chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; SORE THROAT; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 161 pounds, and height was not reported. The patient's past medical history included mood change, not sleeping, chest pain, frequent bowel movement, faeces discoloured more orange in color, pain between shoulder blades, faeces soft or sluggish, itching on front leg, unspecified sleep issues, and sweating, and concurrent conditions included acromegaly. The patient was previously treated with acetylsalicylic acid for chest pain; and experienced vulvovaginal swelling when treated with octreotide for acromegaly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included octreotide acetate for acromegaly, cyclobenzaprine hydrochloride, fenofibrate, ibuprofen, macrogol 3350, and tramadol.  On JUN-2021, the subject experienced generalised aching. On JUN-2021, the subject experienced sore throat. On JUN-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Growth hormone stimulation test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalised aching, nausea, and sore throat. This report was non-serious.
This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 50-year-old male patient who received TWINRIX (adult). Concomitant products included HAB. On 12th December 2014, the patient received the 2nd dose of TWINRIX adult (unknown) 1 ml. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too long was unknown. Additional information was provided as follow: The 2nd dose of TWINRIX was delayed by 2 months. The 1st dose was given on 09 September 2014 and the 2nd dose was given on 12 December 2014. No adverse event was reported.
She was not provided a VIS form before the influenza vaccination and the vaccine was administered in her bicep, NOT her deltoid. She is in pain and scared it is infected because it is swollen to the size of a gold ball and very hot to the touch.
Patient reported approx. 10 min. after vaccination - reported itching around injection site and increased heart rate.  Approximately 10 minutes later returned to clinic and reported that itching spread to entire left arm and was noticing swelling and warmth.  Symptoms improved with diphenhydramine (Benadryl) 25 mg PO.  No further issues reported by patient.
Initial misuse report received from a healthcare professional on 16 January 2014. The cases were received at agency on 21 March 2014. It was reported that 74-year-old patient had received; FLUZONE ID vaccine inadvertently. No adverse event was reported. List of documents held by sender: none.
Information has been received from a physician concerning an 18-month-old male twin with no pertinent medical history and no drug reactions/allergies who on 08-FEB-2007 was vaccinated IM with the first 656495/1209F). There was no concomitant medication. On 08-FEB-2007, after the patient was released from care, he experienced 3 hours of uncontrollable crying. His mom administered Motrin to him one hour prior to returning to the office. he was additionally given Tylenol at the office and Benadryl one hour after the Tylenol. The physician noted that the child seemed sensitive to light and was banging his head. A follow-up was made the next day, in which the parent stated that the child was fine and playing. The outcome was recovered on 09-FEB-2007. The twin brother who was also vaccinated experienced no adverse effect. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested. 02/11/2010 Follow up information was received from a physician who reports that on 08 FEB 2007, within 9 minutes of vaccine the patient developed photophobia,  head shaking and banging, uncontrolled crying and holding his head. The event lasted for 2-3 hours. The patient had not illness at the time of vaccination. The patient was recovered at the time of reporting. No further information is expected.
The shot was more painful than any other I've ever received, from the "poke" through entire injection. I had dizziness and felt sick to my stomach. Instead of the normal observation period, I was there for ½ hour before well enough to leave. Since the shot, my arm movement has been limited, impeding my daily life. I am normally very flexible. I was able to put my arm behind my back, and reach up between my shoulder blades. Not only can I not do that anymore, but I am having difficulty and pain moving my arm in most directions. I can no longer reach my hand behind my back to scratch, hook my bra, zip-up zippers, etc. Even pulling on and off my pants is now difficult and painful.
Child came back to facility for lead testing of child, and at the time of the visit the mother showed the (R) thigh where DTaP #5 was given on 10/12/07, was swollen.
Headache; Arm started to burn; Arm swollen; Fatigue; A report was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced arm started to burn, arm swollen, fatigue, and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020 at 14:00, approximately 0 hours prior to the onset of the events, arm started to burn, arm swollen and fatigue, and approximately 1 day prior to the onset of the event, headache, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient's arm started to burn after receiving the vaccine. Later that evening her arm became swollen and she felt fatigued. The following morning, 24 Dec 2020, she woke up with a headache and fatigue. She reported taking Tylenol or Advil after a couple days and the pain on her arm decreased, but fatigue and headache were still ongoing.   Treatment for the event included ibuprofen or paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The events arm started to burn and arm swollen were considered resolved on 24 Dec 2020. The outcomes of the events fatigue, and headache, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Myalgia, inflammation at injection site (redness, swelling) Narrative: Six hours after receiving the vaccine, the patient reported redness, swelling and pain at the injection site. she denied any treatment for her symptoms.
