chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 2nd shot 3/2021: numbness and tingling in left jaw, neck, shoulder.- resolved by 10/2021. June 2021 sudden fever, upper back pain followed by a series of events with persistent tachycardia. 2/21/22 booster: that evening experienced same numbness, tingling in left jaw, neck, shoulder.  Left axillary swelling, mild headache and mild upper back pain (less intense than 6/2021).
Around May or June 2021, having chills, and fever and body aches muscle aches. The actual fever lasted a day but the aches lasts for a couple of days.  It drains me enough where it takes me a while to recover from it. I treated the fever with Tylenol other than that I did not take anything else.  In August 2021, I had similar symptoms as I had in May. I just had chills all of a sudden,  that was in the evening.  The next day I was in bed with muscle aches and fever. The following day I was up and about,  I did not have fever, but I was still pretty weak for a day. I thought it was weird because it felt like the flu. but it was odd that it only lasted a day. Because it's very rare I get the flu. It's just odd that I started having these symptoms after I had the vaccine.
101.5 temp; severe headache ;fatigue; muscle pain. 2days, took Tylenol, and lots of fluids, rest.
I spoke to mother, and there was no adverse event. The pharmacist administered this medication to a 16 year old and the vaccine is indicated for 18 and older.
Moderna vaccine given to 17 year old .   I asked nurse if this was approved has my daughter is 17 and nurse stated yes Moderna is approved and that they have been giving to other teens
This spontaneous report was received from a 54 year old female patient regarding herself. Concomitant medications included SINGULAIR, levothyroxine, an unspecified blood pressure medication, an unspecified diabetes/weight loss medication and an unspecified steroid for "eyes". Concurrent medical conditions included high blood pressure and hepatitis C carrier. She had no drug reactions/allergies. On 18-OCT-2016, the patient received ZOSTAVAX subcutaneously (lot number unknown). On 19-OCT-2016, the patient developed a swollen, big hard red rash that itched after receiving ZOSTAVAX. No treatment was given. She did speak with a pharmacist (not further specified). The event was not recovered. Additional information has been requested.
lt deltoid became painful, warm to touch, swollen 24 hrs following inject pt states was febrile; no tx sx resolved in 2-3 days;
h/a, vomiting, maculopapular rash w/conjunctival inj;
Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen (J&J) Vaccine on 3/13/2021. Patient presented to emergency department for altered mental status. Patient admitted for delirium and received Regeneron monoclonal antibody and dexamethasone. Patient went into ventricular fibrillation and expired 10/10/2021 at 0021.
The axillary lymph nodes on my left side became very swollen, and sore. There is a large noticeable lump indicating the inflammation. It is uncomfortable to the point it is difficult to lift my left arm.
Within 24 hours of TD, pt developed rash on forearms and diffuse arthralgias. Rash was non-pruritic. No shortness of breath. Placed on 24 hours of Quarters. Still symptomatic when seen.
Patient was admitted to Hospital admitted as observation on 11/24/21 due to impaired mobility and ADLs
Threw up all that I had eaten for the past 24 Hr. I was not sick. Only threw up.
vocal cord paralysis; This non-serious case was reported by a physician via sales rep and described the occurrence of vocal cord paralysis in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis.   Concurrent medical conditions included pulmonary fibrosis and rheumatoid arthritis.   On 18-SEP-2023, the patient received Arexvy and MODERNA COVID VACCINE. In SEP-2023, 10 days after receiving Arexvy, the patient experienced vocal cord paralysis (Verbatim: vocal cord paralysis). The patient was treated with non-drug therapy (Physiotherapy). The outcome of the vocal cord paralysis was resolving.   It was unknown if the reporter considered the vocal cord paralysis to be related to Arexvy.     It was unknown if the company considered the vocal cord paralysis to be related to Arexvy.   Additional Information: GSK Receipt Date 31-OCT-2023: The reporter stated the 10 days after both vaccines patient got vocal cord paralysis. The patient was undergoing (Physiotherapy) PT for it (vocal cord paralysis) and doing better.  The patient also has comorbidities including pulmonary fibrosis and rheumatoid arthritis. It was unknown if the reporter considered the pulmonary fibrosis, rheumatoid arthritis and vocal cord paralysis to be related to Moderna Covid Vaccine.   The reporter consented to follow up.
