chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an approximately 65 year old female patient with type 2 diabetes and high blood pressure. The medical history of the patient included shingles. On 24-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) in the left arm. Concomitant therapy included meloxicam of 15 milligrams (mg). On 28-MAR-2013, she noticed that she was not able to use her left leg as normal. She thought it was her shoe or heel that was broken. She stated that in the next few days her symptoms became progressively worse. On 28-MAR-2013, she started to feel weakness in her thigh muscles in both legs. Approximately since an unknown date in April 2013 (reported as now), she was reduced to using two canes for walking. Approximately on 10-APR-2013 (yesterday), she took a fall due to the weakness in her legs, just buckled on her and caused her to fall on her face. She was going to be seeing a specialist (spinal Specialist). It was enquired if her if symptoms could be attributed to ZOSTAVAX according to the prescribing information. The patient did not seek any medical attention. She was treated with hydro/acetaminophen for the pain. On 01-APR-2013, magnetic resonance imaging (MRI) was performed and the result was unknown. Outcome of reduced to using two canes for walking was reported as not resolved. Outcome of weakness in her thigh muscles in both legs and fall due to the weakness in her legs was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
DVT in left lower extremity requiring hospitalization. Patient had history of alcoholic cirrhosis and was not hypercoagulable. Hypercoagulability labs were all negative. HIT panel was negative. Pt had extreme LLE pain.
After administration of vaccine, we were notified by local Authority that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  As of this report, the patient has not returned for revaccination.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of PROQUAD, subcutaneous, lot # M021428 with expiry: 29-OCT-2017, for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature of 22 degree Fahrenheit for 4 hours 23 minutes. It had a previous temperature excursions of 32 degree Fahrenheit for 2 hours 5 minutes. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005501.
Suspected vaccination failure/our neighbor got the shingle vaccine and ended up getting; ended up getting the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: This case received from the patient's neighbor via interactive digital media. The reporter's neighbor got the shingle vaccine and ended up getting the shingles, the physician made money and kick backs for administrating these drugs. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR119927, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR119927:Same case/Same reporter
Medical assistant reported VAXELIS was administered after a temperature excursion (8.8°C); This non-serious spontaneous safety report with reference number 02354967 was received by a partner on 16-MAR-2023 and forwarded on 17-MAR-2023 from a HCP.  Due to the nature of the event, the causality between Vaxelis and the reported event "Medical assistant reported VAXELIS was administered after a temperature excursion (8.8°C)" was not applicable.  Further information is expected.
Pt was given a dose of the Baby Pfizer (6m-4y) vaccine accidentally. Should have been given Pedi Pfizer (5y-11y). No adverse signs or symptoms.
8/29/02 Patient was presented with mother to health department where he received Hepatitis B, Td, IPV, and varicella IM and SC. Mother indicated no problems with previous immunizations. Patient admitted to ER with apparent seizure in AM.
Red spot where injected over a week after getting vaccine. Slightly itchy. A little bit raised. Not painful.
covid vaccine breakthrough case   dose 1 Pfizer 2/12/21  EL9269 dose 2 Pfizer 3/5/21  EN6202
This was patients first HPV. Has never had a vaccine reaction before. Had not had breakfast today. She was sitting on exam table after Tdap, HPV and MENACTRA were administered when she told mother she was feeling faint, mom moved close to her and held her in her arms and nursing staff was alerted,  our office emergency response was activated and a series of vitals sign measurements were made, patient was made to lie down supine, while being observed. Her HR remained less than 60/min, in order to take a repeat BP she was assisted to sit up, HR then returned to normal range. She was observed further in room and discharged home since she continued to be stable.
Pt started running elevated temp about 8PM night of the day shot was given; During the night, temp went to 103 & pt would not stop crying; Pt was listless for 3 days p/shot & was irritable for 5 days p/the shot;
Patient came in to receive her 2nd Pfizer Vaccine on 3/23/2021 and was given Moderna in error. Patient has not reported any adverse reactions. This report is for reference only at this time.
