chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- headache and tinnitus started 2 days after H1N1 vaccination, increased blood pressure since then as well. - headache resolved, BP still elevated and still has tinnitus
7/2: Initial itching around injection site; swelling to size of her hand that evening and became very hard. She went to the ER where she received ice and ibuprofen. She had a fever of 101.1F that night at home. Pain and swelling continued and increased. She had pain travel up to  her shoulder blade and arm pit. 7/3: Went to local urgent care and was told to ice and elevate (they wanted to do a cortisone injection, however, the patient has uncontrolled diabetes and they did not think this would be wise). 7/6: She was feeling better. 7/8: Pain returned but was up into her neck. She could not turn her head or lean it up or down. The outside of her neck hurt when she swallowed. Throat is not swelling and no difficulty in breathing, just "horrible" pain. 7/13: arm is feeling better, just sore and tender. Neck still hurting.
Fever 102-103. Inconsolable crying. Excessive sleeping over the next 3 days.
I received the shot at 3:00 pm and by 8:30 I was achy and nauseous. I decided trying to take Tylenol to help alleviate my pain would just come back up as vomit. Within the next hour I had became increasingly nauseous and my hand started to cramp up and go numb. I couldn't move my hands. My husband then decided to call the E.R. and ask if this was a common reaction and they recommended we come in. We got to the hospital and my left hand had started getting feeling back and moving but my right hand had not. They preformed a neurological test and ruled out a stroke and that it was happening on both sides of my body. The ended up giving me a dose of tordol and a shot of antihistamines and sent me home with a prescription for ibuprofen.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 77-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2011, the patient was administered the ZOSTAVAX by a healthcare provider (not further specified) at a facility (lot number, dosage and route of administration not provided). On or about 24-MAY-2013, the patient was treated by a physician at the facility for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a nurse referring to a 12 month old patient of unknown gender. The patient's concomitant medication, medical history and drug allergy were not reported. On an unknown date, the patient received a dose of PNEUMOVAX 23 (route not reported, lot# and expiration date unknown) for prophylaxis (inappropriate age at vaccine administration). No adverse effects were reported.
Information has been received form an healthcare worker (also reported as an office administrator) concerning a 25 year old female patient who in May 2008, was vaccinated with the third dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. On a date reported, the patient was seen by an orthopedic surgeon for pain at the shoulders and knees and numbness in ankles and feet. The orthopedic surgeon was unable to find the cause and referred the patient to another orthopedic surgeon. As of 12-AUG-2008 the patient's symptoms persisted. Additional information has been requested.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Within the next 24 hours I experienced swollen lymph nodes in my neck and under my arms; Within the next 24 hours I experienced tender lymph nodes in my neck and under my arms; Within 15 minutes of receiving the vaccine my eyes felt not normal.; Throat tingled; My eyes were very sensitive to light, more so than normal even wearing sunglasses; My eyes appeared to be fully dilated; I "felt off " for the next 10 days; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 22Feb2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and known allergy to penicillin and intravenous iodine lab dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, telmisartan (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), ezetimibe (MANUFACTURER UNKNOWN) and dapagliflozin propanediol monohydrate (FARXIGA); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021 at 09:45; within 15 minutes of receiving the vaccine, the patient eyes felt not normal and throat tingled, but did not progress to anything approaching serious reaction. The patient waited for another 15 to 20 minutes and returned home. On the same day, her eyes were sensitive to light more so than normal even wearing sunglasses. Shortly after, the patient's granddaughter noticed that the patients' eyes appeared to be fully dilated. They remained fully dilated when the patient went to bed at 22:30. On 24Feb2021 at 06:30, she checked her eyes and they were no longer dilated. On 24Feb2021, the patient experienced swollen and tender lymph nodes in neck and under arms. The patient felt "off" for the next 10 days. The patient saw primary care physician on 10Mar2021 and she advised not to take the second vaccine dose which was scheduled for in 16Mar2021. The physician was most concerned that the dilation of eyes was a neurological reaction and given the other symptoms, a second dose could prove more adverse. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event eyes appeared to be fully dilated was resolved on 23Feb2021, event felt off for the next 10 days was resolved on an unknown date in Mar2021 and the events eyes felt not normal, throat tingled, eyes were very sensitive to light more so than normal even wearing sunglasses and swollen and tender lymph nodes in neck and under arms  were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of sprayer broke and only partial dose was given was received from a registered nurse/health professional concerning a 42-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Nov-2009, the patient received H1N1, Intranasal, for unknown indication. As per the reporter, the nurse who was giving the vaccine had no problem with the first spray, but felt resistance with the second half of the spray which broke into two pieces and the patient received a partial dose. The patient was not injured by the breakage. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
The patient felt like she's been raped; This is a spontaneous report from a non-contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she felt like she's been raped on an unspecified date, after being vaccinated. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
AFTER 5 TO 7 MINUTES, DIZZINESS, WEAK LEGS, BLURRED VISION, SHORTNESS OF BREATH, NAUSEA.
