chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in the upper left arm; Shoulder pain; burning pain; This case was reported by a physician via call center representative and described the occurrence of pain in fingers in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced pain in fingers, pain burning and shoulder pain. On an unknown date, the outcome of the pain in fingers, pain burning and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the pain in fingers, pain burning and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. The patient received Shingrix approximately 3 weeks ago before reporting. Approximately 2.5 hours after receiving the vaccine, the patient developed pain in the upper left arm. The pain moved to the left shoulder and then down to the tips of the fingers in the left hand. The patient described this pain as a fiery, burning pain. The severe pain eventually resolved starting with the finger tips and going up the left arm. The patient was experiencing pain in the upper left arm, but it was not as severe. The severe pain lasted for approximately 3 days. The reporter saw the patient in the office on the day of reporting. Emergency room visit required. The reporter did not provide any additional details.
Flu shot injected (IM) in left deltoid, then next day she developed symptoms: pain on movement and could not lift or abduct left arm, could not reach overhead to wash hair, or reach to lift: seen on 10/22/15 and 11/19/15.
At her annual mammogram, shortly after shot, she had enlarged lymph nodes. Though not certain, believed to have been triggered by the vaccination
29APR94 p/receiving shot started running fever & throat got sore; next day had swelling w/tenderness on rt side of jaw; ran fever fromm 99 to 101.6 cont thru Tuesday til went to PMD; pt was adm to hosp;
systemic macular/papular rash over entire body x/palms/soles 12 days post MR vax; no fever/no arthralgias; no kopliks spots
Difficulty lifting my legs and hips; Difficulty to walk; fell trying to walk up a curb; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of movement disorder in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced movement disorder (Verbatim: Difficulty lifting my legs and hips), walking difficulty (Verbatim: Difficulty to walk) and unable to walk (Verbatim: fell trying to walk up a curb).  The outcome of the movement disorder, walking difficulty and unable to walk were not reported.   It was unknown if the reporter considered the movement disorder, walking difficulty and unable to walk to be related to Arexvy.     It was unknown if the company considered the movement disorder, walking difficulty and unable to walk to be related to Arexvy.   Additional Information: GSK Receipt date: 25-SEP-2023 This case was reported by patient via (Open field AE monitoring) interactive digital media. Follow up was not possible as no contact details were available.
8 days after vaccine arm started to hurt around vaccine area. The next had a rash and itching to the shoulder. Lasted about 4 days. Was able to treat it with topical cortisone.
Information has been received from a physician concerning a 2 month old male who was vaccinated with Rotateq. In March 2007 (last month), the patient experienced 10 to 12 bowel movements a day with severe diarrhea 5 days after the vaccine was given. The 10 to 12 bowel movements with severe diarrheas lasted for 12 days. Subsequently, the patient recovered from the 10 to 12 bowel movements a day with severe diarrhea two weeks after the vaccination was given. Ten to 12 bowel movements a day with severe diarrhea was considered to be disabling and an other important medical event. Unspecified medical attention was sought and the patient was hydrated with oral fluids. Additional information has been requested.
Clots were found in both legs; legs were more swollen than normal and very painful; legs were more swollen than normal and very painful; legs were more swollen than normal and very painful; This is a spontaneous report from a contactable Pfizer employee. A non-pregnant 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot unknown) intramuscularly in the left arm in Jan2021 (at 94-years-old); and the second dose of BNT162B2 (lot unknown) intramuscularly in the left arm in Jan2021 (at 94-years-old); both as single doses for COVID-19 immunisation. Medical history included allergies to shellfish, severe; elderly; and legs were swollen from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were unspecified. It was reported that after vaccines, the legs were more swollen than normal and very painful. Clots were found in both legs and the patient was now (as of 04Jun2021) receiving blood thinners regularly. The events were reported as non-serious and did not require hospitalization. The events required a physician office visit. The clinical outcomes of the events were not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Currently experiencing severe intractable nausea and vomiting (unable to drink even a sip of water), fluctuating blood pressure, a severely racing heart (130bpm), overall weakness and fatigue.  Started the evening of April 20 and became so severe by the evening of April 2021 that had to come to the local emergency room.
Resident received one dose of four doses that were given out of a 10 dose vial.  Vial was short 6 doses.  Vial was dispensed from pharmacy with vial top securely in place.
I began experiencing an odd heartbeat on 07/09/2022 to 07/10/2022, and I sough care at the ER on 07/11/2022. While I was in the ER and was hooked up to Echocardiogram it showed and irregular heartbeat and skipped heartbeats as well. I saw my doctor and was given Zio XT patch to monitor my heartbeats for 3 days, before further tests. I have an upcoming appointment with my Cardiologist to run a stress test, Echocardiogram, and check my carotid artery. I have not received any treatment or diagnosis at this time.
