chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site discolored; Injection site pain/ Injection site tenderness; Injection site redness; Injection site warmth; Injection site itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, 5 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site itching. On an unknown date, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site itching and injection site discoloration were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site itching and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The symptoms continued to get worse over the next few days until the red area was about 6 inches in diameter. The pain was tenderness to the touch. The site was still a little tender, discolored and a little itchy, but the symptoms are getting better daily till the time of reporting. The reporter did not consented to follow-up
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357.
Patient states that she suffered from posterior headaches describes as heaviness, nausea, diarrhea, and fatigue. Thinks she may have had a low grade fever. The nausea and diarrhea resolved within a couple days. Headache ongoing, but improving.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (strength, dose, route, lot# and expiration date were unknown), which were improperly stored. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced severe soreness in the injection site on 10/13/15, then swelling and redness about 3 inches in diameter in the injection was observed the following day and had feverish and cold feeling, weakness and flu like symptoms was experienced the next day. Patient was referred to the physician on the 3rd day 10/15/15 and was given antibiotic.
Initial unsolicited report received from a non-healthcare professional (office staff) on 17 October 2016. This case is linked t to 2016SA191696 (same lot number, same reporter) This case involves a 14 year female patient who was vaccinated with a dose of FLUZONE QIV (lot number: u16848e, expiration date, route of administration, dose and dose in series were not reported) on an unspecified date. The medical history was not reported. It was reported that patient had shot 4-5 years in a row with no other year having trouble. Concomitant medications were not reported. On an unspecified day, following vaccination, the patient complained of severe myalgia and the patient had UTI (urinary tract infection) which was found out in blood work. It was reported that "it was severe enough that you couldn't touch her". Other laboratory test were not reported. Patient sought treatment for severe myalgia (unspecified). On an unspecified date patient recovered from the events (reported as patient was fine now). List of the documents held by sender: none.
received the second dose of Shingrix vaccine in the joint of the arm and not in the deltoid; that a patient complained an had pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 15th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced pain. On 15th February 2020, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provide as follows: No information provided from first dose of Shingrix was provided. The batch number was provided N2376, however was updated to N2E73 as per sales data sheet. The pharmacist reported that a patient complained pain as received the dose of Shingrix vaccine in the joint of the arm and not in the deltoid, which led to vaccine administered at inappropriate site. Consent to follow up was provided.
Patient experienced palpitations, nausea, headache, along with redness and swelling from the injection site towards her anterior axilla about 1 hour after the injection was given per her. She did not report this reaction until 2/24/20. At that time, she had bruising and a knot at the injection site. Other symptoms had subsided per her. She was advised to report these symptoms to her PCP.
Large  red area at injection site also smaller red blotches below the large area, Seems to be getting worse and covering more of my left arm. Feels warm to the touch, itchy, my arm is sore to the touch at injection site.
Received MMR, Hib, and varivax 05/20/02 about 10 days later broke out with five small vesicles on arm.
Gardasil shot was given.  Pain starting in arm of injection site, quickly moved to shoulders and neck. Within two days it included the entire back and hips. Now, nearly a week later it is painful for her to walk and she is complaining that her entire body feels as if it is bruised. 4/8/09-records received-offcie visit 3/26/09-chlamydia positive. First gardasil vaccine received. Oral contraception.  5/1/09-records received for telephone call from parent, C/O headaches, pain and weakness for several days after injection.
TRIGEMINAL NEURALGIA (TIC DOULOUREAUX) / ATTACKS OF SEVERE FACIAL PAIN LASTING SECONDS TO MINUTES / LEVAQUIN 500MG ONCE DAILY /TYLENOL/COND #3 ONE TO TWO THREE TIMES DAILY.
Soreness / Pain in my arm; Light headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness / Pain in my arm) and HEADACHE (Light headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included RISPERIDONE (RISPERDAL), BENZATROPINE and PROPRANOLOL for an unknown indication.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN IN EXTREMITY (Soreness / Pain in my arm) and HEADACHE (Light headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness / Pain in my arm) and HEADACHE (Light headache) had not resolved.            Patient reported that she experienced symptoms on the next day morning after the vaccination and is currently ongoing.
