chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm painful, no redness/swelling, fever of 102, malaise, body aches, headache, chills vomiting. Symptoms continued thru 6/21/11.
Previously healthy term (39 weeks) with uncomplicated pregnancy and delivery was 4.7kg and 8 wk.old on 12/22/22. Patient was breast fed female being seen for wellchild visit ~1100.  Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) lot #FX0079 IM, HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) lot # W021181 Merck, DTaP HepB IPV combined vaccine IM (PEDIARIX) lot 9552X GSK, and rotavirus pentavalent (Rotateq) PO (lot # 1912556 Merck) were given ~1113.  During administration of 2ml dose of Rotateq,  CMA noted that patient appeared to choke on initial couple drops of vaccine.  Placement of administration device relative to patient's tongue and cheek was not reported.  After the event, the MD came in to assess infant who was initially breathing abnormally, taking small short breaths and was making gurgling noises. She began taking deeper breaths within ~10-15 seconds and she then had tachypnea for ~60 seconds afterward.  She was assessed and monitored and returned to baseline without tachypnea within 3-5 minutes. Lungs were reexamined and were clear without upper airway sounds. After ~10 minutes of infant being observed at her baseline, the remainder of the rotateq vaccine was given and was tolerated.  After discharge and going home, patient was lethargic.  Later in the day, pt reportedly became unresponsive and had no tone for 3-5 mins, prompting EMS activation.  In ED, care providers observed similar episodes where patient would stop crying suddenly, became pale and eyes stared off to the right without pt loss of muscle tone or any shaking.  Episodes are 5-15 seconds in duration and a precipitated by crying.  One observed episode was over 1 minute and associated with brief desaturations.  Patient was admitted for further evaluation and spell characterization.  EEG normal. Afebrile.   Patient was discharged home 12/23 per family preference with acetaminophen.  Diagnosis was Brief Resolved Unexplained Event.   No identified association with vaccinations and episodes as described.
PATIENT REPORTED TO PHARMACY BECAUSE HIS ARM WAS RED AND HAD SPREAD DOWN BELOW THE ELBOW. HE REPORTED NO PAIN, SWELLING, OR ITCHING JUST REDNESS. HE HAD CONTACTED HIS DOCTOR WHO HAD TOLD HIM TO KEEP AN EYE ON IT AND PATIENT WAS INSTRUCTED AT PHARMACY TO REPORT TO MD OR ER IF SYMPTOMS WORSEN OR ANY OTHER SYMPTOMS DEVELOP.
Patient called our clinic complaining of an itchy rash all over body on the day after receiving her second Pfizer dose.
8 1/2 x 10 1/2 cm macular confluent rash surrounding 2 vaccine sites (Dapt and HIB in left leg) no pain, erythema and heat.
and then a couple of little ones after; Sharp pain in upper chest; Took breath away; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sharp pain in upper chest), DYSPNOEA (Took breath away) and VACCINATION COMPLICATION (and then a couple of little ones after) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included QUINAPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL, OMEPRAZOLE and ATORVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHEST PAIN (Sharp pain in upper chest) and DYSPNOEA (Took breath away). On an unknown date, the patient experienced VACCINATION COMPLICATION (and then a couple of little ones after). On 04-Feb-2021, CHEST PAIN (Sharp pain in upper chest) and DYSPNOEA (Took breath away) had resolved. At the time of the report, VACCINATION COMPLICATION (and then a couple of little ones after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Infant screamed for 7 1/2 hrs p/recving immun; Site of inject became "fire red" & swollen p/3 hrs; 5 hrs p/inject approx 20 pea-sized welts appeared; Child was taken to ER; DPH was given;
Patient presented to the ED on 2/24/21 with STEMI and was subsequently hospitalized. He also presented to the ED on 3/18/21 with stable angina.
most painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and it was one of his/her most painful shot. The follow-up would not possible, as no contact details were available.