12 hours after receiving her 1st dose of Shingrix she had a herpetic lesion erupt on her left chin area. 30 hours later she presents to Clinic and is treated with Valtrex becuase a 2nd lesion is developing on left mid cheek. chin lesion crusting partially.
Nausea 3-4 days, diarrhea 1 day, soreness at site. Patient received 2nd & 3rd doses with less problem.
developed fussiness day after vaccines and then one week later developed blood in stool concerning.  No vomiting and no documented fever. Normal feeding
DX: Pericarditis; S/S Headache, fever/chills, Acute chest pain or pressure, Chest pain made worse by lying down, deep inspiration, or cough,Chest pain relieved by sitting up or leaning forward-- onset 04/14/2021 "Progressive severe diffuse anterior chest pain radiates towards his anterior neck...describes a pleuritic component to his chest pain."
Swelling of sites of prior dermatologic filler work in face, resolved on its own within 4 hours of onset.
Patient felt sore at injection site. Patient applied VASELINE/VICKS to injection site, but has no relief. She states that the pain is further up toward her shoulder blade and naproxen wasn't helpful.
Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N020010 and expiration date of 13-JAN-2019, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -14 Celsius degrees to -10 Celsius degrees for 30 minutes. Previous temperature excursion was reported as -14 Celsius degrees to -10 Celsius degrees for 12 hours and 30 minutes. The vaccine was reconstituted with properly stored DILUENT MRK. No adverse effects were reported. No digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA003654: US-009507513-1808USA003614.
Light salmon colored hives back of the neck, underarms and lap (thighs and inside the vaginal lips)  Itching, hives, bumps  Prescribed steroidal ointment
2 weeks after vaccine, had cold/flu symptoms; mid-October noticed left shoe was tight; experienced shortness of breath; stairs were especially difficult to navigate without stopping and catching my breath; 12/29/21 noticed left leg & foot were significantly swollen as opposed to right leg & foot  (have picture on phone)  Went to local medical clinic who in turn stated I had a blood clot and sent me to hospital in an ambulance.
Covid Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 011M20A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ROSUVASTATIN, METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], MIRTAZAPINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 10-Feb-2021, VACCINATION SITE REACTION (Covid Arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
The symptoms that occured were shooting nerve pains that went straight up both of my legs at the same time into the center of both buttock cheeks.  I had "painful neuropathy and myopathy", to the extent that my Doctor put me on Lyrica 75mg 2 times per day. By this time, I was already beginning not to feel well and had just returned from an airflight. I had a full blown sinus infection. He believes at this time with the symptoms that I described that it may well have been a reaction to the "preservative" in the seasonal flu vaccine. I continue to this day to be on the Lyrica at 150 mg 2x per day. I am attempting to wean off back to 75 mg per day. The pain has diminished significantly, however, I continue with weakness, tender muscles and neuropathy above my knees. I am also experiences muscle spasms in various places in my arms, chest muscles.
TC from mother- states 2mm area of redness on right thigh at area of injection. Advised can try cool compresses PRN to right thigh. Mom is already giving infant Tylenol. Advised if redness does not subside in a few days or if areas of redness increase consult with PMD. 04/20/05- RTC to mom areas of redness subsided in a few days. No other problems.
The patient says her arm still hurts up to her neck and she is having trouble moving her arm.
On a scale of 1 to 10 with 10 being the most sever, I would estimate my shoulder/arm soreness to be 1 to 2 sore. Only reporting because it has been over 6 weeks since receiving shot. No side effect of 2nd dose, given in the right arm.
Initial information received on 01-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 15 months old patient who received vaccines POLIO VACCINE, ACT-HIB, PENTACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 01-Aug-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. On 01-Aug-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route. On 01-Aug-2018, the patient received a dose of suspect POLIO VACCINE not produced by Sanofi Pasteur lot number not reported. On 01-Aug-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. It was a case of actual medication error due to extra dose administered. It was unknown whether patient had any 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 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.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient had swelling the size of a baseball at the injection site shortly after administration of PNEUMOVAX 23, in January 2013 sometime that week. No treatment information was reported. The patient outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician concerning a 12 year old female who on 08-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included MENACTRA vaccine (dip toxoid) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 10-Oct-2007 the patient was vaccinated IM with the second dose of GARDASIL vaccine (yeast) (lot# 658219/0680U). Three to four days post vaccination of second dose, the patient had experienced supraclavicular adenopathy or severe pain above the shoulder blade. The patient had no problem with her first dose. Unspecified medical attention was sought. Subsequently the patient recovered. No additional quality complaint was involved. Additional information has been requested.
p/recv vax pt exp weakness, nausea, fatigue. ER dx, gastroenteritis, r/o allergic react
p/vax temp above nl, but did not measure;T102 then dropped to 101;went to MD recommended APAP;pt lethargic during entire episode, but ate well;
7 days after receiving the COVID 19 Pfizer shot, I develop Bells Palsy.  I didn't have any issues prior to the shot.  Now my left side of my face is paralyze.
