chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore; hasn't been able to get the second dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The reporter stated that after vaccination with 1st dose, the patient experienced sore arm for couple of days. The reporter stated that, the patient had not yet received dose 2 of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147943:same reporter
Information has been received from a licensed practical nurse concerning a 79 year old female who on 29-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number, site not reported) 0.65ml SQ. Concomitant therapy included simvastatin (MSD), ALTACE, alendronate sodium (manufacturer unknown) and sotalol hydrochloride. On 8-JAN-2009 the patient developed polymyalgia rheumatica after administration of ZOSTAVAX (Oka/Merck). The patient discontinued taking simvastatin (MSD) after the symptoms developed. Sedimentation rate was performed with no result reported. The patient's polymyalgia rheumatica persisted. Additional information has been requested.
Patient developed nausea and vomiting  3/14/21.  was seen at clinic by this provider 3/16/21 and reported at that time continued fatigue but overall symptom improvement.  Vital signs were stable.  pt was advised to orally hydrate and routinely monitor blood sugars and f/u as needed.  On 3/18/21 patient was found down in his motel room by shelter staff unresponsive.  911 was called.  pt transported to hospital by EMS receiving BLS.  Clinic staff was advised by family that patient was pronounced dead that date.
performs a lot of activity with the arm the pain worsens at night / unable to move the arm due to the pain; had pain and some swelling at site of injection /  pain did not diminish but worsened; swelling at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TB74, expiry date unknown) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site swelling and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 74 or 75 years. The patient experienced pain and some swelling at site of injection, first 4 to 5 days after the vaccination. Over the weeks, pain did not diminish but worsened and if the patient performs a lot of activity with the arm the pain worsens at night. Recently during the time of reporting, the patient was unable to move the arm due to the pain. The reporter consented to follow-up. This case had been linked with US2020231855, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231855:same reporter
Fever, Chills, body aches, chest pain, back pain, neck pain, headaches, sore arm, unable to lift right arm ( injection arm), 13 days late for period, sharp pain in uterus. Pain lasted 2-3 days from mild to severe on day 1, severe day 2 (bedridden), & mild day 3. Tylenol taken for pain & sleep. Still no period  outside of normal cycle, which is consistently tracked & documented. This is not normal.
Pt waited the recommended 15 minutes post-injection without incident.  She left the facility and returned shortly thereafter c/o facial swelling and some tingling in her mouth.  Vital signs obtained and wnl. Diphenhydramine 50 mg IM given with good results.  Pt was monitored for 1 hour post injection.  Released when spouse arrived to drive her home.
soreness in arm.  Chills, fever as high as 101.8, body aches, fatigue.  Fever continued the entire next day along with fatigue.  Today, March 27th, I have woken up feeling better, no fever.
Guardian reports onset of whelps that began on face then spread to arms and legs. She gave child Benadryl orally x 3 days and whelps resolved.
PATIENT'S BLOOD PREASURE INCREASED AND FELT NUMBNESS IN THE LEFT SIDE OF THE FACE CAUSING TO SEE BLURRY THROUGH THE LEFT EYE. PATIENT WENT TO THE ER ON 11/12/2021.
After the normal observation period (15 min), patient vomited in the car on the way home. This was approximately 25 minutes after her shot. We returned immediately to the hospital. She only vomited this one time.
Chief Complaint Patient presents with ? Rash     C/o rash to extremities and buttock that started about 3 days ago. ? Edema     C/o edema to lower extremities and abdomen. ? Shortness of Breath     Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby.     Subjective:   HPI Patient is 83 y.o. year old male that presents for acute problem as noted above.  Received call from patient late yesterday evening complaining of petechial rash to extremities.  States they originally were pruritic.  Now states they no longer itch.  Patient states that the rash started about 3 days ago.  His main lower extremities and buttocks.  Also complained of increased edema to lower extremities.  Also feels like his abdomen is swollen.  Patient was treated for diverticular flare middle of February.  Has completed antibiotic specifically Augmentin about 2 weeks ago.  Patient having increased shortness of breath.  States he does have a productive cough in the morning producing yellow sputum.  Afebrile.  Patient does have history of atrial fib.  Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full.  Patient is on Coumadin chronically.  Recent INR has been within normal limits.  Patient does have some tenderness to his abdomen more so to the upper quadrants.  Denies any change in bowel habits.  States he is mildly constipated.  Denies any change in color stool.  Denies any actual chest pain.  Does get remarkably short of breath.   Review of Systems  A 10 point ROS was completed and negative except as noted in HPI  3/12 Presented to Emergency Room - admitted inpatient @ 1144
Vaccine #1: 4/13/21, developed systemic itching -> resolved without treatment   Vaccine #2: 5/4/21, developed systemic itching w/ skin irritation 5 days later --> Benadryl used w/ relief 5/14/21: presented to PCP office for continued systemic itching and treated with prednisone po 40mg QD x5 days Symptoms resolved with treatment until approx. 6/2/2021 when systemic itching returned.  6/13/21: itching returned w/ areas of erythema on forearm and itching of low back. 6/15/21: presented to PCP office for continued symptoms - treated with prednisone po 40mg QD x5 days.   approximately 1/2 week after the 1st injection Major itching began, Lasted about Two weeks, Took over counter Medication (Benadryl etc.) After Second injection the Same itching return Very Severely. On both cases Prednisone Controled the itch. To date 6/28/21 Minor itchy has Continued at a Moderate to lower Level. Itch Cream and other allergy medication by Mouth. All ocassions itch Location  Left arm and hand - Where Surgery + arm staff infection occured in the past. Left Leg  Back of Neck upper back - Where Lamanectomy Surgery occured C1-C7 in the past 1998 Navel area 1 inch wide around Navel where Shingles occured Lower back area where Back injection occured in the past  Right Leg  Right Real bad where Ezeama is Current and in the past Private area Testicles   Please find an account of My Medical reaction to the Pfizer. My Signature below authorized you to obtain medical Records Pertaining to My Pfizer vaccines   At our last appointment, your wife expressed concern that your skin condition be reported to Pfizer since this started after your COVID vaccine.  I have completed the essential portions of the form.  You can add additional information as is appropriate.  See the third page for how to submit the form if you are still interested in doing so.
