chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an over 60 year old female, a practice manager at a physician's office, who "within the last 2 months" (in approximately May 2008), was vaccinated with ZOSTAVAX (Oka/Merck). Four days after vaccination, the patient developed a varicella like rash on her arms and legs. The varicella like rash lasted for 14 days. On 03-JUL-2008 the patient woke up in the middle of the night and had a tingling sensation and parts of her skin were painful to touch. The patient felt like she was experiencing a muscle ache that you would get with the flu. She vomited 3 times over the course of 4 hours and she had a low grade fever of 100F. The following day she was fine except for feeling dehydrated and tired. She had 2 glasses of water. The patient said she had "symptoms similar to food poisoning". The patient was seen by the physician where she works but not the physician who gave the vaccine. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the 65 year old patient with hypothyroidism who on 06-JUN-2008 at 11:40 am was vaccinated subcutaneously with her first dose of ZOSTAVAX (Oka/Merck) (lot #659410/0412X) in her arm. On 09-JUN-2008 the patient developed Poxs on extremities which lasted approximately 3 weeks. No relevant laboratory or diagnostic tests were performed. Subsequently, the patient recovered. On 03-JUL-2008 at approximately 2 am, the patient awoke with a freezing cold sensation with pains in her arms and legs. On touch, her skin hurt. It felt like it was burned. This persisted for approximately 3 hours. Suddenly the patient had a spasm or twitching in her spine at the waist area. This lasted for approximately 30 minutes. The patient's next realization was that it was morning and got out of bed. The feeling of the skin had disappeared and she had no pain in the spine or any of her extremities. The only symptoms she had was an elevated temperature of 102 which responded to TYLENOL and an overall feeling of being tired. Later in the day the patient felt totally normal and her energy level returned. The patient did not report this to her physician as all symptoms disappeared. The patient had never experienced anything even remotely similar to these symptoms and had been exercising daily for many months with no side effects. Additional information is not expected.
Pt recvd vax & exp n/v, hematuria & proteinuria; edema, h/a; dx IgAN, no hypertension but nephrotic synd; w/in 2 mos devel hypertension, renal function reportedly 50% destroyed;
Information has been received from a MA concerning a 69 year old white female who on 03/18/2003 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M).  There was no illness at the time of vaccination.  On 03/19/2003 the patient developed pain and severe erythema.  Medical attention was sought and the patient required prednisone.  Subsequently, the patient recovered.  It was also noted that a number of other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M) and also developed swelling and pain (WAES # 0303USA02187).  No further information is expected.
9:20 AM- During observation, patient began to cough and became uncomfortable in chair. Patient moved to cot by staff and offered water. Patient able to swallow water without struggle. Vitals- 162/98, 98% O2 sat., 78 Pulse, 16 Respiration, lungs clear.  9:38 AM- Patient complain of itchiness. 25 mg Benadryl administered oral per patient request
This spontaneous report has been received from a pharmacist and referred to a female patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date in April 2017 (reported as "one month ago"), the patient was administered a dose of PREVNAR 13 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis and then on 01-MAY-2017 (reported as "today"), instead of waiting eight weeks between vaccine doses as it was recommended, the patient received a dose of PNEUMOVAX 23 (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. There were no adverse effects reported. Additional information is not expected as there was no contact consent provided.
This is a spontaneous report from a non-clinical-study program from a non-contactable consumer. A 2-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced "mild pneumonia" at 23 months in Nov2013 and was visited at the ER. Therapeutic measures were taken as a result of the event includes unspecified antibiotics. The patient recovered after 7 days. No follow-up attempts possible. No further information expected.
I would just say not sure if it's from vaccine exp severe headache 12-18 hrs after vaccination. No other symptoms was unable to return to work.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient called to let the pharmacy knows that he has been feeling a lot of pain especially at the shoulder area since his shot on 4/5. He has been taking ibuprofen 800mg and it did not help with thre pain. He has a hard time putting his arm against the balcony at home. He reported that his symptoms are not getting better. I advise the patient to seek medical help from his primary doctor to assess his shoulder pain.
pt recv vax in 1995 & 10NOV97 MD reported that recent lab eval revealed lack of seroconversion when pt dx w/leukemia;
SWOLLEN/DISCOLORED UPPER ARM WITH A DEFINED MARGIN. ED DIAGNOSED WITH A BONE AND JOINT INFECTION OF THE SHOULDER/UPPER ARM.
