chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Pt recvd 3 doses of Hep B vax SEP90, 22OCT90, 28MAR91 & 8JUL91 it was determined that the titer was neg; booster dose was given 24JUL91 & 26SEP91 titer was neg; 2nd booster dose given on 11FEB91;
patient is late for the second dose / first dose was administrated on July 14 2020 / The patient only received the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 30-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 14th July 2020, batch number- 3C422, expiration date-17th April 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. No adverse events were reported. The reporter consented to follow up.
Sore throat, swollen glands, migraine headache, dizziness, body aches & pain, continued weight loss, loss of appetite, abdominal pain.
No adverse event; Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 21-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-724019, US-MODERNATX, INC.-MOD-2023-724088, US-MODERNATX, INC.-MOD-2023-724177, US-MODERNATX, INC.-MOD-2023-724205 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724019:same reporter US-MODERNATX, INC.-MOD-2023-724088:same reporter US-MODERNATX, INC.-MOD-2023-724177:same reporter US-MODERNATX, INC.-MOD-2023-724205:same reporter
01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad,  01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day.   01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.
20 hours after injection, got severe back pain between shoulders and also lower back, tiredness and nauseous.  Laid down about 3:30 p.m. and slept til next day 8:30 a.m.  Felt better for a couple hours and then started with chills and fever 99.9.  Laid down and about an hour later, it passed and I was back to normal temp.   Injection site is tender but not red or rash.
This spontaneous report as received from a nurse refers to a 7 months 22 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. ON an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313 exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Vaccine given 04/03/12 - seen in office 04/06/12 with (L) arm redness, warmth & pain at inject site. Redness appeared 04/04/12 - continued to increase is size & became more tender & firm - developed mild headache. Treated with cephalexin 500mg TID x 7 days.
No additional adverse effect reported.; a 14-month old patient was administered PROQUAD rather than MMR II on 03-JUN-2020.; The patient also was adrninistered VARlVAX on 03-JUN-2020.; This spontaneous report was received from a medical assistant referring to a 14-month-old patientof unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 03-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number S038144, which upon internal verification has been verified to be valid, expiration date reported and validated as 25-MAY-2021), subcutaneously for prophylaxis (dose, strength, vaccination scheme, site of vaccination were not reported) rather than measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). On the same date, the patient also was administered varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, strength, route of administration, vaccination scheme, site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). Sterile diluent (MERCK STERILE DILUENT) concomitantly used.  No additional adverse effect reported.
PT's right arm became swollen, red and warm to the touch. The swelling reached the elbow and according the the pt was spreading.
Slept x5 hrs then patient became very pale after nursing. Threw up several times (10 episodes in about 2 hours). EMS called and patient taken to ER. Had weak breathing. After each episode emesis. Mom reports patient felt a little better.
Patient received Moderna booster dose in error instead of Pfizer dose 3 which she was expecting. Previous dose 2 of Pfizer was given > 6 months ago. There is no clinical contraindication to mixing and matching booster dose but it was a medication error because the immunizer was supposed to administer Pfizer.
patient presented to clinic with anxiety regarding the vaccine as she has a history of reaction from flu vaccine several years ago. Administration at 1:35 and went to observation area. patient began getting  blotchy on neck around 1:45pm and became more anxious. Denies difficulty breathing or other issues. she was monitored for approximately 40 min in the clinic and during the time period took a dose of PO Benadryl she had with her. she was encouraged to go to ED if needed and patient declined. She left the clinic where she presented back to her job in the cancer center. When arriving at her workplace around 2:48 her Director reports she noticed facial swelling. patient left and went to ED where she received epi and a steroid with symptom relief.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAY-2016 the patient was vaccinated with an improperly stored dose GARDASIL 9 0.5 ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 112 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Stuffy nose; sneezing; runnynose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported for a 12-year-old female patient. A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0191; Expiration date: unknown) via an unspecified route of administration on 27May2021 14:58 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient's Medical History (including any illness at time of vaccination) was none. Patient had not History of all previous immunization with the Pfizer vaccine considered as suspect and not any additional Vaccines Administered on Same Date of the Pfizer Suspect. Family Medical History Relevant to Adverse event was not provided. Patient had not any other history and products. Prior Vaccinations within four weeks prior to the first administration patient had HPV booster shot. The patient's concomitant medications were not reported. Caller was asking question on behalf of her daughter. She had first dose of the Pfizer BioNTech COVID-19 vaccine on 27May2021; second dose was scheduled for 17Jun2021. On 12Jun2021 her daughter has been experiencing a lot of sneezing and a runny nose. It was clarified that patient had runny nose not red nose stated by transfer agent, who gave them their number to see if it was ok to give second dose. Wondering if there were any contraindications to that dose. All events started in the morning and progressed to like evening; exact time unknown by caller. A lot of sneezing it comes and goes. It was ongoing and had improved. Runny nose it was more like stuffy, ongoing, and it has improved. Stuffy nose was initially stated as it was started on Sunday, 13Jun2021. It was like sniffles now. Attempted to clarify. Runny nose and sniffling started the same day. Nose started running, then was sniffling, then stuffy all at the same time. Caller said the stuffy nose has improved and was ongoing. She did not think her daughter's symptoms were caused by the vaccine. She was just realized she did not think it was the vaccine. Caller just wanted to be sure it was ok to get the second dose for her daughter and agreed to be transferred to Pfizer Medical Information to see if they can help answer her question. Patient was taking vaccine to protect her from getting sick from COVID-19. Patient had not any adverse event prior vaccinations. The adverse event did not result into Emergency Room or Physician Office visit. Patient had not received any treatment. Patients had not any Relevant Tests. The outcome of all events was recovering.  Follow attempts are needed. Further information is expected.