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 58 years old female patient who received 0.5 ml FLUZONE QUADRIVALENT lot UJ068AB, expiry date 12 June 2019, via unknown route in the right deltoid on 10-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage as Vaccine had been exposed to temperatures below 32 F. It was reported that patient administered FLUZONE QUADRIVALENT. Vaccine had been exposed to temperatures below 32 F. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Gave Patient 40 mcg Dose of Heplisav-B; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On an unknown date, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported). No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Injection Hurt; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient complained that the Shingrix injection really hurt. The reporter consented to follow up.
Violently ill!!! Program keeps timing out when I describe everything. Not filling this in a third time! Call me if you want to know this info.
I have experienced extreme itching all over my body; welts as big as 3 to 4 inches on my inner thighs and torso; swollen upper and lower lips; swollen cheeks and chin; redness on cheeks; tongue; upper lip.  This has happened about 6 times.  Swelling of lips and extreme itching started on March 7, 2021.  Reoccurences: March 26,  March 28, April 4,  April 22, May 10, June 14, June 30, and today, August 8, 2021.  I have been treated with Hydroxyquin, prescription forms of claritin and pepcid; a steroid shot; benedryl
53 y/o F with a PMH of IDDM, alpha-thalassemia, hypothyroidism, sinusitis, mitral regurgitation, dyslipidemia, and obesity presented to PCP for follow up visit. Patient's listed allergies included penicillin, sulfa antibiotics, and TDaP. Patient was administered PREVNAR 13 at the office. Patient went home and developed significant erythema, swelling, pain, and warmth at injection site. Patient also reported elevated temperature (99.5 degrees F), shivering, and diarrhea. Patient called two days after the vaccination to report the reaction. Patient was instructed to use cold compresses and acetaminophen to self-treat. Patient retuned for a follow up visit 6 days after vaccination. Reaction was resolving and patient was instructed to continue.
slight injection site red rash; This spontaneous report has been received from a physician referring to a 2 year old female patient. No concomitant medication, pertinent medical history or drug reactions/allergies was reported.     On 19-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), injection, 0.5 milliliter, subcutaneously for prophylaxis (lot#, expiration date and strength were not reported, indication reported as "Measles, Mumps, Rubella and Varicella Virus Vaccine").  Other suspect therapies included sterile diluent (STERILE DILUENT) subcutaneously (lot#, expiration date, strength, dose, frequency and indication were not reported).      On 20-JUL-2021, the patient developed a very slight injection site red rash. The patient sought medical attention via unspecified way. Lab diagnostics/studies was not performed.  No treatment was given for the adverse event.  The outcome of the event was unknown. Causality was not reported.
A light rash developed on her face, scalp, and upper back. Over the next 2 days spread over her entire body and darkened in color. Not itchy, no respiratory difficulties or fever.
C/O muscle pain started after 5 days below injection site - started with (+) swelling subsided localized pain 10/30/13 (+) fatigue.