4/23/23 - bit by tick 5/2/23 - sore/painful neck/head - behind ears - search names the area: posterior auricular lymph nodes 5/6&7/23 (overnight)- flu like symptoms - chills, fever (<101), diarrhea, vomiting, headache (mild) 5/8/23 - at-home COVID test was negative 5/8/23 - went to doctor thinking I might have Lyme disease due to tick bite 5/9/23 - had Lyme disease test that came back negative It was pointed out to me that stiff neck had been reported as associated with Covid vaccine, so I reported through VSAF 5/16/23 (today) - sore area behind ears continues, but is very, very mild - almost gone (reporting below as gone) I don't know that this is associated with the vaccine.
Pfizer vaccine in fridge beyond 30 days at time of administration. Pharmacist did not know until after administration. Discussed with patient, who stated following vaccination he was tired and achy. Advised to repeat dosage.
STROKE; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that, "Healthy people and #Jnjvaccineinjured#vaccineinjuredpeople. Need healthy planet. My husband paralyzed and had a stroke after your vaccine what are you doing too help us?". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211244768- stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Severe numbness of face, tongue, nose.  Loss of taste and smell.  Still occurring (past 4 days)
Initial growing pain and slight inflammation from injection site to finger tips. Initial migraine started within 5 hours of shot and lasted 30 hours. Flu like symptoms for the next 7 days with migraine coming and going. Final migraine called for hospilization. CT scan done, no tumor found but slight brain swelling on right side of brain causing servere migraine. Put on morphine and left in hospital till the PM.  Sent home with pain killers and anti biotic for sinus infection suspected.  Sinus infection not related to migraine or brain swelling according to Doctor.
Headache, nausea, chills, joint and back pain, fatigue, soreness at injection site.
Patient immediately began to feel weak and unsteady after vaccine. Taken to obs area. Started to question patient about symptoms. Patient started to stutter/slur her words; had difficulty getting words out. Stated this has never happened to her before. Immediately taken to ED for evaluation. Patient evaluated in ED. Discharged home later that day; speech issue resolved.
Patient stated symptoms started the day after vaccines; c/o fever, rash, redness at the site, itching, heat at injection site, lump at injection site, and pain
numbness in his arm; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a male patient who experienced numbness in his arm, while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In June 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious numbness in his arm (hypoaesthesia) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was numbness in his arm.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for numbness in his arm.  Information on the batch number was requested.  List of document held by sender: none.
Plasma donor reported by phone a rash that developed the morning after a rabies immunization was performed.  The pt reported the rash was similar to "chicken pox" in its appearance and feel.  Pt stated he had.
Increased temp of 105.7 R twitching, jerky body movements, listless. Given Tylenol at home prior to bringing child to office. Motrin given stat, Tepid Sponge.
This spontaneous prospective pregnancy report was received from a currently 21 year old female patient, concerning herself. The patient's concurrent conditions included an unspecified autoimmune disease. She was allergic to AUGMENTIN, MOVEX, doxycycline, and DILAUDID. No information was provided regarding her medical history. On 04-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for Human Papillomavirus prevention (dose, frequency, route of administration, lot number and expiration date were not provided). The patient reported that she found out she was pregnant, after receiving her first dose of GARDASIL 9. She was due for her next dose on 03-MAY-2018 (reported as "this Thursday"). She was not experiencing any untoward effects. The patient did not seek medical attention, and she received no treatment for the event. An unspecified pregnancy test was performed on an unknown date, however, no results were provided. The patient's last menstrual period was 08-MAR-2018.The estimated date of delivery was of 13-DEC-2018. The pregnancy outcome was pending.