Patient reported having a rxn to vaccine to their primary care MD the next day after receiving it. MD in turn told patient to alert pharmacy for proper reporting. Patient's adverse reactions were red face, flushing, faint feeling, weak with achy back and joints. Patient also experienced increased heart rate and slightly lowered blood pressure. Primary care MD administered steroid shot in the office and prescribed the patient Benadryl and Pepcid. Patient experienced similar outcomes after the first shot as well, but didn't know that it was the cause until after the second vaccination produced similar outcomes.
I experienced an Asthma flairs that lasted a couple of weeks. Saw my PCP for this condition. Testing, Full Body Scan MRI and CT, is ongoing at time of reporting.
Swelling, redness and pain at injection site with 24 hours Lethargy, headaches, body aches, cough in last 2 days 4/8/2021
I was hot, cold, had a sore throat, allergy symptoms, cold symptoms. I had been traveling out of the country so I decided to test myself two of my test came back negative but the third one came back positive. I called my doctor after the positive test, she prescribed me PAXLOVID and told me to quarantine. I still have a headache am tired and a cough.
Patient received expired third dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
No side effects were reported by HCP; 16-month-old child received inadvertently both MMR II and PROQUAD the same day on 10/11/2023; patient should have received MMR II and VARIVAX; This spontaneous report was received from a medical assistant referring to a 16-month-old patient of unknown age. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 11-OCT-2023, the patient received 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (lot#: W029554, expiration date was reported as 18-FEB-2024 but upon internal validation indicated as 14-MAR-2024; strength and route of administration were not reported) for prophylaxis and 1 dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) injection (lot#: W039972, expiration date: 02-JUN-2024; strength and route of administration were not reported) for prophylaxis inadvertently (accidental overdose). The patient should have received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (wrong product administered). No side effects were reported (no adverse event).
Hypotensive (diastolic 43, sistolic 103); neurological tingling -upper spine/between shoulder blades; felt crummy; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Dec2020 15:45 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotensive (diastolic 43,sistolic 103), neurological tingling - upper spine/between shoulder blades and generally felt crummy on 21Dec2020 at 15:45 (also reported as occurred within 5 minutes of shot). The patient underwent lab tests and procedures which included blood pressure measurement: 103/43 on 21Dec2020. Event resulted in emergency room and physician's room visit. Treatment received intravenous (IV) fluid replacement, lab tests (unspecified), 6 hour observation. The outcome of events was unknown.  Information on the lot/batch number has been requested.
No additional adverse experiences have been reported; a patient was given PROQUAD and VARlVAX on the same day by accident yesterday; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-JUN-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, 0,5 milliliter, lot # T021640, expiration date: 21-DEC-2021 (route of administration and anatomical location were not reported) for prophylaxis. On the same day, the patient was given by an accident the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0,5 milliliter, lot # T033166 (lot No. T033166 has been verified to be a valid lot number for varicella virus vaccine live, expiration date reported and established as 29-SEP-2022) for prophylaxis (route of administration and anatomical location were not reported). The error was discovered on 23-JUN-2021, reported as today, with vaccine reconciliation.  At the time of the report, no additional adverse experiences were reported by the family of the patient and the family was not notified of the error. The reporter was wondering if Company had any information on the co-administration of the products prior to contacting the patient family. The nurse was inquiring if there are any special things they should be looking out for.
Plan was to discharge patient today if VQ scan is negative. He had to wait for test all day, scheduled last due to positive covid test on admission (false positive). VQ scan done but px left without waiting for result. Repeat CXR also showed new patchy bilateral lower lung ill defined airspace disease - not discussed w/ px and addressed because px left as soon as he got back on the floor. Px left AMA.
Patient presented to ED shortly after vaccination. Reported throat swelling, became nauseous, and was gagging on her saliva. Posterior oropharynx edema was noted. Treated with epinephrine, methylprednisolone, diphenhydramine, and famotidine. Was observed for several hours and discharged in stable condition.
Gross inflammation/induration/tenderness (4"x6") to left deltoid region.
Pain 24 hours after shot - swelling redness lump under tissue 1.5cm. Cont x 4 days came in - Tx ice to area (5 minutes intervals! and BENADRYL 25mg Q6hrs and TYLENOL for pain.
This spontaneous report as received from a Licensed Practical Nurse refers to a 12 month old female patient. On 26-JUL-2018 the patient was vaccinated with improperly stored M-M-R II from dose 1, subcutaneous in the right thigh from lot N027782 expiry date 16-AUG-2019 for prophylaxis. On the same day, the patient was vaccinated with dose 1 of improperly stored VARIVAX from lot R002051 expiry date 22-JAN-2020 by subcutaneous route in the left thigh and dose 1 of improperly stored VAQTA by intramuscular route in the left thigh from lot R002086 expiry date 22-APR-2019; both for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.