chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on upper arm; Allergy; Neck Stiffness; Fever; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and diabetic polyneuropathy (without long term current use of insulin). Concomitant products included insulin nos (Insulin).   On 27th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th June 2019, less than a day after receiving Shingrix, the patient experienced stiff neck and fever. On 2nd July 2019, the patient experienced rash and allergy. On 29th June 2019, the outcome of the stiff neck was recovered/resolved. On an unknown date, the outcome of the rash, fever and allergy were not recovered/not resolved.   It was unknown if the reporter considered the rash, stiff neck, fever and allergy to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix vaccine in left arm. The patient received Shingrix and arrived to physician's office on 2nd July 2019 with a rash surrounding left upper arm due to allergy. The patient also experienced neck stiffness for 48 hours post injection and having fever. Pharmacy and physician's office in same building and they were able to communicate regarding patient's adverse event.
Patient stated that her arm was itching as soon as she got home after receiving vaccine. Patient went to urgent care on 7/15/15 and was diagnosed with cellulitis. She described having blisters covering arm she received vaccine in (right arm).
Pt started feeling short of  breath and dizzy at about 10 minutes after her shot, vitals were monitored and initially normal but she became progressively more sob with tachypnea and associated hypoxia and hypotension. at about 30 minutes post covid booster she required administration of an epi pen and transfer to the local hospital via EMS
Dizziness, weakness, elevated troponin, otitis media, COVID-19 infection Patient presented with elevated troponin likely secondary to rhabdomyolysis.  CT suggestive of mass lesion rectosigmoid area. Brain MRI/MRA unremarkable for metastasis or acute CVA ECHO unremarkable for regional wall motion abnormalities
Patient presented at Emergency Dept. with chest pain, blurred vision left eye; headache; left arm, side and leg pain. BP 150/100; EKG, troponin, brain scan, all negative. Patient admitted overnight, echo stress test in AM also negative. Patient discharged at 3:00PM.
This spontaneous report as received from a nurse refers to a 17 months 15 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided
Tingling; Had difficulty catching her breath, noticed she was not breathing correctly; Felt like she had a band and it was very cold right below her bra area; Felt like a Cold band again, at the top of her chest; Felt like a Cold band in her arm, tingling feeling; Felt like a cold band in her back, tingling feeling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling), DYSPNOEA (Had difficulty catching her breath, noticed she was not breathing correctly), FEELING COLD (Felt like she had a band and it was very cold right below her bra area), FEELING COLD (Felt like a Cold band again, at the top of her chest) and FEELING COLD (Felt like a Cold band in her arm, tingling feeling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PARAESTHESIA, DYSPNOEA, FEELING COLD, FEELING COLD, FEELING COLD, and PARAESTHESIA. On 15-Jan-2021, PARAESTHESIA, DYSPNOEA, FEELING COLD, FEELING COLD, FEELING COLD, and PARAESTHESIA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.
the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago; the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago; the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago; her arm at the injection site started really hurting her; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Sep2021 01:00 (Batch/Lot Number: 30145B2) at the age of 72 years old as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included ibuprofen; and ibuprofen (ADVIL); both taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had pain in her arm. She had several other of the side effects uncomfortable side effects but nothing severe. Starting yesterday (26Sep2021), her arm at the injection site started really hurting her, it hurt the whole time but now it got worse and the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago. Outcome of the events was unknown.
The patient is 33 years old and she got a Hep A vaccine for a child. Wrong age group vaccine given.
Patient called back this evening - noting that the injection site was slightly red but inflamed. "Swelled up" per pt. She was advised to place a cold pack on for 15 minutes and take TYLENOL or ibuprofen. If it worsened to come and see us or her physician.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 13-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. In August 2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and route of administration were unknown) with lot # K026246 and expiration date of 28-JAN-2017. Then in October 2015, the patient received the second dose of GARDASIL 9 with lot # L011846 and expiration date of 16-JUN-2017; in January 2016, the patient received the third dose of GARDASIL 9 with lot # L011846 and expiration date of 16-JUN-2017. Subsequently, on 05-JUL-2016, the patient received a fourth dose of GARDASIL 9 (strength, dose and route of administration were unknown) with lot # L025737 and expiration date of 28-JUL-2017 for the same indication. This last dose was outside the recommendations per the prescribing information of the therapy. There were no concomitant therapies nor adverse effects reported. Additional information has been requested.