Initial unsolicited report received from health authority (under the reference number: 713567) on 03-Apr-2018. This case involves a 31 years old female patient who was vaccinated with a dose of FLUBLOK (Batch number, dose, dose in series, route, site of administration and expiration date were not reported) on 01 Oct 2015. Patient's medical history included chronic fatigue syndrome as underlying disease, other history included chronic Lyme disease. As Concomitant medications, patient received RESTORIL and propranolol. On 01 Oct 2015, same day following the vaccination, patient developed increased overall worsening of pre-existing health conditions to the point patient became disabled. No Lab tests were performed. Corrective treatment was not reported. Outcome of the events was reported as unknown. Case was assessed as serious by the reporter due to disability. List of documents held by sender: none. Sender's Comments: This adult's pre-existing condition got aggravated and had disability following vaccination with FLUBOK TIV. Medical history included chronic fatigue syndrome/ME (ongoing) and chronic Lyme disease. Time to onset was compatible. Additional information would be needed for further assessment. Based on limited information provided the role of vaccine cannot be assessed.
2 days p/vax pt called stating was getting a red tender area @ the site of inject; 4cm area of erythema & firmness surrounding the inject site;
Aproximately 1 hour after vaccine developed hives at site of DTaP injection in left arm, these hives then generalized and his eyes swelled shut.  He returned to my office where he was noted to have stridor without respiratory distress.  He was given SQ epinepherine in the office and transfered to the ER where he received IV Solumedreol and was observed for four hours.  He was discharged on oral steroids for three days and all symptoms resolved.
Client's grandmother called to report. She states since yesterday morning 10/23/2022 whenever the client stands up he gets a shooting pain from back of his head, to his eyes, down his spine. They have been monitoring it since yesterday morning and it's been consistent for over 24 hours. Client took Tylenol which has not improved this shooting pain. Writer advised to get patient seen by physician as soon as possible to find root cause.
Large circular patch around injection site.  Itchy, red, raised area approximately 2.5 inches diameter
pt recvd vax; fainted and fell, hit side of head; recovered soon p/ fainting;cold compresses applied to side of head; BP 90/50;
Red rashes all over the body, still itchy after 2 days now. delivery is in mid october
Onset 4-19-08 - X2 episodes of fainting, SOB, palpitations facial & extremity tingling, X1 syncopal episode 5-2-08 with same symptoms -> seen at ER.
pt recv vax & cried a high pitched inconsolable cry;pt given 1 1/2 dropperful APAP drops;3PM pt fell alseep;530PM pt awoke & drank nutramajin;pt awoke crying burped a small amount of formula & then had projectile vomiting x1;
LEFT ARM SORE FOR 3 DAYS THEN NUMBNESS, SENSITIVITY, PAIN ON RIGHT SIDE OF ABDOMEN STARTED 3 DAYS AFTER INJECTION-RASH STARTED  7 DAYS LATER 1/18/2021. ON 1/19/2021 ORTHOPEDIC DR RULED OUT BACK PROBLEM-COULD BE MUSCLE STRAIN BUT RULE OUT SHINGLES BECAUSE OF THE RASH. URGENT CARE DR DIAGNOSED SHINGLES AND PRESCRIBED VALACYCLOVIR 1 GRAM 3XDAY FOR 7 DAYS
At approximately 3am in the morning after my 2nd dose, I woke up feeling nauseated with an upset stomach and I continued feeling like this for 3 days. I took Imodium to ease the diarrhea pain but it was not effective. For 3 days I was experiencing continuous diarrhea and it was very unusual. On the 3rd day I started feeling better and the next time I had to go my stool was normal and I started feeling better.
Case number PHEH2014US020201, is a combined initial and follow up spontaneous report from a pharmacist received on 07 Oct 2014 and 08 Oct 2014 respectively. This report refers to a 25-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1413301, expiration date: Jun 2015) on 04 Oct 2014. On 05 Oct 2014, next day he had a temperature of 102 which increased to 105 and the patient ended up going to the emergency room. The outcome of the event was unknown. Seriousness and causality were not reported.
p/ pt recv vax approx 17 days later pt devel a ``varicella rash w/approx 50 lesions''. in 7/98 pt devel a 2nd case of varicella w/40-50 ``varicella-like lesions'' rpt MD felt both cases were not related to therapy w/varivax. tests done.