Patient said back of her arm at vaccination site was red and raised and "feverish" about 1.5 inches in diameter. She did not have any other symptoms. She was taking OTC ibuprofen for the pain and swelling.
Patient called - received J&J Covid Vaccine 3/12/21  - has had sharp burning pain in her right arm ever since. Has seen primary care physician several times for it. He advised her to report to us. She can barely use her arm.
Heart palpitations throughout the day in 2 minute bouts whole week of may 17th, Dull chest pain in left chest consistent throughout the day started weekend of May 18th, Elevated heart rate, fatigue, Random elevated HR and palpitations in middle of the night on morning of may 30th.
TC from Russian interpreter stating pt has redness & swelling lt arm by 10JUN swelling inc fr elbow to fingers; pt taken to MD 12JUN but condition had improved & no tx was prescribed
Patient started with symptoms after the second dose with arm pain and then 48 hours after started to experience shortness of breathe and chest pain. After consultation with cardiologist patient was diagnosed with Pericarditis.
Breakthrough case admission after three vaccines Moderna 3/18/21 Lot# 006B21A;  Moderna 4/15/21 Lot# 043B21A;  Moderna 1/8/22 Lot# 084J21A
When I first got the vaccine, the next day when I woke up, the spot where I got the shot was black and blue and a half inch circle. Right under that was a big lump that was red and hot and hard. That was maybe 2 ½ inches. That red hot spot lasted for at least 10 days. On 11/19, I had another event where I had an abscess on the outside of my gum and my face blew right up. My immune system could not keep up. So I went to the doctor and they gave me an antibiotic, and they checked out the red spot and it wasn't anything serious. Antibiotics took care of everything. To this day, there is still a smaller red spot on my arm. No pain and no elevation on the spot.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-DEC-2014 the patient was vaccinated with a dose of ROTATEQ (oral dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
blue chicken wires vision came back; mesh like vision (what you see in one of those mesh hats); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (mesh like vision (what you see in one of those mesh hats)) and CYANOPSIA (blue chicken wires vision came back) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration and Dry eyes. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), VITAMINS NOS and VITAMIN B12 NOS for an unknown indication.   On 07-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VISION BLURRED (mesh like vision (what you see in one of those mesh hats)). On 05-Feb-2021, the patient experienced CYANOPSIA (blue chicken wires vision came back). At the time of the report, VISION BLURRED (mesh like vision (what you see in one of those mesh hats)) and CYANOPSIA (blue chicken wires vision came back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Magnetic resonance imaging: all cleared (normal) All cleared. In January 2021, Ultrasound scan: all cleared (normal) All cleared.         Concomitant medications include unspecified eye drops for macular degeneration and dry eyes.  The patient was seen by his optometrist who "did all the tests" and said nothing was wrong with his eyes. The patient was then seen by his primary doctor to rule out a possible stroke. Per the reporter: just before the second vaccine, the mesh like vision was still there but the blue chicken wires vision was gone. Then the patient got his second vaccine and both mesh like vision and blue chicken wires vision came back and have not gone away.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added patient details and Updated patient event outcome from unknown to not recovered/resolved.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Client has Pfizer vaccines for Covid on 4/1 and 4/29/2021.  After second vaccine, client developed allergic reaction of hives all over body.  Also has had migrane headaches only since receiving second vaccine. On 11/9, client tested PCR + for Covid with symptoms starting on 11/6 - nasal congestion, headache, myalgia.  Reported as a case of breakthrough Covid in a previously vaccinated person
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and ethnicity. No information was provided regarding the patients' previous drug reactions, allergies, concurrent conditions, concomitant medications or medical history. On an unknown date, the patients' were vaccinated with improperly stored doses of GARDASIL 9 (lot# R009615 and expiration date of 07-DEC-2020; (dose, frequency, anatomical location and route of administration were not reported) for prophylaxis.  Nonetheless, no adverse effects were reported.  The vaccine experienced the following temperature excursion on an unknown date: 32degrees Fahrenheit (F) up to 35 F (31.5 F) during a time frame for 5 minutes. Reportedly, there had been a previous temperature excursions of  32 F up to 35 F (33 F) for 10 minutes the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved.
