chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US030837, is an initial spontaneous report received from a consumer on 21 Nov 2016. This report refers to a 82 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: not reported) at dose of 0.5 ml intramuscularly on 03 Nov 2016. On 10 Nov 2016, the patient experienced rash on buttocks. The patient visited his physician and was prescribed triamcinolone acetonide (0.1 percent) cream 2 to 3 times daily for 14 days to buttocks. The reporter was not sure whether the rash was due to vaccine. The outcome of the event was reported as condition improving. The seriousness and causality of the events were not reported.
Bivalent vaccine given too soon. Last monovalent COVID vaccine was administered on 8/23/2022.
Sharp pain immediately after injection in the arm and shoulder area. Patient was monitored for 10 minutes for an allergic reaction but none appeared. Pulse was normal. Patient was encouraged to stay for a longer period of time for monitoring but opted to go home.
Within 30 minutes of first dose of vaccine reported fever/sweaty, higher blood pressure and lightheadedness. Went to the clinic and confirmed through nurse triage that fever and blood pressure were elevated.   Blood pressure ~128/86 Patient's normal range is 90/60 Fever was 99  Next three days: On and off fever that never went above 99. Patient has chills, and normal symptoms when having a 99 degree fever.  For the next 10 days continued to have elevated blood pressure (123-128/80), lightheadedness and vertigo. Blood pressure, lightheadedness and vertigo  continued even when patient is laying down. Stronger adverse effects included numbness, leg pain and chest pain that felt like a heart attack, especially whenever bending leg at the knee.  Symptoms remained constant and did not lessen over the 10 days. On the 11th day adverse effects drastically reduced though blood pressure was still higher than normal but closer to normal range.
Body aches; Head congestion; Fatigue; This is a spontaneous report from a non-contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had body aches; head congestion; and fatigue. The outcome of the events, body aches, head congestion and fatigue, was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received first dose of Moderna Covid19 vaccine at 0812. She was advised to stay in the observation area for 15 min. At the 15 min mark 0827, the patient reported to feeling funny. She expressed tightness on her forehead and numbing of her throat. After 5-10 minutes, she expressed her surrounding face (outer cheeks, forehead) started to feel tingling. Her Watch read her heart rate to be 153 BPM. She was closely monitored for 45 min  after onset of symptoms. She was sipping water and was given a single dose of diphenhydramine 25mg at 0845 once noted that symptoms were not worsening. She remained upright, and alert. No SOB, wheezing, lip/tongue swelling were noted. Symptoms started to subside around 0900, HR was 120 BPM, numbness in throat was going away. We contacted her emergency contact at 0910 for continuous monitoring. Sent patient home with two extra doses of diphenhydramine 25mg to be given 4 hours later if symptoms still present, and advised the patients aunt to monitor for 4 hours for worsening of symptoms.
patient received the Shingrix liquid adjuvant only (unreconstituted dose); patient received the Shingrix liquid adjuvant only (unreconstituted dose); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number L4472, expiry date 08-OCT-2023) for prophylaxis.   On 10-MAY-2023, the patient received the 1st dose of Shingrix. On 10-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received the Shingrix liquid adjuvant only (unreconstituted dose)) and inappropriate dose of vaccine administered (Verbatim: patient received the Shingrix liquid adjuvant only (unreconstituted dose)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received Shingrix liquid adjuvant only (unreconstituted dose), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
The patient called 2 days after getting the injection that he had excess shoulder swelling and was unable to lift his arm above parallel to the ground. He went to orthopedics and they drained his shoulder and tested the fluid for infection. After the culture came back negative for infection he was given a cortisone shot (which he gets regularly) to help with the inflammation. I called him 2 days later and he reported his symptoms have improved greatly. He did request that his second dose be given in a different muscle, which we plan to accommodate.
pt recv vax 1989 & exp inj site rxn consisting of soreness, redness, swelling & warmth for a couple of days & then was fine;
Missed to take last dose of Vivotif; Spontaneous report received on 19FEB2020.  A male consumer reported that he "missed to take last dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. The consumer started taking Vivotif on 13FEB2020 and took the first three doses as per schedule. His last dose of Vivotif was scheduled on 19FEB2020 but he will not be able to take it because someone accidentally threw his last dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed to take last dose of Vivotif (missed dose) as someone accidentally threw his last dose. Vivotif doses should be taken every other day, and the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer missed to take last dose of Vivotif (missed dose) as someone accidentally threw his last dose. Vivotif doses should be taken every other day, and the causality of missed dose is not applicable to Vivotif.
