing after first vaccine and responded well after po Benadryl.  Providers discussed whether to give second vaccine at mobile clinic and decided to go ahead, since first reaction was very mild and totally resolved with time and Benadryl.  Patient also got itching with codeine.  She again did well.  Nothing but mild itch.  No hives or any other reaction.  Kept additional time. Totally resolved by discharge.
Fever returned; Headache/having headaches mostly when i lay down; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (Fever returned) and HEADACHE (Headache/having headaches mostly when i lay down) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 09-Sep-2021, the patient experienced PYREXIA (Fever returned) and HEADACHE (Headache/having headaches mostly when i lay down). On 08-Sep-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 10-Sep-2021, PYREXIA (Fever returned) had resolved. At the time of the report, HEADACHE (Headache/having headaches mostly when i lay down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported   This case was linked to MOD-2021-293439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow-up information received on 12-09-2021 contains non-significant information.
an expired Pentacel dose was given to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious was received from a Physician via Medical Information (Reference number- 00616586) and transmitted to Sanofi on 26-May-2021.  This case involves a 7 months old male patient who received a 0.5 mL expired dose (second dose) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ162ABA and expiry date: 24-Apr-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 26-May-2021.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   The reporter wanted to know wanted to know if it should be counted as a valid dose or if patient needs revaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Its been over a week and I have constant chills and headaches. For 7 days straight I am having chills and headaches. Prior to vacination I never had chills. Also, I had a negative covid test before my vaccination.
Moderna COVID-19 Vaccine EUA It has been almost 2 weeks since my first injection and I am now having redness and swelling at the injection site.  The area is warm and there is a dull ache as well.  I had no issues the first week after the injection.
pt called ofc 15MAR96 reports rash & numbness from forehead to lips on the lt side of face, malaise, chills;instructed to take DPH;25MAR95 pt cont DPH & has some numbness in face;2APR96 diff focusing & thinking things through, foggy head
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (dose, lot number and expiration date were not reported). The vaccine was reconstituted with MERCK STERILE DILUENT. On an unknown date the patient experienced erythema at the injection site. The patient did not recover from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no consent for further contact.
Patient was inadvertently given Hepatitis A- adult instead of Hepatitis A- pediatric dose. Talked to the patient 3 days later and patient's father stated the child had no signs or symptoms of an adverse reaction.
pneumonia; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult female patient who experienced pneumonia while receiving vaccine 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 (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported "Not me. I got a flu shot twice bith times ended up with pneumonia. Haven t gotten one since and haven t gotten pneumonia ever again. Haven t had the flu in years either."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (pneumonia).  At time of reporting, the outcome was Unknown for the event pneumonia.; Sender's Comments: Sanofi Company Comment dated 06-Jan-2022:  This case involves a patient of unspecified demographics who experienced pneumonia after receiving influenza. Further information regarding previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
I suddenly found my arm red, itchy, swollen, and in pain around my infection site after took 1st dose of the Moderna vaccine, and it became bigger and bigger every day. 2days later (4/5/2021), I went to the urgent care, the doctor let me take  Zyrtec and use 1% hydrocortisone cream and recommend me to talk with my primary doctor. It does not work. Today?4/7/2021), I have an appointment with my primary doctor, she recommended me to continue to use Zyrtec and use stronger topical triamcinolone cream twice daily instead of over-the-counter 1% hydrocortisone cream.
Patient reports reddened area at injection site starting as "silver dollar size" the next day (10/5/21) & today (10/6/21) reddened area as large as palm of her hand
DIARRHEA; SLIGHT FEVER; SLEEPING A LOT; SICKNESS; CHILLS; FEELING NOT WELL; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 91 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 08-APR-2021, the subject experienced sleeping a lot. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feeling not well. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced slight fever. On 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, chills, feeling not well, diarrhea, slight fever, sleeping a lot and sickness was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
Felt pretty weird for a few hours,  Went to bed and by 6am I could hardly walk straight to the bathroom, my legs were wobbly and strangely weak.  I also felt some pins sensations in arms and legs.  I had to lay on the sofa all day. I did not go to the ER because of an ice storm that day.  By bedtime I felt a little better, but was anxious beyond belief and could not sleep in the dark. I have never had a flu shot reaction before in all the years I have taken them.  By Monday 1/06/14, I woke up feeling normal again.
No adverse events. This dose of Pfizer was administered inadvertently after the patient had received a dose of the Janssen Covid vaccine in March 2021.
I had a low grade fever with chills throughout the evening and into the night.  At 10:30 pm while getting ready for bed I started having an "Aura" with many Kaleidoscope like twinkles.  I layed down and closed my eyes in the dark bedroom, with my husband monitoring me.  My husband also read me the Side Effects again and watched me until I fell asleep, just a few minutes later.  I woke u fine, just a sore arm.
Macular blanching rash.  It appeared less than 24 hours after the vaccination.  She did not treat the rash.  The rash hurt and itched.  She has felt like she was freezing cold all morning.  Prescribed triamcinolone cream TID  and tylenol.  The rash resolved.
My 2 month old twins were getting their first set of vaccinations at the same time. I split the vaccines in half and two weeks apart since my boys were premature at birth. On 3/14 they received the second half of their vaccines to complete their 2 month set. On 4/25 I received a call from their pediatrician and was told one of my twins was given PPSV23 vaccine instead of PCV13. She had checked the wrong box in the computer and the wrong vaccine was give to one of my twins. She stated they called the CDC for side effects and I was told he will be fine and there are no side effects of the error. Also told I have to start over with this vaccine since the PPSV23 is not effective in children in under 2 years of age. In addition, the medical assistance administering the vaccines did not question why one twin was receiving a different vaccine or ask me if my twins were meant to received different vaccines that day.
Headache, Fever, CHILLS, BODY, FACE, HANDS SWOLLEN Narrative:
A DPT and IPV given in anterior left thigh with 4.5cm by 11.5cm erythematous pseudopodal rx 6 other symptoms
patient was sick after receiving the vaccine twice; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional via social media.  This case involves a patient(age, gender not reported) who was sick (malaise) , while he/she received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. Patient had not had another vaccine over 25 years.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sick (malaise) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign it had been assumed the consumer was referring to the Sanofi flu vaccine  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.