Information has been received from a healthcare worker concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route no reported). The healthcare worker stated that when she was vaccinating the patient, she turned white and fainted. She stated they immediately withdrew the needle and caught the client before she fell off the table. Only one fourth of the vaccine was administered. Patient was laid down on the table and monitored for 45 minutes to 1 hour afterwards. Patient did not want to get more doses of GARDASIL. At the time of the report, the patient had recovered. The patient sought medical attention. Additional information has been requested.
Received vaccine 10/07/2002 IM left deltoid. No swelling, redness or bruising at site. Pain progressively worse, tender over deltoid muscle--painful range of motion. DX: Left deltoid neuropathy, brachial neuritis. See by physician 11/4/02. Rx: Medrol dose pack, VIOXX.
This spontaneous report as received from a registered nurse via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention for the same(visited the doctor). The outcome of shingles was unknown. Additional information has been requested.
back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tired, diarrhea, aches, chills, sweats, headache, sore arm and swelling.
Chest pain presented in entire chest at repotted time. Mildly painful. Self administered regular strength advil (x4 pills) by mouth at onset of symptoms. Symptoms seemed to resolve themselves within hour of taking Advil.
Asymptomatic macular red rash at site of injection, greater than 2 1/2 by 3 1/2 inches. No itching or any systemic symptoms
Injection site swollen right after injection. Provided Benadryl. Monitored regularly and the site changed to flat after an hour.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose and route were not reported, lot # L019298, expiration date 22-JUN-2017). There were no adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
I received the second dose of the Pfizer vaccine on 1/8/2021. The following day I had mild hives on my neck and thigh creases, I attributed it from sweating, hives went away after taking Claritin. The evening of 1/11/2021 I had 1 glass of wine and subsequently broke out into hives all over my chest and neck, took Benadryl that night. In the morning of 1/12/2021 the hives had worsened. I started Prednisone 40mg, Claritin, Pepcid 20mg in the AM and Prednisone 20mg, Benadryl, Pepcid 20mg at night. The following day the hives had mostly resolved and I only took the OTC medications. In the afternoon of 1/13/2021 I rode my stationary bike. After the ride I had broke into hives again on my chest and neck and where my headband sat. I then took Prednisone 40mg, Benadryl 25mg, Pepcid 20mg. Hives have mostly resolved today 1/14/2021, still have the sensation of itchiness. Never had throat closing or shortness of breath.
2 hours after vaccine, I was dizzy, weak, felt like I would have syncopal episode. Heart rate irregular, perspiration, hands shaking. Facial and bilateral limb numbness, mild.   Resolved approximately 1hour after it started.   No symptoms at all in first two hours after vaccination.
patient with 4 doses of COVID vaccine admitted to hospital with PCR + COVID 9/18/22
vaccination site redness; vaccination site swelling; vaccination site itching; vaccination site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "vaccination site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "vaccination site itching"; VACCINATION SITE PAIN (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229741 Same reporter, same drug, same event, different patient;US-PFIZER INC-202300229692 Same reporter, same drug, same event, different patient;
8cm x 5cm induration and redness at site of Pentacel injection Left thigh. Seen by Physician was advised ICE, and tylenol.
JANSSEN COVID VACCINE EUA: Fully vaccinated 34 YOF presented 090321 with loss of taste and smell, congestion, runny nose and dry cough that began 090121.