Information has been received from a health professional concerning a 37 year old white female with no allergies or medical conditions who on 2/18/04 was vaccinated SQ in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647797/0987N). There was no illness at the time of vaccination. Subsequently the patient experienced arm sensitivity, swelling of the arm and a large red area about 5cm. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the patient's large red area about 5cm, arm sensitivity and swelling started on 2/20/04. There were no labs or diagnostic tests done and there were no serious effects. The patient recovered. Another patient had the same experience after vaccination with pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
First vaccine :Heavy period with clots; First vaccine :Heavy period with clots; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (medically significant), HEAVY MENSTRUAL BLEEDING (medically significant) all with onset 10Oct2021, outcome "not recovered" and all described as "First vaccine :Heavy period with clots". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative. Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be excluded based on temporal association and available information. 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.
Broke out in rash on abd, hands, arms, neck. Very itchy, red spots-small blisters. Lasted approx 1 week with low grade fever. Few on legs. No treatment.
Initial unsolicited report received from a consumer (patient's friend) on 5 October 2015. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced pain upon vaccination and when needle withdrawn had bleeding and small drop of clear fluid at site. It was reported that, the patient went for FLUZONE HD vaccination but was not sure which flu vaccine he received and he also thought that it looked like more than 0.5 ml dose. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Day after receiving vaccine started having R arm pain below injection site, very sore to move arm up and traveled to R side of neck.  Today 1/21/21 woke with fever of 100.3 fluctuated to 100.9, headache, still with R arm & neck pain.
Severe generalized welts ranging in size from 5 mm diameter to 12 inches X 4 inches (belly to knee, neck to diaper line & shoulder to elbow).  Would go away and return in new locations. Not itchy.  Afebrile. Good generalized demeanor of child but slightly irritable and warm.  Diphenhydramine 10 mg given ~q12 hours  - did not appear to help. First welts appeared ~28 hrs after vaccination and continued for 3 days.
intermittent chest pain, shortness of breath, dizziness, and arrhythmia starting 3 days after receipt of Pfizer Covid vaccine.
temp 105 (104.5); febrile sz, chicken pox type rash;
Nausea, tired, malaise, 1/27/2010 given vaccine 400p 1/26/2010.
stabbing pain in the back that feels like fire; chest hurts; arm is numb; arm is tingly; feels like she is hungover; heat/hotness at the injection site; arm is swollen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly) and FEELING ABNORMAL (feels like she is hungover) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly), FEELING ABNORMAL (feels like she is hungover), VACCINATION SITE WARMTH (heat/hotness at the injection site) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly), FEELING ABNORMAL (feels like she is hungover), VACCINATION SITE WARMTH (heat/hotness at the injection site) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment medications were provided
When hands under water, feels like "little needles poking my hands", "ultra sensitive" day after H1N1; reported 11/23/09, December 21, 2009, still no change
Patient received his COVID-19 vaccine, the Johnson & Johnson brand, on 9/16/2021.  Following his vaccination, he has had worsening ascending weakness and paresthesia in the bilateral lower extremities.  This initially worsened to the point of requiring a cane, but as of 9-22-2021 he is unable to walk.   In addition, he has noted weakness of the facial muscles and trouble with speaking, swallowing, and breathing.  All of the symptoms have been persistent and worsening over the last several days.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. Patient was seated on exam room table after receiving a dose of TRUMENBA, her face turned white so they laid her down. She recovered in approximately 5 minutes and was able to leave office on her own accord. The outcome of the event was recovered.
severe chills for several hours, moderate fever for several hours, mild fatigue and body aches for several hours
Shingles vaccine given evening of 5-16-19 - one day later I experienced a bad headache, all over body aches, extreme fatigue, nausea and diarrhea for 48 hours or more.
Morning of 7/17 - itchy, swollen, hot, tender 3" by 4" in area of injection. Called MD 7/17 - diagnosed as cellulitis, rx written for Cefadroxil 500 mg bid x 10 days follow-up if need after 10 days or worse.
pt recv vax 11JUL97 2PM-@5PM arm fatigued, severe h/a @ 10PM became nauseous;took Relafen;felt a little better p/MN;felt fine next day;
Child broke out in hives around injection site, this happened immediately. Dr gave Claritin, Pt monitored for 1 hr sent home and told to give Benadryl Q4.
