chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; The patient was inadvertently admnistered one dose of expire M-M-R II; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 06-MAY-2019, the patient was inadvertently administered one dose of expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (expired product administered) rHA, lot number N013866, expiration date 04-MAY-2019 for prophylaxis (dosage schedule, route, and anatomical site were not reported). The sterile diluent used to reconstituted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) one dose,  lot number N012922, and expiration date 15-OCT-2019, was not expired. No adverse effects were reported.
Vertigo and tinnitus, starting 12 hours after the shot and then decreasing progressively over the next 6 days. Then it returned quite strongly on day 7 and hasn?t stopped.
Immediately after the injection, I noticed it was administered very high - near my shoulder - which worried me. The dose was given around 2:30pm on 4/28 and around 2:00am, I had an unusual headache and a sore arm.  Shortly after 5am on 4/29, I had the worst migraine I have ever had in my life.  Migraine, nauseas, slightly dizzy and a dull, limp arm. The pain of the migraine was about a 9.  I had taken an Ibuprofen and tried to sleep the remainder of the day away.  By 6am on 4/30, the migraine was at a 6.  I got up to walk around a bit, eat and drink about 2 16oz bottles of water.  I felt dehydrated so I drank approximately 10 bottles that day and ate salads and fruit only.  I still felt nauseas. By 5/1, I just had a lingering, dull headache but no appetite.  I was back to 'normal' by 5/3.  The injection was administered to my left arm, fairly high, and that did not bother me until late day on 4/29.  My arm felt very heavy and dead.  I used my right hand to lift my left arm.  It was difficult to get my shirts on and off.  There was a constant pain but not intense; dull.  Over time, I massaged my arm, used a massage gun, used Salon Paas pads and cream, used ice and heat packs.  My arm is about 50% better but it is still giving my problems.  Sporadic, dull pain and I am not able to move it all of the way around or back.  I have a time sleeping on it at night so I don't.
Symptomatic, started on 7/9/21 with cough, runny nose, muscles aches, nausea, loss of smell & taste, sore throat, nasal congestion, fever, headache, fatigue abdominal pain, & ear ache.
The evening of receiving vax, the pt experienced a decreased appetite. Pt was awake every three hours all night and experienced several episodes of spitting up the next morning. About 1PM the day after receiving vax, the pt developed a high pitched cry that worsened throughout the afternoon. Pt was seen in ER by 8PM. Pt was treated with Motrin.
Nurse  attempted to vaccinate patient male, with Infant Moderna (6mo-5yrs) Dose #2. When nurse inserted the needle into patients Right Leg, the patient began to resist and move and mom was unable to keep him in a stationary position causing the vaccine dosage to not be fully administered. On the pateients right leg on and near the site of insertion liquid could be seen spilled as well as some being still on the syringe. Due to this it was determined the dose was incomplete and patient would need to be re-vaccinated with a full dose of Moderna (6mo-5yrs) Dose #2. Patient was vaccianted with Moderna (6mo-5yrs) Dose #2 on his Left Leg succefully, remained in the observation area for 15 minutes with no complications. Mom, was aware of the incident throughout the entire time, understood the reason for re-vaccination, agreed to the vaccination. Mom had no additional questions, was given the vaccine fact sheet and given information and instructions on what to do if patient were to develop vaccine reaction related symptoms.
Metallic taste in my mouth; This is a spontaneous report from a contactable Physician (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 07:00 AM at single dose in left arm for COVID-19 immunisation. The first dose of BNT162B2 was administered on 22Dec2020 at 06:00 AM at single dose in left arm. The patient was vaccinated at hospital. Patient age at vaccination was 32 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included psoriatic arthritis. The patient has no known allergies. Concomitant medication included adalimumab (HUMIRA). On 13Jan2021 the patient experienced metallic taste in mouth occurring daily but intermittently, started after first dose but now worse after second dose. No treatment was received for the event. The event had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has been tested for COVID-19 (nasal swab performed on 19Jan2021 which resulted negative).   Information on the lot/batch number has been requested.
Bruising, red pin spots all over body. Went to ER. Very low platelet count.
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (01035471). A contactable healthcare professional on behalf of a pharmacist reported similar events for 3 patients. This is 2nd of three reports. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration on Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient developed severe injection site redness, rash, and soreness in 2018. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018525839 same reporter, drug, event, and different patient; US-PFIZER INC-2018525857 same reporter, drug, event, and different patient.