HSV2 Herpes; On set of Guillain-Barre Syndrome; This is spontaneous report from a contactable consumer.     A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 10:00 (Batch/Lot Number: EL 9263) as single dose for covid-19 immunisation  .  Medical history was not reported.  Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported.  The patient experienced  HSV2 herpes  (hospitalization) on 13Jul2021 23:00 with outcome of recovering;  onset of Guillain-Barre syndrome  (hospitalization) on 26Jul2021 23:00 with outcome of recovering.  The patient was hospitalized for for Guillain-Barre syndrome  for 8 days. The patient was hospitalized for HSV-2 herpes for an unknown period of time.   The patient underwent lab tests and procedures which included : HSV-2 Positive on 13Jul2021; sars-cov-2 test: negative   on 09Aug2021 Nasal Swab.   Therapeutic measures were taken as a result of the reported events including : 4 treatments of IVIg.  Follow up information has been requested.
Shortness of breath with increasing lethargy and malaise. Shortness of breath waxed and waned over past week with nocturnal episodes the worse. Denies Chest pain or radiation since onset. Transient nausea and dizziness over same period. Sent via EMS to ER to rule out myo/endo/pericarditis.
Deceased 11/29/2021; Hospitalized 11/26/2021; COVID-19 positive 11/26/2021; fully vaccinated  BRIEF OVERVIEW Discharge Provider:  MD Primary Care Provider at Discharge:  Admission Date: 11/26/2021 Discharge Date: 11/29/2021 DETAILS OF HOSPITAL STAY PRESENTING PROBLEM: Hypoxia  Pneumonia due to COVID-19 virus  COVID-19   HOSPITAL COURSE: 84-year-old with paroxysmal atrial fibrillation rheumatoid arthritis on chronic methotrexate plus prednisone admitted on 11/26 for hypoxia.  COVID-19 positive.  Patient was admitted to the general medical floor and required escalation in oxygen support.  Code status was no CPR but okay to intubate.  She was placed on dexamethasone for treatment of COVID-19 pneumonia.  She was noted to have increased work of breathing and confusion on 11/28 with atrial fibrillation rapid ventricular response.  She was also noted to have increased oxygen support needs.  Patient was altered however last code status discussion when the patient arrived in the emergency department indicated that she wanted to be intubated if needed.  The patient was intubated on 11/28 and placed on broad-spectrum antibiotics for septic shock.  She was sedated and paralyzed and mechanically ventilated with significant acidosis thought to be secondary to sepsis/shock/respiratory failure.  She was treated aggressively with multiple vasopressors, respiratory and cardiovascular support.  Given her age and multiorgan system failure, her prognosis was extremely guarded.  In discussion with her daughter, it was agreed upon that we withdraw medical therapy.  The patient was extubated on 11/29/2021 and cardiovascular support was stopped.  Time of death was 6:28 p.m. on 11/29/2021
Patient developed intussusception with bilious emesis. Barium enema failed to relieve the intussusception and require surgery.