2:30pm - under tongue and tongue tingling. 2:45pm - mouth and tongue swelling.  300pm - slight fever - 99.5 and eyes irritated and gumming up- 4pm - mouth swelling making swallowing diffucult - eyes really gumming up - fever of 100.8.  500PM - some body temperature issues (shivering then sweating) - fever the same - breathing not an issue, swelling of tongue and mouth not getting worse, shoulder injection site slightly painful but no redness.  8PM - swelling going down, eyes not gumming up, temperature 100.5. Sweated a lot during the night.  Did not take any medicine, just drank water and had some lite food night of the 9th. Fatigue on the 10th, some shoulder swelling and pain.  night of the 10th more night sweats. all other symptoms gone during the day of the 10th.
I started having symptoms 12/31/2021 I went to have a Covid test on 01/02/2022 but tested negative. Three days later on 01/05/2022 I tested positive. Dr. he prescribed multiple vitamin supplements, Zpack,  Albuterol, and Fluvoxamine.  I have recovered but I still have fatigued and cough.
had a blood work and his MMRII and VARIVAX titers were negative; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and with varicella virus vaccine live (oka/merck) (VARIVAX), both for prophylaxis (dose, dose number, route of administration, anatomical injection site, lot number and expiration date were not reported, for both suspect therapies).   On an unknown date, the patient had a blood work and his measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) titers were negative  (antibody test negative). If was unknown if the vaccines were administered on the same date that the blood work was done.  At the reporting time, the outcome of antibody test negative and the causality assessment between the event and the suspect therapies were not reported.
Immediately after vaccine administered, his eyes rolled back in his head, placed him on the ground and he regained consciousness.  BP 120/87, hr 72. He said he only slept a few hours and had a history of fainting after flu shot. He ate a snack and drank water and felt much better . He left after 30 minutes observation.
pt recvd vax;hives x 5 days p/ vax;red spots on arms;saw dermatologist; prednisone for large red,purple & bruise marks on legs,arms,trunk; no info;
Bumps on belly, back, low grade temp, and headache. Dx with Atypical chicken pox.
Parents state that child began with runny nose 20 minutes, post vax, and within 12 hours, was seen by MD, an IHC Provider, where X-rays were taken and a dx of bacterial pneumonia was made by MD. Treated with antibiotics.
Arm swelled and was red.  Size of orange.  Fever of 101.  Hoarseness.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and allergies were not reported. On unknown dates, the unspecified patients were vaccinated with (Merck) PROQUAD, (lot # L017140 with expiration date: 13-NOV-2016), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. Other suspect and concomitant therapies were not reported. No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Tested positive for covid; Tested positive for covid; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. He tested positive for COVID-19 on unknown date. The second dose was rescheduled for 18Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient recieved vaccine at 10am. Reaction did not occur until 2 pm.
Temperature 103.6 - irritability for 48 hours.  Onset for 24 hours 3/25/08 8 hours post immunization.
muscle twitching all over body: triceps, biceps, forearms, hands, shoulders, back, chest, neck, calves, thighs, glutes, feet - this has lasted for 3-4 months  general muscle weakness - this has been noticeable since April  weakness and atrophy in right hand - this has been noticeable since June  neck pain - lasted 2-3 months, started in June/July timeframe  none of these issues existed prior to vaccination
Client started with a rash on 6/2/2014 on her face and sides. She went to her PCP on 6/23/2014 and was diagnosed with strep throat and given ATB as well as prednisone. On 6/17/2014 her legs started swelling and then on 6/30/2014 her arms and joints started welling and becoming painful.
Patient was thought to have a sinus infection post 2nd dose administration treated with first Zpack then Augmentin. Symptoms only slightly improved with left sided facial palsy, temporal swelling, "tightness" to forehead, feeling pain in lymph nodes, and a cold sensation to spinal cord around thoracic area. Was treated with Prednisone which improved facial movement but not much else.  Patient has been to ER twice and all work-ups have been negative.
FLUZONE QIV NP PFS, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA057733(CLUSTER) and 2023SA057309(CLUSTER).  This case involves adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  Outcome:  Unknown for both the reported events   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 the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.