chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalised Itching; Red rash with pain; Red rash with pain; diagnosed with shingles; Irregular heart rate/Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalised Itching), PAIN (Red rash with pain), RASH ERYTHEMATOUS (Red rash with pain), HERPES ZOSTER (diagnosed with shingles) and PALPITATIONS (Irregular heart rate/Palpitations) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination.     Previously administered products included for Shingles: Shingles vaccine (1st dose on 21-Oct-2019 and the 2nd dose on 14-Jul-2020.) from 21-Oct-2019 to 14-Jul-2020; for an unreported indication: VITAMIN B-12 (Injection on left arm.) since 01-Apr-2021. Concurrent medical conditions included Atrial fibrillation since 03-Dec-2019. Concomitant products included METOPROLOL from 01-Jul-2019 to an unknown date and LOSARTAN from 27-Dec-2019 to an unknown date for Blood pressure management, LOVASTATIN from 20-Mar-2008 to an unknown date for Cholesterol, APIXABAN (ELIQUIS) from 14-Jan-2019 to an unknown date for Heart disorder, ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PRURITUS (Generalised Itching), PAIN (Red rash with pain), RASH ERYTHEMATOUS (Red rash with pain), HERPES ZOSTER (diagnosed with shingles) and PALPITATIONS (Irregular heart rate/Palpitations). The patient was treated with GABAPENTIN on 23-Jun-2021 for Adverse event, at a dose of 300 milligram; LIDOCAINE, PRILOCAINE (LIDOCAINE/PRILOCAINE) (topical) ongoing from 16-Jun-2021 for Adverse event, at an unspecified dose and frequency; PREGABALIN (oral) ongoing from 23-Jun-2021 for Adverse event, at a dose of 100 milligram three times a day and CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN AND CODEINE) for Adverse event, at a dose of Every 6 hours. On 12-May-2021, RASH ERYTHEMATOUS (Red rash with pain) had resolved. At the time of the report, PRURITUS (Generalised Itching), PAIN (Red rash with pain) and PALPITATIONS (Irregular heart rate/Palpitations) had not resolved and HERPES ZOSTER (diagnosed with shingles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 121/78 (abnormal) 120/78 mmhg. On 28-Apr-2021, Heart rate: 57 (Low) 57 beats per minute.         Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Added Demographic details, Lab tests data. Concomitant medications and start dates were added. New events for second dose and outcome of the events were updated. On 28-Jul-2021: Follow up received and contain No new information. On 29-Jul-2021: Follow up received and contain No new information.
receiving her vaccine in her thigh; her tongue and lips felt fuzzy; her face was red; tongue felt like it was fuzzy and swelling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6201, NDC number: unknown) dose 1 via an unspecified route of administration, administered in thigh on 28Feb2021 (at the age of 61-years) as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from Dec2005 to an unknown date, lymphoedema from 2009 to an unknown date, had surgery to remove lymph nodes in both arms on an unspecified date. There were no concomitant medications. No PQC was present. Investigation assessment was not provided. On 28Feb2021, the patient received her vaccine in her thigh, her tongue and lips felt fuzzy, her face was red, tongue felt like it was fuzzy and swelling. Patient stated that the symptoms left about 10 or 11 minutes, so they were not there the full 15 minutes and after they drove away, she said she was not making this up and she took off her mask and her face was red. The symptoms disappeared within an hour. Her husband was not concerned at all about the second dose and her brother was a physician as well and he isn't alarmed, but she wanted to double check with Pfizer to see if they have any information on experiences like this. She kind of wanted to know if there were other reports from people like this as well. The clinical outcome of the events her tongue and lips felt fuzzy, her face was red, tongue felt like it was fuzzy, and swelling was reported as recovered on an unspecified date of 2021 and clinical outcome of the event receiving her vaccine in her thigh was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Pfizer bivalent gray booster given after discard date, expired 3/23/23.
Red, itchy, swollen, warm to the touch around the injection site.  March 20th less than 24 hours after 1st dose
HIVES/RASH; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hay fever allergy, ragweed allergy, environmental allergy, occasional drinker, and non smoker, and other pre-existing medical conditions included patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 704A7IA, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced hives/rash. On 01-JUL-2021, Laboratory data included: Blood pressure (NR: not provided) Normal, Blood test (NR: not provided) Normal, and Cholesterol (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives/rash. This report was non-serious.
This spontaneous report as received from a consumer refers to a 60 years old female patient. On an unspecified date the patient was vaccinated with ZOSTAVAX "a shingles shot" (manufacturer unknown) (dose, lot and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient reported that she had a bad reaction to a shingles shot and that she had a rash on her arm because of the shot. No treatment information was reported. The outcome of the patient events was unknown. The relation between a bad reaction to a shingles shot and rash on her arm because of the shot and ZOSTAVAX is unknown. Additional information is not expected.