High fever for longer than 24 hours (101°+), shortness of breath with O2 dropping to 90%, chest pain 9/10 threshold, general weakness, fatigue/exhaustion. Chest pain and shortness of breath remaining 2 weeks post injection.
Itchy red patch around injection site with pain and swelling; Itchy red patch around injection site with pain and swelling; Itchy red patch around injection site with pain and swelling; Itchy red patch around injection site with pain and swelling; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL9262, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 02Mar2021 at 10:00 (at the age of 71 years old) as second dose, single for COVID-19 immunisation. Medical history included thyroid disorder. Patient had other medications in 2 weeks. Patient was not pregnant at the time of vaccination and did not receive any other vaccines in 4 weeks and prior to vaccine the patient was not diagnosed with COVID-19. Patient has known allergies to unspecified medications, food, or other products.The patient previously received the first dose of BNT162B2 (lot number: EL9264), via an unspecified route of administration, administered in right arm on 09Feb2021 at 10:00 (reported as 10:00AM) (at the age of 71 years old) for COVID-19 immunisation. On 03Mar2021, the patient experienced itchy red patch around injection site with pain and swelling. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Felt ?off? with mild h/a in evening of 2/24;  around 2am, 2/25 started slight chills, h/a worsened, body aches?did not feel feverish, but did not check. Could not sleep. R arm bruised & very sore-could not lay on it-applied ice.  Finally at 4:30 AM took two Tylenol & slept until 11am.  Very tired all day & took afternoon nap.  Friday better-just tired & arm sore..
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Additional Details: Provider ordered CT, EKG, and ran bloodwork.
suffered a PE; This is a spontaneous report from a non-contactable consumer via a sales representative. A 23-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 23-years-old, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included hereditary gene disorder with lupus. The patient's concomitant medications were not reported. The patient experienced suffered a PE (pulmonary embolism) on an unspecified date with outcome of unknown. Her team of physicians treating her acutely, did not feel it was attributed to the vaccine and rather due to a hereditary gene disorder with lupus. Event took place after use of product.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
I went to go see my doctor is because I started having a lump under my left armpit, low grade temp, chills, muscle and joint pain, these symptoms started on 10/26/207 and yesterday I saw my doctor and I was scheduled for an ultrasound. My doctor also told me to start taking my Allery medication Claritin and Cephalexin 500 MG 3 times for 1 week, just in case this is some type of allergy.
On this date CDC required the Bivalent Booster and this patient was given the COVID-19 MOD 6-12/A Booster,.
Two hours (2pm) after leaving clinic baby vomited profusely. Mom had just changed formula to Alsoy due to spitting. By 4pm vomiting continued and parents took baby to ER where he was admitted. Pt was on IV's then Pedialite, then Isomil. He kept formula down on 9/19/02 and was discharged at 10:30pm. Vomited again 9/20/02. PCP changed formula to Almenlam on 9/21/02 okay now.
On October 14, 2008 I received an Influenza flu shot at a local store for $25.00 and administered by the Pharmacy Dept. Since that date, I have experienced adverse side effects of the shot with extreme pain to my left arm and limited range of motion. I reported adverse effects on 11/21/09 and 01/08/10 and Jan 13, 2010-Report to Novartis.
1 week after the vaccine my left arm/shoulder was sore and I noticed a firm itch welt at the site of the injection.
Given DTaP #5, IPV #4, MMR #2, Extreme needle phobia, screaming and fighting. Approximately 4-5 minutes after injections developed wheals on right hand dorsal surface. Slight swelling of hand. Redness of both cheeks, slight swelling. Paged Dr. Given Diphenhydramine 25mg liquid PO. Wheals resolved and redness of cheeks decreased before release to PMD.
After the flu shot in the morning, I felt for the following two nights discomfort in my chest.  Faster heart rate, pressure in the chest and heart burn.
"During monitoring period, pt experienced throat itching and slight difficulty swallowing. VS: 145/70 given  Benadryl 25mg by mouth @1400 by onsite provider. Patient was transferred to: home after additional monitoring and relief of symptoms, pt was given ER precautions
Nausea, diarrhea, redness and swelling at injection site, large raised red area with a smaller underlying red area which was painful to touch.