Case number PHEH2013US025049 is an initial spontaneous report received from a nurse on 27 NOV 2013. This report refers to a female patient of unknown age. Past medical history and concomitant medication were not reported. On 25 NOV 2013, she was vaccinated with MENVEO (batch number: M11053) intramuscularly, which was stored at 47F for 48 hours before administration. No adverse event was reported following this administration error.
same day as vax pt exp soreness in arm, as time went on erythema was noted & expanded, pt also c/o feeling tired.
Within 20 hours I could not stand without help, trouble breathing, felt like body shutting down. From onset to admitting in ER time was probably 5 hours from onset. Told I had sepsis pneumonia, white count over 40000. Remained in hospital ICU for 5 days with treatment.
pt stated she started feeling very hot and had trouble breathing.  She was gasping for air and had rapid heart beat.  She felt like she was going to pass out.  She was gasping for air so she laid down.  This entire episode lasted about 10-15 minutes.  She was able to get up and was back to normal but still scared about the episode that happened and worried it would happen again.  Pt states she has not had any further episodes like this.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Fahrenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA006632.
pt devel arm pain & stiffness, w/diff moving arms, 10 days post vax
Breakthrough case admission after 4 vaccines Pfizer 2/2/21 Lot# EM9810;  Pfizer 2/23/21 Lot# EN6202;  Pfizer 11/4/21 Lot# 330268D;  Pfizer 10/13/22 Lot# FH9703
Patient experienced a seizure about 5 minutes after receiving the vaccine. No history of seizure activity ever.
1 day after booster shot my only side effects were associated arm soreness. Second day after shot my arm and armpit were sore, but I experienced some chills and general ill feeling. The third day after I began experiencing tremors in both my hands while at work, and was having hot flashes followed by dizziness/lightheadedness throughout my shift. Now, four days after the shot, I still have soreness and swelling in my armpit and some tremors in my hands.
third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) (batch number kb97c, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 19th August 2021, the patient received the 3rd dose of Shingrix. On 19th August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received 3rd dose of Shingrix, which led to extra dose administered. No further events were reported.  The health care professional agreed to be contacted only via email for follow-up.
feeling uneasy; BP was 150/80; confused; anxiety; flush through my whole body; shaking; didn't feel "right"/felt funny; This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 (at 46 years old) as single dose for covid-19 immunisation. Medical history included ongoing hypotension and ongoing hoshimoto's disease. The patient's concomitant medications were not reported. The patient experienced feeling uneasy, bp was 150/80, confused, anxiety, flush through her whole body, shaking, didn't feel "right"/felt funny all on 19Feb2021 with outcome of unknown. The HCP told patient to take a diphenhydramine hydrochloride (BENADRYL) beforehand, and her cardiologist also provided her with a prednisone dosepak. Clinical course was reported as follows. About 10 minutes after receiving her first dose, the patient reported reactions that "hit her so hard, out of no where" including flushing throughout her entire body, shaking, feeling uneasy like "something is happening".  She tried to cool herself down by taking off her coat. She did not require an epipen. When EMS arrived, her BP was 150/80 mmHg which is out of character for her, as she normally has a BP of 80/40 mmHg (very low, almost "Dead").  She also reports that she "didn't feel right" for the rest of the week following vaccination. She was very confused, didn't feel "right" and had these anxiety/felt funny for a week afterward.  She also reported having Hoshimoto's disease. The people at the vaccination site thought maybe it was anxiety or a panic attack.  She was nervous about receiving her second dose on 12Mar2021.
Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis; Felt very tired after first Booster; Swollen in neck after first booster; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swollen in neck after first booster), LYMPHADENOPATHY (Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis) and FATIGUE (Felt very tired after first Booster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. NDPE 939903, 032M20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Tongue dry in 1999. Concurrent medical conditions included Atrial fibrillation, Blood pressure high and High cholesterol.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING (Swollen in neck after first booster). On 26-Oct-2021, the patient experienced LYMPHADENOPATHY (Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis) and FATIGUE (Felt very tired after first Booster). At the time of the report, SWELLING (Swollen in neck after first booster), LYMPHADENOPATHY (Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis) and FATIGUE (Felt very tired after first Booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: Biopsy ruled out cancer after first booster. In 2021, Computerised tomogram: CT Scan Confirmed larger than normal numerous ones after first booster. In 2021, Ultrasound scan: Ultrasound revealed level 4 carotid canal after first booster.         The patient did not have her medication list on her. No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2022-581493.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Follow-up contains no new information.
his arm is redder; his arm / swelling; his arm / is spreading warm to touch; This case was reported by a other health professional via interactive digital media and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2020, the patient received the 2nd dose of Shingrix. On 23rd August 2020, 3 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and skin warm. On an unknown date, the outcome of the erythema of extremities, swelling arm and skin warm were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient arm was redder and swelling was spreading warm to touch. The patient asked to put cold or warm compress on the site.
