chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itch\ bumps" start breaking out on my face; Poison ivy; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In November 2019, 2 weeks after receiving Shingrix, the patient experienced itchy rash and poison ivy rash. The patient was treated with methylprednisolone (Methylprednisone Dose Pack) and prednisone. On an unknown date, the outcome of the itchy rash and poison ivy rash were unknown.   It was unknown if the reporter considered the itchy rash and poison ivy rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received 1st dose of Shingrix about 4 weeks before the time of reporting. The patient developed bumps that started breaking out her face about 2 weeks before the time of reporting. At first, she thought she had poison Ivy and the physician gave her Methylprednisone but with no change.  The patient got shot one week before and a new prescripation of plain prednisone but new bumps appear everyday.  The bumps were itch a little but other than that they were just ugly.  The patient was enquiring, if the shot could cause them. The patient was scheduled for the follow up shot in about 2 weeks.
Initial health care professional report received on 12 Mar 2010: This patient received expired FLUVIRIN (batch number 1009221P) unknown dose intramuscular, on an unspecified date. No other adverse event was reported.
Pt recv vax on 10/1/98; post vax pt exp cellulitis
Sore arm; My brain is shaking; lumps under my left arm; Lumps under my neck by the column bone; Hard to take a deep breath; Chest hurts; I can't work anymore; Covid arm (Red itchy rash); rash; Vomiting; Headache; chills; Swollen lymph nodes; I couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone) and DYSPNOEA (Hard to take a deep breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced INSOMNIA (I couldn't sleep). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache), CHILLS (chills) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), INSOMNIA (I couldn't sleep), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (chills) had resolved and ELECTRIC SHOCK SENSATION (My brain is shaking) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment product information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-Jul-2021. Events added and event outcome updated.
7-5-10 achy arm and legs then all over.  Temp 102.2.  Enlarged lymph node rt axilla.  Symptoms resolved after a day or two.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Soreness and swelling  upper left arm within 2 hours of injection. Redness (8" strip) upper left arm within 8 hours. Headache, nausea within 12 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: En6203), in left arm, on 03Mar2021 as dose 2, single (Lot number: En6208), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 30145bA), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective and covid-19, included Paxlovid treatment, start date was 07Jul2022 and treatment stop date was 12Jul2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200990572 Same patient, same drug, different event, different dose;
First shot was administered at 5pm and woke up in a cold sweat, vomiting, body aches, no appetite and extremely tired for 3 days.  Also had 3 lesions that looked like a bug bite, never blistered and scabbed over within 48 hours.  After 3 days energy level returned and had a sharp headache lasting 2 weeks with prickling sensations off and on in hands for many months.  Nine months later, 2nd shot was administered and had some of the same symptoms lasting 24 hours with no lesions.  Headache lasted 3 days and prickling sensation would come and go for many months to follow.
Local pain in shoulder; Pain / radiating into neck; Pain / radiating into / back; Welt at injection site; Severe exhaustion; Day 3 with fever; Day 3 with / chills; This case was reported by a pharmacist and described the occurrence of shoulder pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shoulder pain, neck pain, back pain, injection site wheal, exhaustion, fever and chills. On an unknown date, the outcome of the shoulder pain, neck pain, back pain, injection site wheal, exhaustion, fever and chills were unknown.   It was unknown if the reporter considered the shoulder pain, neck pain, back pain, injection site wheal, exhaustion, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her first dose of Shingrix.' She felt local pain in shoulder, radiating into neck and back, welt at injection site and severe exhaustion. And on day 3, she experienced fever and chills. The reporter consented to follow up.
pain; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called regarding pain experienced on an unspecified date. The clinical outcome of pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt had pain/redness/swelling within 4 hrs after receiving injection in L upper arm.  +12 hrs later, L upper arm became extremely itchy/hot to touch and developed a half dollar size bright red circle at injection site.  After 24hrs, symptoms subsided.  7 days after receiving initial injection, pt was weight lifting and upper L arm became itchy and started to develop a welt approximately the size of a half dollar that was blanched in color and hot to touch.  Discomfort subsided approximately 24 hrs later and pt now reports discoloration and some irritation at injection site.