Received the shot, minor pain at injection site. Biked home (~3 miles), minor pain throughout the day at injection site. Went to bed, woke up the next morning (2/6) with itching and rash along back, from hips to hairline at neck, on back of shoulders, biceps, neck, upper chest. area Noticed an outline of bumps/lesions in the shape of the band-aid applied after injection.  Having had shingles once before 8 years ago, this feels a lot like that. Soreness persists at injection site but comparable to flu vaccine.
Shot was given on upper R arm, following morning, joints in wrist completely swollen, went to urgent care, given Keflex/antibiotics and fluid aspiration was done to check for septic joint; pt wore a wrist splint for 2 wks since he was unable to rotate his wrist.
Patient had Tdap and felt ok until he went swimming and diving, got headache. The next day sick and emesis and myalgias, after taco, for a day, then better. Patient traveling, not seen before or since. Patient's mother called said that two hours after patient received Tdap he got a headache and is now vomiting and has pain in his knees.
Vaccine stored at colder temperatures than recommended in the fact sheet were administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine stored at colder temperatures than recommended in the fact sheet were administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035c21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored at colder temperatures than recommended in the fact sheet were administered to patients). At the time of the report, PRODUCT STORAGE ERROR (Vaccine stored at colder temperatures than recommended in the fact sheet were administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  It was reported that for 27 Days, 50 vials with lot number 035c21a was involved. Approximately 150 patients affected Vials stored below recommended temperature for 27 days Vaccine were quarantined immediately when improper storage was recognized.
p/ pt recv vax approx 14 days later pt devel ``probable chickenpox'' w/multiple vesicles on the trunk. MD treated w/calamine lotion, Tylenol, Benadryl
After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.
pt recv vax & devel negative titer by latex agglutination;MD reported 9 patients;
Sharp shooting pains in collar bone area (same side as vaccine) went to hospital lots of test run, heart blood panel was elevated,
Pt presented for her third Pfizer vaccine.  Almost immediately after vaccination, pt c/o Wheezing.  On assessment, pt had audible stridor, could not speak a sentence.   Pt treated with albuterol and epi-pen.  Due to concern for airway, rapid response called and pt taken to the ER. Patient is currently in ICU
mom states 4hr p/vax pt started running t104;states lt thigh became very warm, very swollen;states APAP would not break fever;states fever lessened p/24hr then 100 for 3 more days;had shrilly cry for >2hr 1st 24hr;
Employee received her second dose of Moderna COVID-19 vaccine 20 days after her first dose; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine, and who received her second Moderna Covid-19 vaccine 20 days after her first dose.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 on an undisclosed date.  On an undisclosed date, the patient received her second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection twenty days after her first dose. Treatment information was unknown.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the event, received her second Moderna Covid-19 vaccine 20 days after her first dose, was resolved.; Reporter's Comments: This case concerns a female patient of unknown age, who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration.
Later in the afternoon after the vaccine, 2/4/21, patient has had body aches, fever, sore throat, runny nose, coughing, craving water, no appetite, lethargy; still has all of these reactions. Patient feels hot, but does not have a temperature.
sore arm within an hour (expected); approximately 3 hours after headache, right leg was sore (felt like it was weighted down). next morning the flu like symptoms started:  headache, body aches shoulder down to my feet, temp never over 99.4 but felt feverish, chills, not able to concentrate, head congestion.  Felt just like when I had covid December 2020 but not the tired part I had then.  Finally got over the achiness sometime Saturday late afternoon.
ANAPHYLACTIC REACTION; BLOOD CLOTS; NERVE PAIN IN LEGS AND FEET; This spontaneous report received from a health care professional (retired pediatrician) concerned a 40 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no prior related complaints before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced an anaphylactic reaction and was admitted to the hospital (date unspecified) and was possibly readmitted afterwards. The number of days of hospitalization was not reported and it was unknown if the patient was discharged from the hospital. The reporter was speculating that the patient may have also experienced blood clots. The patient had then begun experiencing nerve pain in legs and feet, and had visited the doctor/healthcare professional office. The magnetic resonance imaging (MRI) and other studies were performed with no outcome. The patient had lost work for a month or two due to the side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, had not recovered from nerve pain in legs and feet, and the outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20220361972-COVID-19 VACCINE AD26.COV2.S-anaphylactic reaction. This event(s) is labeled per RSI and is therefore considered potentially related. 20220361972-COVID-19 VACCINE AD26.COV2.S-blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.