chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia and palpitations, unresolved for hours, resulting in ED visit where atrial fibrillation with rapid ventricular response were diagnosed on EKG. I was given IV fluids and observed on the telemonitor until the abnormal rhythm resolved spontaneously and I was discharged on metoprolol 25 mg once daily until I saw a cardiologist for follow-up. Diagnosed with paroxysmal atrial fibrillation.  I have since had at least 10 additional episodes of atrial fibrillation and I will likely need an ablation for treatment. I'm not convinced it is related to vaccination, but in case it is I am reporting it here. My only risk factor for atrial fibrillation is that my father also has it, but he developed it later in life in the setting of ischemic heart disease, a much more typical presentation. My cardiologist thought it was unlikely to be related to taking methyphenidate as I had been on this same medication and dose for more than 3 years before my arrhythmia occurred.
Headache, Myalgia, shivering/chills, fatique, sore right arm Narrative:
The patient received vaccination 12/28/2000. On 01/01/2001 the patient developed hives "all over the body" and wheezing. The patient was treated with albuterol, prednisone, Tagamet, Zantac, Accolate, Zyrtec, Allegra and 2 other unspecified antihistamines.  The reporter states the hives are resolved with prednisone, but return when the prednisone is stopped.
Flu like symptoms the day of the injection and a day after (nausea, body aches, fever, headaches)
medical professional recommended to him that the second dose is contraindicated; swelling, pain, and stiffness in right arm and shoulder; fever and chills; swelling, pain, and stiffness in right arm and shoulder; swelling, pain, and stiffness in right arm and shoulder; This is a spontaneous report from a Pfizer-sponsored program. A contactable Health Care Professional reported for a male patient that, A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Jun2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Jun2021, the patient experienced medical professional recommended to him that the second dose is contraindicated and swelling, pain, and stiffness in right arm and shoulder, fever and chills. The reporter was reported for a patient who received the first dose of the Covid vaccine, and she said was experiencing delayed reaction from the dose. There was pain and swelling in the right arm, and per agency, it is a side effect from the vaccine. Reporter wanted to know if this is normal and how long side effects will last. Reporter stated the reason she was reporte was because the patient had a medical professional recommend to him that the second dose was contraindicated for him and she just wanted to double check with Pfizer. The first dose was on 04Jun2021 and he had a delayed reaction on 14Jun2021. The patient confirmed at Pfizer Covid-19 Vaccine. The patient had swelling, pain, and stiffness in his right arm and shoulder with fevers and chills that went away after 1 day. It has been steadily improving. He had minimal pain in his right shoulder and arm right now and reporter was trying to explain to him that it was not contraindicated. Reporter had a male patient who received the first dose of Pfizer Covid 19 Vaccine on 04June2021. On 14June2021 the patient experienced swelling, pain & stiffness to the right arm and shoulder. He also experienced fever & chills that lasted for one day. He had minimal pain at this time. The patient was advised by another HCP to refrain from taking the second dose of the Pfizer Covid 19 Vaccine. Reporter was requesting information to inform the patient that the second dose of the vaccine is not contraindicated. Outcome of the medical professional recommended to him that the second dose is contraindicated was unknown whereas, swelling, pain, and stiffness in right arm and shoulder, fever and chills were recovering.
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with RECOMBIVAX HB (lot# L025738, expiration date 14-AUG-2017; L027733, expiration date 13-SEP-2017). The vaccines were improperly stored during the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited report received from a Nurse (LPN) on 25-May-2018. This case involves a patient (age and gender was not reported), who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique because patient inadvertently received ACTHIB component of PENTACEL reconstituted with QUADRACEL vaccine instead of the DTaP/IPV component of PENTACEL. 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 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. Documents held by sender: none.
Vaccine administered on 9/27/2013. Patient reported swelling, redness and occurred next day (9/28/13). On 9/30/13 patient reported a rash around the injection site, but the symptoms improved. Better but not fully recovered.