The patient received her 2nd SHINGRIX vaccine on 7-25-18. That evening she developed redness of left deltoid, swelling, and warmth to the touch. The redness and warmth has spread to around her neck and inferior to her breasts. She has had night sweats, headache, and joint pain.
Muscle aches, dizziness, vomiting, nausea,  Diarrhea, changes in menstrual cycle such as increased duration, increased flow and shortened and inconsistent cycles.
Hearing loss and tinnitus in ears - primarily right ear; Hearing loss and tinnitus in ears - primarily right ear; This is a spontaneous report from a contactable consumer (patient). This 50- year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EP7533), via an unspecified route of administration, on 7Apr2021 at 11:00 am (at the age of 50-years-old) as a single dose for COVID-19 vaccination, in left arm, at a Pharmacy or Drug Store. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP6955, expiration date: unknown) via unspecified route of administration in on 17Mar2021 at 12:00 pm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. Medical history included: Rheumatoid arthritis, hypothyroidism. Concomitant medications included: Thyroid medication. The patient reported hearing loss and tinnitus in ears - primarily right ear on 09Apr2021. No treatment was received. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
I had a respiratory infection, a really bad cough and a lot of mucus. The cough would not stop, I started taking MUCINEX but didn't help much. I t was really hard for me to sleep, I called my doctor and he put me on antibiotics and steroids. After six days, I was feeling about 75 percent better but I was still coughing few weeks after.
A consumer report has been received. The report concerns a female patient. The patient's mother stated that she received nasal FLUMIST on 03-Oct-2012 when she was 19 weeks pregnant. The baby was born 3.5 weeks early. The baby expected delivery date was 24-Feb-2013. It was reported that besides reflux, acid reflux so far everything was okay. No indications besides her being born a few weeks early that anything was amiss. The outcome of the event of born 3.5 weeks early and acid reflux was unknown. The event of born 3.5 weeks early was assessed as non-serious by the reporter. The event of acid reflux had been identified by the company physician from the source documents and added as non-serious adverse event.
24 hours later - low grade fever, body aches, rash, itching, fatigue   Ever since. (Today is the tenth day since the shot)
Vaccine given at 11:15 on 10/16/2004. At 14:35 patient presents to the nursing office with hives. Benadryl 50 mg was given and ineffective. Prednisone 60 mg was given at 15:20 with no effect. Referred to the ER had given Prednisone 20 mg qd x 4 days. Medical Records received on 12/07/2004 states wheezing.
dizziness, numbness lt side of face;ER dx labyrinthitis, early Bells palsy saw MD believes d/t flu vax;
Fussiness and cramping after feeding until passed loose stools.Fussiness awakens child.  Gassy after feeding.  Feeding poorly. Poor feeding and weight loss. No mucous or blood in stool.
Pain, hypersensitivity and development of erythematous, warm, indurated lesion at distal deltoid (over 1in from vaccine injection site) within 12 hours of vaccine, peak 24-96 hours from injection with resolution of erythema in 6 days.
I had my vaccination on 10/18/2022. I had been feeling pain in my stomach for a couple weeks. On 12/06/2022 I sought medical attention for the intense pain and discomfort in my stomach. They ran a CT scan of my abdomen. They diagnosed me with Diverticulosis.
Pt recvd vax 10JUN93 & exp elevated liver function tests; 13JUL93 liver function tests were nl; Reporter MD states that it is possible that the pt's elevated liver funct tests were due to medicines;
Feeling flushed; Hot flashes almost; Chest tight; Tight side arm and chest sharp pain; Right ear feeling full and tinnitus; Site pain soreness; Stiffness and all over body aches and muscle stiffness/tight side arm; All over body aches; Feeing generally not well; Scratchy throat but no swelling or otherwise allergic reaction.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER2613) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included blood clots, postpartum depression, overweight and sulfonamide allergy. Concomitant medications included Fluoxetine hydrochloride (PROZAC), ibuprofen (MOTRIN), paracetamol (TYLENOL), and fluticasone (FLONASE); all on unknown dates for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received levothyroxin(MANUFACTURER UNKNOWN) and metronidazole (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 18:00, the patient was feeling flushed, hot flashes almost, chest tight, tight side arm and chest sharp pain, right ear feeling full and tinnitus, that lasted off and on until the patient went to bed. The shot was completely painless but 20-30 minutes after vaccination, the patient had site pain soreness, stiffness and all over body aches and muscle stiffness. The patient was feeling generally not well and flushed, was by skin with no rash and had scratchy throat but no swelling or otherwise allergic reaction. The patient received treatment for the reported events and blood pressure was examined and observed for 45 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of feeling flushed, hot flashes, chest tight, chest sharp pain, tinnitus, vaccination site pain, stiffness, body aches, feeling unwell and scratchy throat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 10-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Fever, severe muscle pain, severe joint pain.  Gradually increased from 4/14 and peaked about 4/22 , continued, and then abated about 5/4.  Voltaren and Vicodin on the worst days, but pain was still severe.  Pain lasted about 20 days.
