chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA which had lot # M002268 and expiry date: 20-SEP-2017 (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. Is one of the three reports received from the same reporter. Additional information has been requested.
Patient experienced vasovagal syncope x4. Blood pressure 90/60, skin clammy and pale. Patient was laid down with feet elevated and provided a cool compress. Patient's blood pressure reached 118/72 and reported feeling better. Patient was transported via ambulance to the Hospital for further evaluation. Patient required no treatment at the hospital and was discharged home to care of self.
My left upper arm was swollen, red rash and hot to the touch. the next few days it was larger and as of today 2.2.21 it is still red in color and about 2.5 inches in diameter. It is NOT hot and not swollen
Pt had varicella vaccine on 08/03/2000. Diagnosed with varicella in our office on 5/20/05 by NP. Developed rash and fever of 100 oral on 5/19/05. Had less than 50 lesions on face, trunk, legs and arms. Lesions were mix of papules and vesicles. Mildly itchy. Rash crusted by day 5. Fever lasted 24 hrs.
Patient received flu shot and about 2 hours after vaccine was given patient experienced diarrhea, nausea, vomiting, hot flashes and muscle aches
This case was reported by a healthcare professional via a sales representative and described the occurrence of numbness in a female subject aged between 40 and 49 years old who was vaccinated with Hepatitis B vaccine for prophylaxis.  The reporting healthcare professional is the subject.   On an unspecified date years ago, the subject received 1st dose of Engerix B.  At an unspecified time after vaccination with Engerix-B, the subject experienced numbness of the hand and other areas, and hand tingling.  At an unspecified time later, the events resolved.  On an unspecified date later, the subject received the second dose of Engerix-B and the events reocurred.  At the time of reporting the events were resolved.
Headache, Myalgia, Arthralgia, Diarrhea,  NauseaVomiting,  Chills, Fatigue Narrative:
Day following receiving 1st vaccine dose  I experienced major aches throughout entire body, all joints, which did not dissipate until following day.  Felt very fatigued throughout day as well. Slight headache.
pt exp inj site redness; itchiness; heat; puffiness & a 1 1/2 '' welt; no treatment given; symptoms disappeared 3 wks later however pt still has bruise-like mark
Swollen reddened arm and joint pain. Patient complained of respiratory distress and discomfort.
Headache within 2 hours of injection, and flu like sym, chills, fever, muscle and joint aches for 3 days.
The nurse verified a total of 9 administrations of improperly stored vaccines:; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 18-JUL-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot #T006792, expiration date: 24-AUG-2021) 0.5 milliliter (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperatures to which the vaccine was exposed were: -13.5 degrees of Celsius (C), -11.4 C, -1.8 C and the time frame was reported as 24 minutes, 27 minutes, 2 hours and 8 minutes. There was previous temperature excursion reported. A digital data logger was involved.
18 hours post vaccine developed fever 101.8 resolved within 8 hours with fluids + Tylenol  40 post vaccine became  weak and light headed after climbing 1 flight of stairs - SpO%=91 pulse upper 40s  Resolved within 30 with rest  3 days post vaccine left arm + elbow + wrist joint became very very sore - this began 48 hours after vaccine # 1  but was much less severe than after dose 2.  16 days post vaccine it is difficult to move my arm - elbow is severely sore and arm is  weak
26JUL p/vax pt began fever 103 w/ aching to all joints; heaviness in the extremities was taken to MD dx URI; pt then devel nausea & vomit; On 10JUL92 taken to ER; pt tired & lethargic;
11 days after Pfizer booster shot (first two were Moderna) skin started breaking out in extremely itchy hives all over body. At this time it has been 3 days with little to no improvement. Antihistamines such as Zyrtec have helped with itching, but adverse effects are still present. Have never had any allergies to any other foods/medicines.