Patient was vaccinated at 1125 and after she was vaccinated she acknowledged to the RN that she often gets faint with needles. The RN alerted the NP of her history and it was at that time that the patient slumped over in her chair. Patient was assisted to the floor without injuries. EMS called for assistance at that time. Patient was in a stupor, following simple commands, however, with expressive aphasia. Patient regained consciousness and acknowledged that she did not taker her BP meds (losartan) and did not have much to eat before. EMS observed the patient for 30 min and she was released to her sister. Pt was aaox3, pleasant and conversant.
fever 102; vomiting; body aches; site tenderness; rx DPH, APAP ice to site;
Information has been received from a laboratory technician concerning a 15 year old female who on 28-JUN-2007 was vaccinated with a 0.5 ml first dose of Gardasil. On 28-JUN-2007, while still in the physician's office the patient fainted. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. Additional information has been requested. This is one of two reports from the same source.
Client called on 2/11/2021, approximately 2:39 pm.  Reports s/s:  itchy red rash at injection site.  Client was advised to start taking Benadryl per package dosing.  Follow up phone call approximately 6:30 pm.  Client reports no increase in s/s with mild relief.  Client will continue taking Benadryl per package directions.  Follow up phone call on 2/12/2021.  Client reports soreness to left arm and a small bump at injection site.  Rash and redness are improving.  Follow up phone call on 2/15/2021.  Client is doing well.  No s/s and has not taken Benadryl today.
FREEZING/CHILLS; This spontaneous report received from a consumer concerned a 7 decade old male. The patient's weight, height, and medical history were not reported. 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 12-MAR-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced freezing/chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of freezing/chills was not reported. This report was non-serious.
day after injection i had slight head ache on Friday night i was shaking uncontrollably and then Saturday i  got nausea.
Too weak to walk/felt very very weak; Slept alot; Couldn't eat; Headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Too weak to walk/felt very very weak), HYPERSOMNIA (Slept alot), DECREASED APPETITE (Couldn't eat), HEADACHE (Headache) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 22-Apr-2021, the patient experienced ASTHENIA (Too weak to walk/felt very very weak), HYPERSOMNIA (Slept alot), DECREASED APPETITE (Couldn't eat), HEADACHE (Headache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Apr-2021, ASTHENIA (Too weak to walk/felt very very weak), HYPERSOMNIA (Slept alot), DECREASED APPETITE (Couldn't eat), HEADACHE (Headache) and NAUSEA (nausea) had resolved.            No concomitant medications reported.  Treatment of the events were not reported.   This case was linked to MOD-2021-065962 (Patient Link).
My eye gets little bumps all over it - right eye, Bruised-red and itchy swollen right eye.
pt recvd vax 26AUG93, approx 4Pm pt had fever of 105 R; took pt to ER pt admitted for 4 days, fever went up & down r/o UTI;
Vitreous hemorrhage on the left eye; Strange reaction; Second shot really hurt/injection site was sore for several days; Flashes in left eye, like lightning; Bottom part of the left eye was filling up with a sick mucus like fluid; Retina was tearing; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye) and RETINAL TEAR (Retina was tearing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye) (seriousness criterion medically significant), VACCINATION COMPLICATION (Strange reaction) and VACCINATION SITE PAIN (Second shot really hurt/injection site was sore for several days). In April 2021, the patient experienced RETINAL TEAR (Retina was tearing) (seriousness criterion medically significant), PHOTOPSIA (Flashes in left eye, like lightning) and VITREOUS FLOATERS (Bottom part of the left eye was filling up with a sick mucus like fluid). The patient was treated with Surgery (Laser surgery) for Vitreous haemorrhage and Surgery (Laser surgery) for Retinal tear. At the time of the report, VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye), RETINAL TEAR (Retina was tearing), VACCINATION COMPLICATION (Strange reaction), PHOTOPSIA (Flashes in left eye, like lightning), VITREOUS FLOATERS (Bottom part of the left eye was filling up with a sick mucus like fluid) and VACCINATION SITE PAIN (Second shot really hurt/injection site was sore for several days) outcome was unknown.            No concomitant medication information was provided.  Treatment information included laser surgery.  Very limited information regarding this events has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-044452 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
03/1/22 presents to ED for "right hip pain". PMHx of " HTN, atrial fibrillation on Eliquis, hx of CVA"
Patient was given a double dose of IPV. Received Pediarix and IPV. No adverse reaction reported.