Large red lesion around injection site (Approximately 2" x 3") appeared more than a week after the vaccination.  First noticed March 5.  Referred to as "COVID arm"?
Developed a blood clot 3 days later; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative.  A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route, dose number unknown, single for COVID-19 immunization. The patient medical history included DVT from an unknown date and unknown if ongoing. The patient received Eliquis for DVT. The patient concomitant medications were not reported. The patient developed a blood clot 3 days later. The patient received treatment for the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Thrombosis . The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning an "almost 1 year old" female who in September 2006 was vaccinated SC with a dose of PROQUAD (lot number 653668/0518F). In September 2006, the patient had an immediate reaction with swelling upon injection. Subsequently, the patient was recovering from the swelling upon injection. Additional information has been requested.
Red, swollen, sore area at injection site starting the next morning after vaccination.  Area measured approximately 2" x 1.5" at its largest.  Area started to resolve on day 3, but then flared up on day 7, area was red, swollen, and very itchy.  Area began to resolve by day 11.  I still had a slight dark mark on arm up until day 21, approximately 2"x 1".
Left deltoid.  Moderna vaccine given/ mom requested the booster/pharmacist checked age too late. Child only 15 years of age .  No adverse reaction
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 03-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # R002521, expiry date 18-SEP-2019, orally for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 6 hours. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA002697.
flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-healthcare professional.  This case involves a Child female patient who has flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for flu vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event.
vomiting 3-4times @6PM on 3MAR98;diarrhea stools started 630PM on 3MAR98 through 3MAR98;elevated temp 101;tenderness rt leg;irritable;
About six hours after receiving a flu shot, my eyes became bloodsgot and itchy.  the glands under my chin became swollen, as did my salivary glands, and I became extremely fatigued.  i took some Benadryl, and that seemed to help, although the fatigue continued. the next morning, i still felt very fatigued, but the other symptoms had receded, but not disappeared.  I have received flu shots for the past 17 years with no adverse effects until now.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M041080 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. {Additional information has been requested. / Additional information is not expected.; Sender's Comments: US-009507513-1706USA009368:
Received H1N1 Flu-mist vaccine at 4:30 11-19-09. Woke up approx 12 hrs later having seizures. Went to E.R. dx. with tremors. Went to PMD 11-23-09 still having tremors, fatigue, needs assistance to walk. Is to be scheduled for MRI next week.  12/07/09 Vaccine record received for DOS 11/23/09.
I started developing a fever of 100.2 around  11:30pm on 2/3/21, 13 hours after receiving the vaccine.  My fever rose to 101.3 by the following morning. It started to drop to 100.2 again by 9:30pm  on 2/4/21 and was 99.5 by 10am 2/5/21. I had  a severe headache that started as gentle pressure about 2 hours after being vaccinated and escalated to feeling like my head was in a vice  through the morning of 2/5/21. I had severe hip and knee joint pain and muscle pain all of 2/4. I was unable to walk because it hurt badly to put weight on my joints. I had a stiff neck and couldn?t turn my head more than 45% in either direction. I slept no more than 20 mins that night due to the pain.  On 2/4 I developed nose bleeds and incontinence. Those symptoms went away by 2/5.  Dizziness and lightheadedness, fatigue and headache stayed with me for 2 weeks. I am still more tired than usual.
Member received 2nd Moderna Dose 1 week early  During COVID Vaccine POD, a member reported to Medical Group per Supervisor for 2nd dose vaccine.  Member wrote he received first dose on 4 Feb 2021, but was not due for 2nd dose until 4 March 2021.  He received 2nd dose on 24 Feb 2021 and was documented on DHA Form 207 of first dose.
Patient had a hard knot on her arm after the administration of Pneumovax 23 vaccination. Patient was give an ice pack. Patient was suppose to stop by the pharmacy the next day .
15 min AFT Getting boTH Vaccines, pt ReportED THAT She Don't Pain - STARTED in Lower back THEN spread - ALSO swollen cheeks noT TonGUe - no SOB WENT TO ER
muscle aches, joint pain, headache, injection site pain, chills, feeling unwell, fatigue
AFTER RECEIVING THE VACCINE, SHE FELT DIZZY AND NAUSEATED. ON SITE EMS RESPONDED AND VITALS ARE BELOW. PATIENT REPORTED TO NOT EATING ANYTHING YET TODAY. SHE WAS GIVEN WATER AND CRACKERTO EAT. SHE FELT BETTER AND WAS RELEASED TO HOME.
Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6955) via an Intramuscular route of administration in left arm on 19Apr2021 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0162) via an intramuscular route of administration in left arm on 22Mar2021 as dose 1, single for COVID-19 immunization. Concomitant medications included turmeric curcuma longa rhizome (TURMERIC) taken for inflammation, start and stop date were not reported. On 27Jul2021 the patient diagnosed with COVID (COVID-19, vaccination failure). The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 27Jul2021 Nasal Swab. Therapeutic measures were taken as a result of event. On 04Aug2021 it was reported that, other medications taken as vitamins and turmeric for inflammation. It was reported that she did not receive other vaccine in four weeks. She did not diagnose with COVID prior vaccination. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse events treatment recommendation to take sudafed for congestion. Patient was not having known allergies. The outcome of the events was reported as not recovered.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected
Received a NOT reconstituted vaccine/ Without the Lyophilized Antigen Component; Got a NOT reconstituted vx. Repeat dose given 47 mins later; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old patient who received Herpes zoster (Shingrix) (batch number PY3BT, expiry date 25th September 2023) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix. On 11th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: The nurse had reported that, a patient with unknown gender had received a Shingrix vaccine which was not reconstituted with the lyophilized antigen component and 47 minutes later the patient was vaccinated with a reconstituted Shingrix vaccine.  It was the same lot number an expiration date administered. The reporter had consent to follow up by email. Additional supportive information: The patient had received a Shingrix vaccine which was not reconstituted with the lyophilized antigen component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Redness, erythema, below injection site, fever, given Keflex for Cellulitis.
received dose from vial that had black particulates in previous syringe; received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.
facial pain; nausea; Aching; Shivering; Fatigue; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; This case was reported by a other health professional via call center representative and described the occurrence of facial pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2019 13:00, the patient received the 1st dose of Shingrix. On 5th February 2019, 6 hrs after receiving Shingrix, the patient experienced fatigue, ear pain, headache, eye pain and oral pain. On 5th February 2019 19:00, the patient experienced nausea, pain and shivering. On 5th February 2019 23:00, the patient experienced facial pain. On 6th February 2019, the outcome of the fatigue, ear pain, headache, eye pain and oral pain were recovered/resolved. On 6th February 2019 02:00, the outcome of the facial pain, nausea, pain and shivering were recovered/resolved.   It was unknown if the reporter considered the facial pain, nausea, pain, shivering, fatigue, ear pain, headache, eye pain and oral pain to be related to Shingrix.  Additional details were provided as follows: 10 hours after vaccination, the patient experienced facial pan. 6 hours after vaccintaion, the patient experience nausea, pain and shivering. The facial pain was sharp shooting intermittent but ongoing until 2 am the following day. It was began around ear and shot into her forehead,nose,mouth, eye, and chin. The patient stated that, the facial pain was intense may be 7 out of 10 enough, that she considered going to the emergency room. Spontaneously around 2 am, the facial pain was gone and there were no ill effects afterwards than the fatigue. The fatigue was recovered after next day.
Patient woke with pain in the L lateral neck on 10/3/2020, approximately 24 hours after vaccine administered in L deltoid. No pain in shoulder at this time. Neck pain initially described as mild and able to continue with normal activities. Went to gym on 10/5/2020 and able to complete normal exercise routine . Pain increased over the following  days. Pain began to radiate to L occipital region on 10/9/20 and woke patient from sleep, Also difficult to turn head to the side at that time. Denies  paresthesia, weakness at any point. Patient contacted this provider (administered the vaccine) and her PCP on 10/9/2020. Per patient report, discussed symptoms with her PCP via patient messaging portal. States physician did not feel that pain was due to immunization but was likely due to neck strain. As patient reported temporal concern regarding onset neck pain and this injury, report made to VAERS by the administering provider,  in the case there should there be an underlying association. At follow up with patient today 10/15/2020, pain has improved and full ROM in neck. No symptoms in the arms. No headache. Patient is aware report made to VAERS.
Vaccine administered subcutaneously; A spontaneous report was received from a healthcare professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of received vaccine subcutaneously.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) subcutaneously for prophylaxis of COVID-19 infection.  On an unspecified date the patient received the vaccine subcutaneously.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event received vaccine subcutaneously was considered resolved.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This report refers to a case of  incorrect route of product administration (subcutaneously instead of intramuscularly) for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of incorrect route of product administration. Reported event is unlisted for mRNA-1273  and causality was assessed as not applicable.
developed severe left sided neck pain and swelling and left arm pain on 1/24, swelling under left armpit as well
Patient was given PNEUMOVAX and Flu shot on 11/11/08 he developed chills and significant aches and fatigue later that day. Had a large red rash at site of vaccinations with arm pain. Took several days to improve without treatment.
Admitted to hospital with weakness, fatigue, dizziness, found to be COVID 19 +