Arm was red and warm to the touch slightly swollen. I told her to watch over next 24 hours if does not get better or symptoms get worse seek MD treatment.
This spontaneous report as received from a physician refer to a patient of unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On 22-FEB-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB of lot # K008988 and expiry date: 04-FEB-2016 (route, dose# and indication not reported). Concomitant therapy was not mentioned by the reporter. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22. When error discovered facility contacted for course of action. At direction, patient outreached regarding occurrence to offer re-vaccination of dose. No adverse side effects or event as result of dose.
GENERAL PERCEPTION FELT DIFFERENT; POUNDING/RACING HEART PALPITATIONS; A WEIRD, HOT CRAWLING SENSATION INSIDE HEAD; DIARRHEA; WEAKNESS; WORST HEADACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced general perception felt different. On MAY-2021, the subject experienced pounding/racing heart palpitations. On MAY-2021, the subject experienced a weird, hot crawling sensation inside head. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced worst headache. On MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pounding/racing heart palpitations, a weird, hot crawling sensation inside head, diarrhea, worst headache, and chills on 08-MAY-2021, and had not recovered from weakness, and general perception felt different. This report was non-serious.
No reaction other than soreness until this morning when the injection site started to itch, there is a hard lump, and it feels hot. This afternoon there was a second spot a bit lower that is now also red< hot and itchy with 3 smaller bumps that look like hives.
Extreme body aches for 24 hours. Lower back pain. Nausea. Headache. Chills. Low grade fever.
a red area on her arm; a rash, it was 7 inches long and now it is dissipating; had her arm a little sore for 2-3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had her arm a little sore for 2-3 days), VACCINATION SITE ERYTHEMA (a red area on her arm) and VACCINATION SITE RASH (a rash, it was 7 inches long and now it is dissipating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (had her arm a little sore for 2-3 days). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red area on her arm) and VACCINATION SITE RASH (a rash, it was 7 inches long and now it is dissipating). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 21-Jan-2021, VACCINATION SITE PAIN (had her arm a little sore for 2-3 days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (a red area on her arm) and VACCINATION SITE RASH (a rash, it was 7 inches long and now it is dissipating) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
enlarged tender lump in l axillary area - size and pain level varies day to day- most pain ever was about 4/10;  appeared around first of August, first seen by NP for evaluation on Sept  16.2021; monitoring only for now since negative mammogram and US
Blood pressure went to 250; Almost past out after receiving vaccine; Tingling sensation in hand and arm; Light headed; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood pressure went to 250, light headedness, tingling sensation in hand and arm, almost passed out after receiving vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced the event(s) light headed, tingling sensation in hand and arm, almost past out after receiving vaccine. Her blood pressure was reported as high 250/XXX mmHg. The patient forgot the diastolic number. No treatment information was provided.  On 09 Mar 2021, the patient visited her primary physician office where they checked her EKG. The results were normal. The blood pressure was at 142/86 mmHg. The patient's doctor stated that she should not take the second dose based on her medical records.  Action taken with mRNA-1273 in response to the events was drug withdrawn.   The outcome of events, light headed, tingling sensation in hand and arm, almost past out after receiving vaccine was unknown.; Reporter's Comments: 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.
My 15 month daughter was given 2 shots on 8/28/2012. (Hib and DTaP). My daughter spiked a temperature of 102.9 *F and was told by the Drs office to go to the ER. She was taken to the ER where they gave her 5 ML of ibuprofen to bring the fever down. on 8/31/2012, she broke out in a rash all over her body. Again, the Dr was called and we were told to take her to the ER.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine "did" function as intended [considered to mean the vaccine did not function as intended], and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by a physician at a family health clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Felt tenderness L upper arm while showering 10/25/07. Then, felt warmth and tenderness and area raised approx size of orange in Left upper arm.
I got the vaccine and about 15 minutes later I felt a little dizzy. My pressure was checked and it was very high. I believe 175/120. I ended up having to go to the ER. Doctor believed it was a reaction to shot.