Patient ended in the hospital whit blood clots in both of her lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Patient ended in the hospital whit blood clots in both of her lungs) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     The patient's past medical history included Clot blood (Patient had a blood clot 16 yeas ago after a 40hs flight.). Concurrent medical conditions included Allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY THROMBOSIS (Patient ended in the hospital whit blood clots in both of her lungs) (seriousness criteria hospitalization and medically significant). The patient was treated with HEPARIN for Adverse event, at a dose of 1 dosage form and APIXABAN (ELIQUIS) for Adverse event, at a dose of 1 dosage form. At the time of the report, PULMONARY THROMBOSIS (Patient ended in the hospital whit blood clots in both of her lungs) had not resolved.            Patient was prescribed many blood thinners at the hospital. It was reported that patient was taking an unspecified allergy pill and some herbal medications. Patient has profuse spouts of coffin. Company comment: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected event of lung thrombosis, which required hospitalization. The events occurred approximately two weeks after the third dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The medical history of prior blood clots remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: New serious event (thrombosis)added, seriousness criteria upgraded, patient demographics, vaccination date, batch/lot number, treatment, concomitant medication added, narrative updated; Sender's Comments: Company comment: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected event of lung thrombosis, which required hospitalization. The events occurred approximately two weeks after the third dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The medical history of prior blood clots remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
After first dose severe pain and paralysis like inability to lift or bend left arm. This occurred around 5-6pm after receiving the shot that morning. Symptoms subsided about a week after shot.  After second shot similar symptoms but not as severe.  Now I am experiencing terrible muscle pain and stiffness near the elbow joint about 2-3 weeks after 2nd injection. Was hoping it would go away but it is progressively getting worse.
Negative HepB titer result after being immunized; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in an unspecified number of patients who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, every semester a few nursing students would have a negative Hepatitis B titer result even though they had been immunized. The reporter could not quantify number of students with negative results or provide vaccine details. It was not known if the students were dosed with Engerix-B or a vaccine from a different manufacturer. The reporter consented to follow up.
I woke up the next day nauseated, extreme, fatigue, body aches, feverish, I took Tylenol about 6:30Pm fever broke body aches were gone. The following day I woke up tired and my lymph nodes were swollen and by Thursday the swelling went down.
I experienced a new type of headache. It felt deep in my head. Sore spot (lump) in the back of my head. Scalp very tender, Extreme fatigue.  Slept most weekends, could not stay awake.
both IPOL and PENTACEL were administered on same day to a patient with no A/E; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received via a nurse via consumer via phone call (under Medical Information (MI) Inquiry Number:00827476).  This case is linked to case 2021SA357977(cluster).  This case involves a 6-month-old male patient who received both IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on the same day with no adverse event (extra dose administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 25-Oct-2021, the patient received a third 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lyophilized powder for preparation for injection) (lot number: UJ494AAA and expiry date: 09-Jul-2022) via intramuscular route in the left thigh, a third dose of suspect IPV (VERO) (lot number: T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the right thigh for prophylactic vaccination respectively.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Caller would like information possible adverse effects of extra dose of IPOL so that she can inform patient's mother. Caller has (package inserts) PIs for IPOL and PENTACEL, caller was referred to product PIs for more information on potential adverse effects of IPOL administration and PENTACEL administration."  At the time of reporting, no adverse event was reported.   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.
sick twice; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a social media consumer.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
I took over the counter Tylenol and used a heat had.  There is no treatment for Torticollis.
p/vax pt noticed joint pain;as of 6/9/99 pain persists;
Pt had temp in AM 103R given APAP; Seen by MD started Amoxillin 125mg TID; MD said some throat drainage-sz, breathing became harder to ER & started Ceclor 125mg tid sent home & fever subsided; No other signs noted;
Client received her Pfizer COVID vaccine dose #2 (lot # FK5127, exp. 01/24/22) today at the vaccination site. At 1711, client?s mother reported to EMT that her daughter is experiencing headache, lightheadedness, and ?feeling like going to throw up? and EMTs walked client to the anti-gravity chair in a high-fowler position. At 1711, EMT  took client?s vitals: BP 98/70, O2 Sat. 99 %, P 94. PHN lead and RN came to assess client. Client?s mother told PHN her daughter doesn?t have any chronic health conditions and is not on any medications. Client?s mother told PHN her daughter has allergies to walnuts, pecans, and avocadoes. At 1713, client reported her lightheadedness and ?feeling like going to throw up? were gone. At 1717, client reported her headache was gone. At 1725, EMT  took client?s vitals: BP 86/76, O2 Sat. 99 %, P 93. Client?s mother told client ate her last meal at 1500 and declined offer of a snack and water. At 1726, client reported still no headache, lightheadedness, or ?feeling like throwing up.? At 1740, EMT took client?s last vital signs: BP 92/76, O2 Sat. 99 %, P 96. RN educated client?s mother about the adverse reactions to observe and when to seek EMS. PHN educated client?s mother about taking child for a follow-up with her primary care doctor. Client?s mother verbalized understanding. At 1742, client said, ?I feel good? and stood up unassisted. At 1744, client left the site with a steady gait with her mother.