Fever (101.2), tiredness, muscle cramps (not at injection site)lack of appetite (no nausea or vomiting). Fever subsided after six hours or so; muscle cramps recurred during night. More or less back to normal by afternoon of following day.  Symptoms fell well within those listed at CDC website, which reassured me.
Generalized hives/rash was given steroids, Benadryl and epi pen at ER.
Severe swelling of lymph node and inner/outer ear infection on left side. Doctor prescribed ciprofloxacin-hydrocortisone, but insurance only covered ofloxacin otic solution 0.3%.
About 30 small red bumps that are varicella like, fever, rash worse at the injection site, fussy, not sleeping well.
Pt complained of weakness/tiredness; arm pain. Arm was red, swollen and very hot to the touch. Temp 39.1 - pt transferred to Med/Surg unit for IV abx with diagnosis of cellultis.
Information has been received from a licensed practical nurse concerning a 5 year old male with no allergies and no medical history who on 16-SEP-2002 was vaccinated SC in the left thigh with a 0.5 mL first dose of varicella virus vaccine live (Oka/Merck) (Lot# 640822/1153L), expiration date of 14-Feb-2003. Concomitant vaccines administered on the same day included a fourth dose of Prevnar given IM in the right thigh. The child presented to the office on 28-MAR-2007, with probable chicken pox, approximate range of 50 to 249 lesions and no fever. The mother of the child stated that the onset of the outbreak began on 26-Mar-2007 with an itchy rash on the arms, back and stomach. Treatment consisted of comfort measures. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. In follow-up received 04-JUN-2007, it was reported that the patient recovered on 04-APR-2007. Additional information is not expected.
-Patient was given her 2nd covid vaccine (Moderna) 21 days from the first dose (Pfizer).
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II which had lot # L049316 with expiry: 03-DEC-2017 and lot # M006544 with expiry: 03-FEB-2018 (dosing details not provided). The vaccines were exposed to a temperature excursion of 9 degree Celsius for 1 hour 24 minutes, with an additional excursion of 10 degree Celsius for 2 hours for lot # L049316 with expiry: 03-DEC-2017. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling, redness heat - entire upper arm, itchiness approx 4 hrs after inj. Progress to rash on arm over next 24 hrs.
Pfizer-BioNTECH COVID -19 vaccine reconstituted with 1.7 ml of 0.9 ml NS instead of 1.8 ml. As a result only 5 doses administered.  Pt had no adverse reaction noted during the 15 mins observations.
stroke; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. On or about 01-MAR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a physician for stroke. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of stroke was considered to be medically significant.
Non-stop tingling in fingertips and tips of toes. Loss of feeling and sensitivity in fingernails, fingertips, toenails and tips of toes. Tingling and numbness bottom of feet. Not ticklish anymore, cannot feel tickling sensation. Arms and hands  constant feeling of ?falling asleep?, circulation poor. Bouts of lightheadedness. Two instances of extreme sweating and fever like symptoms several weeks after shot.
Vaccine given 5/3/11 at 1002AM mom called 5/4 at 812pm, c/o redness, swollen, painful, warm to touch left arm where pt was given Hep A and PCV 13.
Large rash at vaccination site on right arm (5 inches in diameter) lasting for about two weeks
10 years old and was given the adult dose of 0.5 instead of .25cc.  Talked to parent and child has no adverse reactions
Slight chills and soreness/redness on left arm. Redness has increased, but soreness decreased in past day. No treatment so far.
patient experienced "swelling" at injection site after receiving second dose; This spontaneous report was received from a medical assistant regarding a currently 40-year-old, non-pregnant female patient. The information about the patient's concomitant medication was unknown by the reporter. It was reported she did not have pertinent medical history or drug reactions/allergies.   On 03-JUL-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot 1602284 number and expiration date 26-SEP-2021) intramuscularly for HPV prevention (prophylaxis). Subsequently, on an unspecified date in July 2019 (also reported as: adverse event (AE) onset unknown), the patient experienced "swelling" at the injection site. It was unknown by the reporter if treatment was given for the adverse event, however, it was reported that the patient did not seek medication attention and there were no laboratory diagnostics or studies performed.   At the time of reporting, the outcome of the injection site swelling was unknown. The reporter did not provide a causality assessment between the event occurrence and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
"pt had grandmal sz;mild fever in AM 100 & red throat given amoxicillin;sz 31JUL97 in pM CT scan, EEg & urine screen all nl;"
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient came in with parents to recieve pfizer boster shot and was anxious about recieving a shot. I asked patient to take time to calm down and after some time patient and parents confirmed they were comfortable recieving a shot. Patient passed out few minutes after recieving a shot. 911 was called and they stayed to confirm patient is stable and vitals are ok. Patient left after paramedics confirmed she was ok
Patient said that she was nauseous a couple of hours after getting the shot and threw up. Symptoms resolved quickly.