103.6 temp at highest,  chills and severe headache.  Temperature lasted 2 and half days. Headache began to improve on 5th day.
Shoulder injection site slightly tender but arm from elbow to hand extremely sore, swollen, joints particularly painful continuing to date but gradually lessening. 11/22, 6 - 10 PM, much elevated BP, mental confusion, nausea, migraine, sudden BM. 11/23-24 still have some hand, arm pain as well as back ache. Considered ER visit but took Tylenol, skipped dinner, and went to bed.
Five minutes after vaccination, patient experienced itching and rash on her back. She was assessed by EMS. Benadryl and nebulizer treatments were administered some improvement was noted. However, the itching returned, and the patient stated the itching could be felt in other locations. Patient was transported to Emergency Room for further assessment.
Hospitalized for large amt of sputum production and acute hypoxic respiratory failure due to covid pneumonia
She had redness, itchy and warm feeling below the injection site it started shortly after the vaccination went away for a while and came back the next day. Has redness down the arm, warm to touch & some itching.
Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Patient has pain to (L) deltoid, body ache, fever, dry mouth, currently having pain to injection area.  She will be seen by provider tomorrow  morning.
On 5/7/01, parents declined administration of Prevnar #2; parent states that Prevnar #1 given on 2/22/01 and within 6 hours, had a fever of 103.4F, lasting for 36 hours, labored breathing X 24 hours. Child was not seen in our office or ER for these complaints. MD felt that these symptoms were probable concurrent viral resp. illness.
This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction, allergies and concomitant medications were not reported. The primary reporter stated that on an unknown date, the patients were administered with improperly stored doses of PNEUMOVAX 23, strength, dose, route of administration were not provided (lot # L029306 with expiration date of 13-MAY-2017 and lot # L029306 with expiration date of 23-MAR-2017) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit  and 36 degrees Fahrenheit , 1 cycle for 2 hours and 30 minutes. Cumulative time : 8 hours and 30 minutes/ 2 cycles. Data logger was involved. There were previous excursions of 32 degrees Fahrenheit and 36 degrees Fahrenheit (cycles): 1 cycle for 6 hours.The initial excursion was reported on 29-DEC-2016. Additional information has been requested.
Headache, nausea, vomiting, sensitivity to light, dizziness, joint pain. Patient is following up with primary care doctor.
Per parent report, Rt arm swollen, sore, red, decreased mobility. ER determined this was vaccine reaction and ordered a steroid and Benadryl. Prednisone x 5 days.
Information has been received from a registered nurse concerning a 68 year old female with a history of "possible herpes simplex virus", and no known allergies, who on 25-MAY-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck) (Lot#652966/1211F).  It was noted that the patient had been taking VALTREX daily for 2 years to control the herpes simplex outbreaks, but discontinued it for 30 days prior to receiving the vaccine.  On 04-JUN-2007 (ten days after vaccination) the patient developed lesions in the same area as they had appeared prior to receiving the vaccination.  She started taking VALTREX again and her symptoms resolved.  The physician had her discontinue the VALTREX again for 30 days and her lesions reappeared.  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report proviously submitted on 9/24/2007. Initial informationhas been received from a registered nurse concerning a 68 year old female with a history of "possible herpes simplex virus", and no known allergies, who on 250May-2007 was vaccinated subcutaneously with a dose of ZOSTER vaccine live (OKA/Merck) (Lot # 652965/1211F). It was noted that the patient had been taking VALTREX daily for 2 years to control the herpes simplex outbreaks, but discontineud it for 30 days prior to receiving the vaccine. On 04-JUN-2007 (ten days after vaccination) the patient developed lesions in the same area as the had appeared prior to receiving the vaccination. She started taking VALTREX again and her symptoms resolved. The physiciam had her discontinue the VALTREX again for 30 days and her lesions reappeared. Unspecified medical attention was sought. No lab studies were performed. At the time of this report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient had been under treatment for a circular lesion on her right buttock "about the size of a 50 cent piece". This was being treated with VALTREX which would clear up the lesion but ten days after she stopped taking it the lesion would reappear. She received a first dose of ZOSTER vaccine live (Oka/Merck) (Lot # 652966/1211F) SC in the left arm on 25-MAY-2007 after she was off of VALTREX for 30 days. Ten days after vaccination the lesion reappeared. The patient thought that the vaccine caused the lesion to reappear. The patient's outcome was not reported. Additional information has been requested.