This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-month-old male patient. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date, at 12 months of age, the patient received initial doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), hepatitis A virus vaccine live, influenza virus vaccine (unspecified) and pneumococcal 13v conj vaccine (crm197) for prophylaxis (dose, route and site of administration, lot# and expiration date were not provided for any of the vaccines). Fifteen minutes following administration he developed coughing, pruritus, and facial/lip angioedema. He was evaluated in an emergency department (ED) and received intramuscular epinephrine for presumed influenza virus vaccine (unspecified) anaphylaxis secondary to egg hypersensitivity. Three months later, he developed cough and facial/lip angioedema within five minutes of his 15-months immunization with varicella virus vaccine live (oka/Merck) (manufacturer unknown), Hib conj vaccine (unspecified carrier) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, route and site of administration, lot# and expiration date were not provided for any of the vaccines). On an unknown date, at 17 months of age, the patient was referred for evaluation of anaphylaxis to vaccines. Skin testing was positive for gelatin (11mm), egg (9mm), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (5mm) and varicella virus vaccine live (oka/Merck) (manufacturer unknown) (9mm) and negative to influenza virus vaccine (unspecified) (3mm) with appropriate histamine and saline controls. Radioallergosorbent Testing (RAST) was positive to bovine gelatin (25.1kU/L) and negative to egg. The outcome of the event was not reported. The authors concluded that the patient was sensitized to gelatin, and reacted to gelatin-containing vaccines. They mentioned that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/Merck) (manufacturer unknown) vaccines contain over 10000 micrograms of gelatin per dose, and influenza vaccines include much smaller amounts. The authors considered the event of anaphylactic reaction to be related to vaccines which contained gelatin: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), varicella virus vaccine live (oka/Merck) (manufacturer unknown) and influenza virus vaccine (unspecified). Upon internal review, the event of anaphylactic reaction was considered to be medically significant.
The first thing that happened was that I got really bad chills and aching all over my body. I was feeling nauseous and just really run down and tired. I basically slept for 3 days. From what I remember, after the third day, the chills started wearing off as well as the aches. By the 4th day they were both gone. But the tiredness persisted. I feel like it?s gotten worse. I feel like I can?t fight the feeling of tiredness. I feel like I have to take naps because I just can?t function. After months went by, I knew something was wrong so I went to the doctor and he did blood work on me. The blood work showed that my iron was low but that was the same from 6 months ago, so he said it didn?t cause this because I?ve never been this tired before. There was also a fecal test, and he scheduled me for a sleep study to see if I had sleep apnea ? I?m going to my appointment this week on Thursday 10/21/2021. Then I?m due with a follow up appointment for the results a week after that.
After the first dose of Moderna, 6 hours after taking the COVID19 vaccine the following side effects started: sore arm(swelling feeling at the shot arm), fever, aches throughout body, tired,  and chill.  It lasted for 2 days and suddenly on the 3rd day, a pain under armpit with a lump (the same left arm where the vaccine shot).  That lasted for 2-3 days.
no other issues or concerns noted; a patient was administered an expired dose of ROTATEQ on 01-FEB-2022; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 01-FEB-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as prophylaxis (strength, dose, frequency, and route of administration were not reported; lot number T028131 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent with expiration date on 31-JAN-2022) (expired product administered). No other issues or concerns noted.; Sender's Comments:  US-009507513-2202USA000490:
Patient is 11 years old and was given Pfizer for 12+. No adverse reaction noted.
I received the shot during a prenatal check up and ultrasound that reported no abnormal findings.  Three days later at 21 week pregnant, my water broke and I was in preterm labor with a high grade fever. We went on to lose our son days after the shot( which we we pressured into after refusing it three separate times at the same appointment, and finally giving in). The FDA and CDC has since acknowledged this is a side effect of flu shots in pregnant women.
I got vaccine 3/26/07. On 4/14/07 I notice 3 pimples on my right shoulder. By 4/17/07 there was 2 on my shoulder blade on the 4/18/07 it was all over my back and on my right forehead one under my right nose and one on my left eyebrow. I went to emergency room on 4/20/07. By this time the first outbreaks were getting scabs.
Extreme chill for about 12 hours. Then felt extremely hot for about 24 hours. Whole body ached. Shakiness for bout 3 days.
One minute after the vaccine was given to this patient, she lost consciousness for 5 seconds, involuntary clonic tonic movements of arms and legs, her eyes rolled back and fluttering. Inhalation and exhalation throughout. Skin moist and warm face and trunk. Hands moist and cool, lips pink. No paleness and memory of what happened, no history of seizure disorder.
Sweating Arm pain  Body aches Sore throat Dry cough Fatigue Abdominal pain  Diaphragm pain Congestion Tightness in chest Red mark on arm (10 days later)
Patient had received the first dose of the suspect medication on 04/09/2019. Upon receiving second dose on 07/18/2019 came to ER on 07/19/2019 because of vomiting, nausea and fever.  Fever & NauseaVomiting
Patient presented to urgent care on 1/9/2021 after receiving second COVID-19 vaccination. Patient stated that she had an enlarged tender lymph node in left axilla. Patient endorsed no familial history of cancer. Patient was told to monitor area, there was no further escalation of care.
11/20/2022, during the day, I developed a severe sinus infection. I had post nasal drip, sinuses were stopped up, ear was ringing, I had a cough. It progressively started to get worse, so I went to the doctor on 12/09/2022.
chest pain starting 2am on day following second Pfizer COVID dose, advised pt's mother to contact physician for guidance. pt's mother states severity has decreased since that time. Mother reported it to pharmacy at 11:30am.