Wheezing- Albuterol. Hives - Diphenhydramine.
pt rcvd vax; pt collapsed shortly after vax; MD felt pt may have had vasovagul attack;
experienced a strong medicine-like smell; a rush of warmth throughout my body; felt that my hands were swelling and slightly itchy but they did not appear to be swollen; felt that my hands were swelling and slightly itchy but they did not appear to be swollen; panicked; felt that my throat was tight but I didn't feel short of breath; My BP was elevated at 140s/80s; tachycardic; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscularly at the right arm on 18Dec2020 at 13:00 (1 pm) at single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma r/t environmental allergies, anxiety, and known allergies to PCN, Sulfa, grass, trees, ragweed, weeds, mold, dust mites, cat and dog. Concomitant medication included cetirizine hydrochloride (ZYRTEC), venlafaxine hydrochloride (VENLAFAXINE XR), colecalciferol (VITAMIN D), ibuprofen, and montelukast sodium (SINGULAIR). The patient received the vaccine on 18Dec2020 at approximately 1 pm (13:00) and 5 minutes later (18Dec2020 at 13:05), she experienced a strong medicine-like smell and a rush of warmth throughout her body. She then felt that her hands were swelling and slightly itchy but they did not appear to be swollen. She was panicked and felt that her throat was tight but she didn't feel short of breath. Her BP was elevated at 140s/80s and she was tachycardic. She gave herself an epinephrine injection and about 10 minutes later the occupational health nurse gave her 25 mg Benadryl at her request. The adverse events results in Emergency room/department or urgent care. The clinical outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The history of asthma, allergies, and anxiety may have been contributory.  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.
Sore arm; Numbness; runny nose; deep heavy pressure in the chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA (Numbness), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (deep heavy pressure in the chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA (Numbness), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (deep heavy pressure in the chest). At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA (Numbness), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (deep heavy pressure in the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No treatment medications provided.   This case was linked to MOD-2021-061139 (Patient Link).
On 02/27/2002 after the vaccination. The pt developed swollen, and warm to touch legs. The temperature was not taken. The pt started crying hard 4 to 5 hours after injection. Stated that 2 days after the symptoms resolved. A follow up report received 5/31/2002 adds: No specific site reaction.
Around 9 pm, the night of receiving her 4 mth  vaccines, she was having her diaper changed and mother gave her Tylenol as she had been fussy since the vaccines. She went pale, bluish disolaration of her face, limp and eyes staring straight ahead. Mother unsure how long this lasted but recovered after splashing water on her. Happened a second while EMS was on their way. Again resolved quickly and was back to baseline by the time EMS Arrived. Admitting for overnight observation. Back to baseline for entirety of stay. Normal vitals and ECG. COVID testing negative.
3-day headache, fever, chills, body aches for 2 days, swelling pain and rash extending from injection site in a band around my arm toward lymph node only fading on Sunday following jab on Tuesday, tired and feeling wrung out. Arm is still slightly sore today, 7 days after. Tylenol only to treat. This is my 4th Moderna vaccine (1 Pfizer). Side effects worsen with each dose. Possibly I'm developing an allergy to some component of this vaccine. My next one will be Pfizer.
Mom mentioned at visit on 11/01/04 that when patient received 4y/o shots, her entire right thigh had large red area, now tender surrounding injection site. Mom was aware that local reactions happen, so did not call at time. But mentioned it became so large an area.
Gave patient 2 vaccines in left arm (FLUVIRIN and ADACEL). Patient got up but then sat back down and passed out. Head rolled back and he became rigid and red. Patient's father and I laid him on ground and then I called 911. Patient was stiff for approximately 30 seconds then came to slowly breathing labored and slow. Did not administer any drugs like Epinephrine.
Lump at site of injection, patient felt throat swelling and hard to breath or swallow. Patient took BENADRYL and felt better in the morning.