12 hours after the shot I experienced chills, fever 101.2,  nausea, massive headaches, fatigue, generalized aches and pains. I missed two days of work. I ended up taking acetaminophen 1000mg, Q6 for 36 hours. Symptoms stopped 12 hours after onsent.
shingles after first dose; stress; This is a spontaneous report from Pfizer sponsored program. A non-contactble consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced shingles after first dose on an unspecified date with outcome of unknown, stress on an unspecified date with outcome of unknown. Reported patient was due to receive the second dose of the covid-19 vaccine, patient was diagnosed with shingles after first dose, caller thought shingles was due to stress, caller was inquiring if patient can receive vaccine for shingles and the second dose of the covid-19 vaccine.       No follow-up attempts possible Information related to batch/lot no. could not be requested
Large bruise in area at 9 PM. Extreme fatigue upon awakening. Increase in BP 160/98 late afternoon. Pain in shoulder and neck early evening. Extreme headache/ear ache and jaw pain for several hours. Nausea. Rash developed under eyes.
This case was reported by a physician via sales rep and described the occurrence of chickenpox in a 55-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chickenpox, extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the chickenpox, extensive swelling of vaccinated limb and injection site erythema were recovering/resolving. It was unknown if the reporter considered the chickenpox, extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were as follows: The physician reported that the patient experienced chicken pox breakout all over the body. Along with redness and swelling at the injection site with an area of 5 to 10 inches in diameter. This case was linked with US2018143087, reported by the same reporter for the patient related to the patient in present case.
This is an initial spontaneous report by a contactable physician. This Pfizer sales representative on behalf of a physician for one of his 55 year old male consumer who was administered with PREVNAR 13 unknown dose frequency intramuscular injection at an unknown time in deltoid muscle on 07OCT2013. Relevant medical history was unknown. Relevant concomitant medication was unknown. Vaccines given on the same day were unknown. Vaccines taken with the last four weeks were unknown. In OCT2013 after 12 hours of administration of PREVNAR 13 the patient experienced warmth, pain, swelling, redness and tenderness. Therapeutic measures taken in response to pain included ADVIL. Relevant sibling information was unknown. Relevant lab data was unknown. At time of report it was unknown if he was administering PREVNAR 13. At the time of the report he was not recovered from pain and swelling. At the time of report clinical outcome of other events was unknown.   Follow-up (06DEC2013): Follow-up attempts completed. No further information expected.
Nausea, dizziness, light headed, flushed, hives, intense itching, swelling of face/skin, skin feels hot, feeling ill.
Effects which happened 14 hours after shot: Extreme Lower abdominal pain which made me hump over to walk.  Had, bright light flashes with my eyes closed and pain around my eye socket. Rippling tingles across my chest, arms, and legs.    Had minor head ache which went on and off. Also had minor flu like general muscle pain.  Above pains disappeared  about 7 hours after start. There was NO arm swelling or major arm pain, slight arm soreness the next day when arm is elevated.
Case number PHEH2014US016228, is an initial spontaneous report from a nurse on 12 Aug 2014. This report refers to a 15-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered MenA powder component of MENVEO (batch number: not reported) reconstituted with sterile diluent instead of Men-CYW-135, intramuscularly on 12 Aug 2014. No adverse reactions had occurred since the administration error.
On 9/12/19 around 4 pm the client developed redness, swelling, pain at injection site (right deltoid area) and  pain upon moving right arm.  Per the client the redness was about the size of her palm and the swelling went from her upper arm down to her elbow. She took an Ibuproten last night for pain. This morning the client states her arm isn't as red, swollen or as  painful.  She still has pain upon movement of her arm. The client was encourage to contact her doctor especially if her symptoms became worse.