No adverse event; 0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. Patient received a 0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine. Reporter was unsure of batch number. He was unsure if it was 067140C or 057140C. No treatment medications were reported.   Reporter did not allow further contact
Pain in back of chest, lung area; Pain he is experiencing in his chest is worse on the left side; Couldn't move; Felt very ill; Swollen lymph nodes on his neck; This is a spontaneous report from a contactable consumer (patient's mother). A 24-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown, expiry date and NDC number were not reported) via an unspecified route of administration on 12Apr2021 (at the age of 24-years-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing asthma and he had this condition his whole life. This report was not related to a study or programme. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from an unspecified start date and ongoing. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number was not reported) on an unspecified date for covid-19 immunization. The patient took covid vaccine because he is an essential worker. On an unknown date in Apr2021 the patient experienced pain in back of chest (lung area), swollen lymph nodes on his neck, couldn't move, felt very ill, pain he was experiencing in his chest was worse on the left side, the reporter said it was the side of his body as he got the vaccine on. The patient took a dose of his Breo Inhaler thinking that it would help. He had to miss work to go to the doctor about his symptoms. No investigation assessment. The outcome of the events chest pain, and lymphadenopathy was not recovered and for all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This report was received from Lilly and was assigned manufacturer report number US201011004024. A female patient was vaccinated with a dose of GARDASIL (Lot # not provided) on an unspecified date. It was reported that the patient was diagnosed with mononucleosis twice after taking the dose of GARDASIL and also diagnosed with chronic fatigue syndrome. At the time of this report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This was originally reported by a lawyer. This is one of several reports received from the same source. No further information is available.
Information has been received from a physician concerning a female pt who on an unspecified date was vaccainted with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
Inflammation in the face; This is a Spontaneous report based on the information received by Pfizer from Reference Number: GL-020821-3546). A contactable Other HCP reported similar events for two patients. This is 1st for 2 report.  A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced inflammation in the face where previous filler (Restylane) was injected in. Inflammation occurred within days of 2nd covid vaccination. The outcome of event was unknown. No other information provided.   No follow-up attempts are needed. Information about Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223811 same reporter/product/event, different patients.
Pain, redness, and swelling at injection site.  Body aches, Headache, Continuous Gas and explosive diarrhea on late Wednesday, all day thursday and Friday.  Saturday headache, and  extreem neck and shoulder pain.  I have been taking pepto bismal, eating bland diet, and taking ibuprofen.  Neck and shoulder pain is the worst today.
This spontaneous report was received from a consumer and refers to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in 2017, reported as last year, the patient was vaccinated with an unspecified zoster vaccine live (manufacturer unknown) "an injection" (dose, route, anatomical location, lot # and expiration date were not provided) to avoid shingles. On an unknown date after vaccination, the patient developed shingles in his chest (herpes zoster). It was reported that the shingles the patient experienced "was not that bad and was just a rash" and it did not result in post herpetic neuralgia (PHN) pain. The outcome of herpes zoster and the causality between the event and therapy with zoster vaccine live (manufacturer unknown) were unknown.
She got her vaccine, felt OK.  A day or so later she felt soreness in her arm which she expected.  On 5/15/23 she felt like she was walking sideway and went to her chiropractor and sitting in the office before she saw him she started shaking uncontrollably from chills and could not get warm.  She was out of alignment from her head down to the base.  By the time she got home her fever was 99 and later that day went up to 101.  She still had chills in between and fever of 99 off and on.  Her normal temp is 96-97, so if she has 98-99 it's a fever for her.  She has had a little bit of congestion, but not a whole lot.  She coughs, and also has a pressure on her chest like somebody had a hand on her chest.  She also has no energy at all, mainly been lying down and if she gets up and loads the dishwasher she is exhausted and has to lie down.  If she has to find her phone, she is short of breath and notices that she is breathing through her mouth and not her nose.  Her rib has gone out twice, and has to go back to the chiropractor a couple of times, and he said that those areas somehow are related to her rib.  She has had to sleep in her recliner as she feels better there.  She can't say whether she is worse, but she is not any better for sure.    She has not gone to her doctor, but she did call and asked about it and they told her that they had not heard of any adverse symptoms to the vaccine.  She does not normally take anything for pain and she has been taking Ibuprofen and seems to be doing OK.  When it becomes bedtime the symptoms get worse and that is why she has been taking the Ibuprofen and does not stay awake after taking that.  She also has lost weight during this time.  She finds it hard to want anything to eat, but has been trying to do 2 meals a day.  Sometimes it gets to be 7:30 or 8:00 and would find something to eat like cottage cheese or fruit.  She does not feel like cooking, and her husband will go get something, and she has a sensitivity to gluten and she is watching her diet really close due to her diabetes, and she cannot have a whole lot of stuff.
A health professional report has been received. The report concerns a 10 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on an unknown date. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT which started on 13-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter. 05-Feb-2014: Corrected report 05-Feb-2014 case suppressed as Medication Error with no AE.
A 51 year old male pt born on 1/14/56, was vaccinated after contact to bat with RabAvert in Sept 2006. On 9/30/06 he began to experience severe back pain, so that he was unable to walk or move. Furthermore he developed fever. The pt was admitted to hospital the same day. Radiographs, MRI and multitude of test had led to an unknown etiology for occurrence of the described symptoms. At time of reporting the back pain has not still resolved. Seriousness criterion hospitalisation, causality not related.