NEUROPATHY UNSTABLE ANGINA ACUTE NON ST ELEVATION MI 10/3/2022 - RECURRENCE OF SAME SYMPTOMS
This spontaneous report was received from a pharmacist refers to a female patient over 60 years old. The patient's medical history included bad case of shingles 3 years ago approximately on an unknown date in 2010. On 23-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) as she didn't want to go through shingles again. No concomitant medications were reported. On 24-MAR-2013, the patient experienced itching, swelling and redness around the injection site. Pharmacist stated that the injection site reaction was above the elbow and "the size of an aluminum coke can top". The swelling was sideways more so the patient was referred back to their unspecified physician. The patient was given ZOSTAVAX at another pharmacy. No laboratory diagnostics studies were performed. The outcome of itching, swelling and redness around the injection site was reported as recovering. Additional information is not expected.
Left arm began to ache at night. The next morning I thought I had the flu. Fever of 101-102. Was achy all day and slept. My left arm was swollen and red. Could not lift it.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced cold sores, pruritus and blister. On 17th July 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, cold sores, pruritus and blister were recovered/resolved. It was unknown if the reporter considered the injection site pain, cold sores, pruritus and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The next day post vaccination, the patient experienced pain and soreness at the injection site which lasted for a couple of days. Within a week of vaccination, the patient developed blisters and itching on her buttock area, along with cold sore on lip, this lasted for about 7 to 10 days. The patient gave permission to contact her physician and provided the address details for the same. No further details were provided.
THE PATIENT TOLERATED THE FIRST DOSE WITH NO PROBLEM BUT HAD PROBLEMS WITH HER SECOND DOSE. THE DAY AFTER HER SHOT SHE CALLED STATING THAT THE IMMUNIZATION AREA WAS RED AND SLIGHTLY SWOLLEN. SHE WAS ADVISED TO MARK THE AREA AND TO TAKE SOME BENADRYL TO RELIEVE IT IF IT WAS AN ALLERGIC REACTION. SHE CALLED AGAIN THE NEXT DAY STATING THAT IT IS SLIGHTLY BIGGER BUT NOT DRASTICALLY BIGGER AND THOUGHT IT MAY GET BETTER. ON THE THIRD DAY THE RED AREA BEGAN TO RADIATE HEAT AND SPREAD TO A LARGER AREA OF THE ARM. SHE WAS ADVISED TO GO TO A WALK IN CLINIC. THEY STATED THAT IT MAY BE CELLULITIS AND PRESCRIBED KEFLEX.
She has like little hives; Severe allergic reaction on her face and her neck; This is a spontaneous report received from a contactable consumer. This consumer reported for a patient (Reporters mother).  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical and concomitant medications were not reported. It was reported that, patient got her second dose of the Pfizer vaccine yesterday. Right now, she recently had a severe allergic reaction on her face and her neck, and she had like little hives and her breathing was fine. Reporter was just worried if needed to go to the hospital. The outcome of events was unknown.  Information on lot/batch has been requested.
Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-395739 (Patient Link).
2 hrs after immunization patient shaking, teeth chattering / cold - felt frozen under 3 blankets. Doesn't believe he had a fever. Achy. Fatigued X 12 hours - recovered with rest. No report of redness at site of injections - Reported 2/4/09 at office visit.
Headache; Mild seizure; A spontaneous report was received from a consumer concerning a 51-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild seizure, headache.  The patient's medical history included seizures. Concomitant medications reported were oxcarbazepine 300 mg three tablets twice daily and topiramate 100 mg one tablet twice daily, both were used for an unknown indication.  On 10 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Mar 2021, Patient reported that approximately 30 minutes later after receiving the vaccine, she had a mild seizure that lasted a few seconds. Patient stated she sat still and let it pass.Patient stated she now has a headache. No treatment information was provided.  The seriousness criterion for the event mild seizure was medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, mild seizure and headache was unknown.; Reporter'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.
Swelling, erythema, warmth, itching. Supportive care, Benadryl PRN.