Patient attended small covid vaccine clinic and received first dose of Moderna vaccine. billing rejection stating manufacturer different to initial dose was received. patient was still in waiting area for normal wait time following a vaccination and was questioned if had received a first dose elsewhere. patient responded no. The insurance company was called and provided pharmacy (rite aid) the claim was rejecting against. the pharmacy was called and informed us there was a paid claim for a johnson and johnson vaccine and a consent form on file that was signed by patient and pharmacist. The patient had left the pharmacy and was called to verify but had to leave message. Patient called back and admitted had received the johnson and johnson vaccine. Also stated that had pursued a second manufacturer vaccine at the advice of a physician that is a family friend. After consulting Clinical Specialist determined that a second dose would not be administered due to fact that patient is already fully vaccinated
Covid-19 kicked up my asthma and went on a nebulizer with albuterol and steroid for a few days. I called my doctor and they wanted me to get the infusion or PAXLOVID but by the time I got to the Dr. the window had closed. They put me on a steroid and my symptoms didn't improve. I was evaluated at an urgent care facility the following weekend and they added an antibiotic and by that time there was a case of cellulitis in my left leg. The following week I was recovered.
DAY 1; Large bruise like rash on back and front chest on left side of body. Woke up midnight with expected chills and high fever. DAY 3: large raised red and hot welt near but not on injection site arm. Still present 4 days later. DAY 6; waking up with lightheadedness and dizzy, seeing black when walking. Goes away later in day.
Had general body aches and right arm pain but then 30 hours or so after the shot, I noticed a large lump under my right arm.  It is large and very sore and is uncomfortable to move arm.  About 2-3 inches in diameter.
Tachycardia (up to 155); hypoxia; chest tightness.
Left arm was very sore for about 24-48 hours. Injection site was red and raised, about the size of a 50 cent piece. Soreness went away completely as did the redness. But on day 7-8 after the vaccine, the redness returned and was covering a much larger area than before. It was raised, indurated, hot, red, very itchy and oblong left to right. The size of monopoly money, but raised and hard. Feels like a flexed muscle. It seems to be getting larger as time passes.
1 of 2 adult pts who exp inj site rxns following immun w/Tetanus Toxoid control # 352982; pt recovered;
Pain and redness around injection site. Injection site is warm to the touch and pain extends to underarm.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 3:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 3:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.71.  Concomitant products were not provided. On 13-Feb-2021, Excursion time was 9 AM temperature was 32 total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
feeling bad; swelling of lymph nodes; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (feeling bad), LYMPHADENOPATHY (swelling of lymph nodes) and VACCINATION SITE PAIN (soreness at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 07-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph nodes). On 14-Feb-2021, the patient experienced FEELING ABNORMAL (feeling bad). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad), LYMPHADENOPATHY (swelling of lymph nodes) and VACCINATION SITE PAIN (soreness at the injection site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Hepatic enzyme: elevated (High) elevated.         No concomitant medication details was reported. Treatment include IV fluids
Nearly immediately post injection, my right neck, and then my right arm down to my hand went numb.  That resolved after one hour or so.  There was no weakness.  The next day I had transient flu symptoms (hot, nausea) and a 12 hour headache.  Within a week I had a bad flare of migratory joint pain and swelling in my knees, hips, shoulders, elbows.  The joint symptoms are somewhat better (maybe 50% or less) but have not resolved.
COVID vaccine breakthrough case. Pfizer 1/29/21 EL0142, 2/26/21 5926710001 (lot# per database), and 10/21/21 FE3590.
Sore arm beginning a few hours after injection, fatigue setting in around 4pm. Began feeling chills and shaking around 10:30pm, along with joint pain and discomfort/inability to sleep. Chills subsided around 3am, replaced by joint pain and headache that lasted through morning; took Tylenol (500mg) around 10am, which took the edge off. Joint pain subsided around noon Saturday. Lingering mild headache and stiffness through Monday evening. Overall, super glad to receive vaccine and it just felt like a nasty hangover without the fun. Not sure if it's relevant, but I'm blood type O+