On the morning after my booster vaccine (second booster shot), I was at the breakfast table at 9:30 a.m. about to eat a bowl of hot cereal. As I put my spoon in the bowl, I began to feel nauseous and belched several times, which seemed to relieve the stomach pain from the air pressure in my stomach. After belching, I abruptly fainted - passed out and my head fell over into the cereal bowl. I did not know that this happened until about a minute after I fainted, when I regained consciousness and found myself head-down in the cereal. After I became aware of what happened, My wife, who was sitting beside me at the table described the details of my fainting event
Case number PHEH2011US01521 is an initial spontaneous report received from health care professional on 12 Aug 2011. This report refers to a 15 years old male patient. He was vaccinated with MENVEO (batch number: 090601A) 0.5 ml intramuscularly on 04 Aug 2011. But, he received only the Men CWY liquid conjugate without reconstituting it with the Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
2 weeks after vaccine, developed 2x3 inch area of redness, warm to touch, painful, raised area
3cm diameter pruritic > painful induration, erythema - onset 3 days after vax
Patient complained of redness, swelling, bumpy/lumpy hot to touch and back and chest hurting. No fever just feeling really bad. Patient went to ER and given KEFLEX 500 mg and methocarbamol 150mg tab.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). At the time of the administration of Infanrix, in May 2004, the pt had bronchitis and was receiving azithromycin (Zithromax). On 20May04, the pt received the fifth dose of Infanrix (lot DTPA612A9) in the left thigh. On the same day, the pt also received injections of measles, mumps and rubella virus vaccine (MMR II) and poliomyelitis virus vaccine (Ipol). One day following the admin of Infanrix, on 21May04, the pt experienced an injection site reaction characterized as a red, raised and hot to touch area from the groin to above the knee around the site of injection for Infanrix and a fever of 100.5 F. The pt was seen at a physician's office and was treated with ice and ibuprofen. The events resolved on 22May2004. The nurse considered the events to probably be related to vaccination with Infanrix.
Information has been received from the mother of a 2 month old male with no past medical history, who on an unspecified date was vaccinated intramuscularly with the first dose of COMVAX. Concomitant vaccination included Rotateq. Other concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and "PCB". Subsequently, one to two weeks after vaccination, the patient was diagnosed with a "blood infection, an ear infection and throat infection" and was hospitalized. The patient was hospitalized for 2 days and required 7 days of antibiotic therapy. The patient subsequently recovered on an unspecified date from the events. Additional information has been requested.  01/11/2008 Per CDC: Box 10-date of vaccination : 11/20/07  Box 13-lot # for Comvax: 1244F.   01/11/2008 MR received for ER visit 12/4/2207 with c/o fever and increased sleeping. PE WNL (ENT WNL).  Txd with Tylenol and ceftriaxone and D/Cd. DX:  Fever-Acute.  Leukocytosis-Acute.
Moderate bodyaches, chills & headache from ~10:00pm through the following day until ~ 3:00pm.
Reported by client: Right arm pain and swelling at injection site(stated the size of a baseball).  6 hours later swelling in the right armpit with pain radiating to elbow.
received the vaccine at 10:30am Monday Nov. 16.  Felt fine that day until evening... about 9pm began feeing nauseous and cold, with a slight headache. 11:30pm vomited; nausea briefly abated then returned 1:15am vomited again Second day (Tuesday Nov. 17) still had a headache so took one dose of Tylenol which cleared the headache and it did not return. Feeling slightly better this day and virtually no arm pain at all.  A bit tired. Third day (Wed. Nov. 18) feel fine and back to normal.
Incident Details: Per Dr's 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) by employee in error as patients are now only supposed to receive the bivalent booster per Dr's email. Pt was due for booster at the time they received it, however the bivlalent 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 office 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 Vancouver Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS. Recommendation: I would recommend holding a meeting to notify Leads/Supervisors/Managers of any changes regarding COVID vaccine administration, rather than sending out an email that may not be read by all staff. If an email is needed to be sent, I recommend making it clear that a process is being changed.
Alternating chills and fever, body pain and aches, and general malaise that lasted for roughly 1 1/2 days.  I stayed in bed and rested most of that time until I finally felt better.