Initial report received on 18 August 2009 from another manufacturer (report number WAES 0907USA05484, document number 45223472) who had received the original report from an anonymous consumer. A female patient (demographics not reported) had received an influenza vaccine ("flu shot") 30 years ago on an unspecified date. The trade name, manufacturer name, route and site of administration were not reported. The next day following vaccination, the patient was sick with the flu, bronchitis and an upper respiratory tract infection (not specified). It was not reported whether any diagnostic tests, or laboratory data were performed, or if the patient had received treatment. The recovery status of the patient was not reported. No contact information for follow-up was provided. No further information is expected. Documents held by sender: None.
Left sided facial numbness; Couldn't breathe right due to his throat feeling numb; couldn't breathe right due to his throat feeling numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left sided facial numbness), DYSPNOEA (Couldn't breathe right due to his throat feeling numb) and PHARYNGEAL HYPOAESTHESIA (couldn't breathe right due to his throat feeling numb) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not reported.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (Left sided facial numbness), DYSPNOEA (Couldn't breathe right due to his throat feeling numb) and PHARYNGEAL HYPOAESTHESIA (couldn't breathe right due to his throat feeling numb). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Numbness throat, Numbness in face and Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Breathing difficult, Numbness in face and Numbness throat, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Left sided facial numbness) was resolving and DYSPNOEA (Couldn't breathe right due to his throat feeling numb) and PHARYNGEAL HYPOAESTHESIA (couldn't breathe right due to his throat feeling numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Reporter contact information updated and Pt Initials updated On 09-Aug-2021: Non-significant follow-up information included reporter address added.; Sender's Comments: This case concerns a male of unknown age who experienced nonserious unexpected events of facial hypoesthesia, shortness of breath and throat numbness.  Event onset the same day as the first dose of mRNA-1273. Treatment with ibuprofen and diphenhydramine. Facial hypoesthesia resolving, other outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Within 2 hours of vaccine, pt developed fever, nervousness and pallor.  He was hospitalized and treated with Nystatin and acetaminophen.  The infant recovered.
I developed a swollen, raised, red rash that was hot to the touch and painful, around where the injection had been given.  The reddened skin was about 8 cm. in diameter.    I consulted my doctor via email, and she recommended antihistamines; I took Claritin every day.  The pain and itching resolved after a couple of days, but the redness persisted for several more days (about 7 days total before complete resolution).
Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff). This case was linked with 2019SA067112 (same reporter reporting for twins). This case involves a 17 years old female patient who received vaccine MENACTRA in August 2018 (dosing details lot number was not reported) and again received a standard dose (0.5 ml) (lot-U6220AA, 31-May-2020) via intramuscular route in the left deltoid in 07-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was reported that staff is checking on side effects to look for but states so far they haven't reported any. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
the day after the 2nd shot side effect of body aches for 24 hours. Around 2 weeks after the 2nd dose, I noticed vesicular skin rash with pruritus on my arm and stomach. There was no itching and the rash had persisted for a few days.
Information has been received from a physician concerning a female who was vaccinated with a 0.5mL dose of PNEUMOVAX 23. After vaccination, the patient developed a "cellulitis type" reaction on her arm at the injection site. Additional information has been requested. This is one of several reports from the same source.
I have been experiencing overall of "being unwell" including intermittent palpitations, nausea, lower GI upset/cramping, dizziness, fatigue, chills, low grade temp of 99.5 F,  right sided neck pain, and Headache. Treatments: Tylenol PRN, and PRN Zofran  Outcome: ongoing
reaction in her L arm (injection site); red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction in her L arm (injection site)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Blood pressure high and Heartbeats irregular.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction in her L arm (injection site)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE REACTION (reaction in her L arm (injection site)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported were diabetes type 2, high blood pressure, irregular heart bits medications. Treatment details was not reported by the reporter.
Patient had red area that was hot to the touch that showed up about a week after receiving the shot. It got worse for a couple of days then started showing improvement. Patient saw a doctor who said it could be an infection and gave clindamycin.
Severe, 3 dermatome shingles, nearly confluent, red-based large vesicular very painful rash, lower neck, entire shoulder and upper chest on left-lasting 1 week.  Developed fever peak 103 on day 4.