5 days, post vax, pt developed an itchy rash. Number of lesions is unknown. Pt had no pustules or drainage from the rash.
Client received the 2nd COVID vaccine of Pfizer (Lot# EW0182, expiration 06/28/2021). At 1729, Client reports nausea and wants to vomit. RN, RN, RN, RN, and RN respond to this event. The registered nurses placed Client in an anti-gravity chair and provided an emesis bag. RN responded to this event at 1730. Client appears pale, diaphoretic, states being nausea, wants to vomit, and dizzy. At 1730, vital signs are heart rate 89, oxygen saturation 99%. At 1733, vital signs are blood pressure 110/82, heart rate 62, oxygen saturation 99%. Client is offered supplemental nutrition and fluids. Client accepted both. At 1735, heart rate is 61 and oxygen saturation is 99%. At 1735, PHN responds and speaks to mother to educate her about ED precautions and common adverse effects. Client's mother reports Client has a history of ADHD, takes medications as needed, no known allergies, had a long day, as not ate much today, and was nervous prior to vaccination. At 1736, vital signs are blood pressure 110/78, heart rate 66, oxygen saturation 99%. Client reports no chest pain, no blurred vision, no headache, no shortness of breath, nausea is improving, and skin tone is returning to appropriate coloration of ethnicity. At 1742, vital signs are blood pressure 117/82, heart rate 82, oxygen saturation 99%. Client reports no new symptoms and improvement of nauseousness. At 1753 vital signs are blood pressure 112/68, heart rate 86, oxygen saturation 99%. Client reports all symptoms has resolved and is now hungry. Client stood up with no complaints at 1754. At 1754, Client walked out of facility with a steady gait accompanied by his mother.
Red blotchy and warm at injection site. Feels like a 2 inch knot under the skin. Itches occasionally.
Initial report received from a pharmacist, via Merck, on 08 October 2014. A patient (age, gender, and medical history not reported) received FLUZONE (lot number and administration details not reported) and later experienced Guillain-Barre syndrome. No additional information was reported, and no contact information was provided. Documents held by sender: None.
exactly 7 days  after injection site extremely itchy and large hard welts appear, warm to touch and left arm weakness
COMPLAINT TO PARENT OF HEART BEATING FAST & CHEST PAIN. NO DOCUMENTED FEVER AT ONSET OF SYMPTOMS PER PARENTS. DID DEVELOP FEVER WITHIN 4-6 HOURS OF ONSET OF SYMPTOMS. 10/24/09 FOLLOW UP:HAD FEVER THROUGHOUT EVENING 10/23 AND EARLY AM HOURS. STILL WITH RECURRING FEVER, GENERAL MALAISE AND HEADACHE ON/OFF AS OF 9:00AM.
Arm swelled up and turned red and hot;  swelling was 6 inches wide and around entire arm.  Very itchy.  Had a 101 temperature not relieved by Advil for about 24 hours;  generally feeling very unwell.  Had upper respiratory symptoms for about 7 days after.  Arm swelling lasted a week, itching lasted more than two weeks in very large area.
1. Sore upper left arm for a few days 2. Mild numbness in left arm from elbow down to fingers similar to tendonitis (experienced from day 1 to current day 10) 3. Significant upper body itchy rash on abdomen, back, arms, hands, chest, neck and face starting 8 days after injection and continuing.