Marked swelling, induration and tenderness. Was very red, but redness resolved over the weekend.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patient's developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 7 year old patient who on 6/17/96 was vaccinated with a dose of varicella virus vaccine live. On 4/12/03, the patient developed chicken pox. The previously vaccinated patient's including two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Triggered Migraine headache within 30 min.  Within 6 hrs large red circle on upper arm. Within 11 hrs very large bullous areas appear and continue to grow over the following 12 hours  Currently  the several large blisters have joined into one  very large one that is 2" long by 2" wide by 1/2 " high  I would like to submit photos.  Please let me know how I can do this.
2 days post intramuscular vaccine pt. returned to clinic with +. swollen red, hard lt. deltiod. Associated with + pain, +paresthesias, +itching, no discharge or pus visible. puncture marks with peripheral bruising at area oblong 8*2.5x 5.5 inches. increase compare lt. in circumference of arm by 2 inches.
Per patient - "chest pain, SOB , dizziness, headache, foggy, inflammation of lungs"
This spontaneous report was received from a physician refers to a 61 year old male patient. On 06-SEP-2011, the patient was vaccinated with a single dose of 0.65 ml ZOSTAVAX subcutaneous injection, (lot number reported as 669866/0360AA, expiration date as 09-SEP-2012, Batch number 9989115). Concomitant medications included CRESTOR, hydrochlorothiazide, HYZAAR, omeprazole and VERAMYST spray. In December 2011 ("3 months after the vaccination was initiated"), the patient experienced flushing from head to trunk lasting 3 hours in duration several times per week. Though the symptoms had subsided in the last 6 to 9 months (approximately January or April 2012)< but had not stopped completely. The outcome of the event was reported as recovering at the time of this report. The patient sought medical attention (office visit). Additional information has been requested.
choking on the blood.; nosebleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Apr2021 14:30 (Lot number: EN6206) at the age of 44 years as dose 2, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Relevant medical history included: "Breast Cancer IDC, stage 1", start date: 2018 (unspecified if ongoing), notes: no lymph involvement. Concomitant medication(s) included: ZOLOFT. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer/EN6207, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 19Mar2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "started menstrual bleeding that lasted continually for 68 days", "severe headaches", "Migraines". The following information was reported: CHOKING (medically significant) with onset 2021, outcome "unknown", described as "choking on the blood."; EPISTAXIS (medically significant) with onset 2021, outcome "unknown", described as "nosebleed". The events "choking on the blood." and "nosebleed" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: test type Nasal Swab. Therapeutic measures were taken as a result of choking, epistaxis. After the second dose of the Covid vaccine the patient was taken to urgent care for a nosebleed that would not stop. It was so severe that the patient was choking on the blood. The treatment of the event included Nurtec, Nose packed, Ibuprofen.  No follow-up attempts are possible. No further information is expected.
No adverse event occurred, just reporting vaccination error in giving a third Shingles dose, state Immunization System showed only his first dose so the pharmacist on duty gave an additional dose (based on the system showing only one prior dose given on 2-15-22
11FEB93 fever (low grade); 12FEB92 red, macular, papular rash (face & trunk) & some petechiae; 15FEB93 bad cough, high fever; 15FEB92 adm to hosp-TM's red bilaterally; nares thick yellow discharge; eyes injected bilaterally; lips parched;
A pharmacist reported that his infant son received his third dose of Prevnar along with DTP (manufacturer unknown) on an unspecified date at approximately 6 months of age. The infant's medical history includes a milk protein allergy and rectal bleeding. On day post vaccination, the infant developed mild rectal bleeding that lasted about 3 days. No further information was available at the date of this report. The infant developed rectal bleeding following receipt of his first dose of Prevnar at approximately 2 months of age and his second dose of Prevnar along with DTP (manufacturer unknown) and Motrin (ibuprofen) at approximately 4 months of age (see MCN HQWYE482905JUN03 and MCNHQWYE192006JUN03).
Whole left arm under injection site became swollen with a big lump that turned red and was hot to the touch which didn't go away until 9/6. Got fever of 104 all through the night with body aches chills, and sweat shakes,  and a pounding headache (the headache lasted 2 days)
Chills, cannot get warm.  Every joint aches. It is painful to move.  I have extreme fatigue.   I still have these symptoms and they don't seem to be going away or easing up.  I have not sought treatment for these symptoms.
pt recv vax 10AM & 2PM t103.2 ax; suggested tepid bath, APAP & call MD; did not see MD-but said to cont tx; 10PM t104.6 A: vomiting 3x @ noc; called ER @3AM; t105.8 A; did not go in; 19APR saw MD, t99
patient was administered the vaccine too low and experienced swelling below the injection site, localized reaction from vaccination, and cellulitis.
73 yr old patient received Infanrix instead of Boostrix today; 73 yr old patient received Infanrix instead of Boostrix today; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 73-year-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 10-NOV-2023, the patient received Infanrix. On 10-NOV-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: 73 yr old patient received Infanrix instead of Boostrix today) and inappropriate age at vaccine administration (Verbatim: 73 yr old patient received Infanrix instead of Boostrix today). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Nov-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received Infanrix instead of Boostrix on the day of reporting at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.