19 weeks pregnant at time of administration (EDD 03/02/2022) of second dose on 10/5/21.  Side effects after 1st dose 9/10 included body aches, shoulder pain, lethargy, increased allergy symptoms for 48 hours, irritation at previous injection sites (IM progesterone given days before) and headache (lasting 2 weeks).  Symptoms after 2nd injection on 10/5 included swelling and soreness at injection site.  Positive for covid on 12/30/2021 with symptoms starting on 12/27/21 (less than 3 months after vaccination)
3wk p/vax pt exp lyme-like rash; dermatologist who saw the rash was unsure of the cause of the rash
Red - erythema, heat to area of injection 6 1/2 x 5cm induration.
extreme pain and burning of entire right arm and hand immediately on injection.. severe body ache with joint pain occurred in 5th hour after injection followed with fever and chills
Pt stated the injection site got extremely red and swollen. It did not hurt - but pt got flu shot in opposite arm and did not have any reaction to that vaccine.
Case number PHEH2015US000678, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 62 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly at a dose of 0.5 ml on 31 Dec 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Information has been received from a physician concerning a female (age unspecified) who on 18-APR-2007 was vaccinated with a first dose of Gardasil. Subsequently, on an unspecified date, the patient experienced nausea and vomiting. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. This is in follow-up to report (s) previously submitted on 5/14/2007; 7/6/2007. Follow up information received from the physician stated that on an unspecified date the patient received the second dose GARDASUK (Lot # not reported). The physician stated that the patient did not have any problems with the second vaccination. Additional information has been requested. Initial and follow up information has been received from a physician concerning a 16 year old female who at 13:00 on 18-APR-2007 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 654702/0011U). Subsequently, at 13:30 that same day the patient experienced nausea and vomiting. The patient sought unspecified medical attention. It was reported that on 20-APR-2007 that patient had recovered from the events. Additional information has been requested.
Throat tightness. Required ER visit. Treated with Benadryl and one dose of steroid.
vague aches; reddish color to her cheeks; Serum sickness-like reaction; malaise; fever 101 at night; hands and legs go numb all night; reactions to the injection site with redness areas around patient arms; weakness; Initial information regarding an unsolicited valid non-serious case was received from a Physician via Agency (Reference number- 00357713) and transmitted to Sanofi on 12-Nov-2020.  This case involves a 43 year old female patient who experienced serum sickness-like reaction, malaise, fever 101 at night (pyrexia), hands and legs go numb all night (hypoaesthesia), vague aches (pain), reactions to the injection site with redness areas around patient arms (injection site erythema) and weakness (asthenia) and occasionally had reddish color to her cheeks (Erythema), while she received RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 22-Oct-2020, the patient that was bitten on the right cheek.  On 22-Oct-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE standard dose and standard strength (lot number: T18813M) via unknown route in an unknown site for post exposure immunization.   On an unknown date, she received a second dose of the RABIES (HDC) VACCINE standard dose and standard strength (lot number: T18813M) via unknown route in an unknown site.   On an unknown date, she received a third dose of the RABIES (HDC) VACCINE standard dose and standard strength (lot number: T18813M) via unknown route in an unknown site.  On 05-Nov-2020, she received a fourth dose of the RABIES (HDC) VACCINE standard dose and standard strength (lot number: T18813M) via unknown route in right and left arms  On an unknown date, patient states that she had serum sickness like reactions (serum sickness-like reaction) (like it was stated in the package insert). Patient also states that her symptoms became more pronounced after each dose and the symptoms began two or three days after each dose.   On an unknown date, the patient presented with vague aches (pain), fever 101 at night (pyrexia), weakness (asthenia), malaise, aches and hurts all over (pain) occasional reddish color to her cheeks (Erythema), and her hands and legs go numb all night (hypoaesthesia). Patient mentioned she had local reactions to the injection site with redness areas around her arms (injection site erythema).  On 05-Nov-2020, she received a fourth dose of the RABIES (HDC) VACCINE standard dose and standard  patient stated that the last injection they gave her half the dose in the left arm and half the dose in the right arm, she did not have any reaction and physician wanted to know how long these symptoms will persist as the package insert does not say anything about that.  Patient stated that she had completed four doses and knows the package insert recommends five.  Laboratory test were not reported.    Patient recieved IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS] as a corrective treatment.  Event outcome was reported as Unknown for all the events.