Body aches and pains; Severe headache; Body aches and pains; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Body aches and pains), HEADACHE (Severe headache) and MYALGIA (Body aches and pains) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not had allergies to (medications, food and other products).  It was reported that patient did not had any chronic illness at the time of vaccination.  They were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine  Patient did not had ever COVID positive test or did not diagnosed with COVID positive test.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, the patient experienced PAIN (Body aches and pains), HEADACHE (Severe headache) and MYALGIA (Body aches and pains). At the time of the report, PAIN (Body aches and pains), HEADACHE (Severe headache) and MYALGIA (Body aches and pains) had not resolved.            On 08-Jun-2022, received fourth second booster dose of mRNA-1273 (Moderna COVID-19 Vaccine)  On 01-Nov-2021, the patient received first booster dose (no further information available)  There were no information about first primary and second primary dose  No concomitant medication information was provided.  It was reported that patient symptoms were not getting any better.  No treatment medication were provided.
Moderna first 2 doses and Pfizer next 2.   Blood in urine starting at around 3PM on day of injection and it lasted until about 2 PM on the next day . Never had blood in my urine before and have not had any blood in my urine since the last occurrence on 4/8/22. I had no pain when I urinated or fever just a soreness in my right arm. I checked on the web and saw that blood in the ursine has occurred in a small number of cases  as well as if the injection is accidently injected in blood stream.  If I had any further effects I would have gone to  see my doctor.
Patient was fine during and after giving vaccine, but after they left the pharmacy, the front end manager  of the store called us over due to a 'patient fainting in the aisle'.  The patient had fainted, hit his right cheek into a shelf and collapsed on the floor (per mom).  Patient was awake, but dizzy when I approached.  We applied cold compresses to his face and kept him alert until the EMS arrived.  Mom decided not to have them take him to the hospital, and she took him home.  I followed up with mom around 3pm and she said he was back to his normal self.
Could not sleep well; Chills; Body is achy; Felt tired; Stiff arms, legs, and neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff arms, legs, and neck), INSOMNIA (Could not sleep well), FATIGUE (Felt tired), CHILLS (Chills) and MYALGIA (Body is achy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included VITAMINS NOS and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff arms, legs, and neck), FATIGUE (Felt tired) and MYALGIA (Body is achy). On 02-Apr-2021, the patient experienced INSOMNIA (Could not sleep well) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Apr-2021, FATIGUE (Felt tired) had resolved. On 02-Apr-2021, INSOMNIA (Could not sleep well) and CHILLS (Chills) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff arms, legs, and neck) and MYALGIA (Body is achy) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-049696 (Patient Link).
No a loss of motion in the affected arm; Worsening arm pain; Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 3rd July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm and injection site pain. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the pain in arm, injection site pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: After receiving the 2nd dose of Shingrix on left deltoid the patient experience worsening arm pain that progressed from left side injection site pain to no a loss of motion in the affected arm. The reporter consent to follow up.  The reported batch number 4702Z for Shingrix did not exist and was updated to 47D2Z as per the sales database.
cried alot;sz about 11PM;highest temp about 103R;mom did not take to Er or physician;
Extreme nerve pain Sensitivity to light focus issue sinus pain  ear pain  neck pain  jaw pain  nauseous
Patient reported to pharmacist that he is experiencing pain down his left arm that started after receiving flu vaccination. Patient was advised to seek care from PCP if it persists. Which he did on 10/31/18. His MD prescribed ibuprofen to help with the pain. The patient reports that the MD advised him to follow up with office if ibuprofen does not help or if pain persists. Patient reported that he received a vaccination at his MD office around the time he received the flu vaccine here.