Patient with local reaction, left upper thigh. Warmth and redness about 10x6 inches.
Patient called at around 10 AM on 3/25/2021 and explained that she had developed a rash that morning. It started in her scalp, moved to her face, and then onto her throat. She was at work at this time. I advised her to take a 25 mg Benadryl (which may cause drowsiness). Based on her size (145 lbs) employee did not recommend she take a 50 mg Benadryl. Patient did not know if she had a fever or not. She reported NO fever at that time. Employee called her back at 6:30 PM to check on her. She said she had to leave work around 2 pm; she was feeling bad, achey. She said she took some ibuprofen as she was feeling achey and feverish. she didn't feel the need to go to the doctor or urgent care at this time.
Pain in vaccine site arm evening of and day after getting vaccine; headache ~18+ hours after getting vaccine; fatigued day after getting vaccine
no adverse effects; The patient was vaccinated with improperly stored vaccines.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 09-MAR-2020, the patient was vaccinated with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  recombinant Human albumin (rHA) (PROQUAD) 0.5 milliliter, subcutaneous in the left thigh, with lot# S030093, expiration date on 24-MAR-2021, and with diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(KINRIX) (strength, frequency, and expiration date were unknown) 0.5 milliliter, intramuscular in the left thigh, with lot# PP9L5 for prophylaxis.   Administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion between -14 and -10 degrees Celsius (-11.2C) for 3 hour and 42 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects reported.  The temperarure excursion was no reported for the other vaccine.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008890: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008933: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2003USA002275: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008888: US-009507513-2008USA008887: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008879:
cold sore; This case was reported by a consumer via interactive digital media and described the occurrence of cold sores in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had cold sores in the past. The patient received a dose of Shingrix and got another cold sores. The patient asked that it could had been a side effect. The follow-up could not be possible as no contact details were available.
Massive side effects in people with epilepsy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Massive side effects in people with epilepsy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Massive side effects in people with epilepsy). At the time of the report, ADVERSE REACTION (Massive side effects in people with epilepsy) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided.
From telephone call received on 1/25/01, it was reported that a 16 year female patient received  a Fluzone SV '01-'02 vaccination administration on 10/17/01. four days later, it was reported the patient became pale, sweaty, and experienced nausea and body aches. The patient had been seen in physician's office on 10/16/01 and was diagnosed with viral pharyngitis. Reportedly, the symptoms resolved.
Fever at 102 degrees, headache. Child was on day 3 of a 5 day regime of azithromycin for an ear infection.
no other AE occurred.; VAQTA was administered to a 1 month old patient on 4/17/2023; patient was supposed to receive a hepatitis B vaccine.; This spontaneous report was received from a nurse and refers to an 1-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscular injection, 1 dose, lot number: w028554, expiration date: 10-JUL-2024, administered for prophylaxis (exact dose, strength, and route of administration were not provided) (product administered to patient of inappropriate age). The reporter stated that the patient was supposed to receive hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (wrong product administered). No other adverse event occurred (no adverse event).
No Adverse Effect, but given 2nd dose at 13 days as opposed to 21 days.
pt says his heart started racing, he was dizzy, had SOB, and hands were shaking.  Pt called PCP which told him to get to an ER. He went to ER. They did several test.  His heart was miss-firing.  They gave him some medication which brought heart rate down but needed to had have an electrical shock.  This brought his heart rate down to 85.  He has been referred to a Cardiologist which he will schedule appt today.
45mins p/vax pt had severe h/a, not relieved w/APAP;@ time of report (2 days) the h/a was improving;24hrs p/inj a tingling, odd" feeling in forehead by 48hrs this sensation was from forehead down to upper lip;24hrs eyes watering, sore throa
Low grade fever, headache, shivering, nausea,fatigue, severe muscle pain.