Headache, Myalgia SINUS COLD SYMPTOMS AND ROSY CHEEKS Narrative:
Initial report was received from a health care professional on 25 April 2011. An 89-year-old male patient had received on 15 April 2011 a dose of ADACEL (lot number, route and site of administration not reported) and an unspecified amount of time after vaccination experienced bilateral lower limb swelling and itching. According to the reporter the patient symptoms were "getting better" but had not resolved. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Benadryl was given and patient was observed for an hour and stated she felt better when she left. Patient was not driving the car.
an episode of idiopathic thrombocytopenic purpura (ITP); bleed out; getting blisters in the mouth; Initial information received on 26-Apr-2021 regarding an unsolicited valid serious case from a consumer.  This case involves male patient (in his early 60s in 2011) who experienced an episode of idiopathic thrombocytopenic purpura (ITP) (immune thrombocytopenia), getting blisters in the mouth (oral mucosal blistering) and bleed out (haemorrhage), after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication(s) were given to the patient.  In Nov-2011, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UT473AB and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. The patient reported that the he only had the lot number and no other identifiers of the vaccine and that the provider told the consumer that he had a Sanofi vaccine.  In 2011, the patient developed a serious episode of idiopathic thrombocytopenic purpura (ITP) (immune thrombocytopenia) (one week latency), described as getting blisters in the mouth (oral mucosal blistering) (one week latency), had a platelet count of 1000 from 190000 the week prior and being a bleed out (haemorrhage) (one week latency). These events were assessed as medically significant. The patient was in inpatient hospitalization and reported that a week before the vaccine he had a physical and his platelet count then was 190000. The patient remained in the hospital for 4 weeks.  The patient was treated with chemotherapy to get the immune system on track, while he was in the hospital.  The patient recovered from all the reported events on an unknown date.  It was reported that he was now looking into getting the COVID-19 (coronavirus disease) vaccine but was informed that the COVID-19 vaccine should not be given if someone experienced ITP after receiving a vaccine with the same ingredients as the Covid-19 vaccine; that the consumer did not get the high dose in 2011. Reported that he does not have good site and was needing to transfer the phone to the spouse to type in a website for him. There was no more information for this report due to the consumer not having the information.; Sender's Comments: This case involves male patient who had immune thrombocytopenia, oral mucosal blistering and haemorrhage, a week after vaccination with FLUZONE. The time to onset is compatible. Platelet count of the patient was 1000 from 190000 (the week prior before the vaccination). However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In MAY-2023, less than 2 months after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2023 The patient self-reported this case. The patient got his 1st dose of Shingrix vaccine the 2nd week of April 2023.  Patient reported pain at the injection site, and it had not gone away for 6 weeks.  Patient reported it started in the morning and when moving the arm, it hurts and gets worse. The lot number and expiry date were not provided.  No additional information was reported.  Consented for follow up could not be obtained.
Swelling and pain at left shoulder after receiving pneumonia and influenza shot two days prior to admission. Both vaccines where administered at the same day and at the same site. Erythema and edema to left shoulder.
After receiving moderns covid 19 vaccine on January 14. A rash appeared at the injection site on January 23.
Patient developed absolutely classic itchy rash consistent with chickenpox (varicella), complete with a "dewdrop on a rose petal". I was advised to submit this VAER by our infectious disease department.
This spontaneous report as received from a registered nurse refers to an unspecified patient. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On 15-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # and expiry date unspecified) dose 1 (dosage regimen, frequency and route of administration was not reported). Subsequently, on 15-AUG-2016, the patient was vaccinated with GARDASIL 9 dose 2 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Erythematous swell about the injection site. Approximately 2 cm, raised edges, tender to palpation.
The patient came into the  clinic for their second dose of the covid vaccine. The patient's first dose was Moderna. The second dose that was administered was Pfizer. The clinic nurse was not aware the patient had received moderna for the first dose until they gave the vaccine card to the nurse. The clinic that was being held was a public Pfizer clinic. Pharmacy was notified. The patient felt fine and was sent home after the 15 minute wait time post vaccine adminstration.
Felt like throat was closed; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left on 19Jul2021 (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient felt like throat was closed (medically significant) on 06Aug2021 with outcome of not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101041671 Same patient/product, different dose/events
Pt c/o headache and itching on trunk. Symptoms started 48 hrs. after vaccines.