Medical Assistants only gave solution that has blue top (Dtap/IPV) but not powder (Hib) so it wasn't mixed together with no reported adverse event; Initial information was received on 25-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient to whom medical assistants only gave solution that has blue top of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but not powder (hib) so it wasn't mixed together with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2023, the patient received a 0.5 ml, (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot number, expiry date: unknown, strength: standard) via unknown route in unknown administration site for Immunization.  On 09-Aug-2023, medical assistants only gave solution that has blue top (dtap/ipv) but not powder (hib) so it wasn't mixed together with no reported adverse event (single component of a two-component product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a nurse via call center representative and described the occurrence of erythema in a 17-year-old female patient who received MENVEO (batch number M16075, expiry date 31st March 2018). On 16th March 2017, the patient received MENVEO (intramuscular) .5 ml. On 16th March 2017, less than an hour after receiving MENVEO, the patient experienced erythema. The patient was treated with triamcinolone and non-drug therapy (Cold Compress). In March 2017, the outcome of the erythema was recovered/resolved. The reporter considered the erythema to be related to MENVEO. Additional details were reported as follows: The nurse reported that the patient experienced 6 cm red erythema area within 20 minutes of receiving MENVEO. Cold compresses and Triamcinolone cream 0.1 percent was applied 3 times daily for 10 days.
A covid vaccine bottle was opened on 10/20/21 at 12pm and one dose was administered. A covid vaccine dose was administered to Patient from the same bottle on 10/21/2021 at 11:40am.
Pt. seen for 20 mo. physical examination received DTaP- IPV-Hep B Temp 101 that night-next day right deltoid with large confluent area of erythema, mild edema and warmth, 3 tiny vesicles at site of Band-Aid. Diagnosed probable early cellulitis/ localized reaction to DTaP/IPV. Prescribed Augmentin- Benadryl- Cool Compress.
PATIENT STATED SHE HAD ITCHING THE DAY AFTER RECEIVING THE VACCINE AT THE STORE AND A RED RASH. HURTS TO LAY ON LEFT ARM AND HEAT BOTHERS THAT ARM NOW. DOES HAVE A SMALL KNOT AT INJECTION SITE, NO REDNESS OR RASH AT THE TIME OF DOCTOR VISIT. SITE THAT SHE SAYS VACCINE WAS GIVEN IS LOWER LEFT ARM AND NOT THE DELTOID AREA.
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 21-APR-2016, the patient was vaccinated with expired PNEUMOVAX 23 lot # K018528, expiration date-14-APR-2016 (expired product administered). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Nurse stated PNEUMOVAX 23 did not have any temperature excursions prior to administration. Additional information has been requested.
One day post vax, the pt developed flu-like symptoms and had pain on the right side of her chest. The pt noted that she then went to to an emergency facility where she was diagnosed with severe bacterial pneumonia that was confirmed by cultures. She spend 9 days in the hospital where she received unspecified IV antibiotics. Therapy was switched to Keflex for 10 days once she was discharged from the hospital. ON 1/15/01, the pt returned and was subsequently diagnosed with inflammation of the pleural cavity. She was discharged. F/U her admitting dx were R upper lobe pneumonia, COPD and asthma. The pt recovered. The hospital physician did not consider this event to be secondary to vaccine administration.
swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side; arm is still little sore; swollen pretty much in the side that got the shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side), VACCINATION SITE PAIN (arm is still little sore) and VACCINATION SITE SWELLING (swollen pretty much in the side that got the shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPCID), MELOXICAM, ALPRAZOLAM (XANAX), LORATADINE (CLARITIN [LORATADINE]), VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side), VACCINATION SITE PAIN (arm is still little sore) and VACCINATION SITE SWELLING (swollen pretty much in the side that got the shot). At the time of the report, SWELLING (swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side) and VACCINATION SITE SWELLING (swollen pretty much in the side that got the shot) outcome was unknown and VACCINATION SITE PAIN (arm is still little sore) had not resolved.            Concomitant medication include Pepcid. No treatment information was reported Patient has got her vaccine on non dominant, upper arm.
Improper storage of product in use; No additional adverse events; This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 28-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T032932, that has been verified to be valid for varicella virus vaccine live (Oka/Merck) (VARIVAX) , expiration date reported as 28-SEP-2022, 1 dosage form for prophylaxis (strength and administration route were not provided) (product storage error).  The vaccine was exposed to a temperature above of less 3 Celsius degrees (C) for a time frame of 3 hours; the vaccine did not experience previous temperature excursions. No adverse events were reported.