There is a possibility the patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml of the Moderna Bivalent presentation for 6 months to 5 years. A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Pain in arm and swelling  Tiredness Headache Muscle pain Chills Fever Nausea Cough
Narrative: Patient talked of itching bilateral arms and back: Vitals: @ 10:55- BP156/76; HR 67; O2 sats 96% @11:07 - BP 148/71; HR 61; O2 sats 100% @ 11:17 -BP 126/58; HR 56; O2 sats 98%. Patient monitored, ice pack and water given. Patient felt better and left the premises.
Patient complained of scratchy throat, tongue tingling , cough and difficulty swallowing 15 minutes after administering vaccine.  Administered 50mg, Benadryl IM, after 15 minutes patient continued to complain of difficulty swallowing and was administered 0.3mg, Epinephrine, IM.  Monitored patient for 1 hour until symptoms resolved.  Patient dismissed in no apparent distress.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 5th April 2018 15:00, the patient received SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and erythematous rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site erythema, injection site rash and erythematous rash were recovering/resolving. The reporter considered the injection site erythema, injection site rash and erythematous rash to be possibly related to SHINGRIX. Additional information was received as follows: The patient received the vaccine in the left deltoid. The health care professional reported that the patient developed a red rash at the injection site, on the trunk and on the face after receiving SHINGRIX. The reporter did not know how long after the SHINGRIX, the reactions started. The patient took BENADRYL which seemed to help.
Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization, reaction(s): "I was sick for days after horrible arm pain", "I was sick for days after horrible arm pain". The following information was reported: PAIN (non-serious), outcome "unknown".  Additional Information: I just watched what it made me feel it reminded me of the pain I had from the booster and the vaccine for COVID-19 that I received because I was sick for days after horrible arm pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
11/3/09 Complained of rash-hivelike, nausea and vomiting and stomach ache. Temperature 96.1. Given Benadryl and Prochloperozire for nausea.
Information has been received from a LPN concerning a 5 year old male pt with no medical history or allergies, who on 05/06/03 at 10:00AM was vaccinated SC in the right arm with a second dose of MMRII (Lot # 644507/1038M). Concomitant therapy that same day, at that same time, included a fifth dose of DTAP (Infanrix, Lot # 586A9) given IM in the left arm and a fourth dose of IPV (Lot # W0704) given SC in the left arm. There was no illness at the time of vaccination.  Subsequently the pt developed a red rash and itching.  Unspecified medical attention was sought. No diagnostic or lab tests were performed.  The pt was treated with comfort measures included anti itch medication and Tylenol.  It was reported that the pt was scheduled to be seen in the office on 05/14/03. Follow up information reported that the nurse stated that as of 05/14/03 the pt had not been seen in the office for follow up. The nurse reported that she assumed that the pt had recovered from the events, as she had not heard back from the parents. The nurse asked if this lot # has had similar adverse reactions reported.  The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that two other children had developed a red rash and itching (WAES @ 0305USA01205 & 0305USA01564). Follow up information from the nurse indicated that on 05/09/03 the pt developed "soreness" red rash with itching at injection site." It was reported that there were no known adverse events for the pt or a sibling following prior vaccinations. It was reported that the pt recovered, date not provided. Additional information is not expected.