Dizziness/vertigo when lying down at night. Also occurs when turning over and when I first sit up and reach to a side.  Not every night but most.  Has relieved a bit with less frequency but not gone away.  Some nights are worse than others...somewhat random.  Doctor performed Epley maneuver but it did not relieve it. Also, suggested using dramamine at night and claritin during the day. Have not noticed any change but just started.
Muscle aches; joints ache; slight head ache; This is a spontaneous report from a contactable consumer.  A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Jan2021 at 13:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), montelukast (MANUFACTURER UNKNOWN), and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) from unknown dates for an unknown indication and experienced drug allergy.   On 25Jan2021 at 19:00, the patient experienced muscle aches, joints ache, and slight headache (reported as in the morning).  The patient did not receive any treatment for the events. The clinical outcomes of muscle aches, joints ache, and slight headache were recovering.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
got the shot and she's still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient did not know what to say about her friend.  The patient got the shingles shot and she still had shingles she had them for 2 months now. The follow-up would not possible, as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary immunization, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Client received shots at approximately 1030 without incident. He was chatting and walking around following administration. While standing at the back door at checkout speaking with his grandmother, client's sister said "he's seeing black." Client appeared flushed with pink cheeks. Client advised to sit down immediately, seemed disoriented and needed assistance from EMT to get down to the floor. Client then laid down on a mat at 1044. Client grew pale when lying down. Cool damp paper was applied to the back of the client's neck. Juice given, client sat up to consume. Client reported "feeling better" and moved to a chair. Client reported feeling "light headed and clammy" again and was moved back down to prone position on the mat with feet elevated on chair. Client declined more juice. Since client received vaccines at 1030 and was still unable to progress from sitting to standing at 1055, 911 care was initiated. Since the clinic was at a local fire station and staff were present, they were able to begin care without formally making the 911 call. EMTs attended to client until 1130 when ambulance transport to the Hospital occurred.
Fever/shivering - less than 12 hours Muscle aches - 24 hours Fatigue - 24 hours Headache - 24 hours Enlarged left axillary lymph node - 3 days
Client initially developed a migraine and fever the evening of vaccination. At 3:30 am the following day the patient began vomiting and had fainted and passed out in the shower. Client is currently, "experiencing light headedness and is fighting off a cold."
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 03-JUL-2013, the patient was vaccinated with a first dose of GARDASIL and on 11-SEP-2013, the patient received the second dose. The patient received the third dose of GARDASIL (Lot number, expiry date, route and dose were not reported for all) as early as 23-OCT-2013. No adverse effects reported. Additional information has been requested.
lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious.  Information on the Lot/Batch Number has been requested.
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.  Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts.  She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown.  The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown.  Information about lot/batch number has been requested.
8 red spots; Puffed up near injection site; Stomach pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (8 red spots), ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and VACCINATION SITE SWELLING (Puffed up near injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Allergy (chocolate allergy.) and Lactose intolerant. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea). On 16-Feb-2021, the patient experienced ERYTHEMA (8 red spots) and VACCINATION SITE SWELLING (Puffed up near injection site). At the time of the report, ERYTHEMA (8 red spots), ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and VACCINATION SITE SWELLING (Puffed up near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included drink fluids and pepto bismol.
Inject was given below the deltoid muscle. Patient has a large, red, itchy, painful, warm bump at injection site. Will advise patient on how to keep clean with topical anesthetics and to treat the pain and inflammation with oral ibuprofen. Will advise patient to seek care at urgent care if it worsens tomorrow.
Incident details: Per Drs. (Medical Director) email sent out on 9/1/22- 'the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand'. The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked.  Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
Administration error: Given Kinrix instead of Pediarix. Patient hs been more sleepy but reactive and eating well for 2 days according to parents.
"I had gallbladder inflammation that started on 1/2/21 and I received my vaccine on 12/30/20. My gallbladder finally had to come out on 2/10/21. I had never had any gallbladder issues".  Narrative:
Case number PHEH2014US014997 is an initial spontaneous report from a medical assistant received on 24 Jul 201 with a follow-up from a medical assistant received on 21 Oct 2014. This report refers to an 18-year-old male patient. Past medical history and concomitant medications were not provided. His vaccination status was up-to-date. He was vaccinated with 0.5 ml of expired MENVEO (batch number: M11075) intramuscular into left arm on 07 Jul 2014. No adverse reactions have occurred following this medication error. Repeat dose of vaccine was offered but it was declined. Follow up information received from the medical assistant on 21 Oct 2014: Patient demographics (height and weight) site of vaccination (left arm) and narrative (repeat dose declined) were updated.
Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative.  Information on the lot/batch number has been requested.